STUDY NO. 00-6130

SPONSOR STUDY NO. 211-DIPE-S 

GASOLINE DIPE VAPOR CONDENSATE:

A 13-WEEK WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

WITH NEUROTOXICITY ASSESSMENTS AND 4-WEEK IN VIVO 

GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS

Final Report

Volume I of IV

Submitted to: American Petroleum Institute (API)

1220 L Street, Northwest

Washington, DC 20005-4070

Attn: Thomas M. Gray, M.S., D.A.B.T.

Date: 31 May 2013

Page 1 of 1446



Huntingdon Life Sciences 00-6130 Page 5 

211-DIPE-S Final Report 

GASOLINE DIPE VAPOR CONDENSATE:

A 13-WEEK WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

WITH NEUROTOXICITY ASSESSMENTS AND 4-WEEK IN VIVO 

GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS

SUMMARY

This study was designed to assess the potential inhalation toxicity of Gasoline DIPE 

Vapor Condensate when administered via whole-body exposures to Sprague Dawley rats 

for 13 weeks followed by a 4 week recovery period. The assessments included routine 

toxicology parameters as well as detailed evaluations of neurotoxicity parameters 

(presented in this report except GFAP evaluations appended to this report) and 

genotoxicity and immunotoxicity parameters (appended to this report). The test 

substance was administered (using a nitrogen enriched air mixture) at target 

concentrations of 2000, 10000 and 20000 mg/m3 for 6 hours/day, generally 5 days/week 

for 13 weeks (at least 65 exposures). In addition, an Air Control group received nitrogen 

enriched air only while in chamber. Exposure levels were determined using an infra-red 

spectrophotometer 4 times per chamber per day. Additionally, the test substance’s major 

components were assayed once per chamber per week. Particle size distribution 

measurements were also made once per chamber per week using a TSI Aerodynamic 

Particle Sizer. 

Viability checks were performed twice daily to check for mortality and signs of severe 

toxic or pharmacologic effects. Physical observations and body weights were collected 

twice pretest and weekly during the study period. Feed consumption measurements were 

obtained beginning the week prior to treatment initiation and weekly during the study. 

Ophthalmoscopic examinations were conducted pretest and at study termination. 

Functional observational batteries and motor activity assessments were performed pretest 

and after 4, 8 and 13 weeks of exposure. Hematology, coagulation and clinical chemistry 

studies were performed at 4 weeks and termination of the exposures. After 13 weeks of 

exposures, all animals were sacrificed except recovery animals, which were sacrificed 

after an additional 4-week recovery period. Selected organs were weighed and 

organ/body weight and organ/brain weight ratios calculated. Complete macroscopic 

postmortem examinations were performed on all animals. Histopathological evaluations 

(including neuropathology evaluations) of all selected or prescribed tissues were 

conducted on all Air Control and 20000 mg/m3 exposed animals at the Terminal interval 

but no evaluations were made at the Recovery interval. Lungs and gross lesions were 

examined for all animals at the Terminal interval.
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SUMMARY

The mean (± standard deviation) analytical exposure concentrations of Gasoline DIPE 

Vapor Condensate were determined to be 0 ± 0, 1995 ± 132, 10030 ± 692 and 20120 

± 869 mg/m3 for the Air Control and the exposure groups, respectively. The analytically 

measured exposure levels of the airborne test substance were acceptably close, in the 

opinion of the study director, to the targeted exposure levels. Chamber environmental 

conditions averaged 24°C temperature and 50% relative humidity. Particle sizing results 

indicated that the atmospheres were essentially vapor only, as expected, since there was 

no substantial difference between the particulate levels in the test substance chambers 

and the Air Control chambers. Analysis of the major components in the neat test 

substance and the test atmospheres showed a reasonably close comparison between the 

neat test substance and the vaporized test substance. This data demonstrated that the test 

animals were exposed, as expected, to all of the major components of the test substance 

in their reasonably proper proportion. The data was consistent from week-to-week 

during the study indicating stability of the test substance and the atmosphere generation 

techniques.

There was no test substance-related mortality throughout the exposure and recovery 

phases of the study. The test animals were unremarkable during the in-chamber exposure 

periods. During the non-exposure periods, an exposure-related increase in the frequency 

of red nasal discharge observations was seen in the 20000 mg/m3 exposed animals 

compared to the Air Control animals and the other test substance exposed animals

starting as early as Week 2 for the males and Week 4 for the females. These observations 

abated during the recovery period. There were no indications of treatment-related ocular 

disease in the test substance exposed animals. There were no exposure-related 

differences in absolute body weights or in body weight changes or in feed consumption 

in the test substance exposed animals compared to the Air Control animals. Test 

substance exposure was not associated with any change in counts of the 26 nominal FOB 

measures, or the 4 continuous FOB measures or with changes in motor activity. 

There were exposure-related differences in hematology values in test substance exposed 

animals compared to the Air Control animals at the 4th week and terminal and recovery 

intervals. These differences were limited to statistically significant decreases (21-23%) 

in reticulocyte counts for the 20000 mg/m3 exposed male animals which occurred at both 

exposures period intervals (4th week and terminal) and at termination of the recovery 

interval. Statistically significant (13-17%) decreases also occurred in reticulocyte counts 

for the 2000 and 10000 mg/m3 exposed male animals but only at the 4th week interval. 

Similar differences did not occur in female animals at any exposure level and any interval

but there were statistically significant (35-36%) decreases in absolute monocytes for the 

20000 mg/m3 exposed female animals but only at the 4th week and recovery intervals. 

There were no exposure-related differences in coagulation values in test substance 
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211-DIPE-S Final Report 

SUMMARY

exposed animals compared to the Air Control animals at the 4th week and Terminal 

intervals. There were exposure-related differences in clinical chemistry values in the test 

substance exposed animals compared to the Air Control animals at the 4th week and 

terminal and recovery intervals. Decreases, relative to control values, occurred in several 

serum enzymes for test substance-exposed groups after 4 or 13 weeks of exposure and/or 

at the end of the recovery period. Enzymes affected were aspartate aminotransferase, 

lactate dehydrogenase, creatine kinase and sorbitol dehydrogenase. While some of the 

differences (e.g. lactate dehydrogenase and sorbitol dehydrogenase) were consistently 

statistically significant at the 4 and 13 weeks and/or recovery intervals, decreases in these 

enzymes are not usually considered an adverse response to treatment and there were no 

corresponding histopathology findings. 

There were no exposure-related differences in organ weights and brain measurements in 

the test substance exposed animals compared to the Air Control animals at the Terminal 

and/or Recovery intervals. No gross abnormalities related to test substance exposure 

were evident at necropsy examination. Microscopic findings that were considered 

exposure-related were found only in the kidneys of male animals exposed to 

20000 mg/m3

 of Gasoline DIPE Vapor Condensate following the Terminal sacrifice. 

These renal histopathologic changes were consistent with hyaline droplet nephropathy, 

attributable to accumulation of alpha-2 microglobulin within renal tubular epithelial cells. 

This species- and gender-specific change has been well documented in male rats exposed 

to a variety of hydrocarbon compounds and is not considered relevant to humans. No test 

substance related histopathologic changes were noted in other protocol-specified tissues,

including lung, nasoturbinates and larynx. No microscopic changes attributable to test 

substance exposure were observed in brain, spinal cord, eyes with optic nerve, peripheral 

nerves or ganglia among the 20000 mg/m3 exposed satellite animals.

In conclusion, thirteen weeks of exposure of rats to Gasoline DIPE Vapor Condensate 

resulted in hydrocarbon nephropathy in male animals exposed to 20000 mg/m3

 of vapor. 

However, this finding has been generally accepted (US EPA 1991. Alpha 2 

microglobulin: association with chemically induced renal toxicity and neoplasia in male 

rat. In Risk Assessment Forum, p.85. US Govt. Printing Office, Washington, DC.) not to 

be relevant to human risk assessment. Thirteen weeks of exposure of rats to Gasoline 

DIPE Vapor Condensate also resulted in increased red nasal discharge and slight, nonreversible decreases in reticulocyte values (at the 4th week and terminal and recovery 

intervals) in the male animals exposed to 20000 mg/m3 of vapor. Therefore, the 

10000 mg/m3 exposure level (excluding male rat nephropathy) was considered a no 

observable adverse effect level (NOAEL). The NOAEL for other satellite study 

endpoints are included in the Table on page 8. 
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211-DIPE-S Final Report 

SUMMARY

Study Type 

[Laboratory] 

Duration of 

Exposure 

Basis for NOAEL NOAEL

Inhalation Subchronic1 

[HLS,

East Millstone, NJ]

13 weeks Positive:

altered increases in red nasal 

discharge and slight, nonreversible decreases in 

reticulocyte values in the male 

animals exposed to

20000 mg/m3 

10000mg/m3

Neurobehavioral and 

Neuropathologic Effects

4 weeks Negative 20000mg/m3

Micronucleus2

[HLS,

Eye Suffolk, England] 

4 weeks Negative 20000mg/m3

Sister Chromatid 

Exchange3

[BioReliance,

Rockville, MD]

4 weeks Negative 20000mg/m3

Immunotoxicity4

[ImmunoTox Inc, 

Richmond, VA] 

4 weeks Positive:

significant decrease in the IgM 

antibody-forming cell (AFC) 

response to the T-dependent 

antigen, sheep erythrocytes, in 

the female animals exposed to 

20000 mg/m3

10000mg/m3

GFAP5

[Molecular 

Neurotoxicology Lab - 

NIOSH,

Morgantown, VA]

13 weeks Negative 20000mg/m3

1

Light Hydrocarbon Nephropathy observed in males at 20000mg/m3 exposure level 

2

Appendix X: Micronucleus Satellite Study Report 

3

Appendix Y: Sister Chromatid Exchange Satellite Study Report 

4

Appendix Z: Immunotoxicity Satellite Study Report 

5

Appendix AA: GFAP Satellite Study Report 
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TABLE OF CONTENTS

VOLUME I

COVER PAGE.....................................................................................................................1 

STATEMENT OF COMPLIANCE .....................................................................................2 

SIGNATURE PAGE............................................................................................................3 

QUALITY ASSURANCE STATEMENT ..........................................................................4 

SUMMARY .........................................................................................................................5 

TABLE OF CONTENTS .....................................................................................................9 

1. INTRODUCTION................................................................................................13 

2. MATERIALS AND METHODS

2.1. Study Management ....................................................................................13 

2.2. Study Dates ................................................................................................13 

2.3. Experimental Outline .................................................................................15 

2.4. Test Substance ...........................................................................................17 

2.5. Test Animals ..............................................................................................18 

2.6. Animal Assignment ...................................................................................19 

2.7. Animal Identification .................................................................................20 

2.8. Veterinary Care ..........................................................................................20 

2.9. Husbandry During Non-Exposure Periods.................................................20 

2.10. Husbandry During Exposure Periods .........................................................22 

2.11. Test Substance Administration and Chamber Operation ...........................23 

2.12. Experimental Evaluations ..........................................................................27 

2.13. Neurobehavioral Studies ............................................................................29 

2.14. Clinical Pathology ......................................................................................31 

2.15. Genotoxicity Evaluations ...........................................................................35 

2.16. Immunotoxicity Evaluations ......................................................................36 

2.17. Postmortem Evaluations ............................................................................37 

2.18. Neuropathology Sacrifice ...........................................................................41 

2.19. GFAP Evaluations .....................................................................................42 

2.20. Statistical Analysis .....................................................................................43 

2.21. Data Storage ...............................................................................................45 

2.22. Regulatory References ...............................................................................45 

2.23. Protocol Deviations ....................................................................................47 
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TABLE OF CONTENTS

3. RESULTS AND DISCUSSION

3.1. Chamber Monitoring ..................................................................................48 

3.2. Mortality.....................................................................................................50 

3.3. Clinical Observations .................................................................................50 

3.4. Ophthalmoscopic Examinations ................................................................51 

3.5. Body Weights .............................................................................................51 

3.6. Feed Consumption .....................................................................................51 

3.7. Neurobehavioral Studies ............................................................................51 

3.8. Clinical Pathology ......................................................................................53 

3.9. Organ Weights and Brain Measurements ..................................................54 

3.10. Pathology ...................................................................................................55 

4. CONCLUSION ....................................................................................................57 

REFERENCES ..................................................................................................................58 

FIGURES

1. Chamber Generation System and Whole-Body Exposure Chamber ...........................61 

2. Mean Body Weights – Males (Main/Recovery) ..........................................................63 

3. Mean Body Weights – Females (Main/Recovery) .......................................................64 

4. Mean Feed Consumption – Males (Main/Recovery) ...................................................65 

5. Mean Feed Consumption – Females (Main/Recovery) ...............................................66 

GENERAL PREFACE ......................................................................................................67 

TABLES

1. Summary of In-Chamber Observations .......................................................................68 

2. Summary of Clinical Observations ..............................................................................73 

3. Summary of Ophthalmoscopic Findings ......................................................................82 

 Ophthalmologist Reports ..............................................................................................83 

 Summary of Ophthalmology Observations ..................................................................87 

4. Mean Body Weights .....................................................................................................95 

5. Mean Body Weight Change from Baseline................................................................105 

6. Mean Feed Consumption Values ...............................................................................117 

7. Summary of FOB and Motor Activity Analyses ........................................................127 

8. Mean Motor Activity Values .....................................................................................139 

9. Summary of Functional Observational Battery Evaluations ......................................147 
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TABLE OF CONTENTS

10. Mean Hematology Values ..........................................................................................179 

11. Mean Coagulation Values ..........................................................................................192 

12. Mean Clinical Chemistry Values ...............................................................................197 

13. Mean Organ Weights and Brain Measurements ........................................................216 

14. Incidence Summary Report for Gross Necropsy Observations ..................................243 

15. Incidence Summary of Microscopic Findings with Severity Levels ..........................247 

APPENDICES

A. Chamber Monitoring Results .....................................................................................267 

B. Individual Clinical Observations ...............................................................................292 

C. Individual Ophthalmology Observations ...................................................................321 

D. Individual Body Weights ...........................................................................................361 

Volume II

COVER PAGE.................................................................................................................381 

TABLE OF CONTENTS .................................................................................................382 

APPENDICES

E. Individual Body Weight Change from Baseline. .......................................................383 

F. Individual Feed Consumption Values ........................................................................399 

G. Individual Motor Activity Values ..............................................................................419 

H. Individual Functional Observational Battery Evaluations .........................................435 

I. Individual Hematology Values ..................................................................................472 

J. Individual Coagulation Values ...................................................................................513 

K. Individual Clinical Chemistry Values ........................................................................530 

L. Individual Organ Weights and Brain Measurements .................................................591 

M. Individual Animal Gross and Microscopic Observations ..........................................630 
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TABLE OF CONTENTS

Volume III

COVER PAGE.................................................................................................................816 

TABLE OF CONTENTS .................................................................................................817 

APPENDICES

N. Equipment List ...........................................................................................................818 

O. Miran Calibration .......................................................................................................821 

P. Chamber Distribution Records ..................................................................................824 

Q. Testing Room and Chambers Environmental Monitoring .........................................826 

R. Animal Termination History ......................................................................................828 

S. Analytical Report .......................................................................................................844 

T. Neurobehavioral Positive Control ..............................................................................869 

U. Neuropathology Historical Control ............................................................................962 

V. Protocol and Protocol Amendment ............................................................................968 

W. Testing Facility Personnel ........................................................................................1056 

Volume IV

COVER PAGE...............................................................................................................1057 

TABLE OF CONTENTS ...............................................................................................1058 

APPENDICES

X. Micronucleus Satellite Study Report ......................................................................1059 

Y. Sister Chromatid Exchange Satellite Study Report ................................................1159 

Z. Immunotoxicity Satellite Study Report ..................................................................1251 

AA.GFAP Satellite Study Report ..................................................................................1315 

BB. Report Amendments ...............................................................................................1446 
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1. INTRODUCTION

This study was designed to assess the potential inhalation toxicity of Gasoline 

DIPE Vapor Condensate when administered via whole-body exposures to rats for 

at least 13 weeks followed by a 4 week recovery period. The assessment included 

routine toxicology parameters as well as detailed evaluations of neurotoxicity, 

genotoxicity and immunotoxicity parameters. 

