PAGE 1 OF 633 PAGES 

SODIUM GLUCOHEPTONATE (EC 250-480-2)

ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH 

REPRODUCTION/DEVELOPMENTAL TOXICITY 

SCREENING TEST IN THE RAT (OECD 422)

RE-ISSUED REPORT 

PROJECT NUMBER: 41104692R

AUTHORS: L A McRae 

P Watson 

STUDY SPONSOR: TEST FACILITY: 

Harcros Chemicals Inc. 

3452 Corporate Drive 

Dalton GA 30720 

UNITED STATES OF AMERICA 

Harlan Laboratories Ltd. 

Shardlow Business Park 

Shardlow 

Derbyshire 

DE72 2GD 

UK 

Telephone: +44 (0) 1332 792896 

Facsimile: +44 (0) 1332 799018 

TEST SITES: 

Histology Processing: 

Propath UK Ltd 

Willow Court 

Netherwood Road 

Rotherwas 

Hereford 

HR2 6JU 

Histopathology Examination: 

Peter Millar Associates 

3 Queen Charlotte Lane 

Edinburgh 

SCOTLAND 

EH6 6AY 

United Kingdom 
PAGE 2 PROJECT NUMBER: 41104692R 
   
PAGE 4 PROJECT NUMBER: 41104692R 
   
PAGE 6 PROJECT NUMBER: 41104692R 

PAGE 8 PROJECT NUMBER: 41104692R 
 PROJECT NUMBER: 41104692R PAGE 9

RESPONSIBLE PERSONNEL 

The following scientific and supervisory personnel were involved in the study: 

ANALYTICAL CHEMISTRY 

P Watson 

Harlan Laboratories Ltd., Shardlow, UK 

CLINICAL PATHOLOGY 

J Kemp 

Harlan Laboratories Ltd., Shardlow, UK 

ANIMAL HEALTH 

P Highton 

Harlan Laboratories Ltd., Shardlow, UK 

HISTOLOGY PROCESSING 

Principal Investigator: N Fower 

Propath UK Ltd., Hereford, UK 

HISTOPATHOLOGY EXAMINATION 

Principal Investigator: P Millar 

Peter Millar Associates Ltd., Edinburgh, UK 
PAGE 10 PROJECT NUMBER: 41104692R 
 PROJECT NUMBER: 41104692R PAGE 11

CONTENTS 

QUALITY ASSURANCE REPORT 3

GLP COMPLIANCE STATEMENT 5

AUTHENTICATION 7

RESPONSIBLE PERSONNEL 9

CONTENTS 11

SUMMARY 15

1. INTRODUCTION 19

2. TEST ITEM AND EXPERIMENTAL PREPARATION 20

2.1 Description, Identification and Storage Conditions 20

2.2 Preparation of Test Item 20

3. METHODS 20

3.1 Animals and Animal Husbandry 20

3.2 Procedure 22

3.3 Observations 23

3.4 Evaluation of Data 30

4. DEVIATIONS FROM STUDY PLAN 33

5. ARCHIVES 33

6. RESULTS 35

6.1 Adult Responses 35

6.2 Reproductive Performance 37

6.3 Litter Responses 38

6.4 Laboratory Investigations 40

6.5 Pathology 41

7. DISCUSSION 43

8. CONCLUSION 43

9. REFERENCES 44

TABULAR SUMMARY REPORT OF EFFECTS ON REPRODUCTION/ 

DEVELOPMENT 45

KEY TO TABLES AND APPENDICES 46

KEY TO SCORING SYSTEM AND EXPLANATION FOR BEHAVIOURAL 

ASSESSMENTS AND SENSORY REACTIVITY TESTS 47

TABLES 53

Table 1 Summary of Reproductive Performance - Group Values 54

Table 2 Summary Incidence of Daily Clinical Observations 55

Table 3 Summary Incidence of Behavioural Assessments (Observations) 58

Table 4 Group Mean Behavioural Assessments (Scores) 62

Table 5 Group Mean Functional Test Values and Standard Deviations 76

Table 6 Group Mean Sensory Reactivity Assessments (Scores) 78

Table 7 Group Mean Body Weight Values 80

Table 8 Group Mean Body Weight Gains 83

Table 9 Group Mean Food Consumptions 86

Table 10 Food Efficiency 89

Table 11 Group Mean Daily Water Consumptions 91
PAGE 12 PROJECT NUMBER: 41104692R 

Table 12 Summary Incidence of Mating Performance, Fertility and Gestation 

Lengths 93

Table 13 Group Mean Litter Size and Litter Weights 94

Table 14 Group Mean Implantation Losses and Survival Indices Values 95

Table 15 Group Mean Sex Ratio Values 96

Table 16 Summary Incidence of Clinical Signs for Offspring 97

Table 17 Group Mean Reflexological Responses for Offspring 98

Table 18 Group Mean Haematological Values 99

Table 19 Group Mean Blood Chemical Values 103

Table 20 Summary Incidence of Offspring Necropsy Findings 107

Table 21 Summary Incidence of Necropsy Findings 108

Table 22 Group Mean Organ Weights with Corresponding Relative 

(% of Body Weight) Organ Weights 110

FIGURES 115

Figure 1 Group Mean Body Weights - Males 116

Figure 2 Group Mean Body Weights - Females 117

Figure 3 Group Mean Food Consumption - Males 119

Figure 4 Group Mean Food Consumption - Females 120

APPENDICES 121

Appendix 1 Individual Daily Clinical Observations 122

Appendix 2 Individual Behavioural Assessments (Observations) 268

Appendix 3 Individual and Group Mean Behavioural Assessments (Scores) 276

Appendix 4 Individual and Group Mean Functional Test Values (Grip Strength) 332

Appendix 5 Individual and Group Mean Functional Test Values (Motor Activity) 340

Appendix 6 Individual and Group Mean Sensory Reactivity Assessments 348

Appendix 7 Individual and Group Mean Body Weights 356

Appendix 8 Individual and Group Mean Body Weight Gains 368

Appendix 9 Individual and Group Mean Food Consumption Values for Females 

Following Mating and During Lactation 380

Appendix 10 Individual Mating Performance, Fertility and Gestation Lengths 384

Appendix 11 Individual and Group Mean Litter Size and Litter Weights 388

Appendix 12 Individual and Group Mean Implantation Losses and Survival Indices 392

Appendix 13 Individual and Group Mean Sex Ratio Values for Offspring 396

Appendix 14 Individual Clinical Signs for Offspring 400

Appendix 15 Individual and Group Mean Reflexological Responses for Offspring 404

Appendix 16 Individual Haematological Values 408

Appendix 17 Individual Coagulation Values 416

Appendix 18 Individual Blood Chemical Values 424

Appendix 19 Individual Bile Acid Values 432

Appendix 20 Individual Necropsy Findings for Offspring 440

Appendix 21 Individual Necropsy Findings 444

Appendix 22 Individual Organ Weights 452

Appendix 23 Individual Relative Organ Weights 460

Appendix 24 Histopathology Phase Report 472
 PROJECT NUMBER: 41104692R PAGE 13

Appendix 25 Chemical Analysis of Test Item Formulations, Methods and Results 591

Appendix 26 Study Plan 596

Appendix 27 Histology Processing Phase Test Site Quality Assurance Statement 618

Appendix 28 Histology Processing Phase Test Site Statement of Compliance 619

Appendix 29 Histology Processing Phase Test Site Statement of GLP Compliance 620

Appendix 30 Statement of GLP Compliance in Accordance with 

Directive 2004/9/EC 621

Appendix 31 Certificates of Analysis of Diet Used 622

Appendix 32 Laboratory Methods 625

Appendix 33 Normal Ranges for Reproductive Parameters in the Pregnant and 

Lactating Female Wistar Han TM:RccHanTM:WIST Strain Rat 627

Appendix 34 Normal Ranges for Offspring Parameters in the Wistar HanTM: 

RccHanTM:WIST Strain Rat 628

Appendix 35 Normal Ranges for Haematological and Blood Chemical Values 

in the Wistar HanTM:RccHanTM:WIST Strain Rat 629

Appendix 36 Normal Ranges for Functional Performance Assessments 

in the Wistar HanTM:RccHanTM:WIST Strain Rat 631

Appendix 37 Normal Ranges for Absolute and Body Weight-Relative Organ Weight 

Values in the Wistar HanTM:RccHanTM:WIST Strain Rat 632
PAGE 14 PROJECT NUMBER: 41104692R 
 PROJECT NUMBER: 41104692R PAGE 15

Sodium Glucoheptonate (EC 250-480-2): 

ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY STUDY WITH 

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT 

(OECD 422) 

SUMMARY 

Introduction. The study was designed to investigate the systemic toxicity and potential 

adverse effects of the test item on reproduction (including offspring development) and is 

designed to be compatible with the requirements of the OECD Guidelines for Testing of 

Chemicals No. 422 “Combined Repeated Dose Toxicity Study with the Reproduction/ 

Developmental Toxicity Screening Test” (adopted 22 March 1996). 

This study was also designed to be compatible with the Commission Regulation (EC) No. 

440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No. 

1907/2006 of the European Parliament and of the Council on the Registration, 

Evaluation, Authorisation and Restriction of Chemicals (REACH). 

Methods. The test item was administered by gavage to three groups, each of twelve 

male and twelve female Wistar HanTM:RccHanTM:WIST strain rats, for up to eight weeks 

(including a two week pre-pairing phase, pairing, gestation and early lactation for 

females), at dose levels of 30, 300 and 1000 mg/kg bw/day (incorporating a test item 

correction factor for 50.5% w/w purity minus 49.5% w/w test item water content). A 

control group of twelve males and twelve females was dosed with vehicle alone (Distilled 

water). 

Clinical signs, behavioural assessments, body weight change and food and water 

consumption were monitored during the study. 

Pairing of animals within each dose group was undertaken on a one male: one female 

basis within each treatment group on Day 15 of the study, with females subsequently 

being allowed to litter and rear their offspring to Day 5 of lactation. 

During the lactation phase, daily clinical observations were performed on all surviving 

offspring, together with litter size and offspring weights and assessment of surface 

righting reflex. 

Extensive functional observations were performed on five selected males from each 

dose group after the completion of the pairing phase, and for five selected parental 

females from each dose group on Day 4 post partum. Haematology and blood chemistry 
PAGE 16 PROJECT NUMBER: 41104692R 

were evaluated prior to termination on five selected males and females from each dose 

group. 

Adult males were terminated on Day 43, followed by the termination of all females and 

offspring on Day 5 post partum. Any female which did not produce a pregnancy was 

terminated on or after Day 25 post coitum. All animals were subjected to a gross 

necropsy examination and histopathological evaluation of selected tissues was 

performed. 

Results. 

Adult Responses: 

Mortality. There were no unscheduled deaths in this study. 

Clinical Observations. No toxicologically significant clinical observations were detected. 

Behavioural Assessment. There were no treatment-related changes in the behavioural 

parameters measured. 

Functional Performance Tests. There were no treatment-related changes in functional 

performance. 

Sensory Reactivity Assessments. There were no treatment-related changes in 

sensory reactivity. 

Body Weight. There were no convincing treatment-related adverse findings. 

Food Consumption. No adverse effects on food consumption or food efficiency were 

detected in test animals in comparison with controls. 

Water Consumption. No intergroup differences were detected. 

Reproductive Performance: 

Mating. There were no treatment-related effects on mating.

Fertility. No treatment-related effects on conception rates were identified.

Gestation Lengths. There were no differences in gestation lengths between treated 

females when compared to controls. The distribution for treated females was comparable 

to that of the controls.
 PROJECT NUMBER: 41104692R PAGE 17

Litter Responses: 

Offspring Litter Size, Sex Ratio and Viability. Of the litters born, litter size at birth and 

over subsequent days post partum was comparable to controls. 

Sex ratio were also comparable to controls.

Offspring Growth and Development. There were no significant differences in litter 

weights or mean offspring body weights between control and treated animals. Statistical 

analysis of the data did not reveal any convincing intergroup differences. 

Laboratory Investigations: 

Haematology. No toxicologically significant effects were detected in the haematological 

parameters examined. 

Blood Chemistry. No toxicologically significant effects were detected in the blood 

chemical parameters examined. 

Pathology: 

Necropsy. No treatment-related macroscopic abnormalities were observed in any animal 

at study termination. 

Organ Weights. There were no convincing treatment-related organ weight changes 

detected in test animals in comparison with controls. 

Histopathology. No treatment-related histopathological changes in the tissues 

examined were detected. 

Conclusion. The oral administration of Sodium Glucoheptonate (EC 250-480-2) 

(incorporating a test item correction factor for 50.5% w/w purity minus 49.5% w/w test 

item water content) to rats by gavage, at dose levels of 30, 300 and 1000 mg/kg bw/day 

did not produce any convincing adverse effects of treatment and on this basis the ‘No 

Observed Adverse Effect Level’ (NOAEL) and possible ‘No Observed Effect Level’ 

(NOEL) for systemic toxicity for either sex was considered to be 1000 mg/kg bw/day. 

No treatment-related effects were observed for reproduction, the ‘No Observed Effect 

Level’ (NOEL) for reproductive toxicity was therefore considered to be 1000 mg/kg 

bw/day. 
PAGE 18 PROJECT NUMBER: 41104692R 
 PROJECT NUMBER: 41104692R PAGE 19

Sodium Glucoheptonate (EC 250-480-2): 

ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY STUDY WITH 

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT 

(OECD 422) 

1. INTRODUCTION 

The study was performed according to the Study Plan presented in Appendix 26 and was 

designed to screen for potential adverse effects of the test item on reproduction, 

including offspring development, following repeated oral administration to the Wistar 

HanTM:RccHanTM:WIST strain rat for up to eight weeks (including a two week pre-pairing 

phase, pairing, gestation and early lactation), at dose levels of 30, 300 and 1000 mg/kg 

bw/day (incorporating a test item correction factor for 50.5% w/w purity minus 49.5% w/w 

test item water content). A control group was dosed with vehicle alone (Distilled water). 

The study was designed to be compatible with the requirements of the OECD Guidelines 

for Testing of Chemicals, No.422: “Combined Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity Screening Test” (adopted 22 March 1996). 

This study was also designed to be compatible with the Commission Regulation (EC) No. 

440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No. 

1907/2006 of the European Parliament and of the Council on the Registration, 

Evaluation, Authorisation and Restriction of Chemicals (REACH). 

The rat was selected for this study as it is a readily available rodent species historically 

used in safety evaluation studies and is acceptable to appropriate regulatory authorities. 

The dose levels were chosen based on the results of previous toxicity work (Harlan 

Laboratories Project Number: 41104691). The oral route was selected as the most 

appropriate route of exposure, based on the physical properties of the test item. The 

results of the study are believed to be of value in predicting the likely toxicity of the test 

item to man and to screen for potential adverse effects on reproduction. 

Shortly after the final report was issued a number of pages were discovered to incorrectly 

reference the test item. As this error could be misleading it is considered appropriate 

that the report be re-issued in its entirety and the original version be withdrawn. 

The study was performed between 03 December 2012 and 09 August 2013 (date of final 

histopathology report). The in-life phase of the study was conducted between 

05 December 2012 (first day of treatment) and 15 January 2013 (final necropsy). 
PAGE 20 PROJECT NUMBER: 41104692R 

2. TEST ITEM AND EXPERIMENTAL PREPARATION 

2.1 Description, Identification and Storage Conditions 

Sponsor's identification : Sodium Glucoheptonate (EC 250-480-2) 

Description : Dark brown liquid 

Purity : 50.5% (solids) 

Batch number : 921000100 

Label : SGH Intermediate Lot 921000100 

Date received : 09 February 2012 

Storage conditions : Room temperature in the dark 

Expiry date : 09 February 2015 

The integrity of supplied data relating to the identity, purity and stability of the test item is 

the responsibility of the sponsor. 

2.2 Preparation of Test Item 

For the purpose of this study the test item was prepared at the appropriate 

concentrations as a solution in Distilled water. The stability and homogeneity of the test 

item formulations were determined by Harlan Laboratories Ltd., Shardlow, UK, Analytical 

Services. Results show the formulations to be stable for at least seven days. 

Formulations were therefore prepared weekly and stored at approximately 4oC in the 

dark. 

Samples of each test item formulation were taken and analysed for concentration of 

Sodium Glucoheptonate (EC 250-480-2) at Harlan Laboratories Ltd., Shardlow, UK, 

Analytical Services. The method used for analysis of formulations and the results 

obtained are given in Appendix 25. The results indicate that the prepared formulations 

were within acceptable ranges for the purpose of this study. 

3. METHODS 

3.1 Animals and Animal Husbandry 

A sufficient number of male and female Wistar HanTM:RccHanTM:WIST strain rats were 

obtained from Harlan Laboratories U.K. Ltd., Blackthorn, Bicester, Oxon, UK. On receipt 

the animals were examined for signs of ill-health or injury. The animals were 

acclimatised for six days during which time their health status was assessed. A total of 

ninety six animals (forty eight males and forty eight females) were accepted into the 

study. At the start of treatment the males weighed 302 to 346g, the females weighed 

191 to 217g, and were approximately twelve weeks old. 
 PROJECT NUMBER: 41104692R PAGE 21

Initially, all animals were housed in groups of four in solid floor polypropylene cages with 

stainless steel mesh lids and softwood flake bedding (Datesand Ltd., Cheshire, UK). 

During the pairing phase, animals were transferred to polypropylene grid floor cages 

suspended over trays lined with absorbent paper on a one male: one female basis within 

each dose group. Following evidence of successful mating, the males were returned to 

their original cages. Mated females were housed individually during gestation and 

lactation in solid floor polypropylene cages with stainless steel mesh lids and softwood 

flakes. 

The animals were allowed free access to food and water. A pelleted diet (Rodent 2018C 

Teklad Global Certified Diet, Harlan Laboratories U.K. Ltd., Oxon, UK) was used. 

Certificates of analysis of the batches of diet used are given in Appendix 31. Mains 

drinking water was supplied from polycarbonate bottles attached to the cage. The diet 

and drinking water were considered not to contain any contaminant at a level that might 

have affected the purpose or integrity of the study. Environmental enrichment was 

provided in the form of wooden chew blocks and cardboard fun tunnels (Datesand Ltd., 

Cheshire, UK) except for paired animals and mated females during gestation and 

lactation. 

The animals were housed in a single air-conditioned room within the Harlan Laboratories 

Ltd., Shardlow, UK, Barrier Maintained Rodent Facility. The rate of air exchange was at 

least fifteen air changes per hour and the low intensity fluorescent lighting was controlled 

to give twelve hours continuous light and twelve hours darkness. Environmental 

conditions were continuously monitored by a computerised system and print-outs of 

hourly temperatures and humidities are included in the study records. The temperatures 

and relative humidity controls were set to achieve target values of 21 ± 2°C and 55 ± 

15% respectively. There were no deviations from these targets. 

The animals were allocated to dose groups using a randomisation procedure based on 

stratified body weights, group mean body weights were then determined to ensure 

similarity between the dose groups. The animals were uniquely identified within the 

study by an ear punching system routinely used in these laboratories. 
PAGE 22 PROJECT NUMBER: 41104692R 

3.2 Procedure 

Animals were allocated to treatment groups as follows: 

Treatment 

Group 

Dose Level # 

(mg/kg bw/day) 

Dose level of 

Test Item (as 

supplied) 

(mg/kg bw/day)

Treatment 

Volume 

(ml/kg) 

Concentration # 

(mg/ml) 

Animal Numbers 

Male Female 

Control 0 0 5 0 12 (1-12) 12 (13-24)

Low 30 59.4 5 6 12 (25-36) 12 (37-48)

Intermediate 300 594 5 60 12 (49-60) 12 (61-72)

High 1000 1980 5 200 12 (73-84) 12 (85-96)

# = Including a correction factor of 50.5% w/w (i.e. concentration of test item minus test item water content 

(49.5% w/w)) 

The numbers in parentheses ( ) show the individual animal numbers allocated to each 

treatment group. 

The test item was administered daily by gavage using a stainless steel cannula attached 

to a disposable plastic syringe. Control animals were treated in an identical manner with 

5 ml/kg of Distilled water. 

The volume of test and control item administered to each animal was based on the most 

recent scheduled body weight and was adjusted at regular intervals. 

Chronological Sequence of Study 

i) Groups of twelve male and twelve female animals were treated daily at the 

appropriate dose level throughout the study (except for females during parturition 

where applicable). The first day of dosing was designated as Day 1 of the study. 

ii) Prior to the start of treatment and once weekly thereafter, all animals were 

observed for signs of functional/behavioural toxicity. 

iii) On Day 15, animals were paired on a 1 male: 1 female basis within each dose 

group for a maximum of fourteen days. 

iv) Following evidence of mating (designated as Day 0 post coitum) the males were 

returned to their original cages and females were transferred to individual cages. 

v) On completion of the pairing phase (during Week 6), five selected males per dose 

group were evaluated for functional/sensory responses to various stimuli. 
 PROJECT NUMBER: 41104692R PAGE 23

vi) Pregnant females were allowed to give birth and maintain their offspring until Day 

5 post partum. Litter size, offspring weight and sex, surface righting and clinical 

signs were also recorded during this period. 

vii) At Day 4 post partum, five selected females per dose group were evaluated for 

functional/sensory responses to various stimuli. 

viii) Blood samples were taken from five males from each dose group for 

haematological and blood chemical assessments on Day 42. The male dose 

groups were killed and examined macroscopically on Day 43. 

ix) Blood samples were taken from five randomly selected females from each dose 

group for haematological and blood chemical assessment on Day 4 post partum. 

At Day 5 post partum, all females and surviving offspring were killed and 

examined macroscopically. Any female which did not produce a pregnancy was 

also killed and examined macroscopically (Day 25 post coitum). 

3.3 Observations 

3.3.1 Clinical Observations 

All animals were examined for overt signs of toxicity, ill-health and behavioural change 

immediately before dosing, up to thirty minutes after dosing, and one and five hours after 

dosing during the working week. Animals were observed immediately before dosing 

soon after dosing and one hour after dosing at weekends and public holidays (except for 

females during parturition where applicable). All observations were recorded. 

3.3.2 Functional Observations 

Prior to the start of treatment and at weekly intervals thereafter, all animals were 

observed for signs of functional/behavioural toxicity. Functional performance tests were 

also performed on five selected males and females from each dose level, prior to 

termination, together with an assessment of sensory reactivity to various stimuli. 

3.3.2.1 Behavioural Assessments 

Detailed individual clinical observations were performed for each animal using a purpose 

built arena. The following parameters were observed: 

Gait Hyper/Hypothermia 

Tremors Skin colour 

Twitches Respiration 
PAGE 24 PROJECT NUMBER: 41104692R 

Convulsions Palpebral closure 

Bizarre/Abnormal/Stereotypic behaviour Urination 

Salivation Defecation 

Pilo-erection Transfer arousal 

Exophthalmia Tail elevation 

Lachrymation 

This test was developed from the methods used by Irwin (1968) and Moser et al (1988). 

The scoring system used is outlined in The Key to Scoring System and Explanation for 

Behavioural Assessments and Sensory Reactivity Tests. 

3.3.2.2 Functional Performance Tests 

Motor Activity. Purpose-built 44 infra-red beam automated activity monitors were used 

to assess motor activity. Animals were randomly allocated to the activity monitors. The 

tests were performed at approximately the same time on each occasion, under similar 

laboratory conditions. The evaluation period was thirty minutes for each animal. The 

percentage of time each animal was active and mobile was recorded for the overall thirty 

minute period and also during the final 20% of the period (considered to be the 

asymptotic period, Reiter and Macphail, 1979). 

Forelimb/Hindlimb Grip Strength. An automated meter was used. Each animal was 

allowed to grip the proximal metal bar of the meter with its forepaws. The animal was 

pulled by the base of the tail until its grip was broken. The animal was drawn along the 

trough of the meter by the tail until its hind paws gripped the distal metal bar. The animal 

was pulled by the base of the tail until its grip was broken. A record of the force required 

to break the grip for each animal was made. Three consecutive trials were performed for 

each animal. The assessment was developed from the method employed by Meyer et al

(1979).

3.3.2.3 Sensory Reactivity 

Each animal was individually assessed for sensory reactivity to auditory, visual and 

proprioceptive stimuli. This assessment was developed from the methods employed by 

Irwin (1968) and Moser et al (1988). 

The following parameters were observed: 

Grasp response Touch escape 

Vocalisation Pupil reflex 

Toe pinch Blink reflex 
 PROJECT NUMBER: 41104692R PAGE 25

Tail pinch Startle reflex 

Finger approach 

Normal range data for the functional performance test parameters are presented in 

Appendix 36. 

3.3.3 Body Weight 

Individual body weights were recorded on Day 1 (prior to dosing) and then weekly for 

males until termination and weekly for females until mating was evident. Body weights 

were then recorded for females on Days 0, 7, 14 and 20 post coitum, and on Days 1 and 

4 post partum. Body weights were also recorded at terminal kill. 

Normal range data for body weight changes in pregnant and lactating females are 

presented in Appendix 33. 

3.3.4 Food Consumption 

During the pre-pairing period, weekly food consumption was recorded for each cage of 

adults. This was continued for males after the mating phase. For females showing 

evidence of mating, food consumption was recorded for the periods covering post coitum

Days 0-7, 7-14 and 14-20. For females with live litters, food consumption was recorded 

on Days 1 and 4 post partum. 

Food efficiency (the ratio of body weight change/dietary intake) was calculated 

retrospectively for males throughout the study period (with the exception of the mating 

phase) and for females during the pre-pairing phase. Due to offspring growth and milk 

production, food efficiency could not be accurately calculated for females during 

gestation and lactation. 

Normal range data for pregnant and lactating females are presented in Appendix 33. 

3.3.5 Water Consumption 

Water intake was measured daily during the first two weeks of the study. 

3.3.6 Reproduction Screening 

Normal range data for reproductive parameters and offspring are presented in 

Appendix 33 and Appendix 34. 
PAGE 26 PROJECT NUMBER: 41104692R 

3.3.6.1 Mating 

Animals were paired on a 1 male: 1 female basis within each dose group, for a period of 

up to fourteen days. Cage tray-liners were checked each morning for the presence of 

ejected copulation plugs and each female was examined for the presence of a copulation 

plug in the vagina. A vaginal smear was prepared for each female and the stage of 

oestrus or the presence of sperm was recorded. The presence of sperm within the 

vaginal smear and/or vaginal plug in situ was taken as positive evidence of mating (Day 

0 of gestation) and the males were subsequently returned to their original holding cages 

(unless required for additional pairing). Mated females were housed individually during 

the period of gestation and lactation. 

3.3.6.2 Pregnancy and Parturition 

Each pregnant female was observed at approximately 0830, 1230 and 1630 hours and 

around the period of expected parturition. Observations were carried out at 

approximately 0830 and 1230 hours at weekends and public holidays. The following was 

recorded for each female: 

i) Date of pairing 

ii) Date of mating 

iii) Date and time of observed start of parturition 

iv) Date and time of observed completion of parturition 

3.3.6.3 Litter Data 

On completion of parturition (Day 0 post partum), the number of live and dead offspring 

was recorded. Offspring were individually identified within each litter by tattoo on Day 1 

post partum.

For each litter the following was recorded: 

i) Number of offspring born 

ii) Number of offspring alive recorded daily and reported on Days 1 and 4 post 

 partum 

iii) Sex of offspring on Days 1 and 4 post partum

iv) Clinical condition of offspring from birth to Day 5 post partum
 PROJECT NUMBER: 41104692R PAGE 27

v) Individual offspring weights on Days 1 and 4 post partum (litter weights were 

 calculated retrospectively from this data) 

3.3.6.4 Physical Development 

All live offspring were assessed for surface righting reflex on Day 1 post partum. 

3.3.7 Laboratory Investigations 

Haematological and blood chemical investigations were performed on five males and five 

females selected from each test and control group prior to termination (Day 42 for males 

and Day 4 post partum for females). Blood samples were obtained from the lateral tail 

vein. Where necessary repeat samples were taken by cardiac puncture at termination. 

Animals were not fasted prior to sampling. 

The methods used for haematological and blood chemical investigations are given in 

Appendix 32 and normal ranges are shown in Appendix 35. 

3.3.7.1 Haematology 

The following parameters were measured on blood collected into tubes containing 

potassium EDTA anti-coagulant: 

Haemoglobin (Hb) 

Erythrocyte count (RBC) 

Haematocrit (Hct) 

Erythrocyte indices - mean corpuscular haemoglobin (MCH) 

 - mean corpuscular volume (MCV) 

 - mean corpuscular haemoglobin concentration (MCHC) 

Total leucocyte count (WBC) 

Differential leucocyte count - neutrophils (Neut) 

 - lymphocytes (Lymph) 

 - monocytes (Mono) 

 - eosinophils (Eos) 

 - basophils (Bas) 

Platelet count (PLT) 

Reticulocyte count (Retic) - Methylene blue stained slides were prepared but 

reticulocytes were not assessed 

Prothrombin time (CT) was assessed by ‘Innovin’ and Activated partial thromboplastin 

time (APTT) was assessed by ‘Actin FS’ using samples collected into sodium citrate 

solution (0.11 mol/l). 
PAGE 28 PROJECT NUMBER: 41104692R 

3.3.7.2 Blood Chemistry 

The following parameters were measured on plasma from blood collected into tubes 

containing lithium heparin anti-coagulant: 

Urea Calcium (Ca++) 

Glucose Inorganic phosphorus (P) 

Total protein (Tot.Prot.) Aspartate aminotransferase (ASAT) 

Albumin Alanine aminotransferase (ALAT) 

Albumin/Globulin (A/G) ratio (by calculation) Alkaline phosphatase (AP) 

Sodium (Na+) Creatinine (Creat) 

Potassium (K+) Total cholesterol (Chol) 

Chloride (Cl-) Total bilirubin (Bili) 

 Bile acids 

3.3.8 Pathology 

Adult males were killed by intravenous overdose of a suitable barbiturate agent followed 

by exsanguination on Day 43. Adult females were killed by intravenous overdose of a 

suitable barbiturate agent followed by exsanguination on Day 5 post partum. Surviving 

offspring were terminated via intracardiac overdose of sodium pentobarbitone. Any 

females which failed to achieve pregnancy or produce a litter were killed on or after Day 

25 post coitum. 

For all females, the uterus was examined for signs of implantation and the number of 

uterine implantations in each horn was recorded. This procedure was enhanced; as 

necessary, by staining the uteri with a 0.5% ammonium polysulphide solution (Salewski 

1964). The corpora lutea were also counted. 

All adult animals and offspring, including those dying during the study, were subjected to 

a full external and internal examination, and any macroscopic abnormalities were 

recorded. 

3.3.8.1 Organ Weights 

The following organs were dissected free from fat and weighed before fixation from five 

selected males and five selected females from each dose group. Tissues shown in bold 

were weighed from all remaining animals: 

Adrenals Prostate 

Brain Seminal vesicles 

Epididymides Spleen 
 PROJECT NUMBER: 41104692R PAGE 29

Heart Testes 

Kidneys Thymus 

Liver Thyroid (weighed post-fixation with Parathyroid) 

Ovaries Uterus (weighed with Cervix) 

Pituitary (post fixation) 

Normal ranges for these organ weights are given in Appendix 37. 

3.3.8.2 Histopathology 

Samples of the following tissues were removed from five selected males and five 

selected females from each dose group and preserved in buffered 10% formalin, except 

where stated. Tissues shown in bold were preserved from all remaining anmals: 

Adrenals Ovaries 

Aorta (thoracic) Pancreas 

Bone & bone marrow (femur including stifle joint) Pituitary 

Bone & bone marrow (sternum) Prostate 

Brain (including cerebrum, cerebellum and pons) Oesophagus 

Caecum Rectum 

Coagulating gland Salivary glands (submaxillary) 

Colon Sciatic nerve 

Duodenum Seminal vesicles 

Epididymides Skin (hind limb) 

Eyes* Spinal cord (cervical, mid-thoracic and 

Gross lesions lumbar) 

Heart Spleen 

Ileum (including peyer’s patches) Stomach 

Jejunum Thyroid/parathyroid 

Kidneys Trachea

Liver Testes

Lungs (with bronchi) # Thymus 

Lymph nodes (mandibular and mesenteric) Urinary bladder

Mammary gland Uterus/Cervix

Muscle (skeletal) Vagina 

 

* = eyes fixed in Davidson’s fluid 

 = preserved in Bouin’s fluid then transferred to 70% Industrial Methylated Spirits (IMS) approximately 

 forty-eight hours later 

# = lungs were inflated to approximately normal inspiratory volume with buffered 10% formalin before 

 immersion in fixative 
PAGE 30 PROJECT NUMBER: 41104692R 

Tissues were despatched to the histology processing Test Site (Propath UK Ltd., Willow 

Court, Netherwood Road, Hereford, HR2 6JU, UK) for processing (Principal Investigator: 

N Fower). The tissues from five selected control and 1000 mg/kg bw/day dose group 

animals, any animals dying during the study, and any animals which failed to mate or did 

not achieve a pregnancy were prepared as paraffin blocks, sectioned at a nominal 

thickness of 5 μm and stained with haematoxylin and eosin for subsequent microscopic 

examination. The tissues shown in bold from the remaining control and 1000 mg/kg 

bw/day animals were also processed. In addition, sections of testes and epididymides 

from all control and 1000 mg/kg bw/day males were also stained with Periodic AcidSchiff (PAS) stain and examined. 

Microscopic examination was conducted by the Study Pathologist (Principal Investigator 

Peter Millar at Peter Millar Associates Ltd., 3 Queen Charlotte Lane, Edinburgh, 

Scotland, EH6 6AY). A complete histopathology phase report, including methods, is 

presented in Appendix 24. 

3.4 Evaluation of Data 

3.4.1 Treatment of Data 

Data were processed to give group mean values and standard deviations where 

appropriate. 

Data shown in the appendices are frequently rounded values for presentation purposes. 

Group mean values are generally calculated using unrounded values, therefore, it is not 

always possible to calculate the exact group values from the individual values presented 

in the appendices. 

For body weights and food consumptions during gestation, group mean values were 

calculated using data from females which were observed to give birth to offspring. 

For body weights and food consumptions during lactation, group mean values were 

calculated using data from females with live young at Day 5 of lactation. 

3.4.2 Reproductive Indices 

3.4.2.1 Mating Performance and Fertility 

The following parameters were calculated from the individual data during the mating 

period of the parental generation: 

i) Pre-coital Interval 
 PROJECT NUMBER: 41104692R PAGE 31

Calculated as the time elapsing between initial pairing and the observation of positive 

evidence of mating. 

ii) Fertility Indices 

For each group the following were calculated: 

Mating Index (%) = Number of animals paired

Number of animals mated x 100 

Pregnancy Index (%) = Number of animals mated

Number of pregnant females x 100 

3.4.2.2 Gestation and Parturition Data 

The following parameters were calculated for individual data during the gestation and 

parturition period of the parental generation. 

i) Gestation Length 

Calculated as the number of days of gestation including the day for observation of mating 

and the start of parturition. 

ii) Parturition Index 

The following was calculated for each group: 

Parturition Index (%) = Number of pregnant females

Number of females delivering live offspring x 100 

3.4.2.3 Litter Responses 

The standard unit of assessment was considered to be the litter, therefore, values were 

first calculated for each litter and the group mean was calculated using the individual 

litter values. Group mean values included all litters reared to termination (Day 5 of age). 

i) Implantation Losses (%) 

Group mean percentile pre-implantation and post-implantation loss were calculated for 

each female/litter as follows: 

Pre–implantation loss = Number of corpora lutea

Number of corpora lutea - number of implantation sites x100 
PAGE 32 PROJECT NUMBER: 41104692R 

Post–implantation loss = Number of implantation sites

Number of implantation sites - Total number of offspring born x 100 

ii) Live Birth and Viability Indices 

The following indices were calculated for each litter as follows: 

Live Birth Index (%) = Number of offspring born

Number of offspring alive on Day 1 x 100 

Viability Index (%) = Number of offspring alive on Day 1

Number of offspring alive on Day 4 x 100 

iii) Sex Ratio (% males) 

Sex ratio was calculated for each litter on Days 1 and 4 post partum, using the following 

formula: 

Total number of offspring

Number of male offspring x 100 

3.4.3 Statistical Analysis 

Where considered appropriate, quantitative data was subjected to statistical analysis to 

detect the significance of intergroup differences from control; statistical significance was 

achieved at a level of p<0.05. Statistical analysis was performed on the following 

parameters: 

Grip Strength, Motor Activity, Body Weight, Body Weight Change, Food Consumption 

during gestation and lactation, Pre-Coital Interval, Gestation Length, Litter Size, Litter 

Weight, Sex Ratio, Corpora Lutea, Implantation Sites, Implantation Losses, Viability 

Indices, Offspring Body Weight, Offspring Body Weight Change, Offspring Surface 

Righting, Haematology, Blood Chemistry, Absolute Organ Weights, Body WeightRelative Organ Weights. 

Data were analysed using the decision tree from the ProvantisTM Tables and Statistics 

Module as detailed below: 

Where appropriate, data transformations were performed using the most suitable 

method. The homogeneity of variance from mean values was analysed using Bartlett’s 

test. Intergroup variances were assessed using suitable ANOVA, or if required, ANCOVA 

with appropriate covariates. Any transformed data were analysed to find the lowest 

treatment level that showed a significant effect, using the Williams Test for parametric 

data or the Shirley Test for non-parametric data. If no dose response was found, but the 
 PROJECT NUMBER: 41104692R PAGE 33

data showed non-homogeneity of means, the data were analysed by a stepwise 

Dunnett’s (parametric) or Steel (non-parametric) test to determine significant difference 

from the control group. Where the data were unsuitable for these analyses, pair-wise 

tests was performed using the Student t-test (parametric) or the Mann-Whitney U test 

(non-parametric). 

Data not analysed by the Provantis data capture system were assessed separately using 

the SPSS statistical package. Initially, the homogeneity of the data was assessed using 

Levene’s test. Where Levene’s test was shown to be non-significant (p≥0.05), 

parametric analysis of the data was applied, incorporating analysis of variance (ANOVA). 

If this data was shown to be significant, this analysis was followed by pair-wise 

comparisons using Dunnett’s test. Where Levene’s test was significant, non-parametric 

analysis of the data was analysed incorporating the Kruskal-Wallis test which if 

significant, was followed by the Mann-Whitney U test. Dose response relationship was 

also investigated by linear regression. Where the data was unsuitable for these 

analyses, then pair-wise tests were performed using the Student t-test (parametric) or 

the Mann-Whitney U test (non-parametric). 

Due to the preponderance of non-normally distributed data, reproductive parameters 

(implantation losses, offspring sex ratio and offspring surface righting) were analysed 

using non-parametric analyses. 

Probability values (p) were calculated as follows: 

p<0.001 *** 

p<0.01 ** 

p<0.05 * 

p0.05 (not significant) 

4. DEVIATIONS FROM STUDY PLAN 

There were no deviations to the Study Plan. 

