FINAL REPORT

Study Title

REPEATED DOSE 28-DAY ORAL TOXICITY STUDY WITH

M-(2,3-EPOXYPROPOXY)-N,N-BIS(2,3-EPOXYPROPYL)ANILINE

BY DAILY GAVAGE

IN THE RAT

Author

Dr. C.G.M. Beerens-Heijnen

Test Facility

WIL Research Europe B.V.

Hambakenwetering 7

5231 DD ‘s-Hertogenbosch

The Netherlands

 

Laboratory Project Identification

Project 501432

Substance 204415/A

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1. CONTENTS 

1. CONTENTS ...................................................................................................................................... 2

2. STATEMENT OF GLP COMPLIANCE ............................................................................................. 3

3. LEAD QUALITY ASSURANCE STATEMENT .................................................................................. 4

4. SUMMARY ........................................................................................................................................ 5

5. INTRODUCTION .............................................................................................................................. 7

5.1. Preface ..................................................................................................................................... 7

5.2. Study plan ................................................................................................................................ 7

5.3. Aim of the study ....................................................................................................................... 8

5.4. Guidelines ................................................................................................................................ 8

5.5. Storage and retention of records and materials ....................................................................... 8

6. MATERIALS AND METHODS .......................................................................................................... 9

6.1. Test substance ......................................................................................................................... 9

6.1.1. Test substance information ............................................................................................. 9

6.1.2. Study specific test substance information ...................................................................... 9

6.1.3. Test substance preparation ............................................................................................ 9

6.1.4. Chemical analysis of dose preparations ......................................................................... 9

6.2. Test system ............................................................................................................................10

6.3. Allocation ................................................................................................................................10

6.4. Animal husbandry ..................................................................................................................10

6.5. Treatment ...............................................................................................................................11

6.6. Observations ..........................................................................................................................11

6.7. Clinical laboratory investigations ............................................................................................12

6.8. Pathology ...............................................................................................................................13

6.8.1. Necropsy .......................................................................................................................13

6.8.2. Organ weights ...............................................................................................................14

6.8.3. Histotechnology ............................................................................................................14

6.8.4. Histopathology ..............................................................................................................14

6.9. Electronic data capture ..........................................................................................................14

6.10. Interpretation ..........................................................................................................................15

6.11. List of deviations ....................................................................................................................15

6.11.1. List of protocol deviations ........................................................................................15

6.11.2. List of standard operating procedures deviations ....................................................15

7. RESULTS .......................................................................................................................................16

7.1. Analysis of dose preparations (see also APPENDIX 3) .........................................................16

7.2. Observations ..........................................................................................................................16

7.2.1. Mortality ........................................................................................................................16

7.2.2. Clinical signs .................................................................................................................16

7.2.3. Functional observations ................................................................................................16

7.2.4. Body weights .................................................................................................................16

7.2.5. Food consumption ........................................................................................................17

7.3. Clinical laboratory investigations ............................................................................................17

7.3.1. Haematology .................................................................................................................17

7.3.2. Clinical biochemistry .....................................................................................................17

7.4. Pathology ...............................................................................................................................18

7.4.1. Macroscopic examination .............................................................................................18

7.4.2. Organ weights ...............................................................................................................19

7.4.3. Microscopic examination (see also APPENDIX 4) .......................................................19

8. DISCUSSION AND CONCLUSION ................................................................................................21

9. REFERENCES ...............................................................................................................................23

APPENDICES 

 

APPENDIX 1 FIGURES AND SUMMARY TABLES

APPENDIX 2 INDIVIDUAL DATA TABLES

APPENDIX 3 FORMULATION ANALYSIS REPORT

APPENDIX 4 HISTOPATHOLOGY REPORT

APPENDIX 5 SUMMARY OF DOSE RANGE FINDING STUDY

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4. SUMMARY 

Title 

Repeated dose 28-day oral toxicity study with m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline 

by daily gavage in the rat.

Guidelines 

The study was based on the following guidelines. 

- EC No 440/2008, B.7 Repeated Dose (28 days) Toxicity (oral), 2008. 

- OECD 407, Repeated Dose 28-day Oral Toxicity Study in Rodents, 2008. 

- OPPTS 870.3050, Repeated dose 28-day oral toxicity study in rodents. Office of Prevention, 

Pesticides and Toxic Substances (7101), EPA 712-C-00-366, 2000. 

Rationale for dose levels 

Based on the results of a 5- to10-day range finding study (Project 501433; See APPENDIX 5), the 

dose levels for this 28-day oral gavage study were selected to be 0, 50, 150 and 450 mg/kg. 

Study outline 

The test substance, formulated in propylene glycol, was administered daily for 28 days by oral gavage 

to SPF-bred Wistar rats. One control group and three treated groups were tested, each consisting of 5 

males and 5 females. 

Evaluated parameters 

Chemical analyses of formulations were conducted once during the study to assess accuracy, 

homogeneity and stability over 6 hours. 

The following parameters were evaluated: clinical signs daily; functional observation tests in week 4; 

body weight and food consumption weekly; clinical pathology and macroscopy at termination; organ 

weights and histopathology on a selection of tissues. 

RESULTS 

Formulation analyses confirmed that formulations of test substance in propylene glycol were prepared 

accurately and homogenously, and were stable over at least 6 hours. 

No mortality occurred in the study. 

At 50 mg/kg, treatment resulted in changes in the gastro-intestinal tract and changes in organ weights 

of the male reproductive system. 

The local gastro-intestinal tract findings were noted consisting of hemorrhage and hypertrophy with 

villous stunting in the duodenum in males and females. In addition, lymphoid atrophy in the Peyer’s 

patches and erythrophagocytosis and/or discolouration in the mesenteric and pancreatic lymph nodes 

was noted. 

At 150 mg/kg, treatment resulted in clinical signs, changes in the gastro-intestinal tract, changes in 

blood parameters, changes in the reproductive organs of females, changes in organ weights of the 

male reproductive system and slight changes in the adrenal glands. 

During the in-life phase, hunched posture (with or without lethargy) was observed in all animals on two 

treatment days. 

Local effects in the gastro-intestinal tract consisted of hemorrhage in the duodenum, hypertrophy with 

villous stunting, gelatinous content and thickened wall in the duodenum and in the jejunum. In the 

stomach effects included ulcer, hyperplasia, foci and irregular surface of the forestomach. In addition, 

lymphoid atrophy in the Peyer’s patches, increased mast cells in the mesenteric lymph node, lymphoid 

hyperplasia of the pancreatic lymph node and erythrophagocytosis and/or discolouration in the 

mesenteric and pancreatic lymph nodes were noted. Centrilobular hypertrophy in the liver was noted 

in one female, although not correlating to higher liver weight or effects at the macroscopic 

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examinations. Changes in the female reproductive organs consisted of atrophy of the uterus (with 

lower uterus weight), cervix and vagina. 

Effects on blood parameters included higher bilirubin, potassium, cholesterol and bile acid levels in 

males and/or females. 

At 450 mg/kg, treatment resulted in poor health status of the animals during the study period, in 

changes in the gastro-intestinal tract, changes in blood parameters, changes in the male and female 

reproductive organs and in changes in liver and renal system. 

Reduced body weight gain and food consumption, reduced motor activity and several symptoms 

indicative of ill health including lethargy, hunched posture, piloerection, pale faeces, lean appearance 

and ptosis were noted among all animals. All animals survived the scheduled study duration. 

Local effects in the gastro-intestinal tract consisted of hemorrhage and hypertrophy with villous 

stunting, gelatinous content and thickened wall in the duodenum and in the jejunum. In the stomach 

effects included ulcer, hyperplasia, foci and irregular surface of the forestomach. In addition, lymphoid 

atrophy in the Peyer’s patches, increased mast cells in the mesenteric lymph node, lymphoid 

hyperplasia of the pancreatic lymph node and erythrophagocytosis and/or discolouration in the 

mesenteric and pancreatic lymph nodes were noted. 

Changes in the reproductive organs consisted of atrophy in the uterus, cervix and vagina 

(macroscopically seen as reduced size and/or weight of ovaries and uterus), a small prostate gland 

(with normal histology), and reduced contents of the seminal vesicles and coagulating glands were 

noted. Macroscopically, a reduced size and weight of the prostate and seminal vesicles was observed. 

Other microscopic findings consisted of centrilobular hypertrophy in the liver (correlating to higher liver 

weight), discoloration of kidney, vacuolation of the zona fasciculata of the adrenal glands (with 

macroscopic discolouration, enlargement and increase in weight), and lymphoid hyperplasia of the 

renal lymph nodes (macroscopically supported by enlargement). 

Effects on blood parameters consisted of changes in red blood cell parameters, platelet counts and 

activated partial thromboplastin time, and higher bilirubin, cholesterol, potassium and bile acid levels, 

and lower albumin, creatinine, glucose, sodium and chloride levels in one or both sexes. 

The lower prostate and seminal vesicle weight observed at 50 and 150 mg/kg was slight in nature and 

had no microscopic correlate. As such they were considered not adverse at these dose levels. 

The shift in type of white blood cells (i.e. higher neutrophil counts with lower lymphocyte counts 

observed in males at 150 and 450 mg/kg and females at 50, 150 and 450 mg/kg) was considered to 

be related to the lymphoid atrophy in the thymus and spleen as recorded at 450 mg/kg. This lymphoid 

atrophy was considered to be a secondary non-specific response to stress associated with treatment. 

Therefore, the change in white blood cells may be considered not to be of primary toxicological 

significance. 

CONCLUSION 

Based on the local effects in the gastrointestinal tract (duodenum, Peyer’s patches and lymph nodes), 

likely to be secondary effects due to the irritation potential of the test substance, starting at the lowest 

dose level of 50 mg/kg/day, a local No Observed Adverse Effect Level (NOAEL) could not be 

established in this study. 

The systemic NOAEL is considered to be 50 mg/kg/day, essentially based on atrophy of the female 

reproductive organs (uterus, cervix and vagina) observed at 150 mg/kg/day. 

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5. INTRODUCTION 

Information concerning the dose range finding study (project 501433) is given in APPENDIX 5. 

5.1. Preface 

Sponsor Huntsman Advanced Materials (Switzerland) GmbH

Contact person: Dr. Rita Petschel

Klybeckstrasse 200

4057 BASEL

Switzerland

Study Monitor Mr. Matthieu Ott

Study Director Dr. C.G.M. Beerens-Heijnen

WIL Research Europe B.V.

Hambakenwetering 7

5231 DD 's-Hertogenbosch

The Netherlands

Tel: +31 73 640 6700

Fax: +31 73 640 6799

Email: chantal.beerens@wilresearch.com

Coordinating Biotechnician C. Gerritsen (WIL Research Europe B.V.)

Clinical Pathology Dr. M. Stitzinger (WIL Research Europe B.V.)

Analytical Chemistry Dr. Ir. E. Baltussen (Principal Scientist, WIL Research Europe B.V.) 

Necropsy Ing T.A. Mijnders (WIL Research Europe B.V.)

Histotechnology W. Verhoef (WIL Research Europe B.V.)

Histopathology Drs. J.F.M. Lensen (Principal Scientist, WIL Research Europe B.V)

QA C.J. Mitchell, B.Sc. (WIL Research Europe B.V.):

christine.mitchell@wilresearch.com

Test facility Management H.H. Emmen, M.Sc. (WIL Research Europe B.V.): 

harry.emmen@wilresearch.com

Test Facility WIL Research Europe B.V.

Hambakenwetering 7

5231 DD ‘s-Hertogenbosch

The Netherlands

5.2. Study plan 

Experimental starting date 27 October 2012 (allocation dose range finding study)

Treatment 09 November 2012 to 06 December 2012

Blood sampling 07 December 2012

Necropsy 07 December 2012

Experimental completion date 07 December 2012 (end of in-life phase)

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5.3. Aim of the study 

The nature and purpose of this toxicity study was to assess the toxic potential of the test substance 

when administered to rats by daily oral gavage for a period of 28 days. A No Observed Adverse Effect 

Level (NOAEL) was evaluated. 

This study should provide a rational basis for toxicological risk assessment in man. The oral route was 

selected as it is a possible route of human exposure during manufacture, handling or use of the test 

substance. 

5.4. Guidelines 

As required by the Dutch Act on Animal Experimentation (February 1997), the protocol was reviewed 

and agreed by the Animal Welfare Officer and the Ethical Committee (DEC 97-03-15). The study 

procedures described in this report were based on the following guidelines: 

1. Commission regulation (EC) No 440/2008 Part B: Methods for the Determination of Toxicity and 

other Health Effects; B.7: "Repeated Dose (28 days) Toxicity (oral)". Official Journal of the 

European Union No. L142, May 2008. 

2. Organization for Economic Co-operation and Development (OECD), OECD Guidelines for 

Testing of Chemicals, Section 4, Health Effects, No. 407: "Repeated Dose 28-day Oral Toxicity 

Study in Rodents", Paris Cedex, 03 October 2008. 

3. United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 

870.3050, Repeated dose 28-day oral toxicity study in rodents. Office of Prevention, Pesticides 

and Toxic Substances (7101), EPA 712-C-00-366, July 2000. 

5.5. Storage and retention of records and materials 

Records and materials pertaining to the study including protocol, raw data, specimens (except 

specimens requiring refrigeration or freezing) and the final report are retained in the WIL Research 

Europe archives for a period of at least 10 years after finalization of the report. After this period, the 

sponsor will be contacted to determine how the records and materials should be handled. WIL 

Research Europe will retain information concerning decisions made. 

Those specimens requiring refrigeration or freezing will be retained by WIL Research Europe for as 

long as the quality of the specimens permits evaluation but no longer than three months after 

finalization of the report. 

WIL Research Europe will retain a test substance sample until the expiry date, but no longer than 10 

years after finalization of the report. After this period the sample will be destroyed. 

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6. MATERIALS AND METHODS 

6.1. Test substance 

6.1.1. Test substance information 

Identification m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline

Description Clear slightly yellow very viscous liquid

Batch AAB0581300

Purity/Composition 100% Mono constituent substance

Test substance storage In refrigerator (2-8°C) in the dark

Stability under storage conditions Stable

Expiry date 10 April 2013

6.1.2. Study specific test substance information 

Purity/composition correction factor 

required

No 

Hygroscopic Not indicated

Volatile Yes, vapour pressure: <13 Pa at 293K

Specific Gravity / Density 1.215 - 1.225 g/cm3(25°C)

pH (1% in water, indicative range) 7.9-8.6 (determined at WIL Research Europe B.V.) 

Stability at higher temperatures Yes, maximum temperature: 50°C, 

maximum duration: 1 h

Stability in vehicle:

 Propylene glycol Stable at a concentration range of 1 to 90 mg/g during 

storage at room temperature under normal laboratory light 

conditions for at least 6 hours.

Solubility in vehicle:

 Propylene glycol Not indicated

6.1.3. Test substance preparation 

Vehicle Propylene glycol (Merck, Darmstadt, Germany), specific gravity 1.036. 

Rationale for vehicle Based on trial formulations performed at WIL Research Europe and on 

information provided by the sponsor. 

Method of formulation Formulations (w/w) were prepared daily within 6 hours prior to dosing, 

and were homogenized to visually acceptable levels. Adjustment was 

made for specific gravity/density of the test substance (1.220, average of 

range 1.215-1.225 g/cm3) and specific gravity of the vehicle. No 

correction was made for the purity of the test substance. 

Storage conditions At ambient temperature. 

6.1.4. Chemical analysis of dose preparations 

Analyses were conducted on a single occasion during the treatment phase, according to a validated 

method (project 501424). Samples of formulations were analyzed for homogeneity (highest and lowest 

concentration) and accuracy of preparation (all concentrations). Stability in vehicle over 6 hours at 

room temperature under normal laboratory light conditions was also determined (highest and lowest 

concentration). 

The accuracy of preparation was considered acceptable if the mean measured concentrations were 

85-115% for suspensions. Homogeneity was demonstrated if the coefficient of variation was ≤ 10%. 

Formulations were considered stable if the relative difference before and after storage was maximally 

10%. 

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6.2. Test system 

Test system Rat: Crl:WI(Han) (outbred, SPF-Quality). 

Rationale Recognized by international guidelines as the recommended test system 

(e.g. EPA, FDA, OECD and EC). 

Source Charles River Deutschland, Sulzfeld, Germany. 

Total number of animals 20 males and 20 females (females were nulliparous and non-pregnant). 

Age at start of treatment Approximately 6 weeks. 

Identification Earmark and tattoo. 

Randomization By computer-generated random algorithm according to body weight, with 

all animals within ± 20% of the sex mean. 

Acclimatization period At least 5 days before the start of treatment under laboratory conditions. 

Health inspection Upon receipt of the animals. 

6.3. Allocation 

Group Dose level 1 Dose volume Number of animals Animal numbers

mg/kg mL/kg Males Females Males Females

1 0 (vehicle) 5 5 5 1-5 21-25

2 50 5 5 5 6-10 26-30

3 150 5 5 5 11-15 31-35

4 450 5 5 5 16-20 36-40

1 Dose levels were based on results of a dose range finding study with m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline 

(project 501433). A summary of the results is included in this report (see APPENDIX 5).

6.4. Animal husbandry 

Room number A0.10 (A0.23 for motor activity measurements). 

Conditions Environmental controls for the animal room were set to maintain 18 to 

24°C, a relative humidity of 40 to 70%, approximately 15 room air 

changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to 

these conditions were maintained in the raw data and had no effect on 

the outcome of the study. 

Accommodation Group housing of 5 animals per sex in Macrolon cages (MIV type, height 

18 cm) with sterilized sawdust as bedding material (Litalabo, S.P.P.S., 

Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lilico 

& Son (Wonham Mill Ltd), Surrey, United Kingdom). During locomotor 

activity monitoring, animals were housed individually in a Hi-temp 

polycarbonate cage (Ancare corp., USA; dimensions: 48.3 x 26.7 x 20.3 

cm) without cage-enrichment or bedding material. 

Diet Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® 

Spezialdiäten GmbH, Soest, Germany). During motor activity 

measurements, animals had no access to food. 

Water Free access to tap water except during motor activity measurements. 

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Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed 

according to facility standard procedures. There were no findings that could interfere with the study. 

6.5. Treatment 

Method Oral gavage, using a plastic feeding tube. 

Formulations were placed for at least 10 minutes on a magnetic stirrer 

during dosing. 

Dose volume 5 mL/kg body weight. 

Actual dose volumes were calculated weekly according to the latest body 

weight. 

Frequency Once daily, 7 days per week, approximately the same time each day with 

a maximum of 6 hours difference between the earliest and latest dose. 

Duration of treatment At least 28 days. 

Animals were dosed up to the day prior to necropsy. 

6.6. Observations 

Mortality / Viability At least twice daily. 

Clinical signs At least once daily from start of treatment onwards, detailed clinical 

observations were made in all animals immediately (0-15 minutes) after 

dosing (as no peak effect of clinical signs occurred in the range finding 

study, see APPENDIX 5). Once prior to start of treatment and at weekly 

intervals, this was also performed outside the home cage in a standard 

arena. The time of onset, grade and duration of any observed signs were 

recorded. Signs were graded for severity and the maximum grade was 

predefined at 3 or 4. Grades were coded as slight (grade 1), moderate 

(grade 2), severe (grade 3) and very severe (grade 4). For certain signs, 

only its presence (grade 1) or absence (grade 0) was scored. In the data 

tables, the scored grades are reported, as well as the percentage of 

animals affected in summary tables. 

Functional Observations During week 4 of treatment, the following tests were performed on all 

animals. 

- hearing ability (HEARING), pupillary reflex (PUPIL L/R), static 

righting reflex (STATIC R) and grip strength (GRIP) (Score 0 = 

normal/present, score 1 = abnormal/absent). 

- locomotor activity (recording period: 1-hour under normal laboratory 

light conditions, using a computerized monitoring system, Kinder 

Scientific LLC, Poway, USA). Total movements and ambulations are 

reported. Ambulations represent movements characterized by a 

relocation of the entire body position like walking, whereas total 

movements represent all movements made by the animals, 

including ambulations but also smaller or more fine movements like 

grooming, weaving or movements of the head. 

 No specific time for functional observations was applied, as no peak effect 

of clinical signs occurred in the range finding study, see APPENDIX 5.

Body weights Weekly. 

Food consumption Weekly. 

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Water consumption Subjective appraisal was maintained during the study, but no quantitative 

investigation introduced as no effect was suspected. 

6.7. Clinical laboratory investigations 

Blood samples were collected under anaesthesia using isoflurane (Abbott B.V., Hoofddorp, The 

Netherlands) between 7.00 and 10.30 a.m. on the day of necropsy at the end of the treatment. 

Animals were deprived of food overnight (for a maximum of 24 hours), but water was available. 

Blood samples were drawn from the retro-orbital sinus and collected into tubes (Greiner Bio-One 

GmbH, Kremsmünster, Austria) prepared with EDTA for haematological parameters (0.5 mL), with 

citrate for clotting tests (0.45 mL) and Li-heparin treated tubes for clinical biochemistry parameters (0.5 

mL). An additional blood sample (0.25 mL) was collected into untreated tubes for determination of bile 

acids. The following parameters were determined: 

Parameter Abbreviation Unit

Haematology a

White blood cells WBC 109/L

Differential leucocyte count %WBC

neutrophils, lymphocytes, monocytes,

eosinophils, basophils

Red blood cells 1012/L

Reticulocytes %RBC %RBC

Red blood cell distribution width RDW %

Haemoglobin mmol/L

Haematocrit L/L

Mean corpuscular volume MCV fL

Mean corpuscular haemoglobin MCH fmol

Mean corpuscular haemoglobin 

concentration

MCHC mmol/L

Platelets 109/L

Clotting Potential b

Prothrombin time PT s

Activated Partial thromboplastin time APTT s

Clinical Biochemistry c

Alanine aminotransferase ALAT U/L

Aspartate aminotransferase ASAT U/L

Alkaline phosphatase ALP U/L

Total Protein g/L

Albumin g/L

Total Bilirubin μmol/L 

Urea mmol/L

Creatinine μmol/L

Glucose mmol/L

Cholesterol mmol/L

Sodium mmol/L

Potassium mmol/L

Chloride mmol/L

Calcium mmol/L

Inorganic Phosphate Inorg. Phos mmol/L

a

 Instrumentation: ADVIA 120 (Siemens Healthcare Diagnostics B.V., Breda, The Netherlands).

b Instrumentation: STA Compact (Diagnostica Stago S.A.S., Asnières, France). 

c Instrumentation: Olympus AU400 (Beckman Coulter Nederland B.V., Woerden, The Netherlands). 

Bile acids μmol/L

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6.8. Pathology 

6.8.1. Necropsy 

All animals were deeply anaesthetized using isoflurane (Abbott B.V., Hoofddorp, The Netherlands) 

and subsequently exsanguinated and subjected to a full post mortem examination. Animals were 

deprived of food overnight (with a maximum of 24 hours) prior to scheduled necropsy. All animals 

assigned to the study were necropsied and descriptions of all macroscopic abnormalities recorded. 

Samples of the following tissues and organs were collected from all animals at necropsy and fixed in 

10% buffered formalin (neutral phosphate buffered 4% formaldehyde solution, Klinipath, Duiven, The 

Netherlands): 

Identification marks: not processed Ovaries

Adrenal glands (Pancreas)

(Aorta) Peyer's patches [jejunum, ileum] if detectable

Brain [cerebellum, mid-brain, cortex] (Pituitary gland)

Caecum (Preputial gland)

Cervix Prostate gland

(Clitoral gland) Rectum

Colon (Salivary glands - mandibular, sublingual)

Duodenum Sciatic nerve

Epididymides * Seminal vesicles including coagulating gland

Eyes (including optic nerve [if detectable] and 

harderian gland) *

Skeletal muscle

(Skin)

(Female mammary gland area) Spinal cord -cervical, midthoracic, lumbar

Femur including joint Spleen

Heart Sternum with bone marrow

Ileum Stomach

Jejunum Testes *

Kidneys Thymus

(Larynx) Thyroid including parathyroid [if detectable]

(Lacrimal gland, exorbital) (Tongue)

Liver Trachea

Lung, infused with formalin Urinary bladder

Lymph nodes - mandibular, mesenteric Uterus

(Nasopharynx) Vagina

(Oesophagus) All gross lesions

* Fixed in modified Davidson's solution, prepared at WIL Research Europe using Formaldehyde 37-40%, Ethanol, Acetic acid 

- glacial (all Merck, Darmstadt, Germany) and Milli-Ro water (Millipore Corporation, Bedford, USA). Tissues were transferred 

to formalin after fixation for at least 24 hours. 

Tissues/organs mentioned in parentheses were not examined by the pathologist, since no signs of 

toxicity were noted at macroscopic examination. 

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6.8.2. Organ weights 

The following organ weights and terminal body weight were recorded from all animals on the 

scheduled day of necropsy: 

Adrenal glands Spleen

Brain Testes

Epididymides Thymus

Heart Uterus (including cervix) 

Kidneys Prostate1

Liver Seminal vesicles including coagulating glands 1

Ovaries Thyroid including parathyroid1

1 weighed when fixed for at least 24 hours. 

6.8.3. Histotechnology 

All organ and tissue samples, as defined under Histopathology (following), were processed, 

embedded in paraffin wax (Klinipath, Duiven, The Netherlands), cut at a thickness of 2-4 micrometers 

and stained with haematoxylin and eosin (Klinipath, Duiven, The Netherlands). 

6.8.4. Histopathology

The following slides were examined by a pathologist: 

- all tissues collected at the scheduled sacrifice from all group 1 and 4 animals, 

- the following organs of all males and/or females of group 2 and 3, based on (possible) treatmentrelated changes in these organs in group 4: Thymus, stomach, duodenum, jejunum, peyer’s patches, 

spleen, mesenteric lymph node, mandibular lymph nodes, adrenal glands, femur including joint, 

prostate gland, seminal vesicles, coagulating glands, liver, uterus, cervix and vagina, 

- all gross lesions. 

All abnormalities were described and included in the report. An attempt was made to correlate gross 

observations with microscopic findings. 

Histopathology was subjected to a peer review. 

6.9. Electronic data capture 

Observations/measurements in the study were recorded electronically using the following 

programme(s): 

- REES Centron Environmental Monitoring system version SQL 2.0 (REES Scientific, Trenton, NJ, 

USA): Environmental monitoring. 

- TOXDATA version 8.0 (WIL Research Europe B.V., ‘s-Hertogenbosch, The Netherlands): Mortality 

/ Clinical signs / Body weights (Body weight for health monitoring purposes were recorded 

manually) / Food consumption / Organ weights.

- Motor Monitor version 08356-14 (Kinder Scientific LLC, Poway, USA): Motor activity measurement 

- Advia 120 version V.3.1.8.0.MS (Siemens Healthcare Diagnostics B.V., Breda, The Netherlands): 

Haematology 

- STA Compact® version 107.07 (Diagnostica Stago S.A.S., Asnières, France): Clotting 

parameters. 

- Olympus AU 400 version 8.2A (Beckman Coulter Nederland B.V., Woerden, The Netherlands):

Clinical biochemistry. 

- Pathdata version 6.2D (Pathology Data Systems, Basel, Switzerland): Histopathology 

- Empower version 7.00 (Waters, Milford, MA, USA): Formulation analysis 

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6.10. Interpretation 

The following statistical methods were used to analyze the data: 

 If the variables could be assumed to follow a normal distribution, the Dunnett-test (Ref. 1; manyto-one t-test) based on a pooled variance estimate was applied for the comparison of the treated 

groups and the control groups for each sex. 

 The Steel-test (Ref. 2; many-to-one rank test) was applied if the data could not be assumed to 

follow a normal distribution. 

 The Fisher Exact-test (Ref. 3) was applied to frequency data. 

 The Kruskal-Wallis nonparametric ANOVA test (Ref. 4) was applied to motor activity data to 

determine intergroup differences. In case intergroup differences were seen, the Wilcoxon test 

(Ref. 5) was applied to compare the treated groups to the control group. 

All tests were two-sided and in all cases p < 0.05 was accepted as the lowest level of significance. 

Group means were calculated for continuous data and medians were calculated for discrete data 

(scores) in the summary tables. Test statistics were calculated on the basis of exact values for means 

and pooled variances. Individual values, means and standard deviations may have been rounded off 

before printing. Therefore, two groups may display the same printed means for a given parameter, yet 

display different test statistics values. 

6.11. List of deviations 

6.11.1. List of protocol deviations 

1 Prior to necropsy the terminal body weight of animal nos. 26, 27 and 28 was not determined.

Evaluation: Sufficient information is available to evaluate the organ weight data in this study. 

The study integrity was not adversely affected by the deviation. 

6.11.2. List of standard operating procedures deviations 

Any deviations from standard operating procedures were evaluated and filed in the study file. There 

were no deviations from standard operating procedures that affected the integrity of the study. 

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7. RESULTS

For further detail on summary data, see APPENDIX 1 and on individual data, see APPENDIX 2.

7.1. Analysis of dose preparations (see also APPENDIX 3)

The concentrations analysed in the formulations of Group 2, Group 3 and Group 4 were in agreement 

with target concentrations (i.e. mean accuracies between 85% and 115%). No test substance was 

detected in the Group 1 formulation. 

The formulations of Group 2 and Group 4 were homogeneous (i.e. coefficient of variation ≤ 10%). 

Formulations at the entire range were stable when stored at room temperature under normal 

laboratory light conditions for at least 6 hours.

7.2. Observations

7.2.1. Mortality

No mortality occurred during the study period.

7.2.2. Clinical signs

At 450 mg/kg, lethargy, hunched posture, piloerection, pale faeces, lean appearance and ptosis were 

noted among all animals during the study period.

At 150 mg/kg hunched posture (with or without lethargy) was observed in all animals on two treatment 

days.

Salivation seen after dosing among animals of the 50, 150 and 450 mg/kg dose group during the 

treatment period was considered to be a physiological response rather than a sign of systemic toxicity 

considering the nature and minor severity of the effect and its time of occurrence (i.e. after dosing). 

This sign may be related to irritancy/taste of the test substance.

Other findings that were noted in these animals consisted of rales, chromodacryorrhoea and scabs on 

the shoulder. These findings were observed in individual animals only and were considered to be 

within the normal range of biological variation for rats of this age and strain.

7.2.3. Functional observations

A lower motor activity was recorded for males and females at 450 mg/kg, as shown by a statistically 

significant lower number of total movements and ambulations (ambulation counts not statistically 

significant in males). This difference appeared essentially confined to the habituation phase (i.e. the 

first 10 minutes of the measurement). The other groups showed a normal motor activity habituation 

profile with high activity in the first interval that decreased over the duration of the test period.

Hearing ability, pupillary reflex, static righting reflex and grip strength were normal in all animals. 

7.2.4. Body weights

All animals at 450 mg/kg showed lower body weight gain compared to control animals throughout the 

treatment period. Slight body weight loss (up to -4%) was noted in three males at 450 mg/kg during 

the first week, which slightly recovered thereafter. Body weight loss (up to -10%) was also noted in 

four females at 450 mg/kg in Week 4 when compared to Week 3. Mean body weights at the end of the 

treatment period were approximately 40 and 20% lower than controls in males and females 

respectively.

No treatment-related findings on body weights and body weight gain were noted at 50 and 150 mg/kg.

The slight lower body weight gain observed in males treated at 150 mg/kg (achieving a level of 

statistical significance for weight gain) was slight and within the normal range of variation. Therefore 

this finding was considered to be of no toxicological relevance.

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7.2.5. Food consumption 

At 450 mg/kg, food consumption before or after correction for body weight was lower than controls in 

males and females throughout the treatment period. 

No toxicologically significant changes in food consumption before or after correction for body weight 

were noted at 50 and 150 mg/kg. 

7.3. Clinical laboratory investigations 

7.3.1. Haematology 

Treatment with 50 mg/kg resulted in the following (statistically significant) changes in haematology 

parameters, compared to controls: 

- Higher relative neutrophil count in females 

Treatment with 150 mg/kg resulted in the following (statistically significant) changes in haematology 

parameters, compared to controls: 

- Higher relative neutrophil count in males and females 

- Lower relative lymphocyte count in males and in females (not statistically significant for females) 

Treatment with 450 mg/kg resulted in the following (statistically significant) changes in haematology 

parameters, compared to controls: 

- Higher relative neutrophil count in males and females 

- Lower relative lymphocyte count in males and females (not statistically significant for females) 

- Higher relative monocyte count in females 

- Lower red blood cell count in males and females 

- Higher reticulocyte count in males and females 

- Higher red blood cell distribution width (RDW) in males 

- Lower haemoglobin level in males and females 

- Lower haematocrit in males and females (not statistically significant for females) 

- Lower mean corpuscular haemoglobin concentration (MCHC) in males (not statistically significant) 

and females 

- Higher platelet count in males and females 

- Shortened activated partial thromboplastin time (APTT) in males (not statistically significant) and 

females 

No treatment related changes in haematology parameters were noted in males treated at 50 mg/kg. 

7.3.2. Clinical biochemistry 

Treatment with 150 mg/kg resulted in the following (statistically significant) changes in clinical 

biochemistry parameters, compared to controls:

- Higher bilirubin level in males (not statistically significant) and females 

- Higher cholesterol level in females 

- Higher bile acid level in females (not statistically significant) 

- Higher potassium level in males and females 

Treatment with 450 mg/kg resulted in the following (statistically significant) changes in clinical 

biochemistry parameters, compared to controls: 

- Lower albumin level in males and females 

- Higher bilirubin level in males and females 

- Lower creatinine level in males and females 

- Lower glucose level in males and females (not statistically significant for females) 

- Higher cholesterol level in males and females 

- Higher bile acid level in males and females (not statistically significant for females) 

- Lower sodium level in males 

- Lower chloride level in males and females 

- Higher potassium level in females (not statistically significant) 

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No treatment related changes in clinical biochemistry parameters were noted in animals treated at 50 

mg/kg. 

All other (statistically significant) changes in clinical biochemistry parameters between treated and 

control animals were considered to be of no toxicological significance as these changes occurred in 

the absence of a treatment-related distribution and/or were within the normal range of variation. 

7.4. Pathology 

7.4.1. Macroscopic examination 

Treatment with 50 mg/kg resulted in the following macroscopic findings: 

- Pancreatic lymph node, discolouration reddish was noted in 1/5 female. 

Treatment with 150 mg/kg resulted in the following macroscopic findings 

- Stomach, forestomach irregular surface was noted in 5/5 male and 3/5 female. 

- Stomach, forestomach focus/foci, yellowish/tan, reddish/dark red was noted in 1/5 male. 

- Duodenum, wall thickened/dilation was noted in 3/5 male and 3/5 female. 

- Duodenum, contents gelatinous was noted in 3/5 male and 2/5 female. 

- Jejunum, wall thickened/dilation was noted in 2/5 male and 2/5 female. 

- Jejunum, contents gelatinous was noted in 2/5 male and 1/5 female. There was no microscopic 

correlate to this finding. 

- Mesenteric lymph node, discolouration reddish/dark red/purple was noted in 4/5 male and 2/5 

female. 

- Pancreatic lymph node, enlarged was noted in 2/5 male and 1/5 female. 

- Pancreatic lymph node, discolouration reddish was noted in 1/5 male and 2/5 female. 

- Uterus, reduced in size was noted in 1/5 female. 

Treatment with 450 mg/kg resulted in the following macroscopic findings 

- Emaciated was noted in 4/5 male and 5/5 female. 

- Thymus, reduced in size was noted in 5/5 male and 4/5 female. 

- Stomach, forestomach irregular surface was noted in 4/5 male and 5/5 female. 

- Stomach, forestomach focus/foci, yellowish/tan, reddish/dark red was noted in 3/5 female. 

- Duodenum, wall thickened/dilation was noted in 4/5 male and 4/5 female. 

- Duodenum, contents gelatinous was noted in 3/5 male and 1/5 female. 

- Jejunum, wall thickened/dilation was noted in 4/5 male and 4/5 female. 

- Jejunum, contents gelatinous was noted in 4/5 male and 2/5 female. There was no microscopic 

correlate to this finding. 

- Mesenteric lymph node, discolouration reddish/dark red/purple was noted in 5/5 male and 4/5 

female. 

- Pancreatic lymph node, enlarged was noted in 3/5 male and 4/5 female. 

- Renal lymph node, enlarged was noted in 1/5 male and 1/5 female. 

- Adrenal glands, discolouration pale was noted in 4/5 male and 4/5 female. 

- Kidneys, discolouration greenish was noted in 5/5 male and 5/5 female. 

- Uterus, reduced in size was noted in 5/5 female. 

- Ovaries, reduced in size was noted in 3/5 female. 

- Prostate gland, reduced in size was noted in 5/5 male. 

- Seminal vesicles, reduced in size was noted in 5/5 male. 

All other macroscopic findings recorded were considered to be within the normal range of background 

pathology encountered in rats of this age and strain. 

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7.4.2. Organ weights 

Treatment with 50 mg/kg resulted in the following organ weight changes, when compared to controls: 

- Lower prostate weights and a trend towards lower seminal vesicle weights. 

Treatment with 150 mg/kg resulted in the following organ weight changes, when compared to controls: 

- Lower prostate weights, lower prostate to body weight ratio, lower seminal vesicle weights and 

a trend towards lower seminal vesicle weights to body weight ratio. 

- Lower uterus weight, lower uterus to body weight ratio (not statistically significant) 

Treatment with 450 mg/kg resulted in the following changes in organ weight which were considered to 

be related to treatment: 

- Lower terminal body weight in males and females. 

- Higher liver weights in females and higher liver to body weight ratio in males and females. 

- Higher adrenal gland weights and higher adrenal gland to body weight ratio in males and 

females (not statistically significant in females regarding the ratio) 

- Lower thymus weight and thymus to body weight ratio in males and females 

- Lower prostate weight and prostate to body weight ratio, seminal vesicles weight and seminal 

vesicles weight to body weight ratio. 

- Lower uterus weight and uterus to body weight ratio. 

Higher liver and kidney to body weight ratios were noted in males at 150 mg/kg. Lower thymus weight 

and thymus to body weight ratio was observed in females at 150 mg/kg. In the lack of any relevant 

corroborative findings at the microscopic examinations, these organ weight changes were considered 

to be without toxicological significance. 

The higher brain, heart, thyroid, kidney, testes and epididymides weight at 450 mg/kg was considered 

to be related to the lower terminal body weight and occurred in the absence of microscopic correlates. 

In addition, lower spleen weight in both sexes occurred without any corroborative findings. Therefore, 

these findings were considered not to be toxicologically relevant. 

7.4.3. Microscopic examination (see also APPENDIX 4)

Treatment resulted in the following microscopic findings in males or females starting at 50 mg/kg:

- Duodenum, hemorrhage was present in 4/5 male (4 minimal) and 3/5 female (3 minimal) rats at 

50 mg/kg, in 3/5 male (3 minimal) and 4/5 female (1 minimal, 3 slight) rats at 150 mg/kg and in 5/5 

male (2 minimal, 3 slight) and 4/5 female (2 minimal, 2 slight) rats treated at 450 mg/kg. 

- Duodenum, hypertrophy with villous stunting was present in 5/5 male (4 minimal, 1 slight) and 5/5 

female (2 minimal, 3 slight) rats treated at 50 mg/kg, in 5/5 male (5 slight) and 5/5 female (1 

minimal, 3 slight, 1 moderate) rats treated at 150 mg/kg and in 5/5 male (1 slight, 4 moderate) and 

5/5 female (4 slight, 1 moderate) rats treated at 450 mg/kg. This finding corresponded with the 

macroscopic finding wall thickened.