2. MATERIALS AND METHODS 

2.1. STUDY MANAGEMENT

2.1.1. SPONSOR

American Petroleum Institute (API)

1220 L Street, Northwest 

Washington, D.C. 20005-4070 

2.1.2. SPONSOR REPRESENTATIVE

Thomas M. Gray, M.S., D.A.B.T. 

2.1.3. TESTING FACILITY

Huntingdon Life Sciences (HLS) 

Mettlers Road

East Millstone, New Jersey 08875-2360 

2.1.4. STUDY DIRECTOR

Gary M. Hoffman, B.A., D.A.B.T. 

2.1.5. CONTRIBUTORS

Departmental supervisory personnel are listed on the personnel 

page of this report (Appendix W).

2.2. STUDY DATES

2.2.1. STUDY INITIATION

17 December 2001 (Date Study Director signed the Protocol) 
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2.2.2. DATE OF ANIMAL RECEIPT 

24 January 2002 (main/recovery/neuropathology study animals) 

2.2.3. EXPOSURE INITIATION 

12 February 2002 (Experimental Start Date) 

2.2.4. EXPOSURE TERMINATION 

13 - 14 May 2002 

2.2.5. TERMINAL SACRIFICE 

13 - 14 May 2002 (main study animals) 

16 - 17 May 2002 (neuropathology study animals) 

2.2.6. RECOVERY SACRIFICE 

14 June 2002 

2.2.7. EXPERIMENTAL TERMINATION 

29 May 2013 (Date of last data collection = Date final report is 

signed by the Pathologist) 

2.2.8. STUDY COMPLETION 

31 May 2013 (Date Final Report is signed by the Study Director)
Huntingdon Life Sciences 00-6130 

 211-DIPE-S 2.3. EXPERIMENTAL OUTLINE 

Group 

Exposure 

Levela Number of Animals (MAIN and RECOVERY STUDIES) 

(mg/m3) 

Initialb

Clinical Laboratory Studies Necropsy Mic

4 Weeks & 

Terminal 

Recoveryc Terminal Recoveryc Term

M F M F M F M F M F M 

I (control) 0 (air only) 20 20 10 10 10 10 10 10 10 10 10 II (low) 2,000 10 10 9 d 10 - - 9 d 10 - - 9 d III (mid) 10,000 10 10 10 10 - - 10 10 - - 10 IV (high) 20,000 20 20 10 10 10 10 10 10 10 10 10 

aExposures were 6 hours/day, generally 5 days/week for 13 weeks for at least 65 exposures for Main and Recovery Stu

exposed on test days when FOB and motor activity evaluations were performed. 

bThis number of animals includes 10/sex/group designated for the Terminal Sacrifice (Main Study animals) and 10/sex/grou

designated for Recovery after the Terminal Sacrifice (Recovery Study animals). 

cThe recovery period was 4 weeks. It was decided by the Sponsor that Clinical Laboratory Studies would not be performed on 

if no significant effects were observed in animals during the exposure period. Past testing on gasoline, gasoline ble

oxygenates had not demonstrated delayed expression of toxicity after exposure was terminated that had not been seen in ex

study, only hematology and clinical chemistry were performed for the Recovery interval. 

dA Group II male animal (#2070) was euthanized on 29April02 as a result of an accidental injury. Since this animal w

designated for GFAP evaluation after 13 weeks of exposure, it was decided to replace this animal with 1 of 10 male animStudy evaluations. 

M = Male; F = Female; The first day of exposure was Day 0. 
Huntingdon Life Sciences 00-6130 

 211-DIPE-S EXPERIMENTAL OUTLINE (CONTINUED) 

Group 

Exposure 

Levela Number of Animals (SATELLITE STUDIES) 

(mg/m3) 

Initialb Neuropathology GFAP Immunotoxicity 

(

M F M F M F M F 

I (control) 0 (air only) 15 25 5 5 5 5 - 10 II (low) 2,000 15 25 5 5 5 5 - 10 III (mid) 10,000 15 25 5 5 5 5 - 10 IV (high) 20,000 15 25 5 5 5 5 - 10 

 aExposures were 6 hours/day, generally 5 days/week for 13 weeks for at least 65 exposures for Neuropathology and GFAP St

hours/day, generally 5 days/week for 4 weeks for 20 exposures for Genotoxicity and Immunotoxicity Studies. Animals w

days when FOB and motor activity evaluations were performed. 

bThis number of animals included 5/sex/group designated for neuropathology after the Terminal Sacrifice, 5/sex/grou

evaluation after the Terminal Sacrifice, 10 females/group designated for Immunotoxicity (PFC) evaluations following a 4 w

5/sex/group designated for Genotoxicity (Micronucleus and Sister Chromatid Exchange) evaluations following a 4 week e

Immunotoxicity and Genotoxicity evaluations, separate groups of animals (10 females and 5/sex/evaluation, respectivelycontrol animals for these evaluations. For Immunotoxicity evaluations, positive control rats were given a dose of 50 mg/kg intraperitoneally once per day for 4 days prior to sacrifice. For Genotoxicity evaluations, positive control rats were given a and 40 mg/kg (Micronucleus) CP intraperitoneally within 24 hours prior to sacrifice. These positive control animals were noto dosing and sacrifice. 

M = Male; F = Female; The first day of exposure was Day 0. GFAP = Glial Fibrillary Acidic Protein; SCE = Sister Chromatid Exchange; PFC = Plaque Forming Cell 
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 211-DIPE-S Final Report 

2.4. TEST SUBSTANCE 

Gasoline DIPE Vapor Condensate 

2.4.1. SUPPLIER 

Chevron Global Technology Services Co. 

100 Chevron Way 

Richmond, CA 94802-9627 

2.4.2. LOT NUMBER 

API 01-06 

2.4.3. PURITY 

100% Gasoline DIPE Vapor Condensate 

2.4.4. DESCRIPTION 

Colorless liquid 

2.4.5. DATE RECEIVED 

7 December 2001 

2.4.6. EXPIRATION DATE 

Not available, stable per MSDS. The test substance stability was 

tested concurrently with the study and the results (see Appendix S) 

showed it to be stable for the duration of the study. 

2.4.7. ANALYSIS 

Documentation of the identity, strength, composition, and method of 

synthesis, fabrication and/or derivation of the batch of the test 

substance and the maintenance of these records was the 

responsibility of the Sponsor. 

2.4.8. STORAGE 

Room temperature 
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 211-DIPE-S Final Report 

2.4.9. DISPENSING 

The test substance was received from Chevron Research Company 

in 100-gallon cylinders. Since only 5-gallon cylinders were 

practical to be used for exposure operations, the test substance was 

dispensed, as needed, at the Testing Facility from the 100 gallon 

cylinders into 5-gallon cylinders using nitrogen pressurization. 

2.4.10. ARCHIVAL SAMPLE 

A sample from the lot of test substance is stored in the Archives of 

the Testing Facility under conditions specified for test substance 

storage. 

2.4.11. DISPOSITION 

The unused portion of the test substance as well as any empty test 

substance containers were returned to the sponsor on 

11 January 07. Empty test substance containers were returned to 

the sponsor on an as needed basis. The sponsor was responsible 

for tracking their disposition. 

2.5. TEST ANIMALS 

2.5.1. SPECIES 

Albino Rats (Outbred) VAF/Plus

Sprague-Dawley – derived [Crl:CD® (SD) IGS BR] 

2.5.2. SUPPLIER 

Charles River Laboratories 

Kingston, New York 12484 

2.5.3. JUSTIFICATION FOR TEST ANIMAL SELECTION 

The rat is a rodent animal model commonly utilized in toxicity 

studies as recommended in the referenced guidelines. In addition, 

a historical database is available for comparative evaluation. 
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 211-DIPE-S Final Report 

2.5.4. NUMBER OF ANIMALS 

Placed on test: 

310 total (130 males, 180 females) 

2.5.5. AGE AT RECEIPT AND AT INITIATION OF EXPOSURE 

Study Phase 

Age at Receipt 

(weeks) 

Age at Exposures Initiation 

(weeks) 

Main/Recovery ~6 ~9 

Neuropathology ~6 ~9 

GFAP ~6 ~9 

Genotoxicity ~4 ~6 

Immunotoxicity ~4 ~7 

Note: Females were nulliparous and non-pregnant. 

2.5.6. WEIGHT AT INITIATION OF EXPOSURES (GRAMS) 

Study Phase 

Male Female 

Mean Range Mean Range 

Main/Recovery 306 277-351 222 192-263 

Neuropathology 301 254-331 226 201-257 

GFAP 308 280-336 217 188-240 

Genotoxicity 123 108-138 113 95-130 

Immunotoxicity - - 182 165-204 

Individual weights of animals placed on test were within ±20% of 

the mean weight for each sex. 

2.5.7. ACCLIMATION PERIOD 

Animals were acclimated for up to three weeks. All animals were 

examined during the acclimation period to confirm suitability for 

study. 

2.6. ANIMAL ASSIGNMENT 

More animals than required for the study were purchased and acclimated. 

Animals considered suitable for study on the basis of pretest physical 

examinations, body weight data and pretest ophthalmology evaluations were 

randomly assigned by a computerized random sort program, by sex, to 
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control or treated groups in an attempt to equalize mean group body 

weights. The Main/Recovery study and each of the Neuropathology, GFAP, 

Genotoxicity and Immunotoxicity studies were randomized separately. 

Disposition of all animals not utilized in the study is maintained in the study 

file. 

2.7. ANIMAL IDENTIFICATION 

Each rat was identified with a metal ear tag bearing its assigned animal 

number. The assigned animal number plus the study number comprised 

the unique animal number for each animal. When a tag was lost, it was 

replaced. In addition, each cage was provided with a cage card, which 

was color-coded for exposure level identification and contained study 

number and animal number information. 

2.8. VETERINARY CARE 

Animals were monitored by the technical staff for any conditions 

requiring possible veterinary care. 

2.9. HUSBANDRY DURING NON-EXPOSURE PERIODS 

2.9.1. FACILITIES MANAGEMENT/ANIMAL HUSBANDRY 

Currently acceptable practices of good animal husbandry were 

followed e.g., Guide for the Care and Use of Laboratory Animals; 

National Academy Press, 1996. Huntingdon Life Sciences, East 

Millstone, New Jersey is fully accredited by the Association for 

Assessment and Accreditation of Laboratory Animal Care 

International (AAALAC). 

2.9.2. HOUSING 

Animals younger than 5 weeks at receipt were housed 2/cage during 

the initial week of acclimation. Animals 5 weeks or older were 

housed individually in suspended stainless steel wire mesh cages. 

2.9.3. FEED 

Certified Rodent Diet, No. 5002; (Meal) (PMI Nutrition 

International, St. Louis, Missouri) was available without 

restriction. Fresh feed was presented weekly. 
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2.9.4. FEED ANALYSIS 

Analysis of each feed lot used during this study was performed by 

the manufacturer. Results are maintained on file by the 

manufacturer. There were no known contaminants in the feed 

which were expected to interfere with the results of this study. 

2.9.5. WATER 

Water (Elizabethtown Water Company, Westfield, New Jersey) 

was available without restriction via an automated watering 

system. 

2.9.6. WATER ANALYSIS 

Monthly water analyses are conducted by Elizabethtown Water 

Company, Westfield, New Jersey (Raritan-Millstone Plant) to 

ensure that water meets standards specified under the EPA Federal 

Safe Drinking Water Act Regulations (40 CFR Part 141). In 

addition, water samples are collected biannually from 

representative rooms in the Testing Facility; chemical and 

microbiological water analyses are conducted on these samples by 

a subcontract laboratory. Results of all water analyses are 

maintained on file at the Testing Facility. There were no known 

contaminants in the water, which were expected to interfere with 

the results of this study. 

2.9.7. ENVIRONMENTAL CONDITIONS 

Light/Dark Cycle 

A twelve hour light/dark cycle controlled via an automatic timer 

was provided. 

Temperature 

Temperature was monitored in accordance with Testing Facility 

SOPs and maintained within the specified range to the maximum 

extent possible. 

Desired: 18 to 26°C 

Actual: 19 to 25°C 

Daily Average: 19 to 23°C 
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 211-DIPE-S Final Report 

Relative Humidity 

Relative humidity was monitored in accordance with Testing 

Facility SOPs and maintained within the specified range to the 

maximum extent possible. Excursions outside the specified ranges 

were not considered to have affected the integrity of the study. 

Desired: 30 to 70% 

Actual: 25 to 76% 

Daily Average: 40 to 59% 

2.10. HUSBANDRY DURING EXPOSURE PERIODS 

2.10.1. HOUSING 

Animals were individually housed in stainless steel, wire mesh 

cages within a 1000 Liter stainless steel and glass whole-body 

exposure chamber. Two chambers were used for each exposure 

level, in general one for male animals and one for female animals, 

with the placement of the animals in the whole-body exposure 

chambers rotated weekly to ensure uniform exposure of the 

animals. A description of the animal rotation is included in the 

raw data. 

2.10.2. FEED 

None was provided during exposure. 

2.10.3. WATER 

None was provided during exposure. 

2.10.4. ENVIRONMENTAL CONDITIONS 

Chamber static pressure and airflow were monitored continuously 

and recorded every half-hour during the exposure. Chamber 

temperature and relative humidity were also monitored 

continuously and recorded every half-hour during the exposure and 

maintained, to the maximum extent possible, within the ranges 

presented below. Excursions outside the specified ranges were not 

considered to have affected the integrity of the study. ` 
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Temperature 

Desired: 20 to 24°C 

Actual: 21 to 28°C 

Relative Humidity 

Desired: 40 to 60% 

Actual: 37 to 69% 

2.11. TEST SUBSTANCE ADMINISTRATION AND CHAMBER 

OPERATION 

2.11.1. ROUTE OF ADMINISTRATION 

Inhalation via whole-body exposures. 

2.11.2. JUSTIFICATION FOR ROUTE OF ADMINISTRATION 

The inhalation route is one of the potential routes of human 

exposure to this test substance and is the route specified in the 

referenced guidelines. 