5. ARCHIVES 

Unless instructed otherwise by the Sponsor, specimens (as long as the quality permits 

evaluation), the study plan, raw data (paper and electronic) generated at the test facility, 

all original data including tissue blocks and tissue slides generated at the histology 

processing Test Site, the original histopathology report and any raw data generated at 

the histology examination test site, and the final report will be retained in the Harlan 

Laboratories Ltd., Shardlow, UK archives for five years after which instructions will be 
PAGE 34 PROJECT NUMBER: 41104692R 

sought as to further retention or disposal. Further retention or return of the data will be 

chargeable to the Sponsor. 
 PROJECT NUMBER: 41104692R PAGE 35

6. RESULTS 

6.1 Adult Responses 

6.1.1 Mortality 

There were no unscheduled deaths on the study. 

6.1.2 Clinical Observations 

A summary incidence of clinical observations is given in Table 2. Individual data are 

given in Appendix 1. 

No toxicologically significant adverse findings were detected. 

Incidental findings involved noisy respiration which developed from Day 31 in one female 

at 30 and 300 mg/kg bw/day and in one 1000 mg/kg bw/day male. This finding was 

accompanied on Day 42 in the 30 mg/kg bw/day female by laboured respiration, 

increased salivation, pilo-erection and hunched posture. Given the isolated nature of 

these changes, they were considered attributable to the gavage procedure rather than a 

direct effect of the test item (or vehicle). 

Remaining findings involved the presence (from Day 31) of a small mass under the right 

forelimb of one 1000 mg/kg bw/day female. While the aetiology of the swelling is 

uncertain, there was no indication this swelling caused distress or impaired the animals 

movement and microscopic evaluation concluded this finding not to be a consequence of 

treatment. 

Four males treated with 300 mg/kg bw/day had generalised scab formation from Day 19 

onwards. Observations of this nature are commonly observed in group housed animals 

and result from social interaction and are therefore considered unrelated to test item 

toxicity. 

6.1.3 Functional Observations 

A summary incidence of behavioural assessment observations is given in Table 3 and 

group mean behavioural assessment scores are given in Table 4. Group mean 

functional test values and standard deviations are given in Table 5 (statistically 

significant differences are indicated). Individual values are given in Appendices 2 to 5. 

Group mean sensory reactivity assessment scores are given in Table 6. Individual 

responses are given in Appendix 6. 
PAGE 36 PROJECT NUMBER: 41104692R 

6.1.3.1 Behavioural Assessments 

There were no treatment-related changes in behavioural assessments. 

All inter and intra group differences in urination, defecation and transfer arousal scores 

were considered to be a result of normal variation for rats of the strain and age used and 

were considered to be of no toxicological importance. 

6.1.3.2 Functional Performance Tests 

There were no treatment related changes detected in the functional performance 

measurements. 

Females treated with 300 and 1000 mg/kg bw/day showed a slight but statistically 

significant increase (p<0.05) in one of three hind limb grip strength measurements. In 

the absence of a dose dependent trend or other evidence to suggest an association with 

test item toxicity it is reasonable to assume that the isolated nature of these observations 

indicate this finding to be a result of biological variation rather than an association with 

test item toxicity. 

6.1.3.3 Sensory Reactivity Assessments 

There were no treatment-related changes in sensory reactivity. 

All inter and intra group differences in sensory reactivity scores were considered to be a 

result of normal variation for rats of the strain and age used and were of no toxicological 

importance. 

6.1.4 Body Weight 

Group mean body weights, body weight changes and standard deviations are given in 

Table 7 and Table 8 (statistically significant differences are indicated). Group mean body 

weight data are presented graphically in Figure 1 and Figure 2. Individual data are given 

in Appendix 7 and Appendix 8. 

Group mean gains for males tested at 1000 mg/kg bw/day were slightly lower (p<0.05) 

than that of the controls at Week 2 but showed recovery thereafter. Body weight gains in 

one or more test groups at Week 4 and during the final week of treatment exceeded that 

of the controls. However, as weight gains are seldom seen as an adverse effect of 

treatment, under the conditions of this study they were considered attributable to natural 

variability. 
 PROJECT NUMBER: 41104692R PAGE 37

Body weight development in females treated with 1000 mg/kg bw/day was generally 

slightly lower than that of the concurrent controls. However, there was no supporting 

evidence to support any significance to this trend and as individual values with few 

exceptions were similar to the controls, this finding was considered to be fortuitous. 

6.1.5 Food Consumption 

Group mean food consumptions are given in Table 9 and are presented graphically in 

Figure 3 and Figure 4. Individual and group mean food consumptions for females 

following mating and during lactation are presented in Appendix 9. 

Food efficiencies for males and females during the pre-mating phase are given in Table 

10. 

No adverse effect on food consumption or food efficiency was detected in treated 

animals in comparison with controls throughout the study. 

6.1.6 Water Consumption 

Group mean daily water consumptions are given in Table 11. 

Gravimetric measurement of water consumption undertaken during the pre-pairing phase 

did not reveal any adverse effect. 

6.2 Reproductive Performance 

6.2.1 Mating 

A summary of adult performance is given in Table 1. A summary incidence for mating 

performance is presented in Table 12. Individual data are given in Appendix 10. 

No treatment-related effects were detected in mating performance. 

With the exception of one paired control male and female all females mated within the 

first four days of pairing. 

Statistical analysis of the pre-coital interval data did not reveal any significant intergroup 

differences. 
PAGE 38 PROJECT NUMBER: 41104692R 

6.2.2 Fertility 

A summary of adult performance is given in Table 1. Group values for fertility, litter data 

and implantation losses are given in Tables 12, 13 and 14. Individual data are given in 

Appendices 10 to 12. 

No treatment-related effects were detected on fertility for treated animals when 

compared to controls. 

One control female (No. 21) did not achieve pregnancy following evidence of mating. In 

the absence of histopathological correlates this intergroup difference was considered to 

be incidental. In addition, one 300 mg/kg bw/day female (No. 69) did not achieve 

pregnancy following evidence of mating. However, there were no histopathological 

correlates in the reproductive organs, the male partner was observed at necropsy to 

have small epididymides (given the isolated nature this finding it was considered not to 

be related to test item toxicity) with histopathological examination determining severe 

bilateral hypospermia and severe bilateral germinal epithelial atrophy; thus accounting 

for the probable absence of pregnancy in female No.69. 

6.2.3 Gestation Length 

A summary incidence of gestation lengths is given in Table 12. Individual gestation 

lengths are given in Appendix 10. 

No treatment-related effects were detected in the length of gestation for treated females 

when compared to controls. All animals showed gestation lengths between 22 to 241⁄2 

days. 

6.3 Litter Responses 

In total ten control females, all twelve females from the 30 mg/kg bw/day dose group, 

eleven females from the 300 mg/kg bw/day dose group and all twelve females from the 

1000 mg/kg bw/day dose group gave birth to a live litter and successfully reared young to 

Day 5 age. 

The following assessment of litter response is based on all litters reared to termination on 

Day 5 of lactation/age. 
 PROJECT NUMBER: 41104692R PAGE 39

6.3.1 Offspring Litter Size, Sex Ratio and Viability 

Group mean corpora lutea and implantation counts, litter size, implantation losses, 

survival indices and sex ratio are given in Tables 13 to 15. Individual data are given in 

Appendices 11 to 13. 

No treatment related effects were detected. 

No significant differences were detected for corpora lutea, implantation counts or litter 

viability for treated animals when compared to controls. A slight reduction (p<0.05) in 

litter size for offspring born was identified in females treated with 1000 mg/kg bw/day in 

comparison with controls. However, individual litter sizes at birth were for the most part 

within historical background ranges, therefore in the absence of any supporting evidence 

of reproductive toxicity this isolated intergroup difference was considered not to be 

treatment-related. 

6.3.2 Offspring Growth and Development 

Group values for total litter weights, offspring body weight and body weight change, 

surface righting reflex and a summary incidence of clinical signs are given in Tables 13, 

16 and 17. Individual values and observations are given in Appendices 11, 14 and 15. 

There were no significant differences in litter weights or mean offspring body weights 

between control and treated animals. Statistical analysis of the data did not reveal any 

significant intergroup differences. 

Litters from females treated with 1000 mg/kg bw/day showed a slight reduction in litter 

weight compared to litters from control animals. This reduction is thought to be 

attributable to two small litters within the 1000 mg/kg bw/day dose group. In the absence 

of a statistically significant difference and as the majority of the litter weights were within 

normal historical background ranges, the difference is considered not to represent a true 

effect of treatment. 

No overt clinical evidence of toxicity was detected for offspring from treated females 

when compared to controls. The incidental clinical signs detected throughout the control 

and treated groups, consisting of small size, offspring found dead or missing, bruising, 

cold and physical injuries were considered to be low incidence findings observed in 

offspring in studies of this type, and were unrelated to test item toxicity. 
PAGE 40 PROJECT NUMBER: 41104692R 

6.4 Laboratory Investigations 

6.4.1 Haematology 

Group mean values and standard deviations for test and control group animals are given 

in Table 18 (statistically significant differences are indicated). Individual data are given in 

Appendix 16 and Appendix 17. 

There were no toxicologically significant treatment-related effects detected in the 

haematological parameters. 

Males treated with 1000 mg/kg bw/day showed statistically significant reductions for 

haemoglobin (p<0.05), erythrocyte count (p<0.05) and haematocrit (p<0.01) when 

compared to control animals. However, the majority of individual vales remained similar 

to that of the concurrent control and in the absence of any supporting indications of an 

anaemia, the most plausible reason for these changes is a non-specific “stress 

response” and not test item toxicity. 

Females treated with 1000 mg/kg bw/day had a statistically significant reduction in total 

leucocyte count and lymphocyte count and a statistically significant increase in 

eosinophil count. The majority of individual values were within the normal range for rats 

of strain and age used and in the absence of any supporting microscopic findings, the 

intergroup differences were considered not to be of toxicological significance. 

No such findings were apparent in animals of either sex treated with 300 or 30 mg/kg 

bw/day. 

6.4.2 Blood Chemistry 

Group mean values and standard deviations for test and control group animals are given 

in Table 19 (statistically significant differences are indicated). Individual data are given in 

Appendices 18 and 19. 

Males treated with 1000 or 300 mg/kg bw/day had statistically significant reductions in 

total protein (p<0.05) and creatinine (p<0.05) and a statistically significant increase in 

albumin/globulin ratio (p<0.05 or p<0.01 respectively). In the absence of any convincing 

trends among individual values or histopathological correlates these isolated changes 

were considered not to be indicative of hepatic or renal impairment but more likely a 

result of biological variability. 
 PROJECT NUMBER: 41104692R PAGE 41

A slight but statistically significant reduction in inorganic phosphate concentrations was 

identified among females receiving 300 mg/kg bw/day (p<0.05) and 1000 mg/kg bw/day 

p<0.01). Individual values were within the normal historical background ranges for rats 

of the strain and age used and in the absence of associated changes, the toxicological 

significance of this finding is considered to be highly dubious. 

Females treated with 1000 mg/kg bw/day also showed a statistically significant reduction 

in calcium. In the absence of any supporting biochemical or microscopic findings, this 

intergroup difference was considered spurious. 

Females treated with 30 mg/kg bw/day showed a slight increase (p<0.05) for plasma 

glucose levels which in the absence of a dose-dependent trend was considered to have 

arisen fortuitously. 

6.5 Pathology 

6.5.1 Necropsy 

A summary incidence of necropsy findings is given in Tables 20 and 21. Individual data 

are given in Appendices 20 and 21. 

Offspring

No treatment-related macroscopic abnormalities were detected for interim death or 

terminal kill offspring. The incidental findings observed were those occasionally 

observed in reproductive studies of this type and were considered to be unrelated to 

toxicity of the test item. 

Adults

One male treated with 1000 mg/kg bw/day had a dark spleen and reddened lungs at 

necropsy, both the lungs and spleen were found to be congested, the lungs were also 

found to contain moderate peribronchiolar intra-alveolar pink fluid when analysed 

microscopically. 

This may have been a result of a partial mal-dose during the study. However, given the 

isolated nature of this finding it was considered incidental and not to be related to test 

item toxicity. 

One male treated with 300 mg/kg bw/day had small epididymides and small, flaccid 

testes. In addition, one female treated with 1000 mg/kg bw/day had a mass under the 

right forelimb at necropsy. Upon histopathological evaluation this was confirmed to be 

an adenocarcinoma. Furthermore, one control male was noted to have small seminal 
PAGE 42 PROJECT NUMBER: 41104692R 

vesicles and one control female an increased left renal pelvic space and mineral calculi 

in the urinary bladder at necropsy. Such observations represent common sporadic 

finding amongst rats of the strain and age used in the study and since there was neither 

a dose-response relationship nor a similar finding amongst the remaining animals at any 

dose level, these isolated findings were considered not to represent a treatment-related 

effect. 

6.5.2 Organ Weights 

Group mean absolute and body weight-relative organ weights and standard deviations 

for test and control group animals are presented in Table 22 (statistically significant 

differences are indicated). Individual data are given in Appendix 22 and Appendix 23. 

There were no treatment-related changes detected in the organ weights of either sex of 

test animals in comparison with controls. 

Incidental findings involved males treated with 1000 mg/kg bw/day that showed a 

statistically significant reduction (p<0.01) in absolute and relative pituitary weight 

compared with controls. In addition, 1000 mg/kg bw/day females showed a slight but 

statistically significant increase (p<0.05) in both absolute and relative thyroid/parathyroid. 

However, the great majority of male individual values and all female values were within 

the expected historical ranges for animals of this age and strain. Furthermore, there was 

no evidence of microscopic pituitary changes or any other apparent changes which may 

indicate endocrine imbalances and, consequently, these findings were considered 

spurious and considered not to be indicative of test item toxicity. 

An increase (p<0.05) for uterus/cervix weights was identified in the females treated at 

1000 mg/kg bw/day. However, the majority of individual values were within the 

anticipated historical ranges. Furthermore there was no histopatholigical indication of an 

associated treatment related response and on this basis this finding was considered to 

have arisen fortuitously. 

6.5.3 Histopathology 

A complete histopathology phase report is presented in Appendix 24. 

No treatment-related histopathological changes in the tissues examined were detected. 

All remaining morphological changes were those commonly observed in laboratory 

maintained rats of the age and strain employed and there were no differences in 

incidence or severity between control and treatment groups that were considered to be of 

toxicological significance. 
 PROJECT NUMBER: 41104692R PAGE 43

7. DISCUSSION 

The oral administration to rats of Sodium Glucoheptonate (EC 250-480-2) for a period of 

up to eight weeks (including two weeks pre-pairing, gestation and early lactation period 

for females) at dose levels of 30, 300 and 1000 mg/kg bw/day (incorporating a test item 

correction factor for 50.5% w/w purity minus 49.5% w/w test item water content) resulted 

in no toxicologically significant treatment-related findings. 

The incidental findings identified in this study (slight impairment of bodyweight 

development in either sex treated with 1000 mg/kg bw/day and minor haematological 

changes in 1000 mg/kg bw/day males) were considered to be either low incidence 

changes attributable to biological variability and/or sporadic findings that lacked any 

convincing supporting histopathological evidence to suggest they represented a 

convincing treatment-related effect. Furthermore there were no differences on the 

completeness of stages or cell populations of the testes recorded between controls and 

1000 mg/kg bw/day animals and all but two mated females (control and 300 mg/kg 

bw/day) gave birth to a live litter and successfully reared their young to Day 5 of age. In 

relation to offspring, there were no notable significant differences in litter weights or 

mean offspring body weights between control and treated animals. On this basis, the ‘No 

Observed Adverse Effect Level’ (NOAEL) and possible ‘No Observed Effect Level’ 

(NOEL) for systemic toxicity for either sex was considered to be 1000 mg/kg bw/day. 

No treatment-related effects were observed for reproduction and on this basis the ‘No 

Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 

1000 mg/kg bw/day. 

8. CONCLUSION 

The oral administration to rats of Sodium Glucoheptonate (EC 250-480-2) (incorporating 

a test item correction factor for 50.5% w/w purity minus 49.5% w/w test item water 

content) to rats by gavage, at dose levels of 30, 300 and 1000 mg/kg bw/day did not 

produce any convincing adverse effects of treatment and on this basis the ‘No Observed 

Adverse Effect Level’ (NOAEL) and possible ‘No Observed Effect Level’ (NOEL) for 

systemic toxicity for either sex was considered to be 1000 mg/kg bw/day. 

No treatment-related effects were observed for reproduction, the ‘No Observed Effect 

Level’ (NOEL) for reproductive toxicity was therefore considered to be 1000 mg/kg 

bw/day. 
PAGE 44 PROJECT NUMBER: 41104692R 

9. REFERENCES 

Irwin, S. (1968). Comprehensive Observational Assessment: la. A Systematic, 

Quantitative Procedure for Assessing the Behavioral and Physiologic State of the Mouse. 

Psychopharmacologia 13, 222-257. 

Meyer, O.A., et al (1979). A Method for the Routine Assessment of Fore- and Hindlimb 

Grip Strength of Rats and Mice. Neurobehavioral Toxicology 1, 233-236. 

Moser, V.C., et al (1988). Comparison of Chlordimeform and Carbaryl using a Functional 

Observational Battery. Fundamental and Applied Toxicology 11, 189-206. 

Reiter, L.W., and MacPhail, R.C. (1979). Motor Activity: A Survey of Methods with 

Potential Use in Toxicology Testing. Neurobehavioral Toxicology 1 (1), 53-66. 

Salewski, E. (1964). Färbemethode zum makroskopischen Nachweis von 

Implantationsstellen am Uterus der Ratte. Naunyn - Schmiedebergs Arch Exp Path 

Pharmakol. 247, 367. 
 PROJECT NUMBER: 41104692R PAGE 45

TABULAR SUMMARY REPORT OF EFFECTS ON REPRODUCTION/DEVELOPMENT 

Observations Dose Level (mg/kg bw/day) 

0 (Control) 30 300 1000 

Paired animals n 12 12 12 12 

Females showing evidence of copulation n 12 12 12 12 

Pregnant females n 11 12 11 12 

Conception Days 1-5 n 10 12 11 12 

Conception Day 11 n 1 0 0 0 

Gestation = 22 Days n 0 1 0 3 

Gestation = 22 1⁄2 Days n 1 3 1 1 

Gestation = 23 Days n 3 3 2 2 

Gestation = 23 1⁄2 Days n 7 5 6 6 

Gestation = 24 1⁄2 Days 0 0 2 0 

Dams with live young born n 11 12 11 12 

Dams with live young at Day 4 post partum n 10 12 11 12 

Corpora lutea/dam 15.0 14.5 14.9 13.3 

Implants/dam 14.2 13.7 14.5 11.8 

Live offspring/dam at Day 1 post partum 13.1 12.8 13.3 10.3 

Live offspring/dam at Day 4 post partum 13.0 12.3 12.8 10.2 

Sex ratio: % males at Day 1 post partum 54.9 53.4 53.7 50.9 

Sex ratio: % males at Day 4 post partum 55.4 54.2 54.3 51.7 

Litter weight (g) at Day 1 post partum 77.18 73.06 82.80 64.46 

Litter weight (g) at Day 4 post partum 106.82 99.76 112.78 90.87 

Male offspring weight (g) at Day 1 post partum 6.08 6.02 6.48 6.54 

Male offspring weight (g) at Day 4 post partum 8.47 8.57 9.11 9.56 

Female offspring weight (g) at Day 1 post partum 5.85 5.63 6.07 6.19 

Female offspring weight (g) at Day 4 post partum 8.15 8.12 8.65 9.10 

LOSS OF OFFSPRING/DAM 

Pre-implantation (corpora lutea minus implantations) 

0 n 7 8 8 4 

1 n 1 2 0 4 

2 n 1 1 1 2 

3 n 0 0 1 0 

5 n 1 0 0 1 

6 n 0 1 0 1 

Pre-natal (implantations minus live births) 

0 n 3 5 1 4 

1 n 5 5 7 4 

2 n 2 2 3 2 

3 n 0 0 0 1 

4 n 1 0 0 0 

5 n 0 0 0 1 

Post natal (live births minus offspring alive on Day 4 post 

partum) 

0 n 8 9 9 10 

1 n 1 2 1 1 

2 n 1 0 0 1 

3 n 0 2 0 0 

4 n 0 0 1 0 

14 n 1 0 0 0 

 

n = Number 

x = Mean 

x

x

x

x

x

x

x

x

x

x

x

x
PAGE 46 PROJECT NUMBER: 41104692R 

KEY TO TABLES AND APPENDICES 

M Male 

F Female 

S.D. Standard deviation 

N Number of animals/litters 

. No data available 

- Not applicable 

1+ Occasional spermatozoa present 

2+ Continuous few spermatozoa in all fields

3+ Many spermatozoa in all fields

H Haemorrhage 

PT Plug detected on tray liner 

PV Vaginal plug 

P Pregnant 

NP Not pregnant (values excluded from mean and sd) 

TLL Total litter loss (values excluded from mean and sd, where applicable) 

N/A Not applicable 

 

% Food 

Efficiency x 100

Group mean food consumption (g/rat/day) x number of days

Group mean body weight gain (g/rat/period) 





 







Statistical Footnotes: 

* Significantly different from control group p<0.05 

** Significantly different from control group p<0.01 

*** Significantly different from control group p<0.001 

n Data not appropriate for statistical analysis 

Organ Weight Footnotes: 

Epididys Epididymides 

Bodywt Body weight 

Thyroid Thyroid/Parathyroid 

Uterus Uterus with Cervix 
 PROJECT NUMBER: 41104692R PAGE 47

KEY TO SCORING SYSTEM AND EXPLANATION FOR BEHAVIOURAL 

ASSESSMENTS AND SENSORY REACTIVITY TESTS 

1. NEUROLOGIC 

These parameters are the first to be evaluated when the animal is placed in the arena: 

1.1 Transfer Arousal (Time to Movement) and Locomotion 

-2 = animal stays in one place 

-1 = slow, deliberate movement 

0 = moderate, undisturbed investigation of environment 

1 = active progression around arena 

2 = darting movements 

1.2 Tail Elevation 

0 = flattened 

1 = rigidly horizontally extended 

2 = rigidly diagonally elevated 

3 = rigidly vertical 

4 = diagonally retrograde (past vertical) 

2. GAIT AND CO-ORDINATION 

Tiptoe Hindlimbs raised on tiptoe during movement 

High stepping Forelimbs lifted high during movement 

Spastic Shuffling of limbs 

Waddling Lateral movements 

Dysmetric Unco-ordinated movement with tremors 

Splayed Thighs splayed outwards, animal appears crouched 

Scissor Forelimbs cross over when extended 

Ataxic Lack of co-ordinated movement of trunk, pelvis and 

limbs 

Observation graded: Slight 

 Moderate (does not fall) 

 Extreme (falls repeatedly) 
PAGE 48 PROJECT NUMBER: 41104692R 

KEY TO SCORING SYSTEM AND EXPLANATION FOR BEHAVIOURAL 

ASSESSMENTS AND SENSORY REACTIVITY TESTS (CONTINUED) 

3. CNS EXCITATION 

3.1 Tremors 

These are general involuntary movements of the muscles 

Exertion only occurs during movement 

Rest only occurs when animal is resting 

Whole body 

Head only 

Body only 

Tail only 

When present, any observation is also graded: 

Slight 

Moderate 

Extreme 

3.2 Twitches 

Identified as brief, coarse jerks of body or limbs – observation graded: 

Slight 

Moderate 

Extreme 

3.3 Convulsions 

Clonic Convulsions with alternate contraction and relaxation of 

muscles 

Running excitement Often accompanied by clonic convulsions 

Champing Clonus of the paws only 

Hopping Animal repeatedly “hops” into the air 

Asphyxeal Terminal convulsion, results in death from respiratory failure 

Tonic Seizure in which the head, body and limbs are arched 

backwards 

Emprosthotonus Seizure where the head, body and limbs are arched forwards 

3.4 Bizarre Behaviour 

Any bizarre behaviour is recorded using a unique code. 
 PROJECT NUMBER: 41104692R PAGE 49

KEY TO SCORING SYSTEM AND EXPLANATION FOR BEHAVIOURAL 

ASSESSMENTS AND SENSORY REACTIVITY TESTS (CONTINUED) 

4. AUTONOMIC 

Salivation* Excessive visible wetness around the mouth 

Pilo-erection* Fur stands up - marked cases are described as “puff 

ball” appearance 

Exophthalmia Bulging eyes 

Lachrymation Tear staining (clear fluid) 

Chromodacryorrhea (red/pink fluid) 

Hyperthermia 

Hypothermia 

Skin colour* Blue (cyanotic) 

Redness of extremities 

Skin pallor 

Respiration Decreased respiratory rate 

 Gasping 

 Increased rate 

 Laboured 

 Noisy 

Palpebral closure Degree of eyelid closure eg ptosis - observation is 

graded: 

Slight 

Moderate 

Severe 

Urination and defecation During the study this can only be observed as 

urogenital wetness and/or diarrhoea. In the open 

arena, the number of occasions that the animal 

defecates/urinates is recorded 

 

* When present, observation is graded slight, moderate or extreme. 
PAGE 50 PROJECT NUMBER: 41104692R 

KEY TO SCORING SYSTEM AND EXPLANATION FOR BEHAVIOURAL 

ASSESSMENTS AND SENSORY REACTIVITY TESTS (CONTINUED) 

5. MANIPULATIVE TESTS 

Performed in the open arena: 

5.1 Grasp Response 

The animal is grasped around the body and its reaction is scored: 

0 = no response 

1 = animal struggles slightly but becomes passive 

2 = animal repeatedly struggles with/without vocalisation 

3 = animal struggles violently with/without vocalisation 

4 = animal attempts to bite operator 

5.2 Vocalisation 

The number of vocalisations exhibited by the animal during handling. 

5.3 Toe Pinch 

On handling one toe of a hindfoot is lightly pressed with a pair of forceps: 

-3 = no response 

-2 = animal shows awareness of actions 

-1 = withdrawal 

0 = rapid withdrawal with single vocalisation 

1 = rapid withdrawal with multiple vocalisations 

5.4 Tail Pinch 

Whilst animal is in the arena, the end of the tail is lightly pressed with forceps: 

-2 = no response 

-1 = animal freezes/shows awareness of grasping 

0 = animal attempts to escape/struggles with none or single vocalisation 

1 = animal struggles violently with multiple vocalisations 
 PROJECT NUMBER: 41104692R PAGE 51

KEY TO SCORING SYSTEM AND EXPLANATION FOR BEHAVIOURAL 

ASSESSMENTS AND SENSORY REACTIVITY TESTS (CONTINUED) 

5.5 Finger Approach 

Whilst animal is in the arena the operator moves one finger towards the animal: 

-1 = animal is oblivious to approach 

0 = animal is aware of finger but is unmoved 

1 = head sways from side to side 

2 = moves towards finger 

3 = investigates finger by moving onto it 

5.6 Touch Escape 

Whilst animal is in the arena the operator runs his finger down the body of the animal: 

-2 = no response 

-1 = animal twitches ears, investigates finger 

0 = animal crouches 

1 = animal moves away but is unhurried 

2 = animal moves away as if startled 

5.7 Pupil Reflex 

The animal is placed in a darkened area to allow the pupils to dilate. A light beam is 

shone into each eye separately and the pupil is observed for immediate constriction. 

The response recorded: 

-2 = no response 

-1 = sluggish 

0 = normal 

5.8 Blink Reflex (Palpebral Closure) 

The operator attempts to touch the eye of the rat, the response is recorded: 

-2 = no response 

-1 = sluggish 

0 = normal blink reflex 

1 = rapid or repeated eye blink 
PAGE 52 PROJECT NUMBER: 41104692R 

KEY TO SCORING SYSTEM AND EXPLANATION FOR BEHAVIOURAL 

ASSESSMENTS AND SENSORY REACTIVITY TESTS (CONTINUED) 

5.9 Startle Reflex 

A sharp sudden noise is produced by a noise generator or finger snap or similar. Each 

animal is held lightly but firmly facing the origin of the noise. The response is recorded: 

-1 = no response 

0 = normal 

1 = hyper-responsive 
 PROJECT NUMBER: 41104692R PAGE 53 

TABLES
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 1 Summary of Reproductive Performance - Group Values 

Dose Group (mg/kg bw

 0 (Control) 30 

Males 

Initial group size 12 12 Paired 12 12 Failed to induce pregnancy in female partner 1 0 Induced pregnancy in female partner 11 12 Surviving to terminal necropsy 12 12 

Females 

Initial group size 12 12 Paired 12 12 Non-pregnant 1 0 Pregnant 11 12 Rearing young to Day 5 of age 10 12 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 2 Summary Incidence of Daily Clinical Observations  Day Numbers Relative to Start Date Sex: Male  Group 1 Group 2 Group 3 Group 4  0(Control) 30 mg/kg bw/day 300 mg/kg bw/day 1000 mg/kg bw/day Abnormal Gait  Number of Animals . . 1 .  Days from ƒ to . . 8 43 . Scab  Number of Animals . . 4 .  Days from ƒ to . . 19 43 . Scheduled kill  Number of Animals 12 12 12 12  Days from ƒ to 43 43 43 43 43 43 43 43 Noisy respiration  Number of Animals . . . 1  Days from ƒ to . . . 35 35 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 2 (continued) Summary Incidence of Daily Clinical Observations  Day Numbers Relative to Start Date Sex: Female  Group 1 Group 2 Group 3 Group 4  0(Control) 30 mg/kg bw/day 300 mg/kg bw/day 1000 mg/kg bw/day Littering  Number of Animals 1 . 2 2  Days from ƒ to 38 38 . 40 40 40 40 Not Observed Due to Littering  Number of Animals 1 . 2 2  Days from ƒ to 38 38 . 40 40 40 40 Mass  Number of Animals . . . 1  Days from ƒ to . . . 31 44 Respiration ƒ Laboured  Number of Animals . 1 . .  Days from ƒ to . 42 42 . . Scheduled kill  Number of Animals 12 12 12 12  Days from ƒ to 42 52 42 46 42 45 42 46 Increased salivation  Number of Animals . 1 . .  Days from ƒ to . 42 42 . . Noisy respiration  Number of Animals . 1 1 .  Days from ƒ to . 42 42 31 32 . 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 2 (continued) Summary Incidence of Daily Clinical Observations  Day Numbers Relative to Start Date Sex: Female  Group 1 Group 2 Group 3 Group 4  0(Control) 30 mg/kg bw/day 300 mg/kg bw/day 1000 mg/kg bw/day Piloƒerection  Number of Animals . 1 . .  Days from ƒ to . 42 42 . . Hunched posture  Number of Animals . 1 . .  Days from ƒ to . 42 42 . . 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 3 Summary Incidence of Behavioural Assessments (Observations)  Day Numbers Relative to Start Date Group (Sex) Clinical Sign -1 7 14 20 27 35 41/4 post partum#

 1(M) ANIMALS ALIVE 12 12 12 12 12 12 12  ANIMALS NORMAL 12 12 12 12 12 12 12  1(F) ANIMALS ALIVE 12 12 12 12 12 12 12  ANIMALS NORMAL 12 12 12 12 12 12 12 # = Day 25 post coitum

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 3 (continued) Summary Incidence of Behavioural Assessments (Observations)  Day Numbers Relative to Start Date Group (Sex) Clinical Sign -1 7 14 20 27 35 41/4 post partum

 2(M) ANIMALS ALIVE 12 12 12 12 12 12 12  ANIMALS NORMAL 12 12 12 12 12 12 12  2(F) ANIMALS ALIVE 12 12 12 12 12 12 12  ANIMALS NORMAL 12 12 12 12 12 12 12 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 3 (continued) Summary Incidence of Behavioural Assessments (Observations)  Day Numbers Relative to Start Date Group (Sex) Clinical Sign -1 7 14 20 27 35 41/4 post partum#

 3(M) ANIMALS ALIVE 12 12 12 12 12 12 12  ANIMALS NORMAL 12 12 12 12 12 12 12  3(F) ANIMALS ALIVE 12 12 12 12 12 12 12  ANIMALS NORMAL 12 12 12 12 12 12 12 # = Day 25 post coitum

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 3 (continued) Summary Incidence of Behavioural Assessments (Observations)  Day Numbers Relative to Start Date Group (Sex) Clinical Sign -1 7 14 20 27 35 41/4 post partum

 4(M) ANIMALS ALIVE 12 12 12 12 12 12 12  ANIMALS NORMAL 12 12 12 12 12 12 12  4(F) ANIMALS ALIVE 12 12 12 12 12 12 12  ANIMALS NORMAL 12 12 12 12 12 12 12 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 4 Group Mean Behavioural Assessments (Scores)  Day: ƒ1 Relative to Start Date  Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(M) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(M) Mean 0.0 0.2 0.1 0.0  S.D. 0.0 0.4 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(M) Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(M) Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 4 (continued) Group Mean Behavioural Assessments (Scores)  Day: ƒ1 Relative to Start Date  Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(F) Mean 0.0 0.3 0.1 0.0  S.D. 0.0 0.5 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(F) Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(F) Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(F) Mean 0.0 0.3 0.1 0.0  S.D. 0.0 0.5 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 4 (continued) Group Mean Behavioural Assessments (Scores)  Day: 7 Relative to Start Date  Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(M) Mean 0.0 0.4 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(M) Mean 0.0 0.3 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(M) Mean 0.0 0.2 0.1 0.0  S.D. 0.0 0.4 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(M) Mean 0.0 0.2 0.1 0.0  S.D. 0.0 0.4 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 4 (continued) Group Mean Behavioural Assessments (Scores)  Day: 7 Relative to Start Date  Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(F) Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(F) Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(F) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(F) Mean 0.0 0.0 0.1 0.0  S.D. 0.0 0.0 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 4 (continued) Group Mean Behavioural Assessments (Scores)  Day: 14 Relative to Start Date  Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(M) Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(M) Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(M) Mean 0.0 0.4 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(M) Mean 0.0 0.3 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 4 (continued) Group Mean Behavioural Assessments (Scores)  Day: 14 Relative to Start Date  Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(F) Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(F) Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(F) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(F) Mean 0.0 0.3 0.1 0.0  S.D. 0.0 0.5 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 4 (continued) Group Mean Behavioural Assessments (Scores)  Day: 20 Relative to Start Date  Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(M) Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(M) Mean 0.0 0.2 0.1 0.0  S.D. 0.0 0.4 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(M) Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(M) Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 4 (continued) Group Mean Behavioural Assessments (Scores)  Day: 20 Relative to Start Date  Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(F) Mean 0.0 0.3 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(F) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(F) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(F) Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 4 (continued) Group Mean Behavioural Assessments (Scores)  Day: 27 Relative to Start Date  Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(M) Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(M) Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(M) Mean 0.0 0.0 0.1 0.0  S.D. 0.0 0.0 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(M) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 4 (continued) Group Mean Behavioural Assessments (Scores)  Day: 27 Relative to Start Date  Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(F) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(F) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(F) Mean 0.0 0.3 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(F) Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 4 (continued) Group Mean Behavioural Assessments (Scores)  Day: 35 Relative to Start Date  Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(M) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(M) Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(M) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(M) Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 4 (continued) Group Mean Behavioural Assessments (Scores)  Day: 35 Relative to Start Date  Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(F) Mean 0.0 0.2 0.1 0.0  S.D. 0.0 0.4 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(F) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(F) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(F) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 4 (continued) Group Mean Behavioural Assessments (Scores)  Day: 41 Relative to Start Date  Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(M) Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(M) Mean 0.0 0.0 0.3 0.0  S.D. 0.0 0.0 0.9 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(M) Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(M) Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 4 (continued) Group Mean Behavioural Assessments (Scores)  Day: 4 post partum# 

 Transfer Urinƒ Defƒ Tail elƒ  Group arousal ation ecation evation  (Sex)  1(F) Mean 0.0 0.3 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(F) Mean 0.0 0.2 0.2 0.0  S.D. 0.0 0.4 0.4 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(F) Mean 0.0 0.2 0.1 0.0  S.D. 0.0 0.4 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(F) Mean 0.0 0.3 0.1 0.0  S.D. 0.0 0.5 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ # = Day 25 post coitum

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 5 Group Mean Functional Test Values and Standard Deviations  Test 1 Test 1 Test 2 Test 2 Test 3 Test 3 Overall Overall Last 20%  Group Forelimb Hindlimb Forelimb Hindlimb Forelimb Hindlimb activity mobile activity  (Sex) g g g g g g  1(M) Mean 1081.2 395.6 1025.2 433.8 900.4 378.4 281.6 0.0n 25.0  S.D. 302.0 195.8 420.1 217.6 199.1 87.4 126.0 0.0 32.1  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(M) Mean 936.6 574.4 871.6 419.8 954.0 398.0 343.6 0.8n 44.2  S.D. 278.5 61.6 351.3 95.4 361.9 139.8 121.4 1.3 54.1  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(M) Mean 1128.0 424.8 835.4 355.2 1054.6 449.4 278.6 0.4n 15.0  S.D. 174.1 122.7 236.1 152.0 296.5 152.1 79.9 0.5 14.7  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(M) Mean 1062.4 489.4 969.0 445.0 1085.6 487.8 400.4 1.2n 38.4  S.D. 254.5 277.5 82.5 260.7 249.4 71.2 147.5 1.3 62.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ General Footnote: Unit = Time (seconds) for Motor Activity Assessments Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 5 (continued) Group Mean Functional Test Values and Standard Deviations  Test 1 Test 1 Test 2 Test 2 Test 3 Test 3 Overall Overall Last 20%  Group Forelimb Hindlimb Forelimb Hindlimb Forelimb Hindlimb activity mobile activity  (Sex) g g g g g g  1(F) Mean 801.4 231.4 728.8 243.0 828.4 359.8 466.6 2.0 40.4  S.D. 156.8 117.3 104.4 79.4 163.8 161.6 103.0 1.6 34.3  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(F) Mean 954.0 396.6 879.4 334.2 826.8 378.6 462.8 2.0 29.4  S.D. 364.1 171.7 369.2 136.6 228.8 122.2 128.6 1.2 49.4  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(F) Mean 848.2 380.6 1074.8 622.6* 845.0 345.6 309.4 1.6 62.6  S.D. 229.2 54.2 242.3 283.4 290.6 170.4 155.0 1.5 47.8  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(F) Mean 953.4 429.2 1041.4 488.4* 882.0 379.4 387.0 3.8 67.8  S.D. 341.3 227.2 370.4 278.7 294.1 165.6 223.6 2.6 53.1  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ General Footnote: Unit = Time (seconds) for Motor Activity Assessments Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 6 Group Mean Sensory Reactivity Assessments (Scores)  Grasp Vocalƒ Toe Tail Finger Touch Pupil Blink Startle  Group response isation pinch pinch approach escape reflex reflex reflex  (Sex)  1(M) Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  2(M) Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  3(M) Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  4(M) Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 6 (continued) Group Mean Sensory Reactivity Assessments (Scores)  Grasp Vocalƒ Toe Tail Finger Touch Pupil Blink Startle  Group response isation pinch pinch approach escape reflex reflex reflex  (Sex)  1(F) Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  2(F) Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  3(F) Mean 0.0 0.2 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.4 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  4(F) Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 7 Group Mean Body Weight Values  Body Weights (g)  ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ  Day Numbers Relative to Start Date  Group  (Sex) 1 8 15 22 29 36 43  1(M) Mean 326.0 346.1 362.8 370.2 377.3 389.8 387.8  S.D. 9.0 10.9 12.6 13.5 13.2 13.6 19.8  N 12 12 12 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  2(M) Mean 324.9 342.8 359.0 365.8 374.8 386.9 391.2  S.D. 6.9 8.1 11.0 12.2 13.3 14.3 15.2  N 12 12 12 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  3(M) Mean 321.3 336.9 355.8 356.9 369.5 386.3 392.7  S.D. 10.9 13.2 13.7 20.5 25.0 19.8 17.9  N 12 12 12 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  4(M) Mean 327.2 344.7 357.1 363.3 377.8 391.8 396.8  S.D. 8.9 13.0 16.5 16.9 17.3 21.0 23.1  N 12 12 12 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 7 (continued) Group Mean Body Weight Values  Body Weights (g)  ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ  Day Numbers Relative to Start Date  Group  (Sex) 1 8 15  1(F) Mean 206.2 218.9 227.7  S.D. 5.1 12.3 13.4  N 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  2(F) Mean 202.5 213.2 223.3  S.D. 6.6 7.8 7.8  N 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  3(F) Mean 207.4 217.4 227.3  S.D. 5.7 6.6 7.6  N 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  4(F) Mean 201.5 210.4 218.3  S.D. 6.8 11.0 13.6  N 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 7 (continued) Group Mean Body Weight Values 