- Peyer’s patches, lymphoid atrophy was present in 1/5 female (1 slight) treated at 50 mg/kg, in 1/5 

male (1 slight) and 1/5 female (1 moderate) rats treated at 150 and in 3/5 male (2 minimal, 1 

slight) and 4/5 female (1 minimal, 3 slight) rats at 450 mg/kg. 

- Mesenteric lymph node, erythrophagocytosis was present in 1/5 male (slight) and 1/5 female 

(minimal) rats treated at 50 mg/kg, in 5/5 male (3 slight, 2 moderate) and 3/5 female (3 slight) rats 

at 150 mg/kg and in 5/5 male (5 moderate) and 5/5 female (3 slight, 2 moderate) rats at 450 

mg/kg. This finding correlated with the macroscopic finding discolouration reddish/dark red/purple. 

Treatment resulted in the following microscopic findings in males or females starting at 150 mg/kg:

- Stomach, ulcer forestomach was present in 2/5 male rat (1 slight, 1 moderate) treated at 150 

mg/kg and in 5/5 male (1 moderate, 4 marked) and 5/5 female (5 marked) rats at 450 mg/kg. This 

finding corresponded with the macroscopic finding forestomach discoloured focus/foci. 

- Stomach, hyperplasia forestomach was present at increased incidence and severity in 5/5 male 

(3 slight, 2 moderate) and 5/5 female (3 minimal, 1 slight, 1 moderate) rats treated at 150 mg/kg 

and in 5/5 male (2 slight, 3 moderate) and 5/5 female (4 moderate, 1 marked) rats at 450 mg/kg. 

This finding was present at a background incidence and severity in 1/5 male (minimal) 50 mg/kg 

treated. This finding corresponded with the macroscopic finding forestomach irregular surface. 

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- Jejunum, hypertrophy with villous stunting was present in 2/5 male (1 minimal, 1 slight) and 1/5 

female (1 minimal) rats at 150 mg/kg and in 5/5 male (3 slight, 2 moderate) and 5/5 female (1 

minimal, 4 slight) rats at 450 mg/kg. This finding corresponded with the macroscopic finding wall 

thickened.

- Mesenteric lymph node, lymphoid atrophy was present in 3/5 male (3 minimal) and 2/5 female (2 

minimal) rats treated at 150 mg/kg and in 5/5 male (1 minimal, 2 slight, 2 moderate) and 4/5 

female (2 minimal, 2 slight) rats at 450 mg/kg. 

- Mesenteric lymph node, increased mast cells were present in 5/5 male (3 slight, 2 moderate) 

and 3/5 female (3 slight) rats treated at 150 mg/kg and in 1/5 male (1 slight) and 2/5 female (2 

slight) rats at 450 mg/kg. 

- Uterus, cervix and vagina, atrophy was present in 2/5 female rats treated at 150 and 5/5 female 

rats at 450 mg/kg. 

- Liver, centrilobular hypertrophy was present in 1/5 female (minimal) at 150 mg/kg and in 5/5 

female (1 minimal, 4 slight) rats. 

Treatment resulted in the following microscopic findings in males or females at 450 mg/kg:

- Thymus, lymphoid atrophy was present in 5/5 male ( 1 minimal, 3 slight, 1 marked) and 5/5 

female (1 minimal, 2 slight, 2 moderate) rats. This finding corresponded with the macroscopic 

finding reduced in size. 

- Jejunum, hemorrhage was present in 3/5 male (2 minimal, 1 slight) and 3/5 female (3 slight) rats. 

- Spleen, lymphoid atrophy was present in 5/5 male (1 minimal, 4 slight) and 1/5 female (minimal) 

rats. 

- Adrenal glands, vacuolation zona fasciculata was present at increased incidence and severity in 

4/5 male (2 minimal, 2 slight) and 4/5 female (1 minimal, 3 slight) rats. This finding was present at 

a background incidence and severity in 1/5 male (minimal) at 50 mg/kg and 1/5 male (minimal) at 

150 mg/kg. This finding corresponded with the macroscopic finding discoloured.

- Femur including joint, decreased bone, secondary spongiosa was present in 5/5 male (2 slight, 

3 moderate) and 5/5 female (1 minimal, 3 slight, 1 moderate) rats. This was likely related to the 

emaciation. 

- Prostate gland, small with normal histology was present in 5/5 male rats. This finding 

corresponded with the macroscopic finding reduced in size. 

- Seminal vesicles, reduced contents was bilaterally present in 5/5 male (5 slight) rats and, as 

background finding, it was unilaterally present in 1/5 (moderate) control Group rat. This finding 

corresponded with the macroscopic finding reduced in size. 

- Coagulating glands, reduced contents was present in 5/5 male (5 slight) rats. 

In addition, there were microscopic findings in organs that were only sampled in animals which 

showed macroscopic findings at 50, 150 and 450 mg/kg: 

- Pancreatic lymph node, erythrophagocytosis was present in 1/5 female at 50 mg/kg (1 lymph 

node sampled), in 2/5 female and 1/5 male at 150 mg/kg (3 and 2 lymph nodes sampled 

respectively) treated rats. This correlated with the macroscopic finding discolouration reddish.

- Pancreatic lymph node, lymphoid hyperplasia was present 2/5 male and 3/5 female at 150 

mg/kg (2 and 3 lymph nodes sampled respectively) and in 3/5 male and 4/5 female at 450 mg/kg 

(3 and 4 lymph nodes sampled respectively) treated rats. This correlated with the macroscopic 

finding enlarged. 

- Renal lymph node, lymphoid hyperplasia was present 1/5 male and 1/5 female at 450 mg/kg 

(both 1 lymph node sampled) treated rats. This correlated with the macroscopic finding enlarged. 

All other microscopic findings recorded were considered to be within the normal range of background 

pathology encountered in rats of this age and strain. 

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8. DISCUSSION AND CONCLUSION 

Wistar rats were treated with m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline for 28 

consecutive days by daily oral gavage at dose levels of 50, 150 and 450 mg/kg. 

Formulation analyses confirmed that formulations of test substance in propylene glycol were prepared 

accurately and homogenously, and were stable over at least 6 hours. 

At 50 mg/kg, local gastro-intestinal tract findings were noted consisting of hemorrhage and 

hypertrophy with villous stunting in the duodenum in males and females. In addition, lymphoid atrophy 

in the Peyer’s patches and erythrophagocytosis and/or discolouration in the mesenteric and pancreatic 

lymph nodes was noted. 

At 150 mg/kg, during the in-life phase, hunched posture (with or without lethargy) was observed in all 

animals on two treatment days. 

Local effects in the gastro-intestinal tract consisted of hemorrhage in the duodenum, hypertrophy with 

villous stunting, gelatinous content and thickened wall in the duodenum and in the jejunum. In the 

stomach effects included ulcer, hyperplasia, foci and irregular surface of the forestomach. In addition, 

lymphoid atrophy in the Peyer’s patches, increased mast cells in the mesenteric lymph node, lymphoid 

hyperplasia of the pancreatic lymph node and erythrophagocytosis and/or discolouration in the 

mesenteric and pancreatic lymph nodes were noted. Centrilobular hypertrophy in the liver was noted 

in one female, although not correlating to higher liver weight or effects at the macroscopic 

examinations. Changes in the female reproductive organs consisted of atrophy of the uterus (with 

lower uterus weight), cervix and vagina.

Effects on blood parameters included higher bilirubin, potassium, cholesterol and bile acid levels in 

males and/or females. 

At 450 mg/kg, reduced body weight gain and food consumption, reduced motor activity and several 

symptoms indicative of ill health including lethargy, hunched posture, piloerection, pale faeces, lean 

appearance and ptosis were noted among all animals. All animals survived the scheduled study 

duration. 

Local effects in the gastro-intestinal tract consisted of hemorrhage and hypertrophy with villous 

stunting, gelatinous content and thickened wall in the duodenum and in the jejunum. In the stomach 

effects included ulcer, hyperplasia, foci and irregular surface of the forestomach. In addition, lymphoid 

atrophy in the Peyer’s patches, increased mast cells in the mesenteric lymph node, lymphoid 

hyperplasia of the pancreatic lymph node and erythrophagocytosis and/or discolouration in the 

mesenteric and pancreatic lymph nodes were noted. 

Changes in the reproductive organs consisted of atrophy in the uterus, cervix and vagina 

(macroscopically seen as reduced size and/or weight of ovaries and uterus), a small prostate gland 

(with normal histology), and reduced contents of the seminal vesicles and coagulating glands were 

noted. Macroscopically, a reduced size and weight of the prostate and seminal vesicles was observed. 

Other microscopic findings consisted of centrilobular hypertrophy in the liver (correlating to higher liver 

weight), discoloration of kidney, vacuolation of the zona fasciculata of the adrenal glands (with 

macroscopic discolouration, enlargement and increase in weight), and lymphoid hyperplasia of the 

renal lymph nodes (macroscopically supported by enlargement). 

Effects on blood parameters consisted of changes in red blood cell parameters, platelet counts and 

activated partial thromboplastin time, and higher bilirubin, cholesterol, potassium and bile acid levels, 

and lower albumin, creatinine, glucose, sodium and chloride levels in one or both sexes. 

The lower prostate and seminal vesicle weight observed at 50 and 150 mg/kg was slight in nature and 

had no microscopic correlate. As such they were considered not adverse at these dose levels. 

The shift in type of white blood cells (i.e. higher neutrophil counts with lower lymphocyte counts 

observed in males at 150 and 450 mg/kg and females at 50, 150 and 450 mg/kg) was considered to 

be related to the lymphoid atrophy in the thymus and spleen as recorded at 450 mg/kg. This lymphoid 

atrophy was considered to be a secondary non-specific response to stress associated with treatment. 

Therefore, the change in white blood cells may be considered not to be of primary toxicological 

significance. 

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CONCLUSION 

Based on the local effects in the gastrointestinal tract (duodenum, Peyer’s patches and lymph nodes), 

likely to be secondary effects due to the irritation potential of the test substance, starting at the lowest 

dose level of 50 mg/kg/day, a local No Observed Adverse Effect Level (NOAEL) could not be 

established in this study. 

The systemic NOAEL is considered to be 50 mg/kg/day, essentially based on atrophy of the female 

reproductive organs (uterus, cervix and vagina) observed at 150 mg/kg/day. 

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9. REFERENCES 

Ref. 1 C.W. Dunnett, A Multiple Comparison Procedure for Comparing Several Treatments 

with a Control, J. Amer. Stat. Assoc. 50, 1096-1121 (1955). 

Ref. 2 R.G. Miller, Simultaneous Statistical Inference, Springer Verlag, New York (1981). 

Ref. 3 R.A. Fisher, Statistical Methods for Research Workers, Oliver and Boyd, Edinburgh 

(1950). 

Ref. 4 Kruskal W.H. and Wallis W.A.. Use of ranks in one-criterion variance analysis. Journal 

of the American Statistical Association 47 (260): 583-621, December (1952). 

Ref. 5 Wilcoxon, F. Individual comparisons by ranking methods. Biometrics, 1, 80-83 (1945). 

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APPENDIX 1 

- Page 1 - 

APPENDIX 1 FIGURES AND SUMMARY TABLES 

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Project 501432

APPENDIX 1

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APPENDIX 1

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APPENDIX 1

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APPENDIX 1

CLINICAL SIGNS SUMMARY 

.: Observation performed, sign not present 

%: Percent of affected animals (0=less than 5%, 1=between 5% and 15%,..., A=more than 95%) 

G: Median value of the highest individual daily grades 

MALES 

TREATMENT 

SIGN (MAX. GRADE) 

(LOCATION) 

WEEK: 

DAY: 

1 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

4 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

GROUP 1 (CONTROL) 

No clinical signs noted 

GROUP 2 (50 MG/KG) 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . . 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

 %: . . . . . . . . . . . 2 A A A A A A A A A A A A A A A A 

GROUP 3 (150 MG/KG) 

Posture 

Hunched posture (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

 %: . . . . . . . . . . . . A A . . . . . . . . . . . . . . 

Skin / fur 

Piloerection (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

 %: . . . . . . . . . . . . 2 2 . . . . . . . . . . . . . . 

Secretion / excretion 

Salivation (3) G: . . . 1 1 1 1 1 1 1 1 1 2 2 1 1 1 2 2 2 2 2 2 2 2 2 2 2 

 %: . . . 2 6 6 4 4 4 6 6 6 A A A A A A A A A A A A A A A A 

GROUP 4 (450 MG/KG) 

Behavior 

Lethargy (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

 %: . . . . . . . . . . . . . 8 . . . . . . . . . . . . . . 

Posture 

Hunched posture (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

 %: . . . . . . A A A A A A A A A A A A A A A A A A A A A A 

Skin / fur 

Piloerection (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

 %: . . . . . . 4 A A A A A A A A A A A A 8 A A A A A A A A 

Secretion / excretion 

Salivation (3) G: . . . 1 1 1 1 1 1 1 1 2 2 2 1 1 2 2 3 3 3 3 3 3 3 3 3 3 

 %: . . . 8 A A A A A A A A A A A A A A A A A A A A A A A A 

Faeces pale (1) G: . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

 %: . . . . . . . . . . 6 8 A A A A A A A A A A A A A A A A 

Various 

Lean (1) G: . . . . . . . . . . . . . . . . . . . . . . . 1 1 1 1 1 

 %: . . . . . . . . . . . . . . . . . . . . . . . 2 2 2 2 A 

Ptosis (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

 %: . . . . . . . . . . . . . A . . . . . . . . . . . . . . 

FEMALES 

TREATMENT 

SIGN (MAX. GRADE) 

(LOCATION) 

WEEK: 

DAY: 

1 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

4 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

GROUP 1 (CONTROL) 

No clinical signs noted 

GROUP 2 (50 MG/KG) 

Breathing 

Rales (3) G: . . . . . . . . . . . . . . . . . . 1 1 . . . . . . . . 

 %: . . . . . . . . . . . . . . . . . . 2 2 . . . . . . . . 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . . 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

 %: . . . . . . . . . . . 6 A A A A A A A A A A A A A A A A 

− Page 6 − 08Feb13 15h00 

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APPENDIX 1

CLINICAL SIGNS SUMMARY 

.: Observation performed, sign not present 

%: Percent of affected animals (0=less than 5%, 1=between 5% and 15%,..., A=more than 95%) 

G: Median value of the highest individual daily grades 

FEMALES 

TREATMENT 

SIGN (MAX. GRADE) 

(LOCATION) 

WEEK: 

DAY: 

1 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

4 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

GROUP 3 (150 MG/KG) 

Posture 

Hunched posture (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

 %: . . . . . . . . . . . . A A . . . . . . . . . . . . . . 

Breathing 

Rales (3) G: . . . . . . . . . . . . . . . . . . 1 . . . . . . . . . 

 %: . . . . . . . . . . . . . . . . . . 2 . . . . . . . . . 

Skin / fur 

Scabs (3) G: . . . . . . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 . . . 

(Shoulder right) %: . . . . . . . . . . . . . . . . 2 2 2 2 2 2 2 2 2 . . . 

Secretion / excretion 

Salivation (3) G: . . . . 1 1 1 1 1 1 1 1 2 2 1 1 1 2 2 2 2 2 2 2 2 2 2 2 

 %: . . . . 4 6 2 2 2 2 4 4 A A A A A A A A A A A A A A A A 

GROUP 4 (450 MG/KG) 

Behavior 

Lethargy (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

 %: . . . . . . . . . . . . . A . . . . . . . . . . . . . . 

Posture 

Hunched posture (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

 %: . . . . . . 8 8 A A A A A A A A A A A A A A A A A A A A 

Breathing 

Rales (3) G: . . . . . . . . . . . . . . . . . . . . . . . . 1 1 1 . 

 %: . . . . . . . . . . . . . . . . . . . . . . . . 2 2 2 . 

Skin / fur 

Piloerection (1) G: . . . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

 %: . . . . . . . . . . . . . A A A A A A A 2 2 2 2 2 6 6 8 

Secretion / excretion 

Salivation (3) G: . . . 1 1 1 1 1 1 1 1 2 2 2 1 1 2 2 3 3 3 3 3 3 3 3 3 3 

 %: . . . A A A A A A A A A A A A A A A A A A A A A A A A A 

Chromodacryorrhoea (3) G: . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

(Snout) %: . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 

Faeces pale (1) G: . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

 %: . . . . . . . . . . 8 A A A A A A A A A A A A A A A A A 

Various 

Lean (1) G: . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 1 

 %: . . . . . . . . . . . . . . . . . . . . . . . . . 4 4 A 

Ptosis (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

 %: . . . . . . . . . . . . . A . . . . . . . . . . . . . . 

− Page 7 − 08Feb13 15h00 

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APPENDIX 1

FUNCTIONAL OBSERVATIONS SUMMARY 

+/++ Steel−test significant at 5% (+) or 1% (++) level 

MALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

AT WEEK4 

HEARING MEDIAN 0 0 0 0 

SCORE 0/1 N 5 5 5 5 

 

PUPIL L MEDIAN 0 0 0 0 

SCORE 0/1 N 5 5 5 5 

PUPIL R MEDIAN 0 0 0 0 

SCORE 0/1 N 5 5 5 5 

STATIC R MEDIAN 0 0 0 0 

SCORE 0/1 N 5 5 5 5 

GRIP MEDIAN 0 0 0 0 

SCORE 0/1 N 5 5 5 5 

FEMALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

AT WEEK4 

HEARING MEDIAN 0 0 0 0 

SCORE 0/1 N 5 5 5 5 

 

PUPIL L MEDIAN 0 0 0 0 

SCORE 0/1 N 5 5 5 5 

PUPIL R MEDIAN 0 0 0 0 

SCORE 0/1 N 5 5 5 5 

STATIC R MEDIAN 0 0 0 0 

SCORE 0/1 N 5 5 5 5 

GRIP MEDIAN 0 0 0 0 

SCORE 0/1 N 5 5 5 5 

− Page 8 − 08Feb13 15h00 

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- Page 9 - 

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APPENDIX 1

MOTOR ACTIVITY TEST SUMMARY

MALES

AT WEEK 4

GROUP 1

CONTROL

Total Movements MEAN1 2991 4012 3697 1201*

ST.DEV 992 1159 1695 417

N 5 5 5 5

Ambulations MEAN1 625 903 852 338

ST.DEV 249 249 306 126

N 5 5 5 5

*/** Wilcoxon test significant at 5% (*) or 1% (**) level 

1

 Group mean of all intervals combined

2

 Mean counts per interval.

GROUP 2

50 MG/KG

GROUP 3

150 MG/KG

GROUP 4

450 MG/KG

0

200

400

600

800

1000

1200

1400

1600

1800

1 2 3 4 5 6 7 8 9 10 11 12

Counts

Interval (5 min)

Total Movements Males2 

Group 1

Group 2

Group 3

Group 4

0

50

100

150

200

250

300

350

400

450

1 2 3 4 5 6 7 8 9 10 11 12

Counts

Interval (5 min)

Ambulations Males2 

Group 1

Group 2

Group 3

Group 4

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APPENDIX 1

MOTOR ACTIVITY TEST SUMMARY

FEMALES

WEEK 4 

GROUP 1

CONTROL

MEAN1 5171 5394 4343 1228*

ST.DEV 1246 1104 1568 512

N 5 5 5 5

Ambulations MEAN1 1345 1609 1313 390*

ST.DEV 311 406 505 196

N 5 5 5 5

*/** Wilcoxon test significant at 5% (*) or 1% (**) level 

1

 Group mean of all intervals combined

2

 Mean counts per interval.

Total Movements

GROUP 2

50 MG/KG

GROUP 3

150 MG/KG

GROUP 4

450 MG/KG

0

200

400

600

800

1000

1200

1400

1600

1800

1 2 3 4 5 6 7 8 9 10 11 12

Counts

Interval (5 min)

Total Movements Females2 

Group 1

Group 2

Group 3

Group 4

0

100

200

300

400

500

600

700

1 2 3 4 5 6 7 8 9 10 11 12

Counts

Interval (5 min)

Ambulations Females2 

Group 1

Group 2

Group 3

Group 4

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 33 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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APPENDIX 1

BODY WEIGHTS (GRAM) SUMMARY 

*/** Dunnett−test based on pooled variance significant at 5% (*) or 1% (**) level 

MALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

TREATMENT 

DAY 1 MEAN 171 168 170 165 

WEEK 1 ST.DEV 5.1 9.6 8.1 9.6 

 N 5 5 5 5 

 

DAY 8 MEAN 213 206 201 166 ** 

WEEK 2 ST.DEV 6.6 14.8 11.6 17.4 

 N 5 5 5 5 

DAY 15 MEAN 253 240 236 179 ** 

WEEK 3 ST.DEV 9.3 19.5 15.2 21.2 

 N 5 5 5 5 

DAY 22 MEAN 284 265 264 187 ** 

WEEK 4 ST.DEV 14.0 28.6 15.3 21.0 

 N 5 5 5 5 

DAY 28 MEAN 305 281 276 187 ** 

WEEK 4 ST.DEV 14.4 32.9 15.2 20.7 

 N 5 5 5 5 

FEMALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

TREATMENT 

DAY 1 MEAN 134 135 138 134 

WEEK 1 ST.DEV 5.6 6.5 7.3 6.7 

 N 5 5 5 5 

 

DAY 8 MEAN 150 155 154 139 

WEEK 2 ST.DEV 9.9 8.6 8.6 3.8 

 N 5 5 5 5 

DAY 15 MEAN 171 170 174 149 ** 

WEEK 3 ST.DEV 11.4 6.8 7.3 1.8 

 N 5 5 5 5 

DAY 22 MEAN 182 183 188 158 ** 

WEEK 4 ST.DEV 6.9 7.6 12.1 9.3 

 N 5 5 5 5 

DAY 28 MEAN 192 192 192 151 ** 

WEEK 4 ST.DEV 14.9 11.8 7.8 14.6 

 N 5 5 5 5 

− Page 11 − 08Feb13 15h07 

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APPENDIX 1

BODY WEIGHT GAIN (%) SUMMARY 

*/** Dunnett−test based on pooled variance significant at 5% (*) or 1% (**) level 

MALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

TREATMENT 

DAY 1 MEAN 0 0 0 0 

WEEK 1 ST.DEV 0.0 0.0 0.0 0.0 

 N 5 5 5 5 

 

DAY 8 MEAN 24 23 18 * 0 ** 

WEEK 2 ST.DEV 2.0 3.2 1.4 5.6 

 N 5 5 5 5 

DAY 15 MEAN 48 43 39 * 8 ** 

WEEK 3 ST.DEV 3.2 5.9 4.5 7.8 

 N 5 5 5 5 

DAY 22 MEAN 66 58 55 13 ** 

WEEK 4 ST.DEV 5.3 10.6 6.0 7.9 

 N 5 5 5 5 

DAY 28 MEAN 78 67 63 * 13 ** 

WEEK 4 ST.DEV 5.9 12.5 6.7 8.1 

 N 5 5 5 5 

FEMALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

TREATMENT 

DAY 1 MEAN 0 0 0 0 

WEEK 1 ST.DEV 0.0 0.0 0.0 0.0 

 N 5 5 5 5 

 

DAY 8 MEAN 11 15 11 4 ** 

WEEK 2 ST.DEV 3.1 2.5 1.0 4.0 

 N 5 5 5 5 

DAY 15 MEAN 28 25 26 12 ** 

WEEK 3 ST.DEV 4.9 3.7 3.0 6.1 

 N 5 5 5 5 

DAY 22 MEAN 36 35 36 18 ** 

WEEK 4 ST.DEV 1.0 4.4 3.4 11.3 

 N 5 5 5 5 

DAY 28 MEAN 43 41 39 13 ** 

WEEK 4 ST.DEV 5.7 5.0 3.3 15.1 

 N 5 5 5 5 

− Page 12 − 08Feb13 15h07 

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APPENDIX 1

FOOD CONSUMPTION (G/ANIMAL/DAY) SUMMARY 

MALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

TREATMENT 

DAYS 1−8 MEAN 19 18 17 11 

WEEKS 1−2 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

 

DAYS 8−15 MEAN 21 20 20 11 

WEEKS 2−3 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

 

DAYS 15−22 MEAN 21 21 21 12 

WEEKS 3−4 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

 

DAYS 22−28 MEAN 22 21 21 12 

WEEK 4 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

MEAN OF MEANS 

OVER TREATMENT MEAN 21 20 20 11 

FEMALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

TREATMENT 

DAYS 1−8 MEAN 14 14 13 10 

WEEKS 1−2 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

 

DAYS 8−15 MEAN 15 14 14 10 

WEEKS 2−3 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

 

DAYS 15−22 MEAN 14 14 14 11 

WEEKS 3−4 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

 

DAYS 22−28 MEAN 15 16 13 10 

WEEK 4 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

MEAN OF MEANS 

OVER TREATMENT MEAN 14 15 14 10 

− Page 13 − 08Feb13 15h07 

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APPENDIX 1

RELATIVE FOOD CONSUMPTION (G/KG BODY WEIGHT/DAY) SUMMARY 

MALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

TREATMENT 

DAYS 1−8 MEAN 90 87 86 65 

WEEKS 1−2 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

 

DAYS 8−15 MEAN 83 82 83 59 

WEEKS 2−3 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

 

DAYS 15−22 MEAN 75 78 78 64 

WEEKS 3−4 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

 

DAYS 22−28 MEAN 72 75 76 64 

WEEK 4 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

MEAN OF MEANS 

OVER TREATMENT MEAN 80 80 81 63 

FEMALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

TREATMENT 

DAYS 1−8 MEAN 92 91 85 73 

WEEKS 1−2 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

 

DAYS 8−15 MEAN 86 83 80 65 

WEEKS 2−3 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

 

DAYS 15−22 MEAN 79 79 75 68 

WEEKS 3−4 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

 

DAYS 22−28 MEAN 76 81 70 65 

WEEK 4 ST.DEV −−− −−− −−− −−−

 N (CAGE) 1 1 1 1 

MEAN OF MEANS 

OVER TREATMENT MEAN 83 83 78 68 

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APPENDIX 1

HAEMATOLOGY SUMMARY 

*/** Dunnett−test based on pooled variance significant at 5% (*) or 1% (**) level 

+/++ Steel−test significant at 5% (+) or 1% (++) level 

MALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

END OF TREATMENT 

WBC MEAN 8.1 7.6 9.3 9.5 

10E9/L ST.DEV 1.8 0.8 2.1 2.8 

 N 5 5 5 5 

 

Neutrophils MEAN 11.2 12.2 30.4 + 76.2 + 

%WBC ST.DEV 1.9 3.1 8.7 12.6 

 N 5 5 5 5 

Lymphocytes MEAN 85.7 85.0 66.0 + 20.4 + 

%WBC ST.DEV 2.1 3.5 8.7 11.0 

 N 5 5 5 5 

Monocytes MEAN 2.0 1.7 2.9 3.0 

%WBC ST.DEV 0.1 0.4 0.6 1.4 

 N 5 5 5 5 

Eosinophils MEAN 0.8 0.8 0.6 0.3 

%WBC ST.DEV 0.2 0.3 0.1 0.3 

 N 5 5 5 5 

Basophils MEAN 0.2 0.3 0.2 0.1 

%WBC ST.DEV 0.1 0.1 0.1 0.1 

 N 5 5 5 5 

Red blood cells MEAN 8.13 8.38 7.88 6.77 ** 

10E12/L ST.DEV 0.30 0.27 0.28 0.34 

 N 5 5 5 5 

Reticulocytes MEAN 2.5 2.4 2.4 7.4 + 

%RBC ST.DEV 0.2 0.5 0.6 0.9 

 N 5 5 5 5 

RDW MEAN 11.7 11.4 11.7 14.2 ** 

% ST.DEV 1.1 0.5 1.4 0.9 

 N 5 5 5 5 

Haemoglobin MEAN 9.7 9.9 9.2 7.8 ** 

mmol/L ST.DEV 0.1 0.3 0.4 0.8 

 N 5 5 5 5 

Haematocrit MEAN 0.435 0.446 0.421 0.362 ** 

L/L ST.DEV 0.009 0.016 0.021 0.033 

 N 5 5 5 5 

MCV MEAN 53.6 53.2 53.5 53.4 

fL ST.DEV 2.3 0.7 1.6 3.0 

 N 5 5 5 5 

MCH MEAN 1.19 1.18 1.17 1.15 

fmol ST.DEV 0.05 0.03 0.03 0.07 

 N 5 5 5 5 

MCHC MEAN 22.20 22.10 21.92 21.56 

mmol/L ST.DEV 0.58 0.40 0.61 0.26 

 N 5 5 5 5 

Platelets MEAN 904 934 991 1441 ** 

10E9/L ST.DEV 56 103 142 290 

 N 5 5 5 5 

PT MEAN 17.3 16.4 16.8 17.8 

s ST.DEV 0.7 0.8 0.9 1.1 

 N 5 5 5 5 

APTT MEAN 15.1 15.1 16.5 12.0 

s ST.DEV 2.7 2.1 2.6 2.6 

 N 5 5 5 5 

− Page 15 − 08Feb13 15h07 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 38 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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Project 501432

APPENDIX 1

HAEMATOLOGY SUMMARY 

*/** Dunnett−test based on pooled variance significant at 5% (*) or 1% (**) level 

+/++ Steel−test significant at 5% (+) or 1% (++) level 

FEMALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

END OF TREATMENT 

WBC MEAN 4.5 4.9 5.7 6.5 

10E9/L ST.DEV 1.2 1.8 1.7 1.4 

 N 4 5 5 5 

 

Neutrophils MEAN 8.8 13.7 + 19.5 + 68.9 + 

%WBC ST.DEV 1.6 3.8 6.0 7.9 

 N 4 5 5 5 

Lymphocytes MEAN 88.4 83.2 76.4 26.8 

%WBC ST.DEV 2.2 3.9 6.2 7.8 

 N 4 5 5 5 

Monocytes MEAN 1.6 1.7 2.7 3.7 + 

%WBC ST.DEV 0.4 0.6 0.8 0.3 

 N 4 5 5 5 

Eosinophils MEAN 1.1 1.2 1.2 0.5 

%WBC ST.DEV 0.2 0.2 0.4 0.3 

 N 4 5 5 5 

Basophils MEAN 0.1 0.1 0.1 0.0 

%WBC ST.DEV 0.1 0.1 0.1 0.1 

 N 4 5 5 5 

Red blood cells MEAN 7.75 7.71 8.29 6.54 ** 

10E12/L ST.DEV 0.25 0.21 0.31 0.78 

 N 4 5 5 5 

Reticulocytes MEAN 2.0 2.3 2.1 6.6 + 

%RBC ST.DEV 0.4 0.4 0.9 1.4 

 N 4 5 5 5 

RDW MEAN 13.4 10.7 11.3 13.3 

% ST.DEV 6.2 0.4 1.5 0.5 

 N 4 5 5 5 

Haemoglobin MEAN 9.1 9.0 9.4 7.6 ** 

mmol/L ST.DEV 0.4 0.2 0.4 0.9 

 N 4 5 5 5 

Haematocrit MEAN 0.405 0.401 0.425 0.358 

L/L ST.DEV 0.008 0.011 0.024 0.046 

 N 4 5 5 5 

MCV MEAN 52.3 51.9 51.2 54.6 

fL ST.DEV 2.6 0.8 1.5 1.7 

 N 4 5 5 5 

MCH MEAN 1.18 1.16 1.13 1.16 

fmol ST.DEV 0.08 0.02 0.02 0.03 

 N 4 5 5 5 

MCHC MEAN 22.49 22.41 22.08 21.18 ** 

mmol/L ST.DEV 0.49 0.18 0.36 0.26 

 N 4 5 5 5 

Platelets MEAN 946 881 1050 1311 * 

10E9/L ST.DEV 169 114 113 228 

 N 4 5 5 5 

PT MEAN 16.7 16.2 16.4 16.8 

s ST.DEV 0.7 0.5 0.7 1.0 

 N 5 5 5 4 

APTT MEAN 15.7 15.2 13.6 12.4 ** 

s ST.DEV 0.8 1.2 1.8 0.8 

 N 5 5 5 4 

− Page 16 − 08Feb13 15h07 

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APPENDIX 1

CLINICAL BIOCHEMISTRY SUMMARY 

*/** Dunnett−test based on pooled variance significant at 5% (*) or 1% (**) level 

MALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

END OF TREATMENT 

ALAT MEAN 43.3 39.6 73.9 * 50.9 

U/L ST.DEV 10.1 9.7 19.3 23.4 

 N 5 5 5 5 

 

ASAT MEAN 76.6 77.1 90.6 73.7 

U/L ST.DEV 6.5 6.3 20.3 10.1 

 N 5 5 5 5 

ALP MEAN 197 189 175 136 

U/L ST.DEV 51 68 33 48 

 N 5 5 5 5 

Total protein MEAN 64.2 63.7 61.3 63.4 

g/L ST.DEV 2.5 1.1 2.0 2.4 

 N 5 5 5 5 

Albumin MEAN 32.8 32.7 31.2 29.6 ** 

g/L ST.DEV 1.3 0.7 1.0 1.2 

 N 5 5 5 5 

Total bilirubin MEAN 2.6 2.4 3.4 4.4 ** 

umol/L ST.DEV 0.2 0.2 0.7 0.9 

 N 5 5 5 5 

Urea MEAN 8.4 6.3 8.2 8.3 

mmol/L ST.DEV 1.8 1.0 0.8 1.4 

 N 5 5 5 5 

Creatinine MEAN 37.2 35.0 35.9 32.8 ** 

umol/L ST.DEV 2.6 1.1 1.0 2.4 

 N 5 5 5 5 

Glucose MEAN 7.55 8.21 7.62 5.72 ** 

mmol/L ST.DEV 0.80 0.67 1.00 0.32 

 N 5 5 5 5 

Cholesterol MEAN 2.01 2.04 2.07 3.23 ** 

mmol/L ST.DEV 0.22 0.21 0.31 0.45 

 N 5 5 5 5 

Bile Acids MEAN 41.4 23.7 51.9 111.8 * 

umol/L ST.DEV 16.1 13.9 7.7 68.2 

 N 5 5 5 5 

Sodium MEAN 142.0 141.4 141.8 140.2 * 

mmol/L ST.DEV 0.6 1.1 0.6 1.7 

 N 5 5 5 5 

Potassium MEAN 4.15 4.18 4.61 * 4.10 

mmol/L ST.DEV 0.20 0.25 0.28 0.31 

 N 5 5 5 5 

Chloride MEAN 100 101 101 97 ** 

mmol/L ST.DEV 1 1 2 2 

 N 5 5 5 5 

Calcium MEAN 2.74 2.72 2.73 2.70 

mmol/L ST.DEV 0.05 0.04 0.03 0.04 

 N 5 5 5 5 

Inorg.Phos MEAN 2.55 2.35 2.36 2.71 

mmol/L ST.DEV 0.17 0.13 0.22 0.31 

 N 5 5 5 5 

− Page 17 − 08Feb13 15h07 

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Project 501432

APPENDIX 1

CLINICAL BIOCHEMISTRY SUMMARY 

*/** Dunnett−test based on pooled variance significant at 5% (*) or 1% (**) level 

FEMALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

END OF TREATMENT 

ALAT MEAN 41.6 37.3 56.8 46.5 

U/L ST.DEV 7.8 7.0 22.8 11.3 

 N 5 5 5 5 

 

ASAT MEAN 96.4 71.9 82.2 77.3 

U/L ST.DEV 24.1 5.3 11.7 13.0 

 N 5 5 5 5 

ALP MEAN 107 100 107 81 

U/L ST.DEV 21 27 40 16 

 N 5 5 5 5 

Total protein MEAN 64.2 66.3 62.8 61.1 

g/L ST.DEV 2.7 4.3 1.6 2.8 

 N 5 5 5 5 

Albumin MEAN 34.7 35.6 33.4 29.4 ** 

g/L ST.DEV 1.8 2.0 0.3 1.4 

 N 5 5 5 5 

Total bilirubin MEAN 2.4 2.4 3.5 ** 3.4 * 

umol/L ST.DEV 0.3 0.3 0.8 0.4 

 N 5 5 5 5 

Urea MEAN 8.2 8.0 9.7 8.0 

mmol/L ST.DEV 0.4 1.0 1.7 1.6 

 N 5 5 5 5 

Creatinine MEAN 38.2 38.2 39.8 33.6 * 

umol/L ST.DEV 1.6 2.2 1.8 3.4 

 N 5 5 5 5 

Glucose MEAN 6.83 6.09 7.28 5.93 

mmol/L ST.DEV 0.59 0.72 0.72 1.03 

 N 5 5 5 5 

Cholesterol MEAN 1.11 1.63 2.01 * 2.57 ** 

mmol/L ST.DEV 0.30 0.42 0.75 0.09 

 N 5 5 5 5 

Bile Acids MEAN 22.4 18.4 71.8 70.7 

umol/L ST.DEV 8.2 8.9 59.0 51.8 

 N 5 5 5 5 

Sodium MEAN 140.9 142.2 141.6 140.9 

mmol/L ST.DEV 0.8 1.1 1.7 1.6 

 N 5 5 5 5 

Potassium MEAN 3.82 3.67 4.17 * 4.13 

mmol/L ST.DEV 0.20 0.19 0.10 0.26 

 N 5 5 5 5 

Chloride MEAN 102 104 101 99 ** 

mmol/L ST.DEV 1 1 1 1 

 N 5 5 5 5 

Calcium MEAN 2.66 2.70 2.72 2.70 

mmol/L ST.DEV 0.05 0.11 0.03 0.10 

 N 5 5 5 5 

Inorg.Phos MEAN 2.21 2.00 2.24 2.45 

mmol/L ST.DEV 0.26 0.18 0.25 0.49 

 N 5 5 5 5 

− Page 18 − 08Feb13 15h07 

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Project 501432

APPENDIX 1

MACROSCOPIC FINDINGS SUMMARY 

# / ## Fisher's Exact test significant at 5% (#) or 1% (##) level 

MALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

END OF TREATMENT 

Animals examined 5 5 5 5 

Animals without findings 3 5 0 0 

 

Animals affected 2 0 5 5 

General observations 

Emaciated 0 0 0 4 # 

Stomach 

Focus/foci 0 0 1 0 

Grown together with: 0 0 0 1 

Irregular surface 0 0 5 ## 4 # 

Duodenum 

Focus/foci 0 0 1 0 

Thickened 0 0 3 4 # 

Contents: 0 0 0 1 

Gelatinous 0 0 3 3 

Jejunum 

Thickened 0 0 2 4 # 

Gelatinous 0 0 2 4 # 

Liver 

Reduced in size 0 0 1 0 

Kidneys 

Pelvic dilation 0 0 1 0 

Focus/foci 0 0 1 0 

Discolouration 0 0 0 5 ## 

Epididymides 

Nodule(s) 1 0 0 0 

Prostate 

Reduced in size 0 0 0 5 ## 

Seminal vesicles 

Reduced in size 1 0 0 5 # 

Adrenal glands 

Discolouration 0 0 0 4 # 

Thymus 

Reduced in size 0 0 0 5 ## 

Mesenteric lymph n 

Discolouration 0 0 4 # 5 ## 

Mandibular lymph n 

Discolouration 0 0 1 0 

Renal lymph node 

Enlarged 0 0 0 1 

Pancreatic lymph n 

Enlarged 0 0 2 3 

Discolouration 0 0 1 0 

FEMALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

END OF TREATMENT 

Animals examined 5 5 5 5 

Animals without findings 3 3 0 0 

 