2.11.3. FREQUENCY OF ADMINISTRATION 

Once daily, 6 hours/day. 

2.11.4. DURATION OF ADMINISTRATION 

The test substance was administered for 6 hours/day, generally 

5 days per week for 13 weeks for at least 65 exposures for 

Main/Recovery/Neuropathology/GFAP Studies. Animals were not 

exposed on test days when FOB and motor activity evaluations 

were performed. Animals for the Genotoxicity and 

Immunotoxicity evaluations were exposed for 6 hours/day, 

generally 5 days per week for 4 weeks for at least 20 exposures. 

Test substance administration continued through the day prior to 

necropsy for all animals except the animals in Groups I and IV 

designated for recovery which were held untreated for at least 

4 additional weeks prior to necropsy. 
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2.11.5. ADMINISTRATION OF TEST SUBSTANCE 

The test substance was administered as a vapor in the breathing air 

of the animals. The test atmosphere was generated by an 

appropriate procedure determined during pre-study trials. The 

trials were performed to evaluate the optimal set of conditions and 

equipment to generate a stable atmosphere at the target exposure 

levels and maintain uniform conditions throughout the exposure 

chambers. Two chambers (designated chambers A and B) were used 

for each exposure level, in general one for male animals and one for 

female animals. 

Group I 

Houseline nitrogen was delivered from a regulator with a 

backpressure gauge via 1⁄4” tubing to a flowmeter regulated by a 

metering valve. This nitrogen flow (~ 20 Lpm) was then split via a 

1⁄4” stainless steel “T” to both chamber turrets of the 1m3 glass and 

stainless steel exposure chambers where it was mixed with room 

air as it was drawn into the chambers. 

Groups II, III and IV 

Houseline nitrogen was delivered from a regulator with a 

backpressure gauge through a stainless steel fitting to create three 

flow systems: the test substance pressurization flow, the purge 

flow and the volatilization flow. 

The nitrogen for the test substance pressurization flow was 

directed through a metering valve, attached to a backpressure 

gauge, into the vapor inlet valve of the test substance cylinder. 

The metering valve was used to adjust and maintain the pressure 

within the cylinder. From the pressurized cylinder, the test 

substance flowed from the liquid outlet valve through a disconnect 

fitting and through a filter to prevent equipment contamination. 

From the filter, the test substance flowed to a liquid flowmeter via 

1

/8” tubing. The outlet of the flowmeter was regulated by a 

metering valve. From this metering valve, the test substance 

flowed via 1

/8” tubing onto the glass helix of a counter current 

volatilization chamber. This glass helix was heated by a nichrome 

wire which was controlled by an autotransformer and was inserted 

in the center of the glass tube that supported the helix. The 
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targeted temperature within the counter current chamber for each 

group (83°F for Group II, 80°F for Group III and 78°F for Group 

IV) was monitored using a digital alarm module. 

The nitrogen for the purge flow system was directed, via 1⁄4” tubing 

to a flowmeter regulated by a metering valve. The purge nitrogen 

was delivered via 1/8” tubing to the bottom of the tube containing 

the nichrome wire. This nitrogen flow continuously purged the 

area surrounding the nichrome wire within the tube, thereby, 

protecting the wire from oxidation. 

The nitrogen for the volatilization system was directed via 1⁄4” 

tubing to a flowmeter regulated by a metering valve. From the 

flowmeter, the volatilization nitrogen (~ 20 Lpm) flowed via 1⁄4” 

tubing to a ball and socket joint at the bottom of the volatilization 

chamber. This nitrogen flowed up through the volatilization 

chamber passing over the coil and volatilizing the test substance. 

The pressure within the counter-current volatilization chamber was 

maintained slightly negative to the room and was monitored with a 

pressure gauge. 

This test substance laden nitrogen exited the top of the 

volatilization chamber through a stainless steel “T” which divided 

the flow, via 1⁄2” tubing, to the turrets of two 1m3 glass and 

stainless steel exposure chambers. As the test substance laden 

nitrogen was drawn into each of the chambers, it was mixed with 

room air. 

The whole-body exposure chambers each had a volume of 

approximately 1000 Liters (1m3). Each chamber was operated at a 

minimum flow rate of 200 Liters per minute. The final airflow 

was set to provide at least one air change (calculated by dividing 

the chamber volume by the airflow rate) in 5.0 minutes (12 air 

changes/hour) and a T99 equilibrium time (calculated by 

multiplying the air change by the exponential factor 4.6) of at most 

23 minutes. 
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Group Airflow Rate Air Change T99

(Lpm) (min) (min)

 Chambers A/B Chambers A/B Chambers A/B

I 232/224 4.3/4.5 20/21

II 227/221 4.4/4.5 20/21

III 227/227 4.4/4.4 20/20

IV 224/224 4.5/4.5 21/21

This chamber size and airflow rates were considered adequate to 

maintain the oxygen level at least 19% and the animal loading 

factor below 5%. At the end of each exposure, all animals 

generally remained in the chamber for a minimum of 30 minutes. 

During this time, each chamber was operated at approximately the 

same flow rate using clean air only. The chambers were exhausted 

through the in house filtering system, which consisted of a coarse 

filter, a HEPA filter and activated charcoal. 

See Figure 1 and Appendix N for equipment details. 

2.11.6. EXPOSURE CONCENTRATION DETERMINATION 

A nominal exposure concentration was calculated. The flow of air 

through the chamber was monitored using appropriate calibrated 

equipment. The test substance consumed (weight difference of the 

5 gallon cylinder) during the exposure (mg) was divided by the 

total volume of air (m3

) passing through the chamber (volumetric 

combined flow rate for the 2 chambers times total exposure time) 

to calculate the nominal concentration (mg/m3). 

During each exposure, measurements of airborne concentrations were 

performed in the animals’ breathing zone at least 4 times using an 

appropriate sampling procedure (~20 Lpm) and infrared (IR) 

spectrophotometric analytical procedure. Also, one charcoal tube 

sample was collected (0.2 Lpm) per chamber per week and analyzed 

by gas chromatography (GC) to characterize at least 10 major 

components (comprising at least 80% by weight of the test substance) 

to show test substance stability and comparison between the neat 

liquid test substance and the vaporized test atmospheres. 

See Appendices N and O for equipment details. See Appendix S 

for Analytical Report. 
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2.11.7. PARTICLE SIZE DISTRIBUTION ANALYSIS 

During each week of exposure, particle size determinations were 

performed using a TSI Aerodynamic Particle Sizer to characterize 

the aerodynamic particle size distribution of any aerosol present. 

The samples were drawn for 20 seconds at a flow rate of 5.00 

Lpm. The mass median aerodynamic diameter, geometric standard 

deviation and total mass concentration were calculated based on 

the amount of particles collected. 

See Appendix N for equipment details. 

2.11.8. CHAMBER AND EXPOSURE ROOM ENVIRONMENT 

Chamber oxygen levels (maintained at least 19%) were measured 

pretest and at the beginning and end of the study. Air samples in 

the exposure room were taken in the vapor generation area pretest 

and at the beginning and end of the study. Light (maintained 

approximately 30-40 foot-candles at 1.0 meter above the floor) and 

noise levels (maintained below 85 decibels) in the exposure room 

were measured pretest and at the beginning and end of the study. 

See Appendix N for equipment details. 

2.12. EXPERIMENTAL EVALUATIONS 

2.12.1. VIABILITY CHECKS (IN-CAGE) 

Animals were observed in their cages twice daily for general 

appearance, mortality and signs of severe toxic or pharmacologic 

effects. 

2.12.2. PHYSICAL EXAMINATIONS 

All animals were observed as a group at least once during each 

exposure. 
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Each animal (except Neuropathology, GFAP, Genotoxicity and 

Immunotoxicity animals) was removed from its cage and examined 

twice pretest and once weekly during the study period. 

Examinations included observations of general condition, skin and 

fur, eyes, nose, oral cavity, abdomen and external genitalia as well 

as evaluations of respiration, palpation for tissue masses, 

circulatory effects, autonomic effects, central nervous system 

effects, changes in motor activity, and reactivity to handling or 

sensory stimuli. Neuropathology, GFAP, Genotoxicity and 

Immunotoxicity animals were removed from their cage and 

examined once pretest before selection for the study. 

2.12.3. OPHTHALMOSCOPIC EXAMINATION 

All animals (except Genotoxicity and Immunotoxicity animals) were 

examined pretest and at study termination. Eyelids, lacrimal 

apparatus and conjunctiva were examined grossly; cornea, anterior 

chamber, lens, vitreous humor, retina and optic disc were examined 

by indirect ophthalmoscopy. The eyes were examined after 

instillation of a mydriatic (Mydriacyl® 1%). 

2.12.4. BODY WEIGHT 

Animals were removed from their cages and weighed twice 

pretest, weekly during treatment and terminally (after fasting). 

Terminal, fasted body weights were obtained just prior to 

necropsy. 

2.12.5. FEED CONSUMPTION 

Feed consumption was measured (weighed) during the week prior to 

treatment initiation and weekly throughout the study. Feed was 

available without restriction 7 days/week except during inhalation 

exposures and when fasting prior to blood collection. Animals 

were presented with weighed feeders at the scheduled intervals. 

After 7 days, the feeders were reweighed and the resulting weight 

subtracted from the initial feeder weight to obtain the grams of 

feed consumed per animal per week. The grams consumed per 

kilogram of body weight per day was then calculated for each 

animal. 
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Calculation 

Feed Consumption (g/kg/day) = grams of feed consumed ÷ 7 days 

 body weight (kg)a

a

Average of current and prior measurement 

2.13. NEUROBEHAVIORAL STUDIES 

Testing was staggered over four sessions with approximately equal 

numbers of animals per sex per exposure group in each session. Animals 

being tested were not exposed on days of neurological evaluations, and 

testing was conducted at least 16 hours after the previous exposure. 

Testing was performed on the Neuropathology and the GFAP animals. 

Noise level in the functional observational battery room was maintained 

within a level of 55 to 65 decibels by a white noise generator, Model MDF 

5001 (MDF Products, Inc. Danbury, Connecticut). Temperature, 

humidity, noise level and illumination of each room were measured and 

recorded to ensure that variations in environmental conditions were 

minimal during all evaluations. The functional observational battery was 

performed for all animals before evaluation of motor activity. 

2.13.1. FUNCTIONAL OBSERVATIONAL BATTERY 

Method 

A functional observational battery (Moser, 1989) was performed 

on 10 animals/sex/group. With the exception of pretest, 

evaluations were performed “blind”, i.e., the observer did not 

know the identity of the animal’s exposure group. Time of testing 

was balanced across treatment groups. 

The following evaluations were performed as part of the functional 

observational battery: 

Home Cage Evaluations: posture, vocalization and palpebral 

closure. 

Handling Evaluations: reactivity to general stimuli (such as 

removal from cage or handling); assessment of signs of autonomic 

function: lacrimation, salivation, altered fur appearance, or 

red/crusty deposits around eyes. 
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Open Field Evaluations: arousal level, locomotion and gait; count 

of urination and defecation; convulsions, tremors, abnormal 

movements or behaviors, excessive or repetitive actions; 

piloerection and exophthalmos. 

Reflex Assessments: response to visual (approach response) and 

auditory (finger snap) stimuli; response to a tail pinch; pinna 

reflex; pupillary function. 

Grip Strength (Meyer et al., 1979): Grip strength was measured 

using a Grip Strength Meter (Columbus Instruments International 

Corporation, Columbus, Ohio). 

Landing Foot Splay: Each animal was dropped into a pan of sand 

from a height of one foot. The distance between the marks left by 

the hindpaws was measured in centimeters. 

Proprioception: Animals were restrained on a horizontal surface 

by grasping the thorax. The observer gently pulled back on the 

hindlimb of the rat so that the dorsal surface of the paw was on the 

testing surface, and then released the hindlimb. The ability of the 

animal to return the limb to a normal position was evaluated. 

Air Righting Ability: Animals were held upside down and 

dropped from a height of one foot into a container of bedding. The 

landing position of each animal was recorded. 

Body Weight: Animals were removed from their cages and 

weighed using a Mettler Balance, Model PE4000 (Mettler 

Instrument Corporation, Hightstown, New Jersey). 

Frequency 

Pretest and during the 4th, 8th and 13th weeks of exposure. 

Temperature 

Temperature was monitored and recorded twice daily, just prior to 

the first evaluation and just after the last evaluation. 

Desired: 18 to 26°C 

Actual: 21 to 23°C 
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Relative Humidity 

Relative humidity was monitored and recorded twice daily, just 

prior to the first evaluation and just after the last evaluation. 

Excursions outside the specified range did not affect the integrity 

of the study. 

Desired: 30 to 70% 

Actual: 32 to 76% 

Noise Level 

Noise level was monitored using a Digital Sound Level Meter 

(Sper Scientific, Ltd., Scottsdale, Arizona) and recorded twice 

daily, just prior to the first evaluation and just after the last 

evaluation. 

Desired: 55 to 65 dB 

Actual: 60 dB 

Illumination 

Illumination was monitored using a Photometer 1 (Quantum 

Instruments, Inc., Garden City, New York) and recorded twice 

daily, just prior to the first evaluation and just after the last 

evaluation. 

Desired: <80 footcandles 

Actual: 54 to 57 footcandles 

2.13.2. MOTOR ACTIVITY 

Method 

Using a modified version of Schulze’s procedures (Schulze, 1990), 

the locomotor activity of 10 animals/sex/group was monitored 

using an automated Photobeam Activity System (San Diego 

Instruments, Inc., San Diego, California). Sessions were 

60 minutes in length; each session was divided into 12 intervals of 

5 minutes. The time of testing was balanced across treatment 

groups. 
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Frequency 

Pretest and during the 4th, 8th and 13th weeks of exposure. 

Temperature 

Temperature was monitored and recorded twice daily, just prior to 

the first evaluation and just after the last evaluation. 

Desired: 18 to 26°C 

Actual: 22 to 24°C 

Relative Humidity 

Relative humidity was monitored and recorded twice daily, just 

prior to the first evaluation and just after the last evaluation. 

Excursions outside the specified ranges were not considered to 

have affected the integrity of the study. 

Desired: 30 to 70% 

Actual: 28 to 72% 

Noise Level 

Noise level was monitored using a Digital Sound Level Meter, 

Model 840029 (Sper Scientific, Ltd., Scottsdale, Arizona) and 

recorded twice daily, just prior to the first evaluation and just after 

the last evaluation. 

Desired: 55 to 65 dB 

Actual: 60 to 62 dB 

Illumination 

Illumination was monitored using a Photometer 1 (Quantum 

Instruments, Inc., Garden City, New York) and recorded twice 

daily, just prior to the first evaluation and just after the last 

evaluation. 

Desired: <80 footcandles 

Actual: 56 to 59 footcandles 
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2.14. CLINICAL PATHOLOGY 

Clinical pathology procedures and parameters were based on those 

recommended in guidelines published by the Joint Scientific Committee 

for International Harmonization of Clinical Pathology Testing in 

“Harmonization of Animal Clinical Pathology Testing in Toxicity and 

Safety Studies”, Fund. Appl. Tox.: 29, 198-201 (1996). 