Group(Sex) 

Body Weight (g)

Day Numbers 

Gestation Lactation

0 7 14 20 1 4

1(F) Mean 230.9 258.1 288.6 358.5 257.9 271.2 

S.D. 18.5 16.9 19.5 24.2 19.8 21.0 N 11 11 11 11 10 10 

2(F) Mean 226.1 254.9 287.9 351.0 258.4 271.5

S.D. 8.0 8.2 12.3 18.2 17.3 15.7 N 12 12 12 12 12 12 

3(F) Mean 227.5 259.5 292.8 361.6 261.5 275.5

S.D. 9.4 11.8 17.3 24.0 14.5 14.0 N 11 11 11 11 11 11 

4(F) Mean 221.1 249.5 278.8 336.0 261.2 271.7

S.D. 16.4 19.2 22.5 33.9 22.5 20.1 N 12 12 12 12 12 12 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 8 Group Mean Body Weight Gains  Increase in Body Weight (g)  Day Numbers Relative to Start Date  Abs %  Gain Gain  Group From: 1 8 15 22 29 36 1 1  (Sex) To: 8 15 22 29 36 43 43 43  1(M) Mean 20.1 16.7 7.4 7.1 12.5 ƒ1.9 61.8 18.9  S.D. 4.0 4.3 6.5 7.3 4.8 8.2 14.6 4.3  N 12 12 12 12 12 12 12 12  2(M) Mean 17.8 16.3 6.8 9.0 12.2 4.3* 66.3 20.4  S.D. 5.1 5.8 3.5 6.3 4.1 4.4 11.4 3.4  N 12 12 12 12 12 12 12 12  3(M) Mean 15.6 18.9 1.1 12.6* 16.8 6.4** 71.3 22.2  S.D. 6.4 4.7 13.1 9.5 9.9 7.2 11.8 3.6  N 12 12 12 12 12 12 12 12  4(M) Mean 17.5 12.4* 6.2 14.5* 14.0 5.0** 69.6 21.2  S.D. 6.7 4.4 5.9 3.9 5.4 4.6 15.3 4.1  N 12 12 12 12 12 12 12 12 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 8 (continued) Group Mean Body Weight Gains  Increase in Bodyweight (g)  Day Numbers Relative to Start Date  Abs %  Gain Gain  Group From: 1 8 1 1  (Sex) To: 8 15 15 15  1(F) Mean 12.8 8.8 21.5 10.4  S.D. 10.5 4.5 11.8 5.7  N 12 12 12 12  2(F) Mean 10.7 10.2 20.8 10.3  S.D. 4.9 4.8 6.9 3.6  N 12 12 12 12  3(F) Mean 10.0 9.9 19.9 9.6  S.D. 5.5 5.3 6.1 3.0  N 12 12 12 12  4(F) Mean 8.9 7.8 16.8 8.2  S.D. 4.9 4.4 7.7 3.6  N 12 12 12 12 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 8 (continued) Group Mean Body Weight Gains 

Increase in Body Weight (g) 

Days

 Cumulative Body Weight Change (g) 

Days 

 Gestation Lactation GestationGroup (sex) 

From: 0 7 14 1 0 0

To: 7 14 20 4 14 20

1(F) Mean 27.2 30.5 69.8 13.3 57.7 127.5 

 S.D. 4.8 5.0 8.5 6.3 6.1 11.8 

 N 11 11 11 10 11 11 

2(F) Mean 28.8 33.0 63.1 13.1 61.8 124.9 S.D. 6.0 6.0 8.7 6.3 9.8 16.7 

 N 12 12 12 12 12 12 

3(F) Mean 31.9 33.4 68.8 14.1 65.3 134.1 

 S.D. 6.1 6.4 9.7 8.2 11.4 18.7  N 11 11 11 11 11 11 

4(F) Mean 28.4 29.3 57.3 10.5 57.7 114.9 S.D. 6.5 5.8 18.2 8.7 10.8 24.2 

 N 12 12 12 12 12 12 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 9 Group Mean Food Consumptions  Day Numbers Relative to Start Date  Group From: 1 8 29 36  (Sex) To: 8 15 36 43  1(M) Mean 21.6 22.6 22.5 21.8  N 12 12 12 12  2(M) Mean 21.1 22.1 23.0 22.7  N 12 12 12 12  3(M) Mean 20.6 22.2 24.1 23.4  N 12 12 12 12  4(M) Mean 20.6 21.1 20.4 22.4  N 12 12 12 12 Food Consumption = g/animal/day. Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day  
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 9 (continued) Group Mean Food Consumptions  Day Numbers Relative to Start Date  Group From: 1 8  (Sex) To: 8 15  1(F) Mean 16.5 17.6  N 12 12  2(F) Mean 15.8 17.1  N 12 12  3(F) Mean 16.1 17.1  N 12 12  4(F) Mean 15.5 17.0  N 12 12 Food Consumption = g/animal/day. Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 9 (continued) Group Mean Food Consumptions 

 Day Numbers  Gestation Lactation 

Group (Sex) 

From: 0 7 14 1 To: 7 14 20 4 

1(F) Mean 22.8 23.1 27.8 28.3 

S.D. 2.1 3.4 3.3 4.2 N 11 11 11 10 

2(F) Mean 21.9 23.6 26.8 27.8 

S.D. 2.1 4.0 2.9 6.3 N 12 12 12 12 

3(F) Mean 23.1 23.8 27.8 30.3 

S.D. 2.2 3.8 2.6 4.6 N 11 11 11 11 

4(F) Mean 22.2 24.3 26.6 29.1 

S.D. 3.4 2.8 3.3 5.5 N 12 12 12 12 

Food Consumption = g/animal/day. Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 10 Food Efficiency  Day Numbers Relative to Start Date  Group From: 1 8 29 36  (Sex) To: 8 15 36 43  1(M) Mean 13.2 10.5 7.9 ƒ1.5  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ  2(M) Mean 12.1 10.5 7.6 2.7  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ  3(M) Mean 10.7 12.2 9.9 3.7  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ  4(M) Mean 12.2 8.4 9.9 3.2  N 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day   
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 10 (continued) Food Efficiency  Day Numbers Relative to Start Date  Group From: 1 8  (Sex) To: 8 15  1(F) Mean 11.0 7.1  N 12 12  ƒƒƒƒ ƒƒƒƒ  2(F) Mean 9.6 8.6  N 12 12  ƒƒƒƒ ƒƒƒƒ  3(F) Mean 8.9 8.2  N 12 12  ƒƒƒƒ ƒƒƒƒ  4(F) Mean 8.3 6.6  N 12 12  ƒƒƒƒ ƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 11 Group Mean Daily Water Consumptions  Day Numbers Relative to Start Date  Group From: 2 3 4 5 6 7 8 9 10 11 12 13 14  (Sex) To: 3 4 5 6 7 8 9 10 11 12 13 14 15  1(M) Mean 26.7 33.3 29.3 34.3 30.3 33.3 32.3 31.7 31.3 36 34 31.7 32  N 12 12 12 12 12 12 12 12 12 12 12 12 12  2(M) Mean 30 37.3 32.3 39.3 32 32.7 36.3 35 35.3 35.7 38 37.3 33. N 12 12 12 12 12 12 12 12 12 12 12 12 12  3(M) Mean 31 36.3 29.3 35.7 30.7 33 32 37.3 33 38 41 34.7 33. N 12 12 12 12 12 12 12 12 12 12 12 12 12  4(M) Mean 28.7 35.7 25 35 28.3 27.7 35 36.7 29 30 31.3 31.3 29. N 12 12 12 12 12 12 12 12 12 12 12 12 12 Water Consumption = g/animal/day. Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 11 (continued) Group Mean Daily Water Consumptions  Day Numbers Relative to Start Date  Group From: 2 3 4 5 6 7 8 9 10 11 12 13 14  (Sex) To: 3 4 5 6 7 8 9 10 11 12 13 14 15  1(F) Mean 23.3 28.7 21.7 27 26.3 25.3 27 26 27.3 26.3 25.3 24.7 27  N 12 12 12 12 12 12 12 12 12 12 12 12 12  2(F) Mean 21 24 22.3 26.7 22.3 23 26 23.7 23.3 25.3 26.3 24 23. N 12 12 12 12 12 12 12 12 12 12 12 12 12  3(F) Mean 23.7 27 22.3 26 24.7 25 28 27.7 25.3 25.7 28.3 24.3 27  N 12 12 12 12 12 12 12 12 12 12 12 12 12  4(F) Mean 22 29.3 21 27.3 21.3 26.3 28 28 23 26.7 27.3 25 25. N 8 12 12 12 12 12 12 12 12 12 12 12 12 Water Consumption = g/animal/day. Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day   
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 12 Summary Incidence of Mating Performance, Fertility and Gestation Lengths 

Group 

Number

of 

Males 

Paired

Number of Females Pre-Coital Interval (Days) Mating 

Index 

(%) 

Pregnancy

Index 

(%) 

Gestation Length (D

Paired Mated Pregnant 1 2 3 4 11 22 221⁄2 23 23

1 12 12 12 11 3 4 3 1 1 100 92 0 1 3 7 2 12 12 12 12 4 1 4 3 0 100 100 1 3 3 5 3 12 12 12 11 3 3 5 1 0 100 92 0 1 2 6 4 12 12 12 12 1 3 5 3 0 100 100 3 1 2 6 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 13 Group Mean Litter Size and Litter Weights 

Group 

Number 

of 

Corpora 

Lutea 

Number of 

Implantation

Sites 

Total 

Number of Offspring 

Born 

Number of Live 

Offspring 

Litter Weight 

(g) 

Offspring Weight (g) 

Day 1 Day 4 

Day 1 Day 4 Day 1 Day 4 Males Females Males Female

1 Mean 15.0 14.2 13.3 13.1 13.0 77.18 106.82 6.08 5.85 8.47 8.15 

S.D. 2.4 2.1 2.3 2.3 2.4 9.92 11.98 0.51 0.43 0.96 0.92 N 10 10 10 10 10 10 10 10 10 10 10 

2 Mean 14.5 13.7 12.9 12.8 12.3 73.06 99.76 6.02 5.63 8.57 8.12 

S.D. 1.8 2.8 2.8 2.8 2.8 11.64 15.36 0.54 0.65 1.20 1.27 

N 12 12 12 12 12 12 12 12 12 12 12 

3 Mean 14.9 14.5 13.3 13.3 12.8 82.80 112.78 6.48 6.07 9.11 8.65 

S.D. 2.3 2.1 2.1 2.1 1.9 11.47 14.18 0.62 0.63 1.19 1.10 N 11 11 11 11 11 11 11 11 11 11 11 

4 Mean 13.3 11.8 10.4* 10.3 10.2 64.46 90.87 6.54 6.19 9.56 9.10 

S.D. 2.5 3.3 3.8 3.7 3.7 21.55 26.23 0.60 0.76 1.48 1.51 N 12 12 12 12 12 12 12 12 12 12 12 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 14 Group Mean Implantation Losses and Survival Indices Values 

Group 

PreImplantation 

Loss (%)

Post -

Implantation 

Loss (%) 

Live 

Birth 

Index (%) 

Viability Index (%) 

1 Mean 4.7 6.4 98.6 99.1 

S.D. 9.5 5.1 4.5 2.9 N 10 10 10 10 

2 Mean 6.2 5.4 98.8 96.2 

S.D. 14.3 5.2 2.9 7.4 N 12 12 12 12 

3 Mean 2.7 8.3 100.0 97.0 

S.D. 6.0 4.1 0.0 7.7 N 11 11 11 11 

4 Mean 12.4 13.6 99.4 98.7 

S.D. 16.2 17.5 2.1 3.1 N 12 12 12 12 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 15 Group Mean Sex Ratio Values 

Group 

Sex Ratio (% Males) Post Partum Day: 

At birth 1 4 

1 Mean 55.6 54.9 55.4 

S.D. 8.5 8.6 8.8 N 10 10 10 

2 Mean 53.9 53.4 54.2 

S.D. 13.2 13.1 13.1 N 12 12 12 

3 Mean 53.7 53.7 54.3 

S.D. 13.4 13.4 13.4 N 11 11 11 

4 Mean 50.9 50.9 51.7 

S.D. 15.3 15.3 16.1 N 12 12 12 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 16 Summary Incidence of Clinical Signs for Offspring 

Dose Level (mg/kg bw/day) 

0 (Control) 30 300 

Number of litters 11 12 11 Small . 1M 1F (2) . Cold . 8M 6F (1) . Bruising to neck region . 1F (1) . 

Swollen abdomen . 1M (1) . 

Swollen snout . . . 

Missing 4M 11F (2) 3M 3F (3) 2M 3F (2) Found dead 2M (1) 2M (2) . () = Number of litters 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 17 Group Mean Reflexological Responses for Offspring 

Group Surface Righting (% passed) 

1 Mean 94.6 

S.D. 6.8 N 11 

2 Mean 91.6 

S.D. 7.2 N 12 

3 Mean 94.7 

S.D. 9.4 N 11 

4 Mean 97.8 

S.D. 5.6 N 12 

 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 18 Group Mean Haematological Values  Group Hb RBC Hct MCH MCV MCHC WBC Neut  (Sex) g/dl 10^12/l % pg fl g/dl 10^9/l 10^9/l  1(M) Mean 16.58 9.104 50.60 18.20 55.58 32.78 8.20 1.608  S.D. 0.41 0.171 1.29 0.50 1.56 0.26 2.21 1.226  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  2(M) Mean 16.12 9.062 49.16 17.84 54.26 32.82 9.54 1.282  S.D. 0.97 0.545 3.08 0.51 1.48 0.19 0.71 0.506  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  3(M) Mean 15.88 8.954 48.66 17.70 54.36 32.60 6.84 1.244  S.D. 0.64 0.296 1.44 0.19 0.49 0.37 1.87 0.585  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  4(M) Mean 14.80* 8.280* 44.90** 17.88 54.26 32.92 6.00 0.870  S.D. 1.47 0.875 4.70 0.19 0.42 0.23 1.18 0.382  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 18 (continued) Group Mean Haematological Values  Group Lymph Mono Eos Bas CT PLT APTT  (Sex) 10^9/l 10^9/l 10^9/l 10^9/l Seconds 10^9/l Seconds  1(M) Mean 6.566 0.014n 0.014n 0.000n 9.72 529.2 15.34  S.D. 1.390 0.031 0.031 0.000 0.66 41.4 3.39  N 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  2(M) Mean 8.240 0.018n 0.000n 0.000n 9.72 625.0 15.88  S.D. 1.018 0.040 0.000 0.000 0.41 71.8 1.50  N 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  3(M) Mean 5.546 0.000n 0.050n 0.000n 9.72 600.4 15.04  S.D. 1.739 0.000 0.062 0.000 0.59 108.7 1.67  N 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  4(M) Mean 5.070 0.000n 0.058n 0.000n 9.60 531.0 13.32  S.D. 1.237 0.000 0.058 0.000 0.49 47.2 1.88  N 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 18 (continued) Group Mean Haematological Values  Group Hb RBC Hct MCH MCV MCHC WBC Neut  (Sex) g/dl 10^12/l % pg fl g/dl 10^9/l 10^9/l  1(F) Mean 12.96 6.822 39.82 19.00 58.36 32.58 7.48 1.966  S.D. 1.02 0.607 3.32 0.34 1.10 0.29 1.55 0.899  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  2(F) Mean 13.44 7.288 41.06 18.46 56.38 32.76 5.98 1.894  S.D. 0.59 0.393 1.38 0.61 1.69 0.55 1.29 0.926  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  3(F) Mean 13.04 6.866 39.84 19.00 58.10 32.70 6.20 2.038  S.D. 1.34 0.687 3.49 0.61 1.39 0.68 2.02 0.847  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  4(F) Mean 12.78 6.834 39.06 18.72 57.16 32.76 4.90* 1.526  S.D. 3.04 1.652 9.42 0.57 1.62 0.33 1.35 0.598  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 18 (continued) Group Mean Haematological Values  Group Lymph Mono Eos Bas CT PLT APTT  (Sex) 10^9/l 10^9/l 10^9/l 10^9/l Seconds 10^9/l Seconds  1(F) Mean 5.514 0.000n 0.000n 0.000n 9.76 912.2 15.88  S.D. 1.497 0.000 0.000 0.000 1.01 33.4 2.85  N 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  2(F) Mean 4.086 0.000n 0.000n 0.000n 9.33 812.2 15.45  S.D. 1.026 0.000 0.000 0.000 0.21 422.7 1.05  N 5 5 5 5 4 5 4  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  3(F) Mean 4.148 0.014n 0.000n 0.000n 9.76 891.4 14.58  S.D. 1.451 0.031 0.000 0.000 0.77 104.7 2.39  N 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  4(F) Mean 3.350* 0.000n 0.028*,n 0.000n 9.74 658.6 16.10  S.D. 0.976 0.000 0.048 0.000 0.62 375.2 1.45  N 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 19 Group Mean Blood Chemical Values  Tot.  Group Urea Glucose Prot. Albumin A/G Na+ K+ Clƒ Ca++  (Sex) mg/dl mg/dl g/dl g/dl Ratio mmol/l mmol/l mmol/l mmol/l  1(M) Mean 55.8 173.6 6.798 3.70 1.198 146.0 5.094 101.0 2.652  S.D. 7.8 15.2 0.583 0.37 0.118 2.2 1.185 1.2 0.089  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  2(M) Mean 49.6 178.6 6.590 3.56 1.180 145.6 4.686 101.6 2.590  S.D. 4.3 9.2 0.270 0.11 0.098 2.4 0.416 1.7 0.078  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  3(M) Mean 47.8 155.6 6.236* 3.60 1.368* 148.4 4.688 102.6 2.598  S.D. 5.8 31.9 0.414 0.22 0.121 2.3 0.140 2.6 0.119  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  4(M) Mean 47.4 163.0 6.100* 3.56 1.432** 145.8 4.816 100.2 2.632  S.D. 8.8 13.8 0.377 0.13 0.138 2.3 0.738 1.6 0.049  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 19 (continued) Group Mean Blood Chemical Values  Group P ASAT ALAT AP Creat Chol Bili Bile Acid  (Sex) mmol/l IU/l IU/l IU/l mg/dl mg/dl mg/dl μmol/l 

 1(M) Mean 2.10 109.6 62.6 151.6 0.808 80.0 0.092 11.16  S.D. 0.32 21.4 5.6 29.6 0.181 15.0 0.024 10.55  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(M) Mean 1.82 115.0 67.0 131.8 0.768 85.4 0.076 8.86  S.D. 0.28 27.0 6.2 19.3 0.058 11.8 0.018 6.15  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(M) Mean 2.14 129.2 65.0 156.0 0.678* 81.2 0.064 9.52  S.D. 0.27 18.2 11.7 61.3 0.039 5.9 0.015 9.53  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(M) Mean 2.02 141.0 73.6 147.6 0.630* 75.0 0.088 14.44  S.D. 0.27 44.9 26.2 36.0 0.053 7.0 0.020 11.49  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 19 (continued) Group Mean Blood Chemical Values  Tot.  Group Urea Glucose Prot. Albumin A/G Na+ K+ Clƒ Ca++  (Sex) mg/dl mg/dl g/dl g/dl Ratio mmol/l mmol/l mmol/l mmol/l  1(F) Mean 47.6 126.6 6.294 3.76 1.476 145.0 4.716 102.4 2.596  S.D. 3.6 10.9 0.343 0.18 0.102 2.9 0.470 1.8 0.040  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  2(F) Mean 58.0 155.8* 5.916 3.54 1.496 145.8 4.718 104.0 2.550  S.D. 11.0 22.6 0.352 0.27 0.236 1.8 0.694 1.4 0.118  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  3(F) Mean 49.8 130.2 6.050 3.60 1.470 145.0 4.246 103.2 2.478  S.D. 3.1 11.0 0.524 0.29 0.096 1.9 0.330 1.9 0.128  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  4(F) Mean 52.6 141.8 5.894 3.56 1.560 146.2 4.770 103.6 2.404*  S.D. 7.7 14.6 0.680 0.29 0.217 3.8 0.691 2.4 0.201  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 19 (continued) Group Mean Blood Chemical Values  Group P ASAT ALAT AP Creat Chol Bili Bile Acid  (Sex) mmol/l IU/l IU/l IU/l mg/dl mg/dl mg/dl μmol/l 

 1(F) Mean 1.66 85.6 80.4 113.6 0.664 77.8 0.084 11.36  S.D. 0.31 15.0 15.9 29.1 0.032 28.4 0.011 8.71  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2(F) Mean 1.34 141.6 95.8 159.8 0.850 73.6 0.078 15.54  S.D. 0.34 61.1 25.9 83.7 0.264 11.8 0.013 10.83  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3(F) Mean 1.14* 113.8 74.8 144.2 0.734 78.8 0.068 12.28  S.D. 0.34 42.5 8.9 58.5 0.130 7.7 0.013 9.99  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4(F) Mean 0.66** 117.2 80.2 179.6 0.696 78.4 0.080 11.56  S.D. 0.34 46.5 8.1 93.2 0.129 15.2 0.020 4.87  N 5 5 5 5 5 5 5 5  ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 20 Summary Incidence of Offspring Necropsy Findings 

Interim Deaths Terminal Kill (Day 

Group Post-Partum Day of Termination Number of affected Litters Number of offspring Macroscopic Findings Number of Litters Number of Offspring 

1 Pre Day 1 1 2M Autolytic changes detected 10 . 

2 Pre Day 1 1 1M Autolytic changes detected 1 1F 

 1 1 1M Autolytic changes detected 11 . 

3 1 1M 

 10 . 

4 1 1 1M Autolytic changes detected 2 2F 

 10 . 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 21 Summary Incidence of Necropsy Findings  ------------ MALES -------Removal Reason: SCHEDULED KILL ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 0 30 300 1 (Control) mg/kg bw/da Number of Animals Examined : 12 12 12  Group : (1) (2) (3)  ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒBrain (Including Cerebrum, Cerebellum And Pons);  Submitted........................................................................................ (6) (6) (5)  No Visible Lesions............................................................................... 6 5 5  Damaged On Removal .............................................................................. 0 1 0 Epididymides;  Submitted........................................................................................ (12) (12) (12)  No Visible Lesions............................................................................... 12 12 11  Small ........................................................................................... 0 0 1 Lungs (With Bronchi);  Submitted........................................................................................ (6) (6) (5)  No Visible Lesions............................................................................... 6 6 5  Reddened ........................................................................................ 0 0 0 Seminal Vesicles;  Submitted........................................................................................ (12) (12) (12)  No Visible Lesions............................................................................... 11 12 12  Small; right horn ............................................................................... 1 0 0 Spleen;  Submitted........................................................................................ (6) (6) (5)  No Visible Lesions............................................................................... 6 6 5  Dark ............................................................................................ 0 0 0 Testes;  Submitted........................................................................................ (12) (12) (12)  No Visible Lesions............................................................................... 12 12 11  Small ........................................................................................... 0 0 1  Flaccid ......................................................................................... 0 0 1 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 21 (continued) Summary Incidence of Necropsy Findings  ----------- FEMALES ------Removal Reason: SCHEDULED KILL ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 0 30 300 1 (Control) mg/kg bw/da Number of Animals Examined : 12 12 12  Group : (1) (2) (3)  ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒGross Lesions;  Submitted........................................................................................ (12) (12) (12)  No Visible Lesions............................................................................... 12 12 12  Mass; right fore limb ........................................................................... 0 0 0 Kidneys;  Submitted........................................................................................ (6) (5) (5)  No Visible Lesions............................................................................... 5 5 5  Increased Pelvic Space; left .................................................................... 1 0 0 Urinary Bladder;  Submitted........................................................................................ (6) (5) (5)  No Visible Lesions............................................................................... 5 5 5  Mineral Calculi ................................................................................. 1 0 0 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 22 Group Mean Organ Weights with Corresponding Relative (% of Body Weight) Organ W ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ MALES ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ FEMALES ƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 0 30 300 1000 0 30 300 1000 Control mg/kg bw/day Control mg/kg bw/day  ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒTerminal Bodyweight ........... Mean (g) 387.8 391.2 392.7 396.8 271.8 270.7 278.3 273.2 S.D. 19.8 15.2 17.9 23.1 19.8 16.6 17.7 21.0 N 12 12 12 12 12 12 12 12 Adrenals ...................... Mean (g) 0.06822 0.07550 0.08304 0.08130 0.10566 0.09568 0.09664 0.10288 S.D. 0.01271 0.01836 0.01392 0.00665 0.01676 0.01249 0.01112 0.01068 N 5 5 5 5 5 5 5 5  Mean (%) 0.018 0.019 0.021 0.021 0.039 0.035 0.035 0.03 S.D. 0.003 0.004 0.003 0.002 0.006 0.005 0.003 0.00 N 5 5 5 5 5 5 5 5 Brain (Including Cerebrum, Cerebellum And Pons) .......... Mean (g) 2.04764 2.08708 2.04328 2.04698 1.89254 1.86992 1.92750 1.86830 S.D. 0.10479 0.07051 0.12760 0.05783 0.07104 0.05434 0.10713 0.06019 N 5 5 5 5 5 5 5 5  Mean (%) 0.532 0.518 0.517 0.522 0.696 0.674 0.707 0.68 S.D. 0.019 0.011 0.027 0.012 0.052 0.039 0.051 0.06 N 5 5 5 5 5 5 5 5 Epididymides .................. Mean (g) 1.50231 1.48043 1.41907 1.47703  S.D. 0.21300 0.23576 0.37600 0.12940  N 12 12 12 12  Mean (%) 0.387 0.378 0.362 0.374  S.D. 0.051 0.058 0.097 0.042  N 12 12 12 12 Heart ......................... Mean (g) 0.99584 1.01492 1.08980 1.02040 0.88390 0.90178 0.87132 0.86090 S.D. 0.03942 0.08959 0.11791 0.10876 0.10378 0.05219 0.06145 0.12236 N 5 5 5 5 5 5 5 5  Mean (%) 0.259 0.252 0.276 0.260 0.324 0.325 0.319 0.31 S.D. 0.010 0.017 0.029 0.025 0.035 0.016 0.025 0.02 N 5 5 5 5 5 5 5 5 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 22 (continued) Group Mean Organ Weights with Corresponding Relative (% of Body Weigh ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ MALES ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ FEMALES ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 0 30 300 1000 0 30 300 1000 Control mg/kg bw/day Control mg/kg bw/day  ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒKidneys ....................... Mean (g) 2.37476 2.24916 2.33842 2.25434 1.72216 1.72392 1.66360 1.68630 S.D. 0.19848 0.19924 0.23691 0.06681 0.11285 0.09355 0.19112 0.11478 N 5 5 5 5 5 5 5 5  Mean (%) 0.617 0.557 0.591 0.575 0.632 0.620 0.608 0.62 S.D. 0.042 0.037 0.049 0.026 0.035 0.031 0.055 0.02 N 5 5 5 5 5 5 5 5 Liver ......................... Mean (g) 11.9881 12.2413 11.7700 11.5083 11.3415 11.2092 10.9708 10.9126 S.D. 0.98753 1.27728 1.00921 1.25170 0.37037 0.52721 0.51282 1.44201 N 5 5 5 5 5 5 5 5  Mean (%) 3.117 3.033 2.978 2.932 4.169 4.038 4.016 3.99 S.D. 0.239 0.255 0.265 0.253 0.281 0.256 0.120 0.29 N 5 5 5 5 5 5 5 5 Ovaries ....................... Mean (g) 0.12268 0.11463 0.11986 0.12328 S.D. 0.02237 0.02122 0.01244 0.01441 N 12 12 12 12  Mean (%) 0.046 0.042 0.043 0.04 S.D. 0.009 0.006 0.004 0.00 N 12 12 12 12 Pituitary ..................... Mean (g) 0.01053 0.01124 0.01071 0.00841** 0.01362 0.01458 0.01492 0.01438 S.D. 0.00128 0.00214 0.00219 0.00137 0.00286 0.00282 0.00254 0.00285 N 12 12 12 12 12 12 12 12  Mean (%) 0.003 0.003 0.003 0.002** 0.005 0.005 0.005 0.00 S.D. 0.000 0.001 0.001 0.000 0.001 0.001 0.001 0.00 N 12 12 12 12 12 12 12 12 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Table 22 (continued) Group Mean Organ Weights with Corresponding Relative (% of Body Weigh ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ MALES ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ FEMALES ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 0 30 300 1000 0 30 300 1000 Control mg/kg bw/day Control mg/kg bw/day  ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒProstate ...................... Mean (g) 0.65223 0.66563 0.60388 0.58856  S.D. 0.07289 0.12843 0.11031 0.15725  N 12 12 12 12  Mean (%) 0.168 0.170 0.154 0.147  S.D. 0.020 0.033 0.030 0.032  N 12 12 12 12 Seminal Vesicles .............. Mean (g) 2.33127 2.10186 2.26599 2.06461  S.D. 0.19256 0.39853 0.40337 0.39151  N 12 12 12 12  Mean (%) 0.602 0.537 0.578 0.521  S.D. 0.052 0.101 0.101 0.098  N 12 12 12 12 Spleen ........................ Mean (g) 0.72358 0.70430 0.72820 0.76134 0.64742 0.62800 0.68288 0.66776 S.D. 0.11851 0.05583 0.07667 0.06513 0.06510 0.13053 0.07843 0.08914 N 5 5 5 5 5 5 5 5  Mean (%) 0.188 0.175 0.184 0.194 0.238 0.226 0.250 0.24 S.D. 0.028 0.011 0.019 0.013 0.022 0.045 0.031 0.04 N 5 5 5 5 5 5 5 5 Testes ........................ Mean (g) 3.84450 3.72373 3.51740 3.82026  S.D. 0.41833 0.25064 0.79151 0.33606  N 12 12 12 12  Mean (%) 0.993 0.952 0.898 0.966  S.D. 0.113 0.061 0.203 0.102  N 12 12 12 12 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Table 22 (continued) Group Mean Organ Weights with Corresponding Relative (% of Body Weigh ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ MALES ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ FEMALES ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 0 30 300 1000 0 30 300 1000 Control mg/kg bw/day Control mg/kg bw/day  ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒThymus ........................ Mean (g) 0.39198 0.47070 0.41596 0.42490 0.26990 0.27214 0.23954 0.25296 S.D. 0.05982 0.09849 0.06967 0.09363 0.11311 0.08815 0.03036 0.06277 N 5 5 5 5 5 5 5 5  Mean (%) 0.102 0.117 0.105 0.108 0.098 0.098 0.088 0.09 S.D. 0.015 0.023 0.018 0.021 0.038 0.032 0.013 0.02 N 5 5 5 5 5 5 5 5 Thyroid/Parathyroid ........... Mean (g) 0.01754 0.02020 0.01952 0.02070 0.01294 0.01728 0.01708 0.01872 S.D. 0.00512 0.00125 0.00411 0.00155 0.00186 0.00493 0.00409 0.00373 N 5 5 5 5 5 5 5 5  Mean (%) 0.005 0.005 0.005 0.005 0.005 0.006 0.006 0.00 S.D. 0.001 0.000 0.001 0.000 0.000 0.002 0.002 0.00 N 5 5 5 5 5 5 5 5 Uterus & Cervix ............... Mean (g) 0.74216 0.69504 0.67338 0.63584 S.D. 0.15435 0.08060 0.09863 0.13801 N 12 12 12 12  Mean (%) 0.274 0.257 0.243 0.23 S.D. 0.057 0.030 0.039 0.04 N 12 12 12 12   
PAGE 114 PROJECT NUMBER: 41104692R 
 PROJECT NUMBER: 41104692R PAGE 115

FIGURES 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Figure 1 Group Mean Body Weights - Males 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Figure 2 Group Mean Body Weights - FemalesPre-Pairing 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Figure 2 (continued) Group Mean Body Weights - Females Gestation 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Figure 3 Group Mean Food Consumption - Males 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Figure 4 Group Mean Food Consumption - Females
 PROJECT NUMBER: 41104692R PAGE 121 