Animals affected 2 2 5 5 

General observations 

Emaciated 0 0 0 5 ## 

− Page 19 − 08Feb13 15h07 

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Project 501432

APPENDIX 1

MACROSCOPIC FINDINGS SUMMARY 

# / ## Fisher's Exact test significant at 5% (#) or 1% (##) level 

FEMALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

END OF TREATMENT 

Stomach 

Focus/foci 0 0 0 3 

Grown together with: 0 0 0 1 

Irregular surface 0 0 3 5 ## 

Duodenum 

Thickened 0 0 3 3 

Contents: 0 0 0 3 

Dilation 0 0 0 1 

Gelatinous 0 0 2 1 

Jejunum 

Thickened 0 0 2 3 

Contains fluid 0 0 0 1 

Contents: 0 0 0 2 

Dilation 0 0 0 1 

Gelatinous 0 0 1 2 

Liver 

Focus/foci 0 0 1 0 

Kidneys 

Pelvic dilation 0 0 0 1 

Discolouration 0 0 0 5 ## 

Ovaries 

Reduced in size 0 0 0 3 

Uterus 

Reduced in size 0 0 1 5 ## 

Contains fluid 2 1 0 0 

Adrenal glands 

Enlarged 0 0 0 1 

Discolouration 0 0 1 4 # 

Thymus 

Reduced in size 0 0 0 4 # 

Mesenteric lymph n 

Discolouration 0 0 2 4 # 

Renal lymph node 

Enlarged 0 0 0 1 

Discolouration 0 0 0 1 

Pancreatic lymph n 

Enlarged 0 0 1 4 # 

Discolouration 0 1 2 0 

− Page 20 − 08Feb13 15h07 

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Project 501432

APPENDIX 1

ORGAN WEIGHTS (GRAM) SUMMARY 

*/** Dunnett−test based on pooled variance significant at 5% (*) or 1% (**) level 

MALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

END OF TREATMENT 

BODY W. MEAN 285 260 257 170 ** 

(GRAM) ST.DEV 13 30 16 20 

 N 5 5 5 5 

 

BRAIN MEAN 2.05 1.95 1.99 1.78 ** 

(GRAM) ST.DEV 0.11 0.11 0.06 0.08 

 N 5 5 5 5 

HEART MEAN 0.869 0.782 0.793 0.585 ** 

(GRAM) ST.DEV 0.052 0.058 0.074 0.087 

 N 5 5 5 5 

LIVER MEAN 8.53 8.02 8.47 7.25 

(GRAM) ST.DEV 0.66 1.11 0.56 0.72 

 N 5 5 5 5 

THYROIDS MEAN 0.024 0.023 0.023 0.019 

(GRAM) ST.DEV 0.002 0.003 0.002 0.004 

 N 5 5 5 5 

THYMUS MEAN 0.529 0.417 0.403 0.081 ** 

(GRAM) ST.DEV 0.067 0.070 0.108 0.065 

 N 5 5 5 5 

KIDNEYS MEAN 2.25 2.16 2.25 1.78 ** 

(GRAM) ST.DEV 0.23 0.22 0.16 0.17 

 N 5 5 5 5 

ADRENALS MEAN 0.058 0.056 0.058 0.078 ** 

(GRAM) ST.DEV 0.008 0.002 0.005 0.012 

 N 5 5 5 5 

SPLEEN MEAN 0.573 0.511 0.484 0.335 ** 

(GRAM) ST.DEV 0.035 0.086 0.034 0.059 

 N 5 5 5 5 

TESTES MEAN 3.04 3.20 3.16 2.61 * 

(GRAM) ST.DEV 0.14 0.17 0.37 0.24 

 N 5 5 5 5 

PROSTATE MEAN 0.529 0.353 * 0.305 ** 0.182 ** 

(GRAM) ST.DEV 0.146 0.062 0.061 0.046 

 N 5 5 5 5 

EPIDIDYMIDES MEAN 0.751 0.747 0.733 0.597 ** 

(GRAM) ST.DEV 0.038 0.065 0.035 0.035 

 N 5 5 5 5 

SEMINAL VES MEAN 0.990 0.797 0.685 ** 0.265 ** 

(GRAM) ST.DEV 0.151 0.109 0.112 0.151 

 N 5 5 5 5 

− Page 21 − 08Feb13 15h07 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 44 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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Project 501432

APPENDIX 1

ORGAN/BODY WEIGHT RATIOS (%) SUMMARY 

*/** Dunnett−test based on pooled variance significant at 5% (*) or 1% (**) level 

MALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

END OF TREATMENT 

BODY W. MEAN 285 260 257 170 ** 

(GRAM) ST.DEV 13 30 16 20 

 N 5 5 5 5 

 

BRAIN MEAN 0.72 0.76 0.78 1.06 ** 

(%) ST.DEV 0.01 0.08 0.05 0.12 

 N 5 5 5 5 

HEART MEAN 0.305 0.302 0.308 0.343 * 

(%) ST.DEV 0.017 0.019 0.013 0.021 

 N 5 5 5 5 

LIVER MEAN 2.99 3.07 3.29 * 4.27 ** 

(%) ST.DEV 0.10 0.09 0.19 0.26 

 N 5 5 5 5 

THYROIDS MEAN 0.008 0.009 0.009 0.011 ** 

(%) ST.DEV 0.001 0.001 0.001 0.002 

 N 5 5 5 5 

THYMUS MEAN 0.186 0.160 0.156 0.046 ** 

(%) ST.DEV 0.022 0.011 0.033 0.031 

 N 5 5 5 5 

KIDNEYS MEAN 0.79 0.83 0.87 * 1.05 ** 

(%) ST.DEV 0.06 0.05 0.03 0.04 

 N 5 5 5 5 

ADRENALS MEAN 0.020 0.022 0.023 0.046 ** 

(%) ST.DEV 0.003 0.003 0.003 0.007 

 N 5 5 5 5 

SPLEEN MEAN 0.202 0.195 0.188 0.196 

(%) ST.DEV 0.016 0.015 0.013 0.017 

 N 5 5 5 5 

TESTES MEAN 1.07 1.24 1.23 1.54 ** 

(%) ST.DEV 0.05 0.12 0.18 0.19 

 N 5 5 5 5 

PROSTATE MEAN 0.185 0.138 0.119 * 0.106 ** 

(%) ST.DEV 0.049 0.032 0.025 0.024 

 N 5 5 5 5 

EPIDIDYMIDES MEAN 0.264 0.289 0.286 0.353 ** 

(%) ST.DEV 0.023 0.027 0.024 0.028 

 N 5 5 5 5 

SEMINAL VES MEAN 0.349 0.309 0.267 0.152 ** 

(%) ST.DEV 0.061 0.053 0.048 0.077 

 N 5 5 5 5 

− Page 22 − 08Feb13 15h07 

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APPENDIX 1

ORGAN WEIGHTS (GRAM) SUMMARY 

*/** Dunnett−test based on pooled variance significant at 5% (*) or 1% (**) level 

FEMALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

END OF TREATMENT 

BODY W. MEAN 176 179 176 138 ** 

(GRAM) ST.DEV 11 1 9 13 

 N 5 2 5 5 

 

BRAIN MEAN 1.85 1.82 1.87 1.77 

(GRAM) ST.DEV 0.05 0.08 0.06 0.07 

 N 5 5 5 5 

HEART MEAN 0.573 0.601 0.589 0.518 

(GRAM) ST.DEV 0.082 0.025 0.101 0.081 

 N 5 5 5 5 

LIVER MEAN 5.02 5.45 5.59 6.12 ** 

(GRAM) ST.DEV 0.45 0.17 0.59 0.39 

 N 5 5 5 5 

THYROIDS MEAN 0.022 0.021 0.023 0.022 

(GRAM) ST.DEV 0.004 0.002 0.004 0.004 

 N 5 5 5 5 

THYMUS MEAN 0.443 0.397 0.329 * 0.093 ** 

(GRAM) ST.DEV 0.060 0.079 0.057 0.037 

 N 5 5 5 4 

KIDNEYS MEAN 1.48 1.49 1.51 1.48 

(GRAM) ST.DEV 0.12 0.13 0.16 0.08 

 N 5 5 5 5 

ADRENALS MEAN 0.061 0.066 0.060 0.079 

(GRAM) ST.DEV 0.012 0.008 0.011 0.010 

 N 5 5 5 5 

SPLEEN MEAN 0.372 0.360 0.351 0.269 * 

(GRAM) ST.DEV 0.066 0.056 0.036 0.058 

 N 5 5 5 5 

OVARIES MEAN 0.193 0.125 0.105 0.088 * 

(GRAM) ST.DEV 0.108 0.014 0.024 0.015 

 N 5 5 5 5 

UTERUS MEAN 0.662 0.462 0.294 0.149 * 

(GRAM) ST.DEV 0.484 0.196 0.111 0.028 

 N 5 5 5 5 

− Page 23 − 08Feb13 15h07 

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Project 501432

APPENDIX 1

ORGAN/BODY WEIGHT RATIOS (%) SUMMARY 

*/** Dunnett−test based on pooled variance significant at 5% (*) or 1% (**) level 

FEMALES 

GROUP 1 

CONTROL 

GROUP 2 

50 MG/KG 

GROUP 3 

150 MG/KG 

GROUP 4 

450 MG/KG 

END OF TREATMENT 

BODY W. MEAN 176 179 176 138 ** 

(GRAM) ST.DEV 11 1 9 13 

 N 5 2 5 5 

 

BRAIN MEAN 1.05 1.01 1.07 1.29 ** 

(%) ST.DEV 0.05 0.08 0.06 0.09 

 N 5 2 5 5 

HEART MEAN 0.324 0.331 0.334 0.376 

(%) ST.DEV 0.037 0.002 0.048 0.044 

 N 5 2 5 5 

LIVER MEAN 2.85 3.00 3.19 4.45 ** 

(%) ST.DEV 0.21 0.11 0.31 0.20 

 N 5 2 5 5 

THYROIDS MEAN 0.013 0.012 0.013 0.016 

(%) ST.DEV 0.002 0.002 0.002 0.004 

 N 5 2 5 5 

THYMUS MEAN 0.250 0.218 0.187 ** 0.066 ** 

(%) ST.DEV 0.023 0.037 0.025 0.021 

 N 5 2 5 4 

KIDNEYS MEAN 0.84 0.82 0.86 1.07 ** 

(%) ST.DEV 0.05 0.06 0.07 0.06 

 N 5 2 5 5 

ADRENALS MEAN 0.035 0.034 0.034 0.058 ** 

(%) ST.DEV 0.005 0.002 0.005 0.009 

 N 5 2 5 5 

SPLEEN MEAN 0.210 0.186 0.200 0.194 

(%) ST.DEV 0.025 0.034 0.013 0.028 

 N 5 2 5 5 

OVARIES MEAN 0.112 0.072 0.060 0.063 

(%) ST.DEV 0.067 0.013 0.013 0.008 

 N 5 2 5 5 

UTERUS MEAN 0.366 0.345 0.167 0.108 * 

(%) ST.DEV 0.249 0.130 0.062 0.019 

 N 5 2 5 5 

− Page 24 − 08Feb13 15h07 

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m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Project 501432 

APPENDIX 1 

- Page 1 - 

APPENDIX 2 INDIVIDUAL DATA TABLES 

Final Report - Page 48 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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Project 501432

APPENDIX 2

MORTALITY DATA 

MALES 

ANIMAL SCHEDULED 

SACRIFICE 

TREATMENT 

FROM 

 

TO 

GROUP 1 (CONTROL) 

1 07DEC12 09NOV12 06DEC12 

2 07DEC12 09NOV12 06DEC12 

3 07DEC12 09NOV12 06DEC12 

4 07DEC12 09NOV12 06DEC12 

5 07DEC12 09NOV12 06DEC12 

GROUP 2 (50 MG/KG) 

6 07DEC12 09NOV12 06DEC12 

7 07DEC12 09NOV12 06DEC12 

8 07DEC12 09NOV12 06DEC12 

9 07DEC12 09NOV12 06DEC12 

10 07DEC12 09NOV12 06DEC12 

GROUP 3 (150 MG/KG) 

11 07DEC12 09NOV12 06DEC12 

12 07DEC12 09NOV12 06DEC12 

13 07DEC12 09NOV12 06DEC12 

14 07DEC12 09NOV12 06DEC12 

15 07DEC12 09NOV12 06DEC12 

GROUP 4 (450 MG/KG) 

16 07DEC12 09NOV12 06DEC12 

17 07DEC12 09NOV12 06DEC12 

18 07DEC12 09NOV12 06DEC12 

19 07DEC12 09NOV12 06DEC12 

20 07DEC12 09NOV12 06DEC12 

FEMALES 

ANIMAL SCHEDULED 

SACRIFICE 

TREATMENT 

FROM 

 

TO 

GROUP 1 (CONTROL) 

21 07DEC12 09NOV12 06DEC12 

22 07DEC12 09NOV12 06DEC12 

23 07DEC12 09NOV12 06DEC12 

24 07DEC12 09NOV12 06DEC12 

25 07DEC12 09NOV12 06DEC12 

GROUP 2 (50 MG/KG) 

26 07DEC12 09NOV12 06DEC12 

27 07DEC12 09NOV12 06DEC12 

28 07DEC12 09NOV12 06DEC12 

29 07DEC12 09NOV12 06DEC12 

30 07DEC12 09NOV12 06DEC12 

GROUP 3 (150 MG/KG) 

31 07DEC12 09NOV12 06DEC12 

32 07DEC12 09NOV12 06DEC12 

33 07DEC12 09NOV12 06DEC12 

34 07DEC12 09NOV12 06DEC12 

35 07DEC12 09NOV12 06DEC12 

GROUP 4 (450 MG/KG) 

36 07DEC12 09NOV12 06DEC12 

37 07DEC12 09NOV12 06DEC12 

38 07DEC12 09NOV12 06DEC12 

39 07DEC12 09NOV12 06DEC12 

40 07DEC12 09NOV12 06DEC12 

− Page 2 − 08Feb13 15h09 

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APPENDIX 2

CLINICAL SIGNS 

.: Observation performed, sign not present 

G: Highest daily grades 

MALES 

TREATMENT 

SIGN (MAX. GRADE) 

(LOCATION) 

WEEK: 

DAY: 

1 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

4 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

GROUP 1 (CONTROL) 

ANIMAL 1 

No clinical signs noted 

ANIMAL 2 

No clinical signs noted 

ANIMAL 3 

No clinical signs noted 

ANIMAL 4 

No clinical signs noted 

ANIMAL 5 

No clinical signs noted 

GROUP 2 (50 MG/KG) 

ANIMAL 6 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

ANIMAL 7 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

ANIMAL 8 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

ANIMAL 9 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

ANIMAL 10 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . . 2 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

GROUP 3 (150 MG/KG) 

ANIMAL 11 

Posture 

Hunched posture (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

Skin / fur 

Piloerection (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

Secretion / excretion 

Salivation (3) G: . . . . 1 1 1 1 1 1 1 1 2 2 1 1 1 2 2 2 2 2 2 2 2 2 2 2 

ANIMAL 12 

Posture 

Hunched posture (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

Secretion / excretion 

Salivation (3) G: . . . . . . 1 1 1 1 1 1 2 2 1 1 1 2 2 2 2 2 2 2 2 2 2 2 

ANIMAL 13 

Posture 

Hunched posture (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

Secretion / excretion 

Salivation (3) G: . . . . 1 . . . . 1 1 1 2 2 1 1 1 2 2 2 2 2 2 2 2 2 2 2 

ANIMAL 14 

Posture 

Hunched posture (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

Secretion / excretion 

Salivation (3) G: . . . . . 1 . . . . . . 2 2 1 1 1 2 2 2 2 2 2 2 2 2 2 2 

ANIMAL 15 

Posture 

Hunched posture (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

Secretion / excretion 

Salivation (3) G: . . . 1 1 1 . . . . . . 2 2 1 1 1 2 2 2 2 2 2 2 2 2 2 2 

− Page 3 − 08Feb13 15h09 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 50 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
Project 501432

APPENDIX 2

CLINICAL SIGNS 

.: Observation performed, sign not present 

G: Highest daily grades 

MALES 

TREATMENT 

SIGN (MAX. GRADE) 

(LOCATION) 

WEEK: 

DAY: 

1 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

4 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

GROUP 4 (450 MG/KG) 

ANIMAL 16 

Behavior 

Lethargy (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

Posture 

Hunched posture (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Skin / fur 

Piloerection (1) G: . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Secretion / excretion 

Salivation (3) G: . . . 1 1 1 1 1 1 1 1 2 2 2 1 1 2 2 3 3 3 3 3 3 3 3 3 3 

Faeces pale (1) G: . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Various 

Lean (1) G: . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

Ptosis (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

ANIMAL 17 

Behavior 

Lethargy (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

Posture 

Hunched posture (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Skin / fur 

Piloerection (1) G: . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Secretion / excretion 

Salivation (3) G: . . . 1 1 1 1 1 1 1 1 2 2 2 1 1 2 2 3 3 3 3 3 3 3 3 3 3 

Faeces pale (1) G: . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Various 

Lean (1) G: . . . . . . . . . . . . . . . . . . . . . . . 1 1 1 1 1 

Ptosis (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

ANIMAL 18 

Posture 

Hunched posture (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Skin / fur 

Piloerection (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Secretion / excretion 

Salivation (3) G: . . . 1 1 1 1 1 1 1 1 2 2 2 1 1 2 2 3 3 3 3 3 3 3 3 3 3 

Faeces pale (1) G: . . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Various 

Lean (1) G: . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

Ptosis (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

ANIMAL 19 

Behavior 

Lethargy (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

Posture 

Hunched posture (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Skin / fur 

Piloerection (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Secretion / excretion 

Salivation (3) G: . . . 1 1 1 1 1 1 1 1 2 2 2 1 1 2 2 3 3 3 3 3 3 3 3 3 3 

Faeces pale (1) G: . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Various 

Lean (1) G: . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

Ptosis (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

ANIMAL 20 

Behavior 

Lethargy (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

Posture 

Hunched posture (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Skin / fur 

Piloerection (1) G: . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 . 1 1 1 1 1 1 1 1 

Secretion / excretion 

Salivation (3) G: . . . . 1 1 1 1 1 1 1 2 2 2 1 1 2 2 3 3 3 3 3 3 3 3 3 3 

Faeces pale (1) G: . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Various 

− Page 4 − 08Feb13 15h09 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 51 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
Project 501432

APPENDIX 2

CLINICAL SIGNS 

.: Observation performed, sign not present 

G: Highest daily grades 

MALES 

TREATMENT 

SIGN (MAX. GRADE) 

(LOCATION) 

WEEK: 

DAY: 

1 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

4 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

GROUP 4 (450 MG/KG) 

Lean (1) G: . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

Ptosis (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

FEMALES 

TREATMENT 

SIGN (MAX. GRADE) 

(LOCATION) 

WEEK: 

DAY: 

1 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

4 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

GROUP 1 (CONTROL) 

ANIMAL 21 

No clinical signs noted 

ANIMAL 22 

No clinical signs noted 

ANIMAL 23 

No clinical signs noted 

ANIMAL 24 

No clinical signs noted 

ANIMAL 25 

No clinical signs noted 

GROUP 2 (50 MG/KG) 

ANIMAL 26 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . . 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

ANIMAL 27 

Breathing 

Rales (3) G: . . . . . . . . . . . . . . . . . . 1 1 . . . . . . . . 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . . 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

ANIMAL 28 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

ANIMAL 29 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

ANIMAL 30 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

GROUP 3 (150 MG/KG) 

ANIMAL 31 

Posture 

Hunched posture (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

Breathing 

Rales (3) G: . . . . . . . . . . . . . . . . . . 1 . . . . . . . . . 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . 1 1 2 2 1 1 1 2 2 2 2 2 2 2 2 2 2 2 

ANIMAL 32 

Posture 

Hunched posture (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

Secretion / excretion 

Salivation (3) G: . . . . . 1 . . . . . . 1 2 1 1 1 2 2 2 2 2 2 2 2 2 2 2 

− Page 5 − 08Feb13 15h09 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 52 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
Project 501432

APPENDIX 2

CLINICAL SIGNS 

.: Observation performed, sign not present 

G: Highest daily grades 

FEMALES 

TREATMENT 

SIGN (MAX. GRADE) 

(LOCATION) 

WEEK: 

DAY: 

1 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

4 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

GROUP 3 (150 MG/KG) 

ANIMAL 33 

Posture 

Hunched posture (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

Secretion / excretion 

Salivation (3) G: . . . . . . . . . . . . 2 2 1 1 1 2 2 2 2 2 2 2 2 2 2 2 

ANIMAL 34 

Posture 

Hunched posture (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

Secretion / excretion 

Salivation (3) G: . . . . 1 1 . . . . . . 2 2 1 1 1 2 2 2 2 2 2 2 2 2 2 2 

ANIMAL 35 

Posture 

Hunched posture (1) G: . . . . . . . . . . . . 1 1 . . . . . . . . . . . . . . 

Skin / fur 

Scabs (3) G: . . . . . . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 . . . 

(Shoulder right) 

Secretion / excretion 

Salivation (3) G: . . . . 1 1 1 1 1 1 1 1 2 2 1 1 1 2 2 1 2 2 2 2 2 2 2 2 

GROUP 4 (450 MG/KG) 

ANIMAL 36 

Behavior 

Lethargy (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

Posture 

Hunched posture (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Skin / fur 

Piloerection (1) G: . . . . . . . . . . . . . 1 1 1 1 1 1 1 . . . . . 1 1 1 

Secretion / excretion 

Salivation (3) G: . . . 1 1 1 1 1 1 1 1 2 2 2 1 1 2 2 2 3 3 3 3 3 3 3 3 3 

Chromodacryorrhoea (3) G: . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

(Snout) 

Faeces pale (1) G: . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Various 

Lean (1) G: . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 1 

Ptosis (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

ANIMAL 37 

Behavior 

Lethargy (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

Posture 

Hunched posture (1) G: . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Skin / fur 

Piloerection (1) G: . . . . . . . . . . . . . 1 1 1 1 1 1 1 . . . . . 1 1 1 

Secretion / excretion 

Salivation (3) G: . . . 1 1 1 1 1 1 1 1 2 2 2 1 1 2 2 3 3 3 3 3 3 3 3 3 3 

Faeces pale (1) G: . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Various 

Lean (1) G: . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

Ptosis (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

ANIMAL 38 

Behavior 

Lethargy (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

Posture 

Hunched posture (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Skin / fur 

Piloerection (1) G: . . . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Secretion / excretion 

Salivation (3) G: . . . 1 1 1 1 1 1 1 1 2 2 2 1 1 2 2 3 3 3 3 3 3 3 3 3 3 

Faeces pale (1) G: . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Various 

Lean (1) G: . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

Ptosis (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

− Page 6 − 08Feb13 15h09 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 53 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
Project 501432

APPENDIX 2

CLINICAL SIGNS 

.: Observation performed, sign not present 

G: Highest daily grades 

FEMALES 

TREATMENT 

SIGN (MAX. GRADE) 

(LOCATION) 

WEEK: 

DAY: 

1 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

. 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

4 

1 

. 

2 

. 

3 

. 

4 

. 

5 

. 

6 

. 

7 

GROUP 4 (450 MG/KG) 

ANIMAL 39 

Behavior 

Lethargy (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

Posture 

Hunched posture (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Skin / fur 

Piloerection (1) G: . . . . . . . . . . . . . 1 1 1 1 1 1 1 . . . . . . . 1 

Secretion / excretion 

Salivation (3) G: . . . 1 1 1 1 1 1 1 1 2 2 2 1 1 2 2 3 3 3 3 3 3 3 3 3 3 

Faeces pale (1) G: . . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Various 

Lean (1) G: . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 1 

Ptosis (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

ANIMAL 40 

Behavior 

Lethargy (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

Posture 

Hunched posture (1) G: . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Breathing 

Rales (3) G: . . . . . . . . . . . . . . . . . . . . . . . . 1 1 1 . 

Skin / fur 

Piloerection (1) G: . . . . . . . . . . . . . 1 1 1 1 1 1 1 . . . . . . . . 

Secretion / excretion 

Salivation (3) G: . . . 1 1 1 1 1 1 1 1 2 2 2 1 1 2 2 3 3 2 3 3 3 3 3 3 3 

Faeces pale (1) G: . . . . . . . . . . 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

Various 

Lean (1) G: . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

Ptosis (3) G: . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . 

− Page 7 − 08Feb13 15h09 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 54 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
Project 501432

APPENDIX 2

FUNCTIONAL OBSERVATIONS 

MALES 

AT WEEK4 

ANIMAL HEARING 

SCORE 0/1 

PUPIL L 

SCORE 0/1 

PUPIL R 

SCORE 0/1 

STATIC R 

SCORE 0/1 

GRIP 

SCORE 0/1 

GROUP 1 (CONTROL) 

1 0 0 0 0 0 

2 0 0 0 0 0 

3 0 0 0 0 0 

4 0 0 0 0 0 

5 0 0 0 0 0 

GROUP 2 (50 MG/KG) 

6 0 0 0 0 0 

7 0 0 0 0 0 

8 0 0 0 0 0 

9 0 0 0 0 0 

10 0 0 0 0 0 

GROUP 3 (150 MG/KG) 

11 0 0 0 0 0 

12 0 0 0 0 0 

13 0 0 0 0 0 

14 0 0 0 0 0 

15 0 0 0 0 0 

GROUP 4 (450 MG/KG) 

16 0 0 0 0 0 

17 0 0 0 0 0 

18 0 0 0 0 0 

19 0 0 0 0 0 

20 0 0 0 0 0 

FEMALES 

AT WEEK4 

ANIMAL HEARING 

SCORE 0/1 

PUPIL L 

SCORE 0/1 

PUPIL R 

SCORE 0/1 

STATIC R 

SCORE 0/1 

GRIP 

SCORE 0/1 

GROUP 1 (CONTROL) 

21 0 0 0 0 0 

22 0 0 0 0 0 

23 0 0 0 0 0 

24 0 0 0 0 0 

25 0 0 0 0 0 

GROUP 2 (50 MG/KG) 

26 0 0 0 0 0 

27 0 0 0 0 0 

28 0 0 0 0 0 

29 0 0 0 0 0 

30 0 0 0 0 0 

GROUP 3 (150 MG/KG) 

31 0 0 0 0 0 

32 0 0 0 0 0 

33 0 0 0 0 0 

34 0 0 0 0 0 

35 0 0 0 0 0 

− Page 8 − 08Feb13 15h09 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 55 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
Project 501432

APPENDIX 2

FUNCTIONAL OBSERVATIONS 

FEMALES 

AT WEEK4 

ANIMAL HEARING 

SCORE 0/1 

PUPIL L 

SCORE 0/1 

PUPIL R 

SCORE 0/1 

STATIC R 

SCORE 0/1 

GRIP 

SCORE 0/1 

GROUP 4 (450 MG/KG) 

36 0 0 0 0 0 

37 0 0 0 0 0 

38 0 0 0 0 0 

39 0 0 0 0 0 

40 0 0 0 0 0 

− Page 9 − 08Feb13 15h09 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 56 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
- Page 10 -

Project 501432

APPENDIX 2

MOTOR ACTIVITY TEST - TOTAL MOVEMENTS

MALES 

AT WEEK 4

1 2 3 4 5 6 7 8 9 10 11 12 Total

1 1510 986 665 495 46 93 26 0 0 62 0 0 3883

2 590 224 270 66 44 327 9 0 2 45 0 6 1583

3 1285 552 174 421 9 27 4 5 7 10 4 1 2499

4 1117 938 554 351 276 230 94 0 55 309 1 23 3948

5 601 429 414 22 247 158 18 132 422 470 10 117 3040

6 1199 651 223 63 448 139 23 193 171 0 11 1 3122

7 927 543 427 234 344 300 216 272 284 15 399 346 4307

8 1651 1076 633 556 490 334 430 173 66 8 312 7 5736

9 1534 397 170 4 215 290 11 24 48 87 0 4 2784

10 1352 1029 337 514 202 409 11 104 61 59 2 31 4111

11 890 466 198 19 157 4 54 0 23 10 0 319 2140

12 1132 805 366 636 329 275 191 818 534 56 0 222 5364

13 846 384 68 38 647 335 0 51 35 17 12 2 2435

14 1051 585 256 209 371 0 13 151 45 41 114 17 2853

15 966 841 513 489 703 256 532 597 245 289 256 7 5694

16 108 51 60 133 79 26 125 238 34 68 3 0 925

17 295 41 252 70 195 19 23 18 12 67 0 3 995

18 259 236 246 58 101 135 118 72 17 30 10 6 1288

19 440 230 160 162 240 130 138 40 265 15 30 45 1895

20 210 110 45 15 85 40 3 46 142 164 16 27 903

GROUP 4 (450 MG/KG)

GROUP 3 (150 MG/KG)

ANIMAL Interval (5 min.)

GROUP 1 (CONTROL)

GROUP 2 (50 MG/KG)

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 57 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
- Page 11 -

Project 501432

APPENDIX 2

MOTOR ACTIVITY TEST - AMBULATIONS

MALES 

AT WEEK 4

1 2 3 4 5 6 7 8 9 10 11 12 Total

1 355 223 139 130 2 35 1 0 0 23 0 0 908

2 162 15 50 5 8 20 0 0 0 3 0 0 263

3 296 112 34 82 0 0 0 0 0 0 0 0 524

4 311 206 106 45 9 32 0 0 18 63 0 0 790

5 184 155 85 3 35 39 1 1 0 138 0 0 641

6 342 242 53 0 123 6 1 16 52 0 1 0 836

7 230 101 88 39 55 55 38 61 42 0 99 46 854

8 424 344 120 155 55 86 85 29 0 0 0 0 1298

9 339 89 51 0 44 90 0 0 0 0 0 0 613

10 316 257 86 138 46 52 1 0 1 7 0 11 915

11 265 171 73 0 9 0 0 0 0 0 0 104 622

12 245 169 70 95 83 61 20 185 112 0 0 43 1083

13 300 138 7 7 164 86 0 0 0 0 0 0 702

14 282 114 56 36 91 0 1 2 0 0 2 0 584

15 298 215 122 50 142 43 116 113 57 47 67 0 1270

16 18 5 5 60 28 5 33 81 1 39 0 0 275

17 89 7 83 7 52 0 0 0 0 1 0 0 239

18 73 59 77 5 26 59 48 15 3 18 0 0 383

19 135 59 43 42 74 29 23 4 112 6 5 7 539

20 71 41 10 8 37 1 0 0 47 34 1 4 254

GROUP 3 (150 MG/KG)

GROUP 4 (450 MG/KG)

ANIMAL Interval (5 min.)

GROUP 1 (CONTROL)

GROUP 2 (50 MG/KG)

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- Page 12 -

Project 501432

APPENDIX 2

MOTOR ACTIVITY TEST - TOTAL MOVEMENTS

FEMALES

WEEK 4

1 2 3 4 5 6 7 8 9 10 11 12 Total

21 1710 981 796 217 588 77 2 17 359 485 232 42 5506

22 1054 581 439 460 449 337 45 7 0 575 381 273 4601

23 1610 1004 566 893 1132 832 652 124 23 2 1 183 7022

24 723 542 890 139 591 65 12 2 273 336 47 21 3641

25 1610 874 605 656 461 98 213 3 498 63 0 2 5083

26 1150 1056 440 455 712 536 364 473 166 244 749 318 6663

27 1207 619 724 677 716 519 5 580 37 305 581 510 6480

28 1536 849 655 545 719 550 3 0 4 5 10 0 4876

29 1587 724 879 344 612 509 38 22 0 7 6 2 4730

30 1222 652 474 100 761 206 7 68 645 36 1 47 4219

31 713 544 198 64 187 397 77 10 2 67 4 7 2270

32 1266 839 641 636 268 213 405 259 39 46 19 176 4807

33 1169 906 539 604 241 803 183 748 564 248 150 358 6513

34 1175 738 601 415 97 421 6 117 527 37 11 394 4539

35 827 1055 396 256 349 169 469 7 8 32 17 1 3586

36 203 1 32 163 13 176 1 2 56 9 81 136 873

37 342 60 21 148 61 142 0 44 136 1 0 36 991

38 280 201 169 33 95 15 31 106 40 22 58 166 1216

39 330 312 198 241 134 192 176 163 131 111 117 10 2115

40 295 127 165 95 0 67 102 8 3 15 66 4 947

GROUP 3 (150 MG/KG)

GROUP 4 (450MG/KG)

ANIMAL Interval (5 min.)

GROUP 1 (CONTROL)

GROUP 2 (50 MG/KG)

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Project 501432

APPENDIX 2

MOTOR ACTIVITY TEST - AMBULATIONS

FEMALES

WEEK 4

1 2 3 4 5 6 7 8 9 10 11 12 Total

21 652 340 260 30 164 0 0 1 98 121 28 0 1694

22 356 150 103 151 91 73 0 0 0 173 83 96 1276

23 443 268 76 256 237 167 97 0 0 1 1 26 1572

24 215 129 229 6 157 4 1 0 38 108 2 2 891

25 450 266 118 161 112 1 10 0 171 2 0 0 1291

26 397 320 139 175 246 168 117 138 59 29 260 112 2160

27 404 208 243 204 200 157 0 159 3 54 133 131 1896

28 497 218 198 132 205 109 1 0 0 0 0 0 1360

29 441 188 213 58 134 139 0 0 0 0 0 0 1173

30 399 214 158 20 284 80 0 23 273 0 1 6 1458

31 206 153 16 4 7 136 7 0 0 1 0 1 531

32 468 310 186 226 81 61 132 10 0 1 0 38 1513

33 337 260 123 189 72 229 58 243 163 61 1 78 1814

34 507 254 165 129 26 157 2 2 202 6 0 141 1591

35 286 342 105 81 113 76 111 0 0 0 0 0 1114

36 62 0 0 48 0 77 0 0 13 4 18 5 227

37 115 9 5 92 37 31 0 0 43 0 0 0 332

38 79 82 51 4 20 0 0 27 12 0 4 3 282

39 95 113 69 96 45 68 64 48 39 56 32 0 725

40 120 76 84 48 0 6 34 0 1 0 13 0 382

GROUP 4 (450 MG/KG)

ANIMAL Interval (5 min)

GROUP 2 (50 MG/KG)

GROUP 3 (150 MG/KG)

GROUP 1 (CONTROL)

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APPENDIX 2

BODY WEIGHTS (GRAM) 

MALES 

TREATMENT 

DAYS 

WEEKS 

ANIMAL 

1 

1 

8 

2 

15 

3 

22 

4 

28 

4 

GROUP 1 (CONTROL) 

1 173 219 263 301 324 

2 171 216 257 287 309 

3 169 209 245 270 296 

4 164 203 241 269 286 

5 178 217 258 292 308 

GROUP 2 (50 MG/KG) 

6 171 213 254 286 306 

7 182 225 262 297 317 

8 167 207 239 263 277 

9 159 198 233 258 271 

10 159 186 212 223 233 

GROUP 3 (150 MG/KG) 

11 165 194 235 265 276 

12 165 195 225 259 277 

13 173 203 229 251 262 

14 183 221 262 290 301 

15 164 194 227 256 266 

GROUP 4 (450 MG/KG) 

16 167 177 191 199 185 

17 151 145 157 168 175 

18 162 155 167 170 167 

19 169 164 171 179 185 

20 177 189 210 217 221 

FEMALES 

TREATMENT 

DAYS 

WEEKS 

ANIMAL 

1 

1 

8 

2 

15 

3 

22 

4 

28 

4 

GROUP 1 (CONTROL) 

21 126 137 163 173 176 

22 137 157 179 185 203 

23 141 162 186 191 211 

24 132 145 158 178 180 

25 135 147 171 184 191 

GROUP 2 (50 MG/KG) 

26 137 154 167 190 196 

27 137 158 172 190 201 

28 125 141 159 172 171 

29 143 163 174 184 194 

30 135 160 176 180 196 

GROUP 3 (150 MG/KG) 

31 129 144 167 175 185 

32 135 148 174 186 190 

33 147 165 185 200 202 

34 144 160 177 200 197 

35 136 152 168 177 184 

− Page 14 − 08Feb13 15h14 

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APPENDIX 2

BODY WEIGHTS (GRAM) 

FEMALES 

TREATMENT 

DAYS 

WEEKS 

ANIMAL 

1 

1 

8 

2 

15 

3 

22 

4 

28 

4 

GROUP 4 (450 MG/KG) 

36 132 138 147 154 146 

37 136 137 148 164 165 

38 124 137 151 164 163 

39 142 146 150 143 129 

40 137 138 151 164 151 

− Page 15 − 08Feb13 15h14 

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Project 501432

APPENDIX 2

BODY WEIGHT GAIN (%) 

MALES 

TREATMENT 

DAYS 

WEEKS 

ANIMAL 

1 

1 

8 

2 

15 

3 

22 

4 

28 

4 

GROUP 1 (CONTROL) 

1 0 27 52 74 87 

2 0 26 50 68 81 

3 0 24 45 60 75 

4 0 24 47 64 74 

5 0 22 45 64 73 

GROUP 2 (50 MG/KG) 

6 0 25 49 67 79 

7 0 24 44 63 74 

8 0 24 43 57 66 

9 0 25 47 62 70 

10 0 17 33 40 47 

GROUP 3 (150 MG/KG) 

11 0 18 42 61 67 

12 0 18 36 57 68 

13 0 17 32 45 51 

14 0 21 43 58 64 

15 0 18 38 56 62 

GROUP 4 (450 MG/KG) 

16 0 6 14 19 11 

17 0 −4 4 11 16 

18 0 −4 3 5 3 

19 0 −3 1 6 9 

20 0 7 19 23 25 

FEMALES 

TREATMENT 

DAYS 

WEEKS 

ANIMAL 

1 

1 

8 

2 

15 

3 

22 

4 

28 

4 

GROUP 1 (CONTROL) 

21 0 9 29 37 40 

22 0 15 31 35 48 

23 0 15 32 35 50 

24 0 10 20 35 36 

25 0 9 27 36 41 

GROUP 2 (50 MG/KG) 

26 0 12 22 39 43 

27 0 15 26 39 47 

28 0 13 27 38 37 

29 0 14 22 29 36 

30 0 19 30 33 45 

GROUP 3 (150 MG/KG) 

31 0 12 29 36 43 

32 0 10 29 38 41 

33 0 12 26 36 37 

34 0 11 23 39 37 

35 0 12 24 30 35 

− Page 16 − 08Feb13 15h14 

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Project 501432

APPENDIX 2

BODY WEIGHT GAIN (%) 

FEMALES 

TREATMENT 

DAYS 

WEEKS 

ANIMAL 

1 

1 

8 

2 

15 

3 

22 

4 

28 

4 

GROUP 4 (450 MG/KG) 

36 0 5 11 17 11 

37 0 1 9 21 21 

38 0 10 22 32 31 

39 0 3 6 1 −9 

40 0 1 10 20 10 

− Page 17 − 08Feb13 15h14 

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APPENDIX 2

FOOD CONSUMPTION (G/ANIMAL/DAY) 

MALES 

TREATMENT 

DAYS 

WEEKS 

CAGE 

1−8 

1−2 

8−15 

2−3 

15−22 

3−4 

22−28 

4 

GROUP 1 (CONTROL) 

1 19 21 21 22 

GROUP 2 (50 MG/KG) 

2 18 20 21 21 

GROUP 3 (150 MG/KG) 

3 17 20 21 21 

GROUP 4 (450 MG/KG) 

4 11 11 12 12 

FEMALES 

TREATMENT 

DAYS 

WEEKS 

CAGE 

1−8 

1−2 

8−15 

2−3 

15−22 

3−4 

22−28 

4 

GROUP 1 (CONTROL) 

5 14 15 14 15 

GROUP 2 (50 MG/KG) 

6 14 14 14 16 

GROUP 3 (150 MG/KG) 

7 13 14 14 13 

GROUP 4 (450 MG/KG) 