Blood were obtained from lightly anesthetized (carbon dioxide/oxygen; 

60%/40%) animals via puncture of the orbital sinus (retrobulbar). Rats were 

fasted overnight prior to blood collection. The Main Study animals 

(10/sex/group) were bled at the Interim (~4 weeks) and Terminal intervals. 

Groups I & IV animals in Recovery (10/sex/group) were bled for hematology 

and clinical chemistry only. 

2.14.1. HEMATOLOGY 

Blood for hematology studies was collected (approximately 

0.25 mL) into tubes containing EDTA anticoagulant. 

Blood samples were analyzed as follows: 

ADVIA 120 HematologyAnalyzer, Bayer Corporation. 

Hemoglobin concentration 

Hematocrit 

Erythrocyte count 

Platelet count 

Mean corpuscular volume 

Mean corpuscular hemoglobin 

Mean corpuscular hemoglobin concentration 

Total leukocyte count 

Reticulocyte count 

Differential leukocyte count1

Other 

Erythrocyte morphology (Henry, 1991)

 

1

When questionable values were obtained, manual differential leukocyte counts (Henry, 1991) and 

absolute value calculations were performed for verification. 
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2.14.2. COAGULATION 

Blood for coagulation studies was collected (approximately 

1.0 mL) into tubes containing sodium citrate anticoagulant. 

Blood samples were analyzed as follows: 

Mechanical clot detection system, STA Compact®, 

Diagnostica Stago Products 

Prothrombin time 

Activated partial thromboplastin time 

2.14.3. CLINICAL CHEMISTRY 

Blood for clinical chemistry studies was collected (approximately 

1.5 mL for all rats except ~1.0 mL for the female rats at the 4th

week interval) into tubes with no anticoagulant, allowed to clot, 

and centrifuged to obtain serum. 

Blood samples were analyzed as follows: 

Hitachi 717, Roche Corporation Automatic Analyzer 

Aspartate aminotransferase (Kinetic - Modified IFCC Technique)

Alanine aminotransferase (Kinetic - Modified IFCC Technique)

Alkaline phosphatase (Kinetic – Modified AMP Buffer)

Lactate dehydrogenase (Kinetic - Lactate-pyruvate Technique)

Sorbitol dehydrogenase (Sigma Diagnostics NADH)

Blood urea nitrogen (Kinetic - Modified Urease)

Creatinine (Kinetic –Modified Jaffe Method)

Glucose (Hexokinase Method)

Creatine kinase (Kinetic – Modified NAC Method)

Cholesterol (Enzymatic – Modified Trinder Method)

Total protein (Biuret Technique)

Albumin (Bromocresol Green Method)

Total bilirubin (Modified Wahlefield et al.)

Direct bilirubin (Modified Jendrassik and Grof Method)

Sodium (Ion Selective Electrode)

Potassium (Ion Selective Electrode)

Chloride (Ion Selective Electrode)

Calcium (Cresolphthalein Complexone Method)
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Inorganic phosphorus (Phosphomolybdate - UV Method)

Gamma-glutamyl transferase (Kinetic – Modified Persijn and Vander Silk 

 Method) 

Bile acids (Mashige, et al., Enzymatic Method, Sigma)

Other 

Globulin (calculated value; total protein - albumin)

Albumin/globulin ratio (calculated value; albumin ÷ globulin)

Indirect bilirubin (calculated value; total bilirubin – direct bilirubin)

2.14.4. RETENTION/STORAGE OF SPECIMENS 

Any remaining (frozen) serum, which may have limited storage 

stability, will be stored for up to six months after completion of 

assays and will then be discarded. Peripheral blood smears will be 

retained and archived with the study. 

2.15. GENOTOXICITY EVALUATIONS 

Note: The same animals were used for both of the following evaluations 

except a separate positive control group was used for each evaluation: 

Sister Chromatid Exchange (SCE) Evaluations 

Sprague Dawley-derived (CD) rats, 5/sex/group, were exposed to 

Gasoline DIPE Vapor Condensate via inhalation for a 4 week (5 days per 

week) exposure period by Huntingdon Life Sciences (PRC). PRC 

personnel also performed the treatment of non-exposed (5/sex) positive 

control animals (5 mg/kg cyclophosphamide, IP with a 0.5 mg/mL 

solution @ 10 mL/kg, within 24 hours prior to sacrifice). BioReliance 

personnel sacrificed (isoflurane inhalation) the animals on the day after 

the final exposure, collected blood (2-4 mL placed into sodium heparin 

tubes) from the abdominal aorta and transported the samples on ice packs 

to BioReliance, Rockville, MD (attn: Ramadevi Gudi, Ph.D.). Upon 

receipt, samples were processed and evaluated for determination of SCE 

response as detailed in the referenced guidelines and procedures. The 

Testing Facility was responsible for the GLP compliance of this 

subcontractor. 

See the BioReliance report (not included within this report) for materials 

& methods, results, discussion and conclusion. 
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Micronucleus Evaluations 

Sprague Dawley-derived (CD) rats, 5/sex/group, were exposed to 

Gasoline DIPE Vapor Condensate via inhalation for a 4 week (5 days per 

week) exposure period by Huntingdon Life Sciences (PRC). PRC 

personnel also performed the treatment of non-exposed (5/sex) positive 

control animals (40 mg/kg cyclophosphamide, IP with a 4.0 mg/mL 

solution @ 10 mL/kg, within 24 hours prior to sacrifice). The positive 

control animals were sacrificed under carbon dioxide anesthesia. 

BioReliance personnel removed the femurs immediately after the blood 

sample collection for the SCE evaluation and prepared fixed, unstained 

slides which PRC personnel shipped to Eye Research Centre, Eye, 

Suffolk, UK (attn: Christine Mason, B.Sc.). Upon receipt, the slides were 

stained and evaluated for determination of micronucleus response as 

detailed in the referenced guidelines and procedures. The Testing Facility 

was responsible for the GLP compliance of this subcontractor. 

See the Huntingdon UK report (not included within this report) for 

materials & methods, results, discussion and conclusion. 

2.16. IMMUNOTOXICITY EVALUATIONS 

Female Sprague Dawley-derived (CD) rats, 10/group, were exposed to 

Gasoline DIPE Vapor Condensate via inhalation for a 4 week (5 days per 

week) exposure period by Huntingdon Life Sciences (PRC). PRC 

personnel also performed the treatment of non-exposed (10 females) 

positive control animals (50 mg/kg cyclophosphamide, IP with a 5 mg/mL 

solution @ 10 mL/kg, once per day for four days prior to sacrifice). Four 

days prior to sacrifice, animals were sensitized with sheep red blood cells 

(2 x 108) via tail vein injection by ImmunoTox, Inc. personnel. On the 

day after the final exposure, blood samples were obtained from 

anesthetized (carbon dioxide/oxygen) animals via orbital collection, and 

the serum separated and frozen at –70oC by PRC personnel. PRC 

personnel then sacrificed the animals via carbon dioxide inhalation. The 

thymus of each animal was removed, weighed, and preserved (10% 

neutral buffered formalin) for possible histopathology. The spleen of each 

animal was aseptically removed, weighed and shipped intact in 

HEPES/EBSS/Gentamicin solution (prepared at PRC) in individual 

shipping containers on wet ice (2-8o

C) via overnight delivery to 

ImmunoTox., Inc., FedEx Station 3 South, 10th Street, Richmond, VA 

(attn: Vanessa L. Peachee, M.S.). Upon receipt, spleen samples were 
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further processed for determination of Plaque Forming Cell (PFC) 

response as detailed in the referenced guidelines and procedures. The 

frozen serum samples will be retained by the Testing Facility until the 

spleen samples are evaluated for all subchronic inhalation studies in this test 

program and then discarded if not needed by the subcontractor. The Testing 

Facility was responsible for the GLP compliance of this subcontractor. 

See the Immunotox report (not included within this report) for materials & 

methods, results, discussion and conclusion. 

2.17. POSTMORTEM EVALUATIONS 

2.17.1. NECROPSY INFORMATION 

Necropsy of all animals was performed after having been treated 

for 13 weeks and/or held for approximately 4 weeks of recovery. 

Animals were fasted overnight prior to necropsy. A necropsy 

schedule was established to ensure that approximately equal 

numbers of males and females were examined on each day of 

necropsy and that examination of animals of both sexes were 

performed at similar times of the day throughout the necropsy 

period. 

Method of Euthanasia 

Exsanguination following carbon dioxide inhalation for Main 

Study and Recovery Study animals. 

2.17.2. MACROSCOPIC EXAMINATIONS 

Complete macroscopic postmortem examinations were performed 

on all Main/Recovery and Neuropathology animals. The GFAP 

animal (Animal No. 2070) that was sacrificed for humane reasons 

prior to termination was also subject to a macroscopic 

examination. The macroscopic postmortem examinations included 

examination of the external surface and all orifices; the external 

surfaces of the brain and spinal cord; the organs and tissues of the 

cranial, thoracic, abdominal and pelvic cavities and neck; and the 

remainder of the carcass for the presence of macroscopic 

morphologic abnormalities. 
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2.17.3. ORGAN WEIGHTS 

Organs indicated in Table I (page 39) were weighed for all Main 

and Recovery Study animals at the scheduled necropsy. Prior to 

weighing, the organs were carefully dissected and properly 

trimmed to remove adipose and other contiguous tissues in a 

uniform manner. Organs were weighed as soon as possible after 

dissection in order to avoid drying. Paired organs were weighed 

together. 

2.17.4. TISSUES PRESERVED AND EXAMINED HISTOPATHOLOGICALLY 

The tissues listed in Table I (page 39) were obtained at the 

scheduled sacrifice interval and preserved for all Main and 

Recovery Study animals. In addition, slides of the indicated 

tissues were prepared and examined microscopically for Main 

Study and Recovery (gross lesions only) animals. Any 

abnormalities not noted during macroscopic examinations which 

were seen during histology processing were recorded. 

Screening for alpha 2u-globulin nephropathy 

Slides were prepared from tissue samples of the kidneys of all 

Groups I and IV main study male animals from the terminal 

necropsy, using hematoxylin and eosin stain only, not with Mallory 

Heidenhain stain. 
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TABLE I 

TISSUE WEIGHED PRESERVED 

EXAMINED 

MICROSCOPICALLY 

 Groups 

I, IV II, III 

Adrenal glands X X X 

Aorta (thoracic) X X 

Bone (sternum/femur with articular 

surface) 

 X X 

Bone marrow (femur) X a a 

Brain (medulla/pons, cerebrum and 

 cerebellum) X X X 

Epididymides X X X 

Esophagus X X 

Eyes with optic nerve X 

Heart X X X 

Kidneys X X X 

Lacrimal glands X 

Large intestine (cecum, colon and rectum) X X 

Larynxb X X 

Liver X X X 

Lungs (with mainstem bronchi) X X X X 

Lymph nodes (mediastinal and mesenteric) X X 

Mammary gland X 

Muscle (biceps femoris) X 

Nasopharyngeal tissuec X X 

Nerve (sciatic) X X 

Ovaries X X X 

Pancreas X X 

Pituitary X 

Prostate X X X 

Salivary glands with submandibular lymph 

Node X X 

Seminal vesicles X X X 
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TISSUE WEIGHED PRESERVED 

EXAMINED 

MICROSCOPICALLY 

 Groups 

I, IV II, III 

Skin X 

Small intestine (duodenum, ileum, 

 jejunum) 

 

X X 

Spinal cord (cervical, thoracic, lumbar) X X 

Spleen X X X 

Stomach X X 

Testes X X X 

Thymus X X X 

Thyroid (with parathyroids) X X 

Trachea X X 

Urinary bladder X X 

Uterus (body/horns with cervix) X X X 

Zymbal’s gland X 

Gross lesions and tissue masses X X X 

a

No examination; bone marrow smears were prepared and archived. 

b

The laryngeal mucosa was examined. Sections of the larynx examined included the epithelium covering the 

base of the epiglottis, the ventral pouch and the medial surfaces of the vocal processes of the arytenoid 

cartilages. 

c

Four sections of the nasopharyngeal tissue were examined. This included sections through the nasal cavity 

and examinations of the squamous, transitional, respiratory and olfactory epithelia. 

Preservatives 

All tissues - 10% neutral buffered formalin. 

Eyes were placed in glutaraldehyde/paraformaldehyde initially and 

then retained in 10% formalin. Testes and epididymides were 

placed in Modified Davidson’s solution initially and then retained 

in 10% formalin. Lungs and urinary bladder were infused with 

formalin prior to their immersion into a larger volume of the same 

fixative. 
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Processing 

After fixation, the tissues and organs from all animals were 

routinely processed, embedded in paraffin, cut at a microtome 

setting of 4-7 microns, mounted on glass slides, stained with 

hematoxylin and eosin and examined by light microscopy. The 

bones were decalcified in Decalcifier IITM. 

After decalcification the skull was serially sectioned transversely 

at approximately one centimeter intervals. All sections were 

examined, post-fixation, for the presence of macroscopically 

visible morphologic abnormalities. Four sections per animal, 

described as follows, were processed, embedded in paraffin, cut at 

4-7 microns, mounted on glass slides, stained with hematoxylin 

and eosin and examined by light microscopy. The first section 

included the area between the upper incisor tooth and incisive 

papilla. The second section included the area between the incisive 

papilla and the first palatal ridge. The third section included the 

area between the second palatal ridge and first upper molar tooth. 

The fourth section included the area between the first upper molar 

tooth and nasopharynx. 

Larynx sections were prepared from two sites; one was the area of 

the ventral diverticulum and the other was the area of the ventral 

seromucous glands at the base of the epiglottis. These were 

classified as Larynx: Ventral Diverticulum (V-DVTC) and 

Larynx: Ventral Seromucous Glands (V-SM-G), respectively, for 

the purposes of data entry. In a few instances, sections of larynx 

were not from the aforementioned planes of section. These were 

classified simply as Larynx for the purposes of data entry. 

2.18. NEUROPATHOLOGY SACRIFICE 

Following 13 weeks of exposures, designated animals (5/sex/group) were 

anesthetized with an intraperitoneal injection (~1.5 mL/kg or 

~0.6 mL/male and ~0.4 mL/female) of ketamine/xylazine/acepromazine 

and transcardially perfused with phosphate buffered saline followed by 

1% glutaraldehyde and 4% paraformaldehyde in the same buffer. After 

perfusion, the tissues listed in Table II below were obtained. 

Measurement of the size (length and width) and weight of the whole brain 
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(cerebrum, cerebellum and pons-medulla) were made. All tissues were 

then placed into a fresh solution of the same fixative prior to processing. 