APPENDICES 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 Individual Daily Clinical Observations  Day Numbers Relative to Start Date Group Animal 1 1 1 1 2 2 2 2 3 3 3 3 4 4 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post  1(M) 1 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  2 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  3 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  4 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  5 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  6 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  7 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  8 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  9 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  10 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  11 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  12 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 4 5 5 5 6 6 6 6 7 7 7 7 8 8 (Sex) Number Clinical Sign 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post  1(M) 1 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  2 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  3 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  4 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  5 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  6 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  7 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  8 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  9 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  10 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  11 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  12 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 8 8 9 9 9 9 10 10 10 10 11 11 11 12 (Sex) Number Clinical Sign 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre  1(M) 1 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  2 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  3 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  4 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  5 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  6 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  7 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  8 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  9 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  10 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  11 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  12 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 12 12 13 13 13 13 14 14 14 14 15 15 15 15 (Sex) Number Clinical Sign Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h  1(M) 1 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  2 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  3 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  4 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  5 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  6 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  7 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  8 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  9 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  10 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  11 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  12 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 16 16 16 16 17 17 17 17 18 18 18 19 19 19 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  1(M) 1 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  2 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  3 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  4 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  5 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  6 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  7 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  8 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  9 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  10 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  11 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  12 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 20 20 20 20 21 21 21 22 22 22 23 23 23 23 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  1(M) 1 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  2 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  3 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  4 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  5 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  6 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  7 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  8 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  9 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  10 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  11 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  12 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 24 24 24 24 25 25 25 26 26 26 27 27 27 27 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  1(M) 1 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  2 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  3 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  4 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  5 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  6 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  7 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  8 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  9 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  10 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  11 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  12 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 28 28 28 29 29 29 29 30 30 30 30 31 31 31 (Sex) Number Clinical Sign Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  1(M) 1 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  2 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  3 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  4 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  5 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  6 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  7 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  8 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  9 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  10 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  11 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  12 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 31 32 32 32 33 33 33 34 34 34 34 35 35 35 (Sex) Number Clinical Sign 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h  1(M) 1 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  2 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  3 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  4 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  5 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  6 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  7 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  8 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  9 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  10 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  11 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  12 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 35 36 36 36 36 37 37 37 37 38 38 38 38 39 (Sex) Number Clinical Sign 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre  1(M) 1 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  2 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  3 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  4 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  5 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  6 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  7 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  8 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  9 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  10 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  11 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  12 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 39 39 40 40 40 41 41 41 41 42 42 42 42 43 (Sex) Number Clinical Sign Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h A.M.  1(M) 1 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  2 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  3 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  4 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  5 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  6 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  7 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  8 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  9 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  10 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  11 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  12 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date Group Animal 1 1 1 1 2 2 2 2 3 3 3 3 4 4 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post  2(M) 25 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  26 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  27 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  28 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  29 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  30 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  31 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  32 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  33 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  34 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  35 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  36 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 4 5 5 5 6 6 6 6 7 7 7 7 8 8 (Sex) Number Clinical Sign 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post  2(M) 25 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  26 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  27 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  28 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  29 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  30 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  31 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  32 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  33 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  34 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  35 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  36 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 8 8 9 9 9 9 10 10 10 10 11 11 11 12 (Sex) Number Clinical Sign 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre  2(M) 25 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  26 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  27 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  28 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  29 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  30 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  31 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  32 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  33 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  34 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  35 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  36 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 12 12 13 13 13 13 14 14 14 14 15 15 15 15 (Sex) Number Clinical Sign Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h  2(M) 25 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  26 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  27 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  28 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  29 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  30 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  31 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  32 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  33 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  34 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  35 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  36 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 16 16 16 16 17 17 17 17 18 18 18 19 19 19 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  2(M) 25 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  26 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  27 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  28 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  29 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  30 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  31 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  32 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  33 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  34 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  35 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  36 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 20 20 20 20 21 21 21 22 22 22 23 23 23 23 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  2(M) 25 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  26 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  27 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  28 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  29 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  30 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  31 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  32 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  33 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  34 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  35 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  36 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 24 24 24 24 25 25 25 26 26 26 27 27 27 27 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  2(M) 25 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  26 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  27 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  28 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  29 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  30 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  31 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  32 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  33 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  34 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  35 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  36 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 28 28 28 29 29 29 29 30 30 30 30 31 31 31 (Sex) Number Clinical Sign Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  2(M) 25 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  26 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  27 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  28 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  29 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  30 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  31 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  32 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  33 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  34 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  35 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  36 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 31 32 32 32 33 33 33 34 34 34 34 35 35 35 (Sex) Number Clinical Sign 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h  2(M) 25 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  26 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  27 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  28 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  29 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  30 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  31 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  32 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  33 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  34 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  35 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  36 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 35 36 36 36 36 37 37 37 37 38 38 38 38 39 (Sex) Number Clinical Sign 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre  2(M) 25 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  26 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  27 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  28 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  29 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  30 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  31 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  32 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  33 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  34 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  35 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  36 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 39 39 40 40 40 41 41 41 41 42 42 42 42 43 (Sex) Number Clinical Sign Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h A.M.  2(M) 25 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  26 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  27 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  28 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  29 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  30 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  31 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  32 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  33 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  34 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  35 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  36 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date Group Animal 1 1 1 1 2 2 2 2 3 3 3 3 4 4 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post  3(M) 49 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  50 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  51 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  52 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  53 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  54 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  55 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  56 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  57 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  58 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  59 No Abnormalities Detected X X X X X X X X X X X X X X  Abnormal Gait . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 4 5 5 5 6 6 6 6 7 7 7 7 8 8 (Sex) Number Clinical Sign 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post  3(M) 49 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  50 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  51 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  52 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  53 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  54 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  55 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  56 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  57 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  58 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  59 No Abnormalities Detected X X X X X X X X X X X X . .  Abnormal Gait . . . . . . . . . . . . X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 8 8 9 9 9 9 10 10 10 10 11 11 11 12 (Sex) Number Clinical Sign 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre  3(M) 49 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  50 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  51 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  52 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  53 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  54 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  55 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  56 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  57 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  58 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  59 No Abnormalities Detected . . . . . . . . . . . . . .  Abnormal Gait X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 12 12 13 13 13 13 14 14 14 14 15 15 15 15 (Sex) Number Clinical Sign Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h  3(M) 49 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  50 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  51 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  52 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  53 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  54 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  55 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  56 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  57 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  58 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  59 No Abnormalities Detected . . . . . . . . . . . . . .  Abnormal Gait X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 16 16 16 16 17 17 17 17 18 18 18 19 19 19 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  3(M) 49 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  50 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  51 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  52 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  53 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  54 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  55 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  56 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  57 No Abnormalities Detected X X X X X X X X X X X X . .  Scab . . . . . . . . . . . . X X  Scheduled kill . . . . . . . . . . . . . .  58 No Abnormalities Detected X X X X X X X X X X X X . .  Scab . . . . . . . . . . . . X X  Scheduled kill . . . . . . . . . . . . . .  59 No Abnormalities Detected . . . . . . . . . . . . . .  Abnormal Gait X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 20 20 20 20 21 21 21 22 22 22 23 23 23 23 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  3(M) 49 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  50 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  51 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  52 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  53 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  54 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  55 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  56 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  57 No Abnormalities Detected . . . . . . . . . . X X X X  Scab X X X X X X X X X X . . . .  Scheduled kill . . . . . . . . . . . . . .  58 No Abnormalities Detected . . . . . . . . . . X X X X  Scab X X X X X X X X X X . . . .  Scheduled kill . . . . . . . . . . . . . .  59 No Abnormalities Detected . . . . . . . . . . . . . .  Abnormal Gait X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 24 24 24 24 25 25 25 26 26 26 27 27 27 27 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  3(M) 49 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  50 No Abnormalities Detected X X X X X X X X X X . . . .  Scab . . . . . . . . . . X X X X  Scheduled kill . . . . . . . . . . . . . .  51 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  52 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  53 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  54 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  55 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  56 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  57 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  58 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  59 No Abnormalities Detected . . . . . . . . . . . . . .  Abnormal Gait X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 28 28 28 29 29 29 29 30 30 30 30 31 31 31 (Sex) Number Clinical Sign Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  3(M) 49 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  50 No Abnormalities Detected . . . . . . . . . . . . . .  Scab X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  51 No Abnormalities Detected X X X . . . . . . . . . . .  Scab . . . X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  52 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  53 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  54 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  55 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  56 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  57 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  58 No Abnormalities Detected X X X . . . . . . . . . . .  Scab . . . X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  59 No Abnormalities Detected . . . . . . . . . . . . . .  Abnormal Gait X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 31 32 32 32 33 33 33 34 34 34 34 35 35 35 (Sex) Number Clinical Sign 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h  3(M) 49 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  50 No Abnormalities Detected . . . . . . . . . . . . . .  Scab X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  51 No Abnormalities Detected . . . . . . . . . . . . . .  Scab X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  52 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  53 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  54 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  55 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  56 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  57 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  58 No Abnormalities Detected . . . . . . . . . . . . . .  Scab X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  59 No Abnormalities Detected . . . . . . . . . . . . . .  Abnormal Gait X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 35 36 36 36 36 37 37 37 37 38 38 38 38 39 (Sex) Number Clinical Sign 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre  3(M) 49 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  50 No Abnormalities Detected . . . . . . . . . . . . . .  Scab X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  51 No Abnormalities Detected . . . . . . . . . . . . . .  Scab X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  52 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  53 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  54 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  55 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  56 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  57 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  58 No Abnormalities Detected . . . . . . . . . . . . . .  Scab X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  59 No Abnormalities Detected . . . . . . . . . . . . . .  Abnormal Gait X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 39 39 40 40 40 41 41 41 41 42 42 42 42 43 (Sex) Number Clinical Sign Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h A.M.  3(M) 49 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  50 No Abnormalities Detected . . . . . . . . . . . . . X  Scab X X X X X X X X X X X X X .  Scheduled kill . . . . . . . . . . . . . X  51 No Abnormalities Detected . . . . . . . . . . . . . X  Scab X X X X X X X X X X X X X .  Scheduled kill . . . . . . . . . . . . . X  52 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  53 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  54 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  55 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  56 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  57 No Abnormalities Detected X X X X X X X X X X X X X X  Scab . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . X  58 No Abnormalities Detected . . . . . . . . . . . . . .  Scab X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  59 No Abnormalities Detected . . . . . . . . . . . . . .  Abnormal Gait X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date Group Animal 1 1 1 1 2 2 2 2 3 3 3 3 4 4 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post  3(M) 60 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 4 5 5 5 6 6 6 6 7 7 7 7 8 8 (Sex) Number Clinical Sign 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post  3(M) 60 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 8 8 9 9 9 9 10 10 10 10 11 11 11 12 (Sex) Number Clinical Sign 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre  3(M) 60 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 12 12 13 13 13 13 14 14 14 14 15 15 15 15 (Sex) Number Clinical Sign Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h  3(M) 60 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 16 16 16 16 17 17 17 17 18 18 18 19 19 19 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  3(M) 60 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 20 20 20 20 21 21 21 22 22 22 23 23 23 23 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  3(M) 60 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 24 24 24 24 25 25 25 26 26 26 27 27 27 27 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  3(M) 60 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 28 28 28 29 29 29 29 30 30 30 30 31 31 31 (Sex) Number Clinical Sign Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  3(M) 60 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 31 32 32 32 33 33 33 34 34 34 34 35 35 35 (Sex) Number Clinical Sign 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h  3(M) 60 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 35 36 36 36 36 37 37 37 37 38 38 38 38 39 (Sex) Number Clinical Sign 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre  3(M) 60 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 39 39 40 40 40 41 41 41 41 42 42 42 42 43 (Sex) Number Clinical Sign Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h A.M.  3(M) 60 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date Group Animal 1 1 1 1 2 2 2 2 3 3 3 3 4 4 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post  4(M) 73 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  74 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  75 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  76 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  77 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  78 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  79 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  80 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  81 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  82 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  83 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  84 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 4 5 5 5 6 6 6 6 7 7 7 7 8 8 (Sex) Number Clinical Sign 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post  4(M) 73 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  74 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  75 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  76 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  77 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  78 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  79 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  80 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  81 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  82 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  83 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  84 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 8 8 9 9 9 9 10 10 10 10 11 11 11 12 (Sex) Number Clinical Sign 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre  4(M) 73 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  74 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  75 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  76 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  77 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  78 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  79 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  80 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  81 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  82 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  83 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  84 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 12 12 13 13 13 13 14 14 14 14 15 15 15 15 (Sex) Number Clinical Sign Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h  4(M) 73 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  74 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  75 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  76 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  77 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  78 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  79 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  80 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  81 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  82 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  83 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  84 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 16 16 16 16 17 17 17 17 18 18 18 19 19 19 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  4(M) 73 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  74 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  75 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  76 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  77 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  78 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  79 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  80 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  81 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  82 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  83 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  84 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 20 20 20 20 21 21 21 22 22 22 23 23 23 23 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  4(M) 73 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  74 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  75 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  76 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  77 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  78 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  79 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  80 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  81 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  82 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  83 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  84 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 24 24 24 24 25 25 25 26 26 26 27 27 27 27 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  4(M) 73 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  74 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  75 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  76 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  77 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  78 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  79 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  80 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  81 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  82 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  83 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  84 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 28 28 28 29 29 29 29 30 30 30 30 31 31 31 (Sex) Number Clinical Sign Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  4(M) 73 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  74 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  75 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  76 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  77 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  78 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  79 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  80 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  81 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  82 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  83 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  84 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 31 32 32 32 33 33 33 34 34 34 34 35 35 35 (Sex) Number Clinical Sign 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h  4(M) 73 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  74 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  75 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  76 No Abnormalities Detected X X X X X X X X X X X X . .  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . X X  77 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  78 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  79 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  80 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  81 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  82 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  83 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  84 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 35 36 36 36 36 37 37 37 37 38 38 38 38 39 (Sex) Number Clinical Sign 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre  4(M) 73 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  74 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  75 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  76 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  77 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  78 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  79 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  80 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  81 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  82 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  83 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  84 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 39 39 40 40 40 41 41 41 41 42 42 42 42 43 (Sex) Number Clinical Sign Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h A.M.  4(M) 73 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  74 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  75 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  76 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  Noisy respiration . . . . . . . . . . . . . .  77 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  78 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  79 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  80 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  81 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  82 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  83 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X  84 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . X X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date Group Animal 1 1 1 1 2 2 2 2 3 3 3 3 4 4 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post  1(F) 13 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  14 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  15 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  16 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  17 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  18 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  19 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  20 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  21 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  22 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  23 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  24 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 5 5 5 6 6 6 6 7 7 7 7 8 8 8 (Sex) Number Clinical Sign Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  1(F) 13 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  14 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  15 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  16 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  17 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  18 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  19 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  20 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  21 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  22 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  23 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  24 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 9 9 9 9 10 10 10 10 11 11 11 12 12 12 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  1(F) 13 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  14 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  15 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  16 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  17 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  18 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  19 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  20 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  21 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  22 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  23 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  24 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 13 13 13 14 14 14 14 15 15 15 15 16 16 16 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  1(F) 13 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  14 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  15 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  16 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  17 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  18 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  19 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  20 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  21 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  22 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  23 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  24 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 17 17 17 17 18 18 18 19 19 19 20 20 20 20 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  1(F) 13 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  14 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  15 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  16 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  17 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  18 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  19 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  20 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  21 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  22 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  23 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  24 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 21 21 22 22 22 23 23 23 23 24 24 24 24 25 (Sex) Number Clinical Sign Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre  1(F) 13 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  14 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  15 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  16 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  17 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  18 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  19 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  20 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  21 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  22 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  23 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  24 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 25 26 26 26 27 27 27 27 28 28 28 29 29 29 (Sex) Number Clinical Sign 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h Pre Post 1h  1(F) 13 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  14 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  15 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  16 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  17 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  18 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  19 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  20 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  21 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  22 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  23 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  24 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 30 30 30 30 31 31 31 31 32 32 32 33 33 33 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  1(F) 13 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  14 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  15 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  16 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  17 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  18 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  19 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  20 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  21 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  22 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  23 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  24 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 34 34 34 35 35 35 35 36 36 36 36 37 37 37 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  1(F) 13 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  14 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  15 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  16 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  17 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  18 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  19 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  20 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  21 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  22 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  23 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  24 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 38 38 38 38 39 39 39 40 40 40 41 41 41 41 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  1(F) 13 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  14 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  15 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  16 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  17 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  18 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  19 No Abnormalities Detected . . . . X X X X X X X X X X  Littering X X X X . . . . . . . . . .  Not Observed Due to Littering . X X X . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  20 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  21 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  22 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  23 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  24 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 42 42 42 42 43 43 43 43 43 44 44 44 44 44 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre Post 1h 5h A.M. Pre Post 1h 5h  1(F) 13 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  14 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  15 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  16 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . .  17 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . .  18 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  19 No Abnormalities Detected X X X X X . . . . . . . . .  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  20 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . .  21 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  22 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . .  23 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  24 No Abnormalities Detected X X X X . X X X X X . . . .  Scheduled kill . . . . . . . . . X . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 45 45 45 45 46 46 46 47 47 47 48 48 48 48 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre 1h Pre Post 1h Pre Post 1h 5h  1(F) 13 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  14 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  15 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  16 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  17 No Abnormalities Detected X X X X . X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  18 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  19 No Abnormalities Detected . . . . . . . . . . . . . .  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  20 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  21 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  22 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  23 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  24 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 49 49 49 50 50 50 50 51 51 51 51 52 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h A.M.  1(F) 13 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  14 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  15 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  16 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  17 No Abnormalities Detected X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . X  18 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  19 No Abnormalities Detected . . . . . . . . . . . .  Littering . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  20 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  21 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  22 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  23 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  24 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date Group Animal 1 1 1 1 2 2 2 2 3 3 3 3 4 4 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post  2(F) 37 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  38 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  39 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  40 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  41 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  42 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  43 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  44 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  45 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  46 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  47 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 5 5 5 6 6 6 6 7 7 7 7 8 8 8 (Sex) Number Clinical Sign Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  2(F) 37 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  38 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  39 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  40 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  41 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  42 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  43 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  44 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  45 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  46 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  47 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 9 9 9 9 10 10 10 10 11 11 11 12 12 12 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  2(F) 37 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  38 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  39 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  40 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  41 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  42 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  43 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  44 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  45 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  46 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  47 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 13 13 13 14 14 14 14 15 15 15 15 16 16 16 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  2(F) 37 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  38 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  39 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  40 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  41 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  42 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  43 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  44 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  45 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  46 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  47 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 17 17 17 17 18 18 18 19 19 19 20 20 20 20 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  2(F) 37 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  38 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  39 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  40 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  41 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  42 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  43 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  44 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  45 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  46 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  47 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 21 21 22 22 22 23 23 23 23 24 24 24 24 25 (Sex) Number Clinical Sign Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre  2(F) 37 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  38 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  39 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  40 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  41 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  42 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  43 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  44 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  45 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  46 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  47 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 25 26 26 26 27 27 27 27 28 28 28 29 29 29 (Sex) Number Clinical Sign 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h Pre Post 1h  2(F) 37 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  38 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  39 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  40 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  41 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  42 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  43 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  44 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  45 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  46 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  47 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 30 30 30 30 31 31 31 31 32 32 32 33 33 33 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  2(F) 37 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  38 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  39 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  40 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  41 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  42 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  43 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  44 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  45 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  46 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  47 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 34 34 34 35 35 35 35 36 36 36 36 37 37 37 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  2(F) 37 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  38 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  39 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  40 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  41 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  42 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  43 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  44 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  45 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  46 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  47 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 38 38 38 38 39 39 39 40 40 40 41 41 41 41 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  2(F) 37 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  38 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  39 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  40 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  41 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  42 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  43 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  44 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  45 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  46 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  47 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 42 42 42 42 43 43 43 43 43 44 44 44 44 44 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre Post 1h 5h A.M. Pre Post 1h 5h  2(F) 37 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  38 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . .  39 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . .  40 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . .  41 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  42 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  43 No Abnormalities Detected X X X X . X X X X X . . . .  Scheduled kill . . . . . . . . . X . . . .  44 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  45 No Abnormalities Detected X X X X . X X X X X . . . .  Scheduled kill . . . . . . . . . X . . . .  46 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  47 No Abnormalities Detected X X X X . X X X X X . . . .  Scheduled kill . . . . . . . . . X . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 45 45 45 45 46 46 46 47 47 47 48 48 48 48 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre 1h Pre Post 1h Pre Post 1h 5h  2(F) 37 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  38 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  39 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  40 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  41 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  42 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  43 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  44 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  45 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  46 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  47 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 49 49 49 50 50 50 50 51 51 51 51 52 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h A.M.  2(F) 37 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  38 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  39 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  40 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  41 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  42 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  43 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  44 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  45 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  46 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  47 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date Group Animal 1 1 1 1 2 2 2 2 3 3 3 3 4 4 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post  2(F) 48 No Abnormalities Detected X X X X X X X X X X X X X X  Respiration ƒ Laboured . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Increased salivation . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  Piloƒerection . . . . . . . . . . . . . .  Hunched posture . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 5 5 5 6 6 6 6 7 7 7 7 8 8 8 (Sex) Number Clinical Sign Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  2(F) 48 No Abnormalities Detected X X X X X X X X X X X X X X  Respiration ƒ Laboured . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Increased salivation . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  Piloƒerection . . . . . . . . . . . . . .  Hunched posture . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 9 9 9 9 10 10 10 10 11 11 11 12 12 12 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  2(F) 48 No Abnormalities Detected X X X X X X X X X X X X X X  Respiration ƒ Laboured . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Increased salivation . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  Piloƒerection . . . . . . . . . . . . . .  Hunched posture . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 13 13 13 14 14 14 14 15 15 15 15 16 16 16 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  2(F) 48 No Abnormalities Detected X X X X X X X X X X X X X X  Respiration ƒ Laboured . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Increased salivation . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  Piloƒerection . . . . . . . . . . . . . .  Hunched posture . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 17 17 17 17 18 18 18 19 19 19 20 20 20 20 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  2(F) 48 No Abnormalities Detected X X X X X X X X X X X X X X  Respiration ƒ Laboured . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Increased salivation . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  Piloƒerection . . . . . . . . . . . . . .  Hunched posture . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 21 21 22 22 22 23 23 23 23 24 24 24 24 25 (Sex) Number Clinical Sign Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre  2(F) 48 No Abnormalities Detected X X X X X X X X X X X X X X  Respiration ƒ Laboured . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Increased salivation . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  Piloƒerection . . . . . . . . . . . . . .  Hunched posture . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 25 26 26 26 27 27 27 27 28 28 28 29 29 29 (Sex) Number Clinical Sign 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h Pre Post 1h  2(F) 48 No Abnormalities Detected X X X X X X X X X X X X X X  Respiration ƒ Laboured . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Increased salivation . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  Piloƒerection . . . . . . . . . . . . . .  Hunched posture . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 30 30 30 30 31 31 31 31 32 32 32 33 33 33 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  2(F) 48 No Abnormalities Detected X X X X X X X X X X X X X X  Respiration ƒ Laboured . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Increased salivation . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  Piloƒerection . . . . . . . . . . . . . .  Hunched posture . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 34 34 34 35 35 35 35 36 36 36 36 37 37 37 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  2(F) 48 No Abnormalities Detected X X X X X X X X X X X X X X  Respiration ƒ Laboured . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Increased salivation . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  Piloƒerection . . . . . . . . . . . . . .  Hunched posture . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 38 38 38 38 39 39 39 40 40 40 41 41 41 41 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  2(F) 48 No Abnormalities Detected X X X X X X X X X X X X X X  Respiration ƒ Laboured . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Increased salivation . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  Piloƒerection . . . . . . . . . . . . . .  Hunched posture . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 42 42 42 42 43 43 43 43 43 44 44 44 44 44 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre Post 1h 5h A.M. Pre Post 1h 5h  2(F) 48 No Abnormalities Detected X . . . . X X X X . X X X X  Respiration ƒ Laboured . X . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Increased salivation . X . . . . . . . . . . . .  Noisy respiration . X . . . . . . . . . . . .  Piloƒerection . . X X . . . . . . . . . .  Hunched posture . X X X . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 45 45 45 45 46 46 46 47 47 47 48 48 48 48 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre 1h Pre Post 1h Pre Post 1h 5h  2(F) 48 No Abnormalities Detected . . . . . . . . . . . . . .  Respiration ƒ Laboured . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Increased salivation . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  Piloƒerection . . . . . . . . . . . . . .  Hunched posture . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 49 49 49 50 50 50 50 51 51 51 51 52 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h A.M.  2(F) 48 No Abnormalities Detected . . . . . . . . . . . .  Respiration ƒ Laboured . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  Increased salivation . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . .  Piloƒerection . . . . . . . . . . . .  Hunched posture . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date Group Animal 1 1 1 1 2 2 2 2 3 3 3 3 4 4 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post  3(F) 61 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  62 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  63 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  64 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  65 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  66 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  67 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  68 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  69 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  70 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  71 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 5 5 5 6 6 6 6 7 7 7 7 8 8 8 (Sex) Number Clinical Sign Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  3(F) 61 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  62 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  63 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  64 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  65 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  66 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  67 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  68 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  69 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  70 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  71 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 9 9 9 9 10 10 10 10 11 11 11 12 12 12 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  3(F) 61 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  62 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  63 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  64 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  65 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  66 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  67 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  68 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  69 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  70 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  71 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 13 13 13 14 14 14 14 15 15 15 15 16 16 16 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  3(F) 61 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  62 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  63 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  64 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  65 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  66 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  67 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  68 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  69 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  70 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  71 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 17 17 17 17 18 18 18 19 19 19 20 20 20 20 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  3(F) 61 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  62 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  63 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  64 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  65 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  66 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  67 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  68 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  69 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  70 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  71 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 21 21 22 22 22 23 23 23 23 24 24 24 24 25 (Sex) Number Clinical Sign Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre  3(F) 61 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  62 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  63 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  64 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  65 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  66 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  67 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  68 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  69 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  70 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  71 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 25 26 26 26 27 27 27 27 28 28 28 29 29 29 (Sex) Number Clinical Sign 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h Pre Post 1h  3(F) 61 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  62 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  63 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  64 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  65 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  66 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  67 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  68 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  69 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  70 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  71 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 30 30 30 30 31 31 31 31 32 32 32 33 33 33 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  3(F) 61 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  62 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  63 No Abnormalities Detected X X X X . . . . . . . X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . X X X X X X X . . .  64 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  65 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  66 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  67 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  68 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  69 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  70 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  71 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 34 34 34 35 35 35 35 36 36 36 36 37 37 37 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  3(F) 61 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  62 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  63 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  64 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  65 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  66 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  67 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  68 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  69 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  70 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  71 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 38 38 38 38 39 39 39 40 40 40 41 41 41 41 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  3(F) 61 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  62 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  63 No Abnormalities Detected X X X X X X X . . . X X X X  Littering . . . . . . . X X X . . . .  Not Observed Due to Littering . . . . . . . . X X . . . .  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  64 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  65 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  66 No Abnormalities Detected X X X X X X X . . . X X X X  Littering . . . . . . . X X X . . . .  Not Observed Due to Littering . . . . . . . . X X . . . .  Scheduled kill . . . . . . . . . . . . . .  67 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  68 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  69 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  70 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  71 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 42 42 42 42 43 43 43 43 43 44 44 44 44 44 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre Post 1h 5h A.M. Pre Post 1h 5h  3(F) 61 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  62 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  63 No Abnormalities Detected X X X X . X X X X . X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  64 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . .  65 No Abnormalities Detected X X X X . X X X X X . . . .  Scheduled kill . . . . . . . . . X . . . .  66 No Abnormalities Detected X X X X . X X X X . X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  67 No Abnormalities Detected X X X X . X X X X X . . . .  Scheduled kill . . . . . . . . . X . . . .  68 No Abnormalities Detected X X X X . X X X . X . . . .  Scheduled kill . . . . . . . . . X . . . .  69 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  70 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  71 No Abnormalities Detected X X X X . X X X X X . . . .  Scheduled kill . . . . . . . . . X . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 45 45 45 45 46 46 46 47 47 47 48 48 48 48 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre 1h Pre Post 1h Pre Post 1h 5h  3(F) 61 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  62 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  63 No Abnormalities Detected . . . . . . . . . . . . . .  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . . . .  64 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  65 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  66 No Abnormalities Detected . . . . . . . . . . . . . .  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  67 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  68 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  69 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  70 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  71 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 49 49 49 50 50 50 50 51 51 51 51 52 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h A.M.  3(F) 61 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  62 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  63 No Abnormalities Detected . . . . . . . . . . . .  Littering . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  Noisy respiration . . . . . . . . . . . .  64 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  65 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  66 No Abnormalities Detected . . . . . . . . . . . .  Littering . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  67 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  68 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  69 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  70 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  71 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date Group Animal 1 1 1 1 2 2 2 2 3 3 3 3 4 4 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post  3(F) 72 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 5 5 5 6 6 6 6 7 7 7 7 8 8 8 (Sex) Number Clinical Sign Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  3(F) 72 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 9 9 9 9 10 10 10 10 11 11 11 12 12 12 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  3(F) 72 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 13 13 13 14 14 14 14 15 15 15 15 16 16 16 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  3(F) 72 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 17 17 17 17 18 18 18 19 19 19 20 20 20 20 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  3(F) 72 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 21 21 22 22 22 23 23 23 23 24 24 24 24 25 (Sex) Number Clinical Sign Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre  3(F) 72 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 25 26 26 26 27 27 27 27 28 28 28 29 29 29 (Sex) Number Clinical Sign 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h Pre Post 1h  3(F) 72 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 30 30 30 30 31 31 31 31 32 32 32 33 33 33 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  3(F) 72 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 34 34 34 35 35 35 35 36 36 36 36 37 37 37 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  3(F) 72 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 38 38 38 38 39 39 39 40 40 40 41 41 41 41 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  3(F) 72 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 42 42 42 42 43 43 43 43 43 44 44 44 44 44 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre Post 1h 5h A.M. Pre Post 1h 5h  3(F) 72 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 45 45 45 45 46 46 46 47 47 47 48 48 48 48 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre 1h Pre Post 1h Pre Post 1h 5h  3(F) 72 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 49 49 49 50 50 50 50 51 51 51 51 52 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h A.M.  3(F) 72 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date Group Animal 1 1 1 1 2 2 2 2 3 3 3 3 4 4 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post  4(F) 85 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  86 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  87 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  88 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  89 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  90 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  91 No Abnormalities Detected X X X X X X X X X X X X X X  Mass . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  92 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  93 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  94 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  95 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 5 5 5 6 6 6 6 7 7 7 7 8 8 8 (Sex) Number Clinical Sign Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  4(F) 85 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  86 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  87 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  88 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  89 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  90 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  91 No Abnormalities Detected X X X X X X X X X X X X X X  Mass . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  92 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  93 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  94 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  95 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 9 9 9 9 10 10 10 10 11 11 11 12 12 12 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  4(F) 85 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  86 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  87 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  88 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  89 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  90 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  91 No Abnormalities Detected X X X X X X X X X X X X X X  Mass . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  92 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  93 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  94 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  95 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 13 13 13 14 14 14 14 15 15 15 15 16 16 16 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  4(F) 85 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  86 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  87 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  88 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  89 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  90 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  91 No Abnormalities Detected X X X X X X X X X X X X X X  Mass . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  92 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  93 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  94 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  95 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 17 17 17 17 18 18 18 19 19 19 20 20 20 20 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  4(F) 85 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  86 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  87 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  88 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  89 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  90 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  91 No Abnormalities Detected X X X X X X X X X X X X X X  Mass . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  92 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  93 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  94 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  95 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 21 21 22 22 22 23 23 23 23 24 24 24 24 25 (Sex) Number Clinical Sign Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre  4(F) 85 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  86 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  87 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  88 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  89 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  90 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  91 No Abnormalities Detected X X X X X X X X X X X X X X  Mass . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  92 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  93 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  94 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  95 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 25 26 26 26 27 27 27 27 28 28 28 29 29 29 (Sex) Number Clinical Sign 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h Pre Post 1h  4(F) 85 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  86 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  87 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  88 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  89 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  90 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  91 No Abnormalities Detected X X X X X X X X X X X X X X  Mass . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  92 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  93 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  94 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  95 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 30 30 30 30 31 31 31 31 32 32 32 33 33 33 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  4(F) 85 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  86 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  87 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  88 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  89 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  90 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  91 No Abnormalities Detected X X X X . . . . . . . . . .  Mass . . . . X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  92 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  93 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  94 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  95 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 34 34 34 35 35 35 35 36 36 36 36 37 37 37 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  4(F) 85 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  86 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  87 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  88 No Abnormalities Detected X X X X X X X X X X X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  89 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  90 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  91 No Abnormalities Detected . . . . . . . . . . . . . .  Mass X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  92 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  93 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  94 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  95 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 38 38 38 38 39 39 39 40 40 40 41 41 41 41 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  4(F) 85 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  86 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  87 No Abnormalities Detected X X X X X X X . . . X X X X  Littering . . . . . . . X X X . . . .  Not Observed Due to Littering . . . . . . . . X X . . . .  Scheduled kill . . . . . . . . . . . . . .  88 No Abnormalities Detected X X X X X X X . . . X X X X  Littering . . . . . . . X X X . . . .  Not Observed Due to Littering . . . . . . . . X X . . . .  Scheduled kill . . . . . . . . . . . . . .  89 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  90 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  91 No Abnormalities Detected . . . . . . . . . . . . . .  Mass X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  92 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  93 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  94 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . .  95 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 42 42 42 42 43 43 43 43 43 44 44 44 44 44 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre Post 1h 5h A.M. Pre Post 1h 5h  4(F) 85 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  86 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  87 No Abnormalities Detected X X X X . X X X X . X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  88 No Abnormalities Detected X X X X . X X X X . X X X X  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  89 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . .  90 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  91 No Abnormalities Detected . . . . . . . . . . . . . .  Mass X X X X . X X X X X . . . .  Scheduled kill . . . . . . . . . X . . . .  92 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . .  93 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . .  94 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . .  95 No Abnormalities Detected X X X X . X X X X . X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 45 45 45 45 46 46 46 47 47 47 48 48 48 48 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre 1h Pre Post 1h Pre Post 1h 5h  4(F) 85 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  86 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  87 No Abnormalities Detected . . . . . . . . . . . . . .  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  88 No Abnormalities Detected . . . . . . . . . . . . . .  Littering . . . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  89 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  90 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  91 No Abnormalities Detected . . . . . . . . . . . . . .  Mass . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  92 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . .  93 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  94 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . .  95 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 49 49 49 50 50 50 50 51 51 51 51 52 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h A.M.  4(F) 85 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  86 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  87 No Abnormalities Detected . . . . . . . . . . . .  Littering . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  88 No Abnormalities Detected . . . . . . . . . . . .  Littering . . . . . . . . . . . .  Not Observed Due to Littering . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  89 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  90 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  91 No Abnormalities Detected . . . . . . . . . . . .  Mass . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  92 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  93 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  94 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . .  95 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date Group Animal 1 1 1 1 2 2 2 2 3 3 3 3 4 4 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post  4(F) 96 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 5 5 5 6 6 6 6 7 7 7 7 8 8 8 (Sex) Number Clinical Sign Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  4(F) 96 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 9 9 9 9 10 10 10 10 11 11 11 12 12 12 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  4(F) 96 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 13 13 13 14 14 14 14 15 15 15 15 16 16 16 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  4(F) 96 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 17 17 17 17 18 18 18 19 19 19 20 20 20 20 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  4(F) 96 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 21 21 22 22 22 23 23 23 23 24 24 24 24 25 (Sex) Number Clinical Sign Post 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h 5h Pre  4(F) 96 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 25 26 26 26 27 27 27 27 28 28 28 29 29 29 (Sex) Number Clinical Sign 1h Pre Post 1h Pre Post 1h 5h Pre Post 1h Pre Post 1h  4(F) 96 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day y 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 30 30 30 30 31 31 31 31 32 32 32 33 33 33 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h Pre Post 1h  4(F) 96 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 34 34 34 35 35 35 35 36 36 36 36 37 37 37 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h Pre Post 1h  4(F) 96 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 38 38 38 38 39 39 39 40 40 40 41 41 41 41 (Sex) Number Clinical Sign Pre Post 1h 5h Pre Post 1h Pre Post 1h Pre Post 1h 5h  4(F) 96 No Abnormalities Detected X X X X X X X X X X X X X X  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 42 42 42 42 43 43 43 43 43 44 44 44 44 44 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre Post 1h 5h A.M. Pre Post 1h 5h  4(F) 96 No Abnormalities Detected X X X X X . . . . . . . . .  Scheduled kill . . . . X . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 45 45 45 45 46 46 46 47 47 47 48 48 48 48 (Sex) Number Clinical Sign Pre Post 1h 5h A.M. Pre 1h Pre Post 1h Pre Post 1h 5h  4(F) 96 No Abnormalities Detected . . . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 1 (continued) Individual Daily Clinical Observations  Day Numbers Relative to Start Date (continued) Group Animal 49 49 49 50 50 50 50 51 51 51 51 52 (Sex) Number Clinical Sign Post 1h 5h Pre Post 1h 5h Pre Post 1h 5h A.M.  4(F) 96 No Abnormalities Detected . . . . . . . . . . . .  Scheduled kill . . . . . . . . . . . . X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 2 Individual Behavioural Assessments (Observations)  Day Numbers Relative to Start Date Group Animal (Sex) Number Clinical Sign -1 7 14 20 27 35 41  1(M) 1 No Abnormalities Detected X X X X X X X  2 No Abnormalities Detected X X X X X X X  3 No Abnormalities Detected X X X X X X X  4 No Abnormalities Detected X X X X X X X  5 No Abnormalities Detected X X X X X X X  6 No Abnormalities Detected X X X X X X X  7 No Abnormalities Detected X X X X X X X  8 No Abnormalities Detected X X X X X X X  9 No Abnormalities Detected X X X X X X X  10 No Abnormalities Detected X X X X X X X  11 No Abnormalities Detected X X X X X X X  12 No Abnormalities Detected X X X X X X X X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 2 (continued) Individual Behavioural Assessments (Observations)  Day Numbers Relative to Start Date Group Animal (Sex) Number Clinical Sign -1 7 14 20 27 35 4 post partum# 

 1(F) 13 No Abnormalities Detected X X X X X X X  14 No Abnormalities Detected X X X X X X X  15 No Abnormalities Detected X X X X X X X  16 No Abnormalities Detected X X X X X X X  17 No Abnormalities Detected X X X X X X X  18 No Abnormalities Detected X X X X X X X  19 No Abnormalities Detected X X X X X X X  20 No Abnormalities Detected X X X X X X X  21 No Abnormalities Detected X X X X X X X  22 No Abnormalities Detected X X X X X X X  23 No Abnormalities Detected X X X X X X X  24 No Abnormalities Detected X X X X X X X # = Day 25 post coitum for Female 21 

X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 2 (continued) Individual Behavioural Assessments (Observations)  Day Numbers Relative to Start Date Group Animal (Sex) Number Clinical Sign -1 7 14 20 27 35 41  2(M) 25 No Abnormalities Detected X X X X X X X  26 No Abnormalities Detected X X X X X X X  27 No Abnormalities Detected X X X X X X X  28 No Abnormalities Detected X X X X X X X  29 No Abnormalities Detected X X X X X X X  30 No Abnormalities Detected X X X X X X X  31 No Abnormalities Detected X X X X X X X  32 No Abnormalities Detected X X X X X X X  33 No Abnormalities Detected X X X X X X X  34 No Abnormalities Detected X X X X X X X  35 No Abnormalities Detected X X X X X X X  36 No Abnormalities Detected X X X X X X X X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 2 (continued) Individual Behavioural Assessments (Observations)  Day Numbers Relative to Start Date Group Animal (Sex) Number Clinical Sign -1 7 14 20 27 35 4 post partum

 2(F) 37 No Abnormalities Detected X X X X X X X  38 No Abnormalities Detected X X X X X X X  39 No Abnormalities Detected X X X X X X X  40 No Abnormalities Detected X X X X X X X  41 No Abnormalities Detected X X X X X X X  42 No Abnormalities Detected X X X X X X X  43 No Abnormalities Detected X X X X X X X  44 No Abnormalities Detected X X X X X X X  45 No Abnormalities Detected X X X X X X X  46 No Abnormalities Detected X X X X X X X  47 No Abnormalities Detected X X X X X X X  48 No Abnormalities Detected X X X X X X X X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 2 (continued) Individual Behavioural Assessments (Observations)  Day Numbers Relative to Start Date Group Animal (Sex) Number Clinical Sign -1 7 14 20 27 35 41  3(M) 49 No Abnormalities Detected X X X X X X X  50 No Abnormalities Detected X X X X X X X  51 No Abnormalities Detected X X X X X X X  52 No Abnormalities Detected X X X X X X X  53 No Abnormalities Detected X X X X X X X  54 No Abnormalities Detected X X X X X X X  55 No Abnormalities Detected X X X X X X X  56 No Abnormalities Detected X X X X X X X  57 No Abnormalities Detected X X X X X X X  58 No Abnormalities Detected X X X X X X X  59 No Abnormalities Detected X X X X X X X  60 No Abnormalities Detected X X X X X X X X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 2 (continued) Individual Behavioural Assessments (Observations)  Day Numbers Relative to Start Date Group Animal (Sex) Number Clinical Sign -1 7 14 20 27 35 4 post partum#

 3(F) 61 No Abnormalities Detected X X X X X X X  62 No Abnormalities Detected X X X X X X X  63 No Abnormalities Detected X X X X X X X  64 No Abnormalities Detected X X X X X X X  65 No Abnormalities Detected X X X X X X X  66 No Abnormalities Detected X X X X X X X  67 No Abnormalities Detected X X X X X X X  68 No Abnormalities Detected X X X X X X X  69 No Abnormalities Detected X X X X X X X  70 No Abnormalities Detected X X X X X X X  71 No Abnormalities Detected X X X X X X X  72 No Abnormalities Detected X X X X X X X # = Day 25 post coitum for Female 69 

X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 2 (continued) Individual Behavioural Assessments (Observations)  Day Numbers Relative to Start Date Group Animal (Sex) Number Clinical Sign -1 7 14 20 27 35 41  4(M) 73 No Abnormalities Detected X X X X X X X  74 No Abnormalities Detected X X X X X X X  75 No Abnormalities Detected X X X X X X X  76 No Abnormalities Detected X X X X X X X  77 No Abnormalities Detected X X X X X X X  78 No Abnormalities Detected X X X X X X X  79 No Abnormalities Detected X X X X X X X  80 No Abnormalities Detected X X X X X X X  81 No Abnormalities Detected X X X X X X X  82 No Abnormalities Detected X X X X X X X  83 No Abnormalities Detected X X X X X X X  84 No Abnormalities Detected X X X X X X X X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 2 (continued) Individual Behavioural Assessments (Observations)  Day Numbers Relative to Start Date Group Animal (Sex) Number Clinical Sign -1 7 14 20 27 35 4 post partum