8 10 10 11 10 

− Page 18 − 08Feb13 15h14 

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APPENDIX 2

RELATIVE FOOD CONSUMPTION (G/KG BODY WEIGHT/DAY) 

MALES 

TREATMENT 

DAYS 

WEEKS 

CAGE 

1−8 

1−2 

8−15 

2−3 

15−22 

3−4 

22−28 

4 

GROUP 1 (CONTROL) 

1 90 83 75 72 

GROUP 2 (50 MG/KG) 

2 87 82 78 75 

GROUP 3 (150 MG/KG) 

3 86 83 78 76 

GROUP 4 (450 MG/KG) 

4 65 59 64 64 

FEMALES 

TREATMENT 

DAYS 

WEEKS 

CAGE 

1−8 

1−2 

8−15 

2−3 

15−22 

3−4 

22−28 

4 

GROUP 1 (CONTROL) 

5 92 86 79 76 

GROUP 2 (50 MG/KG) 

6 91 83 79 81 

GROUP 3 (150 MG/KG) 

7 85 80 75 70 

GROUP 4 (450 MG/KG) 

8 73 65 68 65 

− Page 19 − 08Feb13 15h14 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 66 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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Project 501432

APPENDIX 2

HAEMATOLOGY 

MALES 

END OF TREATMENT 

ANIMAL WBC 

10E9/L 

Neutrophils 

%WBC 

Lymphocytes 

%WBC 

Monocytes 

%WBC 

Eosinophils 

%WBC 

GROUP 1 (CONTROL) 

1 7.1 11.6 85.3 1.9 1.0 

2 10.5 10.2 87.1 1.9 0.6 

3 6.2 11.5 85.3 2.1 0.9 

4 9.3 13.9 82.8 2.1 0.9 

5 7.2 8.9 88.2 2.1 0.5 

GROUP 2 (50 MG/KG) 

6 8.5 11.8 85.4 1.8 0.6 

7 6.6 14.6 82.2 1.8 1.3 

8 7.3 15.6 81.4 1.8 1.0 

9 7.1 11.1 85.9 2.0 0.6 

10 8.4 7.7 90.3 1.0 0.7 

GROUP 3 (150 MG/KG) 

11 11.7 28.4 69.0 2.0 0.4 

12 6.5 29.8 65.9 3.4 0.6 

13 11.1 42.0 54.5 2.7 0.6 

14 8.1 33.5 62.3 3.5 0.6 

15 8.9 18.1 78.3 2.7 0.7 

GROUP 4 (450 MG/KG) 

16 14.2 90.0 9.0 1.0 0.0 

17 8.6 73.3 22.6 3.8 0.3 

18 9.2 88.4 9.2 2.2 0.2 

19 6.7 68.0 27.1 4.1 0.7 

20 8.7 61.5 33.9 4.1 0.4 

MALES 

END OF TREATMENT 

ANIMAL Basophils 

%WBC 

Red blood cells 

10E12/L 

Reticulocytes 

%RBC 

RDW 

% 

Haemoglobin 

mmol/L 

GROUP 1 (CONTROL) 

1 0.1 7.79 2.6 11.0 9.6 

2 0.2 8.42 2.3 10.7 9.7 

3 0.2 8.21 2.4 12.1 9.7 

4 0.3 8.40 2.8 11.2 9.5 

5 0.2 7.84 2.6 13.3 9.8 

GROUP 2 (50 MG/KG) 

6 0.4 8.39 2.4 11.2 9.8 

7 0.2 8.02 3.2 11.9 9.4 

8 0.1 8.50 2.0 10.9 10.1 

9 0.3 8.74 2.4 11.9 10.0 

10 0.3 8.25 2.1 11.1 10.1 

GROUP 3 (150 MG/KG) 

11 0.3 8.27 2.1 10.8 9.7 

12 0.2 7.95 2.4 11.5 9.3 

13 0.2 7.53 3.2 12.1 8.8 

14 0.2 7.71 1.7 10.3 8.8 

15 0.3 7.93 2.7 13.8 9.6 

− Page 20 − 08Feb13 15h14 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 67 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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Project 501432

APPENDIX 2

HAEMATOLOGY 

MALES 

END OF TREATMENT 

ANIMAL Basophils 

%WBC 

Red blood cells 

10E12/L 

Reticulocytes 

%RBC 

RDW 

% 

Haemoglobin 

mmol/L 

GROUP 4 (450 MG/KG) 

16 0.0 6.22 6.9 14.0 6.6 

17 0.1 6.88 8.0 15.3 8.6 

18 0.0 6.82 7.0 13.8 7.4 

19 0.1 6.80 8.7 15.0 8.2 

20 0.1 7.14 6.4 13.0 8.3 

MALES 

END OF TREATMENT 

ANIMAL Haematocrit 

L/L 

MCV 

fL 

MCH 

fmol 

MCHC 

mmol/L 

Platelets 

10E9/L 

GROUP 1 (CONTROL) 

1 0.443 56.9 1.24 21.72 893 

2 0.444 52.8 1.15 21.76 972 

3 0.422 51.4 1.18 22.94 819 

4 0.435 51.8 1.13 21.88 921 

5 0.431 55.0 1.25 22.70 915 

GROUP 2 (50 MG/KG) 

6 0.450 53.7 1.17 21.74 992 

7 0.420 52.4 1.17 22.30 805 

8 0.457 53.7 1.18 22.06 847 

9 0.459 52.5 1.14 21.71 1049 

10 0.444 53.8 1.22 22.67 979 

GROUP 3 (150 MG/KG) 

11 0.451 54.5 1.17 21.42 1049 

12 0.424 53.4 1.18 22.03 1111 

13 0.414 55.0 1.16 21.17 1040 

14 0.392 50.9 1.14 22.42 1007 

15 0.425 53.6 1.21 22.55 746 

GROUP 4 (450 MG/KG) 

16 0.313 50.4 1.07 21.15 1909 

17 0.391 56.9 1.24 21.87 1225 

18 0.343 50.3 1.08 21.56 1428 

19 0.379 55.7 1.20 21.57 1175 

20 0.385 53.9 1.17 21.67 1469 

MALES 

END OF TREATMENT 

ANIMAL PT 

s 

APTT 

s 

GROUP 1 (CONTROL) 

1 18.1 16.7 

2 17.9 17.6 

3 16.4 13.0 

4 17.1 16.6 

5 16.8 11.4 

− Page 21 − 08Feb13 15h14 

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Project 501432

APPENDIX 2

HAEMATOLOGY 

MALES 

END OF TREATMENT 

ANIMAL PT 

s 

APTT 

s 

GROUP 2 (50 MG/KG) 

6 16.3 13.5 

7 15.5 12.6 

8 16.8 17.3 

9 17.5 17.1 

10 16.1 14.9 

GROUP 3 (150 MG/KG) 

11 16.9 16.9 

12 16.0 12.0 

13 16.1 18.4 

14 18.2 17.3 

15 16.8 18.0 

GROUP 4 (450 MG/KG) 

16 19.0 16.1 

17 18.8 13.1 

18 17.8 9.5 

19 16.7 10.5 

20 16.7 10.8 

FEMALES 

END OF TREATMENT 

ANIMAL WBC 

10E9/L 

Neutrophils 

%WBC 

Lymphocytes 

%WBC 

Monocytes 

%WBC 

Eosinophils 

%WBC 

GROUP 1 (CONTROL) 

21 5.9 7.0 90.8 1.1 1.0 

22 3.4 9.0 88.5 1.5 1.0 

23 3.6 10.9 85.5 2.1 1.4 

24 −−− −−− −−− −−− −−−

25 4.9 8.4 88.8 1.6 1.1 

GROUP 2 (50 MG/KG) 

26 7.8 12.6 83.7 2.5 1.0 

27 3.9 18.6 78.6 1.6 1.0 

28 5.1 9.4 88.3 0.9 1.3 

29 4.2 16.5 80.1 1.8 1.5 

30 3.3 11.4 85.5 1.7 1.2 

GROUP 3 (150 MG/KG) 

31 5.2 18.6 78.4 2.3 0.5 

32 7.1 25.0 70.6 2.9 1.4 

33 7.7 10.7 84.6 3.3 1.2 

34 3.6 18.1 78.7 1.6 1.6 

35 5.1 25.3 69.7 3.4 1.4 

GROUP 4 (450 MG/KG) 

36 6.8 58.5 37.6 3.6 0.3 

37 8.0 74.4 21.7 3.5 0.4 

38 7.0 64.3 31.1 3.7 0.7 

39 4.3 78.3 17.8 3.6 0.3 

40 6.5 68.8 26.0 4.2 0.9 

− Page 22 − 08Feb13 15h14 

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APPENDIX 2

HAEMATOLOGY 

FEMALES 

END OF TREATMENT 

ANIMAL Basophils 

%WBC 

Red blood cells 

10E12/L 

Reticulocytes 

%RBC 

RDW 

% 

Haemoglobin 

mmol/L 

GROUP 1 (CONTROL) 

21 0.1 8.04 1.7 9.7 8.9 

22 0.1 7.85 1.9 10.1 8.7 

23 0.1 7.47 2.5 22.7 9.5 

24 −−− −−− −−− −−− −−−

25 0.2 7.63 1.8 11.2 9.3 

GROUP 2 (50 MG/KG) 

26 0.1 7.37 2.0 10.4 8.7 

27 0.1 7.90 2.9 11.4 9.1 

28 0.2 7.71 1.9 10.3 9.1 

29 0.1 7.85 2.5 10.8 9.1 

30 0.2 7.74 2.4 10.8 8.9 

GROUP 3 (150 MG/KG) 

31 0.2 8.19 2.2 10.1 9.3 

32 0.1 7.87 3.3 11.9 9.0 

33 0.2 8.73 2.6 10.4 10.1 

34 0.0 8.26 1.1 13.6 9.3 

35 0.1 8.39 1.5 10.5 9.3 

GROUP 4 (450 MG/KG) 

36 0.0 6.81 5.4 12.9 7.5 

37 0.0 7.26 5.1 12.7 8.6 

38 0.1 6.99 7.6 13.7 8.2 

39 0.0 5.26 6.7 13.7 6.2 

40 0.1 6.40 8.4 13.6 7.3 

FEMALES 

END OF TREATMENT 

ANIMAL Haematocrit 

L/L 

MCV 

fL 

MCH 

fmol 

MCHC 

mmol/L 

Platelets 

10E9/L 

GROUP 1 (CONTROL) 

21 0.400 49.8 1.11 22.37 788 

22 0.397 50.6 1.10 21.84 980 

23 0.414 55.5 1.27 22.85 1169 

24 −−− −−− −−− −−− −−−

25 0.407 53.4 1.22 22.90 846 

GROUP 2 (50 MG/KG) 

26 0.384 52.1 1.18 22.57 983 

27 0.411 52.0 1.15 22.20 862 

28 0.410 53.1 1.18 22.24 920 

29 0.401 51.1 1.15 22.60 693 

30 0.397 51.3 1.15 22.43 946 

GROUP 3 (150 MG/KG) 

31 0.426 52.0 1.13 21.78 949 

32 0.404 51.3 1.14 22.18 929 

33 0.465 53.3 1.15 21.64 1090 

34 0.415 50.2 1.13 22.49 1205 

35 0.415 49.4 1.10 22.31 1079 

− Page 23 − 08Feb13 15h14 

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APPENDIX 2

HAEMATOLOGY 

FEMALES 

END OF TREATMENT 

ANIMAL Haematocrit 

L/L 

MCV 

fL 

MCH 

fmol 

MCHC 

mmol/L 

Platelets 

10E9/L 

GROUP 4 (450 MG/KG) 

36 0.354 51.9 1.11 21.31 1603 

37 0.409 56.4 1.19 21.03 1229 

38 0.390 55.8 1.18 21.16 983 

39 0.288 54.7 1.18 21.55 1336 

40 0.348 54.4 1.14 20.87 1402 

FEMALES 

END OF TREATMENT 

ANIMAL PT 

s 

APTT 

s 

GROUP 1 (CONTROL) 

21 16.3 15.1 

22 15.7 15.0 

23 17.4 15.4 

24 16.7 17.0 

25 17.3 15.9 

GROUP 2 (50 MG/KG) 

26 15.4 13.8 

27 16.7 16.4 

28 15.9 15.3 

29 16.6 16.2 

30 16.2 14.2 

GROUP 3 (150 MG/KG) 

31 16.8 13.9 

32 17.2 15.8 

33 16.8 14.6 

34 16.0 12.8 

35 15.4 11.0 

GROUP 4 (450 MG/KG) 

36 18.1 12.4 

37 16.8 13.1 

38 16.7 12.9 

39 −−− −−−

40 15.6 11.3 

− Page 24 − 08Feb13 15h14 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Final Report - Page 71 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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APPENDIX 2

CLINICAL BIOCHEMISTRY 

MALES 

END OF TREATMENT 

ANIMAL ALAT 

U/L 

ASAT 

U/L 

ALP 

U/L 

Total protein 

g/L 

Albumin 

g/L 

GROUP 1 (CONTROL) 

1 50.5 67.4 179 67.0 34.5 

2 55.2 76.7 188 64.4 32.0 

3 30.0 84.3 138 61.5 31.3 

4 43.4 73.7 201 66.3 33.7 

5 37.2 80.8 277 61.8 32.4 

GROUP 2 (50 MG/KG) 

6 54.3 79.3 296 63.3 32.0 

7 41.3 80.0 140 63.8 32.7 

8 35.7 75.7 142 62.9 32.1 

9 38.8 66.9 151 65.6 33.3 

10 27.7 83.5 216 62.9 33.4 

GROUP 3 (150 MG/KG) 

11 73.7 88.8 223 63.2 31.7 

12 90.7 99.3 173 63.6 31.7 

13 41.2 61.5 130 60.3 29.5 

14 84.5 117.1 173 60.1 31.5 

15 79.6 86.1 176 59.3 31.6 

GROUP 4 (450 MG/KG) 

16 29.2 62.5 200 64.3 28.0 

17 85.6 69.4 116 60.3 29.2 

18 35.9 88.8 171 66.0 29.9 

19 39.9 77.9 104 61.4 29.6 

20 64.0 69.7 87 65.0 31.3 

MALES 

END OF TREATMENT 

ANIMAL Total bilirubin 

umol/L 

Urea 

mmol/L 

Creatinine 

umol/L 

Glucose 

mmol/L 

Cholesterol 

mmol/L 

GROUP 1 (CONTROL) 

1 2.4 8.5 37.0 6.49 2.23 

2 2.6 10.0 41.0 8.33 2.06 

3 2.8 5.6 35.6 7.10 1.73 

4 2.7 9.9 34.3 8.32 2.19 

5 2.4 8.0 38.3 7.49 1.84 

GROUP 2 (50 MG/KG) 

6 2.4 7.3 34.3 7.28 2.28 

7 2.6 5.9 36.3 7.86 1.92 

8 2.3 5.2 35.6 8.80 2.23 

9 2.3 7.4 35.0 8.25 1.95 

10 2.6 5.7 33.6 8.87 1.81 

GROUP 3 (150 MG/KG) 

11 2.7 7.7 35.6 8.37 2.27 

12 3.9 9.3 35.6 7.31 1.95 

13 2.6 8.3 37.7 8.58 2.43 

14 4.0 7.2 35.0 7.77 2.07 

15 3.6 8.6 35.6 6.08 1.63 

− Page 25 − 08Feb13 15h14 

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Project 501432

APPENDIX 2

CLINICAL BIOCHEMISTRY 

MALES 

END OF TREATMENT 

ANIMAL Total bilirubin 

umol/L 

Urea 

mmol/L 

Creatinine 

umol/L 

Glucose 

mmol/L 

Cholesterol 

mmol/L 

GROUP 4 (450 MG/KG) 

16 3.6 6.2 28.9 5.51 2.87 

17 4.3 9.8 33.0 5.29 3.22 

18 6.0 9.3 35.0 5.83 3.41 

19 3.9 8.3 34.3 6.08 2.76 

20 4.2 8.0 33.0 5.90 3.87 

MALES 

END OF TREATMENT 

ANIMAL Bile Acids 

umol/L 

Sodium 

mmol/L 

Potassium 

mmol/L 

Chloride 

mmol/L 

Calcium 

mmol/L 

Inorg.Phos 

mmol/L 

GROUP 1 (CONTROL) 

1 25.9 142.3 4.23 100 2.81 2.77 

2 33.8 142.4 4.22 100 2.74 2.64 

3 68.3 141.2 4.22 100 2.67 2.59 

4 41.6 142.5 3.80 99 2.75 2.37 

5 37.6 141.7 4.30 101 2.74 2.38 

GROUP 2 (50 MG/KG) 

6 24.7 140.1 4.17 100 2.72 2.50 

7 21.1 142.0 4.51 101 2.69 2.18 

8 15.8 141.9 4.22 102 2.75 2.26 

9 46.5 140.4 4.16 101 2.77 2.44 

10 10.3 142.6 3.82 102 2.68 2.37 

GROUP 3 (150 MG/KG) 

11 50.5 141.8 4.42 103 2.76 2.06 

12 46.1 141.3 4.40 100 2.77 2.40 

13 52.2 141.5 4.55 100 2.72 2.24 

14 64.8 141.6 5.08 99 2.70 2.47 

15 46.1 142.8 4.61 102 2.72 2.62 

GROUP 4 (450 MG/KG) 

16 70.2 137.3 3.74 94 2.69 2.41 

17 53.9 141.5 3.81 98 2.68 2.85 

18 197.6 140.5 4.13 95 2.71 3.16 

19 173.7 141.1 4.42 98 2.66 2.69 

20 63.7 140.7 4.38 98 2.77 2.43 

FEMALES 

END OF TREATMENT 

ANIMAL ALAT 

U/L 

ASAT 

U/L 

ALP 

U/L 

Total protein 

g/L 

Albumin 

g/L 

GROUP 1 (CONTROL) 

21 31.7 81.8 114 62.5 33.6 

22 50.5 90.0 116 68.9 37.8 

23 48.4 138.7 107 63.5 34.1 

24 38.2 80.4 73 63.2 34.6 

25 39.0 91.0 127 62.9 33.6 

− Page 26 − 08Feb13 15h14 

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APPENDIX 2

CLINICAL BIOCHEMISTRY 

FEMALES 

END OF TREATMENT 

ANIMAL ALAT 

U/L 

ASAT 

U/L 

ALP 

U/L 

Total protein 

g/L 

Albumin 

g/L 

GROUP 2 (50 MG/KG) 

26 25.4 63.8 66 72.2 38.1 

27 36.4 77.3 112 65.7 35.3 

28 41.7 69.9 78 68.9 37.2 

29 41.4 73.3 123 62.8 33.9 

30 41.7 75.1 123 62.0 33.7 

GROUP 3 (150 MG/KG) 

31 59.3 76.2 107 63.7 33.7 

32 51.2 67.4 96 64.5 33.6 

33 53.7 79.3 100 60.8 32.9 

34 28.1 93.5 61 63.6 33.4 

35 91.6 94.6 170 61.4 33.2 

GROUP 4 (450 MG/KG) 

36 43.9 69.3 73 60.7 29.9 

37 58.8 97.6 100 64.0 30.4 

38 57.2 83.0 94 64.0 30.5 

39 40.0 69.8 62 58.2 27.2 

40 32.4 66.9 76 58.5 29.0 

FEMALES 

END OF TREATMENT 

ANIMAL Total bilirubin 

umol/L 

Urea 

mmol/L 

Creatinine 

umol/L 

Glucose 

mmol/L 

Cholesterol 

mmol/L 

GROUP 1 (CONTROL) 

21 2.5 8.6 36.3 7.04 1.03 

22 2.8 7.6 39.0 6.59 1.59 

23 2.4 8.3 37.0 6.09 1.05 

24 2.1 8.1 40.3 6.77 1.12 

25 2.2 8.5 38.3 7.68 0.77 

GROUP 2 (50 MG/KG) 

26 2.6 8.4 38.3 4.99 1.19 

27 2.2 6.2 39.0 6.42 2.07 

28 2.0 8.2 37.7 5.83 2.01 

29 2.5 8.6 41.0 6.29 1.23 

30 2.7 8.7 35.0 6.90 1.63 

GROUP 3 (150 MG/KG) 

31 4.0 9.5 41.7 6.81 1.44 

32 3.7 8.8 39.0 8.40 1.62 

33 2.7 10.8 41.7 7.57 2.52 

34 2.6 7.5 39.0 6.64 1.39 

35 4.4 11.7 37.7 7.00 3.08 

GROUP 4 (450 MG/KG) 

36 3.7 10.2 35.0 5.28 2.49 

37 3.9 8.0 35.0 4.96 2.57 

38 3.5 8.6 35.6 6.01 2.72 

39 3.1 6.0 27.6 5.79 2.55 

40 3.0 7.1 35.0 7.63 2.53 

− Page 27 − 08Feb13 15h14 

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APPENDIX 2

CLINICAL BIOCHEMISTRY 

FEMALES 

END OF TREATMENT 

ANIMAL Bile Acids 

umol/L 

Sodium 

mmol/L 

Potassium 

mmol/L 

Chloride 

mmol/L 

Calcium 

mmol/L 

Inorg.Phos 

mmol/L 

GROUP 1 (CONTROL) 

21 18.1 140.2 3.68 101 2.63 2.48 

22 30.7 141.2 3.79 102 2.75 1.80 

23 18.7 139.9 4.02 102 2.63 2.35 

24 13.2 141.6 3.59 101 2.65 2.26 

25 31.4 141.6 4.04 104 2.64 2.16 

GROUP 2 (50 MG/KG) 

26 7.8 142.8 3.69 103 2.84 2.10 

27 10.4 143.0 3.36 104 2.66 1.81 

28 26.0 143.0 3.74 105 2.77 2.21 

29 21.1 140.5 3.73 104 2.56 1.82 

30 26.9 141.6 3.85 102 2.67 2.06 

GROUP 3 (150 MG/KG) 

31 53.7 139.8 4.23 100 2.70 1.99 

32 51.1 140.2 4.05 102 2.71 2.14 

33 50.8 143.0 4.31 103 2.76 2.32 

34 27.9 141.3 4.13 101 2.72 2.14 

35 175.7 143.7 4.15 100 2.69 2.63 

GROUP 4 (450 MG/KG) 

36 52.6 141.5 4.31 100 2.73 2.53 

37 160.0 138.9 3.94 97 2.79 2.54 

38 68.6 142.8 4.07 99 2.80 3.16 

39 40.5 139.6 4.49 99 2.58 1.86 

40 31.6 141.6 3.85 100 2.61 2.17 

− Page 28 − 08Feb13 15h14 

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Project 501432

APPENDIX 2

MACROSCOPIC FINDINGS 

MALES 

ALL NECROPSIES 

ANIMAL ORGAN FINDING DAY OF DEATH 

GROUP 1 (CONTROL) 

1 Seminal vesicles Left side: reduced in size. Scheduled sacrifice, 07Dec2012 

2 No findings noted Scheduled sacrifice, 07Dec2012 

3 Epididymides Left side, tail: nodule(s), d=6x5 mm, Scheduled sacrifice, 07Dec2012 

 yellowish, soft. 

4 No findings noted Scheduled sacrifice, 07Dec2012 

5 No findings noted Scheduled sacrifice, 07Dec2012 

GROUP 2 (50 MG/KG) 

6 No findings noted Scheduled sacrifice, 07Dec2012 

7 No findings noted Scheduled sacrifice, 07Dec2012 

8 No findings noted Scheduled sacrifice, 07Dec2012 

9 No findings noted Scheduled sacrifice, 07Dec2012 

10 No findings noted Scheduled sacrifice, 07Dec2012 

GROUP 3 (150 MG/KG) 

11 Stomach Forestomach: irregular surface. Scheduled sacrifice, 07Dec2012 

 Duodenum Wall: thickened. 

 Contents: gelatinous. 

 Mesenteric lymph n Discolouration, reddish. 

12 Stomach Forestomach: irregular surface. Scheduled sacrifice, 07Dec2012 

 Kidneys Right side: pelvic dilation. 

 Mesenteric lymph n Discolouration, dark red. 

 Pancreatic lymph n Enlarged. 

 Discolouration, reddish. 

13 Stomach Forestomach: focus/foci, d=12x5 mm, Scheduled sacrifice, 07Dec2012 

 tan. 

 Forestomach: irregular surface. 

 Kidneys Left side: focus/foci, isolated, 

 reddish. 

 Mesenteric lymph n Discolouration, dark red. 

 Pancreatic lymph n Enlarged. 

14 Stomach Forestomach: irregular surface. Scheduled sacrifice, 07Dec2012 

 Duodenum Wall: thickened. 

 Contents: gelatinous. 

 Jejunum Wall: thickened. 

 Contents: gelatinous. 

 Liver Left lateral lobe: reduced in size. 

 Mandibular lymph n Left side: discolouration, reddish. 

15 Stomach Forestomach: irregular surface. Scheduled sacrifice, 07Dec2012 

 Duodenum Focus/foci, d=4x3 mm, reddish. 

 Wall: thickened. 

 Contents: gelatinous. 

 Jejunum Wall: thickened. 

 Contents: gelatinous. 

 Mesenteric lymph n Discolouration, dark red. 

GROUP 4 (450 MG/KG) 

16 Stomach Grown together with: liver processus Scheduled sacrifice, 07Dec2012 

 papilaris. 

 Kidneys Both sides: discolouration, greenish. 

 Prostate Reduced in size. 

 Seminal vesicles Both sides: reduced in size. 

 Thymus Reduced in size. 

 Mesenteric lymph n Discolouration, dark red. 

17 General observations Emaciated. Scheduled sacrifice, 07Dec2012 

 Stomach Forestomach: irregular surface. 

 Duodenum Wall: thickened. 

 Contents: gelatinous. 

 Jejunum Wall: thickened. 

 Contents: gelatinous. 

 Kidneys Both sides: discolouration, greenish. 

 Prostate Reduced in size. 

 Seminal vesicles Both sides: reduced in size. 

− Page 29 − 08Feb13 15h14 

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Project 501432

APPENDIX 2

MACROSCOPIC FINDINGS 

MALES 

ALL NECROPSIES 

ANIMAL ORGAN FINDING DAY OF DEATH 

GROUP 4 (450 MG/KG) 

 Adrenal glands Both sides: discolouration, pale. 

 Thymus Reduced in size. 

 Mesenteric lymph n Discolouration, dark red. 

 Pancreatic lymph n Enlarged. 

18 General observations Emaciated. Scheduled sacrifice, 07Dec2012 

 Stomach Forestomach: irregular surface. 

 Duodenum Wall: thickened. 

 Contents: gelatinous. 

 Jejunum Wall: thickened. 

 Contents: gelatinous. 

 Kidneys Both sides: discolouration, greenish. 

 Prostate Reduced in size. 

 Seminal vesicles Both sides: reduced in size. 

 Adrenal glands Both sides: discolouration, pale. 

 Thymus Reduced in size. 

 Mesenteric lymph n Discolouration, purple. 

19 General observations Emaciated. Scheduled sacrifice, 07Dec2012 

 Stomach Forestomach: irregular surface. 

 Duodenum Wall: thickened. 

 Contents: gelatinous. 

 Jejunum Wall: thickened. 

 Contents: gelatinous. 

 Kidneys Both sides: discolouration, greenish. 

 Prostate Reduced in size. 

 Seminal vesicles Both sides: reduced in size. 

 Adrenal glands Both sides: discolouration, pale. 

 Thymus Reduced in size. 

 Mesenteric lymph n Discolouration, dark red. 

 Renal lymph node Both sides: enlarged. 

 Pancreatic lymph n Enlarged. 

20 General observations Emaciated. Scheduled sacrifice, 07Dec2012 

 Stomach Forestomach: irregular surface. 

 Duodenum Wall: thickened. 

 Contents: gelatinous. 

 Jejunum Wall: thickened. 

 Contents: gelatinous. 

 Kidneys Both sides: discolouration, greenish. 

 Prostate Reduced in size. 

 Seminal vesicles Both sides: reduced in size. 

 Adrenal glands Both sides: discolouration, pale. 

 Thymus Reduced in size. 

 Mesenteric lymph n Discolouration, dark red. 

 Pancreatic lymph n Enlarged. 

FEMALES 

ALL NECROPSIES 

ANIMAL ORGAN FINDING DAY OF DEATH 

GROUP 1 (CONTROL) 

21 No findings noted Scheduled sacrifice, 07Dec2012 

22 Uterus Contains fluid. Scheduled sacrifice, 07Dec2012 

23 Uterus Contains fluid. Scheduled sacrifice, 07Dec2012 

24 No findings noted Scheduled sacrifice, 07Dec2012 

25 No findings noted Scheduled sacrifice, 07Dec2012 

GROUP 2 (50 MG/KG) 

26 No findings noted Scheduled sacrifice, 07Dec2012 

27 No findings noted Scheduled sacrifice, 07Dec2012 

28 Pancreatic lymph n Discolouration, reddish. Scheduled sacrifice, 07Dec2012 

− Page 30 − 08Feb13 15h14 

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Project 501432

APPENDIX 2

MACROSCOPIC FINDINGS 

FEMALES 

ALL NECROPSIES 

ANIMAL ORGAN FINDING DAY OF DEATH 

GROUP 2 (50 MG/KG) 

29 No findings noted Scheduled sacrifice, 07Dec2012 

30 Uterus Contains fluid. Scheduled sacrifice, 07Dec2012 

GROUP 3 (150 MG/KG) 

31 Pancreatic lymph n Enlarged. Scheduled sacrifice, 07Dec2012 

32 Stomach Forestomach: irregular surface. Scheduled sacrifice, 07Dec2012 

 Duodenum Wall: thickened. 

 Contents: gelatinous. 

 Pancreatic lymph n Discolouration, reddish. 

33 Stomach Forestomach: irregular surface. Scheduled sacrifice, 07Dec2012 

 Duodenum Wall: thickened. 

 Jejunum Wall: thickened. 

 Liver Left lateral lobe: focus/foci, many, 

 red−brown. 

 Uterus Reduced in size. 

 Mesenteric lymph n Discolouration, dark red. 

34 Stomach Forestomach: irregular surface. Scheduled sacrifice, 07Dec2012 

 Duodenum Wall: thickened. 

 Contents: gelatinous. 

 Jejunum Wall: thickened. 

 Contents: gelatinous. 

 Adrenal glands Both sides: discolouration, pale. 

35 Mesenteric lymph n Discolouration, dark red. Scheduled sacrifice, 07Dec2012 

 Pancreatic lymph n Discolouration, reddish. 

GROUP 4 (450 MG/KG) 

36 General observations Emaciated. Scheduled sacrifice, 07Dec2012 

 Stomach Forestomach: irregular surface. 

 Duodenum Contents: gelatinous. 

 Wall: dilation. 

 Jejunum Wall: dilation. 

 Contents: gelatinous. 

 Kidneys Both sides: discolouration, greenish. 

 Ovaries Both sides: reduced in size. 

 Uterus Reduced in size. 

 Adrenal glands Both sides: discolouration, pale. 

 Thymus Reduced in size. 

 Mesenteric lymph n Discolouration, dark red. 

 Pancreatic lymph n Enlarged. 

37 General observations Emaciated. Scheduled sacrifice, 07Dec2012 

 Stomach Forestomach: irregular surface. 

 Duodenum Wall: thickened. 

 Contents: gelatinous. 

 Jejunum Wall: thickened. 

 Contents: gelatinous. 

 Kidneys Right side: pelvic dilation. 

 Both sides: discolouration, greenish. 

 Uterus Reduced in size. 

 Adrenal glands Both sides: discolouration, pale. 

 Mesenteric lymph n Discolouration, purple. 

 Pancreatic lymph n Enlarged. 

38 General observations Emaciated. Scheduled sacrifice, 07Dec2012 

 Stomach Forestomach, wall: focus/foci, d=3x3 

 mm, yellowish, dark red. 

 Forestomach: irregular surface. 

 Duodenum Wall: thickened. 

 Contents: gelatinous. 

 Jejunum Wall: thickened. 

 Contents: gelatinous. 

 Kidneys Both sides: discolouration, greenish. 

 Uterus Reduced in size. 

 Adrenal glands Both sides: discolouration, pale. 

 Thymus Reduced in size. 

− Page 31 − 08Feb13 15h14 

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Project 501432

APPENDIX 2

MACROSCOPIC FINDINGS 

FEMALES 

ALL NECROPSIES 

ANIMAL ORGAN FINDING DAY OF DEATH 

GROUP 4 (450 MG/KG) 

 Pancreatic lymph n Enlarged. 

39 General observations Emaciated. Scheduled sacrifice, 07Dec2012 

 Stomach Forestomach: focus/foci, yellowish, 

 reddish. 

 Grown together with: liver, processus 

 papillarus. 

 Forestomach: irregular surface. 

 Jejunum Contains fluid, gelatinous. 

 Kidneys Both sides: discolouration, greenish. 

 Ovaries Both sides: reduced in size. 

 Uterus Reduced in size. 

 Adrenal glands Enlarged. 

 Thymus Reduced in size. 

 Mesenteric lymph n Discolouration, dark red. 

 Renal lymph node Left side: discolouration, dark red. 

40 General observations Emaciated. Scheduled sacrifice, 07Dec2012 

 Stomach Forestomach, wall: focus/foci, d=9x7 

 mm, yellowish, dark red. 

 Forestomach: irregular surface. 

 Duodenum Wall: thickened. 

 Contents: gelatinous. 

 Jejunum Wall: thickened. 

 Contents: gelatinous. 

 Kidneys Both sides: discolouration, greenish. 

 Ovaries Both sides: reduced in size. 

 Uterus Reduced in size. 

 Adrenal glands Both sides: discolouration, pale. 

 Thymus Reduced in size. 

 Mesenteric lymph n Discolouration, dark red. 

 Renal lymph node Both sides: enlarged. 

 Pancreatic lymph n Enlarged. 

− Page 32 − 08Feb13 15h14 

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Project 501432

APPENDIX 2

ORGAN WEIGHTS (GRAM) 

MALES 

END OF TREATMENT 

ANIMAL BODY W. 

(GRAM) 

BRAIN 

(GRAM) 

HEART 

(GRAM) 

LIVER 

(GRAM) 

THYROIDS 

(GRAM) 

GROUP 1 (CONTROL) 

1 302 2.15 0.954 9.52 0.027 

2 291 2.14 0.818 8.84 0.023 

3 277 1.95 0.859 8.11 0.022 

4 269 1.92 0.871 7.86 0.021 

5 286 2.09 0.841 8.32 0.025 

GROUP 2 (50 MG/KG) 

6 282 1.84 0.843 9.03 0.023 

7 296 2.07 0.798 9.13 0.027 

8 255 1.95 0.799 7.72 0.019 

9 251 2.04 0.786 7.79 0.025 

10 218 1.84 0.686 6.43 0.020 

GROUP 3 (150 MG/KG) 

11 257 2.07 0.805 7.83 0.022 

12 255 1.91 0.802 9.01 0.022 

13 246 1.96 0.760 8.43 0.021 

14 284 2.01 0.900 9.07 0.022 

15 245 2.04 0.698 8.01 0.026 

GROUP 4 (450 MG/KG) 

16 173 1.75 0.632 7.11 0.023 

17 156 1.68 0.482 6.70 0.019 

18 153 1.81 0.537 7.20 0.018 

19 166 1.88 0.567 6.75 0.013 

20 204 1.79 0.708 8.47 0.022 

MALES 

END OF TREATMENT 

ANIMAL THYMUS 

(GRAM) 

KIDNEYS 

(GRAM) 

ADRENALS 

(GRAM) 

SPLEEN 

(GRAM) 

TESTES 

(GRAM) 

GROUP 1 (CONTROL) 

1 0.496 2.66 0.054 0.589 3.06 

2 0.558 2.13 0.047 0.531 3.20 

3 0.484 2.18 0.059 0.541 2.82 

4 0.473 2.15 0.062 0.606 3.00 

5 0.632 2.12 0.067 0.600 3.11 

GROUP 2 (50 MG/KG) 

6 0.458 2.35 0.056 0.573 3.11 

7 0.507 2.25 0.054 0.587 3.44 

8 0.425 2.27 0.054 0.543 3.30 

9 0.361 2.17 0.060 0.472 3.10 

10 0.336 1.78 0.056 0.378 3.05 

GROUP 3 (150 MG/KG) 

11 0.450 2.17 0.053 0.436 3.15 

12 0.294 2.36 0.054 0.499 3.64 

13 0.323 2.08 0.063 0.500 2.86 

14 0.563 2.48 0.057 0.522 2.76 

15 0.387 2.18 0.062 0.461 3.39 

− Page 33 − 08Feb13 15h14 

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APPENDIX 2

ORGAN WEIGHTS (GRAM) 

MALES 

END OF TREATMENT 

ANIMAL THYMUS 

(GRAM) 

KIDNEYS 

(GRAM) 

ADRENALS 

(GRAM) 

SPLEEN 

(GRAM) 

TESTES 

(GRAM) 

GROUP 4 (450 MG/KG) 

16 0.011 1.89 0.098 0.307 2.84 

17 0.053 1.64 0.075 0.291 2.42 

18 0.075 1.62 0.069 0.288 2.37 

19 0.080 1.73 0.068 0.364 2.88 

20 0.187 2.02 0.082 0.424 2.52 

MALES 

END OF TREATMENT 

ANIMAL PROSTATE 

(GRAM) 

EPIDIDYMIDES 

(GRAM) 

SEMINAL VES 

(GRAM) 

GROUP 1 (CONTROL) 

1 0.479 0.722 0.808 

2 0.770 0.704 0.907 

3 0.556 0.800 0.995 

4 0.414 0.769 1.027 

5 0.427 0.761 1.212 

GROUP 2 (50 MG/KG) 

6 0.289 0.721 0.701 

7 0.324 0.817 0.888 

8 0.455 0.817 0.688 

9 0.348 0.704 0.930 

10 0.347 0.678 0.780 

GROUP 3 (150 MG/KG) 

11 0.303 0.735 0.586 

12 0.246 0.791 0.605 

13 0.252 0.725 0.638 

14 0.331 0.701 0.739 

15 0.395 0.713 0.855 

GROUP 4 (450 MG/KG) 

16 0.182 0.594 0.462 

17 0.130 0.544 0.163 

18 0.217 0.595 0.181 

19 0.143 0.613 0.128 

20 0.236 0.639 0.392 

− Page 34 − 08Feb13 15h14 

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Project 501432

APPENDIX 2

ORGAN/BODY WEIGHT RATIOS (%) 

MALES 

END OF TREATMENT 

ANIMAL BODY W. 