TABLE II 

Tissue 

Preserved 

(Groups) 

Microscopic 

Examination 

Groups 

All I and IV II and III 

brain (forebrain, central cerebrum, hippocampus, basal 

ganglia, midbrain, cerebellum and pons, medulla) X X 

eye with optic nerve X X 

spinal cord (cervical, thoracic, lumbar, cross and 

longitudinal sections) X X 

sciatic nerve (cross and longitudinal sections) X X 

tibial nerve (cross and longitudinal sections) X X 

sural nerve (cross and longitudinal sections) X X 

trigeminal ganglia X X 

dorsal root ganglia (from C3-C6 and L4-L6) X X 

dorsal root fibers (from C3-C6 and L4-L6) X X 

ventral root fibers (from C3-C6 and L4-L6) X X 

lungs and trachea X X X 

tissues with macroscopic findings X X X 

Peripheral nerves were post-fixed in 1% osmium tetroxide, 

processed and embedded in epoxy resin and sectioned at 

approximately 2 microns and stained with toluidine blue. All other 

tissues, including the brain, eye with optic nerve, spinal cord, 

trigeminal ganglia, dorsal root ganglia, dorsal and ventral root 

fibers, lungs and trachea were processed by standard techniques, 

embedded in paraffin and sectioned at approximately 6 microns. 

The tissues listed in Table II above were examined microscopically 

for all animals as indicated. Tissues with macroscopic lesions 

were examined in all animals. Any abnormalities not noted during 

macroscopic postmortem examinations, which were seen during 

histological processing, were recorded. 

2.19. GFAP EVALUATIONS 

Sprague Dawley-derived (CD) rats, 5/sex/group, were exposed to 

Gasoline DIPE Vapor Condensate via inhalation for a 13 week (5 days per 

week) exposure period by Huntingdon Life Sciences (PRC). United States 
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Center for Disease Control (CDC) Health Effects Laboratory personnel 

sacrificed (via carbon dioxide inhalation) the animals after the 13 week 

exposure period, and removed, weighed and processed the brains. PRC 

personnel shipped the samples on dry ice to the CDC Health Effects 

Laboratory, Morgantown, WV (attn: James P. O’Callaghan, Ph.D.). Upon 

receipt, samples were further processed for determination of GFAP 

response as detailed in the referenced guidelines and procedures. The 

Sponsor was responsible for the spirit of GLP compliance of this 

subcontractor. 

See the CDC report (not included within this report) for materials & 

methods, results, discussion and conclusion. 

2.20. STATISTICAL ANALYSIS 

The following parameters were analyzed statistically: 

mean body weight values and body weight changes (from pretest) 

mean feed consumption values (presented as grams of feed/kg of body 

weight/day) 

mean clinical pathology values 

mean organ weights, organ/body weight ratios and organ/brain weight 

ratios 

mean motor activity counts 

mean FOB data including forelimb and hindlimb grip strength 

 measurements and mean landing foot splay measurements 

2.20.1. METHOD OF ANALYSIS 

Mean values of all exposure groups were compared to the mean 

value for the control group at each time interval. 

Evaluation of equality of group means was made by the 

appropriate statistical method, followed by a multiple comparison 

test if needed. Bartlett’s test (Bartlett, 1937; Sokal and Rohlf, 

1995) was performed to determine if groups had equal variances. 

For all parameters except organ weights, if the variances were 

equal, parametric procedures were used; if not, nonparametric 

procedures were used. Organ weight data was analyzed only by 

parametric methods. The parametric method was the standard oneway analysis of variance (ANOVA) using the F ratio to assess 

significance (Armitage, 1971; Dunlap and Duffy, 1975). If 
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significant differences among the means were indicated, additional 

tests were used to determine which means were significantly 

different from the control: Dunnett’s (Dunlap et al., 1981; Dunnett, 

1955, 1964), Williams (Williams, 1971, 1972), or Cochran and 

Cox’s modified t-test (Cochran and Cox, 1959). The 

nonparametric method was the Kruskal-Wallis test (Kruskal and 

Wallis, 1952, 1953) and if differences were indicated, Shirley’s 

test (Shirley, 1977), Steel’s test (Steel, 1959) or Pairwise 

Comparison with Bonferroni Correction (Games and Howell, 

1976) were used to determine which means differed from control. 

Bartlett’s test for equality of variance was conducted at the 1% 

significance level; all other statistical tests were conducted at the 

5% and 1% significance levels. 

Motor Activity and Functional Observational Battery (FOB) Data: 

All analyses included sex as an independent variable. In those 

instances where there were significant effects of sex, separate 

analyses by sex may have been done to explain the nature of the 

effect. The analyses were performed by Mark J. Nicolich, Ph.D., 

Statistician, ExxonMobil Biomedical Sciences, Inc, Annandale, 

NJ. The Sponsor was responsible for the Subcontractor’s GLP 

compliance. 

Motor Activity Data: The analysis of the motor activity used a 

mixed model analysis of covariance with an unstructured error 

relationship among the 5 minute periods, and a first order 

autoregressive error structure on weeks. The pretest response was 

used as the covariate. The residuals from the model were tested 

for normality at the p<0.01 level of significance. If the residuals 

were not normally distributed, the dependent variable (number of 

beam breaks) was converted to a function of its percentile rank, 

then transformed by the inverse normal distribution (the 

transformation is known as Blom's transformation where the rank 

order is replaced by [rank-0. 375]/[n+0.25]), and reanalyzed 

(Blom, 1958). 

Functional Observational Data: Some of the sensorimotor and 

observational battery variables were measured on a continuous 

scale and some were measured on a nominal or count scale. All 

measures were classified as either continuous or nominal. The 
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analysis of the continuous variables was conducted by a mixed 

model analysis of covariance with a first order autoregressive error 

structure on the time points. The pretest response was used as the 

covariate. The residuals from the model were tested for normality 

at the p<0.01 level of significance. Those variables that did not 

exhibit normally distributed residuals at the 0.01 level were 

transformed by Blom's normalized rank transformation and 

reanalyzed (Blom, 1958). The nominal data of the functional 

observational battery was analyzed by a cumulative logit repeated 

measures analysis with contrast terms to test for differences 

between control and dosed groups (Agresti, 1989). For the 

measures that were count data (such as number of rears or number 

of urinations), the count responses may have been grouped into 

several data ranges to allow sufficient data in the cells. For 

example, the count of urinations might have been separated into 

three groups of 0, 1 to 4, 5 or more, and analyzed. 

2.21. DATA STORAGE 

All raw data, preserved specimens, and retained samples, as well as the 

original study protocol and the original final report are to be maintained in 

the Archives of the Testing Facility (including those generated by the 

subcontractors) upon completion of the study. The Sponsor will 

determine the final disposition of these materials. 

2.22. REGULATORY REFERENCES 

2.22.1. TEST GUIDELINES 

This study was designed to meet or exceed the pertinent 

requirements of: 

US EPA Vehicle Emissions Inhalation Exposure Guideline 79.61, 

CFR Vol. 59, No. 122, 27 June 1994. 

US EPA Subchronic Toxicity Study with Specific Health Effect 

Assessments 79.62, CFR Vol. 59, No. 122, 27 June 1994. 

US EPA OPPTS Health Effects Test Guidelines 870.3465, 90-Day 

Inhalation Toxicity, August 1998. 
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US EPA OPPTS Health Effects Test Guidelines 870.1350, Acute 

Inhalation Toxicity with Histopathology (respiratory tract 

histopathology sections, only), Public Draft June 1996. 

US EPA OPPTS Health Effects Test Guidelines 870.6200, 

Neurotoxicity Screening Battery, August 1998. 

US EPA Neuropathology Assessments 79.66, CFR Vol. 59, 

No. 122, 27 June 1994. 

US EPA GFAP Assay 79.67, CFR Vol. 59, No. 122, 27 June 1994. 

US EPA OPPTS Health Effects Test Guidelines 870.7800, 

Immunotoxicity, August 1998. 

US EPA Micronucleus Assay 79.64, CFR Vol. 59, No. 122, 

27 June 1994. 

US EPA OPPTS Health Effects Test Guidelines 870.5395, 

Mammalian Erythrocyte Micronucleus Test, August 1998. 

US EPA SCE Assay 79.65, CFR Vol. 59, No. 122, 27 June 1994. 

2.22.2. GOOD LABORATORY PRACTICES 

This study was conducted in accordance with the United States 

Environmental Protection Agency’s (EPA) Good Laboratory 

Practice Standards 79.60, CFR Vol. 59, No. 122, 27 June 1994, 

with the exception of the characterization of the test substance, 

which was not available prior to the experimental initiation. 

2.22.3. ANIMAL WELFARE ACT COMPLIANCE 

This study complied with all appropriate parts of the Animal 

Welfare Act Regulations: 9 CFR Parts 1 and 2 Final Rules, 

Federal Register, Volume 54, No. 168, August 31, 1989, 

pp. 36112-36163, effective October 30, 1989 and 9 CFR Part 3 

Animal Welfare Standards; Final Rule, Federal Register, 

Volume 56, No. 32, February 15, 1991, pp. 6426-6505, effective 

March 18, 1991. 
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2.23. PROTOCOL DEVIATIONS 

The following protocol deviations occurred during the study but were not 

considered to have compromised the validity or integrity of the study: 

1. Due to oversight, none of the exposure room (test substance 

concentration, light and sound) and chamber environmental (oxygen) 

parameters required to be measured at the middle of the study 

(Week 6) were collected. 

2. Due to fasting that night, the Group I animals were removed early 

(before the thirty minute simulated clearing period was completed) 

from the exposure chamber on 12 March 2002. 

3. The testes from Animal Nos. 4067 and 4069 were not fixed in 

Modified Davidson’s solution as required by protocol. 
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3. RESULTS AND DISCUSSION 

3.1. CHAMBER MONITORING 

(Figure 1, Appendices A, P, Q & S)

Chamber distribution analyses (see Appendix P) showed that the test 

substance was evenly distributed within each chamber. Chamber 

monitoring (see Appendix Q) showed that the chamber oxygen levels 

were at least 20%. Chamber room monitoring (see Appendix Q) showed 

that no test substance was present in the room and that the sound and light 

levels were acceptable.

The target and mean (± standard deviation) analytical (IR) and nominal 

concentrations (see Appendix A) are summarized as follows: 

Group Test 

Substance 

Target 

Concentration 

(mg/m3) 

Analytical 

Concentration* 

(mg/m3

) 

Nominal 

Concentration* 

(mg/m3

) 

I Air Control 0 0 ± 0 0 ± 0 

II Gasoline DIPE 

Vapor 

Condensate 

2000 1995 ± 132 2068 ± 83 

III Gasoline DIPE 

Vapor 

Condensate 

10000 10030 ± 692 9827 ± 284 

IV Gasoline DIPE 

Vapor 

Condensate 

20000 20120 ± 869 19070 ± 513 

*These are averages for the two chambers for each exposure level since no 

significant difference between chambers was seen. These mean and SD are for 

all individual daily measurements (see Appendix A) throughout the study. 

The analytically measured exposure levels of the airborne test substance 

were acceptably close, in the opinion of the study director, to the targeted 

exposure levels. The slight differences (<6%) between measured and 

nominal concentrations were typical for this type of vapor exposure where 
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a ratio of 1:1 is expected. Chamber environmental conditions averaged 

24°C temperature and 50% relative humidity. 

Mean particle size distribution measurements for the exposures are 

summarized as follows: 

Group 

Test 

Substance 

Mass Median 

Aerodynamic 

Diameter* 

(μm) 

Geometric 

Standard 

Deviation* 

Total 

Mass 

Concentration*

(mg/m3

) 

I Air Control 2.299 2.172 5.17 x 10-3

II Gasoline DIPE 

Vapor 

Condensate 

1.861 2.036 4.15 x 10-3

III Gasoline DIPE 

Vapor 

Condensate 

1.541 2.158 5.91 x 10-3

IV Gasoline DIPE 

Vapor 

Condensate 

1.605 2.195 6.33 x 10-3

*These are averages for the two chambers for each exposure level since no 

significant difference between chambers was seen. 

These results indicated that the atmospheres were essentially vapor only, 

as expected, since there was no substantial difference between the test 

substance chambers and the air control chambers. Some particles are 

invariably present in chamber atmospheres, representing background air. 

It is unlikely that gasoline vapor condensed on these particles given the 

volatility of these light end vapor components and the high level of 

consistency in constituent proportions demonstrated analytically from 

week to week as next discussed. 

Analysis of the major components in the neat test substance and the test 

atmospheres (see Appendix S) showed a reasonably close comparison 

between the neat test substance and the vaporized test substance. This 

data demonstrated that the test animals were exposed, as expected, to all 

of the major components of the test substance in their reasonably proper 

proportion. The data was consistent from week-to-week during the study 
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indicating stability of the test substance and the atmosphere generation 

techniques. 

3.2. MORTALITY 

(Appendix R) 

All animals survived throughout the exposure and recovery phases of the 

study except a 2000 mg/m3 exposed male animal (#2070) which was 

euthanized on Study Day 76 as a result of an accidental injury. Since this 

animal was 1 of 5 male animals from this test group designated for GFAP 

evaluation after 13 weeks of exposure, it was decided to replace this 

animal with 1 of 10 male animals (#2060) from this test group designated 

for Main Study evaluations. 

3.3. CLINICAL OBSERVATIONS 

3.3.1. IN-CHAMBER OBSERVATIONS 

(Table 1) 

The test animals were unremarkable during the exposure periods. 

3.3.2. WEEKLY CLINICAL OBSERVATIONS 

(Table 2 & Appendix B) 

An exposure-related increase in the frequency of red nasal 

discharge observations was seen in the 20000 mg/m3

 exposed 

animals compared to the Air Control animals and the other test 

substance exposed animals starting as early as Week 2 for the 

males and Week 4 for the females. These observations abated 

during the recovery period. Otherwise, the test animals were 

generally unremarkable during the non-exposure periods 

(afternoon evaluations). Scattered observations such as 

chromodacryorrhea were noted but were not attributed to 

treatment.
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3.4. OPHTHALMOSCOPIC EXAMINATIONS 

(Table 3 & Appendix C) 

In the opinion of the veterinary ophthalmologist, there were no indications 

of treatment-related ocular disease in the test substance exposed animals. 

3.5. BODY WEIGHTS 

(Figures 2 - 3, Tables 4 - 5 & Appendices D - E) 

There were no exposure-related differences in absolute body weights or in 

body weight changes in the test substance exposed animals compared to 

the Air Control animals. A few statistically significant increases (relative 

to control values) were noted at weeks 9-12 in the 10000 mg/m3 exposed 

female animals compared to the Air Control animals. However, these 

were not in a treatment-related pattern. Also, increases in body weights 

are not usually considered an adverse response to treatment.

3.6. FEED CONSUMPTION 

(Figures 4 - 5, Table 6 & Appendix F) 

There were no exposure-related differences in feed consumption in the test 

substance exposed animals compared to the Air Control animals. A few 

statistically significant increases (relative to control values) were noted at 

weeks 7, 8 and 10 in the 20000 mg/m3 exposed female animals compared 

to the Air Control animals. However, these were not in a treatmentrelated pattern. Also, increases in feed consumption are not usually 

considered an adverse response to treatment. Feed consumption also 

increased during the recovery period probably since the animals were no 

longer in the exposure chambers without feed for 6 hours per day.