 4(F) 85 No Abnormalities Detected X X X X X X X  86 No Abnormalities Detected X X X X X X X  87 No Abnormalities Detected X X X X X X X  88 No Abnormalities Detected X X X X X X X  89 No Abnormalities Detected X X X X X X X  90 No Abnormalities Detected X X X X X X X  91 No Abnormalities Detected X X X X X X X  92 No Abnormalities Detected X X X X X X X  93 No Abnormalities Detected X X X X X X X  94 No Abnormalities Detected X X X X X X X  95 No Abnormalities Detected X X X X X X X  96 No Abnormalities Detected X X X X X X X X = Present Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 Individual and Group Mean Behavioural Assessments (Scores)  Day: ƒ1 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(M) 1 0 0 0 0  2 0 0 0 0  3 0 0 0 0  4 0 0 0 0  5 0 0 0 0  6 0 0 0 0  7 0 1 0 0  8 0 0 0 0  9 0 0 0 0  10 0 0 0 0  11 0 0 0 0  12 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: ƒ1 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(F) 13 0 0 0 0  14 0 0 0 0  15 0 0 0 0  16 0 1 0 0  17 0 1 1 0  18 0 0 0 0  19 0 0 0 0  20 0 1 0 0  21 0 0 0 0  22 0 0 0 0  23 0 0 0 0  24 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.3 0.1 0.0  S.D. 0.0 0.5 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: ƒ1 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(M) 25 0 0 0 0  26 0 0 0 0  27 0 0 0 0  28 0 0 0 0  29 0 1 1 0  30 0 1 0 0  31 0 0 0 0  32 0 0 0 0  33 0 0 0 0  34 0 0 0 0  35 0 0 0 0  36 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.1 0.0  S.D. 0.0 0.4 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: ƒ1 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(F) 37 0 0 0 0  38 0 0 0 0  39 0 0 0 0  40 0 0 0 0  41 0 0 0 0  42 0 0 0 0  43 0 0 0 0  44 0 1 0 0  45 0 0 0 0  46 0 1 0 0  47 0 0 0 0  48 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: ƒ1 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(M) 49 0 0 0 0  50 0 0 0 0  51 0 0 0 0  52 0 0 0 0  53 0 0 0 0  54 0 1 0 0  55 0 1 0 0  56 0 0 0 0  57 0 0 0 0  58 0 0 0 0  59 0 0 0 0  60 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: ƒ1 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(F) 61 0 0 0 0  62 0 1 0 0  63 0 0 0 0  64 0 0 0 0  65 0 0 0 0  66 0 0 0 0  67 0 0 0 0  68 0 0 0 0  69 0 0 0 0  70 0 1 0 0  71 0 0 0 0  72 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: ƒ1 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(M) 73 0 1 0 0  74 0 0 0 0  75 0 0 0 0  76 0 0 0 0  77 0 0 0 0  78 0 0 0 0  79 0 0 0 0  80 0 0 0 0  81 0 0 0 0  82 0 1 0 0  83 0 0 0 0  84 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: ƒ1 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(F) 85 0 0 0 0  86 0 0 0 0  87 0 0 0 0  88 0 1 1 0  89 0 0 0 0  90 0 1 0 0  91 0 0 0 0  92 0 0 0 0  93 0 0 0 0  94 0 0 0 0  95 0 0 0 0  96 0 1 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.3 0.1 0.0  S.D. 0.0 0.5 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 7 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(M) 1 0 0 0 0  2 0 0 0 0  3 0 0 0 0  4 0 1 0 0  5 0 0 0 0  6 0 0 0 0  7 0 1 0 0  8 0 0 0 0  9 0 1 0 0  10 0 1 0 0  11 0 1 0 0  12 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.4 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 7 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(F) 13 0 0 0 0  14 0 0 0 0  15 0 0 0 0  16 0 0 0 0  17 0 0 0 0  18 0 0 0 0  19 0 0 0 0  20 0 1 0 0  21 0 0 0 0  22 0 0 0 0  23 0 1 0 0  24 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 7 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(M) 25 0 0 0 0  26 0 1 0 0  27 0 0 0 0  28 0 0 0 0  29 0 1 0 0  30 0 0 0 0  31 0 1 0 0  32 0 0 0 0  33 0 0 0 0  34 0 1 0 0  35 0 0 0 0  36 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.3 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 7 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(F) 37 0 1 0 0  38 0 0 0 0  39 0 0 0 0  40 0 1 0 0  41 0 0 0 0  42 0 0 0 0  43 0 0 0 0  44 0 0 0 0  45 0 0 0 0  46 0 0 0 0  47 0 0 0 0  48 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 7 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(M) 49 0 0 0 0  50 0 0 0 0  51 0 0 0 0  52 0 0 0 0  53 0 1 1 0  54 0 0 0 0  55 0 0 0 0  56 0 0 0 0  57 0 0 0 0  58 0 0 0 0  59 0 1 0 0  60 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.1 0.0  S.D. 0.0 0.4 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 7 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(F) 61 0 0 0 0  62 0 0 0 0  63 0 0 0 0  64 0 0 0 0  65 0 0 0 0  66 0 1 0 0  67 0 0 0 0  68 0 0 0 0  69 0 0 0 0  70 0 0 0 0  71 0 0 0 0  72 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 7 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(M) 73 0 0 0 0  74 0 0 0 0  75 0 1 0 0  76 0 0 1 0  77 0 0 0 0  78 0 0 0 0  79 0 0 0 0  80 0 0 0 0  81 0 0 0 0  82 0 0 0 0  83 0 0 0 0  84 0 1 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.1 0.0  S.D. 0.0 0.4 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 7 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(F) 85 0 0 0 0  86 0 0 0 0  87 0 0 0 0  88 0 0 0 0  89 0 0 0 0  90 0 0 1 0  91 0 0 0 0  92 0 0 0 0  93 0 0 0 0  94 0 0 0 0  95 0 0 0 0  96 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.1 0.0  S.D. 0.0 0.0 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 14 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(M) 1 0 0 0 0  2 0 0 0 0  3 0 0 0 0  4 0 0 0 0  5 0 0 0 0  6 0 0 0 0  7 0 0 0 0  8 0 0 0 0  9 0 0 0 0  10 0 0 0 0  11 0 0 0 0  12 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 14 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(F) 13 0 0 0 0  14 0 0 0 0  15 0 0 0 0  16 0 0 0 0  17 0 0 0 0  18 0 0 0 0  19 0 0 0 0  20 0 0 0 0  21 0 0 0 0  22 0 0 0 0  23 0 0 0 0  24 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 14 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(M) 25 0 0 0 0  26 0 0 0 0  27 0 0 0 0  28 0 0 0 0  29 0 0 0 0  30 0 0 0 0  31 0 0 0 0  32 0 0 0 0  33 0 0 0 0  34 0 0 0 0  35 0 0 0 0  36 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 14 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(F) 37 0 0 0 0  38 0 1 0 0  39 0 0 0 0  40 0 0 0 0  41 0 0 0 0  42 0 0 0 0  43 0 0 0 0  44 0 0 0 0  45 0 0 0 0  46 0 0 0 0  47 0 1 0 0  48 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 14 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(M) 49 0 1 0 0  50 0 1 0 0  51 0 0 0 0  52 0 0 0 0  53 0 0 0 0  54 0 0 0 0  55 0 1 0 0  56 0 0 0 0  57 0 1 0 0  58 0 0 0 0  59 0 1 0 0  60 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.4 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 14 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(F) 61 0 0 0 0  62 0 0 0 0  63 0 0 0 0  64 0 0 0 0  65 0 0 0 0  66 0 1 0 0  67 0 0 0 0  68 0 0 0 0  69 0 0 0 0  70 0 0 0 0  71 0 0 0 0  72 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 14 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(M) 73 0 0 0 0  74 0 0 0 0  75 0 0 0 0  76 0 1 0 0  77 0 0 0 0  78 0 0 0 0  79 0 0 0 0  80 0 1 0 0  81 0 1 0 0  82 0 0 0 0  83 0 0 0 0  84 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.3 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 14 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(F) 85 0 0 0 0  86 0 1 1 0  87 0 0 0 0  88 0 1 0 0  89 0 0 0 0  90 0 1 0 0  91 0 0 0 0  92 0 0 0 0  93 0 0 0 0  94 0 0 0 0  95 0 0 0 0  96 0 1 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.3 0.1 0.0  S.D. 0.0 0.5 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 20 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(M) 1 0 0 0 0  2 0 0 0 0  3 0 1 0 0  4 0 0 0 0  5 0 0 0 0  6 0 0 0 0  7 0 0 0 0  8 0 1 0 0  9 0 0 0 0  10 0 0 0 0  11 0 0 0 0  12 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 20 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(F) 13 0 1 0 0  14 0 0 0 0  15 0 0 0 0  16 0 0 0 0  17 0 0 0 0  18 0 0 0 0  19 0 1 0 0  20 0 1 0 0  21 0 0 0 0  22 0 0 0 0  23 0 0 0 0  24 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.3 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 20 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(M) 25 0 0 0 0  26 0 1 1 0  27 0 0 0 0  28 0 0 0 0  29 0 0 0 0  30 0 0 0 0  31 0 0 0 0  32 0 1 0 0  33 0 0 0 0  34 0 0 0 0  35 0 0 0 0  36 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.1 0.0  S.D. 0.0 0.4 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 20 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(F) 37 0 1 0 0  38 0 0 0 0  39 0 0 0 0  40 0 0 0 0  41 0 0 0 0  42 0 0 0 0  43 0 0 0 0  44 0 0 0 0  45 0 0 0 0  46 0 0 0 0  47 0 0 0 0  48 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 20 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(M) 49 0 0 0 0  50 0 0 0 0  51 0 0 0 0  52 0 0 0 0  53 0 0 0 0  54 0 1 0 0  55 0 1 0 0  56 0 0 0 0  57 0 0 0 0  58 0 0 0 0  59 0 0 0 0  60 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 20 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(F) 61 0 0 0 0  62 0 0 0 0  63 0 0 0 0  64 0 0 0 0  65 0 0 0 0  66 0 1 0 0  67 0 0 0 0  68 0 0 0 0  69 0 0 0 0  70 0 0 0 0  71 0 0 0 0  72 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 20 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(M) 73 0 0 0 0  74 0 0 0 0  75 0 0 0 0  76 0 0 0 0  77 0 0 0 0  78 0 1 0 0  79 0 1 0 0  80 0 0 0 0  81 0 0 0 0  82 0 0 0 0  83 0 0 0 0  84 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 20 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(F) 85 0 0 0 0  86 0 0 0 0  87 0 0 0 0  88 0 0 0 0  89 0 0 0 0  90 0 0 0 0  91 0 0 0 0  92 0 0 0 0  93 0 0 0 0  94 0 0 0 0  95 0 0 0 0  96 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 27 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(M) 1 0 0 0 0  2 0 0 0 0  3 0 1 0 0  4 0 0 0 0  5 0 1 0 0  6 0 0 0 0  7 0 0 0 0  8 0 0 0 0  9 0 0 0 0  10 0 0 0 0  11 0 0 0 0  12 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 27 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(F) 13 0 0 0 0  14 0 0 0 0  15 0 0 0 0  16 0 0 0 0  17 0 0 0 0  18 0 0 0 0  19 0 0 0 0  20 0 0 0 0  21 0 0 0 0  22 0 1 0 0  23 0 0 0 0  24 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 27 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(M) 25 0 0 0 0  26 0 0 0 0  27 0 0 0 0  28 0 0 0 0  29 0 0 0 0  30 0 0 0 0  31 0 0 0 0  32 0 0 0 0  33 0 0 0 0  34 0 0 0 0  35 0 0 0 0  36 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 27 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(F) 37 0 0 0 0  38 0 0 0 0  39 0 0 0 0  40 0 0 0 0  41 0 1 0 0  42 0 0 0 0  43 0 0 0 0  44 0 0 0 0  45 0 0 0 0  46 0 0 0 0  47 0 0 0 0  48 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 27 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(M) 49 0 0 0 0  50 0 0 0 0  51 0 0 0 0  52 0 0 0 0  53 0 0 0 0  54 0 0 0 0  55 0 0 0 0  56 0 0 0 0  57 0 0 1 0  58 0 0 0 0  59 0 0 0 0  60 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.1 0.0  S.D. 0.0 0.0 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 27 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(F) 61 0 1 0 0  62 0 0 0 0  63 0 1 0 0  64 0 0 0 0  65 0 0 0 0  66 0 1 0 0  67 0 0 0 0  68 0 0 0 0  69 0 0 0 0  70 0 0 0 0  71 0 0 0 0  72 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.3 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 27 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(M) 73 0 0 0 0  74 0 0 0 0  75 0 0 0 0  76 0 0 0 0  77 0 1 0 0  78 0 0 0 0  79 0 0 0 0  80 0 0 0 0  81 0 0 0 0  82 0 0 0 0  83 0 0 0 0  84 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 27 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(F) 85 0 0 0 0  86 0 1 0 0  87 0 0 0 0  88 0 0 0 0  89 0 1 0 0  90 0 0 0 0  91 0 0 0 0  92 0 0 0 0  93 0 0 0 0  94 0 0 0 0  95 0 0 0 0  96 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.0 0.0  S.D. 0.0 0.4 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 35 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(M) 1 0 0 0 0  2 0 0 0 0  3 0 0 0 0  4 0 0 0 0  5 0 0 0 0  6 0 0 0 0  7 0 0 0 0  8 0 0 0 0  9 0 1 0 0  10 0 0 0 0  11 0 0 0 0  12 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 35 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(F) 13 0 0 1 0  14 0 0 0 0  15 0 1 0 0  16 0 0 0 0  17 0 0 0 0  18 0 0 0 0  19 0 1 0 0  20 0 0 0 0  21 0 0 0 0  22 0 0 0 0  23 0 0 0 0  24 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.1 0.0  S.D. 0.0 0.4 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 35 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(M) 25 0 0 0 0  26 0 0 0 0  27 0 0 0 0  28 0 0 0 0  29 0 0 0 0  30 0 0 0 0  31 0 0 0 0  32 0 0 0 0  33 0 0 0 0  34 0 0 0 0  35 0 0 0 0  36 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 35 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(F) 37 0 0 0 0  38 0 0 0 0  39 0 0 0 0  40 0 0 0 0  41 0 0 0 0  42 0 1 0 0  43 0 0 0 0  44 0 0 0 0  45 0 0 0 0  46 0 0 0 0  47 0 0 0 0  48 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 35 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(M) 49 0 0 0 0  50 0 0 0 0  51 0 0 0 0  52 0 0 0 0  53 0 0 0 0  54 0 0 0 0  55 0 1 0 0  56 0 0 0 0  57 0 0 0 0  58 0 0 0 0  59 0 0 0 0  60 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 35 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(F) 61 0 0 0 0  62 0 0 0 0  63 0 0 0 0  64 0 0 0 0  65 0 0 0 0  66 0 0 0 0  67 0 0 0 0  68 0 0 0 0  69 0 1 0 0  70 0 0 0 0  71 0 0 0 0  72 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 35 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(M) 73 0 0 0 0  74 0 0 0 0  75 0 0 0 0  76 0 0 0 0  77 0 0 0 0  78 0 0 0 0  79 0 0 0 0  80 0 0 0 0  81 0 0 0 0  82 0 0 0 0  83 0 0 0 0  84 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 35 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(F) 85 0 0 0 0  86 0 0 0 0  87 0 0 0 0  88 0 0 0 0  89 0 0 0 0  90 0 0 0 0  91 0 0 0 0  92 0 0 0 0  93 0 0 0 0  94 0 0 0 0  95 0 1 0 0  96 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 41 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(M) 1 0 1 0 0  2 0 0 0 0  3 0 0 0 0  4 0 0 0 0  5 0 0 0 0  6 0 0 0 0  7 0 0 0 0  8 0 0 0 0  9 0 0 0 0  10 0 0 0 0  11 0 0 0 0  12 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.1 0.0 0.0  S.D. 0.0 0.3 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 4 post partum#

 Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  1(F) 13 0 0 0 0  14 0 0 0 0  15 0 1 0 0  16 0 0 0 0  17 0 0 0 0  18 0 1 0 0  19 0 0 0 0  20 0 0 0 0  21 0 0 0 0  22 0 0 0 0  23 0 0 0 0  24 0 1 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.3 0.0 0.0  S.D. 0.0 0.5 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ # = Day 25 post coitum for Female 21 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 41 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(M) 25 0 0 0 0  26 0 0 0 0  27 0 0 3 0  28 0 0 0 0  29 0 0 0 0  30 0 0 0 0  31 0 0 0 0  32 0 0 0 0  33 0 0 0 0  34 0 0 0 0  35 0 0 0 0  36 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.3 0.0  S.D. 0.0 0.0 0.9 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 4 post partum

 Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  2(F) 37 0 0 0 0  38 0 0 0 0  39 0 0 0 0  40 0 0 0 0  41 0 0 0 0  42 0 0 0 0  43 0 0 0 0  44 0 1 0 0  45 0 0 0 0  46 0 0 0 0  47 0 1 1 0  48 0 0 1 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.2 0.0  S.D. 0.0 0.4 0.4 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 41 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(M) 49 0 0 0 0  50 0 0 0 0  51 0 0 0 0  52 0 0 0 0  53 0 0 0 0  54 0 0 0 0  55 0 0 0 0  56 0 0 0 0  57 0 0 0 0  58 0 0 0 0  59 0 0 0 0  60 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 4 post partum# 

 Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  3(F) 61 0 1 1 0  62 0 0 0 0  63 0 0 0 0  64 0 0 0 0  65 0 1 0 0  66 0 0 0 0  67 0 0 0 0  68 0 0 0 0  69 0 0 0 0  70 0 0 0 0  71 0 0 0 0  72 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.1 0.0  S.D. 0.0 0.4 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ # = Day 25 post coitum for Female 69 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 41 Relative to Start Date  Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(M) 73 0 0 0 0  74 0 0 0 0  75 0 0 0 0  76 0 0 0 0  77 0 0 0 0  78 0 0 0 0  79 0 0 0 0  80 0 0 0 0  81 0 0 0 0  82 0 0 0 0  83 0 0 0 0  84 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 3 (continued) Individual and Group Mean Behavioural Assessments (Scores)  Day: 4 post partum

 Group Animal Transfer Urinƒ Defƒ Tail elƒ  (Sex) Number arousal ation ecation evation  4(F) 85 0 0 0 0  86 0 0 0 0  87 0 1 1 0  88 0 0 0 0  89 0 1 0 0  90 0 0 0 0  91 0 0 0 0  92 0 1 0 0  93 0 0 0 0  94 0 0 0 0  95 0 0 0 0  96 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 0.0 0.3 0.1 0.0  S.D. 0.0 0.5 0.3 0.0  N 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 4 Individual and Group Mean Functional Test Values (Grip Strength)  Day: 41 Relative to Start Date  Group Animal Test 1 Test 1 Test 2 Test 2 Test 3 Test 3  (Sex) Number Forelimb Hindlimb Forelimb Hindlimb Forelimb Hindlimb  g g g g g g  1(M) 1 793 225 1269 285 747 422  2 1075 228 1574 326 958 400  3 774 322 503 291 659 282  4 1439 656 756 467 1160 490  5 1325 547 1024 800 978 298  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 1081.2 395.6 1025.2 433.8 900.4 378.4  S.D. 302.0 195.8 420.1 217.6 199.1 87.4  N 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 4 (continued) Individual and Group Mean Functional Test Values (Grip Strength)  Day: 4 post partum

 Group Animal Test 1 Test 1 Test 2 Test 2 Test 3 Test 3  (Sex) Number Forelimb Hindlimb Forelimb Hindlimb Forelimb Hindlimb  g g g g g g  1(F) 13 541 129 706 296 940 260  14 885 303 806 345 812 389  15 924 108 737 207 1042 622  18 888 387 830 141 699 321  19 769 230 565 226 649 207  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 801.4 231.4 728.8 243.0 828.4 359.8  S.D. 156.8 117.3 104.4 79.4 163.8 161.6  N 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 4 (continued) Individual and Group Mean Functional Test Values (Grip Strength)  Day: 41 Relative to Start Date  Group Animal Test 1 Test 1 Test 2 Test 2 Test 3 Test 3  (Sex) Number Forelimb Hindlimb Forelimb Hindlimb Forelimb Hindlimb  g g g g g g  2(M) 25 1408 506 1033 541 1179 590  26 841 625 962 476 1479 318  27 927 536 1312 434 786 356  28 830 652 412 327 660 487  29 677 553 639 321 666 239  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 936.6 574.4 871.6 419.8 954.0 398.0  S.D. 278.5 61.6 351.3 95.4 361.9 139.8  N 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 4 (continued) Individual and Group Mean Functional Test Values (Grip Strength)  Day: 4 post partum

 Group Animal Test 1 Test 1 Test 2 Test 2 Test 3 Test 3  (Sex) Number Forelimb Hindlimb Forelimb Hindlimb Forelimb Hindlimb  g g g g g g  2(F) 37 1257 546 1359 549 924 577  41 466 334 995 199 508 292  42 960 386 1013 308 806 333  44 1347 569 611 371 1133 411  46 740 148 419 244 763 280  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 954.0 396.6 879.4 334.2 826.8 378.6  S.D. 364.1 171.7 369.2 136.6 228.8 122.2  N 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 4 (continued) Individual and Group Mean Functional Test Values (Grip Strength)  Day: 41 Relative to Start Date  Group Animal Test 1 Test 1 Test 2 Test 2 Test 3 Test 3  (Sex) Number Forelimb Hindlimb Forelimb Hindlimb Forelimb Hindlimb  g g g g g g  3(M) 49 1231 484 618 128 1175 562  50 913 286 630 312 1066 541  51 965 599 826 347 616 561  52 1259 414 1193 493 1429 224  53 1272 341 910 496 987 359  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 1128.0 424.8 835.4 355.2 1054.6 449.4  S.D. 174.1 122.7 236.1 152.0 296.5 152.1  N 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 4 (continued) Individual and Group Mean Functional Test Values (Grip Strength)  Day: 4 post partum

 Group Animal Test 1 Test 1 Test 2 Test 2 Test 3 Test 3  (Sex) Number Forelimb Hindlimb Forelimb Hindlimb Forelimb Hindlimb  g g g g g g  3(F) 61 1254 450 832 566 1273 621  62 717 316 1411 859 652 284  65 748 420 893 323 828 388  67 722 348 1005 395 520 187  70 800 369 1233 970 952 248  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 848.2 380.6 1074.8 622.6 845.0 345.6  S.D. 229.2 54.2 242.3 283.4 290.6 170.4  N 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 4 (continued) Individual and Group Mean Functional Test Values (Grip Strength)  Day: 41 Relative to Start Date  Group Animal Test 1 Test 1 Test 2 Test 2 Test 3 Test 3  (Sex) Number Forelimb Hindlimb Forelimb Hindlimb Forelimb Hindlimb  g g g g g g  4(M) 73 822 148 1035 147 1091 568  74 750 485 955 770 823 432  75 1244 916 878 349 933 482  76 1279 505 906 298 1100 406  77 1217 393 1071 661 1481 551  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 1062.4 489.4 969.0 445.0 1085.6 487.8  S.D. 254.5 277.5 82.5 260.7 249.4 71.2  N 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 4 (continued) Individual and Group Mean Functional Test Values (Grip Strength)  Day: 4 post partum

 Group Animal Test 1 Test 1 Test 2 Test 2 Test 3 Test 3  (Sex) Number Forelimb Hindlimb Forelimb Hindlimb Forelimb Hindlimb  g g g g g g  4(F) 85 1025 272 974 348 1308 504  86 1120 716 1335 984 1069 496  90 569 207 739 338 708 467  91 656 324 653 357 700 118  96 1397 627 1506 415 625 312  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 953.4 429.2 1041.4 488.4 882.0 379.4  S.D. 341.3 227.2 370.4 278.7 294.1 165.6  N 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 5 Individual and Group Mean Functional Test Values (Motor Activity)  Day: 41 Relative to Start Date  Group Animal Overall Overall Last 20% Last 20%  (Sex) Number activity mobile activity mobile  1(M) 1 118 0 11 0  2 274 0 79 0  3 291 0 0 0  4 254 0 6 0  5 471 0 29 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 281.6 0.0 25.0 0.0  S.D. 126.0 0.0 32.1 0.0  N 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 5 (continued) Individual and Group Mean Functional Test Values (Motor Activity)  Day: 4 post partum

 Group Animal Overall Overall Last 20% Last 20%  (Sex) Number activity mobile activity mobile  1(F) 13 423 2 9 0  14 546 1 49 0  15 310 0 4 0  18 492 4 53 0  19 562 3 87 1  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 466.6 2.0 40.4 0.2  S.D. 103.0 1.6 34.3 0.4  N 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 5 (continued) Individual and Group Mean Functional Test Values (Motor Activity)  Day: 41 Relative to Start Date  Group Animal Overall Overall Last 20% Last 20%  (Sex) Number activity mobile activity mobile  2(M) 25 316 1 86 0  26 205 0 6 0  27 284 3 0 0  28 386 0 118 0  29 527 0 11 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 343.6 0.8 44.2 0.0  S.D. 121.4 1.3 54.1 0.0  N 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 5 (continued) Individual and Group Mean Functional Test Values (Motor Activity)  Day: 4 post partum

 Group Animal Overall Overall Last 20% Last 20%  (Sex) Number activity mobile activity mobile  2(F) 37 373 4 6 0  41 469 1 19 0  42 369 2 3 0  44 422 2 2 0  46 681 1 117 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 462.8 2.0 29.4 0.0  S.D. 128.6 1.2 49.4 0.0  N 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 5 (continued) Individual and Group Mean Functional Test Values (Motor Activity)  Day: 41 Relative to Start Date  Group Animal Overall Overall Last 20% Last 20%  (Sex) Number activity mobile activity mobile  3(M) 49 364 0 41 0  50 177 0 11 0  51 344 1 5 0  52 289 1 9 0  53 219 0 9 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 278.6 0.4 15.0 0.0  S.D. 79.9 0.5 14.7 0.0  N 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 5 (continued) Individual and Group Mean Functional Test Values (Motor Activity)  Day: 4 post partum

 Group Animal Overall Overall Last 20% Last 20%  (Sex) Number activity mobile activity mobile  3(F) 61 227 0 14 0  62 296 1 10 0  65 204 4 110 2  67 240 1 102 0  70 580 2 77 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 309.4 1.6 62.6 0.4  S.D. 155.0 1.5 47.8 0.9  N 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 5 (continued) Individual and Group Mean Functional Test Values (Motor Activity)  Day: 41 Relative to Start Date  Group Animal Overall Overall Last 20% Last 20%  (Sex) Number activity mobile activity mobile  4(M) 73 604 3 148 1  74 240 0 23 0  75 499 1 17 0  76 323 0 0 0  77 336 2 4 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 400.4 1.2 38.4 0.2  S.D. 147.5 1.3 62.0 0.4  N 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 5 (continued) Individual and Group Mean Functional Test Values (Motor Activity)  Day: 4 post partum

 Group Animal Overall Overall Last 20% Last 20%  (Sex) Number activity mobile activity mobile  4(F) 85 603 7 88 3  86 464 4 127 0  90 481 5 19 1  91 15 0 5 0  96 372 3 100 1  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  Mean 387.0 3.8 67.8 1.0  S.D. 223.6 2.6 53.1 1.2  N 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 6 Individual and Group Mean Sensory Reactivity Assessments  Day: 41 Relative to Start Date  Group Animal Grasp Vocalƒ Toe Tail Finger Touch Pupil Blink Startle  (Sex) Number response isation pinch pinch approach escape reflex reflex reflex  1(M) 1 0 0 0 0 0 0 0 0 0  2 0 0 0 0 0 0 0 0 0  3 0 0 0 0 0 0 0 0 0  4 0 0 0 0 0 0 0 0 0  5 0 0 0 0 0 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 6 (continued) Individual and Group Mean Sensory Reactivity Assessments  Day: 4 post partum

 Group Animal Grasp Vocalƒ Toe Tail Finger Touch Pupil Blink Startle  (Sex) Number response isation pinch pinch approach escape reflex reflex reflex  1(F) 13 0 0 0 0 0 0 0 0 0  14 0 0 0 0 0 0 0 0 0  15 0 0 0 0 0 0 0 0 0  18 0 0 0 0 0 0 0 0 0  19 0 0 0 0 0 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 6 (continued) Individual and Group Mean Sensory Reactivity Assessments  Day: 41 Relative to Start Date  Group Animal Grasp Vocalƒ Toe Tail Finger Touch Pupil Blink Startle  (Sex) Number response isation pinch pinch approach escape reflex reflex reflex  2(M) 25 0 0 0 0 0 0 0 0 0  26 0 0 0 0 0 0 0 0 0  27 0 0 0 0 0 0 0 0 0  28 0 0 0 0 0 0 0 0 0  29 0 0 0 0 0 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 6 (continued) Individual and Group Mean Sensory Reactivity Assessments  Day: 4 post partum

 Group Animal Grasp Vocalƒ Toe Tail Finger Touch Pupil Blink Startle  (Sex) Number response isation pinch pinch approach escape reflex reflex reflex  2(F) 37 0 0 0 0 0 0 0 0 0  41 0 0 0 0 0 0 0 0 0  42 0 0 0 0 0 0 0 0 0  44 0 0 0 0 0 0 0 0 0  46 0 0 0 0 0 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 6 (continued) Individual and Group Mean Sensory Reactivity Assessments  Day: 41 Relative to Start Date  Group Animal Grasp Vocalƒ Toe Tail Finger Touch Pupil Blink Startle  (Sex) Number response isation pinch pinch approach escape reflex reflex reflex  3(M) 49 0 0 0 0 0 0 0 0 0  50 0 0 0 0 0 0 0 0 0  51 0 0 0 0 0 0 0 0 0  52 0 0 0 0 0 0 0 0 0  53 0 0 0 0 0 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 6 (continued) Individual and Group Mean Sensory Reactivity Assessments  Day: 4 post partum

 Group Animal Grasp Vocalƒ Toe Tail Finger Touch Pupil Blink Startle  (Sex) Number response isation pinch pinch approach escape reflex reflex reflex  3(F) 61 0 0 0 0 0 0 0 0 0  62 0 0 0 0 0 0 0 0 0  65 0 0 0 0 0 0 0 0 0  67 0 0 0 0 0 0 0 0 0  70 0 1 0 0 0 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  Mean 0.0 0.2 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.4 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 6 (continued) Individual and Group Mean Sensory Reactivity Assessments  Day: 41 Relative to Start Date  Group Animal Grasp Vocalƒ Toe Tail Finger Touch Pupil Blink Startle  (Sex) Number response isation pinch pinch approach escape reflex reflex reflex  4(M) 73 0 0 0 0 0 0 0 0 0  74 0 0 0 0 0 0 0 0 0  75 0 0 0 0 0 0 0 0 0  76 0 0 0 0 0 0 0 0 0  77 0 0 0 0 0 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 6 (continued) Individual and Group Mean Sensory Reactivity Assessments  Day: 4 post partum

 Group Animal Grasp Vocalƒ Toe Tail Finger Touch Pupil Blink Startle  (Sex) Number response isation pinch pinch approach escape reflex reflex reflex  4(F) 85 0 0 0 0 0 0 0 0 0  86 0 0 0 0 0 0 0 0 0  90 0 0 0 0 0 0 0 0 0  91 0 0 0 0 0 0 0 0 0  96 0 0 0 0 0 0 0 0 0  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  Mean 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  S.D. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0  N 5 5 5 5 5 5 5 5 5  ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 7 Individual and Group Mean Body Weights  Body Weights (g)  ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ  Day Numbers Relative to Start Date  Group Animal  (Sex) Number 1 8 15 22 29 36 43  1(M) 1 317 340 360 371 385 395 396  2 317 332 347 362 376 388 386  3 333 356 363 379 382 394 384  4 319 344 357 366 372 380 369  5 330 355 376 385 374 382 388  6 340 360 383 388 393 408 413  7 333 354 372 378 392 410 418  8 335 358 374 367 368 390 391  9 323 338 355 360 369 382 387  10 315 329 342 342 353 370 361  11 316 336 353 359 365 371 353  12 334 351 371 385 398 407 408  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  Mean 326.0 346.1 362.8 370.2 377.3 389.8 387.8  S.D. 9.0 10.9 12.6 13.5 13.2 13.6 19.8  N 12 12 12 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 7 (continued) Individual and Group Mean Body Weights  Body Weights (g)  ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ  Day Numbers Relative to Start Date  Group Animal  (Sex) Number 1 8 15 22 29 36 43  2(M) 25 332 353 371 386 400 420 425  26 324 348 362 365 378 392 395  27 335 353 366 375 391 398 408  28 320 335 349 358 370 380 384  29 331 350 375 382 388 401 404  30 313 329 351 359 370 379 385  31 327 342 362 366 376 384 386  32 328 343 359 364 377 391 396  33 321 338 353 356 359 372 373  34 314 341 361 370 367 381 375  35 329 349 365 368 367 374 384  36 325 332 334 340 354 371 379  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  Mean 324.9 342.8 359.0 365.8 374.8 386.9 391.2  S.D. 6.9 8.1 11.0 12.2 13.3 14.3 15.2  N 12 12 12 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 7 (continued) Individual and Group Mean Body Weights  Body Weights (g)  ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ  Day Numbers Relative to Start Date  Group Animal  (Sex) Number 1 8 15 22 29 36 43  3(M) 49 335 341 359 379 390 404 407  50 329 348 375 360 371 379 397  51 313 315 335 322 319 351 371  52 326 340 355 333 333 373 385  53 333 355 374 387 402 416 418  54 322 336 356 369 389 395 404  55 329 347 367 376 388 402 410  56 331 355 368 372 376 395 396  57 315 331 357 356 389 408 408  58 306 327 344 335 353 365 362  59 302 319 340 345 360 372 374  60 315 329 340 349 364 375 380  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  Mean 321.3 336.9 355.8 356.9 369.5 386.3 392.7  S.D. 10.9 13.2 13.7 20.5 25.0 19.8 17.9  N 12 12 12 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 7 (continued) Individual and Group Mean Body Weights  Body Weights (g)  ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ  Day Numbers Relative to Start Date  Group Animal  (Sex) Number 1 8 15 22 29 36 43  4(M) 73 324 341 355 362 380 394 397  74 315 336 346 352 364 372 368  75 323 327 336 345 364 381 390  76 326 339 356 366 388 400 397  77 332 352 370 371 385 401 409  78 315 328 332 345 353 362 368  79 321 342 350 349 362 369 376  80 331 361 377 383 400 412 421  81 336 357 371 374 387 403 408  82 333 352 367 363 375 387 390  83 346 367 383 400 411 438 449  84 324 334 342 349 364 382 388  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  Mean 327.2 344.7 357.1 363.3 377.8 391.8 396.8  S.D. 8.9 13.0 16.5 16.9 17.3 21.0 23.1  N 12 12 12 12 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 7 (continued) Individual and Group Mean Body Weights  Body Weights (g)  ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ  Day Numbers Relative to Start Date  Group Animal  (Sex) Number 1 8 15  1(F) 13 208 223 235  14 211 225 237  15 202 207 220  16 213 220 226  17 206 249 257  18 206 223 236  19 201 206 219  20 207 211 212  21 205 220 228  22 207 218 219  23 195 202 208  24 213 223 235  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  Mean 206.2 218.9 227.7  S.D. 5.1 12.3 13.4  N 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 7 (continued) Individual and Group Mean Body Weights  Body Weights (g)  ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ  Day Numbers Relative to Start Date  Group Animal  (Sex) Number 1 8 15  2(F) 37 204 206 223  38 201 206 209  39 200 207 211  40 203 212 221  41 195 205 221  42 194 206 220  43 199 217 227  44 195 211 223  45 212 227 232  46 204 215 230  47 209 225 235  48 214 221 228  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  Mean 202.5 213.2 223.3  S.D. 6.6 7.8 7.8  N 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 7 (continued) Individual and Group Mean Body Weights  Body Weights (g)  ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ  Day Numbers Relative to Start Date  Group Animal  (Sex) Number 1 8 15  3(F) 61 205 206 225  62 201 214 225  63 217 220 231  64 208 219 236  65 202 217 226  66 208 224 230  67 207 216 224  68 207 224 235  69 217 221 236  70 200 211 219  71 204 209 210  72 213 228 231  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  Mean 207.4 217.4 227.3  S.D. 5.7 6.6 7.6  N 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 7 (continued) Individual and Group Mean Body Weights  Body Weights (g)  ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ  Day Numbers Relative to Start Date  Group Animal  (Sex) Number 1 8 15  4(F) 85 192 201 208  86 198 205 213  87 199 207 215  88 210 226 237  89 206 216 221  90 200 207 221  91 201 208 219  92 200 213 214  93 212 225 235  94 191 188 190  95 199 206 209  96 210 223 237  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ  Mean 201.5 210.4 218.3  S.D. 6.8 11.0 13.6  N 12 12 12  ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 7 (continued) Individual and Group Mean Body Weights 

Group (Sex) 

Animal Number 

 Body Weights (g) Day 

After Mating Lactation 

0 7 14 20 1 4 

1(F) 13 237 256 286 364 261 267 

 14 241 264 297 374 268 283

 15 219 251 280 355 248 268  16 TLL 230 259 285 352 253 259  17 274 301 333 409 291 309  18 236 261 288 345 274 277  19 214 246 275 354 243 261  20 219 244 272 327 233 247  21 NP 228 258 250 255 . .  22 222 257 291 359 251 270  23 206 235 260 323 232 237  24 242 265 308 381 278 293  Mean 230.9 258.1 288.6 358.5 257.9 271.2  S.D. 18.5 16.9 19.5 24.2 19.8 21.0  N 11 11 11 11 10 10 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 7 (continued) Individual and Group Mean Body Weights 

Group (Sex) 

Animal Number 

 Body Weights (g) Day 

After Mating Lactation 

0 7 14 20 1 4 

2(F) 37 223 253 274 317 272 277 

 38 220 246 277 343 237 246

 39 224 249 278 343 269 280  40 224 244 276 330 236 246  41 214 251 280 347 240 255 42 217 248 282 347 250 276  43 232 255 291 353 245 262  44 223 257 298 378 271 283 45 235 257 288 348 271 281  46 225 264 306 369 289 294  47 236 264 294 358 251 273  48 240 271 311 379 270 285  Mean 226.1 254.9 287.9 351.0 258.4 271.5  S.D. 8.0 8.2 12.3 18.2 17.3 15.7  N 12 12 12 12 12 12 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 7 (continued) Individual and Group Mean Body Weights 

Group (Sex) 

Animal Number 

 Body Weights (g) Day 

After Mating Lactation 

0 7 14 20 1 4 

3(F) 61 219 258 293 358 253 282 

 62 220 253 289 367 255 260

 63 232 268 304 386 255 273  64 240 277 318 385 289 302  65 223 260 295 368 276 285  66 233 268 304 388 255 267  67 228 251 285 353 260 273  68 226 261 294 351 254 283  69 NP 231 262 261 266 . .  70 218 244 273 333 259 267  71 218 240 256 311 239 252  72 246 274 310 378 281 287  Mean 227.5 259.5 292.8 361.6 261.5 275.5  S.D. 9.4 11.8 17.3 24.0 14.5 14.0  N 11 11 11 11 11 11 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 7 (continued) Individual and Group Mean Body Weights 

Group (Sex) 