(GRAM) 

BRAIN 

(%) 

HEART 

(%) 

LIVER 

(%) 

THYROIDS 

(%) 

GROUP 1 (CONTROL) 

1 302 0.71 0.316 3.15 0.009 

2 291 0.73 0.281 3.04 0.008 

3 277 0.71 0.310 2.93 0.008 

4 269 0.71 0.324 2.92 0.008 

5 286 0.73 0.294 2.91 0.009 

GROUP 2 (50 MG/KG) 

6 282 0.65 0.299 3.20 0.008 

7 296 0.70 0.270 3.08 0.009 

8 255 0.77 0.313 3.03 0.007 

9 251 0.81 0.313 3.10 0.010 

10 218 0.85 0.315 2.95 0.009 

GROUP 3 (150 MG/KG) 

11 257 0.80 0.313 3.05 0.009 

12 255 0.75 0.315 3.53 0.009 

13 246 0.80 0.309 3.43 0.009 

14 284 0.71 0.317 3.19 0.008 

15 245 0.83 0.285 3.27 0.011 

GROUP 4 (450 MG/KG) 

16 173 1.01 0.365 4.11 0.013 

17 156 1.08 0.309 4.30 0.012 

18 153 1.19 0.351 4.71 0.012 

19 166 1.13 0.342 4.07 0.008 

20 204 0.88 0.347 4.15 0.011 

MALES 

END OF TREATMENT 

ANIMAL THYMUS 

(%) 

KIDNEYS 

(%) 

ADRENALS 

(%) 

SPLEEN 

(%) 

TESTES 

(%) 

GROUP 1 (CONTROL) 

1 0.164 0.88 0.018 0.195 1.01 

2 0.192 0.73 0.016 0.182 1.10 

3 0.175 0.79 0.021 0.195 1.02 

4 0.176 0.80 0.023 0.225 1.12 

5 0.221 0.74 0.023 0.210 1.09 

GROUP 2 (50 MG/KG) 

6 0.162 0.83 0.020 0.203 1.10 

7 0.171 0.76 0.018 0.198 1.16 

8 0.167 0.89 0.021 0.213 1.29 

9 0.144 0.87 0.024 0.188 1.23 

10 0.154 0.82 0.026 0.173 1.40 

GROUP 3 (150 MG/KG) 

11 0.175 0.84 0.021 0.170 1.23 

12 0.115 0.92 0.021 0.196 1.43 

13 0.131 0.85 0.026 0.203 1.16 

14 0.198 0.87 0.020 0.184 0.97 

15 0.158 0.89 0.025 0.188 1.38 

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APPENDIX 2

ORGAN/BODY WEIGHT RATIOS (%) 

MALES 

END OF TREATMENT 

ANIMAL THYMUS 

(%) 

KIDNEYS 

(%) 

ADRENALS 

(%) 

SPLEEN 

(%) 

TESTES 

(%) 

GROUP 4 (450 MG/KG) 

16 0.006 1.09 0.057 0.177 1.64 

17 0.034 1.05 0.048 0.187 1.55 

18 0.049 1.06 0.045 0.188 1.55 

19 0.048 1.04 0.041 0.219 1.74 

20 0.092 0.99 0.040 0.208 1.23 

MALES 

END OF TREATMENT 

ANIMAL PROSTATE 

(%) 

EPIDIDYMIDES 

(%) 

SEMINAL VES 

(%) 

GROUP 1 (CONTROL) 

1 0.159 0.239 0.268 

2 0.265 0.242 0.312 

3 0.201 0.289 0.359 

4 0.154 0.286 0.382 

5 0.149 0.266 0.424 

GROUP 2 (50 MG/KG) 

6 0.102 0.256 0.249 

7 0.109 0.276 0.300 

8 0.178 0.320 0.270 

9 0.139 0.280 0.371 

10 0.159 0.311 0.358 

GROUP 3 (150 MG/KG) 

11 0.118 0.286 0.228 

12 0.096 0.310 0.237 

13 0.102 0.295 0.259 

14 0.117 0.247 0.260 

15 0.161 0.291 0.349 

GROUP 4 (450 MG/KG) 

16 0.105 0.343 0.267 

17 0.083 0.349 0.104 

18 0.142 0.389 0.118 

19 0.086 0.369 0.077 

20 0.116 0.313 0.192 

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APPENDIX 2

ORGAN WEIGHTS (GRAM) 

FEMALES 

END OF TREATMENT 

ANIMAL BODY W. 

(GRAM) 

BRAIN 

(GRAM) 

HEART 

(GRAM) 

LIVER 

(GRAM) 

THYROIDS 

(GRAM) 

GROUP 1 (CONTROL) 

21 163 1.83 0.583 5.14 0.020 

22 188 1.89 0.598 5.41 0.021 

23 187 1.93 0.684 5.23 0.021 

24 167 1.82 0.461 4.26 0.021 

25 177 1.80 0.539 5.05 0.029 

GROUP 2 (50 MG/KG) 

26 −−− 1.85 0.593 5.63 0.023 

27 −−− 1.86 0.644 5.60 0.019 

28 −−− 1.75 0.581 5.29 0.020 

29 180 1.72 0.594 5.27 0.019 

30 178 1.90 0.592 5.47 0.023 

GROUP 3 (150 MG/KG) 

31 170 1.93 0.493 5.41 0.019 

32 179 1.93 0.741 6.60 0.023 

33 186 1.83 0.616 5.58 0.021 

34 179 1.85 0.594 5.15 0.027 

35 164 1.81 0.499 5.22 0.027 

GROUP 4 (450 MG/KG) 

36 133 1.79 0.439 5.84 0.022 

37 150 1.84 0.653 6.26 0.016 

38 151 1.75 0.515 6.67 0.023 

39 120 1.66 0.486 5.66 0.022 

40 135 1.80 0.495 6.17 0.027 

FEMALES 

END OF TREATMENT 

ANIMAL THYMUS 

(GRAM) 

KIDNEYS 

(GRAM) 

ADRENALS 

(GRAM) 

SPLEEN 

(GRAM) 

OVARIES 

(GRAM) 

UTERUS 

(GRAM) 

GROUP 1 (CONTROL) 

21 0.400 1.48 0.055 0.334 0.168 0.423 

22 0.531 1.56 0.059 0.432 0.132 0.875 

23 0.438 1.64 0.077 0.448 0.161 1.415 

24 0.377 1.36 0.047 0.294 0.383 0.305 

25 0.467 1.37 0.069 0.350 0.123 0.290 

GROUP 2 (50 MG/KG) 

26 0.491 1.48 0.070 0.430 0.114 0.328 

27 0.421 1.66 0.078 0.382 0.124 0.476 

28 0.293 1.35 0.060 0.318 0.128 0.273 

29 0.440 1.56 0.063 0.379 0.146 0.456 

30 0.341 1.38 0.057 0.289 0.111 0.777 

GROUP 3 (150 MG/KG) 

31 0.300 1.34 0.045 0.307 0.113 0.351 

32 0.320 1.70 0.068 0.372 0.137 0.390 

33 0.372 1.51 0.070 0.372 0.084 0.186 

34 0.398 1.65 0.067 0.386 0.114 0.380 

35 0.255 1.36 0.051 0.319 0.077 0.161 

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APPENDIX 2

ORGAN WEIGHTS (GRAM) 

FEMALES 

END OF TREATMENT 

ANIMAL THYMUS 

(GRAM) 

KIDNEYS 

(GRAM) 

ADRENALS 

(GRAM) 

SPLEEN 

(GRAM) 

OVARIES 

(GRAM) 

UTERUS 

(GRAM) 

GROUP 4 (450 MG/KG) 

36 0.092 1.40 0.066 0.262 0.068 0.116 

37 0.108 1.51 0.072 0.292 0.101 0.159 

38 0.130 1.59 0.087 0.334 0.105 0.186 

39 0.043 1.41 0.082 0.177 0.083 0.158 

40 −−− 1.47 0.089 0.281 0.081 0.126 

− Page 38 − 08Feb13 15h14 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline

! 

! Thymus weight was excluded due to a biologically unrealistic value

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APPENDIX 2

ORGAN/BODY WEIGHT RATIOS (%) 

FEMALES 

END OF TREATMENT 

ANIMAL BODY W. 

(GRAM) 

BRAIN 

(%) 

HEART 

(%) 

LIVER 

(%) 

THYROIDS 

(%) 

GROUP 1 (CONTROL) 

21 163 1.12 0.358 3.15 0.012 

22 188 1.00 0.318 2.88 0.011 

23 187 1.03 0.366 2.80 0.011 

24 167 1.09 0.276 2.55 0.013 

25 177 1.02 0.305 2.85 0.016 

GROUP 2 (50 MG/KG) 

26 −−− −−− −−− −−− −−−

27 −−− −−− −−− −−− −−−

28 −−− −−− −−− −−− −−−

29 180 0.96 0.330 2.93 0.011 

30 178 1.07 0.333 3.07 0.013 

GROUP 3 (150 MG/KG) 

31 170 1.14 0.290 3.18 0.011 

32 179 1.08 0.414 3.69 0.013 

33 186 0.98 0.331 3.00 0.011 

34 179 1.04 0.332 2.88 0.015 

35 164 1.10 0.304 3.18 0.016 

GROUP 4 (450 MG/KG) 

36 133 1.34 0.330 4.39 0.017 

37 150 1.23 0.435 4.17 0.011 

38 151 1.16 0.341 4.42 0.015 

39 120 1.38 0.405 4.72 0.018 

40 135 1.33 0.367 4.57 0.020 

FEMALES 

END OF TREATMENT 

ANIMAL THYMUS 

(%) 

KIDNEYS 

(%) 

ADRENALS 

(%) 

SPLEEN 

(%) 

OVARIES 

(%) 

UTERUS 

(%) 

GROUP 1 (CONTROL) 

21 0.245 0.91 0.034 0.205 0.103 0.260 

22 0.282 0.83 0.031 0.230 0.070 0.465 

23 0.234 0.88 0.041 0.240 0.086 0.757 

24 0.226 0.81 0.028 0.176 0.229 0.183 

25 0.264 0.77 0.039 0.198 0.069 0.164 

GROUP 2 (50 MG/KG) 

26 −−− −−− −−− −−− −−− −−−

27 −−− −−− −−− −−− −−− −−−

28 −−− −−− −−− −−− −−− −−−

29 0.244 0.87 0.035 0.211 0.081 0.253 

30 0.192 0.78 0.032 0.162 0.062 0.437 

GROUP 3 (150 MG/KG) 

31 0.176 0.79 0.026 0.181 0.066 0.206 

32 0.179 0.95 0.038 0.208 0.077 0.218 

33 0.200 0.81 0.038 0.200 0.045 0.100 

34 0.222 0.92 0.037 0.216 0.064 0.212 

35 0.155 0.83 0.031 0.195 0.047 0.098 

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APPENDIX 2

ORGAN/BODY WEIGHT RATIOS (%) 

FEMALES 

END OF TREATMENT 

ANIMAL THYMUS 

(%) 

KIDNEYS 

(%) 

ADRENALS 

(%) 

SPLEEN 

(%) 

OVARIES 

(%) 

UTERUS 

(%) 

GROUP 4 (450 MG/KG) 

36 0.069 1.05 0.050 0.197 0.051 0.087 

37 0.072 1.00 0.048 0.195 0.067 0.106 

38 0.086 1.05 0.058 0.221 0.070 0.123 

39 0.036 1.17 0.068 0.148 0.069 0.132 

40 −−− 1.09 0.066 0.208 0.060 0.093 

− Page 40 − 08Feb13 15h14 

m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline

! 

! Thymus weight was excluded due to a biologically unrealistic value

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APPENDIX 2

- Page 41 - 

KEY TO MISSING VALUES/REMARKS CLINICAL LABORATORY INVESTIGATIONS

End of Treatment

Haematology:

Animal(s):

39 --- = Citrate sample clotted 

24 --- = EDTA sample clotted

16 Differential leucocyte count was also performed manually because of a technical 

error in the automated count and these results are reported

Clinical Biochemistry: No remarks

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APPENDIX 3 

- Page 1 - 

APPENDIX 3 FORMULATION ANALYSIS REPORT 

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1. CONTENTS 

1. CONTENTS ...................................................................................................................................... 2

2. REPORT APPROVAL ...................................................................................................................... 3

3. SUMMARY ........................................................................................................................................ 4

4. INTRODUCTION .............................................................................................................................. 5

4.1. Preface ...................................................................................................................................... 5

4.2. Aim of the study ........................................................................................................................ 5

5. MATERIALS AND METHODS .......................................................................................................... 5

5.1. Reagents ................................................................................................................................... 5

5.2. Samples .................................................................................................................................... 5

5.3. Analytical method ...................................................................................................................... 5

5.3.1. Analytical conditions ....................................................................................................... 5

5.3.2. Preparation of solutions .................................................................................................. 6

5.3.3. Sample injections ............................................................................................................ 6

5.4. Electronic data capture ............................................................................................................. 6

5.5. Formulas ................................................................................................................................... 7

5.6. Specifications ............................................................................................................................ 7

6. RESULTS ......................................................................................................................................... 8

6.1. Calibration curves ..................................................................................................................... 8

6.2. Samples .................................................................................................................................... 8

6.2.1. Procedural recovery samples ......................................................................................... 8

6.2.2. Test samples ................................................................................................................... 8

TABLES 

Table 1 Procedural recovery samples .............................................................................................. 9

Table 2 Accuracy and homogeneity test .........................................................................................10

Table 3 Stability test ........................................................................................................................10

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- Page 4 - 

3. SUMMARY 

The purpose of this part of the study was to determine the accuracy of preparation, homogeneity and 

stability of the test substance in formulations. 

Accuracy of preparation 

The concentrations analysed in the formulations of Group 2, Group 3 and Group 4 were in agreement 

with target concentrations (i.e. mean accuracies between 85% and 115%). 

No test substance was detected in the Group 1 formulation. 

Homogeneity 

The formulations of Group 2 and Group 4 were homogeneous (i.e. coefficient of variation ≤ 10%). 

Stability 

Formulations at the entire range were stable when stored at room temperature under normal 

laboratory light conditions for at least 6 hours. 

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- Page 5 - 

4. INTRODUCTION 

4.1. Preface 

Study plan analytical phase Start : 27 November 2012

Completion : 28 November 2012

4.2. Aim of the study 

The purpose of the analytical phase was to determine the accuracy of preparation, homogeneity and 

stability of the test substance in formulations. 

5. MATERIALS AND METHODS 

5.1. Reagents 

Water Tap water purified by a Milli-Q water purification system 

(Millipore, Bedford, MA, USA) 

Acetonitrile Biosolve, Valkenswaard, The Netherlands 

All reagents were of analytical grade, unless specified otherwise. 

5.2. Samples 

Accuracy, homogeneity and stability were determined for formulations prepared for use during 

treatment. 

Duplicate samples (approximately 500 mg), which were taken from the formulations using a pipette, 

were accurately weighed into volumetric flasks of 20 or 50 ml. For determination of accuracy, samples 

were taken at middle position (50% height) or at top, middle and bottom position (90%, 50% and 10% 

height). The samples taken at 90%, 50% and 10% height were also used for the determination of the 

homogeneity of the formulations. For determination of stability, additional samples were taken at 50% 

height and stored at room temperature under normal laboratory light conditions for 6 hours. 

The volumetric flasks were filled up to the mark with acetonitrile. The solutions were further diluted to 

obtain an end solution of 30/70 (v/v) acetonitrile/water and concentrations within the calibration range. 

5.3. Analytical method 

5.3.1. Analytical conditions 

Quantitative analysis was based on the analytical method validated for the test substance in project 

501424. 

Analytical conditions: 

Instrument Alliance Separation Module 2695 

(Waters, Milford, MA, USA) 

Detector Dual λ Absorbance Detector 2487 (Waters) 

Column Symmetry Shield RP-18, 100 mm  4.6 mm i.d., dp = 3.5 μm 

(Waters) 

Column temperature 40°C  1°C

Injection volume 100 μl 

Mobile phase 30/70 (v/v) acetonitrile/water 

Flow 1 ml/min 

UV detection 253 nm 

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- Page 6 - 

5.3.2. Preparation of solutions 

Stock and spiking solutions 

Stock and spiking solutions of the test substance were prepared in acetonitrile at concentrations of 

835 - 4035 mg/l. 

Calibration solutions 

Calibration solutions in the concentration range of 0.0400 – 59.7 mg/l were prepared from two stock 

solutions. The end solution of the calibration solutions was 30/70 (v/v) acetonitrile/water. 

Procedural recovery samples 

Approximately 500 mg blank vehicle was spiked with the test substance at a target concentration of 1 

or 90 mg/g. The accuracy samples were treated similarly as the test samples (see paragraph 5.2 

‘Samples’). 

5.3.3. Sample injections 

Calibration solutions were injected in duplicate. Test samples and procedural recovery samples were 

analysed by single injection. 

5.4. Electronic data capture 

System control, data acquisition and data processing were performed using the following programme: 

- Empower version 7.00 (Waters, Milford, MA, USA). 

Temperature, relative humidity and/or atmospheric pressure during sample storage and/or 

performance of the studies was monitored continuously using the following programme: 

- REES Centron Environmental Monitoring system version SQL 2.0 (REES Scientific, Trenton, NJ, 

USA).

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5.5. Formulas 

Response (R) Peak area test substance [units] 

Calibration curve 

N  b C a R

where: 

CN = nominal concentration [mg/l] 

a = slope [units  l/mg] 

b = intercept [units] 

Analysed concentration (CA) [mg/g]

w

d V

a

(R b) CA









where: 

w = weight sample [mg] 

V = volume volumetric flask [ml] 

d = dilution factor 

Recovery 

100 [%]

C

C

N

A



where: 

CN = nominal concentration [mg/g] 

Accuracy 

100 [%]

C

C

T

A



where: 

CT = target concentration [mg/g] 

Relative difference (relative diff.) 

100 [%]

C

CC

0

0t





where: 

Ct = mean concentration of stored samples [mg/g] 

C0 = mean concentration of non-stored samples [mg/g] 

5.6. Specifications 

Preparation of formulations was considered acceptable if the mean accuracy was in the range 

85-115% of the target concentration and if the coefficient of variation was ≤ 10%. Formulations were 

considered stable if the relative difference between the stored and freshly taken samples was ≤ 10%. 

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6. RESULTS 

6.1. Calibration curves 

A calibration curve was constructed using five concentrations. For each concentration, two responses 

were used. Linear regression analysis was performed using the least squares method with a 

1/concentration2 weighting factor. The coefficient of correlation (r) was > 0.99. 

6.2. Samples 

6.2.1. Procedural recovery samples 

The results of the procedural recovery samples are given in Table 1.

The mean recoveries of the procedural recovery samples fell within the criterion of 85-115%. It 

demonstrated that the analytical method was adequate for the determination of the test substance in 

the test samples. 

6.2.2. Test samples 

The results of the test samples are given in Table 2 and Table 3.

Accuracy of preparation 

In the Group 1 formulation, no test substance was detected. 

The concentrations analysed in the formulations of Group 2, Group 3 and Group 4 were in agreement 

with target concentrations (i.e. mean accuracies between 85% and 115%). 

Homogeneity 

The formulations of Group 2 and Group 4 were homogeneous (i.e. coefficient of variation ≤ 10%). 

Stability 

Analysis of Group 2 and Group 4 formulations after storage yielded a relative difference of ≤ 10%. 

Based on this, the formulations were found to be stable during storage at room temperature under 

normal laboratory light conditions for at least 6 hours. 

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- Page 9 - 

TABLES 

Table 1 Procedural recovery samples 

Date of 

preparation

[dd-mm-yy]

Date of 

analysis

[dd-mm-yy]

Target 

concentration

[mg/g]

Nominal 

concentration

[mg/g]

Analysed 

concentration

[mg/g]

Recovery

[%]

Mean 

recovery 

[%]

27-11-12 27-11-12 1 0.980 1.02 104 105

1.01 1.06 105

27-11-12 27-11-12 90 96.5 105 108 109

85.0 92.6 109

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- Page 10 - 

Table 2 Accuracy and homogeneity test 

Group Date of 

analysis 

[dd-mm-yy]

Sample 

position

Concentration

[mg/g]

Accuracy

[%]

Homogeneity 

(coefficient of 

variation)

Target Analysed Individual Mean [%]

1 27-11-12 50% height 0 n.d. n.a.

0 n.d. n.a.

2 27-11-12 90% height 9.64 8.64 89.7 95.1 4.3

9.64 8.94 92.7

50% height 9.64 8.96 92.9

9.64 9.23 95.7

10% height 9.64 9.55 99.1

9.64 9.65 100

3 27-11-12 50% height 28.8 28.2 97.7 98.6 n.a.

28.8 28.7 99.4

4 27-11-12 90% height 85.7 86.6 101 103 1.1

85.7 88.2 103

50% height 85.7 87.8 102

85.7 87.5 102

10% height 85.7 89.1 104

85.7 89.0 104

n.d. Not detected. 

n.a. Not applicable. 

Table 3 Stability test 

Group Date of analysis 

[dd-mm-yy]

Analysed concentration 

[mg/g]

Relative diff. 

t=0 [%] 1t=6 hours

2 27-11-12 9.16 9.30 2

1.5

4 27-11-12 88.0 87.9 3

-0.18

1

 Mean of six samples at t=0 taken at 10%, 50% and 90% height. 

2 Mean of two samples at t=6 hours taken at 50% height. Individual results were 9.22 and 9.39 mg/g. 

3 Mean of two samples at t=6 hours taken at 50% height. Individual results were 87.0 and 88.7 mg/g. 

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APPENDIX 4 

- Page 1 - 

APPENDIX 4 HISTOPATHOLOGY REPORT 

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PATHOLOGY REPORT PAGE : 2/ 151

 TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TABLE OF CONTENTS 

—————————————————————————————————————————————————————————————————————————

 PAGE : 

 

 AUTHENTICATION 3

 

 

PRINCIPAL SECTION 

 SUMMARY 4

 

 METHODS 6

 

 RESULTS 8

 

 CONCLUSIONS 11

 

 

 EXPLANATION OF CODES AND SYMBOLS 12

 

 

SUMMARY TABLES 

 SUMMARY INCIDENCE OF GRADINGS BY ORGAN/GROUP/SEX 

 STATUS AT NECROPSY: K0 

 Incidence table — Selected findings with grades 13

 

 NUMBER OF ANIMALS WITH 

 MICROSCOPIC FINDINGS BY ORGAN/GROUP/SEX 

 STATUS AT NECROPSY: K0 

 Incidence table — All microscopic findings 23

 

 

INDIVIDUAL ANIMAL DATA 

 TABLE OF INDIVIDUAL MICROSCOPIC FINDINGS (AOFT) 31

 

 ANIMAL HEADING DATA DOSE GROUP 01 43

 

 TEXT OF GROSS AND MICROSCOPIC FINDINGS DOSE GROUP 01 44

 

 ANIMAL HEADING DATA DOSE GROUP 02 71

 

 TEXT OF GROSS AND MICROSCOPIC FINDINGS DOSE GROUP 02 72

 

 ANIMAL HEADING DATA DOSE GROUP 03 91

 

 TEXT OF GROSS AND MICROSCOPIC FINDINGS DOSE GROUP 03 92

 

 ANIMAL HEADING DATA DOSE GROUP 04 115

 

 TEXT OF GROSS AND MICROSCOPIC FINDINGS DOSE GROUP 04 116

 

Final Report - Page 100 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
- Page 101 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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PATHOLOGY REPORT PAGE : 4/ 151

PRINCIPAL SECTION TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

SUMMARY 

—————————————————————————————————————————————————————————————————————————

Pathomorphologic examination was performed on 40 Wistar-Han rats (20 

males, 20 females) which had been subjected to a 28 day oral (gavage) 

toxicity study with the test item m-(2,3-epoxypropoxy)-N,N-bis(2,3-

epoxypropyl)aniline. 

The rats were assigned to four dose groups, each containing 5 males and 

5 females. The test item was administered once daily by gavage at doses 

of 50, 150 and 450 mg/kg (dose Groups 2, 3 and 4 respectively) for 28

days. The rats of the control Group 1 received the vehicle, propylene 

glycol, alone. 

At the end of the treatment period all rats from all Groups were killed 

and subjected to complete necropsies. 

Histopathologic examination was performed on an extensive list of organs 

and tissues from all Group 1 and 4 animals as well as the thymus, 

stomach, duodenum, jejunum, Peyer’s patches, spleen, mesenteric lymph 

node, mandibular lymph nodes, adrenal glands and femur including joint 

from all Group 2 and 3 rats, the prostate gland, coagulating glands and 

seminal vesicles from all male Group 2 and 3 rats, the liver, uterus, 

cervix and vagina from all female Group 2 and 3 rats and all organs with 

macroscopic findings from all rats. 

There were no unscheduled deaths.

There were treatment-related macroscopic findings present at 

- 50 and 150 mg/kg in the pancreatic lymph node (discoloured).

- 150 and 450 mg/kg in the stomach (forestomach –irregular surface and –

discoloured focus/foci), duodenum and jejunum (wall thickened and 

contents gelatinous), mesenteric lymph node (discoloured), pancreatic

lymph node (enlarged and discoloured), adrenal glands (discoloured) and 

uterus (reduced in size).

- 450 mg/kg as general emaciation, in the thymus (reduced in size), 

renal lymph node (enlarged), kidneys (discoloured), ovaries (reduced in 

size), prostate gland (reduced in size) and seminal vesicles (reduced in 

size).

There were treatment-related microscopic findings present in males 

and/or females starting at

- 50 mg/kg (Group 2)

Duodenum, hemorrhage was present in male and female rats treated at 50, 

150 and at 450 mg/kg up to slight degree.

Duodenum, hypertrophy with villous stunting was present in male and 

female rats treated at 50, 150 and at 450 mg/kg up to moderate degree. 

This finding corresponded with the macroscopic finding wall thickened.

Peyer’s patches, lymphoid atrophy was present in females treated at 50 

mg/kg and in males and females treated at 150 and at 450 mg/kg up to 

moderate degree. 

Mesenteric lymph node, erythrophagocytosis was present in male and 

female rats treated at 50, 150 and at 450 mg/kg up to moderate degree. 

This finding correlated with the macroscopic finding discolouration 

reddish/dark red/purple. 

- 150 mg/kg (Group 3)

Stomach, ulcer forestomach was present in male rats treated at 150 mg/kg 

and in male and female rats at 450 mg/kg up to marked degree. This 

finding corresponded with the macroscopic finding forestomach

discoloured focus/foci. 

Final Report - Page 102 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 5/ 151

PRINCIPAL SECTION TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

SUMMARY 

—————————————————————————————————————————————————————————————————————————

- 150 mg/kg Continued

Stomach, hyperplasia forestomach was present in male and female rats 

treated at 150 and at 450 mg/kg up to marked degree. This finding was 

also present as a background finding in one 50 mg/kg treated male rat at 

minimal degree. This finding corresponded with the macroscopic finding 

forestomach irregular surface. 

Jejunum, hypertrophy with villous stunting was present in male and 

female rats treated at 150 and at 450 mg/kg up to moderate degree. This 

finding corresponded with the macroscopic finding wall thickened.

Mesenteric lymph node, lymphoid atrophy was present in male and female 

rats treated at 150 and at 450 mg/kg up to moderate degree.

Mesenteric lymph node, increased mast cells were present in male and 

female rats treated at 150 and at 450 mg/kg up to moderate degree.

Liver, centrilobular hypertrophy was present in female rats treated at 

150 and 450 mg/kg up to slight degree.

Uterus, cervix and vagina, atrophy was present in female rats treated at 

150 and 450 mg/kg.

- 450 mg/kg (Group 4)

Thymus, lymphoid atrophy was present in male and female rats treated at 

450 mg/kg up to marked degree. This finding corresponded with the 

macroscopic finding reduced in size. 

Jejunum, hemorrhage was present in male and female rats treated at 450 

mg/kg up to slight degree.

Spleen, lymphoid atrophy was present in male and female rats treated at 

450 mg/kg up to slight degree.

Adrenal glands, vacuolation zona fasciculata was present at increased 

incidence and severity in male and female rats treated at 450 mg/kg up 

to slight degree. The minimal incidence (1/5) and severity (minimal) 

present in males treated at 50 and 150 mg/kg is considered to be within 

background. This finding corresponded with the macroscopic finding 

discoloured.

Femur including joint, decreased bone, secondary spongiosa was present 

in male and female rats treated at 450 mg/kg up to moderate degree.

This was likely related to the emaciation. 

Prostate gland, small with normal histology was present in male rats 

treated at 450 mg/kg. This finding corresponded with the macroscopic 

finding reduced in size. 

Seminal vesicles, reduced contents was bilaterally present in male rats 

treated at 450 mg/kg at slight degree and, as background finding, it was 

unilaterally present in 1/5 control Group rats at moderate degree. This 

finding corresponded with the macroscopic finding reduced in size. 

Coagulating glands, reduced contents was present in male rats treated at 

450 mg/kg at slight degree.

After 28 days treatment with test item m-(2,3-epoxypropoxy) -N,Nbis(2,3-epoxypropyl)aniline there are adverse finding in the form of 

hemorrhage and hypertrophy with villous stunting in the duodenum in both 

sexes at 50 mg/kg; therefore, no dose Group is without adverse findings. 

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PATHOLOGY REPORT PAGE : 6/ 151

PRINCIPAL SECTION TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

METHODS 

—————————————————————————————————————————————————————————————————————————

Study Design

Group Dose level Dose volume Number of animals Animal numbers

mg/kg mL/kg Males Females Males Females

1 0 (vehicle) 5 5 5 1-5 21-25

2 50 5 5 5 6-10 26-30

3 150 5 5 5 11-15 31-35

4 450 5 5 5 16-20 36-40

Administration of the Test Item

The test item m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline was 

administered once daily by gavage for 28 days. The rats of the control 

Group 1 received the vehicle, propylene glycol, alone. 

Necropsy and Histopathology

At the end of the treatment period all animals from all Groups were 

killed. All rats were subjected to complete necropsies. All macroscopic 

abnormalities observed were recorded. 

From the surviving animals, the terminal body weight and the weights of 

the adrenal glands, brain, epididymides, heart, kidneys, liver, ovaries, 

spleen, testes, thymus and uterus (including cervix) were recorded at 

necropsy. Weights of prostate gland, seminal vesicles with coagulating 

glands and thyroid including parathyroid were recorded after fixation 

for at least 24 hours. Body and organ weights are reported in the main 

toxicology report.

Representative tissue samples were preserved from all animals/sex/group. 

Testes, epididymides and eyes (with optic nerves and Harderian glands) 

were initially fixed in Modified Davidson's solution for at least 24 

hours. All other organ samples were fixed in 4% phosphate buffered 

neutral formaldehyde solution (10% formalin). Adrenal glands(2), 

[aorta], brain (cerebellum, mid-brain, cortex)(3), [clitoral gland], 

epididymides(2), [esophagus], eyes [with optic nerve and Harderian 

glands](2), femur including joint(1), heart(1), kidneys(2), [lacrimal 

gland, exorbital], [larynx], large intestine(3): caecum, colon and 

rectum, liver(2), lungs(2), lymph nodes: mandibular(1), -mesenteric(1), 

[nasopharynx], [female mammary gland area], ovaries(2), [pancreas], 

[pituitary gland], [preputial gland], prostate gland(1), [salivary 

glands: mandibular, sublingual], sciatic nerve(1), seminal vesicles with 

coagulating glands(2), skeletal muscle(1), [skin], spinal cord(3): 

cervical, midthoracic and lumbar, small intestine(3): duodenum, jejenum 

and ileum with Peyer's patches, spleen(1), sternum with bone marrow(1), 

stomach(1), testes(2), thymus(1), thyroid glands(2) with parathyroid 

glands(2), [tongue], trachea(1), urinary bladder(1), uterus(3), 

cervix(1), vagina(1) and all gross lesions.

Following fixation, organs (except those listed in brackets) from all 

Group 1 and 4 rats as well as all organs with macroscopic findings from 

all rats were trimmed, processed and embedded in paraffin wax. After 

histopathologic examination slides of the thymus, stomach, duodenum, 

jejunum, Peyer’s patches, spleen, mesenteric lymph node, mandibular 

lymph nodes, adrenal glands and femur including joint from all Group 2 

and 3 rats, the prostate gland, coagulating glands and seminal vesicles 

from all male Group 2 and 3 rats, the liver, uterus, cervix and vagina 

from all female Group 2 and 3 rats were prepared and examined. 

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PATHOLOGY REPORT PAGE : 7/ 151

PRINCIPAL SECTION TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

METHODS 

—————————————————————————————————————————————————————————————————————————

All sections were cut at a thickness of 2-4 micrometers and stained with 

hematoxylin and eosin. Number of sections made are given in parentheses.

All sections were examined by light microscopy in the period 28 January 

– 20 February 2013.

Data Compilation

The animal data and macroscopic findings were electronically transferred 

from the necropsy raw data files of Toxdata system® into the computer 

system PathData© where the microscopic findings were recorded by the 

undersigned pathologist using on-line input under pathology number: 

41310 JOL.

All macroscopic and microscopic findings are given for each animal in 

text form under "Text of Gross and Microscopic Findings". The incidence 

of microscopic findings is also presented in tabular form: “Incidence 

table - all microscopic findings” and “Incidence table – Selected 

findings with grades”. Incidence tables were created by computer.

Histopathological changes were described according to distribution, 

severity and morphological character.

Severity scores were assigned as follows: 

Grade "1": Minimal/very few/very small.

Grade "2": Slight/few/small.

Grade "3": Moderate/moderate number/moderate size.

Grade "4": Marked/many/large.

Grade "5": Massive/extensive number/extensive size.

Grade "p": Finding present, grading not scored.

In the case of findings in bilaterally affected paired organs, the 

severity score of the worst affected organ was recorded and a comment 

was made listing the severity score in the contralateral organ. 

Peer Review

Microscopic findings were subjected to a review by Eric van Esch 

(reviewing pathologist; InSight Pathology B.V.) whereby the reviewer and

study pathologist reached consensus.

Final Report - Page 105 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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PATHOLOGY REPORT PAGE : 8/ 151

PRINCIPAL SECTION TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

RESULTS 

—————————————————————————————————————————————————————————————————————————

Mortality

There were no unscheduled deaths. 

Macroscopic Findings 

Treatment-related macroscopic findings present were

General Observations, emaciated was noted in 4/5 male and 5/5 female 450 

mg/kg treated rats. 

Thymus, reduced in size was noted in 5/5 male and 4/5 female 450 mg/kg 

treated rats.

Stomach, forestomach irregular surface was noted in 5/5 male and 3/5 

female 150 mg/kg and in 4/5 male and 5/5 female 450 mg/kg treated rats.

Stomach, forestomach focus/foci, yellowish/tan, reddish/dark red was 

noted in 1/5 male 150 mg/kg and in 3/5 female 450 mg/kg treated rats.

Duodenum, wall thickened/dilation was noted in 3/5 male and 3/5 female 

150 mg/kg and in 4/5 male and 4/5 female 450 mg/kg treated rats.

Duodenum, contents gelatinous was noted in 3/5 male and 2/5 female 150 

mg/kg and in 4/5 male and 4/5 female 450 mg/kg treated rats.

Jejunum, wall thickened/dilation was noted in 2/5 male and 2/5 female 

150 mg/kg and in 4/5 male and 4/5 female 450 mg/kg treated rats. 

Jejunum, contents/contains fluid gelatinous was noted in 2/5 male and 

1/5 female 150 mg/kg and in 4/5 male and 5/5 female 450 mg/kg treated 

rats. There was no microscopic correlate to this finding.

Mesenteric lymph node, discolouration reddish/dark red/purple was noted 

in 4/5 male and 2/5 female 150 mg/kg and in 5/5 male and 4/5 female 450 

mg/kg treated rats.

Pancreatic lymph node, enlarged was noted in 2/5 male and 1/5 female 150 

mg/kg and 3/5 male and 4/5 female 450 mg/kg treated rats.

Pancreatic lymph node, discolouration reddish was noted in 1/5 female 50 

mg/kg and in 1/5 male and 2/5 female 150 mg/kg treated rats.

Renal lymph node, enlarged was noted in 1/5 male and 1/5 female 450 

mg/kg treated rats.

Adrenal glands, discolouration pale was noted in 1/5 female 150 mg/kg 

and in 4/5 male and 4/5 female 450 mg/kg treated rats.

Kidneys, discolouration greenish was noted in 5/5 male and 5/5 female 

450 mg/kg treated rats.

Uterus, reduced in size was noted in 1/5 150 mg/kg and in 5/5 450 mg/kg 

treated rats.

Ovaries, reduced in size was noted in 3/5 450 mg/kg treated rats.

Prostate gland, reduced in size was noted in 5/5 450 mg/kg treated rats.

Seminal vesicles, reduced in size was noted in 5/5 450 mg/kg treated 

rats.

Final Report - Page 106 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 9/ 151

PRINCIPAL SECTION TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL 

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

RESULTS 

—————————————————————————————————————————————————————————————————————————

Microscopic Findings

There were treatment-related microscopic findings present in males 

and/or females starting at

- 50 mg/kg (Group 2)

Duodenum, hemorrhage was present in 4/5 male (4 minimal) and 3/5 female 

(3 minimal) rats at 50 mg/kg, in 3/5 male (3 minimal) and 4/5 female (1 

minimal, 3 slight) rats at 150 mg/kg and in 5/5 male (2 minimal, 3 

slight) and 4/5 female (2 minimal, 2 slight) rats treated at 450 mg/kg.

Duodenum, hypertrophy with villous stunting was present in 5/5 male (4 

minimal, 1 slight) and 5/5 female (2 minimal, 3 slight) rats treated at 

50 mg/kg, in 5/5 male (5 slight) and 5/5 female (1 minimal, 3 slight, 1 

moderate) rats treated at 150 mg/kg and in 5/5 male (1 slight, 4 

moderate) and 5/5 female (4 slight, 1 moderate) rats treated at 450 

mg/kg. This finding corresponded with the macroscopic finding wall 

thickened.

Peyer’s patches, lymphoid atrophy was present in 1/5 female (1 slight)

treated at 50 mg/kg, in 1/5 male (1 slight) and 1/5 female (1 moderate) 

rats treated at 150 and in 3/5 male (2 minimal, 1 slight) and 4/5 female 

(1 minimal, 3 slight) rats at 450 mg/kg.

Mesenteric lymph node, erythrophagocytosis was present in 1/5 male 

(slight) and 1/5 female (minimal) rats treated at 50 mg/kg, in 5/5 male 

(3 slight, 2 moderate) and 3/5 female (3 slight) rats at 150 mg/kg and 

in 5/5 male (5 moderate) and 5/5 female (3 slight, 2 moderate) rats at 

450 mg/kg. This finding correlated with the macroscopic finding 

discolouration reddish/dark red/purple. 

- 150 mg/kg (Group 3)

Stomach, ulcer forestomach was present in 2/5 male rat (1 slight, 1 

moderate) treated at 150 mg/kg and in 5/5 male (1 moderate, 4 marked) 

and 5/5 female (5 marked) rats at 450 mg/kg. This finding corresponded 

with the macroscopic finding forestomach discoloured focus/foci. 

Stomach, hyperplasia forestomach was present at increased incidence and 

severity in 5/5 male (3 slight, 2 moderate) and 5/5 female (3 minimal, 1 

slight, 1 moderate) rats treated at 150 mg/kg and in 5/5 male (2 slight, 

3 moderate) and 5/5 female (4 moderate, 1 marked) rats at 450 mg/kg. 

This finding was present at a background incidence and severity in 1/5 

male (minimal) 50 mg/kg treated. This finding corresponded with the 

macroscopic finding forestomach irregular surface. 

Jejunum, hypertrophy with villous stunting was present in 2/5 male (1 

minimal, 1 slight) and 1/5 female (1 minimal) rats at 150 mg/kg and in 

5/5 male (3 slight, 2 moderate) and 5/5 female (1 minimal, 4 slight) 

rats at 450 mg/kg. This finding corresponded with the macroscopic 

finding wall thickened.

Mesenteric lymph node, lymphoid atrophy was present in 3/5 male (3 

minimal) and 2/5 female (2 minimal) rats treated at 150 mg/kg and in 5/5 

male (1 minimal, 2 slight, 2 moderate) and 4/5 female (2 minimal, 2 

slight) rats at 450 mg/kg.

Mesenteric lymph node, increased mast cells were present in 5/5 male (3 

slight, 2 moderate) and 3/5 female (3 slight) rats treated at 150 mg/kg 

and in 1/5 male (1 slight) and 2/5 female (2 slight) rats at 450 mg/kg.