3.7. NEUROBEHAVIORAL STUDIES 

3.7.1. MOTOR ACTIVITY 

(Tables 7 (Summary Report) and 8 & Appendix G) 

The results of the analyses indicated statistically significant 

differences in responses in exposure levels for both the original 

data and the Blom transformed data (p<0.002). Specifically, 

contrast analysis of the Blom transformed data showed that 
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response from low and medium exposure groups were significantly 

different from the control group. However, there was no linear 

relationship between exposure levels and response, or any 

consistent change in activity related to exposure. The attached 

data plots do not suggest a consistent exposure related response, 

but show an increase in activity in the female control group and 

decrease in activity in the female mid exposure group only during 

study Week 8 (there was not a statistically significant time by 

exposure effect).

3.7.2. FUNCTIONAL OBSERVATIONAL BATTERY 

(Tables 7 (Summary Report) and 9 & Appendix H) 

FOB Continuous: None of the four continuous measures indicated 

statistically significant exposure related differences. The residuals 

from the forelimb grip strength, foot splay, and Blom transformed 

hindlimb grip strength were normally distributed. The residuals 

from body weight (both observed and Blom transformed data) and 

hindlimb grip strength (observed data) were not normally 

distributed. Because the significance levels for the observed and 

Blom transformed body weight were not near the 0.05 level of 

significance the deviation from normality was not considered 

crucial in these analyses. 

FOB Discrete: For the 26 measures on a nominal or count scale 

only 6 measures showed any variation in response: posture, ease of 

removal, ease of handling, defecation count, urination count, and 

sensitivity to light touch. For these 6 measures none indicated 

statistically significant exposure related differences. For the 

remaining 20 variables all animals, or at most four responses (less 

than 1.5% of the observations), showed the same response in all 

groups at all time points and were not analyzed because of the lack 

of meaningful variation in response. 
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3.8. CLINICAL PATHOLOGY 

3.8.1. HEMATOLOGY 

(Table 10 & Appendix I) 

There were exposure-related differences in hematology values in 

test substance exposed animals compared to the Air Control 

animals at the 4th week and terminal and recovery intervals. These 

differences were limited to statistically significant decreases 

(21-23%) in reticulocyte counts for the 20000 mg/m3 exposed male 

animals which occurred at both exposures period intervals 

(4th week and terminal) and at termination of the recovery interval. 

Statistically significant (13-17%) decreases also occurred in 

reticulocyte counts for the 2000 and 10000 mg/m3 exposed male 

animals but only at the 4th week interval. Similar differences did 

not occur in female animals at any exposure level and any interval 

but there were statistically significant (35-36%) decreases in 

absolute monocytes for the 20000 mg/m3 exposed female animals 

but only at the 4th week and recovery intervals. Other differences 

(such as increases in platelets in all exposed groups of males at the 

terminal interval) were seen but not in an exposure-level related 

pattern and were attributed to normal variability. 

3.8.2. COAGULATION 

(Table 11 & Appendix J) 

There were no exposure-related differences in coagulation values 

in test substance exposed animals compared to the Air Control 

animals at the 4th week and Terminal intervals. A few statistically 

significant differences in prothrombin time and activated partial 

thromboplastin time were noted in males at the 4th week interval 

but were not in a treatment-related pattern or the absolute 

differences were minimal and were not similarly seen at the 

Terminal interval.
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3.8.3. CLINICAL CHEMISTRY 

(Table 12 & Appendix K) 

There were exposure-related differences in clinical chemistry 

values in the test substance exposed animals compared to the Air 

Control animals at the 4th week and terminal and recovery 

intervals. Decreases, relative to control values, occurred in several 

serum enzymes for test substance-exposed groups after 4 weeks of 

exposure and/or at the terminal or recovery intervals. Enzymes 

affected were alanine aminotransferase, aspartate 

aminotransferase, lactate dehydrogenase, creatine kinase and 

sorbitol dehydrogenase. While some of the differences (e.g. 

lactate dehydrogenase and sorbitol dehydrogenase) were 

consistently statistically significant at the 4 weeks and terminal 

and/or recovery intervals, decreases in these enzymes are not 

usually considered an adverse response to treatment and there were 

no corresponding histopathology findings. Other differences (such 

as increases in sodium and/or potassium in all exposed groups of 

females at the terminal interval) were seen but not in an exposurelevel related pattern and were attributed to normal variability. 

3.9. ORGAN WEIGHTS AND BRAIN MEASUREMENTS 

(Table 13 & Appendix L) 

There were no exposure-related differences in organ weights and brain 

measurements in the test substance exposed animals compared to the Air 

Control animals at the Terminal and/or Recovery intervals. A few 

statistically significant differences were noted including decreased 

absolute, but not relative to body weight, lung weights at the Terminal 

interval. However, these were not seen in an exposure level related 

pattern and/or the absolute differences were minimal and there were no 

corresponding histopathology findings. The brain weights in perfused 

Neuropathology animals were lower in general than those in non-perfused 

Main Study animals since the perfusion fixatives desiccate the brain 

tissue. 
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3.10. PATHOLOGY 

3.10.1. MACROSCOPIC 

(Table 14 & Appendix M) 

No gross abnormalities related to test substance exposure were 

evident at necropsy examination. The macroscopic lesions noted 

were similar to those routinely encountered in animals of this age 

and species or were represented by individual animals and 

considered incidental findings.

3.10.2. MICROSCOPIC 

(Table 15 & Appendix M) 

All animals in the Air Control and 20000 mg/m3 exposure groups 

had all protocol-required tissues examined following the Terminal 

sacrifice. The lungs and gross lesions were also examined in all 

test animals following the Terminal sacrifice. No examinations 

were considered necessary for the Recovery animals other than any 

gross lesions. Microscopic findings that were considered 

exposure-related were found only in the kidneys of male animals 

exposed to 20000 mg/m3 of Gasoline DIPE Vapor Condensate 

following the Terminal sacrifice. Because these renal findings 

were expected and have been fully investigated during prior testing 

with gasoline test substances, no further examinations of animals 

from the Terminal or Recovery sacrifice were made for this study.

Kidneys 

Among animals having microscopic examination of complete 

tissues, all male rats exposed to 20000 mg/m3 of Gasoline DIPE 

Vapor Condensate had eosinophilic hyaline granules within the 

cytoplasm of renal proximal tubular epithelial cells. This lesion 

was not noted in control animals or females exposed to the test 

substance. Most 20000 mg/m3 exposed males also had evidence of 

tubular regeneration (basophilic tubules). 

These renal histopathologic changes are consistent with hyaline 

droplet nephropathy, attributable to accumulation of alpha-2 

microglobulin within renal tubular epithelial cells. This species- 
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and gender-specific change has been well documented in male rats 

exposed to a variety of hydrocarbon compounds (Alden, CL, 1986) 

and is not considered relevant to humans. 

Histologic Findings in Kidneys of Rats Exposed to Gasoline 

DIPE Vapor Condensate 

 Affected Animals 

 Males Females 

 Exposure level (mg/m3 x103) 0 20 0 20 

n= 10 10 10 10 

Eosinophilic hyaline granules, 

proximal tubular epithelium 

 

 Minimal 0 1 0 0 

 Slight 0 9 0 0 

Basophilic cortical 

tubules 

 

 Minimal 2 5 0 2 

 Slight 1 2 0 0 

Other tissues: No test substance related histopathologic changes 

were noted in other protocol-specified tissues, including lung, 

nasoturbinates and larynx. 

3.10.3. NEUROPATHOLOGY 

(Table 15 & Appendix M) 

No microscopic changes attributable to test substance exposure 

were observed in brain, spinal cord, eyes with optic nerve, 

peripheral nerves or ganglia among the 20,000 mg/m3

 exposed 

satellite animals. 
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4. CONCLUSION 

Thirteen weeks of exposure of rats to Gasoline DIPE Vapor Condensate resulted 

in hydrocarbon nephropathy in male animals exposed to 20000 mg/m3 of vapor. 

However, this finding has been generally accepted (US EPA 1991. Alpha 2 

microglobulin: association with chemically induced renal toxicity and neoplasia 

in male rat. In Risk Assessment Forum, p.85. US Govt. Printing Office, 

Washington, DC.) not to be relevant to human risk assessment. Thirteen weeks of 

exposure of rats to Gasoline DIPE Vapor Condensate also resulted in increased 

red nasal discharge and slight, non-reversible decreases in reticulocyte values (at 

the 4th week and terminal and recovery intervals) in the male animals exposed to 

20000 mg/m3 of vapor. Therefore, the 10000 mg/m3 exposure level (excluding 

male rat nephropathy) was considered a no observable adverse effect level 

(NOAEL). 
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for routine use in toxicology studies. Journal of American College of Toxicology 9-4: 

455-463. 

Shapiro, S.S. and Wilk, M.B., “An analysis of variance test for normality (complete 

samples)”, Biometrika, 52, 1965, pg 591-611. 

Shirley, E.A.C. 1977. A non-parametric equivalent of Williams’ test for contrasting 

increasing dose levels of a treatment. Biometrics 33: 386-389. 

Sokal, R.R. and Rohlf, F.J. 1995. Biometry. 3rd Edition. San Francisco: W.H. Freeman 

pp. 369-371. 
Huntingdon Life Sciences 00-6130 Page 60 

 211-DIPE-S Final Report 

Steel, R.G.D. 1959. A multiple comparison rank sum test: Treatments versus control. 

Biometrics 15: 560-572. 

Williams, D.A. 1971. A test for differences between treatment means when several dose 

levels are compared with a zero dose control. Biometrics 27: 103-117. 

Williams, D.A. 1972. The comparison of several dose levels with a zero dose control. 

Biometrics 28: 519-531. 
Huntingdon Life Sciences 00-6130 Page 61

 211-DIPE-S Final Report

Group I 

Chamber Generation System 

and Whole-Body Exposure Chamber Figure 1 

Notes: 

1. A pair of chambers was used for the Group I exposures. 

2. Sampling Ports H-11 (left-bottom), H-12 (left-top), H-13 (right-bottom) and 

H-14 (right-top) used for pretest distribution sampling, were located on the 

back wall of the chambers. 
Huntingdon Life Sciences 00-6130 Page 62

 211-DIPE-S Final Report

Groups II, III and IV Chamber Generation System 

and Whole-Body Exposure Chamber Figure 1 

Notes: 

1. A pair of chambers was used for each of the Groups II, III and IV exposures. 

2. Sampling Ports H-11 (left-bottom), H-12 (left-top), H-13 (right-bottom) and 

H-14 (right-top) used for pretest distribution sampling, were located on the 

back wall of the chambers. 
Huntingdon Life Sciences 00-6130 Page 63

 211-DIPE-S Final Report

Males 

Mean Body Weights 

(Main/Recovery) Figure 2 

200

230

260

290

320

350

380

410

440

470

500

530

560

590

-1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Body Weight (grams)

Week

Group I - 0 mg/m^3

Group II - 2,000 mg/m^3

Group III - 10,000 mg/m^3

Group IV - 20,000 mg/m^3
Huntingdon Life Sciences 00-6130 Page 64

 211-DIPE-S Final Report

Females 

Mean Body Weights 

(Main/Recovery) Figure 3 

170

180

190

200

210

220

230

240

250

260

270

280

290

300

310

320

330

340

-1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Week

Body Weight (grams)

Group I - 0 mg/m^3

Group II - 2,000 mg/m^3

Group III - 10,000 mg/m^3

Group IV - 20,000 mg/m^3
Huntingdon Life Sciences 00-6130 Page 65

 211-DIPE-S Final Report

Males 

Mean Feed Consumption 

(Main/Recovery) Figure 4 

40

50

60

70

80

90

100

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Week

Feed Consumption (g/kg/day)

Group I - 0 mg/m^3

Group II - 2,000 mg/m^3

Group III - 10,000 mg/m^3

Group IV - 20,000 mg/m^3
Huntingdon Life Sciences 00-6130 Page 66

 211-DIPE-S Final Report

Females 

Mean Feed Consumption 

(Main/Recovery) Figure 5 

55

60

65

70

75

80

85

90

95

100

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Week

Feed Consumption (g/kg/day)

Group I - 0 mg/m^3

Group II - 2,000 mg/m^3

Group III - 10,000 mg/m^3

Group IV - 20,000 mg/m^3
Huntingdon Life Sciences 00-6130 Page 67 

 211-DIPE-S Final Report 

 

General Preface 

General Notes 

When N (number of animals) presented on the mean tables is less than that 

specified in the Experimental Outline, refer to individual values in appendices for 

an explanation of the missing data. 

Individual animal data values presented in this report may be rounded. 

Unrounded individual animal data values are used to calculate the reported mean 

and standard deviation values. Therefore, use of the reported individual values 

to reproduce means, standard deviations and/or to perform any subsequent 

calculations may produce minor discrepancies between the calculated values 

and those presented in this report. 

Due to computer system limitation, the assigning of group numbers in some 

printouts of the report was different from the protocol and other data. Groups I to 

IV were presented as Groups 1 to 4 in some printouts of this report. 

The following letter designations were used for some printouts for this study: 

00-6130 Toxicity (Main and Recovery) Animals 

00-6130N Neuropathology Animals 

Key to Abbreviations 

M = Males 

F = Females 

SD = Standard Deviation 

N = Number of Animals 
Huntingdon Life Sciences 01-6130 

 211-DIPE-S 

Summary of In-Chamber Observations T

All = 100% of the animals exhibiting a given observation. Note: In-chamber observations are based on all animals present in the exposure chamber at the time, including 

Exposure Day 1 2 3 4 5 6 7 8 9 10 11 Group I – 0 mg/m3 

Normal Within Normal Limits All All All All All All All All All All All Group II – 2000 mg/m3

Normal Within Normal Limits All All All All All All All All All All All Group III – 10000 mg/m3 

Normal Within Normal Limits All All All All All All All All All All All Group IV – 20000 mg/m3 Normal Within Normal Limits All All All All All All All All All All All 
Huntingdon Life Sciences 01-6130 

 211-DIPE-S 

Summary of In-Chamber Observations T

All = 100% of the animals exhibiting a given observation. Note: In-chamber observations are based on all animals present in the exposure chamber at the time, including 

Exposure Day 15 16 17 18 19 20 21 22 23 24 25 Group I – 0 mg/m3 

Normal Within Normal Limits All All All All All All All All All All All Group II – 2000 mg/m3

Normal Within Normal Limits All All All All All All All All All All All Group III – 10000 mg/m3 

Normal Within Normal Limits All All All All All All All All All All All Group IV – 20000 mg/m3 Normal Within Normal Limits All All All All All All All All All All All 
Huntingdon Life Sciences 01-6130 

 211-DIPE-S 

Summary of In-Chamber Observations T

All = 100% of the animals exhibiting a given observation. Note: In-chamber observations are based on all animals present in the exposure chamber at the time, including 

Exposure Day 29 30 31 32 33 34 35 36 37 38 39 Group I – 0 mg/m3 

Normal Within Normal Limits All All All All All All All All All All All Group II – 2000 mg/m3

Normal Within Normal Limits All All All All All All All All All All All Group III – 10000 mg/m3 

Normal Within Normal Limits All All All All All All All All All All All Group IV – 20000 mg/m3 Normal Within Normal Limits All All All All All All All All All All All 
Huntingdon Life Sciences 01-6130 

 211-DIPE-S 

Summary of In-Chamber Observations T

All = 100% of the animals exhibiting a given observation. Note: In-chamber observations are based on all animals present in the exposure chamber at the time, including 

Exposure Day 43 44 45 46 47 48 49 50 51 52 53 Group I – 0 mg/m3 

Normal Within Normal Limits All All All All All All All All All All All Group II – 2000 mg/m3

Normal Within Normal Limits All All All All All All All All All All All Group III – 10000 mg/m3 

Normal Within Normal Limits All All All All All All All All All All All Group IV – 20000 mg/m3 Normal Within Normal Limits All All All All All All All All All All All 
Huntingdon Life Sciences 01-6130 

 211-DIPE-S 

Summary of In-Chamber Observations T

All = 100% of the animals exhibiting a given observation. Note: In-chamber observations are based on all animals present in the exposure chamber at the time, including 

Exposure Day 57 58 59 60 61 62 63 64 65 66 67 Group I – 0 mg/m3 

Normal Within Normal Limits All All All All All All All All All All All Group II – 2000 mg/m3

Normal Within Normal Limits All All All All All All All All All All All Group III – 10000 mg/m3 

Normal Within Normal Limits All All All All All All All All All All All Group IV – 20000 mg/m3 Normal Within Normal Limits All All All All All All All All All All All 
Huntingdon Life Sciences 00-6130 Page 73

 211-DIPE-S Final Report

Summary of Clinical 

Observations Table 2 

For summarization purposes, descriptive comments [i.e., location of scab(s) 

and/or sore(s), etc.] are not presented in this table. These data are contained in 

the study raw data if needed. 