Animal Number 

 Body Weights (g) Day 

After Mating Lactation 

0 7 14 20 1 4 

4(F) 85 194 220 241 296 220 241 

 86 212 237 269 342 260 266

 87 219 249 285 331 272 271  88 247 265 290 357 251 278  89 226 254 282 327 266 275 90 221 255 287 344 268 283  91 219 252 291 366 267 280  92 224 261 287 321 280 279 93 236 273 307 387 282 296  94 194 212 236 292 219 233  95 218 242 264 286 257 257  96 243 274 306 383 292 301  Mean 221.1 249.5 278.8 336.0 261.2 271.7  S.D. 16.4 19.2 22.5 33.9 22.5 20.1  N 12 12 12 12 12 12 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 8 Individual and Group Mean Body Weight Gains  Increase in Body Weight (g)  Day Numbers Relative to Start Date  Group Animal From: 1 8 15 22 29 36  (Sex) Number To: 8 15 22 29 36 43  1(M) 1 23 20 11 14 10 1  2 15 15 15 14 12 ƒ2  3 23 7 16 3 12 ƒ10  4 25 13 9 6 8 ƒ11  5 25 21 9 ƒ11 8 6  6 20 23 5 5 15 5  7 21 18 6 14 18 8  8 23 16 ƒ7 1 22 1  9 15 17 5 9 13 5  10 14 13 0 11 17 ƒ9  11 20 17 6 6 6 ƒ18  12 17 20 14 13 9 1  ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ  Mean 20.1 16.7 7.4 7.1 12.5 ƒ1.9  S.D. 4.0 4.3 6.5 7.3 4.8 8.2  N 12 12 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 8 (continued) Individual and Group Mean Body Weight Gains  Increase in Body Weight (g)  Day Numbers Relative to Start Date  Group Animal From: 1 8 15 22 29 36  (Sex) Number To: 8 15 22 29 36 43  2(M) 25 21 18 15 14 20 5  26 24 14 3 13 14 3  27 18 13 9 16 7 10  28 15 14 9 12 10 4  29 19 25 7 6 13 3  30 16 22 8 11 9 6  31 15 20 4 10 8 2  32 15 16 5 13 14 5  33 17 15 3 3 13 1  34 27 20 9 ƒ3 14 ƒ6  35 20 16 3 ƒ1 7 10  36 7 2 6 14 17 8  ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ  Mean 17.8 16.3 6.8 9.0 12.2 4.3  S.D. 5.1 5.8 3.5 6.3 4.1 4.4  N 12 12 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 8 (continued) Individual and Group Mean Body Weight Gains  Increase in Body Weight (g)  Day Numbers Relative to Start Date  Group Animal From: 1 8 15 22 29 36  (Sex) Number To: 8 15 22 29 36 43  3(M) 49 6 18 20 11 14 3  50 19 27 ƒ15 11 8 18  51 2 20 ƒ13 ƒ3 32 20  52 14 15 ƒ22 0 40 12  53 22 19 13 15 14 2  54 14 20 13 20 6 9  55 18 20 9 12 14 8  56 24 13 4 4 19 1  57 16 26 ƒ1 33 19 0  58 21 17 ƒ9 18 12 ƒ3  59 17 21 5 15 12 2  60 14 11 9 15 11 5  ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ  Mean 15.6 18.9 1.1 12.6 16.8 6.4  S.D. 6.4 4.7 13.1 9.5 9.9 7.2  N 12 12 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 8 (continued) Individual and Group Mean Body Weight Gains  Increase in Body Weight (g)  Day Numbers Relative to Start Date  Group Animal From: 1 8 15 22 29 36  (Sex) Number To: 8 15 22 29 36 43  4(M) 73 17 14 7 18 14 3  74 21 10 6 12 8 ƒ4  75 4 9 9 19 17 9  76 13 17 10 22 12 ƒ3  77 20 18 1 14 16 8  78 13 4 13 8 9 6  79 21 8 ƒ1 13 7 7  80 30 16 6 17 12 9  81 21 14 3 13 16 5  82 19 15 ƒ4 12 12 3  83 21 16 17 11 27 11  84 10 8 7 15 18 6  ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ  Mean 17.5 12.4 6.2 14.5 14.0 5.0  S.D. 6.7 4.4 5.9 3.9 5.4 4.6  N 12 12 12 12 12 12  ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 8 (continued) Individual and Group Mean Body Weight Gains  Increase in Body Weight (g)  Day Numbers Relative to Start Date  Group Animal From: 1 8  (Sex) Number To: 8 15  1(F) 13 15 12  14 14 12  15 5 13  16 7 6  17 43 8  18 17 13  19 5 13  20 4 1  21 15 8  22 11 1  23 7 6  24 10 12  ƒƒƒƒ ƒƒƒƒ  Mean 12.8 8.8  S.D. 10.5 4.5  N 12 12  ƒƒƒƒ ƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 8 (continued) Individual and Group Mean Body Weight Gains  Increase in Body Weight (g)  Day Numbers Relative to Start Date  Group Animal From: 1 8  (Sex) Number To: 8 15  2(F) 37 2 17  38 5 3  39 7 4  40 9 9  41 10 16  42 12 14  43 18 10  44 16 12  45 15 5  46 11 15  47 16 10  48 7 7  ƒƒƒƒ ƒƒƒƒ  Mean 10.7 10.2  S.D. 4.9 4.8  N 12 12  ƒƒƒƒ ƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 8 (continued) Individual and Group Mean Body Weight Gains  Increase in Body Weight (g)  Day Numbers Relative to Start Date  Group Animal From: 1 8  (Sex) Number To: 8 15  3(F) 61 1 19  62 13 11  63 3 11  64 11 17  65 15 9  66 16 6  67 9 8  68 17 11  69 4 15  70 11 8  71 5 1  72 15 3  ƒƒƒƒ ƒƒƒƒ  Mean 10.0 9.9  S.D. 5.5 5.3  N 12 12  ƒƒƒƒ ƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 8 (continued) Individual and Group Mean Body Weight Gains  Increase in Body Weight (g)  Day Numbers Relative to Start Date  Group Animal From: 1 8  (Sex) Number To: 8 15  4(F) 85 9 7  86 7 8  87 8 8  88 16 11  89 10 5  90 7 14  91 7 11  92 13 1  93 13 10  94 ƒ3 2  95 7 3  96 13 14  ƒƒƒƒ ƒƒƒƒ  Mean 8.9 7.8  S.D. 4.9 4.4  N 12 12  ƒƒƒƒ ƒƒƒƒ Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 8 (continued) Individual and Group Mean Body Weight Gains 

Increase in Body Weight (g) 

Days 

 Cumulative Body Weight Change 

Days 

After Mating Lactation After Mating

Group (sex) 

Animal Number 

From: 0 7 14 1 0 0 To: 7 14 20 4 14 20 

1(F) 13 19 30 78 6 49 127 

14 23 33 77 15 56 133 

15 32 29 75 20 61 136 

16 TLL 29 26 67 6 55 122 

17 27 32 76 18 59 135 

18 25 27 57 3 52 109 

19 32 29 79 18 61 140 

20 25 28 55 14 53 108 

21 NP 30 -8 5 . 22 27 

22 35 34 68 19 69 137 

23 29 25 63 5 54 117 

24 23 43 73 15 66 139 

Mean 27.2 30.5 69.8 13.3 57.7 127.5 S.D. 4.8 5.0 8.5 6.3 6.1 11.8 N 11 11 11 10 11 11 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 8 (continued) Individual and Group Mean Body Weight Gains 

Increase in Body Weight (g) 

Days 

 Cumulative Body Weight Change 

Days 

 After Mating Lactation After Mating Group (sex) 

Animal Number 

From: 0 7 14 1 0 0 To: 7 14 20 4 14 20 

2(F) 37 30 21 43 5 51 94 

38 26 31 66 9 57 123 

39 25 29 65 11 54 119 

40 20 32 54 10 52 106 

41 37 29 67 15 66 133 

42 31 34 65 26 65 130 

43 23 36 62 17 59 121 

44 34 41 80 12 75 155 

45 22 31 60 10 53 113 

46 39 42 63 5 81 144 

47 28 30 64 22 58 122 

48 31 40 68 15 71 139 

Mean 28.8 33.0 63.1 13.1 61.8 124.9 S.D. 6.0 6.0 8.7 6.3 9.8 16.7 N 12 12 12 12 12 12 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 8 (continued) Individual and Group Mean Body Weight Gains 

Increase in Body Weight (g) 

Days 

 Cumulative Body Weight Change 

Days 

After Mating Lactation After Mating

Group (sex) 

Animal Number 

From: 0 7 14 1 0 0 To: 7 14 20 4 14 20 

3(F) 61 39 35 65 29 74 139 

62 33 36 78 5 69 147 63 36 36 82 18 72 154 64 37 41 67 13 78 145 65 37 35 73 9 72 145 66 35 36 84 12 71 155 67 23 34 68 13 57 125 68 35 33 57 29 68 125 

69 NP 31 -1 5 30 35 

70 26 29 60 8 55 115 71 22 16 55 13 38 93 72 28 36 68 6 64 132 

Mean 31.9 33.4 68.8 14.1 65.3 134.1 S.D. 6.1 6.4 9.7 8.2 11.4 18.7 N 11 11 11 11 11 11 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 8 (continued) Individual and Group Mean Body Weight Gains 

Increase in Body Weight (g) 

Days 

 Cumulative Body Weight Change 

Days 

 After Mating Lactation After Mating Group (sex) 

Animal Number 

From: 0 7 14 1 0 0 To: 7 14 20 4 14 20 

4(F) 85 26 21 55 21 47 102  86 25 32 73 6 57 130  87 30 36 46 -1 66 112  88 18 25 67 27 43 110  89 28 28 45 9 56 101  90 34 32 57 15 66 123  91 33 39 75 13 72 147  92 37 26 34 -1 63 97  93 37 34 80 14 71 151  94 18 24 56 14 42 98  95 24 22 22 0 46 68  96 31 32 77 9 63 140 

Mean 28.4 29.3 57.3 10.5 57.7 114.9 S.D. 6.5 5.8 18.2 8.7 10.8 24.2 N 12 12 12 12 12 12 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 9 Individual and Group Mean Food Consumption Values for Females Following Mating 

Mean Food Consumption (g/rat/day)

After Mating Lactation

Group (Sex) 

Animal

Number

From: 0 7 14 1

To: 7 14 20 4

1(F) 13 24 14 28 25

 14 24 25 30 30  15 22 23 27 30  16 TLL 27 26 31 14  17 25 27 31 39  18 24 25 27 27  19 21 23 26 29 20 20 21 22 27  21 NP 23 22 21 .  22 22 23 27 27  23 21 22 24 24  24 21 26 33 25 

Mean 22.8 23.1 27.8 28.3 S.D. 2.1 3.4 3.3 4.2N 11 11 11 10 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 9 (continued) Individual and Group Mean Food Consumption Values for Females Followin

Lactation 

Mean Food Consumption (g/rat/day)

After Mating Lactation

Group (Sex) 

Animal

Number

From: 0 7 14 1

To: 7 14 20 4

2(F) 37 23 23 26 24 

 38 20 22 24 18  39 22 25 29 28  40 19 22 24 18  41 23 23 25 28  42 21 14 28 36  43 20 22 24 25  44 25 28 31 27  45 22 25 29 30  46 26 31 32 38  47 21 24 25 32 48 23 26 26 29 

Mean 21.9 23.6 26.8 27.8 S.D. 2.1 4.0 2.9 6.3 N 12 12 12 12 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 9 (continued) Individual and Group Mean Food Consumption Values for Females Followin

Lactation 

Mean Food Consumption (g/rat/day)

After Mating Lactation

Group (Sex) 

Animal

Number

From: 0 7 14 1

To: 7 14 20 4

3(F) 61 24 24 25 34 

 62 22 25 29 28  63 25 27 30 28  64 27 28 30 39  65 25 27 32 32 66 24 25 28 30  67 22 24 27 31  68 23 14 28 35 69 NP 22 20 20  70 20 23 26 27  71 19 20 23 26 72 24 24 28 23 

Mean 23.1 23.8 27.8 30.3 S.D. 2.2 3.8 2.6 4.6 N 11 11 11 11 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 9 (continued) Individual and Group Mean Food Consumption Values for Females Followin

Lactation 

Mean Food Consumption (g/rat/day)

After Mating Lactation

Group (Sex) 

Animal

Number

From: 0 7 14 1

To: 7 14 20 4

4(F) 85 17 20 21 31 

86 20 22 26 30 87 23 26 30 30 88 22 24 26 36 89 23 24 27 29 90 22 23 26 33 91 21 27 31 31 92 25 27 29 23 93 27 27 31 37 94 17 20 22 24 95 21 23 24 1796 28 28 29 28 

Mean 22.2 24.3 26.6 29.1 S.D. 3.4 2.8 3.3 5.5 N 12 12 12 12 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 10 Individual Mating Performance, Fertility and Gestation Lengths Group: 1 Dose Level: 0 (Control) 

Paired Animal Number Pre-Coital Interval (Days) Copulation Plug Count Sperm Reading Score Pregnancy Sta

13 F 1 M 2 6 PT 3+ P 

14 F 2 M 2 4 PT 3+ P 15 F 3 M 1 3 PT 2+ P 

16 F 4 M 3 5 PT H 3+ P (TLL) 17 F 5 M 11 PV 3+ P 18 F 6 M 2 3 PT 3+ P 19 F 7 M 1 5 PT H 3+ P 

20 F 8 M 4 4 PT 1+ P 

21 F 9 M 1 PV 1+ NP 

22 F 10 M 3 6 PT H 3+ P 23 F 11 M 2 4 PT H 3+ P 24 F 12 M 3 3 PT 3+ P 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 10 (continued) Individual Mating Performance, Fertility and Gestation Lengths Group: 2 Dose Level: 30 mg/kg bw/day 

Paired Animal Number Pre-Coital Interval (Days) Copulation Plug Count Sperm Reading Score Pregnancy Sta

37 F 25 M 1 3 PT H 3+ P 

38 F 26 M 4 5 PT 1+ P 

39 F 27 M 4 6 PT 2+ P 

40 F 28 M 3 3 PT H 3+ P 41 F 29 M 1 3 PT 3+ P 

42 F 30 M 1 6 PT H 2+ P 

43 F 31 M 3 2 PT 2+ P 

44 F 32 M 2 5 PT H 2+ P 45 F 33 M 3 5 PT 2+ P 46 F 34 M 1 6 PT H 1+ P 47 F 35 M 3 5 PT H 3+ P 48 F 36 M 4 2 PT H 1+ P 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 10 (continued) Individual Mating Performance, Fertility and Gestation Lengths Group: 3 Dose Level: 300 mg/kg bw/day 

Paired Animal Number Pre-Coital Interval (Days) Copulation Plug Count Sperm Reading Score Pregnancy Sta

61 F 49 M 1 4 PT 2+ P 62 F 50 M 2 5 PT H 3+ P 63 F 51 M 3 2 PT 2+ P 64 F 52 M 3 6 PT H 3+ P 65 F 53 M 2 1 PT 2+ P 66 F 54 M 3 5 PT 3+ P 67 F 55 M 3 4 PT 3+ P 68 F 56 M 2 6 PT 2+ P 69 F 57 M 1 3 PT 1+ NP 70 F 58 M 1 4 PT H 1+ P 71 F 59 M 3 3 PT 3+ P 72 F 60 M 4 4 PT H 3+ P 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 10 (continued) Individual Mating Performance, Fertility and Gestation Lengths Group: 4 Dose Level: 1000 mg/kg bw/day 

Paired Animal Number Pre-Coital Interval (Days) Copulation Plug Count Sperm Reading Score Pregnancy Sta

85 F 73 M 2 2 PT PV 1+ P 

86 F 74 M 2 4 PT H 1+ P 

87 F 75 M 3 2 PT PV 1+ P 

88 F 76 M 3 2 PT 3+ P 89 F 77 M 3 6 PT 3+ P 90 F 78 M 1 5 PT H 3+ P 

91 F 79 M 3 4 PT 3+ P 

92 F 80 M 4 5 PT H 3+ P 

93 F 81 M 3 4 PT H 2+ P 94 F 82 M 4 4 PT 2+ P 

95 F 83 M 4 6 PT 3+ P 

96 F 84 M 2 6 PT H 3+ P 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 11 Individual and Group Mean Litter Size and Litter Weights Group: 1 Dose Level: 0(Control)

Animal/Litter 

Number 

Number of

Corpora 

Lutea 

Number of 

Implantation 

Sites 

Total 

Number of Offspring 

Born 

Number of Live 

Offspring 

Litter Weight 

(g) 

Mean Offspring Weight 

(g) 

Day 1 Day 4 Day 1 Day 4 

Day 1 Day 

Males Females Males 

13 17 15 14 14 14 81.8 106.2 6.0 5.4 7.8 14 14 14 14 14 14 80.6 113.0 5.9 5.6 8.2 15 14 14 12 12 12 80.9 116.7 6.9 6.4 9.9 16 TLL 17 17 14 14 82.6 . 6.1 5.8 . 17 18 18 18 18 18 97.2 131.3 5.5 5.3 7.4 18 11 11 10 10 10 61.0 86.5 6.2 6.0 8.8 19 16 16 14 12 12 74.5 103.9 6.3 6.1 8.8 20 12 12 12 12 12 74.8 104.5 6.2 6.2 8.9 21 NP . . . . . . . . . . 22 17 12 11 11 10 72.6 98.0 6.8 6.4 10.0 23 14 14 13# 13# 13 66.3 99.8 5.5 5.6 7.8 24 17 16 15 15 15 82.1 108.3 5.5 5.4 7.2 

Mean 15.0 14.2 13.3 13.1 13.0 77.18 106.82 6.08 5.85 8.47 

S.D. 2.4 2.1 2.3 2.3 2.4 9.92 11.98 0.51 0.43 0.96 N 10 10 10 10 10 10 10 10 10 10 

# = One offspring not observed until Day 3 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 11 (continued) Individual and Group Mean Litter Size and Litter Weights Group: 2 Dose Level: 30 mg/kg bw/day

Animal/Litter 

Number 

Number of

Corpora 

Lutea 

Number of 

Implantation 

Sites 

Total 

Number of Offspring 

Born 

Number of Live 

Offspring 

Litter Weight 

(g) 

Mean Offspring Weight 

(g) 

Day 1 Day 4 Day 1 Day 4 

Day 1 Day 

Males Females Males 

37 12 6 6 6 6 42.3 66.7 7.1 7.1 11.2 38 15 15 15 15 12 78.3 88.6 5.5 4.9 7.7 39 11 11 10 10 10 67.3 99.0 6.9 6.6 10.1 40 13 13 12 11 9 61.5 76.9 5.8 5.4 8.6 41 16 15 15 15 15 79.0 104.1 5.4 5.2 7.0 42 13 13 12 12 12 78.1 113.6 6.6 6.2 9.5 43 15 15 14 14 14 78.6 107.9 6.0 5.3 8.2 44 15 15 15 14 14 79.4 105.1 5.8 5.5 7.7 45 15 14 12 12 12 69.6 96.7 5.9 5.5 8.2 46 17 15 14 14 13 77.5 109.9 5.9 5.2 8.9 47 16 16 16 16 16 84.5 117.1 5.5 5.1 7.6 48 16 16 14 14 14 80.6 111.5 5.9 5.7 8.2 

Mean 14.5 13.7 12.9 12.8 12.3 73.06 99.76 6.02 5.63 8.57 

S.D. 1.8 2.8 2.8 2.8 2.8 11.64 15.36 0.54 0.65 1.20 N 12 12 12 12 12 12 12 12 12 12 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 11 (continued) Individual and Group Mean Litter Size and Litter Weights Group: 3 Dose Level: 300 mg/kg bw/day

Animal/Litter 

Number 

Number of

Corpora 

Lutea 

Number of 

Implantation 

Sites 

Total 

Number of Offspring 

Born 

Number of Live 

Offspring 

Litter Weight 

(g) 

Mean Offspring Weight 

(g) 

Day 1 Day 4 Day 1 Day 4 

Day 1 Day 

Males Females Males 

61 15 15 15 15 15 89.3 125.5 6.3 5.7 8.8 62 16 16 15 15 15 89.4 114.8 6.3 5.6 7.8 63 17 17 16 16 12 98.4 108.3 6.3 6.0 9.1 64 18 15 13 13 13 95.1 128.5 7.4 7.0 10.1 65 12 12 11 11 11 76.8 118.3 7.2 6.7 11.0 66 17 17 16 16 16 94.7 133.7 6.0 5.8 8.3 67 16 16 14 14 14 82.7 114.3 6.1 5.7 8.3 68 12 12 11 11 11 78.6 114.8 7.4 7.0 10.7 

69 NP 2 

70 11 11 10 10 10 67.5 98.7 6.9 6.5 10.3 71 16 14 12 12 12 65.1 88.1 5.7 5.2 7.7 72 14 14 13 13 12 73.2 95.6 5.8 5.5 8.1 

Mean 14.9 14.5 13.3 13.3 12.8 82.80 112.78 6.48 6.07 9.11 

S.D. 2.3 2.1 2.1 2.1 1.9 11.47 14.18 0.62 0.63 1.19 N 11 11 11 11 11 11 11 11 11 11 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 11 (continued) Individual and Group Mean Litter Size and Litter Weights Group: 4 Dose Level: 1000 mg/kg bw/day

Animal/Litter 

Number 

Number of

Corpora 

Lutea 

Number of 

Implantation 

Sites 

Total 

Number of Offspring 

Born 

Number of Live 

Offspring 

Litter Weight 

(g) 

Mean Offspring Weight 

(g) 

Day 1 Day 4 Day 1 Day 4 

Day 1 Day 

Males Females Males 

85 12 11 11 11 11 63.9 91.8 6.1 5.1 8.7 86 13 13 12 12 11 67.2 93.2 5.8 5.0 8.6 87 11 11 9 9 9 62.5 94.3 6.9 7.0 10.4 88 17 17 14 13 12 81.5 114.2 6.5 6.1 9.8 89 15 9 9 9 9 62.5 92.4 7.0 6.9 10.3 90 14 12 11 11 11 67.1 104.5 6.3 6.0 9.9 91 15 13 13 13 13 82.4 107.3 6.3 6.4 8.2 92 10 9 4 4 4 30.2 48.0 7.9 7.4 12.7 93 17 16 16 16 16 98.7 124.8 6.5 5.8 8.1 94 11 11 10 10 10 57.7 81.6 6.0 5.6 8.4 95 10 5 3 3 3 21.1 33.6 7.2 7.0 11.5 96 15 14 13 13 13 78.7 104.7 6.2 5.9 8.1 

Mean 13.3 11.8 10.4 10.3 10.2 64.46 90.87 6.54 6.19 9.56 

S.D. 2.5 3.3 3.8 3.7 3.7 21.55 26.23 0.60 0.76 1.48 N 12 12 12 12 12 12 12 12 12 12 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 12 Individual and Group Mean Implantation Losses and Survival Indices 

Group (Sex) 

Litter Number 

PreImplantation 

Loss (%)

Post -

Implantation 

Loss (%)

Live 

Birth 

Index (%)

Viability Index (%) 

1(F) 13 12 7 100 100 

14 0 0 100 100 15 0 14 100 100 

16 TLL 0 18 100 0 

17 0 0 100 100 18 0 9 100 100 19 0 13 86 100 20 0 0 100 100 

21 NP . . . . 

22 29 8 100 91 

23 0 7 100 100 24 6 6 100 100 

Mean 4.7 6.4 98.6 99.1 S.D. 9.5 5.1 4.5 2.9 N 10 10 10 10 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 12 (continued) Individual and Group Mean Implantation Losses and Survival Indices 

Group (Sex) 

Litter Number 

PreImplantation 

Loss (%)

Post -

Implantation 

Loss (%) 

Live 

Birth 

Index (%) 

Viability Index (%) 

2(F) 37 50 0 100 100 

 38 0 0 100 80  39 0 9 100 100  40 0 8 92 82  41 6 0 100 100  42 0 8 100 100  43 0 7 100 100  44 0 0 93 100  45 7 14 100 100  46 12 7 100 93  47 0 0 100 100  48 0 13 100 100 

Mean 6.2 5.4 98.8 96.2 S.D. 14.3 5.2 2.9 7.4 N 12 12 12 12 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 12 (continued) Individual and Group Mean Implantation Losses and Survival Indices 

Group (Sex) 

Litter Number 

PreImplantation 

Loss (%)

Post -

Implantation 

Loss (%)

Live 

Birth 

Index (%)

Viability Index (%) 

3(F) 61 0 0 100 100 

62 0 6 100 100 63 0 6 100 75 64 17 13 100 100 

65 0 8 100 100 66 0 6 100 100 67 0 13 100 100 68 0 8 100 100 

69 NP 100 . . . 

70 0 9 100 100 71 13 14 100 100 

72 0 7 100 92 

Mean 2.7 8.3 100.0 97.0 S.D. 6.0 4.1 0.0 7.7 N 11 11 11 11 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 12 (continued) Individual and Group Mean Implantation Losses and Survival Indices 

Group (Sex) 

Litter Number 

PreImplantation 

Loss (%)

Post -

Implantation 

Loss (%) 

Live 

Birth 

Index (%) 

Viability Index (%) 

4(F) 85 8 0 100 100 

86 0 8 100 92 87 0 18 100 100 88 0 18 93 92 89 40 0 100 100 

90 14 8 100 100 

91 13 0 100 100 

92 10 56 100 100 

93 6 0 100 100 94 0 9 100 100 95 50 40 100 100 

96 7 7 100 100 

Mean 12.4 13.6 99.4 98.7 S.D. 16.2 17.5 2.1 3.1 N 12 12 12 12 

Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 13 Individual and Group Mean Sex Ratio Values for Offspring Group: 1 Dose Level: 0 (Control) 

Litter Number 

Sex Ratio (Post Partum) Day: 

At birth 1 4

Male Female % Male Male Female % Male Male Female % Male 

13 10 4 71 10 4 71 10 4 71 14 8 6 57 8 6 57 8 6 57 15 8 4 67 8 4 67 8 4 67 

16 TLL 4 10 29 4 10 29 . . . 

17 9 9 50 9 9 50 9 9 50 18 5 5 50 5 5 50 5 5 50

19 8 6 57 6 6 50 6 6 50 20 5 7 42 5 7 42 5 7 42 

21 NP 

22 6 5 55 6 5 55 6 4 60 23 7 6 54 7 6 54 7 6 54 24 8 7 53 8 7 53 8 7 53 

Mean 55.6 54.9 55.4 S.D. 8.5 8.6 8.8 N 10 10 10 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 13 (continued) Individual and Group Mean Sex Ratio Values for Offspring Group: 2 Dose Level: 30 mg/kg bw/day 

Litter Number 

Sex Ratio (Post Partum) Day: 

At birth 1 4

Male Female % Male Male Female % Male Male Female % Male 

37 4 2 67 4 2 67 4 2 67

38 8 7 53 8 7 53 7 5 58 39 4 6 40 4 6 40 4 6 40 40 7 5 58 6 5 55 5 4 5641 7 8 47 7 8 47 7 8 47 42 9 3 75 9 3 75 9 3 75 42 6 8 43 6 8 43 6 8 43 44 9 6 60 8 6 57 8 6 57 45 9 3 75 9 3 75 9 3 75 46 7 7 50 7 7 50 7 6 54 47 7 9 44 7 9 44 7 9 44 48 5 9 36 5 9 36 5 9 36

Mean 53.9 53.4 54.2 S.D. 13.2 13.1 13.1 N 12 12 12 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 13 (continued) Individual and Group Mean Sex Ratio Values for Offspring Group: 3 Dose Level: 300 mg/kg bw/day 

Litter Number 

Sex Ratio (Post Partum) Day: 

At birth 1 4

Male Female % Male Male Female % Male Male Female % Male 

61 6 9 40 6 9 40 6 9 40 62 8 7 53 8 7 53 8 7 53 63 10 6 63 10 6 63 8 4 67 64 9 4 69 9 4 69 9 4 69 65 7 4 64 7 4 64 7 4 64 66 12 4 75 12 4 75 12 4 75

67 7 7 50 7 7 50 7 7 50 68 4 7 36 4 7 36 4 7 36 

69 NP . . . . . . . . .

70 6 4 60 6 4 60 6 4 60 71 5 7 42 5 7 42 5 7 42 72 5 8 38 5 8 38 5 7 42 

Mean 53.7 53.7 54.3 S.D. 13.4 13.4 13.4 N 11 11 11 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 13 (continued) Individual and Group Mean Sex Ratio Values for Offspring Group: 4 Dose Level: 1000 mg/kg bw/day 

Litter Number 

Sex Ratio (Post Partum) Day: 

At birth 1 4

Male Female % Male Male Female % Male Male Female % Male 

85 8 3 73 8 3 73 8 3 73

86 9 3 75 9 3 75 9 2 82 87 6 3 67 6 3 67 6 3 67 88 5 8 38 5 8 38 5 7 4289 5 4 56 5 4 56 5 4 56 90 5 6 45 5 6 45 5 6 45 91 6 7 46 6 7 46 6 7 46 92 1 3 25 1 3 25 1 3 25 93 9 7 56 9 7 56 9 7 56 94 5 5 50 5 5 50 5 5 50 95 1 2 33 1 2 33 1 2 33 96 6 7 46 6 7 46 6 7 46

Mean 50.9 50.9 51.7 S.D. 15.3 15.3 16.1 N 12 12 12 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 14 Individual Clinical Signs for Offspring Group: 1 Dose Level: 0 (Control) 

Litter Number Affected Offspring Sex and Identity Clinical Observation 

13 No Abnormalities Detected 

14 No Abnormalities Detected 15 No Abnormalities Detected 

16 TLL 4M 10F (Whole litter) Missing 

17 No Abnormalities Detected 18 No Abnormalities Detected 19 2M Found dead 20 No Abnormalities Detected 

21 NP . 

22 F7 Missing 23 No Abnormalities Detected 24 No Abnormalities Detected 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 14 (continued) Individual Clinical Signs for Offspring Group: 2 Dose Level: 30 mg/kg bw/day 

Litter Number Affected Offspring Sex and Identity Clinical Observation 

37 No Abnormalities Detected 

38 M6 F14 F15 Missing 39 No Abnormalities Detected 40 1M Found dead 

 M6 Swollen abdomen  Missing  M7 Small  Missing 

41 No Abnormalities Detected 42 No Abnormalities Detected 43 No Abnormalities Detected 44 1M Found dead 

 8M 6F (Whole litter) Cold 

45 No Abnormalities Detected 46 F11 Bruising to neck region 

 F12 Missing 

47 F11 Small 48 No Abnormalities Detected 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 14 (continued) Individual Clinical Signs for Offspring Group: 3 Dose Level: 300 mg/kg bw/day 

Litter Number Affected Offspring Sex and Identity Clinical Observation 

61 No Abnormalities Detected 

62 No Abnormalities Detected 63 M6 M7 F13 F14 Missing 64 No Abnormalities Detected 65 No Abnormalities Detected 66 No Abnormalities Detected 67 No Abnormalities Detected 68 No Abnormalities Detected 

69 NP . 

70 No Abnormalities Detected 71 No Abnormalities Detected 72 F7 Missing 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 14 (continued) Individual Clinical Signs for Offspring Group: 4 Dose Level: 1000 mg/kg bw/day 

Litter Number Affected Offspring Sex and Identity Clinical Observation 

85 F11 Swollen snout 

 Small 

86 F10 Cold 

 Small  Missing 

87 No Abnormalities Detected 88 1M Found dead 

F13 Missing 

89 No Abnormalities Detected 90 No Abnormalities Detected 91 No Abnormalities Detected 92 No Abnormalities Detected 93 F16 Small 94 No Abnormalities Detected 95 No Abnormalities Detected 96 No Abnormalities Detected 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 15 Individual and Group Mean Reflexological Responses for Offspring Group: 1 Dose Level: 0 (Control) 

Litter Number 

Surface righting 

(Day 1 Post Partum) 

Number of offspring 

% passed 

examined passed 

13 14 14 100.0 14 14 14 100.0 15 12 10 83.3 

16 TLL 14 14 100.0 

17 18 18 100.0 18 10 9 90.0 19 12 12 100.0 20 12 12 100.0 

21 NP . . . 

22 11 10 90.9 23 12 10 83.3 24 15 14 93.3 

 Mean 94.6  S.D. 6.8  N 11 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 15 (continued) Individual and Group Mean Reflexological Responses for Offspring Group: 2 Dose Level: 30 mg/kg bw/day 

Litter Number 

Surface righting 

(Day 1 Post Partum) 

Number of offspring 

% passed 

examined passed 

37 6 6 100.0 38 15 13 86.7 39 10 8 80.0 40 11 10 90.9 41 15 15 100.0 42 12 10 83.3 43 14 14 100.0 44 14 12 85.7 45 12 11 91.7 46 14 14 100.0 47 16 14 87.5 48 14 13 92.9 

 Mean 91.6  S.D. 7.2  N 12 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 15 (continued) Individual and Group Mean Reflexological Responses for Offspring Group: 3 Dose Level: 300 mg/kg bw/day 

Litter Number 

Surface righting 

(Day 1 Post Partum) 

Number of offspring 

% passed 

examined passed 

61 15 15 100.0 62 15 11 86.7 63 16 15 93.8 64 13 13 100.0 65 11 11 100.0 66 16 16 100.0 67 14 14 100.0 68 11 11 100.0 69 NP . . . 70 10 8 80.0 71 12 12 100.0 72 13 12 92.3 

 Mean 94.5  S.D. 9.4  N 11 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 15 (continued) Individual and Group Mean Reflexological Responses for Offspring Group: 4 Dose Level: 1000 mg/kg bw/day 

Litter Number 

Surface righting 

(Day 1 Post Partum) 

Number of offspring 

% passed 

examined passed 

85 11 11 100.0 86 12 11 91.7 87 9 9 100.0 88 13 13 100.0 89 9 9 100.0 90 11 9 81.8 91 13 13 100.0 92 4 4 100.0 93 16 16 100.0 94 10 10 100.0 95 3 3 100.0 96 13 13 100.0 