Final Report - Page 107 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

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PATHOLOGY REPORT PAGE : 10/ 151

PRINCIPAL SECTION TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

RESULTS 

—————————————————————————————————————————————————————————————————————————

Liver, centrilobular hypertrophy was present in 1/5 female (minimal) at 

150 mg/kg and in 5/5 female (1 minimal, 4 slight) rats treated at 450 

mg/kg.

Uterus, cervix and vagina, atrophy was present in 2/5 female rats 

treated at 150 and 5/5 female rats at 450 mg/kg.

- 450 mg/kg (Group 4)

Thymus, lymphoid atrophy was present in 5/5 male ( 1 minimal, 3 slight, 

1 marked) and 5/5 female (1 minimal, 2 slight, 2 moderate) rats treated 

at 450 mg/kg. This finding corresponded with the macroscopic finding 

reduced in size. 

Jejunum, hemorrhage was present in 3/5 male (2 minimal, 1 slight) and 

3/5 female (3 slight) rats treated at 450 mg/kg.

Spleen, lymphoid atrophy was present in 5/5 male (1 minimal, 4 slight) 

and 1/5 female (minimal) rats treated at 450 mg/kg.

Adrenal glands, vacuolation zona fasciculata was present at increased 

incidence and severity in 4/5 male (2 minimal, 2 slight) and 4/5 female 

(1 minimal, 3 slight) rats treated at 450 mg/kg. This finding was 

present at a background incidence and severity in 1/5 male (minimal) at 

50 mg/kg and 1/5 male (minimal) at 150 mg/kg. This finding corresponded 

with the macroscopic finding discoloured.

Femur including joint, decreased bone, secondary spongiosa was present 

in 5/5 male (2 slight, 3 moderate) and 5/5 female (1 minimal, 3 slight, 

1 moderate) rats treated at 450 mg/kg. This was likely related to the 

emaciation. 

Prostate gland, small with normal histology was present in 5/5 male rats 

treated at 450 mg/kg. This finding corresponded with the macroscopic 

finding reduced in size. 

Seminal vesicles, reduced contents was bilaterally present in 5/5 male 

rats (5 slight) treated at 450 mg/kg and, as background finding, it was 

unilaterally present in 1/5 (moderate) control Group rat. This finding 

corresponded with the macroscopic finding reduced in size. 

Coagulating glands, reduced contents was present in 5/5 male (5 slight) 

rats treated at 450 mg/kg.

In addition, there were microscopic findings in organs that were only 

sampled in animals where they had macroscopic findings. 

Pancreatic lymph node, erythrophagocytosis was present in 1/5 female 50 

mg/kg (1 lymph node sampled), in 2/5 female and 1/5 male 150 mg/kg (3 

and 2 lymph nodes sampled respectively) treated rats. This correlated 

with the macroscopic finding discolouration reddish. 

Pancreatic lymph node, lymphoid hyperplasia was present 2/5 male and 3/5 

female 150 mg/kg (2 and 3 lymph nodes sampled respectively) and in 3/5 

male and 4/5 female 450 mg/kg (3 and 4 lymph nodes sampled respectively) 

treated rats. This correlated with the macroscopic finding enlarged.

Renal lymph node, lymphoid hyperplasia was present 1/5 male and 1/5 

female 450 mg/kg (both 1 lymph node sampled) treated rats. This 

correlated with the macroscopic finding enlarged.

All other microscopic findings recorded were considered to be within the 

normal range of background pathology encountered in rats of this age and 

strain.

Final Report - Page 108 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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PATHOLOGY REPORT PAGE : 11/ 151

PRINCIPAL SECTION TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

CONCLUSIONS 

—————————————————————————————————————————————————————————————————————————

Treatment-related morphologic alterations following the administration 

of m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline for 28 days to 

Wistar (HAN) rats, were present in all treated Groups starting at 50 

mg/kg. 

Treatment-related morphologic alterations consisted of 

hemorrhage and hypertrophy with villous stunting in the duodenum, 

lymphoid atrophy in the Peyer’s patches and erythrophagocytosis in the 

mesenteric lymph node starting at 50 mg/kg (Group 2) of; 

ulcer forestomach and hyperplasia forestomach in the stomach, 

hypertrophy with villous stunting in the jejunum, lymphoid atrophy and 

increased mast cells in the mesenteric lymph node, centrilobular 

hypertrophy in the liver and atrophy in the uterus, cervix and vagina

starting at 150 mg/kg (Group 3) and of;

lymphoid atrophy in the thymus, hemorrhage in the jejunum, lymphoid 

atrophy in the spleen, vacuolation zona fasciculata in the adrenal

glands, decreased bone, secondary spongiosa in the femur, small prostate

gland with normal histology and of reduced contents in the seminal

vesicles and coagulating glands at 450 mg/kg (Group 4). 

After 28 days treatment with test item m-(2,3-epoxypropoxy) -N,Nbis(2,3-epoxypropyl) aniline there are adverse findings in both sexes 

starting at 50 mg/kg; therefore, no dose Group is without adverse 

findings. 

Final Report - Page 109 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

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PATHOLOGY REPORT PAGE : 12/ 151

 TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

EXPLANATION OF CODES AND SYMBOLS 

—————————————————————————————————————————————————————————————————————————

CODES AND SYMBOLS USED AT ANIMAL LEVEL:

————————————————————————————————————————

M = Male animal 

F = Female animal 

K0 = Terminal sacrifice group 

CODES AND SYMBOLS USED AT ORGAN LEVEL:

———————————————————————————————————————

G = Gross observation checked off histologically 

* = Comment in text of individual animal data 

0 = Tissue not present for histologic examination 

' = Histologic examination not required 

+ = Organ examined, findings present 

— = Organ examined, no pathologic findings noted (AOFT only) 

( = Only one of paired organs examined/present 

CODES AND SYMBOLS USED AT FINDING LEVEL:

—————————————————————————————————————————

GRADE 1 = Minimal / very few / very small 

GRADE 2 = Slight / few / small 

GRADE 3 = Moderate / moderate number / moderate size 

GRADE 4 = Marked / many / large 

P = Finding present, severity not scored 

( = Finding unilateral in paired organs 

* = Comment in text of individual animal data 

Final Report - Page 110 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 13/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

SUMMARY INCIDENCE OF GRADINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — Selected findings with grades 

—————————————————————————————————————————————————————————————————————————

 SEX : MALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

THYMUS : 5 5 5 5 

— Lymphoid atrophy 

 GRADE 1 : — — — 1 

 GRADE 2 : — — — 3 

 GRADE 4 : — — — 1 

 

 TOTAL AFFECTED : — — — 5 

 MEAN GRADE/TISS.AFF.: — — — 2.2 

—————————————————————————————————————————————————————————————————————————

STOMACH : 5 5 5 5 

— Ulcer, forestomach 

 GRADE 2 : — — 1 — 

 GRADE 3 : — — 1 1 

 GRADE 4 : — — — 4 

 

 TOTAL AFFECTED : — — 2 5 

 MEAN GRADE/TISS.AFF.: — — 2.5 3.8 

.........................................................................

— Hyperpl., forestom. 

 GRADE 1 : — 1 — — 

 GRADE 2 : — — 3 2 

 GRADE 3 : — — 2 3 

 

 TOTAL AFFECTED : — 1 5 5 

 MEAN GRADE/TISS.AFF.: — 1.0 2.4 2.6 

—————————————————————————————————————————————————————————————————————————

DUODENUM : 5 5 5 5 

— Hemorrhage 

 GRADE 1 : — 4 3 2 

 GRADE 2 : — — — 3 

 

 TOTAL AFFECTED : — 4 3 5 

 MEAN GRADE/TISS.AFF.: — 1.0 1.0 1.6 

.........................................................................

Final Report - Page 111 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 14/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

SUMMARY INCIDENCE OF GRADINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — Selected findings with grades 

—————————————————————————————————————————————————————————————————————————

 SEX : MALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

DUODENUM CONT'D. 5 5 5 5 

— Hypertrophy 

 GRADE 1 : — 4 — — 

 GRADE 2 : — 1 5 1 

 GRADE 3 : — — — 4 

 

 TOTAL AFFECTED : — 5 5 5 

 MEAN GRADE/TISS.AFF.: — 1.2 2.0 2.8 

—————————————————————————————————————————————————————————————————————————

JEJUNUM : 5 5 5 5 

— Hemorrhage 

 GRADE 1 : — — — 2 

 GRADE 2 : — — — 1 

 

 TOTAL AFFECTED : — — — 3 

 MEAN GRADE/TISS.AFF.: — — — 1.3 

.........................................................................

— Hypertrophy 

 GRADE 1 : — — 1 — 

 GRADE 2 : — — 1 3 

 GRADE 3 : — — — 2 

 

 TOTAL AFFECTED : — — 2 5 

 MEAN GRADE/TISS.AFF.: — — 1.5 2.4 

—————————————————————————————————————————————————————————————————————————

PEYER'S PATCHES : 5 5 4 3 

— Lymphoid atrophy 

 GRADE 1 : — — — 2 

 GRADE 2 : — — 1 1 

 

 TOTAL AFFECTED : — — 1 3 

 MEAN GRADE/TISS.AFF.: — — 2.0 1.3 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 112 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 15/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

SUMMARY INCIDENCE OF GRADINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — Selected findings with grades 

—————————————————————————————————————————————————————————————————————————

 SEX : MALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

SPLEEN : 5 5 5 5 

— Hemopoietic foci 

 GRADE 1 : 5 2 5 2 

 GRADE 2 : — — — 3 

 

 TOTAL AFFECTED : 5 2 5 5 

 MEAN GRADE/TISS.AFF.: 1.0 1.0 1.0 1.6 

.........................................................................

— Lymphoid atrophy 

 GRADE 1 : — — — 1 

 GRADE 2 : — — — 4 

 

 TOTAL AFFECTED : — — — 5 

 MEAN GRADE/TISS.AFF.: — — — 1.8 

—————————————————————————————————————————————————————————————————————————

MESENT. LYMPH NODE : 5 5 5 5 

— Lymphoid atrophy 

 GRADE 1 : — — 3 1 

 GRADE 2 : — — — 2 

 GRADE 3 : — — — 2 

 

 TOTAL AFFECTED : — — 3 5 

 MEAN GRADE/TISS.AFF.: — — 1.0 2.2 

......................................................................... 

— Increased mast cells 

 GRADE 2 : — — 3 1 

 GRADE 3 : — — 2 — 

 

 TOTAL AFFECTED : — — 5 1 

 MEAN GRADE/TISS.AFF.: — — 2.4 2.0 

.........................................................................

— Erythrophagocytosis 

 GRADE 2 : — 1 3 — 

 GRADE 3 : — — 2 5 

 

 TOTAL AFFECTED : — 1 5 5 

 MEAN GRADE/TISS.AFF.: — 2.0 2.4 3.0 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 113 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 16/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

SUMMARY INCIDENCE OF GRADINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — Selected findings with grades 

—————————————————————————————————————————————————————————————————————————

 SEX : MALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

ADRENAL GLANDS : 5 5 5 5 

— Vacuolation, z.fas. 

 GRADE 1 : — 1 1 2 

 GRADE 2 : — — — 2 

 

 TOTAL AFFECTED : — 1 1 4 

 MEAN GRADE/TISS.AFF.: — 1.0 1.0 1.5 

—————————————————————————————————————————————————————————————————————————

SEMINAL VESICLES : 5 5 5 5 

— Reduced contents 

 GRADE 2 : — — — 5 

 GRADE 3 : 1 — — — 

 

 TOTAL AFFECTED : 1 — — 5 

 MEAN GRADE/TISS.AFF.: 3.0 — — 2.0 

—————————————————————————————————————————————————————————————————————————

COAGULATING GLANDS : 5 5 5 5 

— Reduced contents 

 GRADE 2 : — — — 5 

 

 TOTAL AFFECTED : — — — 5 

 MEAN GRADE/TISS.AFF.: — — — 2.0 

—————————————————————————————————————————————————————————————————————————

FEMUR : 5 5 5 5 

— Decreased bone, 

 GRADE 2 : — — — 2 

 GRADE 3 : — — — 3 

 

 TOTAL AFFECTED : — — — 5 

 MEAN GRADE/TISS.AFF.: — — — 2.6 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 114 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 17/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

SUMMARY INCIDENCE OF GRADINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — Selected findings with grades 

—————————————————————————————————————————————————————————————————————————

 SEX : MALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

PANCREATIC LYMPH NO. : — — 2 3 

— Erythrophagocytosis 

 GRADE 3 : — — 1 — 

 

 TOTAL AFFECTED : — — 1 — 

 MEAN GRADE/TISS.AFF.: — — 3.0 — 

.........................................................................

— Lymphoid hyperplasia 

 GRADE 1 : — — 1 — 

 GRADE 2 : — — — 1 

 GRADE 3 : — — 1 1 

 GRADE 4 : — — — 1 

 

 TOTAL AFFECTED : — — 2 3 

 MEAN GRADE/TISS.AFF.: — — 2.0 3.0 

—————————————————————————————————————————————————————————————————————————

RENAL LYMPH NODE : — — — 1 

— Lymphoid hyperplasia 

 GRADE 2 : — — — 1 

 

 TOTAL AFFECTED : — — — 1 

 MEAN GRADE/TISS.AFF.: — — — 2.0 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 115 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 18/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

SUMMARY INCIDENCE OF GRADINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — Selected findings with grades 

—————————————————————————————————————————————————————————————————————————

 SEX : FEMALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

THYMUS : 5 5 5 5 

— Lymphoid atrophy 

 GRADE 1 : — — — 1 

 GRADE 2 : — — — 2 

 GRADE 3 : — — — 2 

 

 TOTAL AFFECTED : — — — 5 

 MEAN GRADE/TISS.AFF.: — — — 2.2 

—————————————————————————————————————————————————————————————————————————

STOMACH : 5 5 5 5 

— Ulcer, forestomach 

 GRADE 4 : — — — 5 

 

 TOTAL AFFECTED : — — — 5 

 MEAN GRADE/TISS.AFF.: — — — 4.0 

.........................................................................

— Hyperpl., forestom. 

 GRADE 1 : — — 3 — 

 GRADE 2 : — — 1 — 

 GRADE 3 : — — 1 4 

 GRADE 4 : — — — 1 

 

 TOTAL AFFECTED : — — 5 5 

 MEAN GRADE/TISS.AFF.: — — 1.6 3.2 

—————————————————————————————————————————————————————————————————————————

DUODENUM : 5 5 5 5 

— Hemorrhage 

 GRADE 1 : — 3 1 2 

 GRADE 2 : — — 3 2 

 

 TOTAL AFFECTED : — 3 4 4 

 MEAN GRADE/TISS.AFF.: — 1.0 1.8 1.5 

.........................................................................

Final Report - Page 116 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 19/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

SUMMARY INCIDENCE OF GRADINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — Selected findings with grades 

—————————————————————————————————————————————————————————————————————————

 SEX : FEMALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

DUODENUM CONT'D. 5 5 5 5 

— Hypertrophy 

 GRADE 1 : — 2 1 — 

 GRADE 2 : — 3 3 4 

 GRADE 3 : — — 1 1 

 

 TOTAL AFFECTED : — 5 5 5 

 MEAN GRADE/TISS.AFF.: — 1.6 2.0 2.2 

—————————————————————————————————————————————————————————————————————————

JEJUNUM : 5 5 5 5 

— Hemorrhage 

 GRADE 2 : — — — 3 

 

 TOTAL AFFECTED : — — — 3 

 MEAN GRADE/TISS.AFF.: — — — 2.0 

.........................................................................

— Hypertrophy 

 GRADE 1 : — — 1 1 

 GRADE 2 : — — — 4 

 

 TOTAL AFFECTED : — — 1 5 

 MEAN GRADE/TISS.AFF.: — — 1.0 1.8 

—————————————————————————————————————————————————————————————————————————

PEYER'S PATCHES : 5 5 5 5 

— Lymphoid atrophy 

 GRADE 1 : — — — 1 

 GRADE 2 : — 1 — 3 

 GRADE 3 : — — 1 — 

 

 TOTAL AFFECTED : — 1 1 4 

 MEAN GRADE/TISS.AFF.: — 2.0 3.0 1.8 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 117 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 20/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

SUMMARY INCIDENCE OF GRADINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — Selected findings with grades 

—————————————————————————————————————————————————————————————————————————

 SEX : FEMALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

LIVER : 5 5 5 5 

— Hypertrophy, centril 

 GRADE 1 : — — 1 1 

 GRADE 2 : — — — 4 

 

 TOTAL AFFECTED : — — 1 5 

 MEAN GRADE/TISS.AFF.: — — 1.0 1.8 

—————————————————————————————————————————————————————————————————————————

SPLEEN : 5 5 5 5 

— Hemopoietic foci 

 GRADE 1 : 1 2 2 4 

 GRADE 2 : — — — 1 

 

 TOTAL AFFECTED : 1 2 2 5 

 MEAN GRADE/TISS.AFF.: 1.0 1.0 1.0 1.2 

.........................................................................

— Lymphoid atrophy 

 GRADE 1 : — — — 1 

 

 TOTAL AFFECTED : — — — 1 

 MEAN GRADE/TISS.AFF.: — — — 1.0 

—————————————————————————————————————————————————————————————————————————

MESENT. LYMPH NODE : 5 5 5 5 

— Lymphoid atrophy 

 GRADE 1 : — — 2 2 

 GRADE 2 : — — — 2 

 

 TOTAL AFFECTED : — — 2 4 

 MEAN GRADE/TISS.AFF.: — — 1.0 1.5 

.........................................................................

— Increased mast cells 

 GRADE 2 : — — 3 2 

 

 TOTAL AFFECTED : — — 3 2 

 MEAN GRADE/TISS.AFF.: — — 2.0 2.0 

.........................................................................

Final Report - Page 118 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 21/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

SUMMARY INCIDENCE OF GRADINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — Selected findings with grades 

—————————————————————————————————————————————————————————————————————————

 SEX : FEMALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

MESENT. LYMPH NODE : 5 5 5 5 

— Erythrophagocytosis 

 GRADE 1 : — 1 — — 

 GRADE 2 : — — 3 3 

 GRADE 3 : — — — 2 

 

 TOTAL AFFECTED : — 1 3 5 

 MEAN GRADE/TISS.AFF.: — 1.0 2.0 2.4 

—————————————————————————————————————————————————————————————————————————

ADRENAL GLANDS : 5 5 5 5 

— Vacuolation, z.fas. 

 GRADE 1 : — — — 1 

 GRADE 2 : — — — 3 

 

 TOTAL AFFECTED : — — — 4 

 MEAN GRADE/TISS.AFF.: — — — 1.8 

—————————————————————————————————————————————————————————————————————————

FEMUR : 5 5 5 5 

— Decreased bone, 

 GRADE 1 : — — — 1 

 GRADE 2 : — — — 3 

 GRADE 3 : — — — 1 

 

 TOTAL AFFECTED : — — — 5 

 MEAN GRADE/TISS.AFF.: — — — 2.0 

—————————————————————————————————————————————————————————————————————————

PANCREATIC LYMPH NO. : — 1 3 4 

— Erythrophagocytosis 

 GRADE 2 : — 1 1 — 

 GRADE 3 : — — 1 — 

 

 TOTAL AFFECTED : — 1 2 — 

 MEAN GRADE/TISS.AFF.: — 2.0 2.5 — 

.........................................................................

Final Report - Page 119 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 22/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

SUMMARY INCIDENCE OF GRADINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — Selected findings with grades 

—————————————————————————————————————————————————————————————————————————

 SEX : FEMALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

PANCREATIC LYMPH NO. : — 1 3 4 

— Lymphoid hyperplasia 

 GRADE 2 : — — 2 1 

 GRADE 3 : — — 1 3 

 

 TOTAL AFFECTED : — — 3 4 

 MEAN GRADE/TISS.AFF.: — — 2.3 2.8 

—————————————————————————————————————————————————————————————————————————

RENAL LYMPH NODE : — — — 2 

— Lymphoid hyperplasia 

 GRADE 2 : — — — 1 

 

 TOTAL AFFECTED : — — — 1 

 MEAN GRADE/TISS.AFF.: — — — 2.0 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 120 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 23/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13 

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

NUMBER OF ANIMALS WITH MICROSCOPIC FINDINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — All microscopic findings 

—————————————————————————————————————————————————————————————————————————

 SEX : MALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

GENERAL OBSERVATIONS : — — — 4 

— Macro Noted : — — — 4 

—————————————————————————————————————————————————————————————————————————

HEART : 5 — — 5 

— Inflamm. lymphocytic: 1 — — — 

—————————————————————————————————————————————————————————————————————————

LUNG : 5 — — 5 

— Alv. macrophages : 1 — — 3 

— Inflamm. infiltrate : 2 — — — 

— Alveolar inflamm. : 1 — — — 

— Lymphoid hyperplasia: 1 — — — 

—————————————————————————————————————————————————————————————————————————

THYMUS : 5 5 5 5 

— Lymphocytolysis : — — — 3 

— Lymphoid atrophy : — — — 5 

—————————————————————————————————————————————————————————————————————————

TRACHEA : 5 — — 5 

— Inflamm. lymphogran.: 3 — — — 

—————————————————————————————————————————————————————————————————————————

THYROID GLAND : 5 — — 5 

— Hyperpl./hypertrophy: 2 — — 1 

—————————————————————————————————————————————————————————————————————————

PARATHYROID GLANDS : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

STOMACH : 5 5 5 5 

— Forestom. inflamm. : — — 3 — 

— Ulcer, forestomach : — — 2 5 

— Hyperpl., forestom. : — 1 5 5 

— Hemorrhage : — — — 1 

— Cyst(s) : 1 — — — 

—————————————————————————————————————————————————————————————————————————

DUODENUM : 5 5 5 5 

— Hemorrhage : — 4 3 5 

— Hypertrophy : — 5 5 5 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 121 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 24/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

NUMBER OF ANIMALS WITH MICROSCOPIC FINDINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — All microscopic findings 

—————————————————————————————————————————————————————————————————————————

 SEX : MALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

JEJUNUM : 5 5 5 5 

— Hemorrhage : — — — 3 

— Hypertrophy : — — 2 5 

—————————————————————————————————————————————————————————————————————————

ILEUM : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

PEYER'S PATCHES : 5 5 4 3 

— Lymphoid atrophy : — — 1 3 

— Vacuolation : 1 — — — 

—————————————————————————————————————————————————————————————————————————

CECUM : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

COLON : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

RECTUM : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

LIVER : 5 — 1 5 

— Inflamm. cell foci : 4 — — 3 

— Apoptos/s.cell necro: — — — 1 

—————————————————————————————————————————————————————————————————————————

SPLEEN : 5 5 5 5 

— Hemopoietic foci : 5 2 5 5 

— Hemosiderin pigment : 3 4 3 2 

— Lymphoid atrophy : — — — 5 

—————————————————————————————————————————————————————————————————————————

MESENT. LYMPH NODE : 5 5 5 5 

— Lymphoid atrophy : — — 3 5 

— Increased mast cells: — — 5 1 

— Lymphatic ectasia : — — — 2 

— Macrophage foci : 2 — — — 

— Erythrophagocytosis : — 1 5 5 

—————————————————————————————————————————————————————————————————————————

MANDIB.LYMPH NODES : 5 5 5 4 

— Lymphoid atrophy : — — 1 4 

— Erythrophagocytosis : 1 — 1 — 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 122 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 25/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

NUMBER OF ANIMALS WITH MICROSCOPIC FINDINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — All microscopic findings 

—————————————————————————————————————————————————————————————————————————

 SEX : MALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

KIDNEYS : 5 — 2 5 

— Pelvic dilation : — — 1 — 

— Hyaline droplets : 3 — 2 — 

— Inflamm., interstit.: 2 — — 1 

— Basophilia, tubular : 3 — — 2 

—————————————————————————————————————————————————————————————————————————

URINARY BLADDER : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

ADRENAL GLANDS : 5 5 5 5 

— Vacuolation, z.fas. : — 1 1 4 

—————————————————————————————————————————————————————————————————————————

BRAIN : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

SCIATIC NERVE : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

TESTES : 5 — — 5 

— Sperm. giant cells : — — — 1 

—————————————————————————————————————————————————————————————————————————

EPIDIDYMIDES : 5 — — 5 

— Sperm granuloma : 1 — — — 

— Semin. cell debris : — — — 1 

— Inflamm. lymphocytic: — — — 1 

—————————————————————————————————————————————————————————————————————————

PROSTATE GLAND : 5 5 5 5 

— Small, normal histo.: — — — 5 

— Inflamm. lymphocytic: — 1 — — 

—————————————————————————————————————————————————————————————————————————

SEMINAL VESICLES : 5 5 5 5 

— Reduced contents : 1 — — 5 

—————————————————————————————————————————————————————————————————————————

COAGULATING GLANDS : 5 5 5 5 

— Reduced contents : — — — 5 

—————————————————————————————————————————————————————————————————————————

SKELETAL MUSCLE : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

EYES : 5 — — 5 

— Retinal rosettes : — — — 1 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 123 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 26/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

NUMBER OF ANIMALS WITH MICROSCOPIC FINDINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — All microscopic findings 

—————————————————————————————————————————————————————————————————————————

 SEX : MALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

BONE, STERNUM : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

BONE MARROW — STERN. : 5 — — 5 

— Adipocytes : 1 — — 3 

—————————————————————————————————————————————————————————————————————————

SPINAL CORD — THOR. : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

SPINAL CORD — LUMBAR : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

SPINAL CORD — CERV. : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

FEMUR : 5 5 5 5 

— Decreased bone, : — — — 5 

—————————————————————————————————————————————————————————————————————————

JOINTS, KNEE : 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

PANCREATIC LYMPH NO. : — — 2 3 

— Erythrophagocytosis : — — 1 — 

— Lymphatic ectasia : — — 2 2 

— Lymphoid hyperplasia: — — 2 3 

—————————————————————————————————————————————————————————————————————————

RENAL LYMPH NODE : — — — 1 

— Lymphoid hyperplasia: — — — 1 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 124 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 27/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

NUMBER OF ANIMALS WITH MICROSCOPIC FINDINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — All microscopic findings 

—————————————————————————————————————————————————————————————————————————

 SEX : FEMALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

GENERAL OBSERVATIONS : — — — 5 

— Macro Noted : — — — 5 

—————————————————————————————————————————————————————————————————————————

HEART : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

LUNG : 5 — — 5 

— Alv. macrophages : 1 — — 2 

— Inflamm. infiltrate : 2 — — — 

— Alveolar inflamm. : 2 — — 2 

—————————————————————————————————————————————————————————————————————————

THYMUS : 5 5 5 5 

— Lymphocytolysis : 1 — — 3 

— Lymphoid atrophy : — — — 5 

—————————————————————————————————————————————————————————————————————————

TRACHEA : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

THYROID GLAND : 5 — — 5 

— Ectopic thymus : 1 — — — 

—————————————————————————————————————————————————————————————————————————

PARATHYROID GLANDS : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

STOMACH : 5 5 5 5 

— Forestom. inflamm. : — — 1 — 

— Ulcer, forestomach : — — — 5 

— Edema : — — 2 — 

— Hyperpl., forestom. : — — 5 5 

— Vacuol. lim. ridge : 1 — — — 

— Hemorrhage : — — — 1 

—————————————————————————————————————————————————————————————————————————

DUODENUM : 5 5 5 5 

— Hemorrhage : — 3 4 4 

— Hypertrophy : — 5 5 5 

—————————————————————————————————————————————————————————————————————————

JEJUNUM : 5 5 5 5 

— Hemorrhage : — — — 3 

— Hypertrophy : — — 1 5 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 125 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 28/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

NUMBER OF ANIMALS WITH MICROSCOPIC FINDINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — All microscopic findings 

—————————————————————————————————————————————————————————————————————————

 SEX : FEMALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

ILEUM : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

PEYER'S PATCHES : 5 5 5 5 

— Lymphoid atrophy : — 1 1 4 

—————————————————————————————————————————————————————————————————————————

CECUM : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

COLON : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

RECTUM : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

LIVER : 5 5 5 5 

— Inflamm. cell foci : 4 5 5 1 

— Apoptos/s.cell necro: 2 — 2 — 

— Hypertrophy, centril: — — 1 5 

— Necrosis, coag. : — — 1 — 

—————————————————————————————————————————————————————————————————————————

SPLEEN : 5 5 5 5 

— Hemopoietic foci : 1 2 2 5 

— Hemosiderin pigment : 3 5 5 1 

— Lymphoid atrophy : — — — 1 

—————————————————————————————————————————————————————————————————————————

MESENT. LYMPH NODE : 5 5 5 5 

— Lymphoid atrophy : — — 2 4 

— Increased mast cells: — — 3 2 

— Lymphatic ectasia : — — — 1 

— Erythrophagocytosis : — 1 3 5 

—————————————————————————————————————————————————————————————————————————

MANDIB.LYMPH NODES : 5 5 5 5 

— Lymphoid atrophy : — — — 5 

— Erythrophagocytosis : — — — 1 

— Plasmacytosis : — — 1 — 

—————————————————————————————————————————————————————————————————————————

KIDNEYS : 5 — — 5 

— Pelvic dilation : — — — 1 

— Inflamm., interstit.: 1 — — 2 

— Basophilia, tubular : 2 — — 1 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 126 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 29/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

NUMBER OF ANIMALS WITH MICROSCOPIC FINDINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — All microscopic findings 

—————————————————————————————————————————————————————————————————————————

 SEX : FEMALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

URINARY BLADDER : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

ADRENAL GLANDS : 5 5 5 5 

— Extracapsular nodule: — — 1 — 

— Vacuolation, z.fas. : — — — 4 

— Inflamm. lymphocytic: 1 — — — 

—————————————————————————————————————————————————————————————————————————

BRAIN : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

SCIATIC NERVE : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

OVARIES : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

UTERUS : 5 5 5 5 

— Atrophy : — — 2 5 

— Cyclic dilation : 2 1 — — 

—————————————————————————————————————————————————————————————————————————

CERVIX : 5 5 5 5 

— Atrophy : — — 2 5 

—————————————————————————————————————————————————————————————————————————

VAGINA : 5 5 5 5 

— Atrophy : — — 2 5 

— Proestrus epithelium: 2 1 — — 

—————————————————————————————————————————————————————————————————————————

SKELETAL MUSCLE : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

EYES : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

BONE, STERNUM : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

BONE MARROW — STERN. : 5 — — 5 

— Adipocytes : 2 — — 2 

—————————————————————————————————————————————————————————————————————————

SPINAL CORD — THOR. : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

SPINAL CORD — LUMBAR : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 127 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 30/ 151

SUMMARY TABLES TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

NUMBER OF ANIMALS WITH MICROSCOPIC FINDINGS BY ORGAN/GROUP/SEX 

STATUS AT NECROPSY: K0 

Incidence table — All microscopic findings 

—————————————————————————————————————————————————————————————————————————

 SEX : FEMALE

 DOSE GROUP: 01 02 03 04 

 NO.ANIMALS: 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

SPINAL CORD — CERV. : 5 — — 5 

—————————————————————————————————————————————————————————————————————————

FEMUR : 5 5 5 5 

— Decreased bone, : — — — 5 

—————————————————————————————————————————————————————————————————————————

JOINTS, KNEE : 5 5 5 5 

—————————————————————————————————————————————————————————————————————————

PANCREATIC LYMPH NO. : — 1 3 4 

— Erythrophagocytosis : — 1 2 — 

— Lymphatic ectasia : — — — 1 

— Lymphoid hyperplasia: — — 3 4 

—————————————————————————————————————————————————————————————————————————

RENAL LYMPH NODE : — — — 2 

— Erythrophagocytosis : — — — 1 

— Lymphoid hyperplasia: — — — 1 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 128 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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PATHOLOGY REPORT PAGE : 31/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TABLE OF INDIVIDUAL MICROSCOPIC FINDINGS (AOFT) 

DOSE GROUP : 01, CONTROL 

—————————————————————————————————————————————————————————————————————————

ANIMAL NUMBER : 

 1 2 3 4 5 21 22 23 24 25 

 MK0 MK0 MK0 MK0 MK0 FK0 FK0 FK0 FK0 FK0 

—————————————————————————————————————————————————————————————————————————

HEART — — — + — — — — — — 

— Inflamm. lymphocytic . . . 1. . . . . . . 

.........................................................................

LUNG + — + + + +* — + + + 

— Alv. macrophages . . 1. . . . . . . 1. 

— Inflamm. infiltrate . . 2. 1. . . . 1. 2. . 

— Alveolar inflamm. . . . . 1. 1. . . . 1. 

— Lymphoid hyperplasia 1. . . . . . . . . . 

.........................................................................

THYMUS — — — — — + — — — — 

— Lymphocytolysis . . . . . 1. . . . . 

.........................................................................

TRACHEA + + — — + — — — — — 

— Inflamm. lymphogran. 1. 1. . . 1. . . . . . 

.........................................................................

THYROID GLAND — + + — — — — + — — 

— Ectopic thymus . . . . . . . ( P. . . 

— Hyperpl./hypertrophy . 1. 1. . . . . . . . 

.........................................................................

PARATHYROID GLANDS — — — ( — — ( — — — — — 

.........................................................................

STOMACH — — + — — — — — + — 

— Vacuol. lim. ridge . . . . . . . . 1. . 

— Cyst(s) . . 1. . . . . . . . 

.........................................................................

DUODENUM — — — — — — — — — — 

.........................................................................

JEJUNUM — — — — — — — — — — 

.........................................................................

ILEUM — — — — — — — — — — 

.........................................................................

PEYER'S PATCHES — — + — — — — — — — 

— Vacuolation . . 1. . . . . . . . 

.........................................................................

CECUM — — — — — — — — — — 

.........................................................................

COLON — — — — — — — — — — 

.........................................................................

RECTUM — — — — — — — — — — 

.........................................................................

Final Report - Page 129 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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PATHOLOGY REPORT PAGE : 32/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TABLE OF INDIVIDUAL MICROSCOPIC FINDINGS (AOFT) 

DOSE GROUP : 01, CONTROL 

—————————————————————————————————————————————————————————————————————————

ANIMAL NUMBER : 

 1 2 3 4 5 21 22 23 24 25 

 MK0 MK0 MK0 MK0 MK0 FK0 FK0 FK0 FK0 FK0 

—————————————————————————————————————————————————————————————————————————

LIVER + + + — + + + + + — 

— Inflamm. cell foci 1. 1. 1. . 1. 1. 1. 1. 1. . 

— Apoptos/s.cell necro . . . . . 1. . 1. . . 

.........................................................................

SPLEEN + + + + + — + + + — 

— Hemopoietic foci 1. 1. 1. 1. 1. . . 1. . . 

— Hemosiderin pigment . 1. . 1. 1. . 1. 1. 1. . 

.........................................................................

MESENT. LYMPH NODE — + — + — — — — — — 

— Macrophage foci . 1. . 1. . . . . . . 

.........................................................................

MANDIB.LYMPH NODES — — — — + — — — — — 

— Erythrophagocytosis . . . . ( 1. . . . . . 

.........................................................................

KIDNEYS + + + + + + — — + — 

— Hyaline droplets 1. . 1. 2. . . . . . . 

— Inflamm., interstit. ( 1. . 1. . . . . . ( 1. . 

— Basophilia, tubular ( 1. 1. . . ( 1. ( 1. . . ( 1. . 

.........................................................................

URINARY BLADDER — — — — — — — — — — 

.........................................................................

ADRENAL GLANDS — — — — — + — — — — 

— Inflamm. lymphocytic . . . . . ( 1. . . . . 

.........................................................................

BRAIN — — — — — — — — — — 

.........................................................................

SCIATIC NERVE — — — — — — — — — — 

.........................................................................

TESTES — — — — — 

.........................................................................

EPIDIDYMIDES — — +G — — 

— Sperm granuloma . . 3* . . 

.........................................................................

OVARIES — — — — — 

.........................................................................

PROSTATE GLAND — — — — — 

.........................................................................

SEMINAL VESICLES +G — — — — 

— Reduced contents ( 3. . . . . 

.........................................................................

Final Report - Page 130 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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PATHOLOGY REPORT PAGE : 33/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TABLE OF INDIVIDUAL MICROSCOPIC FINDINGS (AOFT) 

DOSE GROUP : 01, CONTROL 

—————————————————————————————————————————————————————————————————————————

ANIMAL NUMBER : 

 1 2 3 4 5 21 22 23 24 25 

 MK0 MK0 MK0 MK0 MK0 FK0 FK0 FK0 FK0 FK0 

—————————————————————————————————————————————————————————————————————————

COAGULATING GLANDS — — — — — 

.........................................................................

UTERUS — +G +G — — 

— Cyclic dilation . P. P. . . 

.........................................................................

CERVIX — — — — — 

.........................................................................

VAGINA — + + — — 

— Proestrus epithelium . P. P. . . 

.........................................................................

SKELETAL MUSCLE — — — — — — — — — — 

.........................................................................

EYES — — — — — — — — — — 

.........................................................................

BONE, STERNUM — — — — — — — — — — 

.........................................................................

BONE MARROW — STERN. — — — — + + — — — + 

— Adipocytes . . . . 1. 1. . . . 1. 

.........................................................................

SPINAL CORD — THOR. — — — — — — — — — — 

.........................................................................

SPINAL CORD — LUMBAR — — — — — — — — — — 

.........................................................................

SPINAL CORD — CERV. — — — — — — — — — — 

.........................................................................

FEMUR — — — — — — — — — — 

.........................................................................

JOINTS, KNEE — — — — — — — — — — 

.........................................................................

PANCREATIC LYMPH NO. . . . . . . . . . . 

.........................................................................

RENAL LYMPH NODE . . . . . . . . . . 

.........................................................................

Final Report - Page 131 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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PATHOLOGY REPORT PAGE : 34/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TABLE OF INDIVIDUAL MICROSCOPIC FINDINGS (AOFT) 

DOSE GROUP : 02, 50 MG/KG 

—————————————————————————————————————————————————————————————————————————

ANIMAL NUMBER : 

 6 7 8 9 10 26 27 28 29 30 

 MK0 MK0 MK0 MK0 MK0 FK0 FK0 FK0 FK0 FK0 

—————————————————————————————————————————————————————————————————————————

THYMUS — — — — — — — — — — 

.........................................................................

STOMACH — + — — — — — — — — 

— Hyperpl., forestom. . 1. . . . . . . . . 

.........................................................................

DUODENUM + + + + + + + + + + 

— Hemorrhage 1. 1. 1. . 1. . . 1. 1. 1. 

— Hypertrophy 1. 2. 1. 1. 1. 1. 1. 2. 2. 2. 

.........................................................................

JEJUNUM — — — — — — — — — — 

.........................................................................

PEYER'S PATCHES — — — — — — — + — — 

— Lymphoid atrophy . . . . . . . 2. . . 

.........................................................................

LIVER ' ' ' ' ' + + + + + 

— Inflamm. cell foci 1. 1. 1. 1. 1. 

.........................................................................

SPLEEN + + — + + + + + + + 

— Hemopoietic foci . 1. . 1. . . 1. . 1. . 

— Hemosiderin pigment 1. 1. . 1. 1. 1. 1. 1. 1. 1. 

.........................................................................

MESENT. LYMPH NODE — — — + — — — — — + 

— Erythrophagocytosis . . . 2. . . . . . 1. 

.........................................................................

MANDIB.LYMPH NODES — — — — — — — — ( — — 

.........................................................................

ADRENAL GLANDS — — — — + — — — — — 

— Vacuolation, z.fas. . . . . 1. . . . . . 

.........................................................................

OVARIES . . . . . 

.........................................................................

PROSTATE GLAND — — + — — 

— Inflamm. lymphocytic . . 1. . . 

.........................................................................