Total represents a cumulative total of all animals with the indicated observation 

one or more times during the study. 

Corresponding exposure levels for each group were as follows: 

 

Group 1 – 0 mg/m3 

Group 2 – 2000 mg/m3

Group 3 – 10000 mg/m3

Group 4 – 20000 mg/m3
25-SEP-2003 10:42 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES # OF ANIMALS EXAMINED 

NORMAL 

WITHIN NORMAL LIMITS 

DEAD 

TERMINAL SACRIFICE 

RECOVERY SACRIFICE REASSIGNED TO SATELLITE 

GROUP 

DERMAL GENERAL 

SCABS 

TABLE 2 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

SUMMARY OF CLINICAL OBSERVATIONS 

DAY OF STUDY 

GROUP# -11 -1 6 13 20 27 34 41 48 55 62 69 76 83 90 91 97 104 111 118 12

1 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 

2 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 

3 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 

4 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 

1 20 20 18 

2 10 10 10 

3 10 10 9 

4 20 20 20 

1 

2 

3 

4 

1 

2 

3 

4 

1 

2 

3 

4 

1 

2 

3 

4 

0 

0 

0 

0 

0 0 

0 0 

0 

0 

0 

0 

0 0 0 0 

0 

0 

0 0 

0 

0 0 

0 

0 0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 0 0 0 0 0 

2 

0 

1 

0 

18 18 16 16 18 

10 10 9 8 7 

9 9 8 9 8 

18 18 16 14 16 

0 

0 

0 

0 0 

0 

0 0 

0 

0 0 

0 

2 

0 

1 

0 

0 

0 

0 0 0 0 

0 0 0 0 

0 

0 

1 

0 

1 

0 

0 

0 

0 

0 

0 0 

0 0 

0 

0 0 

0 

1 

0 

1 

0 

0 

0 

0 0 0 

0 

0 

0 

0 0 

0 

0 0 

0 

1 

0 

0 

0 

0 0 

0 0 

0 0 

0 

0 

0 

0 

0 

0 

1 

0 

18 17 

7 5 

10 9 15 15 

0 0 

0 

0 

0 0 

0 0 

0 

0 0 

0 

0 

0 

0 

0 

0 

0 

0 

0 0 

0 

0 0 

0 0 

0 

0 

0 0 

0 

0 

17 17 

6 7 

8 10 

15 15 

0 

0 

0 0 0 0 

0 0 0 0 

0 

0 

0 0 0 

0 

0 0 

0 

0 

0 0 

0 0 

0 

0 0 

0 

0 

0 

0 0 

15 

6 

9 

14 

0 

0 

0 0 0 0 0 

0 

0 

0 0 

0 

0 0 

0 

0 

16 

6 

9 

16 

0 

0 

0 0 

0 

0 0 0 0 0 

0 

0 

0 

0 0 0 

14 

3 

4 

13 

5 5 

5 5 

0 0 

0 0 

0 

0 0 

0 

0 0 

0 

0 

5 10 10 10 10 15 0 0 0 0 5 0 0 0 0 

5 10 10 10 10 1

0 

0 0 

0 

5 

4 

5 5 

0 0 

0 

0 

0 

1 

0 

0 

0 0 0 0 

9 

0 

0 

9 

0 

0 

0 0 0 0 

0 0 0 0 0 

0 

0 

0 

0 0 

10 

0 

0 

10 

0 0 

0 

0 

0 0 

0 0 

0 0 

0 

0 

0 0 

0 

0 

10 

0 

0 

10 

0 

0 

0 

0 0 

0 0 0 0 0 0 0 0 0 

0 

0 

10 

0 0 

10 

0 0 

0 

0 0 10 0 0 10 0 0 0 

0 0 0 

0 

P
25-SEP-2003 10:42 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES 

TABLE 2 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

SUMMARY OF CLINICAL OBSERVATIONS 

DAY OF STUDY 

GROUP# -11 -1 6 13 20 27 34 41 48 55 62 69 76 83 90 91 97 104 111 118 12

# OF ANIMALS EXAMINED 

ALOPECIA - GENERAL ALOPECIA -

EXTREMITIES/SNOUT 

OCULAR 

CHROMODACRYORRHEA -

BILATERAL 

CHROMODACRYORRHEA -

UNILATERAL 

ORAL/BUCCAL 

NASAL DISCHARGE - RED 

1 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 

2 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 

3 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 

4 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 

1 

2 

3 

4 

1 

2 

3 

4 

1 

2 

3 

4 

1 

2 

3 

4 

1 

2 

3 

4 

0 0 

0 0 0 

0 

0 

0 

0 0 0 

0 

0 

0 

0 0 

0 

0 

0 

0 

0 0 0 0 0 

0 

0 

0 

0 

0 

0 

0 0 

0 0 

0 0 

0 

0 0 

0 

0 0 0 0 0 0 

0 

0 

0 0 

0 

0 0 

0 

0 

0 

0 

0 0 

0 

0 

0 0 0 0 

0 

0 

0 0 

0 

0 

0 

0 0 0 

0 

0 

0 

2 

0 

0 

1 

0 0 0 0 

1 

0 0 

0 

0 

0 

0 0 

0 

1 

0 

0 

1 

0 

0 

1 

0 

1 

0 0 

1 

0 0 

0 

1 

0 

0 

0 0 

2 

1 1 

3 

0 0 

1 

0 

1 1 

0 

1 

0 

0 0 

1 

2 

0 

0 

1 

2 

1 

0 

4 

0 0 0 0 

1 1 

0 

1 

0 

0 

0 

1 1 

0 0 

0 0 

2 

1 

3 

0 

0 0 0 

1 1 

0 

2 

0 

0 0 

1 1 

0 

0 

0 0 

2 

0 

3 

0 

0 

0 

0 

1 1 

0 

2 

0 0 

0 

2 

1 

0 0 0 

1 

4 

1 

2 

0 

0 

0 

0 

1 

1 

0 

2 

0 0 

0 

2 

1 

0 

0 

0 

1 

3 

2 2 

0 

0 

0 

0 

1 1 

0 

2 

0 

0 0 

0 

1 

0 

0 

0 

1 

2 

0 

3 

0 0 0 0 

1 

1 

0 

2 

0 0 

0 0 

2 

0 

0 0 

2 

3 

1 

4 

0 

0 

0 

0 

1 1 

0 

2 

0 

0 0 

0 

1 1 

0 

0 

2 

3 

1 

2 

0 0 0 0 

1 

0 

0 

1 

0 0 

0 

0 

0 0 

0 

0 0 

2 

1 1 

5 10 10 

5 0 0 

5 0 0 

10 10 1

0 0 

0 0 

5 10 10 10 10 1

0 

0 

0 0 0 0 0 0 

0 0 

0 0 0 

0 0 0 0 

0 

0 0 

0 0 

0 

0 

1 

0 0 

1 

0 0 0 

0 

0 

0 

0 0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 0 

0 

0 

0 

0 

0 0 

0 0 0 

0 

0 

0 0 0 

0 

0 

0 

0 0 0 

0 0 

0 

0 0 0 

0 

0 

0 

0 0 

0 

0 0 0 0 0 

0 0 

0 

0 0 0 

0 

0 0 

0 0 0 

P
25-SEP-2003 10:42 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES 

TABLE 2 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

SUMMARY OF CLINICAL OBSERVATIONS 

DAY OF STUDY 

GROUP# -11 -1 6 13 20 27 34 41 48 55 62 69 76 83 90 91 97 104 111 118 12

# OF ANIMALS EXAMINED 

NASAL DISCHARGE - CLEAR 

INCISORS MALOCCLUDED 

1 20 20 

2 10 10 

20 20 20 20 20 20 20 20 

10 10 10 10 10 10 10 10 

3 10 10 10 10 10 

4 20 20 20 20 20 

1 

2 

3 

4 

1 

2 

3 

4 

0 0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 0 0 0 

0 

0 0 0 0 0 0 0 

0 

0 0 0 0 0 

0 

0 

0 0 

0 

0 0 0 

0 

0 

10 10 10 10 10 

20 20 20 20 20 

0 0 

0 0 0 0 0 

1 

0 0 0 

0 

0 

0 

0 

1 

0 0 0 0 0 0 0 

1 

0 

0 

0 0 0 0 0 

1 

0 

0 0 0 0 

0 

0 

1 

20 

10 10 

20 

0 0 

0 

1 

0 0 

0 

1 

20 20 20 20 

10 10 10 10 

10 10 10 10 

20 20 20 20 

0 0 0 0 0 0 

0 

1 

0 0 0 

0 0 0 0 

1 

0 

0 

0 

0 

0 

0 

0 

1 

0 

0 0 

0 

0 0 

0 

0 

5 5 5 

5 

0 

0 0 0 0 0 0 

0 

10 

0 0 

10 

0 

0 

0 

0 0 0 0 0 

10 

0 0 

10 

0 0 0 0 

0 

0 

0 

0 

10 

0 

0 

10 

0 

0 

0 0 0 0 0 0 

10 

0 

0 

10 

0 

0 

0 

0 

0 

0 

0 

0 

1

1

P
25-SEP-2003 10:42 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES 

# OF ANIMALS EXAMINED 

NORMAL 

WITHIN NORMAL LIMITS 

DEAD 

TERMINAL SACRIFICE 

RECOVERY SACRIFICE 

DERMAL GENERAL 

ALOPECIA - GENERAL 

ALOPECIA -

EXTREMITIES/SNOUT 

TABLE 2 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

SUMMARY OF CLINICAL OBSERVATIONS 

DAY OF STUDY 

GROUP# -11 -1 6 13 20 27 34 41 48 55 62 69 76 83 90 91 97 104 111 118 12

1 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 

2 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 

3 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 

4 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 

1 20 20 20 20 20 

2 10 10 9 9 8 

3 10 10 9 9 8 

4 20 20 19 18 17 

1 

2 

3 

4 

1 

2 

3 

4 

1 

2 

3 

4 

1 

2 

3 

4 

0 

0 

0 

0 

0 0 

0 0 

0 0 

0 0 

0 

0 0 0 

0 

0 

0 0 0 0 

0 0 

0 

0 

0 

0 

0 0 0 0 

0 

0 

0 0 0 0 

0 0 

0 

0 

0 

0 

0 

0 0 0 

0 

0 

0 0 

0 

0 0 

0 

0 

1 

0 

0 

0 

0 0 0 

0 0 

0 0 

0 0 

0 0 0 

1 

0 

0 

0 

0 

0 

0 

17 17 15 16 16 15 13 

7 8 8 8 9 8 8 7 5 7 6 6 6 8 

13 11 14 14 16 13 12 

0 

0 

0 

0 

0 0 

0 0 

0 

1 

0 0 

1 

0 

0 

0 

0 

0 

0 0 0 0 

0 0 

0 

1 

0 

0 

1 

0 

1 

0 

0 

0 

0 

0 

0 

0 

0 

0 0 

1 

0 

0 

2 

0 

1 

0 

0 

0 

0 0 0 

0 

0 0 

0 

1 

0 0 

2 

0 

1 

0 

0 0 

0 

0 

0 0 

0 0 0 

1 

0 

0 

2 

0 

1 

0 

0 0 

0 0 0 0 

0 0 

0 

1 

0 

0 

2 

0 

1 

0 

0 

0 

0 0 

0 

0 0 

0 

0 

1 

0 

0 

3 

0 

1 

0 

14 13 10 

8 7 3 

8 8 4 

11 11 9 

0 

0 

0 0 

0 

0 0 0 0 

1 

0 

0 

3 

0 

1 

0 

0 0 

0 0 

0 0 

0 0 0 

1 

0 

0 

3 

0 

2 

0 

5 5 

5 5 

0 0 

0 0 0 

0 

0 

0 

3 

0 

1 

0 

5 10 10 10 10 15 0 0 0 0 

5 0 0 0 0 

5 10 10 10 10 1

0 0 0 

0 

5 5 

5 5 

0 0 

0 0 0 0 0 

0 

0 

0 0 0 

8 

0 0 

8 

0 

0 

0 

0 

0 0 0 

0 

0 

0 0 0 

1 

0 0 0 

9 

0 0 

8 

0 

0 

0 0 

0 

0 0 

0 

0 

0 

0 

0 

1 

0 

0 

0 

9 

0 0 

9 

0 

0 

0 

0 

0 0 

0 0 0 

0 

0 

0 

1 

0 0 0 

9 

0 0 

9 

0 0 

0 0 0 10 0 0 10 

0 

0 

0 

1 

0 

0 

0 

P
25-SEP-2003 10:42 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES 

TABLE 2 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

SUMMARY OF CLINICAL OBSERVATIONS 

DAY OF STUDY 

GROUP# -11 -1 6 13 20 27 34 41 48 55 62 69 76 83 90 91 97 104 111 118 12

# OF ANIMALS EXAMINED 

YELLOW ANO-GENITAL 

STAINING 

OCULAR 

CHROMODACRYORRHEA -

BILATERAL 

CHROMODACRYORRHEA -

UNILATERAL 

LACRIMATION - UNILATERAL 

ORAL/BUCCAL 

NASAL DISCHARGE - RED 

1 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 

2 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 

3 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 

4 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 

1 

2 

3 

4 

1 

2 

3 

4 

1 

2 

3 

4 

1 

2 

3 

4 

1 

2 

3 

4 

0 

0 

0 

0 

0 0 0 0 

0 0 0 0 

0 0 

0 

0 0 

0 

0 

0 

0 

0 0 

0 0 

0 

0 0 

0 0 

0 

0 

0 

0 

0 0 

0 

0 

0 

0 

0 0 

0 

0 0 

0 

0 

0 

0 0 

0 

0 

0 0 

0 0 0 

1 

1 

1 

0 0 0 0 

0 

0 0 0 

0 

0 0 

0 

0 

0 0 

0 0 

0 

1 

1 

0 0 0 0 

0 

0 0 0 

0 

0 0 

0 

0 

0 0 

0 0 

1 

2 2 

0 0 

0 

0 

0 0 

0 

0 

0 

0 0 

0 

0 

0 0 

0 

2 

2 

3 

6 

0 

0 

0 

0 

0 0 

0 

0 

0 0 

0 

1 

0 

0 0 

0 

2 

1 

4 

8 

0 

0 

0 0 0 0 0 0 

0 0 0 0 0 0 

0 

0 

3 

1 

2 

5 

0 

0 0 

0 0 

0 

0 

1 

0 0 

0 

0 0 0 0 

0 

2 

1 

3 

5 

0 0 

0 

0 0 

0 

0 

1 

0 0 0 

0 0 0 0 

1 

2 

0 

3 

2 

0 0 

0 

1 

0 

0 0 

0 

0 

1 

0 

1 

0 

0 0 

0 

3 

0 

3 

5 

0 0 0 

1 

0 0 0 

0 

0 

1 

0 

1 

0 

0 0 

0 

4 

0 

2 

7 

0 0 0 

1 

0 

0 0 

0 

2 

1 

0 

1 

0 

0 0 

0 

3 

0 

2 

7 

0 0 

0 

2 

0 0 0 0 

2 

1 

0 

1 

0 0 

0 

0 

3 

1 

0 

7 

0 

0 

0 

1 

0 0 

0 

0 

1 

1 

0 

0 0 0 

0 0 

2 

1 

0 

5 

5 10 10 10 10 15 0 0 0 0 

5 0 0 0 0 

5 10 10 10 10 1

0 

0 

0 0 0 0 

0 

0 

0 0 

0 

0 

0 

0 

0 0 

0 

0 

0 

0 

0 

0 

0 

0 0 0 0 0 

0 

0 

0 

0 

0 

0 0 

0 

1 

0 

0 

2 

0 0 

0 

0 0 

0 

0 0 

0 

0 

0 

0 

0 

0 0 

0 0 

0 

0 

2 

0 0 

0 0 0 

0 

0 0 

0 0 0 

1 

0 

0 0 

0 0 

0 

0 0 

0 0 0 

0 

0 

0 

0 

0 

0 0 0 

1 

0 

0 0 

0 0 

0 

0 0 

P