 Mean 97.8  S.D. 5.6  N 12 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 16 Individual Haematological Values Group Animal (Sex) Number Week Hb RBC Hct MCH MCV MCHC WBC Neu% Neut Lym% Lymph Mon% Mono Eos% Eos Bas% Bas  Number g/dl 10^12/l % pg fl g/dl 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l 10 1(M) 1 6 16.6 9.35 50.3 17.8 53.8 33.1 5.9 10 0.59 90 5.31 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 2 6 16.6 9.18 51.1 18.1 55.7 32.5 11.2 33 3.70 67 7.50 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 3 6 16.9 9.10 51.8 18.5 56.9 32.6 9.8 14 1.37 86 8.43 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 4 6 16.9 8.94 51.3 18.9 57.3 33.0 7.3 12 0.88 87 6.35 1 0.07 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 5 6 15.9 8.95 48.5 17.7 54.2 32.7 6.8 22 1.50 77 5.24 0 0.00 1 0.07 0 0.00 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 16 (continued) Individual Haematological Values Group Animal (Sex) Number Week Hb RBC Hct MCH MCV MCHC WBC Neu% Neut Lym% Lymph Mon% Mono Eos% Eos Bas% Bas  Number g/dl 10^12/l % pg fl g/dl 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l 10 1(F) 13 6 12.5 6.60 38.2 19.0 57.8 32.8 8.3 36 2.99 64 5.31 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 14 6 13.4 6.97 41.0 19.2 58.7 32.8 8.8 27 2.38 73 6.42 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 15 6 13.2 7.11 40.4 18.5 56.8 32.7 8.7 14 1.22 86 7.48 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 18 6 14.2 7.52 44.2 18.9 58.8 32.1 5.6 15 0.84 85 4.76 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 19 6 11.5 5.91 35.3 19.4 59.7 32.5 6.0 40 2.40 60 3.60 0 0.00 0 0.00 0 0.00 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 16 (continued) Individual Haematological Values Group Animal (Sex) Number Week Hb RBC Hct MCH MCV MCHC WBC Neu% Neut Lym% Lymph Mon% Mono Eos% Eos Bas% Bas  Number g/dl 10^12/l % pg fl g/dl 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l 10 2(M) 25 6 15.4 8.35 46.8 18.5 56.1 32.9 10.5 12 1.26 88 9.24 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 26 6 16.8 9.39 51.5 17.9 54.9 32.7 9.0 17 1.53 82 7.38 1 0.09 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 27 6 15.4 9.04 47.3 17.1 52.3 32.6 9.1 22 2.00 78 7.10 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 28 6 15.5 8.77 46.8 17.7 53.3 33.1 9.0 9 0.81 91 8.19 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 29 6 17.5 9.76 53.4 18.0 54.7 32.8 10.1 8 0.81 92 9.29 0 0.00 0 0.00 0 0.00 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 16 (continued) Individual Haematological Values Group Animal (Sex) Number Week Hb RBC Hct MCH MCV MCHC WBC Neu% Neut Lym% Lymph Mon% Mono Eos% Eos Bas% Bas  Number g/dl 10^12/l % pg fl g/dl 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l 10 2(F) 37 6 14.3 7.56 42.6 18.9 56.4 33.5 4.0 16 0.64 84 3.36 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 41 6 13.8 7.84 42.4 17.5 54.0 32.5 5.6 31 1.74 69 3.86 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 42 6 12.9 7.09 39.5 18.2 55.8 32.6 7.0 37 2.59 63 4.41 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 44 6 13.0 6.94 40.7 18.8 58.6 32.1 7.2 21 1.51 79 5.69 0 0.00 0 0.00 0 0.00 1 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 46 6 13.2 7.01 40.1 18.9 57.1 33.1 6.1 49 2.99 51 3.11 0 0.00 0 0.00 0 0.00 1Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 16 (continued) Individual Haematological Values Group Animal (Sex) Number Week Hb RBC Hct MCH MCV MCHC WBC Neu% Neut Lym% Lymph Mon% Mono Eos% Eos Bas% Bas  Number g/dl 10^12/l % pg fl g/dl 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l 10 3(M) 49 6 15.8 8.84 48.3 17.8 54.6 32.7 4.2 25 1.05 74 3.11 0 0.00 1 0.04 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 50 6 16.2 9.02 49.5 17.9 54.9 32.7 9.4 18 1.69 82 7.71 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 51 6 15.3 8.74 47.7 17.5 54.6 32.1 6.9 29 2.00 71 4.90 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 52 6 15.3 8.73 47.1 17.5 54.0 32.4 6.4 14 0.90 85 5.44 0 0.00 1 0.06 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 53 6 16.8 9.44 50.7 17.8 53.7 33.1 7.3 8 0.58 90 6.57 0 0.00 2 0.15 0 0.00 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 16 (continued) Individual Haematological Values Group Animal (Sex) Number Week Hb RBC Hct MCH MCV MCHC WBC Neu% Neut Lym% Lymph Mon% Mono Eos% Eos Bas% Bas  Number g/dl 10^12/l % pg fl g/dl 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l 10 3(F) 61 6 13.1 7.12 40.4 18.4 56.7 32.5 6.2 22 1.36 78 4.84 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 62 6 10.7 5.67 33.7 18.8 59.4 31.7 9.2 38 3.50 62 5.70 0 0.00 0 0.00 0 0.00 1 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 65 7 13.8 7.02 41.3 19.7 58.8 33.5 3.9 41 1.60 59 2.30 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 67 7 13.7 7.43 41.9 18.5 56.5 32.7 4.9 40 1.96 60 2.94 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 70 6 13.9 7.09 41.9 19.6 59.1 33.1 6.8 26 1.77 73 4.96 1 0.07 0 0.00 0 0.00 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 16 (continued) Individual Haematological Values Group Animal (Sex) Number Week Hb RBC Hct MCH MCV MCHC WBC Neu% Neut Lym% Lymph Mon% Mono Eos% Eos Bas% Bas  Number g/dl 10^12/l % pg fl g/dl 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l 10 4(M) 73 6 13.7 7.53 41.3 18.2 54.9 33.2 4.6 12 0.55 88 4.05 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 74 6 16.5 9.29 50.5 17.8 54.4 32.6 5.4 23 1.24 75 4.05 0 0.00 2 0.11 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 75 6 12.9 7.23 39.0 17.8 53.9 33.0 7.8 10 0.78 90 7.02 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 76 6 15.2 8.49 46.0 17.9 54.2 33.0 6.2 21 1.30 77 4.77 0 0.00 2 0.12 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 77 6 15.7 8.86 47.7 17.7 53.9 32.8 6.0 8 0.48 91 5.46 0 0.00 1 0.06 0 0.00 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 16 (continued) Individual Haematological Values Group Animal (Sex) Number Week Hb RBC Hct MCH MCV MCHC WBC Neu% Neut Lym% Lymph Mon% Mono Eos% Eos Bas% Bas  Number g/dl 10^12/l % pg fl g/dl 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l % 10^9/l 10 4(F) 85 6 7.4 3.95 22.4 18.8 56.7 33.2 2.5 28 0.70 71 1.78 0 0.00 1 0.03 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 86 6 14.1 7.52 43.5 18.7 57.9 32.4 5.4 22 1.19 78 4.21 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 90 6 14.0 7.81 42.8 17.9 54.8 32.6 5.3 34 1.80 64 3.39 0 0.00 2 0.11 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 91 7 13.6 6.98 41.3 19.5 59.2 33.0 5.5 41 2.26 59 3.25 0 0.00 0 0.00 0 0.00  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒ 96 6 14.8 7.91 45.3 18.7 57.2 32.6 5.8 29 1.68 71 4.12 0 0.00 0 0.00 0 0.00 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 17 Individual Coagulation Values  Group Animal  (Sex) Number Week CT APTT  Number Seconds Seconds  1(M) 1 6 10.1 19.0  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  2 6 10.3 18.1  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  3 6 10.2 15.4  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  4 6 9.1 13.5  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  5 6 8.9 10.7 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 17 (continued) Individual Coagulation Values  Group Animal  (Sex) Number Week CT APTT  Number Seconds Seconds  1(F) 13 6 9.3 12.9  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  14 6 11.3 19.2  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  15 6 9.5 13.9  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  18 6 10.1 18.6  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  19 6 8.6 14.8 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 17 (continued) Individual Coagulation Values  Group Animal  (Sex) Number Week CT APTT  Number Seconds Seconds  2(M) 25 6 9.3 13.7  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  26 6 10.1 16.2  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  27 6 9.6 15.9  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  28 6 9.4 15.7  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  29 6 10.2 17.9 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 17 (continued) Individual Coagulation Values  Group Animal  (Sex) Number Week CT APTT  Number Seconds Seconds  2(F) 37 6 . .  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  41 6 9.1 13.9  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  42 6 9.5 16.1  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  44 6 9.5 15.7  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  46 6 9.2 16.1 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 17 (continued) Individual Coagulation Values  Group Animal  (Sex) Number Week CT APTT  Number Seconds Seconds  3(M) 49 6 9.1 12.4  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  50 6 10.4 16.7  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  51 6 9.9 16.2  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  52 6 9.1 15.0  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  53 6 10.1 14.9 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 17 (continued) Individual Coagulation Values  Group Animal  (Sex) Number Week CT APTT  Number Seconds Seconds  3(F) 61 6 9.4 10.8  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  62 6 9.2 16.5  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  65 7 9.7 14.0  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  67 7 11.1 16.7  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  70 6 9.4 14.9 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 17 (continued) Individual Coagulation Values  Group Animal  (Sex) Number Week CT APTT  Number Seconds Seconds  4(M) 73 6 9.1 10.4  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  74 6 9.9 13.9  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  75 6 9.1 15.0  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  76 6 9.7 14.7  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  77 6 10.2 12.6 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 17 (continued) Individual Coagulation Values  Group Animal  (Sex) Number Week CT APTT  Number Seconds Seconds  4(F) 85 6 10.3 16.9  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  86 6 9.5 17.5  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  90 6 9.3 16.0  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  91 7 10.5 16.4  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ  96 6 9.1 13.7 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 18 Individual Blood Chemical Values  Group Animal Tot.  (Sex) Number Week Urea Glucose Prot. Albumin A/G Na+ K+ Clƒ Ca++ P ASAT ALAT AP Creat Chol Bili Number mg/dl mg/dl g/dl g/dl Ratio mmol/l mmol/l mmol/l mmol/l mmol/l IU/l IU/l IU/l mg/dl mg/dl mg/d 1(M) 1 6 69 150 7.10 3.7 1.10 145 7.14 101 2.70 2.1 113 66 189 1.06 98 0.12 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 2 6 49 170 7.25 3.8 1.10 149 4.42 101 2.66 2.1 85 55 155 0.81 81 0.06 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 3 6 52 180 6.65 3.8 1.34 143 4.22 102 2.56 1.6 136 64 170 0.69 58 0.11 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 4 6 56 177 7.15 4.1 1.31 147 5.06 102 2.77 2.5 123 69 121 0.89 75 0.09 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 5 6 53 191 5.84 3.1 1.14 146 4.63 99 2.57 2.2 91 59 123 0.59 88 0.08Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 18 (continued) Individual Blood Chemical Values  Group Animal Tot.  (Sex) Number Week Urea Glucose Prot. Albumin A/G Na+ K+ Clƒ Ca++ P ASAT ALAT AP Creat Chol Bili Number mg/dl mg/dl g/dl g/dl Ratio mmol/l mmol/l mmol/l mmol/l mmol/l IU/l IU/l IU/l mg/dl mg/dl mg/d 1(F) 13 6 43 119 6.53 3.7 1.31 143 4.27 100 2.63 1.5 76 82 90 0.63 81 0.10 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 14 6 49 126 6.68 4.0 1.46 150 4.68 104 2.64 1.8 78 68 126 0.66 61 0.07 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 15 6 49 128 5.93 3.6 1.51 145 5.44 104 2.60 2.0 110 99 159 0.71 73 0.08 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 18 6 45 144 6.39 3.9 1.58 144 4.34 101 2.56 1.8 74 61 93 0.64 50 0.08 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 19 6 52 116 5.94 3.6 1.52 143 4.85 103 2.55 1.2 90 92 100 0.68 124 0.09Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 18 (continued) Individual Blood Chemical Values  Group Animal Tot.  (Sex) Number Week Urea Glucose Prot. Albumin A/G Na+ K+ Clƒ Ca++ P ASAT ALAT AP Creat Chol Bili Number mg/dl mg/dl g/dl g/dl Ratio mmol/l mmol/l mmol/l mmol/l mmol/l IU/l IU/l IU/l mg/dl mg/dl mg/d 2(M) 25 6 43 176 6.98 3.5 1.03 143 4.43 99 2.64 2.0 94 60 112 0.75 90 0.10 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 26 6 53 174 6.76 3.7 1.23 148 4.33 103 2.69 2.1 86 66 146 0.77 104 0.07 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 27 6 49 195 6.42 3.6 1.25 143 4.39 102 2.49 1.4 131 77 157 0.78 76 0.09 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 28 6 54 173 6.45 3.6 1.26 147 5.15 103 2.55 1.9 112 67 128 0.85 77 0.06 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 29 6 49 175 6.34 3.4 1.13 147 5.13 101 2.58 1.7 152 65 116 0.69 80 0.06Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 18 (continued) Individual Blood Chemical Values  Group Animal Tot.  (Sex) Number Week Urea Glucose Prot. Albumin A/G Na+ K+ Clƒ Ca++ P ASAT ALAT AP Creat Chol Bili Number mg/dl mg/dl g/dl g/dl Ratio mmol/l mmol/l mmol/l mmol/l mmol/l IU/l IU/l IU/l mg/dl mg/dl mg/d 2(F) 37 6 57 176 5.52 3.5 1.69 146 5.31 102 2.39 1.1 243 67 133 0.61 84 0.08 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 41 6 77 164 5.73 3.1 1.16 144 5.58 104 2.71 1.0 135 132 53 1.12 56 0.07 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 42 6 54 117 6.22 3.8 1.55 147 4.46 106 2.51 1.6 140 90 134 0.64 79 0.10 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 44 6 49 162 5.76 3.6 1.72 148 3.96 104 2.60 1.8 106 79 204 1.15 67 0.07 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 46 6 53 160 6.35 3.7 1.36 144 4.28 104 2.54 1.2 84 111 275 0.73 82 0.07Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 18 (continued) Individual Blood Chemical Values  Group Animal Tot.  (Sex) Number Week Urea Glucose Prot. Albumin A/G Na+ K+ Clƒ Ca++ P ASAT ALAT AP Creat Chol Bili Number mg/dl mg/dl g/dl g/dl Ratio mmol/l mmol/l mmol/l mmol/l mmol/l IU/l IU/l IU/l mg/dl mg/dl mg/d 3(M) 49 6 46 141 6.32 3.7 1.39 151 4.70 107 2.72 2.1 122 54 262 0.69 75 0.07 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 50 6 44 117 6.60 3.6 1.17 150 4.89 102 2.53 2.5 118 67 126 0.73 78 0.06 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 51 6 47 184 5.77 3.3 1.35 148 4.73 102 2.54 1.8 148 78 128 0.63 90 0.07 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 52 6 44 143 6.65 3.9 1.46 148 4.52 102 2.73 2.3 109 74 154 0.69 79 0.08 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 53 6 58 193 5.84 3.5 1.47 145 4.60 100 2.47 2.0 149 52 110 0.65 84 0.04Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 18 (continued) Individual Blood Chemical Values  Group Animal Tot.  (Sex) Number Week Urea Glucose Prot. Albumin A/G Na+ K+ Clƒ Ca++ P ASAT ALAT AP Creat Chol Bili Number mg/dl mg/dl g/dl g/dl Ratio mmol/l mmol/l mmol/l mmol/l mmol/l IU/l IU/l IU/l mg/dl mg/dl mg/d 3(F) 61 6 53 112 6.22 3.8 1.60 147 4.55 105 2.52 0.8 103 88 129 0.62 82 0.08 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 62 6 53 138 5.13 3.1 1.51 144 4.55 104 2.25 0.8 186 75 139 0.90 74 0.08 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 65 7 46 135 6.17 3.6 1.38 144 3.85 103 2.53 1.3 89 70 92 0.65 78 0.07 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 67 7 49 138 6.44 3.7 1.37 143 3.95 100 2.54 1.6 78 64 117 0.65 70 0.05 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 70 6 48 128 6.29 3.8 1.49 147 4.33 104 2.55 1.2 113 77 244 0.85 90 0.06Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 18 (continued) Individual Blood Chemical Values  Group Animal Tot.  (Sex) Number Week Urea Glucose Prot. Albumin A/G Na+ K+ Clƒ Ca++ P ASAT ALAT AP Creat Chol Bili Number mg/dl mg/dl g/dl g/dl Ratio mmol/l mmol/l mmol/l mmol/l mmol/l IU/l IU/l IU/l mg/dl mg/dl mg/d 4(M) 73 6 55 148 5.48 3.4 1.65 144 4.70 99 2.63 1.9 135 60 112 0.57 83 0.07 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 74 6 37 152 6.29 3.7 1.47 148 4.34 102 2.56 1.9 121 43 129 0.64 81 0.09 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 75 6 51 166 6.09 3.5 1.40 146 4.72 101 2.66 1.9 171 91 154 0.58 68 0.07 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 76 6 39 183 6.48 3.7 1.34 143 4.24 98 2.62 1.9 81 65 206 0.67 75 0.12 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 77 6 55 166 6.16 3.5 1.30 148 6.08 101 2.69 2.5 197 109 137 0.69 68 0.09Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 18 (continued) Individual Blood Chemical Values  Group Animal Tot.  (Sex) Number Week Urea Glucose Prot. Albumin A/G Na+ K+ Clƒ Ca++ P ASAT ALAT AP Creat Chol Bili Number mg/dl mg/dl g/dl g/dl Ratio mmol/l mmol/l mmol/l mmol/l mmol/l IU/l IU/l IU/l mg/dl mg/dl mg/d 4(F) 85 6 55 137 4.82 3.2 1.92 144 5.29 102 2.15 0.6 133 68 155 0.53 67 0.08 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 86 6 50 147 6.20 3.8 1.59 145 4.51 101 2.47 1.0 92 82 110 0.71 88 0.10 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 90 6 51 141 6.15 3.5 1.36 145 4.15 103 2.50 0.8 81 83 334 0.66 76 0.06 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 91 7 43 162 5.70 3.4 1.45 144 4.20 105 2.25 0.8 88 78 107 0.69 62 0.06 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒƒ ƒƒƒƒ 96 6 64 122 6.60 3.9 1.48 153 5.70 107 2.65 0.1 192 90 192 0.89 99 0.10Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 19 Individual Bile Acid Values  Group Animal  (Sex) Number Week Bile Acid  Number μmol/l 

 1(M) 1 6 4.3  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  2 6 7.2  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  3 6 5.2  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  4 6 9.4  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  5 6 29.7 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 19 (continued) Individual Bile Acid Values  Group Animal  (Sex) Number Week Bile Acid  Number μmol/l 

 1(F) 13 6 7.2  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  14 6 9.0  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  15 6 5.8  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  18 6 8.0  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  19 6 26.8 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 19 (continued) Individual Bile Acid Values  Group Animal  (Sex) Number Week Bile Acid  Number μmol/l 

 2(M) 25 6 5.9  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  26 6 7.7  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  27 6 6.3  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  28 6 19.7  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  29 6 4.7 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 19 (continued) Individual Bile Acid Values  Group Animal  (Sex) Number Week Bile Acid  Number μmol/l 

 2(F) 37 6 4.5  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  41 6 23.2  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  42 6 15.6  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  44 6 29.1  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  46 6 5.3 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 19 (continued) Individual Bile Acid Values  Group Animal  (Sex) Number Week Bile Acid  Number μmol/l 

 3(M) 49 6 6.6  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  50 6 6.6  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  51 6 3.9  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  52 6 26.4  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  53 6 4.1 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 19 (continued) Individual Bile Acid Values  Group Animal  (Sex) Number Week Bile Acid  Number μmol/l 

 3(F) 61 6 6.8  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  62 6 29.1  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  65 7 13.8  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  67 7 5.0  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  70 6 6.7 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 19 (continued) Individual Bile Acid Values  Group Animal  (Sex) Number Week Bile Acid  Number μmol/l 

 4(M) 73 6 4.5  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  74 6 8.5  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  75 6 9.5  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  76 6 16.1  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  77 6 33.6 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 19 (continued) Individual Bile Acid Values  Group Animal  (Sex) Number Week Bile Acid  Number μmol/l 

 4(F) 85 6 7.6  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  86 6 10.4  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  90 6 19.8  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  91 7 8.4  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ  96 6 11.6 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 20 Individual Necropsy Findings for Offspring Group: 1 Dose Level: 0 (Control) 

Litter Number 

Interim Deaths 

Necropsy Day (Post 

Partum) 

Offspring Sex & 

Number Macroscopic Observation Total Number of Offspring 

13 10M 4F 14 8M 6F 15 8M 4F 

16 TLL . 

17 9M 9F 18 5M 5F 

19 Pre Day 1 2M Autolytic changes detected 6M 6F 20 5M 7F 

21 NP . 

22 6M 4F 23 7M 6F 24 8M 7F 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 20 (continued) Individual Necropsy Findings for Offspring Group: 2 Dose Level: 30 mg/kg bw/day 

Litter Number 

Interim Deaths Termi

Necropsy Day (Post 

Partum) 

Offspring Sex & 

Number Macroscopic Observation Total Number of Offspring Ma

37 4M 2F No 38 7M 5F No 39 4M 6F No 40 1 1M Autolytic changes detected 5M 4F No 41 7M 8F No 42 9M 3F No 

43 6M 8F No 44 Pre Day 1 1M Autolytic changes detected 8M 6F No 45 9M 3F No 46 7M 6F No 47 F11 

 7M 8F No 

48 5M 9F No 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 20 (continued) Individual Necropsy Findings for Offspring Group: 3 Dose Level: 300 mg/kg bw/day 

Litter Number 

Interim Deaths Termi

Necropsy Day (Post 

Partum) 

Offspring Sex & 

Number Macroscopic Observation Total Number of Offspring Ma

61 6M 9F No 62 8M 7F No 63 8M 4F No 64 9M 4F No 65 M6 Enlarged kid

 6M 4F No 

66 12M 4F No 67 7M 7F No 68 4M 7F No 

69 NP . 

70 6M 4F No 71 5M 7F No 72 5M 7F No 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 20 (continued) Individual Necropsy Findings for Offspring Group: 4 Dose Level: 1000 mg/kg bw/day 

Litter Number 

Interim Deaths Termi

Necropsy Day (Post 

Partum) 

Offspring Sex & 

Number Macroscopic Observation Total Number of Offspring Ma

85 F11 

 8M 2F No 

86 9M 2F No 87 6M 3F No 88 1 1M Autolytic changes detected 5M 7F No 89 5M 4F No 90 5M 6F No 

91 6M 7F No 92 1M 3F No 93 F16 

 9M 6F No 

94 5M 5F No 95 1M 2F No 96 6M 7F No 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 21 Individual Necropsy Findings Group: 1 Dose Level: 0 (Control) Sex: Male  Animal Death  No. Mode Of Death Day (Week) Observation(s) ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 1 SCHEDULED KILL 43 (7) No abnormalities detected  2 SCHEDULED KILL 43 (7) No abnormalities detected  3 SCHEDULED KILL 43 (7) No abnormalities detected  4 SCHEDULED KILL 43 (7) No abnormalities detected  5 SCHEDULED KILL 43 (7) No abnormalities detected  6 SCHEDULED KILL 43 (7) No abnormalities detected  7 SCHEDULED KILL 43 (7) No abnormalities detected  8 SCHEDULED KILL 43 (7) No abnormalities detected  9 SCHEDULED KILL 43 (7) No abnormalities detected  10 SCHEDULED KILL 43 (7) No abnormalities detected  11 SCHEDULED KILL 43 (7) No abnormalities detected  12 SCHEDULED KILL 43 (7) Seminal Vesicles; right horn; Small  All remaining tissues had no abnormalities detected 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 21 (continued) Individual Necropsy Findings Group: 1 Dose Level: 0 (Control) Sex: Female  Animal Death  No. Mode Of Death Day (Week) Observation(s) ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 13 SCHEDULED KILL 43 (7) No abnormalities detected  14 SCHEDULED KILL 43 (7) No abnormalities detected  15 SCHEDULED KILL 43 (7) No abnormalities detected  16 SCHEDULED KILL 45 (7) No abnormalities detected  17 SCHEDULED KILL 52 (8) Kidneys: Left Kidney Retained  Kidneys; left; Increased Pelvic Space  Urinary Bladder; Mineral Calculi: Mineral Calculi deposit approx 8mm x 3m Bladder  All remaining tissues had no abnormalities detected  18 SCHEDULED KILL 43 (7) No abnormalities detected  19 SCHEDULED KILL 43 (7) No abnormalities detected  20 SCHEDULED KILL 46 (7) No abnormalities detected  21 SCHEDULED KILL 42 (6) No abnormalities detected  22 SCHEDULED KILL 45 (7) No abnormalities detected  23 SCHEDULED KILL 43 (7) No abnormalities detected  24 SCHEDULED KILL 44 (7) No abnormalities detected 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 21 (continued) Individual Necropsy Findings Group: 2 Dose Level: 30 mg/kg bw/day Sex: Male 

 Animal Death  No. Mode Of Death Day (Week) Observation(s) ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 25 SCHEDULED KILL 43 (7) No abnormalities detected  26 SCHEDULED KILL 43 (7) No abnormalities detected  27 SCHEDULED KILL 43 (7) Brain (Including Cerebrum, Cerebellum And Pons); Damaged On Removal  All remaining tissues had no abnormalities detected  28 SCHEDULED KILL 43 (7) No abnormalities detected  29 SCHEDULED KILL 43 (7) No abnormalities detected  30 SCHEDULED KILL 43 (7) No abnormalities detected  31 SCHEDULED KILL 43 (7) No abnormalities detected  32 SCHEDULED KILL 43 (7) No abnormalities detected  33 SCHEDULED KILL 43 (7) No abnormalities detected  34 SCHEDULED KILL 43 (7) No abnormalities detected  35 SCHEDULED KILL 43 (7) No abnormalities detected  36 SCHEDULED KILL 43 (7) No abnormalities detected 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 21 (continued) Individual Necropsy Findings Group: 2 Dose Level: 30 mg/kg bw/day Sex: Female 

 Animal Death  No. Mode Of Death Day (Week) Observation(s) ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 37 SCHEDULED KILL 43 (7) No abnormalities detected  38 SCHEDULED KILL 45 (7) No abnormalities detected  39 SCHEDULED KILL 46 (7) No abnormalities detected  40 SCHEDULED KILL 45 (7) No abnormalities detected  41 SCHEDULED KILL 42 (6) No abnormalities detected  42 SCHEDULED KILL 43 (7) No abnormalities detected  43 SCHEDULED KILL 44 (7) No abnormalities detected  44 SCHEDULED KILL 43 (7) No abnormalities detected  45 SCHEDULED KILL 44 (7) No abnormalities detected  46 SCHEDULED KILL 42 (6) No abnormalities detected  47 SCHEDULED KILL 44 (7) No abnormalities detected  48 SCHEDULED KILL 45 (7) No abnormalities detected 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 21 (continued) Individual Necropsy Findings Group: 3 Dose Level: 300 mg/kg bw/day Sex: Male  Animal Death  No. Mode Of Death Day (Week) Observation(s) ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 49 SCHEDULED KILL 43 (7) No abnormalities detected  50 SCHEDULED KILL 43 (7) No abnormalities detected  51 SCHEDULED KILL 43 (7) No abnormalities detected  52 SCHEDULED KILL 43 (7) No abnormalities detected  53 SCHEDULED KILL 43 (7) No abnormalities detected  54 SCHEDULED KILL 43 (7) No abnormalities detected  55 SCHEDULED KILL 43 (7) No abnormalities detected  56 SCHEDULED KILL 43 (7) No abnormalities detected  57 SCHEDULED KILL 43 (7) Epididymides; Small  Testes; Small  Testes; Flaccid  All remaining tissues had no abnormalities detected  58 SCHEDULED KILL 43 (7) No abnormalities detected  59 SCHEDULED KILL 43 (7) No abnormalities detected  60 SCHEDULED KILL 43 (7) No abnormalities detected 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 21 (continued) Individual Necropsy Findings Group: 3 Dose Level: 300 mg/kg bw/day Sex: Female 

 Animal Death  No. Mode Of Death Day (Week) Observation(s) ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 61 SCHEDULED KILL 43 (7) No abnormalities detected  62 SCHEDULED KILL 43 (7) No abnormalities detected  63 SCHEDULED KILL 45 (7) No abnormalities detected  64 SCHEDULED KILL 45 (7) No abnormalities detected  65 SCHEDULED KILL 44 (7) No abnormalities detected  66 SCHEDULED KILL 45 (7) No abnormalities detected  67 SCHEDULED KILL 44 (7) No abnormalities detected  68 SCHEDULED KILL 44 (7) No abnormalities detected  69 SCHEDULED KILL 42 (6) No abnormalities detected  70 SCHEDULED KILL 43 (7) No abnormalities detected  71 SCHEDULED KILL 44 (7) No abnormalities detected  72 SCHEDULED KILL 45 (7) No abnormalities detected 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 21 (continued) Individual Necropsy Findings Group: 4 Dose Level: 1000 mg/kg bw/day Sex: Male  Animal Death  No. Mode Of Death Day (Week) Observation(s) ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 73 SCHEDULED KILL 43 (7) No abnormalities detected  74 SCHEDULED KILL 43 (7) Lungs (With Bronchi); Reddened  Spleen; Dark  All remaining tissues had no abnormalities detected  75 SCHEDULED KILL 43 (7) No abnormalities detected  76 SCHEDULED KILL 43 (7) No abnormalities detected  77 SCHEDULED KILL 43 (7) No abnormalities detected  78 SCHEDULED KILL 43 (7) No abnormalities detected  79 SCHEDULED KILL 43 (7) No abnormalities detected  80 SCHEDULED KILL 43 (7) No abnormalities detected  81 SCHEDULED KILL 43 (7) No abnormalities detected  82 SCHEDULED KILL 43 (7) No abnormalities detected  83 SCHEDULED KILL 43 (7) No abnormalities detected  84 SCHEDULED KILL 43 (7) No abnormalities detected 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 21 (continued) Individual Necropsy Findings Group: 4 Dose Level: 1000 mg/kg bw/day Sex: Female  Animal Death  No. Mode Of Death Day (Week) Observation(s) ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ 85 SCHEDULED KILL 43 (7) No abnormalities detected  86 SCHEDULED KILL 43 (7) No abnormalities detected  87 SCHEDULED KILL 45 (7) No abnormalities detected  88 SCHEDULED KILL 45 (7) No abnormalities detected  89 SCHEDULED KILL 45 (7) No abnormalities detected  90 SCHEDULED KILL 42 (6) No abnormalities detected  91 SCHEDULED KILL 44 (7) Gross Lesions; right fore limb; Mass: Mass found under right fore limb. M Mass appears to be fibrous.  All remaining tissues had no abnormalities detected  92 SCHEDULED KILL 46 (7) No abnormalities detected  93 SCHEDULED KILL 45 (7) No abnormalities detected  94 SCHEDULED KILL 45 (7) No abnormalities detected  95 SCHEDULED KILL 46 (7) No abnormalities detected  96 SCHEDULED KILL 43 (7) No abnormalities detected 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 22 Individual Organ Weights  Group Animal Epididyƒ Seminal  (Sex) Number Day Adrenals Brain mides Heart Kidneys Liver Pituitary Prostate vesicles Spleen Testes Thymus Thyr Number g g g g g g g g g g g g g 1(M) 1 43 0.0875 2.1078 1.8353 0.9967 2.5122 12.4609 0.0117 0.5562 2.1988 0.8087 4.5132 0.3810 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 2 43 0.0611 2.1690 1.3994 1.0165 2.1695 10.6724 0.0092 0.5617 2.4649 0.8087 3.6135 0.4904 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 3 43 0.0722 2.0614 1.8459 0.9466 2.4793 13.1714 0.0098 0.5873 2.6073 0.8074 4.2701 0.3341 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 4 43 0.0664 1.8938 1.3025 0.9711 2.1503 11.3238 0.0087 0.5849 2.2154 0.5620 3.1762 0.3582 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 5 43 0.0539 2.0062 1.3944 1.0483 2.5625 12.3118 0.0117 0.7326 2.1156 0.6311 3.9926 0.3962 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 6 43 1.7266 0.0125 0.6634 2.4086 3.9067  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 7 43 1.5928 0.0107 0.6932 2.4216 4.0443  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 8 43 1.4798 0.0091 0.6600 2.3866 3.7491  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 9 43 1.3355 0.0109 0.6928 1.9355 3.3366  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 10 43 1.5751 0.0119 0.7801 2.3889 4.3972  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 11 43 1.2066 0.0093 0.6030 2.2663 3.5189  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 12 43 1.3338 0.0108 0.7116 2.5657 3.6156 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 22 (continued) Individual Organ Weights  Group Animal Epididyƒ Seminal  (Sex) Number Day Adrenals Brain mides Heart Kidneys Liver Pituitary Prostate vesicles Spleen Testes Thymus Thyr Number g g g g g g g g g g g g g 2(M) 25 43 0.0757 2.1643 1.6035 1.0824 2.4102 12.7258 0.0106 0.8147 2.2111 0.7892 4.0980 0.6063 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 26 43 0.0620 2.1242 1.3489 0.9368 1.9835 11.6257 0.0085 0.5815 2.5333 0.7133 3.7120 0.4773 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 27 43 0.0897 2.0944 1.7319 1.1370 2.4670 14.1766 0.0140 0.7817 2.4463 0.6366 3.4187 0.3280 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 28 43 0.0531 1.9758 1.3426 0.9463 2.1277 10.8200 0.0089 0.5927 2.1263 0.6800 3.5398 0.4694 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 29 43 0.0970 2.0767 1.4128 0.9721 2.2574 11.8584 0.0143 0.5318 2.4213 0.7024 3.8784 0.4725 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 30 43 1.1860 0.0118 0.6153 1.8402 3.8159  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 31 43 1.9084 0.0125 0.6216 1.3412 3.3909  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 32 43 1.3886 0.0139 0.4748 1.8401 3.8649  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 33 43 1.3474 0.0105 0.6983 2.2684 3.4729  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 34 43 1.3282 0.0112 0.7269 2.5704 3.6698  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 35 43 1.8589 0.0106 0.9261 1.4983 4.1610  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 36 43 1.3079 0.0081 0.6222 2.1254 3.6624 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 22 (continued) Individual Organ Weights  Group Animal Epididyƒ Seminal  (Sex) Number Day Adrenals Brain mides Heart Kidneys Liver Pituitary Prostate vesicles Spleen Testes Thymus Thyr Number g g g g g g g g g g g g g 3(M) 49 43 0.1057 1.9627 1.4805 1.2769 2.3286 11.5397 0.0061 0.6524 2.7266 0.8312 3.7350 0.3407 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 50 43 0.0774 1.9889 1.3082 0.9539 2.1117 10.4316 0.0123 0.5004 3.0011 0.7788 3.8981 0.3454 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 51 43 0.0686 2.0279 1.3504 1.0892 2.1057 11.3268 0.0107 0.5542 2.1865 0.6756 3.6956 0.4420 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 52 43 0.0788 1.9699 1.5609 1.0438 2.5069 12.8452 0.0090 0.4864 1.9200 0.7129 3.8825 0.4544 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 53 43 0.0847 2.2670 1.3202 1.0852 2.6392 12.7066 0.0117 0.4971 2.4256 0.6425 3.9176 0.4973 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 54 43 1.3895 0.0099 0.7303 2.6158 3.6659  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 55 43 1.4823 0.0108 0.5493 1.6350 3.9922  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 56 43 2.2286 0.0107 0.7530 2.2260 3.5490  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 57 43 0.6639 0.0149 0.4797 1.7791 1.1726  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 58 43 1.1203 0.0095 0.6207 1.9972 2.9348  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 59 43 1.2938 0.0129 0.6308 2.4870 3.7805  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 60 43 1.8302 0.0100 0.7923 2.1920 3.9850 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 22 (continued) Individual Organ Weights  Group Animal Epididyƒ Seminal  (Sex) Number Day Adrenals Brain mides Heart Kidneys Liver Pituitary Prostate vesicles Spleen Testes Thymus Thyr Number g g g g g g g g g g g g g 4(M) 73 43 0.0779 2.0182 1.5059 1.0182 2.2149 11.8538 0.0096 0.5460 2.1770 0.7374 3.6536 0.4636 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 74 43 0.0825 1.9871 1.7418 1.0161 2.2697 10.8327 0.0095 0.5516 2.3644 0.6672 3.3687 0.2892 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 75 43 0.0732 2.0183 1.5511 0.8636 2.2425 10.7655 0.0074 0.5176 1.7267 0.8337 3.8090 0.3680 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 76 43 0.0912 2.0806 1.4507 1.0336 2.1849 10.5340 0.0071 0.3493 1.5121 0.7592 3.7071 0.5078 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 77 43 0.0817 2.1307 1.5608 1.1705 2.3597 13.5553 0.0084 0.6496 2.1260 0.8092 4.2807 0.4959 0.0 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 78 43 1.3549 0.0068 0.4928 1.8824 3.6576  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 79 43 1.4418 0.0088 0.6079 1.7389 4.3941  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 80 43 1.6325 0.0089 0.8111 2.4837 3.3114  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 81 43 1.2944 0.0083 0.5877 1.9276 3.7675  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 82 43 1.3713 0.0060 0.5678 2.8650 3.7983  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 83 43 1.3544 0.0108 0.9381 2.2804 3.8681  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒ 84 43 1.4647 0.0093 0.4432 1.6911 4.2270 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 22 (continued) Individual Organ Weights  Group Animal Uterus  (Sex) Number Day Adrenals Brain Heart Kidneys Liver Ovaries Pituitary Spleen Thymus & Cervix Thyroid Number g g g g g g g g g g g  1(F) 13 43 0.1295 1.8897 0.8308 1.7485 11.5786 0.1255 0.0120 0.6631 0.1441 0.9736 0.0121 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 14 43 0.1086 1.8195 0.7839 1.6588 11.2761 0.1310 0.0120 0.7481 0.4033 0.8544 0.0137 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 15 43 0.0964 2.0051 0.9259 1.7478 10.9172 0.1510 0.0119 0.6456 0.1806 0.6426 0.0124 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 16 45 0.1543 0.0138 0.9148  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 17 52 0.0707 0.0205 0.8985  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 18 43 0.1093 1.8468 1.0451 1.8787 11.0962 0.1424 0.0139 0.5887 0.3666 0.5866 0.0157 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 19 43 0.0845 1.9016 0.8338 1.5770 11.8395 0.1261 0.0118 0.5916 0.2549 0.6878 0.0108 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 20 46 0.1147 0.0103 0.5930  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 21 42 0.1121 0.0124 0.5968  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 22 45 0.1109 0.0123 0.5224  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 23 43 0.1085 0.0151 0.7904  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 24 44 0.1250 0.0174 0.8450 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 22 (continued) Individual Organ Weights  Group Animal Uterus  (Sex) Number Day Adrenals Brain Heart Kidneys Liver Ovaries Pituitary Spleen Thymus & Cervix Thyroid Number g g g g g g g g g g g  2(F) 37 43 0.1082 1.8504 0.8893 1.5833 10.4163 0.1302 0.0098 0.6424 0.4218 0.6055 0.0242 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 38 45 0.1008 0.0131 0.6234  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 39 46 0.1260 0.0145 0.5906  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 40 45 0.0709 0.0135 0.6797  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 41 42 0.0983 1.8270 0.9266 1.6874 11.7426 0.1006 0.0135 0.4768 0.1905 0.6644 0.0120 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 42 43 0.1043 1.9336 0.8342 1.7642 11.1932 0.1053 0.0154 0.8020 0.2647 0.8020 0.0204 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 43 44 0.1026 0.0109 0.6993  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 44 43 0.0910 1.9219 0.8845 1.7542 11.0636 0.1419 0.0188 0.5254 0.2499 0.8296 0.0145 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 45 44 0.1195 0.0132 0.6846  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 46 42 0.0766 1.8167 0.9743 1.8305 11.6301 0.1488 0.0180 0.6934 0.2338 0.7984 0.0153 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 47 44 0.1069 0.0180 0.7340  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 48 45 0.1220 0.0162 0.6290 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 22 (continued) Individual Organ Weights  Group Animal Uterus  (Sex) Number Day Adrenals Brain Heart Kidneys Liver Ovaries Pituitary Spleen Thymus & Cervix Thyroid Number g g g g g g g g g g g  3(F) 61 43 0.1026 1.8768 0.8517 1.7236 11.3829 0.1264 0.0153 0.7043 0.2457 0.7798 0.0137 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 62 43 0.0835 1.9642 0.9241 1.5115 10.7765 0.1335 0.0175 0.7505 0.2777 0.6077 0.0172 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 63 45 0.1225 0.0149 0.6687  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 64 45 0.1291 0.0114 0.6484  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 65 44 0.1109 2.0416 0.9458 1.9688 11.6347 0.1337 0.0178 0.7444 0.2512 0.8442 0.0207 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 66 45 0.1267 0.0153 0.6543  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 67 44 0.0985 1.7680 0.8347 1.5151 10.6159 0.1095 0.0151 0.5604 0.1959 0.6974 0.0123 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 68 44 0.1088 0.0151 0.6491  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 69 42 0.1152 0.0124 0.4533  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 70 43 0.0877 1.9869 0.8003 1.5990 10.4439 0.1220 0.0187 0.6548 0.2272 0.7264 0.0215 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 71 44 0.0901 0.0102 0.7418  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 72 45 0.1208 0.0153 0.6094 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 22 (continued) Individual Organ Weights  Group Animal Uterus  (Sex) Number Day Adrenals Brain Heart Kidneys Liver Ovaries Pituitary Spleen Thymus & Cervix Thyroid Number g g g g g g g g g g g  4(F) 85 43 0.0886 1.8726 0.6732 1.5354 8.6337 0.1198 0.0136 0.6658 0.2116 0.6706 0.0147 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 86 43 0.0971 1.8671 0.8776 1.5988 10.4339 0.1140 0.0146 0.7037 0.3319 0.6890 0.0233 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 87 45 0.1252 0.0152 0.6132  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 88 45 0.1121 0.0169 0.5779  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 89 45 0.1285 0.0133 0.4728  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 90 42 0.1044 1.9250 0.8206 1.7748 12.2692 0.1105 0.0201 0.5856 0.2340 0.7106 0.0172 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 91 44 0.1169 1.7696 0.9812 1.7212 11.8048 0.1356 0.0125 0.7981 0.1833 0.7313 0.0164 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 92 46 0.1487 0.0122 0.5638  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 93 45 0.1252 0.0170 0.8012  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 94 45 0.0955 0.0125 0.4305  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 95 46 0.1239 0.0091 0.4835  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 96 43 0.1074 1.9072 0.9519 1.8013 11.4212 0.1404 0.0156 0.5856 0.3040 0.8857 0.0220Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 23 Individual Relative Organ Weights  Group Animal Relative Relative Relative Relative Relative Relative Relative  (Sex) Number Day Bodywt Adrenals Brain Epididys Heart Kidneys Liver Pituitary  Number g % % % % % % %  1(M) 1 43 396 0.0221 0.5323 0.4635 0.2517 0.6344 3.1467 0.0030  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2 43 386 0.0158 0.5619 0.3625 0.2633 0.5620 2.7649 0.0024  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3 43 384 0.0188 0.5368 0.4807 0.2465 0.6457 3.4301 0.0026  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4 43 369 0.0180 0.5132 0.3530 0.2632 0.5827 3.0688 0.0024  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  5 43 388 0.0139 0.5171 0.3594 0.2702 0.6604 3.1731 0.0030  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  6 43 413 0.4181 0.0030  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  7 43 418 0.3811 0.0026  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  8 43 391 0.3785 0.0023  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  9 43 387 0.3451 0.0028  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  10 43 361 0.4363 0.0033  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  11 43 353 0.3418 0.0026  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  12 43 408 0.3269 0.0026 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 23 (continued) Individual Relative Organ Weights  (continued)  Group Animal Relative Relative Relative Relative Relative Relative  (Sex) Number Day Prostate Sem.Ves. Spleen Testes Thymus Thyroid  Number % % % % % %  1(M) 1 43 0.1405 0.5553 0.2042 1.1397 0.0962 0.0034  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  2 43 0.1455 0.6386 0.2095 0.9361 0.1270 0.0065  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  3 43 0.1529 0.6790 0.2103 1.1120 0.0870 0.0042  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  4 43 0.1585 0.6004 0.1523 0.8608 0.0971 0.0035  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  5 43 0.1888 0.5453 0.1627 1.0290 0.1021 0.0053  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  6 43 0.1606 0.5832 0.9459  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  7 43 0.1658 0.5793 0.9675  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  8 43 0.1688 0.6104 0.9588  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  9 43 0.1790 0.5001 0.8622  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  10 43 0.2161 0.6617 1.2181  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  11 43 0.1708 0.6420 0.9969  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  12 43 0.1744 0.6288 0.8862 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 23 (continued) Individual Relative Organ Weights  Group Animal Relative Relative Relative Relative Relative Relative Relative  (Sex) Number Day Bodywt Adrenals Brain Epididys Heart Kidneys Liver Pituitary  Number g % % % % % % %  2(M) 25 43 425 0.0178 0.5092 0.3773 0.2547 0.5671 2.9943 0.0025  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  26 43 395 0.0157 0.5378 0.3415 0.2372 0.5022 2.9432 0.0022  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  27 43 408 0.0220 0.5133 0.4245 0.2787 0.6047 3.4747 0.0034  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  28 43 384 0.0138 0.5145 0.3496 0.2464 0.5541 2.8177 0.0023  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  29 43 404 0.0240 0.5140 0.3497 0.2406 0.5588 2.9352 0.0035  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  30 43 385 0.3081 0.0031  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  31 43 386 0.4944 0.0032  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  32 43 396 0.3507 0.0035  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  33 43 373 0.3612 0.0028  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  34 43 375 0.3542 0.0030  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  35 43 384 0.4841 0.0028  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  36 43 379 0.3451 0.0021 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 23 (continued) Individual Relative Organ Weights  (continued)  Group Animal Relative Relative Relative Relative Relative Relative  (Sex) Number Day Prostate Sem.Ves. Spleen Testes Thymus Thyroid  Number % % % % % %  2(M) 25 43 0.1917 0.5203 0.1857 0.9642 0.1427 0.0050  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  26 43 0.1472 0.6413 0.1806 0.9397 0.1208 0.0053  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  27 43 0.1916 0.5996 0.1560 0.8379 0.0804 0.0047  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  28 43 0.1543 0.5537 0.1771 0.9218 0.1222 0.0055  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  29 43 0.1316 0.5993 0.1739 0.9600 0.1170 0.0046  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  30 43 0.1598 0.4780 0.9911  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  31 43 0.1610 0.3475 0.8785  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  32 43 0.1199 0.4647 0.9760  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  33 43 0.1872 0.6082 0.9311  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  34 43 0.1938 0.6854 0.9786  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  35 43 0.2412 0.3902 1.0836  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  36 43 0.1642 0.5608 0.9663 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 23 (continued) Individual Relative Organ Weights  Group Animal Relative Relative Relative Relative Relative Relative Relative  (Sex) Number Day Bodywt Adrenals Brain Epididys Heart Kidneys Liver Pituitary  Number g % % % % % % %  3(M) 49 43 407 0.0260 0.4822 0.3638 0.3137 0.5721 2.8353 0.0015  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  50 43 397 0.0195 0.5010 0.3295 0.2403 0.5319 2.6276 0.0031  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  51 43 371 0.0185 0.5466 0.3640 0.2936 0.5676 3.0530 0.0029  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  52 43 385 0.0205 0.5117 0.4054 0.2711 0.6511 3.3364 0.0023  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  53 43 418 0.0203 0.5423 0.3158 0.2596 0.6314 3.0399 0.0028  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  54 43 404 0.3439 0.0025  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  55 43 410 0.3615 0.0026  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  56 43 396 0.5628 0.0027  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  57 43 408 0.1627 0.0037  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  58 43 362 0.3095 0.0026  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  59 43 374 0.3459 0.0034  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  60 43 380 0.4816 0.0026 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 23 (continued) Individual Relative Organ Weights  (continued)  Group Animal Relative Relative Relative Relative Relative Relative  (Sex) Number Day Prostate Sem.Ves. Spleen Testes Thymus Thyroid  Number % % % % % %  3(M) 49 43 0.1603 0.6699 0.2042 0.9177 0.0837 0.0053  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  50 43 0.1260 0.7559 0.1962 0.9819 0.0870 0.0043  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  51 43 0.1494 0.5894 0.1821 0.9961 0.1191 0.0037  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  52 43 0.1263 0.4987 0.1852 1.0084 0.1180 0.0055  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  53 43 0.1189 0.5803 0.1537 0.9372 0.1190 0.0058  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  54 43 0.1808 0.6475 0.9074  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  55 43 0.1340 0.3988 0.9737  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  56 43 0.1902 0.5621 0.8962  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  57 43 0.1176 0.4361 0.2874  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  58 43 0.1715 0.5517 0.8107  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  59 43 0.1687 0.6650 1.0108  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  60 43 0.2085 0.5768 1.0487 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 23 (continued) Individual Relative Organ Weights  Group Animal Relative Relative Relative Relative Relative Relative Relative  (Sex) Number Day Bodywt Adrenals Brain Epididys Heart Kidneys Liver Pituitary  Number g % % % % % % %  4(M) 73 43 397 0.0196 0.5084 0.3793 0.2565 0.5579 2.9858 0.0024  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  74 43 368 0.0224 0.5400 0.4733 0.2761 0.6168 2.9437 0.0026  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  75 43 390 0.0188 0.5175 0.3977 0.2214 0.5750 2.7604 0.0019  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  76 43 397 0.0230 0.5241 0.3654 0.2604 0.5504 2.6534 0.0018  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  77 43 409 0.0200 0.5210 0.3816 0.2862 0.5769 3.3143 0.0021  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  78 43 368 0.3682 0.0018  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  79 43 376 0.3835 0.0023  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  80 43 421 0.3878 0.0021  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  81 43 408 0.3173 0.0020  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  82 43 390 0.3516 0.0015  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  83 43 449 0.3016 0.0024  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  84 43 388 0.3775 0.0024 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 23 (continued) Individual Relative Organ Weights  (continued)  Group Animal Relative Relative Relative Relative Relative Relative  (Sex) Number Day Prostate Sem.Ves. Spleen Testes Thymus Thyroid  Number % % % % % %  4(M) 73 43 0.1375 0.5484 0.1857 0.9203 0.1168 0.0047  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  74 43 0.1499 0.6425 0.1813 0.9154 0.0786 0.0054  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  75 43 0.1327 0.4427 0.2138 0.9767 0.0944 0.0055  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  76 43 0.0880 0.3809 0.1912 0.9338 0.1279 0.0051  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  77 43 0.1588 0.5198 0.1978 1.0466 0.1212 0.0056  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  78 43 0.1339 0.5115 0.9939  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  79 43 0.1617 0.4625 1.1686  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  80 43 0.1927 0.5900 0.7866  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  81 43 0.1440 0.4725 0.9234  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  82 43 0.1456 0.7346 0.9739  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  83 43 0.2089 0.5079 0.8615  ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ  84 43 0.1142 0.4359 1.0894 Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 23 (continued) Individual Relative Organ Weights  Group Animal Relative Relative Relative Relative Relative Relative Relative Relative Relative Relative Relativ (Sex) Number Day Bodywt Adrenals Brain Heart Kidneys Liver Ovaries Pituitary Spleen Thymus Thyroid Uterus Number g % % % % % % % % % % %  1(F) 13 43 266 0.0487 0.7104 0.3123 0.6573 4.3529 0.0472 0.0045 0.2493 0.0542 0.0045 0.3660 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 14 43 285 0.0381 0.6384 0.2751 0.5820 3.9565 0.0460 0.0042 0.2625 0.1415 0.0048 0.2998 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 15 43 266 0.0362 0.7538 0.3481 0.6571 4.1042 0.0568 0.0045 0.2427 0.0679 0.0047 0.2416 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 16 45 250 0.0617 0.0055 0.3659 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 17 52 314 0.0225 0.0065 0.2861 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 18 43 286 0.0382 0.6457 0.3654 0.6569 3.8798 0.0498 0.0049 0.2058 0.1282 0.0055 0.2051 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 19 43 260 0.0325 0.7314 0.3207 0.6065 4.5537 0.0485 0.0045 0.2275 0.0980 0.0042 0.2645 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 20 46 258 0.0445 0.0040 0.2298 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 21 42 261 0.0430 0.0048 0.2287 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 22 45 271 0.0409 0.0045 0.1928 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 23 43 248 0.0437 0.0061 0.3187 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 24 44 296 0.0422 0.0059 0.2855Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 23 (continued) Individual Relative Organ Weights  Group Animal Relative Relative Relative Relative Relative Relative Relative Relative Relative Relative Relativ (Sex) Number Day Bodywt Adrenals Brain Heart Kidneys Liver Ovaries Pituitary Spleen Thymus Thyroid Uterus Number g % % % % % % % % % % %  2(F) 37 43 278 0.0389 0.6656 0.3199 0.5695 3.7469 0.0468 0.0035 0.2311 0.1517 0.0087 0.2178 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 38 45 246 0.0410 0.0053 0.2534 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 39 46 285 0.0442 0.0051 0.2072 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 40 45 250 0.0284 0.0054 0.2719 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 41 42 265 0.0371 0.6894 0.3497 0.6368 4.4312 0.0380 0.0051 0.1799 0.0719 0.0045 0.2507 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 42 43 273 0.0382 0.7083 0.3056 0.6462 4.1001 0.0386 0.0056 0.2938 0.0970 0.0075 0.2938 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 43 44 245 0.0419 0.0044 0.2854 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 44 43 276 0.0330 0.6963 0.3205 0.6356 4.0086 0.0514 0.0068 0.1904 0.0905 0.0053 0.3006 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 45 44 271 0.0441 0.0049 0.2526 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 46 42 298 0.0257 0.6096 0.3269 0.6143 3.9027 0.0499 0.0060 0.2327 0.0785 0.0051 0.2679 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 47 44 275 0.0389 0.0065 0.2669 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 48 45 286 0.0427 0.0057 0.2199Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