SEMINAL VESICLES — — — — — 

.........................................................................

COAGULATING GLANDS — — — — — 

.........................................................................

Final Report - Page 132 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

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PATHOLOGY REPORT PAGE : 35/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TABLE OF INDIVIDUAL MICROSCOPIC FINDINGS (AOFT) 

DOSE GROUP : 02, 50 MG/KG 

—————————————————————————————————————————————————————————————————————————

ANIMAL NUMBER : 

 6 7 8 9 10 26 27 28 29 30 

 MK0 MK0 MK0 MK0 MK0 FK0 FK0 FK0 FK0 FK0 

—————————————————————————————————————————————————————————————————————————

UTERUS — — — — +G 

— Cyclic dilation . . . . P. 

.........................................................................

CERVIX — — — — — 

.........................................................................

VAGINA — — — — + 

— Proestrus epithelium . . . . P. 

.........................................................................

SKELETAL MUSCLE . . . . . . . . . . 

.........................................................................

EYES . . . . . . . . . . 

.........................................................................

BONE, STERNUM . . . . . . . . . . 

.........................................................................

BONE MARROW — STERN. . . . . . . . . . . 

.........................................................................

SPINAL CORD — THOR. . . . . . . . . . . 

.........................................................................

SPINAL CORD — LUMBAR . . . . . . . . . . 

.........................................................................

SPINAL CORD — CERV. . . . . . . . . . . 

.........................................................................

FEMUR — — — — — — — — — — 

.........................................................................

JOINTS, KNEE — — — — — — — — — — 

.........................................................................

PANCREATIC LYMPH NO. . . . . . . . +G . . 

— Erythrophagocytosis . . . . . . . 2. . . 

.........................................................................

RENAL LYMPH NODE . . . . . . . . . . 

.........................................................................

Final Report - Page 133 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

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PATHOLOGY REPORT PAGE : 36/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TABLE OF INDIVIDUAL MICROSCOPIC FINDINGS (AOFT) 

DOSE GROUP : 03, 150 MG/KG 

—————————————————————————————————————————————————————————————————————————

ANIMAL NUMBER : 

 11 12 13 14 15 31 32 33 34 35 

 MK0 MK0 MK0 MK0 MK0 FK0 FK0 FK0 FK0 FK0 

—————————————————————————————————————————————————————————————————————————

THYMUS — — — — — — — — — — 

.........................................................................

STOMACH +G +G +G +G +G + +G +G +G + 

— Forestom. inflamm. . 1. 2. 2. . . . . 3. . 

— Ulcer, forestomach . . 3. 2. . . . . . . 

— Edema . . . . . . 2. . 2. . 

— Hyperpl., forestom. 2. 3. 2. 3. 2. 1. 1. 2. 3. 1. 

.........................................................................

DUODENUM +G + + +G +G + +G +G +G + 

— Hemorrhage . 1. 1. . 1. . 1. 2. 2. 2. 

— Hypertrophy 2. 2. 2. 2. 2. 1. 2. 3. 2. 2. 

.........................................................................

JEJUNUM + — — +G —G — — +G —G — 

— Hypertrophy 1. . . 2. . . . 1. . . 

.........................................................................

PEYER'S PATCHES — — — + 0 — + — — — 

— Lymphoid atrophy . . . 2. . . 3. . . . 

.........................................................................

LIVER ' ' ' —G ' + + +G + + 

— Inflamm. cell foci . 1. 1. 1. 1. 1. 

— Apoptos/s.cell necro . . . 2. . 1. 

— Hypertrophy, centril . . . 1. . . 

— Necrosis, coag. . . . . . 1. 

.........................................................................

SPLEEN + + + + + + + + + + 

— Hemopoietic foci 1. 1. 1. 1. 1. . 1. . . 1. 

— Hemosiderin pigment 1. 1. . 1. . 1. 1. 2. 1. 1. 

.........................................................................

MESENT. LYMPH NODE +G +G +G + +G + + +G — +G 

— Lymphoid atrophy . 1. 1. . 1. . 1. 1. . . 

— Increased mast cells 3. 2. 2. 2. 3. 2. . 2. . 2. 

— Erythrophagocytosis 2. 2. 3. 2. 3. 2. . 2. . 2. 

.........................................................................

MANDIB.LYMPH NODES — + — +G — — — — + — 

— Lymphoid atrophy . 1. . . . . . . . . 

— Erythrophagocytosis . . . ( 1. . . . . . . 

— Plasmacytosis . . . . . . . . 1. . 

.........................................................................

Final Report - Page 134 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 37/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TABLE OF INDIVIDUAL MICROSCOPIC FINDINGS (AOFT) 

DOSE GROUP : 03, 150 MG/KG 

—————————————————————————————————————————————————————————————————————————

ANIMAL NUMBER : 

 11 12 13 14 15 31 32 33 34 35 

 MK0 MK0 MK0 MK0 MK0 FK0 FK0 FK0 FK0 FK0 

—————————————————————————————————————————————————————————————————————————

KIDNEYS ' +G +G ' ' ' ' ' ' ' 

— Pelvic dilation ( P. . 

— Hyaline droplets 1. 1. 

.........................................................................

ADRENAL GLANDS + — — — — — — — +G — 

— Extracapsular nodule . . . . . . . . ( P. . 

— Vacuolation, z.fas. 1. . . . . . . . . . 

.........................................................................

OVARIES . . . . . 

.........................................................................

PROSTATE GLAND — — — — — 

.........................................................................

SEMINAL VESICLES — — — — — 

.........................................................................

COAGULATING GLANDS — — — — — 

.........................................................................

UTERUS — — +G — + 

— Atrophy . . P. . P. 

.........................................................................

CERVIX — — + — + 

— Atrophy . . P. . P. 

.........................................................................

VAGINA — — + — + 

— Atrophy . . P. . P. 

.........................................................................

SKELETAL MUSCLE . . . . . . . . . . 

.........................................................................

EYES . . . . . . . . . . 

.........................................................................

BONE, STERNUM . . . . . . . . . . 

.........................................................................

BONE MARROW — STERN. . . . . . . . . . . 

.........................................................................

SPINAL CORD — THOR. . . . . . . . . . . 

.........................................................................

SPINAL CORD — LUMBAR . . . . . . . . . . 

.........................................................................

SPINAL CORD — CERV. . . . . . . . . . . 

.........................................................................

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International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 38/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TABLE OF INDIVIDUAL MICROSCOPIC FINDINGS (AOFT) 

DOSE GROUP : 03, 150 MG/KG 

—————————————————————————————————————————————————————————————————————————

ANIMAL NUMBER : 

 11 12 13 14 15 31 32 33 34 35 

 MK0 MK0 MK0 MK0 MK0 FK0 FK0 FK0 FK0 FK0 

—————————————————————————————————————————————————————————————————————————

FEMUR — — — — — — — — — — 

.........................................................................

JOINTS, KNEE — — — — — — — — — — 

.........................................................................

PANCREATIC LYMPH NO. . +G +G . . +G +G . . +G 

— Erythrophagocytosis . 3. . . . . 2. . . 3. 

— Lymphatic ectasia . 1. 3. . . . . . . . 

— Lymphoid hyperplasia . 1. 3. . . 2. 2. . . 3. 

.........................................................................

RENAL LYMPH NODE . . . . . . . . . . 

.........................................................................

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PATHOLOGY REPORT PAGE : 39/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TABLE OF INDIVIDUAL MICROSCOPIC FINDINGS (AOFT) 

DOSE GROUP : 04, 450 MG/KG 

—————————————————————————————————————————————————————————————————————————

ANIMAL NUMBER : 

 16 17 18 19 20 36 37 38 39 40 

 MK0 MK0 MK0 MK0 MK0 FK0 FK0 FK0 FK0 FK0 

—————————————————————————————————————————————————————————————————————————

GENERAL OBSERVATIONS ' +G +G +G +G +G +G +G +G +G 

— Macro Noted . P. P. P. P. P. P. P. P. P. 

.........................................................................

HEART — — — — — — — — — — 

.........................................................................

LUNG — + + — + — + + — + 

— Alv. macrophages . 1. 1. . 2. . . 1. . 1. 

— Alveolar inflamm. . . . . . . 1. 1. . . 

.........................................................................

THYMUS +G +G +G +G +G +G + +G +G +G 

— Lymphocytolysis . 2. 1. 1. . 1. . 1. 3. . 

— Lymphoid atrophy 4. 2. 2. 2. 1. 2. 1. 2. 3. 3. 

.........................................................................

TRACHEA — — — — — — — — — — 

.........................................................................

THYROID GLAND — — — — + — — — — — 

— Hyperpl./hypertrophy . . . . 1. . . . . . 

.........................................................................

PARATHYROID GLANDS — — — ( — — — — — — ( — 

.........................................................................

STOMACH +G +G +G +G +G +G +G +G +G +G 

— Ulcer, forestomach 4. 4. 3. 4. 4. 4. 4. 4. 4. 4. 

— Hyperpl., forestom. 2. 3. 2. 3. 3. 3. 3. 4. 3. 3. 

— Hemorrhage . . . . 2. . . . 3. . 

.........................................................................

DUODENUM + +G +G +G +G +G +G +G + +G 

— Hemorrhage 2. 1. 1. 2. 2. 1. 1. 2. . 2. 

— Hypertrophy 3. 3. 2. 3. 3. 2. 2. 2. 2. 3. 

.........................................................................

JEJUNUM + +G +G +G +G +G +G +G +G +G 

— Hemorrhage 1. . . 1. 2. . 2. 2. . 2. 

— Hypertrophy 2. 2. 3. 2. 3. 1. 2. 2. 2. 2. 

.........................................................................

ILEUM — — — — — — — — — — 

.........................................................................

PEYER'S PATCHES 0 + 0 + + + + — + + 

— Lymphoid atrophy . 2. . 1. 1. 2. 2. . 2. 1. 

.........................................................................

CECUM — — — — — — — — — — 

.........................................................................

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PATHOLOGY REPORT PAGE : 40/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TABLE OF INDIVIDUAL MICROSCOPIC FINDINGS (AOFT) 

DOSE GROUP : 04, 450 MG/KG 

—————————————————————————————————————————————————————————————————————————

ANIMAL NUMBER : 

 16 17 18 19 20 36 37 38 39 40 

 MK0 MK0 MK0 MK0 MK0 FK0 FK0 FK0 FK0 FK0 

—————————————————————————————————————————————————————————————————————————

COLON — — — — — — — — — — 

.........................................................................

RECTUM — — — — — — — — — — 

.........................................................................

LIVER — — + + + + + + + + 

— Inflamm. cell foci . . 1. 1. 1. . 1. . . . 

— Apoptos/s.cell necro . . . . 1. . . . . . 

— Hypertrophy, centril . . . . . 2. 2. 2. 1. 2. 

.........................................................................

SPLEEN + + + + + + + + + + 

— Hemopoietic foci 1. 1. 2. 2. 2. 1. 1. 1. 1. 2. 

— Hemosiderin pigment . 2. . 1. . . . 1. . . 

— Lymphoid atrophy 2. 2. 2. 1. 2. . . . 1. . 

.........................................................................

MESENT. LYMPH NODE +G +G +G +G +G +G +G + +G +G 

— Lymphoid atrophy 2. 3. 3. 2. 1. 2. 1. . 2. 1. 

— Increased mast cells . . . . 2. 2. . . . 2. 

— Lymphatic ectasia . 2. 3. . . . . 1. . . 

— Erythrophagocytosis 3. 3. 3. 3. 3. 2. 3. 2. 3. 2. 

.........................................................................

MANDIB.LYMPH NODES 0 + + + + + + + + + 

— Lymphoid atrophy . 3. 3. 2. 2. 2. 2. 1. 3. 2. 

— Erythrophagocytosis . . . . . . . . . ( 2. 

.........................................................................

KIDNEYS +G +G —G —G —G —G +G —G —G +G 

— Pelvic dilation . . . . . . ( P. . . . 

— Inflamm., interstit. . ( 1. . . . . ( 1. . . ( 1. 

— Basophilia, tubular ( 1. ( 1. . . . . . . . ( 1. 

.........................................................................

URINARY BLADDER — — — — — — — — — — 

.........................................................................

ADRENAL GLANDS + +G +G —G +G —G +G +G +G +G 

— Vacuolation, z.fas. 2. 2. 1. . 1. . 1. 2. 2. 2. 

.........................................................................

BRAIN — — — — — — — — — — 

.........................................................................

SCIATIC NERVE — — — — — — — — — — 

.........................................................................

Final Report - Page 138 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 41/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TABLE OF INDIVIDUAL MICROSCOPIC FINDINGS (AOFT) 

DOSE GROUP : 04, 450 MG/KG 

—————————————————————————————————————————————————————————————————————————

ANIMAL NUMBER : 

 16 17 18 19 20 36 37 38 39 40 

 MK0 MK0 MK0 MK0 MK0 FK0 FK0 FK0 FK0 FK0 

—————————————————————————————————————————————————————————————————————————

TESTES — + — — — 

— Sperm. giant cells . ( 1. . . . 

.........................................................................

EPIDIDYMIDES + + — — — 

— Semin. cell debris ( 1. . . . . 

— Inflamm. lymphocytic . ( 1. . . . 

.........................................................................

OVARIES —G — — —G —G 

.........................................................................

PROSTATE GLAND +G +G +G +G +G 

— Small, normal histo. P. P. P. P. P. 

.........................................................................

SEMINAL VESICLES +G +G +G +G +G 

— Reduced contents 2. 2. 2. 2. 2. 

.........................................................................

COAGULATING GLANDS + + + ( + + 

— Reduced contents 2. 2. 2. ( 2. 2. 

.........................................................................

UTERUS +G +G +G +G +G 

— Atrophy P. P. P. P. P. 

.........................................................................

CERVIX + + + + + 

— Atrophy P. P. P. P. P. 

.........................................................................

VAGINA + + + + + 

— Atrophy P. P. P. P. P. 

.........................................................................

SKELETAL MUSCLE — — — — — — — — — — 

.........................................................................

EYES — — + — — — — — — — 

— Retinal rosettes . . ( 1. . . . . . . . 

.........................................................................

BONE, STERNUM — — — — — — — — — — 

.........................................................................

BONE MARROW — STERN. + + — + — + — — + — 

— Adipocytes 1. 1. . 1. . 1. . . 2. . 

.........................................................................

SPINAL CORD — THOR. — — — — — — — — — — 

.........................................................................

Final Report - Page 139 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 42/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TABLE OF INDIVIDUAL MICROSCOPIC FINDINGS (AOFT) 

DOSE GROUP : 04, 450 MG/KG 

—————————————————————————————————————————————————————————————————————————

ANIMAL NUMBER : 

 16 17 18 19 20 36 37 38 39 40 

 MK0 MK0 MK0 MK0 MK0 FK0 FK0 FK0 FK0 FK0 

—————————————————————————————————————————————————————————————————————————

SPINAL CORD — LUMBAR — — — — — — — — — — 

.........................................................................

SPINAL CORD — CERV. — — — — — — — — — — 

.........................................................................

FEMUR + + + + + + + + + + 

— Decreased bone, 3. 3. 2. 2. 3. 2. 2. 1. 3. 2. 

.........................................................................

JOINTS, KNEE — — — — — — — — — — 

.........................................................................

PANCREATIC LYMPH NO. . +G . +G +G +G +G +G . +G 

— Lymphatic ectasia . 2. . 1. . . . 2. . . 

— Lymphoid hyperplasia . 4. . 2. 3. 3. 3. 3. . 2. 

.........................................................................

RENAL LYMPH NODE . . . +G . . . . +G +G 

— Erythrophagocytosis . . . . . . . . 2. . 

— Lymphoid hyperplasia . . . 2. . . . . . 2. 

.........................................................................

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Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 43/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

ANIMAL HEADING DATA 

DOSE GROUP : 01, CONTROL 

—————————————————————————————————————————————————————————————————————————

 

 ANIMAL SEX DEFINED AND FINAL TEST FIRST AND LAST DATE OF 

 NUMBER M/F STATE OF NECROPSY DAYS DAY UNDER TEST NECROPSY

.........................................................................

 1 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 2 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 3 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 4 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 5 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

.........................................................................

 21 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 22 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 23 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 24 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 25 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

.........................................................................

Final Report - Page 141 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 44/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 1

.........................................................................

* NECROPSY FINDINGS

 SEMINAL VESICLES:

 01: LEFT SIDE: REDUCED IN SIZE. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 —Lymphoid (BALT) hyperplasia, grade 1 

 THYMUS:

 Organ examined, no pathologic findings noted 

 TRACHEA:

 —Inflammation, lymphogranulocytic, grade 1 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 Organ examined, no pathologic findings noted 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

Final Report - Page 142 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 45/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 1

.........................................................................

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 KIDNEYS:

 —Hyaline droplets, bilateral, grade 1 

 —Inflammation, interstitial lymphocytic, unilateral, grade 1 

 —Basophilia, tubular, corticomedullary, unilateral, grade 1 

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 TESTES:

 Organ examined, no pathologic findings noted 

 EPIDIDYMIDES:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 —Reduced contents, unilateral, grade 3 

 This finding corresponds to necropsy observation no: 01.

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

Final Report - Page 143 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 46/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 1

.........................................................................

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 2 

.........................................................................

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

Final Report - Page 144 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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PATHOLOGY REPORT PAGE : 47/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 2

.........................................................................

* MICROSCOPIC FINDINGS

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 Organ examined, no pathologic findings noted 

 THYMUS:

 Organ examined, no pathologic findings noted 

 TRACHEA:

 —Inflammation, lymphogranulocytic, grade 1 

 THYROID GLANDS:

 —Hyperplasia/hypertrophy, follicular diffuse, bilateral,

 grade 1 

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 Organ examined, no pathologic findings noted 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

Final Report - Page 145 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 48/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 2

.........................................................................

 MESENTERIC LYMPH NODE:

 —Macrophage foci, grade 1 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 KIDNEYS:

 —Basophilia, tubular, corticomedullary, bilateral, grade 1 

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 TESTES:

 Organ examined, no pathologic findings noted 

 EPIDIDYMIDES:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

Final Report - Page 146 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 49/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 2

.........................................................................

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 3

.........................................................................

* NECROPSY FINDINGS

 EPIDIDYMIDES:

 01: LEFT SIDE, TAIL: NODULE(S), D=6X5 MM, YELLOWISH, SOFT. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 —Alveolar macrophage foci, grade 1 

 —Inflammatory cell infiltrate, peri— vascular/bronchial,

 grade 2 

 THYMUS:

 Organ examined, no pathologic findings noted 

Final Report - Page 147 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 50/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 3

.........................................................................

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 —Hyperplasia/hypertrophy, follicular diffuse, bilateral,

 grade 1 

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Cyst(s), glandular stomach, grade 1 

 DUODENUM:

 Organ examined, no pathologic findings noted 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 —Vacuolation, grade 1 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 KIDNEYS:

 —Hyaline droplets, bilateral, grade 1 

 —Inflammation, interstitial lymphocytic, bilateral, grade 1 

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

Final Report - Page 148 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 51/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 3

.........................................................................

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 TESTES:

 Organ examined, no pathologic findings noted 

 EPIDIDYMIDES:

 —Sperm granuloma, bilateral, grade 3 

 Grade 2 in contralateral organ 

 This finding corresponds to necropsy observation no: 01.

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

Final Report - Page 149 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 52/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 3

.........................................................................

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 4

.........................................................................

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

* MICROSCOPIC FINDINGS

 HEART:

 —Inflammation lymphocytic, grade 1 

 LUNG:

 —Inflammatory cell infiltrate, peri— vascular/bronchial,

 grade 1 

 THYMUS:

 Organ examined, no pathologic findings noted 

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

 PARATHYROID GLANDS:

 Only one of paired organs examined/present 

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

Final Report - Page 150 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 53/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 4

.........................................................................

 DUODENUM:

 Organ examined, no pathologic findings noted 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 Organ examined, no pathologic findings noted 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 —Macrophage foci, grade 1 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 KIDNEYS:

 —Hyaline droplets, bilateral, grade 2 

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 TESTES:

 Organ examined, no pathologic findings noted 

Final Report - Page 151 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 54/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 4

.........................................................................

 EPIDIDYMIDES:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 152 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 55/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 5

.........................................................................

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

* MICROSCOPIC FINDINGS

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 —Alveolar inflammation, mononuclear, grade 1 

 THYMUS:

 Organ examined, no pathologic findings noted 

 TRACHEA:

 —Inflammation, lymphogranulocytic, grade 1 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

 PARATHYROID GLANDS: 

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 Organ examined, no pathologic findings noted 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

 RECTUM:

 Organ examined, no pathologic findings noted 

Final Report - Page 153 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 56/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 5

.........................................................................

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 —Erythrophagocytosis, unilateral, grade 1 

 KIDNEYS:

 —Basophilia, tubular, corticomedullary, unilateral, grade 1 

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 TESTES:

 Organ examined, no pathologic findings noted 

 EPIDIDYMIDES:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

Final Report - Page 154 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 57/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 5

.........................................................................

 BONE MARROW — STERNAL:

 —Adipocytes, grade 1 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 155 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 58/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL FEMALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 21

.........................................................................

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

* MICROSCOPIC FINDINGS

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 One lung badly inflated with formalin 

 —Alveolar inflammation, mononuclear, grade 1 

 THYMUS:

 —Lymphocytolysis, grade 1 

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

 PARATHYROID GLANDS:

 Only one of paired organs examined/present 

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 Organ examined, no pathologic findings noted 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

Final Report - Page 156 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 59/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 21

.........................................................................

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 —Apoptosis/single cell necrosis, hepatocellular, grade 1 

 SPLEEN:

 Organ examined, no pathologic findings noted 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 KIDNEYS:

 —Basophilia, tubular, corticomedullary, unilateral, grade 1 

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 —Inflammation, lymphocytic, unilateral, grade 1 

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ examined, no pathologic findings noted 

 UTERUS:

 Organ examined, no pathologic findings noted 

 CERVIX:

 Organ examined, no pathologic findings noted 

 VAGINA:

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

Final Report - Page 157 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 60/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 21

.........................................................................

 BONE MARROW — STERNAL:

 —Adipocytes, grade 1 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 22

.........................................................................

* NECROPSY FINDINGS

 UTERUS:

 01: CONTAINS FLUID. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

Final Report - Page 158 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 61/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 22

.........................................................................

* MICROSCOPIC FINDINGS

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 Organ examined, no pathologic findings noted 

 THYMUS:

 Organ examined, no pathologic findings noted 

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 Organ examined, no pathologic findings noted 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

Final Report - Page 159 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 62/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 22

.........................................................................

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 KIDNEYS:

 Organ examined, no pathologic findings noted 

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ examined, no pathologic findings noted 

 UTERUS:

 —Cyclic dilation 

 This finding corresponds to necropsy observation no: 01.

 CERVIX:

 Organ examined, no pathologic findings noted 

 VAGINA:

 —Proestrus epithelium 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

Final Report - Page 160 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 63/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 22

.........................................................................

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 23

.........................................................................

* NECROPSY FINDINGS

 UTERUS:

 01: CONTAINS FLUID. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 —Inflammatory cell infiltrate, peri— vascular/bronchial,

 grade 1 

 THYMUS:

 Organ examined, no pathologic findings noted 

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 —Ectopic thymus, unilateral 

Final Report - Page 161 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 64/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 23

.........................................................................

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 Organ examined, no pathologic findings noted 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 —Apoptosis/single cell necrosis, hepatocellular, grade 1 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 KIDNEYS:

 Organ examined, no pathologic findings noted 

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 BRAIN:

 Organ examined, no pathologic findings noted 

Final Report - Page 162 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 65/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 23

.........................................................................

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ examined, no pathologic findings noted 

 UTERUS:

 —Cyclic dilation 

 This finding corresponds to necropsy observation no: 01.

 CERVIX:

 Organ examined, no pathologic findings noted 

 VAGINA:

 —Proestrus epithelium 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 163 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 66/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL FEMALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 24

.........................................................................

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

* MICROSCOPIC FINDINGS

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 —Inflammatory cell infiltrate, peri— vascular/bronchial,

 grade 2 

 THYMUS:

 Organ examined, no pathologic findings noted 

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Vacuolation, limiting ridge, grade 1 

 DUODENUM:

 Organ examined, no pathologic findings noted 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

Final Report - Page 164 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 67/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 24

.........................................................................

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 KIDNEYS:

 —Inflammation, interstitial lymphocytic, unilateral, grade 1 

 —Basophilia, tubular, corticomedullary, unilateral, grade 1 

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ examined, no pathologic findings noted 

 UTERUS:

 Organ examined, no pathologic findings noted 

 CERVIX:

 Organ examined, no pathologic findings noted 

 VAGINA:

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

Final Report - Page 165 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 68/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 24

.........................................................................

 BONE MARROW — STERNAL:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 25

.........................................................................

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

* MICROSCOPIC FINDINGS

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 —Alveolar macrophage foci, grade 1 

 —Alveolar inflammation, mononuclear, grade 1 

Final Report - Page 166 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 69/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 25

.........................................................................

 THYMUS:

 Organ examined, no pathologic findings noted 

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 Organ examined, no pathologic findings noted 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 Organ examined, no pathologic findings noted 

 SPLEEN:

 Organ examined, no pathologic findings noted 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 KIDNEYS:

 Organ examined, no pathologic findings noted 

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

Final Report - Page 167 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 70/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 01, CONTROL FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 25

.........................................................................

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ examined, no pathologic findings noted 

 UTERUS:

 Organ examined, no pathologic findings noted 

 CERVIX:

 Organ examined, no pathologic findings noted 

 VAGINA:

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 —Adipocytes, grade 1 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 168 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 71/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

ANIMAL HEADING DATA 

DOSE GROUP : 02, 50 MG/KG 

—————————————————————————————————————————————————————————————————————————

 

 ANIMAL SEX DEFINED AND FINAL TEST FIRST AND LAST DATE OF 

 NUMBER M/F STATE OF NECROPSY DAYS DAY UNDER TEST NECROPSY

.........................................................................

 6 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 7 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 8 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 9 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 10 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

.........................................................................

 26 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 27 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 28 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 29 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 30 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

.........................................................................

Final Report - Page 169 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 72/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 6

.........................................................................

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 1 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 SPLEEN:

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

Final Report - Page 170 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 73/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 6

.........................................................................

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 7

.........................................................................

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

Final Report - Page 171 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 74/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 7

.........................................................................

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Hyperplasia, squamous epithelium, diffuse, grade 1 

 DUODENUM:

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

Final Report - Page 172 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 75/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG MALE 

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 7

.........................................................................

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 8

.........................................................................

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 1 

Final Report - Page 173 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 76/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 8

.........................................................................

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 SPLEEN:

 Organ examined, no pathologic findings noted 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 —Inflammation lymphocytic, grade 1 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

Final Report - Page 174 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 77/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 8

.........................................................................

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 9

.........................................................................

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 —Hypertrophy, duodenal villi with villous stunting, grade 1 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 —Erythrophagocytosis, grade 2 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

Final Report - Page 175 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 78/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 9

.........................................................................

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 176 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 79/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 10

......................................................................... 

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 1 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 SPLEEN:

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 —Vacuolation, zona fasciculata, multifocal, bilateral, grade 1 

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

Final Report - Page 177 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 80/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 10

.........................................................................

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 178 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 81/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 26

.........................................................................

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 —Hypertrophy, duodenal villi with villous stunting, grade 1 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ not examined 

 UTERUS:

 Organ examined, no pathologic findings noted 

 CERVIX:

 Organ examined, no pathologic findings noted 

 VAGINA:

 Organ examined, no pathologic findings noted 

Final Report - Page 179 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 82/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 26

.........................................................................

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 27

.........................................................................

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

Final Report - Page 180 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 83/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 27

.........................................................................

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 —Hypertrophy, duodenal villi with villous stunting, grade 1 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ not examined 

 UTERUS:

 Organ examined, no pathologic findings noted 

 CERVIX:

 Organ examined, no pathologic findings noted 

 VAGINA:

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

Final Report - Page 181 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 84/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 27

.........................................................................

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 28

.........................................................................

* NECROPSY FINDINGS

 PANCREATIC LYMPH NODE:

 01: DISCOLOURATION, REDDISH. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

Final Report - Page 182 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 85/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 28

.........................................................................

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 —Lymphoid atrophy, grade 2 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ not examined 

 UTERUS:

 Organ examined, no pathologic findings noted 

 CERVIX:

 Organ examined, no pathologic findings noted 

 VAGINA:

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

Final Report - Page 183 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 86/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 28

.........................................................................

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 —Erythrophagocytosis, grade 2 

 This finding corresponds to necropsy observation no: 01.

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 29

.........................................................................

* NECROPSY FINDINGS

 NO NECROPSY OBSERVATIONS NOTED.

Final Report - Page 184 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 87/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 29

.........................................................................

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 Only one of paired organs examined/present 

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ not examined 

 UTERUS:

 Organ examined, no pathologic findings noted 

 CERVIX:

 Organ examined, no pathologic findings noted 

 VAGINA:

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

Final Report - Page 185 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 88/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 29

.........................................................................

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 30

.........................................................................

* NECROPSY FINDINGS

 UTERUS:

 01: CONTAINS FLUID. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

Final Report - Page 186 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 89/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 30

.........................................................................

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Organ examined, no pathologic findings noted 

 DUODENUM:

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 —Erythrophagocytosis, grade 1 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ not examined 

 UTERUS:

 —Cyclic dilation 

 This finding corresponds to necropsy observation no: 01.

 CERVIX:

 Organ examined, no pathologic findings noted 

 VAGINA:

 —Proestrus epithelium 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

Final Report - Page 187 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 90/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 02, 50 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 30

.........................................................................

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 188 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 91/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

ANIMAL HEADING DATA 

DOSE GROUP : 03, 150 MG/KG 

—————————————————————————————————————————————————————————————————————————

 

 ANIMAL SEX DEFINED AND FINAL TEST FIRST AND LAST DATE OF 

 NUMBER M/F STATE OF NECROPSY DAYS DAY UNDER TEST NECROPSY

.........................................................................

 11 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 12 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 13 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 14 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 15 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

.........................................................................

 31 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 32 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 33 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 34 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 35 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

.........................................................................

Final Report - Page 189 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 92/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 11

.........................................................................

* NECROPSY FINDINGS

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

 DUODENUM:

 01: CONTENTS: GELATINOUS. 

 02: WALL: THICKENED. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, REDDISH. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Hyperplasia, squamous epithelium, diffuse, grade 2 

 This finding corresponds to necropsy observation no: 01.

 DUODENUM:

 No microscopic finding corresponding to necropsy observation no. 01.

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 02.

 JEJUNUM:

 —Hypertophy, jejunal villi with villous stunting, grade 1 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 —Increased mast cells, grade 3 

 —Erythrophagocytosis, grade 2 

 This finding corresponds to necropsy observation no: 01.

Final Report - Page 190 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 93/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 11

.........................................................................

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 —Vacuolation, zona fasciculata, multifocal, bilateral, grade 1 

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 191 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 94/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 12

.........................................................................

* NECROPSY FINDINGS

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, DARK RED. 

 KIDNEYS:

 01: RIGHT SIDE: PELVIC DILATION. 

 PANCREATIC LYMPH NODE:

 01: ENLARGED. 

 02: DISCOLOURATION, REDDISH. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Forestomach inflammation, lymphogranulocytic, grade 1 

 —Hyperplasia, squamous epithelium, diffuse, grade 3 

 This finding corresponds to necropsy observation no: 01.

 DUODENUM:

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 1 

 —Increased mast cells, grade 2 

 —Erythrophagocytosis, grade 2 

Final Report - Page 192 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 95/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 12

.........................................................................

 This finding corresponds to necropsy observation no: 01.

 MANDIBULAR LYMPH NODES:

 —Lymphoid atrophy, bilateral, grade 1 

 KIDNEYS:

 —Pelvic dilation, unilateral 

 This finding corresponds to necropsy observation no: 01.

 —Hyaline droplets, bilateral, grade 1 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 —Erythrophagocytosis, grade 3 

 This finding corresponds to necropsy observation no: 02.

 —Lymphatic ectasia, grade 1 

Final Report - Page 193 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 96/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 12

.........................................................................

 —Lymphoid hyperplasia, grade 1 

 This finding corresponds to necropsy observation no: 01.

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 13

.........................................................................

* NECROPSY FINDINGS

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

 02: FORESTOMACH: FOCUS/FOCI, D=12X5 MM, TAN. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, DARK RED. 

 KIDNEYS:

 01: LEFT SIDE: FOCUS/FOCI, ISOLATED, REDDISH. 

 PANCREATIC LYMPH NODE:

 01: ENLARGED. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Forestomach inflammation, lymphogranulocytic, grade 2 

 —Ulcer, forestomach mucosa, grade 3 

 This finding corresponds to necropsy observation no: 02.

 —Hyperplasia, squamous epithelium, diffuse, grade 2 

 This finding corresponds to necropsy observation no: 01.

Final Report - Page 194 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 97/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 13

.........................................................................

 DUODENUM:

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 1 

 —Increased mast cells, grade 2 

 —Erythrophagocytosis, grade 3 

 This finding corresponds to necropsy observation no: 01.

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 KIDNEYS:

 No microscopic finding corresponding to necropsy observation no. 01.

 —Hyaline droplets, bilateral, grade 1 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

Final Report - Page 195 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 98/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL 

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 13

.........................................................................

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 —Lymphatic ectasia, grade 3 

 —Lymphoid hyperplasia, grade 3 

 This finding corresponds to necropsy observation no: 01.

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 14

.........................................................................

* NECROPSY FINDINGS

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

 DUODENUM:

 01: CONTENTS: GELATINOUS. 

 02: WALL: THICKENED. 

 JEJUNUM:

 01: CONTENTS: GELATINOUS. 

 02: WALL: THICKENED. 

Final Report - Page 196 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 99/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 14

.........................................................................

 LIVER:

 01: LEFT LATERAL LOBE: REDUCED IN SIZE. 

 MANDIBULAR LYMPH NODES:

 01: LEFT SIDE: DISCOLOURATION, REDDISH. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Forestomach inflammation, lymphogranulocytic, grade 2 

 —Ulcer, forestomach mucosa, grade 2 

 —Hyperplasia, squamous epithelium, diffuse, grade 3 

 This finding corresponds to necropsy observation no: 01.

 DUODENUM:

 No microscopic finding corresponding to necropsy observation no. 01.

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 02.

 JEJUNUM:

 No microscopic finding corresponding to necropsy observation no. 01.

 —Hypertophy, jejunal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 02.

 PEYER'S PATCHES:

 —Lymphoid atrophy, grade 2 

 LIVER:

 Organ examined, no pathologic findings noted 

 No microscopic finding corresponding to necropsy observation no. 01.

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 —Increased mast cells, grade 2 

 —Erythrophagocytosis, grade 2 

Final Report - Page 197 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 100/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 14

.........................................................................

 MANDIBULAR LYMPH NODES:

 —Erythrophagocytosis, unilateral, grade 1 

 This finding corresponds to necropsy observation no: 01.

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 198 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 101/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 15

.........................................................................

* NECROPSY FINDINGS

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

 DUODENUM:

 01: FOCUS/FOCI, D=4X3 MM, REDDISH. 

 02: CONTENTS: GELATINOUS. 

 03: WALL: THICKENED. 

 JEJUNUM:

 01: CONTENTS: GELATINOUS. 

 02: WALL: THICKENED. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, DARK RED. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Hyperplasia, squamous epithelium, diffuse, grade 2 

 This finding corresponds to necropsy observation no: 01.

 DUODENUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 1 

 This finding corresponds to necropsy observation no: 01.

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 03.

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 No microscopic finding corresponding to necropsy observation

 no. 01,02.

 PEYER'S PATCHES:

 Tissue not present for histologic examination 

Final Report - Page 199 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 102/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 15

.........................................................................

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 1 

 —Increased mast cells, grade 3 

 —Erythrophagocytosis, grade 3 

 This finding corresponds to necropsy observation no: 01.

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 Organ examined, no pathologic findings noted 

 SEMINAL VESICLES:

 Organ examined, no pathologic findings noted 

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

Final Report - Page 200 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 103/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 15

.........................................................................

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 201 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 104/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 31

.........................................................................

* NECROPSY FINDINGS

 PANCREATIC LYMPH NODE:

 01: ENLARGED. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Hyperplasia, squamous epithelium, diffuse, grade 1 

 DUODENUM:

 —Hypertrophy, duodenal villi with villous stunting, grade 1 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 —Increased mast cells, grade 2 

 —Erythrophagocytosis, grade 2 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ not examined 

 UTERUS:

 Organ examined, no pathologic findings noted 

Final Report - Page 202 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 105/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 31

.........................................................................

 CERVIX:

 Organ examined, no pathologic findings noted 

 VAGINA:

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 —Lymphoid hyperplasia, grade 2 

 This finding corresponds to necropsy observation no: 01.

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 203 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 106/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 32

.........................................................................

* NECROPSY FINDINGS

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

 DUODENUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 PANCREATIC LYMPH NODE:

 01: DISCOLOURATION, REDDISH. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Edema, fore and glandular stomach, grade 2 

 —Hyperplasia, squamous epithelium, diffuse, grade 1 

 This finding corresponds to necropsy observation no: 01.

 DUODENUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 01.

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 —Lymphoid atrophy, grade 3 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

Final Report - Page 204 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 107/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 32

.........................................................................

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 1 

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ not examined 

 UTERUS:

 Organ examined, no pathologic findings noted 

 CERVIX:

 Organ examined, no pathologic findings noted 

 VAGINA:

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 —Erythrophagocytosis, grade 2 

 This finding corresponds to necropsy observation no: 01.

 —Lymphoid hyperplasia, grade 2 

Final Report - Page 205 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 108/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 32

.........................................................................

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 33

.........................................................................

* NECROPSY FINDINGS

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

 DUODENUM:

 01: WALL: THICKENED. 

 JEJUNUM:

 01: WALL: THICKENED. 

 LIVER:

 01: LEFT LATERAL LOBE: FOCUS/FOCI, MANY, RED—BROWN. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, DARK RED. 

 UTERUS:

 01: REDUCED IN SIZE. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Hyperplasia, squamous epithelium, diffuse, grade 2 

 This finding corresponds to necropsy observation no: 01.

 DUODENUM:

 —Hemorrhage, grade 2 

 —Hypertrophy, duodenal villi with villous stunting, grade 3 

Final Report - Page 206 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 109/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 33

.........................................................................

 This finding corresponds to necropsy observation no: 01.

 JEJUNUM:

 —Hypertophy, jejunal villi with villous stunting, grade 1 

 This finding corresponds to necropsy observation no: 01.

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 —Apoptosis/single cell necrosis, hepatocellular, grade 2 

 This finding corresponds to necropsy observation no: 01.

 —Hypertrophy, centrilobular, hepatocellular, grade 1 

 SPLEEN:

 —Hemosiderin pigment, grade 2 

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 1 

 —Increased mast cells, grade 2 

 —Erythrophagocytosis, grade 2 

 This finding corresponds to necropsy observation no: 01.

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ not examined 

 UTERUS:

 —Atrophy, diffuse 

 This finding corresponds to necropsy observation no: 01.

 CERVIX:

 —Atrophy 

 VAGINA:

 —Atrophy 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

Final Report - Page 207 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 110/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 33

.........................................................................

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 34

.........................................................................

* NECROPSY FINDINGS

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

 DUODENUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 JEJUNUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

Final Report - Page 208 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 111/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 34

.........................................................................

 ADRENAL GLANDS:

 01: BOTH SIDES: DISCOLOURATION, PALE. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Forestomach inflammation, lymphogranulocytic, grade 3 

 —Edema, forestomach, grade 2 

 —Hyperplasia, squamous epithelium, diffuse, grade 3 

 This finding corresponds to necropsy observation no: 01.

 DUODENUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 2 

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 01.

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 No microscopic finding corresponding to necropsy observation

 no. 01,02.

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 Organ examined, no pathologic findings noted 

 MANDIBULAR LYMPH NODES:

 —Plasmacytosis, bilateral, grade 1 

 ADRENAL GLANDS:

 No microscopic finding corresponding to necropsy observation no. 01.

 —Extracapsular nodule, unilateral 

Final Report - Page 209 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 112/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 34

.........................................................................

 OVARIES:

 Organ not examined 

 UTERUS:

 Organ examined, no pathologic findings noted 

 CERVIX:

 Organ examined, no pathologic findings noted 

 VAGINA: 

 Organ examined, no pathologic findings noted 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 210 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 113/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 35

.........................................................................

* NECROPSY FINDINGS

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, DARK RED. 

 PANCREATIC LYMPH NODE:

 01: DISCOLOURATION, REDDISH. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 THYMUS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Hyperplasia, squamous epithelium, diffuse, grade 1 

 DUODENUM:

 —Hemorrhage, grade 2 

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 JEJUNUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 —Apoptosis/single cell necrosis, hepatocellular, grade 1 

 —Necrosis, coagulative, focal, grade 1 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 —Increased mast cells, grade 2 

 —Erythrophagocytosis, grade 2 

 This finding corresponds to necropsy observation no: 01.

 MANDIBULAR LYMPH NODES:

 Organ examined, no pathologic findings noted 

Final Report - Page 211 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 114/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 03, 150 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 35

.........................................................................

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ not examined 

 UTERUS:

 —Atrophy, diffuse 

 CERVIX:

 —Atrophy 

 VAGINA:

 —Atrophy 

 SKELETAL MUSCLE:

 Organ not examined 

 EYES:

 Organ not examined 

 BONE (STERNUM):

 Organ not examined 

 BONE MARROW — STERNAL:

 Organ not examined 

 SPINAL CORD — THORACIC SEGMENT:

 Organ not examined 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ not examined 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ not examined 

 FEMUR:

 Organ examined, no pathologic findings noted 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 —Erythrophagocytosis, grade 3 

 This finding corresponds to necropsy observation no: 01.

 —Lymphoid hyperplasia, grade 3 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 212 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 115/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

ANIMAL HEADING DATA 

DOSE GROUP : 04, 450 MG/KG 

—————————————————————————————————————————————————————————————————————————

 

 ANIMAL SEX DEFINED AND FINAL TEST FIRST AND LAST DATE OF 

 NUMBER M/F STATE OF NECROPSY DAYS DAY UNDER TEST NECROPSY

.........................................................................

 16 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 17 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 18 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 19 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 20 M K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

.........................................................................

 36 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 37 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 38 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 39 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

 40 F K0 K0 28 09—NOV—12 06—DEC—12 07—DEC—12

.........................................................................

Final Report - Page 213 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 116/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 16

.........................................................................

* NECROPSY FINDINGS

 THYMUS:

 01: REDUCED IN SIZE. 

 STOMACH:

 01: GROWN TOGETHER WITH: LIVER PROCESSUS PAPILARIS. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, DARK RED. 

 KIDNEYS:

 01: BOTH SIDES: DISCOLOURATION, GREENISH. 

 PROSTATE GLAND:

 01: REDUCED IN SIZE. 

 SEMINAL VESICLES:

 01: BOTH SIDES: REDUCED IN SIZE. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 Organ examined, no pathologic findings noted 

 THYMUS:

 —Lymphoid atrophy (involution), grade 4 

 This finding corresponds to necropsy observation no: 01.

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Noted 

 —Ulcer, forestomach mucosa, grade 4 

 —Hyperplasia, squamous epithelium, diffuse, grade 2 

Final Report - Page 214 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 117/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 16

.........................................................................

 DUODENUM:

 —Hemorrhage, grade 2 

 —Hypertrophy, duodenal villi with villous stunting, grade 3 

 JEJUNUM:

 —Hemorrhage, grade 1 

 —Hypertophy, jejunal villi with villous stunting, grade 2 

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Tissue not present for histologic examination 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 Organ examined, no pathologic findings noted 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Lymphoid atrophy, grade 2 

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 2 

 —Erythrophagocytosis, grade 3 

 This finding corresponds to necropsy observation no: 01.

 MANDIBULAR LYMPH NODES:

 Tissue not present for histologic examination 

 KIDNEYS: 

 No microscopic finding corresponding to necropsy observation no. 01.

 —Basophilia, tubular, corticomedullary, unilateral, grade 1 

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 —Vacuolation, zona fasciculata, multifocal, bilateral, grade 2 

 BRAIN:

 Organ examined, no pathologic findings noted 

Final Report - Page 215 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 118/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 16

.........................................................................

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 TESTES:

 Organ examined, no pathologic findings noted 

 EPIDIDYMIDES:

 —Seminiferous cell debris, unilateral, grade 1 

 PROSTATE GLAND:

 —Small organ with normal histology 

 This finding corresponds to necropsy observation no: 01.

 SEMINAL VESICLES:

 —Reduced contents, bilateral, grade 2 

 This finding corresponds to necropsy observation no: 01.

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 —Reduced contents, bilateral, grade 2 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 —Adipocytes, grade 1 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 —Decreased bone, secondary spongiosa, grade 3 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 216 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 119/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 17

.........................................................................

* NECROPSY FINDINGS

 GENERAL OBSERVATIONS:

 01: EMACIATED. 

 THYMUS:

 01: REDUCED IN SIZE. 

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

 DUODENUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 JEJUNUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, DARK RED. 

 KIDNEYS:

 01: BOTH SIDES: DISCOLOURATION, GREENISH. 

 ADRENAL GLANDS:

 01: BOTH SIDES: DISCOLOURATION, PALE. 

 PROSTATE GLAND:

 01: REDUCED IN SIZE. 

 SEMINAL VESICLES:

 01: BOTH SIDES: REDUCED IN SIZE. 

 PANCREATIC LYMPH NODE:

 01: ENLARGED. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 GENERAL OBSERVATIONS:

 —Macro observation noted 

 This finding corresponds to necropsy observation no: 01.

Final Report - Page 217 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

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International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 120/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 17

.........................................................................

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 —Alveolar macrophage foci, grade 1 

 THYMUS:

 —Lymphocytolysis, grade 2 

 —Lymphoid atrophy (involution), grade 2 

 This finding corresponds to necropsy observation no: 01.

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Ulcer, forestomach mucosa, grade 4 

 This finding corresponds to necropsy observation no: 01.

 —Hyperplasia, squamous epithelium, diffuse, grade 3 

 DUODENUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 3 

 This finding corresponds to necropsy observation no: 01.

 JEJUNUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hypertophy, jejunal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 01.

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 —Lymphoid atrophy, grade 2 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

Final Report - Page 218 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 121/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 17

.........................................................................

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 Organ examined, no pathologic findings noted 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 2 

 —Lymphoid atrophy, grade 2 

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 3 

 —Lymphatic ectasia, grade 2 

 —Erythrophagocytosis, grade 3 

 This finding corresponds to necropsy observation no: 01.

 MANDIBULAR LYMPH NODES:

 —Lymphoid atrophy, bilateral, grade 3 

 KIDNEYS:

 No microscopic finding corresponding to necropsy observation no. 01.

 —Inflammation, interstitial lymphocytic, unilateral, grade 1 

 —Basophilia, tubular, corticomedullary, unilateral, grade 1 

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 —Vacuolation, zona fasciculata, multifocal, bilateral, grade 2 

 This finding corresponds to necropsy observation no: 01.

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 TESTES:

 —Spermatidic giant cells, unilateral, grade 1 

 EPIDIDYMIDES:

 —Inflammation, lymphocytic, unilateral, grade 1 

 PROSTATE GLAND:

 —Small organ with normal histology 

 This finding corresponds to necropsy observation no: 01.

Final Report - Page 219 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 122/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 17

.........................................................................

 SEMINAL VESICLES:

 —Reduced contents, bilateral, grade 2 

 This finding corresponds to necropsy observation no: 01.

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 —Reduced contents, bilateral, grade 2 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 —Adipocytes, grade 1 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 —Decreased bone, secondary spongiosa, grade 3 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 —Lymphatic ectasia, grade 2 

 —Lymphoid hyperplasia, grade 4 

 This finding corresponds to necropsy observation no: 01.

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 220 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 123/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 18

.........................................................................

* NECROPSY FINDINGS

 GENERAL OBSERVATIONS:

 01: EMACIATED. 

 THYMUS:

 01: REDUCED IN SIZE. 

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

 DUODENUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 JEJUNUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, PURPLE. 

 KIDNEYS:

 01: BOTH SIDES: DISCOLOURATION, GREENISH. 

 ADRENAL GLANDS:

 01: BOTH SIDES: DISCOLOURATION, PALE. 

 PROSTATE GLAND:

 01: REDUCED IN SIZE. 

 SEMINAL VESICLES:

 01: BOTH SIDES: REDUCED IN SIZE. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 GENERAL OBSERVATIONS:

 —Macro observation noted 

 This finding corresponds to necropsy observation no: 01.

 HEART:

 Organ examined, no pathologic findings noted 

Final Report - Page 221 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 124/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 18

.........................................................................

 LUNG:

 —Alveolar macrophage foci, grade 1 

 THYMUS:

 —Lymphocytolysis, grade 1 

 —Lymphoid atrophy (involution), grade 2 

 This finding corresponds to necropsy observation no: 01.

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Ulcer, forestomach mucosa, grade 3 

 This finding corresponds to necropsy observation no: 01.

 —Hyperplasia, squamous epithelium, diffuse, grade 2 

 DUODENUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 01.

 JEJUNUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hypertophy, jejunal villi with villous stunting, grade 3 

 This finding corresponds to necropsy observation no: 01.

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Tissue not present for histologic examination 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

 RECTUM:

 Organ examined, no pathologic findings noted 

Final Report - Page 222 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 125/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 18

.........................................................................

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 2 

 —Lymphoid atrophy, grade 2 

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 3 

 —Lymphatic ectasia, grade 3 

 —Erythrophagocytosis, grade 3 

 This finding corresponds to necropsy observation no: 01.

 MANDIBULAR LYMPH NODES:

 —Lymphoid atrophy, bilateral, grade 3 

 KIDNEYS:

 Organ examined, no pathologic findings noted 

 No microscopic finding corresponding to necropsy observation no. 01.

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 —Vacuolation, zona fasciculata, multifocal, bilateral, grade 1 

 This finding corresponds to necropsy observation no: 01.

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 TESTES:

 Organ examined, no pathologic findings noted 

 EPIDIDYMIDES:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 —Small organ with normal histology 

 This finding corresponds to necropsy observation no: 01.

 SEMINAL VESICLES:

 —Reduced contents, bilateral, grade 2 

 This finding corresponds to necropsy observation no: 01.

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 —Reduced contents, bilateral, grade 2 

Final Report - Page 223 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 126/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 18

.........................................................................

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 —Retinal rosettes, unilateral, grade 1 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT: 

 Organ examined, no pathologic findings noted 

 FEMUR:

 —Decreased bone, secondary spongiosa, grade 2 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 19

.........................................................................

* NECROPSY FINDINGS

 GENERAL OBSERVATIONS:

 01: EMACIATED. 

Final Report - Page 224 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 127/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 19

.........................................................................

 THYMUS:

 01: REDUCED IN SIZE. 

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

 DUODENUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 JEJUNUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, DARK RED. 

 KIDNEYS:

 01: BOTH SIDES: DISCOLOURATION, GREENISH. 

 ADRENAL GLANDS:

 01: BOTH SIDES: DISCOLOURATION, PALE. 

 PROSTATE GLAND:

 01: REDUCED IN SIZE. 

 SEMINAL VESICLES:

 01: BOTH SIDES: REDUCED IN SIZE. 

 PANCREATIC LYMPH NODE:

 01: ENLARGED. 

 RENAL LYMPH NODE:

 01: BOTH SIDES: ENLARGED. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 GENERAL OBSERVATIONS:

 —Macro observation noted 

 This finding corresponds to necropsy observation no: 01.

 THYMUS:

 —Lymphocytolysis, grade 1 

 —Lymphoid atrophy (involution), grade 2 

 This finding corresponds to necropsy observation no: 01.

Final Report - Page 225 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 128/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 19

.........................................................................

 PARATHYROID GLANDS:

 Only one of paired organs examined/present 

 STOMACH:

 —Ulcer, forestomach mucosa, grade 4 

 This finding corresponds to necropsy observation no: 01.

 —Hyperplasia, squamous epithelium, diffuse, grade 3 

 DUODENUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 2 

 —Hypertrophy, duodenal villi with villous stunting, grade 3 

 This finding corresponds to necropsy observation no: 01.

 JEJUNUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 1 

 —Hypertophy, jejunal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 01.

 PEYER'S PATCHES:

 —Lymphoid atrophy, grade 1 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 2 

 —Hemosiderin pigment, grade 1 

 —Lymphoid atrophy, grade 1 

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 2 

 —Erythrophagocytosis, grade 3 

 This finding corresponds to necropsy observation no: 01.

 MANDIBULAR LYMPH NODES:

 —Lymphoid atrophy, bilateral, grade 2 

 KIDNEYS:

 No microscopic finding corresponding to necropsy observation no. 01.

 ADRENAL GLANDS:

 No microscopic finding corresponding to necropsy observation no. 01.

 PROSTATE GLAND:

 —Small organ with normal histology 

 This finding corresponds to necropsy observation no: 01.

Final Report - Page 226 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 129/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 19

.........................................................................

 SEMINAL VESICLES:

 —Reduced contents, bilateral, grade 2 

 This finding corresponds to necropsy observation no: 01.

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 Only one of paired organs examined/present 

 —Reduced contents, unilateral, grade 2 

 BONE MARROW — STERNAL:

 —Adipocytes, grade 1 

 FEMUR:

 —Decreased bone, secondary spongiosa, grade 2 

 PANCREATIC LYMPH NODE:

 —Lymphatic ectasia, grade 1 

 —Lymphoid hyperplasia, grade 2 

 This finding corresponds to necropsy observation no: 01.

 RENAL LYMPH NODE:

 —Lymphoid hyperplasia, grade 2 

 This finding corresponds to necropsy observation no: 01.

 ALL OTHER PROTOCOL TISSUES WITHOUT PATHOLOGIC FINDINGS.

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 20

.........................................................................

* NECROPSY FINDINGS

 GENERAL OBSERVATIONS:

 01: EMACIATED. 

 THYMUS:

 01: REDUCED IN SIZE. 

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

Final Report - Page 227 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 130/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 20

.........................................................................

 DUODENUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 JEJUNUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, DARK RED. 

 KIDNEYS:

 01: BOTH SIDES: DISCOLOURATION, GREENISH. 

 ADRENAL GLANDS:

 01: BOTH SIDES: DISCOLOURATION, PALE. 

 PROSTATE GLAND:

 01: REDUCED IN SIZE. 

 SEMINAL VESICLES:

 01: BOTH SIDES: REDUCED IN SIZE. 

 PANCREATIC LYMPH NODE:

 01: ENLARGED. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 GENERAL OBSERVATIONS:

 —Macro observation noted 

 This finding corresponds to necropsy observation no: 01.

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 —Alveolar macrophage foci, grade 2 

 THYMUS:

 —Lymphoid atrophy (involution), grade 1 

 This finding corresponds to necropsy observation no: 01.

 TRACHEA:

 Organ examined, no pathologic findings noted 

Final Report - Page 228 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 131/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 20

.........................................................................

 THYROID GLANDS:

 —Hyperplasia/hypertrophy, follicular diffuse, bilateral,

 grade 1 

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Ulcer, forestomach mucosa, grade 4 

 This finding corresponds to necropsy observation no: 01.

 —Hyperplasia, squamous epithelium, diffuse, grade 3 

 —Hemorrhage, mucosal, focal, grade 2 

 DUODENUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 2 

 —Hypertrophy, duodenal villi with villous stunting, grade 3 

 This finding corresponds to necropsy observation no: 01.

 JEJUNUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 2 

 —Hypertophy, jejunal villi with villous stunting, grade 3 

 This finding corresponds to necropsy observation no: 01.

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 —Lymphoid atrophy, grade 1 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 —Apoptosis/single cell necrosis, hepatocellular, grade 1 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 2 

 —Lymphoid atrophy, grade 2 

Final Report - Page 229 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 132/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 20

.........................................................................

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 1 

 —Increased mast cells, grade 2 

 —Erythrophagocytosis, grade 3 

 This finding corresponds to necropsy observation no: 01.

 MANDIBULAR LYMPH NODES:

 —Lymphoid atrophy, bilateral, grade 2 

 KIDNEYS:

 Organ examined, no pathologic findings noted 

 No microscopic finding corresponding to necropsy observation no. 01.

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 —Vacuolation, zona fasciculata, multifocal, bilateral, grade 1 

 This finding corresponds to necropsy observation no: 01.

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 TESTES:

 Organ examined, no pathologic findings noted 

 EPIDIDYMIDES:

 Organ examined, no pathologic findings noted 

 PROSTATE GLAND:

 —Small organ with normal histology 

 This finding corresponds to necropsy observation no: 01.

 SEMINAL VESICLES:

 —Reduced contents, bilateral, grade 2 

 This finding corresponds to necropsy observation no: 01.

 COAGULATING GLANDS (ANTERIOR PROSTATE):

 —Reduced contents, bilateral, grade 2 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

Final Report - Page 230 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 133/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG MALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 20

.........................................................................

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 —Decreased bone, secondary spongiosa, grade 3 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 —Lymphoid hyperplasia, grade 3 

 This finding corresponds to necropsy observation no: 01.

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 231 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 134/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 36

.........................................................................

* NECROPSY FINDINGS

 GENERAL OBSERVATIONS:

 01: EMACIATED. 

 THYMUS:

 01: REDUCED IN SIZE. 

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

 DUODENUM:

 01: WALL: DILATION. 

 02: CONTENTS: GELATINOUS. 

 JEJUNUM:

 01: WALL: DILATION. 

 02: CONTENTS: GELATINOUS. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, DARK RED. 

 KIDNEYS:

 01: BOTH SIDES: DISCOLOURATION, GREENISH. 

 ADRENAL GLANDS:

 01: BOTH SIDES: DISCOLOURATION, PALE. 

 OVARIES:

 01: BOTH SIDES: REDUCED IN SIZE. 

 UTERUS:

 01: REDUCED IN SIZE. 

 PANCREATIC LYMPH NODE:

 01: ENLARGED. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 GENERAL OBSERVATIONS:

 —Macro observation noted 

 This finding corresponds to necropsy observation no: 01.

Final Report - Page 232 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 135/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 36

.........................................................................

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 Organ examined, no pathologic findings noted 

 THYMUS:

 —Lymphocytolysis, grade 1 

 —Lymphoid atrophy (involution), grade 2 

 This finding corresponds to necropsy observation no: 01.

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Ulcer, forestomach mucosa, grade 4 

 This finding corresponds to necropsy observation no: 01.

 —Hyperplasia, squamous epithelium, diffuse, grade 3 

 DUODENUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 01.

 JEJUNUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hypertophy, jejunal villi with villous stunting, grade 1 

 This finding corresponds to necropsy observation no: 01.

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 —Lymphoid atrophy, grade 2 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

Final Report - Page 233 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 136/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 36

.........................................................................

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Hypertrophy, centrilobular, hepatocellular, grade 2 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 2 

 —Increased mast cells, grade 2 

 —Erythrophagocytosis, grade 2 

 This finding corresponds to necropsy observation no: 01.

 MANDIBULAR LYMPH NODES:

 —Lymphoid atrophy, bilateral, grade 2 

 KIDNEYS:

 Organ examined, no pathologic findings noted 

 No microscopic finding corresponding to necropsy observation no. 01.

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 Organ examined, no pathologic findings noted 

 No microscopic finding corresponding to necropsy observation no. 01.

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ examined, no pathologic findings noted 

 No microscopic finding corresponding to necropsy observation no. 01.

 UTERUS:

 —Atrophy, diffuse 

 This finding corresponds to necropsy observation no: 01.

 CERVIX:

 —Atrophy 

 VAGINA:

 —Atrophy 

Final Report - Page 234 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 137/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 36

.........................................................................

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 —Adipocytes, grade 1 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 —Decreased bone, secondary spongiosa, grade 2 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 —Lymphoid hyperplasia, grade 3 

 This finding corresponds to necropsy observation no: 01.

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

Final Report - Page 235 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 138/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 37

.........................................................................

* NECROPSY FINDINGS

 GENERAL OBSERVATIONS:

 01: EMACIATED. 

 STOMACH:

 01: FORESTOMACH: IRREGULAR SURFACE. 

 DUODENUM:

 01: CONTENTS: GELATINOUS. 

 02: WALL: THICKENED. 

 JEJUNUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, PURPLE. 

 KIDNEYS:

 01: BOTH SIDES: DISCOLOURATION, GREENISH. 

 02: RIGHT SIDE: PELVIC DILATION. 

 ADRENAL GLANDS:

 01: BOTH SIDES: DISCOLOURATION, PALE. 

 UTERUS:

 01: REDUCED IN SIZE. 

 PANCREATIC LYMPH NODE:

 01: ENLARGED. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 GENERAL OBSERVATIONS:

 —Macro observation noted 

 This finding corresponds to necropsy observation no: 01.

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 —Alveolar inflammation, mononuclear, grade 1 

Final Report - Page 236 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 139/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 37

.........................................................................

 THYMUS:

 —Lymphoid atrophy (involution), grade 1 

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Ulcer, forestomach mucosa, grade 4 

 This finding corresponds to necropsy observation no: 01.

 —Hyperplasia, squamous epithelium, diffuse, grade 3 

 DUODENUM:

 No microscopic finding corresponding to necropsy observation no. 01.

 —Hemorrhage, grade 1 

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 02.

 JEJUNUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 2 

 —Hypertophy, jejunal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 01.

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 —Lymphoid atrophy, grade 2 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Inflammatory cell foci, lymphocytic, grade 1 

 —Hypertrophy, centrilobular, hepatocellular, grade 2 

Final Report - Page 237 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 140/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 37

.........................................................................

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 1 

 —Erythrophagocytosis, grade 3 

 This finding corresponds to necropsy observation no: 01.

 MANDIBULAR LYMPH NODES:

 —Lymphoid atrophy, bilateral, grade 2 

 KIDNEYS:

 No microscopic finding corresponding to necropsy observation no. 01.

 —Pelvic dilation, unilateral 

 This finding corresponds to necropsy observation no: 02.

 —Inflammation, interstitial lymphocytic, unilateral, grade 1 

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 —Vacuolation, zona fasciculata, multifocal, bilateral, grade 1 

 This finding corresponds to necropsy observation no: 01.

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ examined, no pathologic findings noted 

 UTERUS:

 —Atrophy, diffuse 

 This finding corresponds to necropsy observation no: 01.

 CERVIX:

 —Atrophy 

 VAGINA:

 —Atrophy 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

Final Report - Page 238 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 141/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 37

.........................................................................

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 —Decreased bone, secondary spongiosa, grade 2 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 —Lymphoid hyperplasia, grade 3 

 This finding corresponds to necropsy observation no: 01.

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 38

.........................................................................

* NECROPSY FINDINGS

 GENERAL OBSERVATIONS:

 01: EMACIATED. 

 THYMUS:

 01: REDUCED IN SIZE. 

 STOMACH:

 01: FORESTOMACH, WALL: FOCUS/FOCI, D=3X3 MM, YELLOWISH, DARK 

 RED. 

 02: FORESTOMACH: IRREGULAR SURFACE. 

Final Report - Page 239 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 142/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 38

.........................................................................

 DUODENUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 JEJUNUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 KIDNEYS:

 01: BOTH SIDES: DISCOLOURATION, GREENISH. 

 ADRENAL GLANDS:

 01: BOTH SIDES: DISCOLOURATION, PALE. 

 UTERUS:

 01: REDUCED IN SIZE. 

 PANCREATIC LYMPH NODE:

 01: ENLARGED. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 GENERAL OBSERVATIONS:

 —Macro observation noted 

 This finding corresponds to necropsy observation no: 01.

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 —Alveolar macrophage foci, grade 1 

 —Alveolar inflammation, mononuclear, grade 1 

 THYMUS:

 —Lymphocytolysis, grade 1 

 —Lymphoid atrophy (involution), grade 2 

 This finding corresponds to necropsy observation no: 01.

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

Final Report - Page 240 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 143/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 38

.........................................................................

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 —Ulcer, forestomach mucosa, grade 4 

 This finding corresponds to necropsy observations nos: 01,02.

 —Hyperplasia, squamous epithelium, diffuse, grade 4 

 DUODENUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 2 

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 01.

 JEJUNUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 2 

 —Hypertophy, jejunal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 01.

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 Organ examined, no pathologic findings noted 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Hypertrophy, centrilobular, hepatocellular, grade 2 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Hemosiderin pigment, grade 1 

 MESENTERIC LYMPH NODE:

 —Lymphatic ectasia, grade 1 

 —Erythrophagocytosis, grade 2 

 MANDIBULAR LYMPH NODES:

 —Lymphoid atrophy, bilateral, grade 1 

Final Report - Page 241 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 144/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 38

.........................................................................

 KIDNEYS:

 Organ examined, no pathologic findings noted 

 No microscopic finding corresponding to necropsy observation no. 01.

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 —Vacuolation, zona fasciculata, multifocal, bilateral, grade 2 

 This finding corresponds to necropsy observation no: 01.

 BRAIN:

 Organ examined, no pathologic findings noted 

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ examined, no pathologic findings noted 

 UTERUS:

 —Atrophy, diffuse 

 This finding corresponds to necropsy observation no: 01.

 CERVIX:

 —Atrophy 

 VAGINA:

 —Atrophy 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

Final Report - Page 242 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 145/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 38

.........................................................................

 FEMUR:

 —Decreased bone, secondary spongiosa, grade 1 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 —Lymphatic ectasia, grade 2 

 —Lymphoid hyperplasia, grade 3 

 This finding corresponds to necropsy observation no: 01.

 RENAL LYMPH NODE:

 Organ not examined 

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 39

.........................................................................

* NECROPSY FINDINGS

 GENERAL OBSERVATIONS:

 01: EMACIATED. 

 THYMUS:

 01: REDUCED IN SIZE. 

 STOMACH:

 01: GROWN TOGETHER WITH: LIVER PROCESSUS PAPILLARUS. 

 02: FORESTOMACH: IRREGULAR SURFACE. 

 03: FORESTOMACH: FOCUS/FOCI, YELLOWISH, REDDISH. 

 JEJUNUM:

 01: CONTAINS FLUID, GELATINOUS. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, DARK RED. 

 KIDNEYS:

 01: BOTH SIDES: DISCOLOURATION, GREENISH. 

Final Report - Page 243 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 146/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 39

.........................................................................

 ADRENAL GLANDS:

 01: ENLARGED. 

 OVARIES:

 01: BOTH SIDES: REDUCED IN SIZE. 

 UTERUS:

 01: REDUCED IN SIZE. 

 RENAL LYMPH NODE:

 01: LEFT SIDE: DISCOLOURATION, DARK RED. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

* MICROSCOPIC FINDINGS

 GENERAL OBSERVATIONS:

 —Macro observation noted 

 This finding corresponds to necropsy observation no: 01.

 HEART:

 Organ examined, no pathologic findings noted 

 LUNG:

 Organ examined, no pathologic findings noted 

 THYMUS:

 —Lymphocytolysis, grade 3 

 —Lymphoid atrophy (involution), grade 3 

 This finding corresponds to necropsy observation no: 01.

 TRACHEA:

 Organ examined, no pathologic findings noted 

 THYROID GLANDS:

 Organ examined, no pathologic findings noted 

 PARATHYROID GLANDS:

 Organ examined, no pathologic findings noted 

 STOMACH:

 Noted 

 —Ulcer, forestomach mucosa, grade 4 

 This finding corresponds to necropsy observation no: 02.

 —Hyperplasia, squamous epithelium, diffuse, grade 3 

 —Hemorrhage, diffuse, grade 3 

 This finding corresponds to necropsy observation no: 03.

Final Report - Page 244 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 147/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 39

.........................................................................

 DUODENUM:

 —Hypertrophy, duodenal villi with villous stunting, grade 2 

 JEJUNUM:

 No microscopic finding corresponding to necropsy observation no. 01.

 —Hypertophy, jejunal villi with villous stunting, grade 2 

 ILEUM:

 Organ examined, no pathologic findings noted 

 PEYER'S PATCHES:

 —Lymphoid atrophy, grade 2 

 CECUM:

 Organ examined, no pathologic findings noted 

 COLON:

 Organ examined, no pathologic findings noted 

 RECTUM:

 Organ examined, no pathologic findings noted 

 LIVER:

 —Hypertrophy, centrilobular, hepatocellular, grade 1 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 1 

 —Lymphoid atrophy, grade 1 

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 2 

 —Erythrophagocytosis, grade 3 

 This finding corresponds to necropsy observation no: 01.

 MANDIBULAR LYMPH NODES:

 —Lymphoid atrophy, bilateral, grade 3 

 KIDNEYS:

 Organ examined, no pathologic findings noted 

 No microscopic finding corresponding to necropsy observation no. 01.

 URINARY BLADDER:

 Organ examined, no pathologic findings noted 

 ADRENAL GLANDS:

 No microscopic finding corresponding to necropsy observation no. 01.

 —Vacuolation, zona fasciculata, multifocal, bilateral, grade 2 

 BRAIN:

 Organ examined, no pathologic findings noted 

Final Report - Page 245 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 148/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13 

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 39

.........................................................................

 SCIATIC NERVE:

 Organ examined, no pathologic findings noted 

 OVARIES:

 Organ examined, no pathologic findings noted 

 No microscopic finding corresponding to necropsy observation no. 01.

 UTERUS:

 —Atrophy, diffuse 

 This finding corresponds to necropsy observation no: 01.

 CERVIX:

 —Atrophy 

 VAGINA:

 —Atrophy 

 SKELETAL MUSCLE:

 Organ examined, no pathologic findings noted 

 EYES:

 Organ examined, no pathologic findings noted 

 BONE (STERNUM):

 Organ examined, no pathologic findings noted 

 BONE MARROW — STERNAL:

 —Adipocytes, grade 2 

 SPINAL CORD — THORACIC SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — LUMBAR SEGMENT:

 Organ examined, no pathologic findings noted 

 SPINAL CORD — CERVICAL SEGMENT:

 Organ examined, no pathologic findings noted 

 FEMUR:

 —Decreased bone, secondary spongiosa, grade 3 

 JOINTS (KNEE):

 Organ examined, no pathologic findings noted 

 PANCREATIC LYMPH NODE:

 Organ not examined 

 RENAL LYMPH NODE:

 —Erythrophagocytosis, grade 2 

 This finding corresponds to necropsy observation no: 01.

—————————————————————————————————————————————————————————————————————————

Final Report - Page 246 of 252 - The use of these studies/documents for regulatory or registration purposes, including but not limited to Registration, Evaluation, 

Authorization and Restriction of Chemical Substances (REACH), without the express written permission of Huntsman 

International LLC is unauthorized and strictly prohibited.
PATHOLOGY REPORT PAGE : 149/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

* STATE AT NECROPSY: K0 

 DAYS ON TEST : 28 * ANIMAL NO. : 40

.........................................................................

* NECROPSY FINDINGS

 GENERAL OBSERVATIONS:

 01: EMACIATED. 

 THYMUS:

 01: REDUCED IN SIZE. 

 STOMACH:

 01: FORESTOMACH, WALL: FOCUS/FOCI, D=9X7 MM, YELLOWISH, DARK 

 RED. 

 02: FORESTOMACH: IRREGULAR SURFACE. 

 DUODENUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 JEJUNUM:

 01: WALL: THICKENED. 

 02: CONTENTS: GELATINOUS. 

 MESENTERIC LYMPH NODE:

 01: DISCOLOURATION, DARK RED. 

 KIDNEYS:

 01: BOTH SIDES: DISCOLOURATION, GREENISH. 

 ADRENAL GLANDS:

 01: BOTH SIDES: DISCOLOURATION, PALE. 

 OVARIES:

 01: BOTH SIDES: REDUCED IN SIZE. 

 UTERUS:

 01: REDUCED IN SIZE. 

 PANCREATIC LYMPH NODE:

 01: ENLARGED. 

 RENAL LYMPH NODE:

 01: BOTH SIDES: ENLARGED. 

 NO OTHER NECROPSY OBSERVATIONS NOTED

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PATHOLOGY REPORT PAGE : 150/ 151

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 40

.........................................................................

* MICROSCOPIC FINDINGS

 GENERAL OBSERVATIONS:

 —Macro observation noted 

 This finding corresponds to necropsy observation no: 01.

 LUNG:

 —Alveolar macrophage foci, grade 1 

 THYMUS:

 —Lymphoid atrophy (involution), grade 3 

 This finding corresponds to necropsy observation no: 01.

 PARATHYROID GLANDS:

 Only one of paired organs examined/present 

 STOMACH:

 —Ulcer, forestomach mucosa, grade 4 

 This finding corresponds to necropsy observations nos: 01,02.

 —Hyperplasia, squamous epithelium, diffuse, grade 3 

 DUODENUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 2 

 —Hypertrophy, duodenal villi with villous stunting, grade 3 

 This finding corresponds to necropsy observation no: 01.

 JEJUNUM:

 No microscopic finding corresponding to necropsy observation no. 02.

 —Hemorrhage, grade 2 

 —Hypertophy, jejunal villi with villous stunting, grade 2 

 This finding corresponds to necropsy observation no: 01.

 PEYER'S PATCHES:

 —Lymphoid atrophy, grade 1 

 LIVER:

 —Hypertrophy, centrilobular, hepatocellular, grade 2 

 SPLEEN:

 —Hemopoietic foci, primarily erythropoiesis, grade 2 

 MESENTERIC LYMPH NODE:

 —Lymphoid atrophy, grade 1 

 —Increased mast cells, grade 2 

 —Erythrophagocytosis, grade 2 

 This finding corresponds to necropsy observation no: 01.

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PATHOLOGY REPORT PAGE : 151/ 151 

INDIVIDUAL ANIMAL DATA TOX : 501432

—————————————————————————————————————————————————————————————————————————

TEST ITEM : m—(2,3—epoxypropoxy)—N,N—bis(2,3— PATHOL. NO.: 41310 JOL

TEST SYSTEM : RAT, 28—Day, Oral DATE : 08—OCT—13

SPONSOR : Huntsman Advanced Materials PathData©System V6.2d1

—————————————————————————————————————————————————————————————————————————

TEXT OF GROSS AND MICROSCOPIC FINDINGS 

DOSE GROUP : 04, 450 MG/KG FEMALE

—————————————————————————————————————————————————————————————————————————

 CONT./FF. ANIMAL NO. : 40

.........................................................................

 MANDIBULAR LYMPH NODES:

 —Lymphoid atrophy, bilateral, grade 2 

 —Erythrophagocytosis, unilateral, grade 2 

 KIDNEYS:

 No microscopic finding corresponding to necropsy observation no. 01.

 —Inflammation, interstitial lymphocytic, unilateral, grade 1 

 —Basophilia, tubular, corticomedullary, unilateral, grade 1 

 ADRENAL GLANDS:

 —Vacuolation, zona fasciculata, multifocal, bilateral, grade 2 

 This finding corresponds to necropsy observation no: 01.

 OVARIES:

 No microscopic finding corresponding to necropsy observation no. 01.

 UTERUS:

 —Atrophy, diffuse 

 This finding corresponds to necropsy observation no: 01.

 CERVIX:

 —Atrophy 

 VAGINA:

 —Atrophy 

 FEMUR:

 —Decreased bone, secondary spongiosa, grade 2 

 PANCREATIC LYMPH NODE:

 —Lymphoid hyperplasia, grade 2 

 This finding corresponds to necropsy observation no: 01.

 RENAL LYMPH NODE:

 —Lymphoid hyperplasia, grade 2 

 This finding corresponds to necropsy observation no: 01.

 ALL OTHER PROTOCOL TISSUES WITHOUT PATHOLOGIC FINDINGS.

—————————————————————————————————————————————————————————————————————————

 

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m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Project 501432 

APPENDIX 5 

 

- Page 1 -

APPENDIX 5 SUMMARY OF DOSE RANGE FINDING STUDY 

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m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Project 501432 

APPENDIX 5 

- Page 2 - 

Summary of Dose Range Finding Study 

Study Plan Treatment: 27 October 2012 to 07 November 2012 

Necropsy: 31 October 2012, 05 November 2012, 07 November 2012 

Aim of the study 

In order to set the dose levels for the main study (Project 501432), a dose range finding study was 

performed (Project 501433).

Guidelines 

No guidelines were applicable as this study was intended for dose level selection purposes only. 

Materials and methods 

If not mentioned otherwise, test system, procedures and techniques were identical to those used 

during the main study. 

Test System/Animal husbandry 

Number of rats/group 3 females (group-housed, allocated at random and identified by 

ear- and tailmark. 

Age at start of treatment Approximately 6-8 weeks. 

Room number A0.10 

Environmental Conditions Actual temperature range: 19.0 – 22.0°C.

 Actual relative humidity range: 42 - 68%. 

Treatment 

Duration of treatment 10 days for group 1 (500 mg/kg) 

5 days for group 2 (1000 mg/kg) 

5 days for group 3 (250 mg/kg) 

Dose levels 250, 500 and 1000 mg/kg body weight. 

No chemical analyses of dose preparations were conducted. 

Dose volume 5 mL/kg body weight/day. 

Vehicle Propylene glycol. 

Observations 

Clinical signs: Daily, at 0-15 minutes, 1 hour (±15 minutes) and 3 hours (± 30 minutes) 

after dosing.

Mortality: At least twice daily. 

Body weights: On Day 1 prior to dosing and on Day 5 and/or 10. 

Food consumption: Over days 1-5 and/or 5-10.

Pathology 

Necropsy: On Day 5 (group 2 and 3) or 10 (group 1) after the last observation of 

clinical signs (scheduled necropsy) or sooner (decedents). No organs 

were fixed. Animals were not fasted prior to necropsy. 

Organ weights: Terminal body weight, kidney, and liver weight. 

List of protocol deviations 

1 On Day 4 the 3 hours after dosing observation was too late performed (approximately 10 

min). 

Evaluation: The slight and incidental deviation from the time schedule was considered not to 

have influenced the dose level selection for the main study.

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m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline Project 501432 

APPENDIX 5 

- Page 3 - 

Results (see also individual data tables on following pages). 

Parameter 250 mg/kg 500 mg/kg 1000 mg/kg

Mortality No mortality. No mortality. No mortality. 

Clinical appearance No findings. Lethargy, hunched posture, 

piloerection, salivation 

Lethargy, hunched posture, 

piloerection, salivation lean 

appearance and ptosis 

Body weight Normal. Reduced body weight gain Body weight loss 

Food consumption Normal. Slightly lower low 

Macroscopic 

examination No abnormalities noted. No abnormalities noted. 

GI-tract distended with gas and 

many dark red foci in glandular 

mucosa of the stomach. 

Organ weights Liver and kidney weights 

considered to be normal. 

Liver and kidney weights 

considered to be normal. 

Liver and kidney weights 

considered to be normal.

Conclusion 

Based on the results of this range finding study, dose levels for the main study were 50, 150 and 450 

mg/kg body weight. 

No clear peak effect of occurrence of clinical signs was observed in the range finding study. 

Therefore, clinical observations in the main study were conducted immediately after dosing, and 

functional observation tests were conducted after dosing at no specific time point, but within a similar 

time period after dosing for the respective animals. 

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