Appendix 23 (continued) Individual Relative Organ Weights  Group Animal Relative Relative Relative Relative Relative Relative Relative Relative Relative Relative Relativ (Sex) Number Day Bodywt Adrenals Brain Heart Kidneys Liver Ovaries Pituitary Spleen Thymus Thyroid Uterus Number g % % % % % % % % % % %  3(F) 61 43 286 0.0359 0.6562 0.2978 0.6027 3.9800 0.0442 0.0053 0.2463 0.0859 0.0048 0.2727 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 62 43 260 0.0321 0.7555 0.3554 0.5813 4.1448 0.0513 0.0067 0.2887 0.1068 0.0066 0.2337 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 63 45 275 0.0445 0.0054 0.2432 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 64 45 318 0.0406 0.0036 0.2039 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 65 44 281 0.0395 0.7265 0.3366 0.7006 4.1405 0.0476 0.0063 0.2649 0.0894 0.0074 0.3004 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 66 45 278 0.0456 0.0055 0.2354 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 67 44 273 0.0361 0.6476 0.3058 0.5550 3.8886 0.0401 0.0055 0.2053 0.0718 0.0045 0.2555 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 68 44 288 0.0378 0.0052 0.2254 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 69 42 267 0.0431 0.0046 0.1698 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 70 43 266 0.0330 0.7470 0.3009 0.6011 3.9263 0.0459 0.0070 0.2462 0.0854 0.0081 0.2731 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 71 44 251 0.0359 0.0041 0.2955 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 72 45 296 0.0408 0.0052 0.2059Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE TOXICITY S

REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 422)

PROJECT NUMBER: 41104692R 

Appendix 23 (continued) Individual Relative Organ Weights  Group Animal Relative Relative Relative Relative Relative Relative Relative Relative Relative Relative Relativ (Sex) Number Day Bodywt Adrenals Brain Heart Kidneys Liver Ovaries Pituitary Spleen Thymus Thyroid Uterus Number g % % % % % % % % % % %  4(F) 85 43 236 0.0375 0.7935 0.2853 0.6506 3.6583 0.0508 0.0058 0.2821 0.0897 0.0062 0.2842 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 86 43 269 0.0361 0.6941 0.3262 0.5943 3.8788 0.0424 0.0054 0.2616 0.1234 0.0087 0.2561 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 87 45 278 0.0450 0.0055 0.2206 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 88 45 284 0.0395 0.0060 0.2035 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 89 45 277 0.0464 0.0048 0.1707 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 90 42 280 0.0373 0.6875 0.2931 0.6339 4.3819 0.0395 0.0072 0.2091 0.0836 0.0061 0.2538 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 91 44 281 0.0416 0.6298 0.3492 0.6125 4.2010 0.0483 0.0044 0.2840 0.0652 0.0058 0.2602 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 92 46 283 0.0525 0.0043 0.1992 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 93 45 302 0.0415 0.0056 0.2653 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 94 45 236 0.0405 0.0053 0.1824 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 95 46 255 0.0486 0.0036 0.1896 ƒƒƒƒƒƒ ƒƒƒƒ ƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒƒ ƒƒƒƒƒƒƒ 96 43 297 0.0362 0.6422 0.3205 0.6065 3.8455 0.0473 0.0053 0.1972 0.1024 0.0074 0.2982Dose Levels: Group 1 ƒ 0(Control) Group 2 ƒ 30 mg/kg bw/day Group 3 ƒ 300 mg/kg bw/day Group 4 ƒ 1000 mg/kg bw/day 
PAGE 472 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 473

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 474 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 475

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 476 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 477

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 478 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 479

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 480 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 481

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 482 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 483

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 484 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 485

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 486 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 487

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 488 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 489

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 490 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 491

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 492 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 493

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 494 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 495

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 496 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 497

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 498 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 499

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 500 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 501

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 502 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 503

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 504 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 505

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 506 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 507

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 508 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 509

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 510 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 511

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 512 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 513

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 514 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 515

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 516 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 517

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 518 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 519

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 520 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 521

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 522 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 523

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 524 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 525

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 526 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 527

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 528 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 529

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 530 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 531

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 532 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 533

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 534 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 535

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 536 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 537

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 538 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 539

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 540 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 541

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 542 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 543

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 544 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 545

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 546 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 547

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 548 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 549

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 550 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 551

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 552 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 553

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 554 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 555

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 556 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 557

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 558 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 559

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 560 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 561

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 562 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 563

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 564 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 565

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 566 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 567

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 568 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 569

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 570 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 571

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 572 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 573

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 574 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 575

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 576 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 577

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 578 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 579

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 580 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 581

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 582 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 583

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 584 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 585

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 586 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 587

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 588 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 589

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
PAGE 590 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 24 (continued) Histopathology Phase Report 
 PROJECT NUMBER: 41104692R PAGE 591

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 25 Chemical Analysis of Test Item Formulations, Methods and Results 

1. METHOD OF ANALYSIS 

1.1 Summary 

The concentration of Sodium Glucoheptonate (EC 250-480-2) in the test item 

formulations was determined by direct injection into a mass spectrometer (MS) using an 

external standard technique. 

1.2 Samples 

The test item formulations were diluted with mobile phase to give a final, theoretical test 

item concentration of approximately 0.001 mg/ml. 

1.3 Standards 

Standard solutions of test item were prepared in mobile phase at a nominal 

concentration of 0.001 mg/ml. 

1.4 Procedure 

The standards and samples were analysed by (MS) using the following conditions: 

HPLC System : Agilent Technologies 1200 MSD, incorporating 

autosampler and workstation 

Mass selective detector 

 Source : electrospray 

 Fragmentation energy : 100 volts 

 Polarity : negative 

 Mode : single ion mode with 225 amu 

 Gas temperature : 350oC 

 Drying gas : 12 litre/minute 

 Nebuliser pressure : 40 psi 

 Capillary voltage : 4000 volts 

 Gain : 1 

Column : N/A 

Mobile phase : methanol: water: ammonia (50:50:0.1, v/v/v) 

Flow rate : 0.5 ml/min 

Injection volume : 10 μl 

Retention time : approximately 0.2 minutes 
PAGE 592 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 25 (continued) Chemical Analysis of Test Item Formulations, Methods 

and Results 

1.5 Homogeneity Determinations 

The test item formulations were assessed visually. 

1.6 Verification of Test Item Formulation Concentrations 

The test item formulations were sampled and analysed within four days of preparation. 

2. RESULTS 

The test item formulations were deemed homogeneous by visual inspection. 

2.1 Verification of Concentration of Test Item Formulations 

Week Number Nominal Concentration 

(mg/ml) 

Concentration Found 

(mg/ml) (expressed as % of 

nominal) 

1 

0 ND - 

11.9 13.2 111 

118.8 106.2 89 

396 484 122 

2 

0 ND - 

11.9 11.2 94 

118.8 133.9 113 

396 384 97 

3 

0 ND - 

11.9 12.7 106 

118.8 114.1 96 

396 374 94 

5 

0 ND - 

11.9 13.4 113 

118.8 131.7 111 

396 412 104 

6 

0 ND - 

11.9 12.1 102 

118.8 120.2 101 

396 410 104 

7 

0 ND - 

11.9 11.6 97 

118.8 118.1 99 

396441 443 112 

 

ND = none detected 

- = not applicable 
 PROJECT NUMBER: 41104692R PAGE 593

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 25 (continued) Chemical Analysis of Test Item Formulations, Methods 

and Results 

3. METHOD VALIDATION 

3.1 Linearity 

A range of standard solutions covering the concentration range 0 to 0.00218 mg/ml, were 

prepared and analysed. 

The detector response was shown to be linear up to 0.00218 mg/ml. 

Standard Concentration (mg/ml) Peak Area (units) 

0.000 0.000 

0.000546 2.851x104 

0.000873 4.143x104 

0.00109 5.092x104 

0.00131 5.499x104 

0.00218 9.109x104 

Slope 4.081x107 

Intercept 3.687x103 

Correlation Coefficient (r) 0.996 

The results are presented graphically in Figure 1. 

3.2 Specificity 

The diluent solvent mobile phase and a blank Distilled Water (control) were analysed. 

The results are shown in the following table: 

Sample Concentration Found 

Mobile Phase None detected 

Distilled Water(control) None detected 

Analysis of the solvent and a blank Distilled Water (control) produced no signal that 

interfered with the signal due to the test item. 
PAGE 594 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 25 (continued) Chemical Analysis of Test Item Formulations, Methods 

and Results 

3.3 Accuracy 

Samples of Distilled Water were accurately fortified with known amounts of test item, and 

analysed: 

Fortification 

(mg/g) 

Concentration Found 

(mg/g) 

% 

Recovered 

Mean Recovery 

(%) 

5.50 5.66 103 

105 

5.48 5.83 106 

502 494 99 

103 

492 531 108 

The analytical method has been considered to be sufficiently accurate for the purpose of 

this study. The test sample results have not been corrected for recovery. 

3.4 Conclusion 

The analytical method has been satisfactorily validated in terms of linearity, specificity 

and accuracy for the purposes of the study. 
 PROJECT NUMBER: 41104692R PAGE 595

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 25 (continued) Chemical Analysis of Test Item Formulations, Methods 

and Results 

Figure 1 Linearity of Detector Response 
PAGE 596 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 Study Plan 
 PROJECT NUMBER: 41104692R PAGE 597

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
PAGE 598 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
 PROJECT NUMBER: 41104692R PAGE 599

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
PAGE 600 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
 PROJECT NUMBER: 41104692R PAGE 601

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
PAGE 602 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
 PROJECT NUMBER: 41104692R PAGE 603

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
PAGE 604 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
 PROJECT NUMBER: 41104692R PAGE 605

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
PAGE 606 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
 PROJECT NUMBER: 41104692R PAGE 607

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
PAGE 608 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
 PROJECT NUMBER: 41104692R PAGE 609

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
PAGE 610 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
 PROJECT NUMBER: 41104692R PAGE 611

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
PAGE 612 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
 PROJECT NUMBER: 41104692R PAGE 613

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
PAGE 614 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
 PROJECT NUMBER: 41104692R PAGE 615

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
PAGE 616 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
 PROJECT NUMBER: 41104692R PAGE 617

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 26 (continued) Study Plan 
PAGE 618 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 27 Histology Processing Phase Test Site Quality Assurance Statement 
 PROJECT NUMBER: 41104692R PAGE 619

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 28 Histology Processing Phase Test Site Statement of Compliance 
PAGE 620 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 29 Histology Processing Phase Test Site Statement of GLP 

Compliance 
 PROJECT NUMBER: 41104692R PAGE 621

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 30 Statement of GLP Compliance in Accordance with Directive 

2004/9/EC 
PAGE 622 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 31 Certificates of Analysis of Diet Used 
 PROJECT NUMBER: 41104692R PAGE 623

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 31 (continued) Certificates of Analysis of Diet Used 
PAGE 624 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 31 (continued) Certificates of Analysis of Diet Used 
 PROJECT NUMBER: 41104692R PAGE 625

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 32 Laboratory Methods 

UNITS 

HAEMATOLOGY 

Parameters measured on potassium EDTA - treated blood: 

Haemoglobin (Hb) - estimated by measurement of cyanmethaemoglobin using the 

Ac

.T5 Diff analyser 

g/dl 

Total erythrocyte count (RBC) - estimated by the Ac

.T5 Diff analyser 1012/l 

Haematocrit (Hct) - derived from MCV and RBC by the Ac

.T5 Diff analyser % 

Mean Corpuscular Haemoglobin (MCH) - derived from the Hb concentration and RBC by 

the Ac

.T5 Diff analyser 

pg 

Mean Corpuscular Volume (MCV) - estimated by the Ac

.T5 Diff analyser fl 

Mean Corpuscular Haemoglobin Concentration (MCHC) - derived from Hb concentration, 

RBC and MCV by the Ac

.T5 Diff analyser 

g/dl 

Total leucocyte count (WBC) - estimated by the Ac

.T5 Diff analyser 109/l 

Differential leucocyte count - determined by visual assessment of May-Grünwald-Giemsa 

stained blood film: 

109

/l 

 Neutrophils (Neut) 

 Lymphocytes (Lymph) 

 Monocytes (Mono) 

 Eosinophils (Eos) 

 Basophils (Bas) 

Platelet count (PLT) - estimated by the Ac

.T5 Diff analyser 109/l 

Reticulocyte count (Retics) - determined by visual assessment of Methylene Blue stained 

blood film prepared but count not performed 

% 

Parameters measured on citrate-treated blood: 

Prothrombin time (CT) - estimated by ‘Innovin’ Dade Siemens reagent kit No. B4212-50 

and Bio Mérieux Option 4 coagulometer 

secs 

Activated partial thromboplastin time (APTT) - estimated by ‘Actin FS’ Dade Siemens 

reagent kit No. B4218-20 and Bio Mérieux Option 4 coagulometer 

secs 
PAGE 626 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 32 (continued) Laboratory Methods 

UNITS 

BLOOD CHEMISTRY 

Parameters measured on lithium heparin treated blood: 

Urea - estimated by ILab reagent kit No. 00182554400 and 

ILab 600 auto-analyser 

mg/dl 

Glucose - estimated by ILab reagent kit No. 0018250840 and 

ILab 600 auto-analyser 

mg/dl 

Total protein (Tot.Prot.) - estimated by ILab reagent kit No. 0018251440 

and ILab 600 auto-analyser 

g/dl 

Albumin - estimated by ILab reagent kit No. 0018250040 and ILab 600 auto-analyser g/dl 

Albumin/Globulin (A/G) ratio = 

total protein albumin

albumin



Sodium (Na+) - estimated by ISE electrode No. 0018262400 and ILab 600 autoanalyser mmol/l 

Potassium (K+) - estimated by ISE electrode No. 0018263500 and ILab 600 autoanalyser mmol/l 

Chloride (Cl-) - estimated by ISE electrode No. 0018263600 and ILab 600 auto-analyser mmol/l 

Calcium (Ca++) - estimated by ILab reagent kit No. 0018250340 

and ILab 600 auto-analyser 

mmol/l 

Inorganic phosphorus (P) - estimated by ILab reagent kit No. 0018251240 

and ILab 600 auto-analyser 

mmol/l 

Aspartate aminotransferase (ASAT) - estimated by ILab reagent kit No. 0018257540 

and ILab 600 auto-analyser 

IU/l 

Alanine aminotransferase (ALAT) - estimated by ILab reagent kit No. 0018257440 

and ILab 600 auto-analyser 

IU/l 

Alkaline phosphatase (AP) - estimated by ILab reagent kit No. 0018252140 

and ILab 600 auto-analyser 

IU/l 

Creatinine (Creat) - estimated by ILab reagent kit No. 0018255540 

and ILab 600 auto-analyser 

mg/dl 

Total cholesterol (Chol) - estimated by ILab reagent kit No. 0018250540 

and ILab 600 auto-analyser 

mg/dl 

Total bilirubin (Bili) - estimated by ILab reagent kit No. 0018254640 

and ILab 600 auto-analyser 

mg/dl 

Bile acids (Bile) - estimated by Randox Kit No. B13863 and ILab 600 auto-analyser μmol/l 
 PROJECT NUMBER: 41104692R PAGE 627

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 33 Normal Ranges for Reproductive Parameters in the Pregnant and 

Lactating Female Wistar Han TM:RccHanTM:WIST Strain Rat 

SUPPLIER: Harlan Laboratories U.K. Ltd. APPROXIMATE AGE: Fourteen to Nineteen weeks 

UPDATED: November 2011 

 Range * No. of Animals 

MATING & GESTATION 

Pre-Coital Interval (Days) 1 - 5 209

(2) (1)

Gestation Lengths (Days) 21.8 - 23.5 213

(22.7) (0.4)

FOOD CONSUMPTIONS (g/rat/day) 

Gestation Days 0 - 7 15 - 23 208

(19) (2)

Gestation Days 7 - 14 17 - 25 208

(21) (2)

Gestation Days 14 - 20 19 - 27 206

(23) (2)

Lactation Days 1 - 4 18 - 36 196 

(27) (4)

BODY WEIGHT CHANGE (g) 

Gestation Days 0 - 7 13 - 35 208

(24) (5)

Gestation Days 7 - 14 16 - 36 180

(26) (5)

Gestation Days 14 - 20 44 - 81 179

(63) (9)

Lactation Days 1 - 4 -3 - 24 209

(10) (7)

CORPORA LUTEA & 

IMPLANTATIONS 

Corpora Lutea (Number) 10 - 19 208

(15) (2)

Implantations (Number) 9 - 18 208 

(13) (2)

Pre-Implantation loss (%) 0 - 27 200

(8) (10)

Post-Implantation loss (%) 0 - 24 207

(7) (8) 

 

* Range = mean ± 2 standard deviations 

(values in brackets indicate group mean and standard deviation respectively)
PAGE 628 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 34 Normal Ranges for Offspring Parameters in the Wistar HanTM: 

RccHanTM:WIST Strain Rat 

SUPPLIER: Harlan Laboratories U.K. Ltd. AGE: 0 – 4 Days 

UPDATED: November 2011 

OFFSPRING DATA Range * No. of Animals 

SURVIVAL INDICES (%) 

Live Birth Indices 97 - 100 214 

 (100) (1) 

Viability on Day 4 92 - 100 214 

 (99) (4) 

LITTER SIZE 

Litter size at birth 7 - 17 213 

 (12) (3) 

Litter size at Day 1 8 - 17 210 

 (12) (2) 

Litter size at Day 4 7 - 17 209 

 (12) (2) 

LITTER WEIGHT (g) 

Litter weight at Day 1 48.2 - 93.1 209 

 (70.6) (11.2) 

Litter weight at Day 4 71.0 - 131.7 208 

 (101.3) (15.2) 

SEX RATIOS 

% Males at Day 1 24 - 76 203 

 (50) (13) 

% Males at Day 4 24 - 76 203 

 (50) (13) 

OFFSPRING BODY WEIGHTS (g) 

Male body Weights at Day 1 4.8 - 7.0 208 

 (5.9) (0.5) 

Male body Weights at Day 4 6.6 - 10.8 209 

 (8.7) (1.0) 

Female body Weights at Day 1 4.6 - 6.7 206 

(5.7) (0.5)

Female body Weight at Day 4 6.5 - 10.1 200 

 (8.3) (0.9) 

DEVELOPMENTAL & REFLEX 

MARKERS 

Surface Righting (%) 61.9 - 100.0 213 

(87.5) (12.8) 

 

* Range = mean ± 2 standard deviations 

(values in brackets indicate group mean and standard deviation respectively)
 PROJECT NUMBER: 41104692R PAGE 629

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 35 Normal Ranges for Haematological and Blood Chemical Values in 

the Wistar HanTM:RccHanTM:WIST Strain Rat 

SUPPLIER: Harlan Laboratories U.K. Ltd. 

UPDATED: November 2011 

APPROXIMATE AGE: Eighteen weeks 

PHASE: Prior to Termination 

HAEMATOLOGY 

Male Female 

Range* No. of 

Animals Range* No. of Animals

Hb (g/dl) 15.4 - 17.2 70 11.7 - 14.7 71 

 (16.3) (0.4) (13.2) (0.8) 

RBC (1012/l) 8.52 - 9.54 62 6.25 - 7.70 67 

 (9.03) (0.25) (6.98) (0.36) 

Hct (%) 44.9 - 50.4 69 35.2 - 43.3 71 

 (47.6) (1.4) (39.2) (2.0) 

MCH (pg) 17.0 - 19.3 67 17.7 - 20.1 69 

 (18.1) (0.6) (18.9) (0.6) 

MCV (fl) 50.5 - 55.5 66 53.1 - 59.2 66 

 (53.0) (1.2) (56.1) (1.5) 

MCHC (g/dl) 32.2 - 35.9 70 32.1 - 35.0 69 

 (34.0) (0.9) (33.6) (0.7) 

WBC (109/l) 4.8 - 9.8 72 2.3 - 8.7 70 

 (7.3) (1.2) (5.5) (1.6) 

Neut (109/l) 0.29 - 1.26 62 0.45 - 2.84 67 

 (0.78) (0.24) (1.64) (0.60) 

Lymph (109/l) 3.97 - 8.70 73 1.49 - 6.28 71 

 (6.33) (1.18) (3.88) (1.20) 

Mono (109/l) 0.00 - 0.00 75 0.00 - 0.00 70 

 (0.00) (0.00) (0.00) (0.00) 

Eos (109/l) 0.00 - 0.13 65 0.00 - 0.02 66 

 (0.05) (0.04) (0.00) (0.01) 

Bas (109/l) 0.00 75 0.00 75 

 

CT (secs) 8.7 - 10.8 60 8.0 - 10.1 68 

 (9.8) (0.5) (9.1) (0.5) 

APTT (secs) 12.8 - 18.6 70 10.9 - 19.7 69 

 (15.7) (1.4) (15.3) (2.2) 

PLT (109/l) 464 - 660 68 570 - 1043 73 

 (562) (49) (807) (118) 

Retics (%) 3.4 - 6.2 5 5.9 - 11.4 5 

 (4.8) (0.7) (8.6) (1.4) 

Meth (%) 1.05 - 1.72 5 0.29 - 1.11 3 

 (1.60) (1.39) (0.70) (0.21) 

 

* Range = mean ± 2 standard deviations 

(values in brackets indicate group mean and standard deviation respectively) 
PAGE 630 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 35 (continued) Normal Ranges for Haematological and Blood Chemical 

Values in the Wistar HanTM:RccHanTM:WIST Strain Rat 

SUPPLIER: Harlan Laboratories U.K. Ltd. APPROXIMATE AGE: Eighteen weeks 

UPDATED: November 2011 PHASE: Prior to Termination 

BLOOD CHEMISTRY 

Male Female 

Range* No. of

Animals Range* No. of

Animals

Urea (mg/dl) 35 - 58 71 37 - 63 67 

 (46) (6) (50) (7) 

Glucose (mg/dl) 118 - 169 64 97 - 149 66 

 (143) (13) (123) (13) 

Tot.Prot. (g/dl) 6.38 - 7.54 65 5.65 - 6.90 67 

 (6.96) (0.29) (6.27) (0.31) 

Albumin (g/dl) 3.4 - 4.2 73 3.2 - 4.0 71 

 (3.8) (0.2) (3.6) (0.2) 

A/G Ratio 1.04 - 1.35 66 1.11 - 1.65 72 

 (1.20) (0.08) (1.38) (0.14) 

Na+ (mmol/l) 145 - 155 68 144 - 152 68 

 (150) (2) (148) (2) 

K+ (mmol/l) 3.90 - 4.92 59 3.70 - 4.90 70 

 (4.41) (0.25) (4.30) (0.30) 

Cl- (mmol/l) 98 - 107 72 100 - 108 74

 (102) (2) (104) (2) 

Ca++ (mmol/l) 2.32 - 3.00 70 2.34 - 2.85 67 

(2.66) (0.17) (2.60) (0.13)

P (mmol/l) 1.2 - 2.7 70 0.2 - 1.7 75 

 (1.9) (0.4) (0.9) (0.4) 

ASAT (IU/l) 56 - 91 65 55 - 92 64 

 (73) (9) (73) (9) 

ALAT (IU/l) 36 - 67 61 31 - 87 66 

 (52) (8) (59) (14) 

AP (IU/l) 80 - 289 68 84 - 240 42 

 (184) (52) (162) (39) 

Creat (mg/dl) 0.56 - 0.87 71 0.59 - 0.81 65 

 (0.71) (0.08) (0.70) (0.06) 

Chol (mg/dl) 56 - 102 68 51 - 78 58 

 (79) (12) (64) (7) 

Bili (mg/dl) 0.00 - 0.16 65 0.00 - 0.11 75 

 (0.08) (0.04) (0.06) (0.03) 

Bile Acids (μmol/l) 0.0 - 13.9 33 4.6 - 21.0 31 

 (6.9) (3.5) (12.8) (4.1) 

 

* Range = mean ± 2 standard deviations 

(values in brackets indicate group mean and standard deviation respectively) 
 PROJECT NUMBER: 41104692R PAGE 631

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 36 Normal Ranges for Functional Performance Assessments in the 

Wistar HanTM:RccHanTM:WIST Strain Rat 

SUPPLIER: Harlan Laboratories U.K. Ltd. APPROXIMATE AGE: Eighteen weeks

UPDATED: October 2009

FUNCTIONAL PERFORMANCE TESTS 

Male Female 

Range* No. of 

Animals Range* No. of Animals 

MOTOR ACTIVITY 

OVERALL ACTIVITY 73 - 558 23 256 - 789 25 

 (315) (121) (522) (133) 

OVERALL MOBILE ACTIVITY 0.0 - 1.7 26 0.0 - 11.7 26 

 (0.4) (0.6) (4.5) (3.6) 

FINAL 20% OVERALL ACTIVITY 0.0 - 27.9 22 19 - 150 20 

 (8.8) - (9.6) (84) (33) 

FINAL 20% MOBILE ACTIVITY 0.0 - 0.0 26 0.0 - 1.2 25 

 (0.0) (0.0) (0.2) (0.5) 

FORELIMB GRIP STRENGTH 574 - 1704 86 417 - 1294 85 

 (1139) (282) (855) (219) 

HINDLIMB GRIP STRENGTH 149 - 699 88 126 - 545 78 

 (424) (137) (335) (105) 

SENSORY REACTIVITY SCORES 

Incidence 

Male 

n = 30 

Female 

n = 29 

GRASP RESPONSE: 0 30 29

VOCALISATION: 0 28 15 

 : 1 2 12 

 : 2 0 1 

 : 3 0 1 

TOE PINCH: 0 30 29 

 

TAIL PINCH: 0 30 29 

 

FINGER APPROACH: 0 30 29 

 

TOUCH ESCAPE: 0 30 27 

 : 1 0 2 

 

PUPIL REFLEX: -1 1 0 

 : 0 29 29 

BLINK REFLEX: 0 30 29 

 

STARTLE REFLEX: 0 30 29 

 

 

* Range = mean ± 2 standard deviations 

(values in brackets indicate group mean and standard deviation respectively) 
PAGE 632 PROJECT NUMBER: 41104692R 

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 37 Normal Ranges for Absolute and Body Weight-Relative Organ 

Weight Values in the Wistar HanTM:RccHanTM:WIST Strain Rat 

SUPPLIER: Harlan Laboratories U.K. Ltd. APPROXIMATE AGE: Eighteen to Twenty Weeks 

UPDATED: November 2011 

MALE ORGAN WEIGHTS 

ABSOLUTE WEIGHT (g) RELATIVE TO TERMINAL BODY 

WEIGHT (%) 

Range (g)* No. of 

Animals Range (%)* No. of Animals 

Adrenals 0.0420 - 0.0809 140 0.0104 - 0.0210 150

 (0.0614) (0.0097) (0.0157) (0.0027) 

Brain 1.8435 - 2.1774 150 0.4340 - 0.5724 151 

 (2.0105) (0.0835) (0.5032) (0.0346) 

Epididymides 1.1566 - 1.6432 222 0.2896 - 0.4105 210 

 (1.3999) (0.1216) (0.3501) (0.0302) 

Heart 1.0013 - 1.4852 139 0.2562 - 0.3723 143 

 (1.2433) (0.1210) (0.3142) (0.0290) 

Kidneys 1.8425 - 2.7070 162 0.4519 - 0.6867 174 

 (2.2747) (0.2161) (0.5693) (0.0587) 

Liver 10.0646 - 15.2853 163 2.7634 - 3.5536 163 

 (12.6750) (1.3052) (3.1585) (0.1975) 

Pituitary 0.0074 - 0.0120 78 0.0020 - 0.0029 73 

(0.0097) (0.0012) (0.0025) (0.0002) 

Prostate 0.3731 - 0.7418 85 0.0925 - 0.1918 89 

(0.5575) (0.0922) (0.1421) (0.0248) 

Seminal vesicles 1.5821 - 2.7187 87 0.3940 - 0.6642 84 

(2.1504) (0.2841) (0.5291) (0.0676) 

Spleen 0.5302 - 0.8397 150 0.1361 - 0.2054 151 

 (0.6850) (0.0774) (0.1708) (0.0173) 

Testes 3.0354 - 4.2231 224 0.7534 - 1.0558 213 

 (3.6292) (0.2969) (0.9046) (0.0756) 

Thymus 0.2866 - 0.6494 149 0.0749 - 0.1634 151 

 (0.4680) (0.0907) (0.1191) (0.0221) 

Thyroid/Parathyroid 0.0107 - 0.0286 159 0.0029 - 0.0070 157 

 (0.0196) (0.0045) (0.0049) (0.0010) 

 

* Range = mean ± 2 standard deviations 

(values in brackets indicate group mean and standard deviation respectively) 
 PROJECT NUMBER: 41104692R PAGE 633

SODIUM GLUCOHEPTONATE (EC 250-480-2): ORAL (GAVAGE) COMBINED REPEAT DOSE 

TOXICITY STUDY WITH REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE 

RAT (OECD 422)

Appendix 37 (continued) Normal Ranges for Absolute and Body Weight-Relative 

Organ Weight Values in the Wistar HanTM:RccHanTM: 

WIST Strain Rat 

SUPPLIER: Harlan Laboratories U.K. Ltd. APPROXIMATE AGE: Eighteen Weeks 

UPDATED: November 2011 

LACTATING FEMALE ORGAN 

WEIGHTS 

ABSOLUTE WEIGHT (g) RELATIVE TO TERMINAL BODY 

WEIGHT (%) 

Range (g)* No. of 

Animals Range (%)* No. of 

Animals 

Adrenals 0.0654 - 0.1085 132 0.0259 - 0.0407 133 

 (0.0870) (0.0108) (0.0333) (0.0037) 

Brain 1.7469 - 1.9906 130 0.6378 - 0.7871 137 

 (1.8687) (0.0609) (0.7125) (0.0373) 

Heart 0.7786 - 1.1823 128 0.3065 - 0.4480 127 

 (0.9805) (0.1009) (0.3772) (0.0354) 

Kidneys 1.2887 - 1.7435 139 0.4980 - 0.6713 150 

 (1.5161) (0.1137) (0.5846) (0.0433) 

Liver 8.5995 - 12.9085 147 3.5429 - 4.6890 145 

 (10.7540) (1.0772) (4.1159) (0.2865) 

Ovaries 0.0822 - 0.1410 134 0.0336 - 0.0519 131 

 (0.1116) (0.0147) (0.0427) (0.0046) 

Pituitary 0.0109 - 0.0171 69 0.0042 - 0.0066 71 

 (0.0140) (0.0015) (0.0054) (0.0006) 

Spleen 0.4475 - 0.7611 124 0.1797 - 0.2755 121 

 (0.6043) (0.0784) (0.2276) (0.0240) 

Thymus 0.1497 - 0.3320 134 0.0607 - 0.1201 128 

 (0.2409) (0.0456) (0.0904) (0.0148) 

Thyroid/Parathyroid 0.0095 - 0.0226 136 0.0037 - 0.0085 134 

 (0.0160) (0.0033) (0.0061) (0.0012) 

Uterus 0.4968 - 0.8480 126 0.2005 - 0.3144 114 

 (0.6724) (0.0878) (0.2575) (0.0285) 

 

* Range = mean ± 2 standard deviations 

(values in brackets indicate group mean and standard deviation respectively)