25-SEP-2003 10:42 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES 

TABLE 2 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

SUMMARY OF CLINICAL OBSERVATIONS 

DAY OF STUDY 

GROUP# -11 -1 6 13 20 27 34 41 48 55 62 69 76 83 90 91 97 104 111 118 12

# OF ANIMALS EXAMINED 

NASAL DISCHARGE - CLEAR 

INCISORS MALOCCLUDED 

INCISORS BROKEN/MISSING 

1 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 

2 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 

3 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 

4 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 

1 

2 

3 

4 

1 

2 

3 

4 

1 

2 

3 

4 

0 0 

0 

0 

0 

0 0 0 0 

0 0 0 

0 0 

0 

0 0 0 

0 

0 0 

0 0 0 

0 0 

0 

0 0 0 0 0 0 

0 0 0 

0 0 

0 

1 

0 0 

0 

0 0 0 

0 0 

0 

0 

0 

1 

0 0 0 0 0 0 

0 0 

0 

0 

0 

1 

0 

0 0 0 0 0 

0 0 

0 

0 0 

1 

0 0 

0 

1 

0 0 

0 0 

0 

0 0 

1 

0 0 0 0 0 0 

0 0 

0 

0 0 0 0 0 0 

1 

0 0 

0 0 

0 

0 0 0 

0 0 

0 

1 

0 

0 

0 0 

0 0 0 0 0 

1 

0 

1 

0 0 

0 0 

0 

0 

0 

0 0 

1 

0 

1 

0 0 

0 0 

0 0 0 0 0 

1 

0 

1 

0 0 

0 0 

0 0 0 0 0 

1 

0 

1 

0 0 

0 0 

0 0 0 0 0 

1 

0 0 0 0 0 

0 

5 10 10 10 10 15 0 0 0 0 5 0 0 0 0 5 10 10 10 10 1

0 0 0 0 0 0 0 0 

0 

0 0 0 

0 0 0 0 0 0 0 0 

0 

0 0 0 

0 0 0 0 0 0 0 0 

0 

0 0 

1 

0 

0 

0 

0 

0 0 0 0 

0 

0 

0 

1 

0 

0 

0 0 

0 0 0 0 

0 

0 0 

1 

P
25-SEP-2003 11:51 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES 

# OF ANIMALS EXAMINED 

NORMAL 

WITHIN NORMAL LIMITS 

DEAD 

TERMINAL SACRIFICE 

TABLE 2 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

SUMMARY OF CLINICAL OBSERVATIONS 

DAY OF STUDY 

GROUP# -11 93 94 TOTAL 

1 5 3 2 

2 5 2 3 

3 5 3 2 

4 5 2 3 

1 5 0 0 5 

2 5 0 0 5 

3 5 0 0 5 

4 5 0 0 5 

1 0 3 2 5 

2 0 2 3 5 

3 0 3 2 5 

4 0 2 3 5 

P
25-SEP-2003 11:51 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES 

# OF ANIMALS EXAMINED 

NORMAL 

WITHIN NORMAL LIMITS 

DEAD 

TERMINAL SACRIFICE 

TABLE 2 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

SUMMARY OF CLINICAL OBSERVATIONS 

DAY OF STUDY 

GROUP# -11 93 94 TOTAL 

1 5 2 3 

2 5 3 2 

3 5 2 3 

4 5 3 2 

1 5 0 0 5 

2 5 0 0 5 

3 5 0 0 5 

4 5 0 0 5 

1 0 2 3 5 

2 0 3 2 5 

3 0 2 3 5 

4 0 3 2 5 

P
Huntingdon Life Sciences 00-6130 Page 82

211-DIPE-S Final Report

Summary of Ophthalmoscopic Findings

Preface Table 3

Table of Contents

Ophthalmologist Reports .................................................................................... 83

Summary of Ophthalmology Observations ......................................................... 87
Tab.le 3 - Pretest (Main Study) 

LIONEL F. RUBIN, V.M.D. 

1116 Saint Andrews Road 

Bryn Mawr, PA 1901 0 

(61 0) 520 9430 

February 2, 2002 

Huntingdon Life Sciences, Inc. 

Mettlers Road, Box 2360 

East Millstone, NJ 08875-2360 

Re: study A-12 00-6130 

Ophthalmoscopic examination of study A-12 00-6130 pretest rats was performed 

January 31, 2002. Rats with ocular abnormalities were identified and should be withdrawn 

from inclusion in the study if convenient. 

Lionel F. Rubin, V. M. D. 

Page 83
Table 3 - Termination (Main Study) 

LIONEL F. RUBIN, V.M.D. 

1116 Saint Andrews Road 

Bryn Mawr, PA 19010 

(61 0) 520 9430 

May 11,2002 

Huntingdon Life Sciences, Inc. 

Mettlers Road, Box 2360 

East Millstone, NJ 08875-2360 

Re: study A-12 00-6130 

Ophthalmoscopic examination of study A-12 00-6130 rats was performed May 10, 

2002 (terminal examination). I have reviewed the findings of the type and incidence of 

ocular abnormalities. There is no indication of dose or compound related ocular disease. 

In my opinion, none of the ocular abnormalities is attributable to the administration of the 

test compound. 

Lionel F. Rubin, V. M.D. 

Page 84
Table 3 - Pretest (Neuropathology) 

LIONEL F. RUBIN, V.M.D. 

1116 Saint Andrews Road 

Huntingdon Life Sciences, Inc. 

Mettlers Road, Box 2360 

East Millstone, NJ 08875-2360 

Re: study A-12 00-6130N 

Bryn Mawr, PA 19010 

(610) 520 9430 

February 2, 2002 

Ophthalmoscopic examination of study A-12 00-6130N pretest rats was performed 

January 31, 2002. Rats with ocular abnormalities were identified and should be withdrawn 

from inclusion in the study if convenient. 

Lionel 

~~ F. Rubin, V. M. D. 

Page 85
Table 3 ·Termination (Neuropathology) 

LIONEL F. RUBIN, V.M.D. 

Huntingdon Life Sciences, Inc. 

Mettlers Road, Box 2360 

East Millstone, NJ 08875-2360 

Re: study A-12 00-6130N 

1116 Saint Andrews Road 

Bryn Mawr, PA 19010 

(61 0) 520 9430 

May 11,2002 

Ophthalmoscopic examination of study A-12 00-6130N rats was performed May 1 0, 

2002 (terminal examination). No ocular abnormalities were seen. There is no indication of 

dose or compound related ocular disease. 

Lionel F. Rubin, V. M.D. 

Page 86
25-SEP-2003 11:57 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 3 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

MALES total number examined 

NO ABNORMALITIES DETECTED 

No statistically significant differences 

SUMMARY OF OPHTHALMOLOGY OBSERVATIONS 

1 

0 

20 

2 

2000 

10 

3 

10000 

10 

WEEK 

20
25-SEP-2003 11:57 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 3 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

FEMALES total number examined 

NO ABNORMALITIES DETECTED 

No statistically significant differences 

SUMMARY OF OPHTHALMOLOGY OBSERVATIONS 

1 

0 

20 

2 

2000 

10 

3 

10000 

10 

WEEK 

20
25-SEP-2003 11:57 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 3 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

MALES total number examined 

CONJUNCTIVA N CONJUNCTIVITIS N 

% 

No statistically significant differences 

SUMMARY OF OPHTHALMOLOGY OBSERVATIONS 

1 

0 

20 

0 0 

0.0 

2 

2000 

10 

1 

1 

10.0 

3 

10000 

10 

0 0 

0.0 

WEEK 

20
25-SEP-2003 11:57 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 3 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

FEMALES total number examined 

IRIS N 

ANTERIOR UVEITIS (IRITIS) N 

% 

CONJUNCTIVA N 

-----------

CONJUNCTIVITIS N 

% 

No statistically significant differences 

SUMMARY OF OPHTHALMOLOGY OBSERVATIONS 

1 

0 

20 

0 0 

0.0 

1 1 

5.0 

2 

2000 

10 

0 0 

0.0 

1 1 

10.0 

3 

10000 

10 

0 0 

0.0 

0 0 

0.0 

WEEK 

20
25-SEP-2003 11:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 3 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

MALES total number examined 

NO ABNORMALITIES DETECTED 

No statistically significant differences 

SUMMARY OF OPHTHALMOLOGY OBSERVATIONS 

1 

0 

5 

2 

2000 

5 

3 

10000 

5 

WEEK 

20
25-SEP-2003 11:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 3 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

FEMALES total number examined 

NO ABNORMALITIES DETECTED 

No statistically significant differences 

SUMMARY OF OPHTHALMOLOGY OBSERVATIONS 

1 

0 

5 

2 

2000 

5 

3 

10000 

5 

WEEK 

20
25-SEP-2003 11:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 3 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

MALES total number examined 

NO ABNORMALITIES DETECTED 

No statistically significant differences 

SUMMARY OF OPHTHALMOLOGY OBSERVATIONS 

1 

0 

5 

2 

2000 

5 

3 

10000 

5 

WEEK 

20
25-SEP-2003 11:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 3 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

FEMALES total number examined 

NO ABNORMALITIES DETECTED 

No statistically significant differences 

SUMMARY OF OPHTHALMOLOGY OBSERVATIONS 

1 

0 

5 

2 

2000 

5 

3 

10000 

5 

WEEK 

20
25-SEP-2003 12:00 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 4 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK -1 MEAN 

S.D. 

N 

WEEK 0 MEAN 

S.D. 

N 

WEEK 1 MEAN 

S.D. 

N 

WEEK 2 MEAN 

S.D. 

N 

WEEK 3 MEAN 

S.D. 

N 

WEEK 4 MEAN 

S.D. 

N 

WEEK 5 MEAN 

S.D. 

N 

WEEK 6 MEAN 

S.D. 

N 

WEEK 7 MEAN 

S.D. 

N 

MEAN BODY WEIGHTS (GRAMS) 

1 

0 

220 

8.1 

20 

306 

13.7 

20 

342 

18.5 

20 

373 

19.6 

20 

399 

19.8 

20 

420 

22.6 

20 

439 

22.4 

20 

455 

23.7 

20 

479 

25.9 

20 

2 

2000 

220 

7.5 

10 

307 

10.4 

10 

342 

11.0 

10 

373 

12.0 

10 

402 

13.9 

10 

427 

16.9 

10 

443 

18.0 

10 

462 

20.2 

10 

482 

22.7 

10 

3 

10000 

220 

8.1 

10 

307 

18.4 

10 

337 

24.9 

10 

369 

26.3 

10 

391 

28.3 

10 

417 

29.1 

10 

435 

31.6 

10 

455 

32.1 

10 

479 

33.4 

10 

20

-----------------------------------------------------------------------------------------------------------------

No statistically significant differences 
25-SEP-2003 12:00 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 4 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 8 MEAN 

S.D. 

N 

WEEK 9 MEAN 

S.D. 

N 

WEEK 10 MEAN 

S.D. 

N 

WEEK 11 MEAN 

S.D. 

N 

WEEK 12 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN BODY WEIGHTS (GRAMS) 

1 

0 

492 

26.5 

20 

507 

27.3 

20 

518 

27.5 

20 

533 

27.6 

20 

542 

28.5 

20 

2 

2000 

497 

23.8 

10 

511 

25.8 

10 

519 

26.5 

10 

532 

29.7 

10 

536 

35.6 

10 

3 

10000 

494 

34.6 

10 

507 

38.3 

10 

522 

41.3 

10 

533 

43.2 

10 

540 

45.2 

10 

20
25-SEP-2003 12:01 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 4 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 13 MEAN 

S.D. 

N 

WEEK 14 MEAN 

S.D. 

N 

WEEK 15 MEAN 

S.D. 

N 

WEEK 16 MEAN 

S.D. 

N 

WEEK 17 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN BODY WEIGHTS (GRAMS) 

1 

0 

538 

33.2 

10 

546 

33.8 

10 

556 

31.9 

10 

565 

35.7 

10 

569 

35.9 

10 

4 

20000 

527 

32.3 

10 

539 

30.7 

10 

554 

30.6 

10 

564 

31.3 

10 

570 

29.6 

10 
25-SEP-2003 12:03 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 4 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK -1 MEAN 

S.D. 

N 

WEEK 0 MEAN 

S.D. 

N 

WEEK 1 MEAN 

S.D. 

N 

WEEK 2 MEAN 

S.D. 

N 

WEEK 3 MEAN 

S.D. 

N 

WEEK 4 MEAN 

S.D. 

N 

WEEK 5 MEAN 

S.D. 

N 

WEEK 6 MEAN 

S.D. 

N 

WEEK 7 MEAN 

S.D. 

N 

MEAN BODY WEIGHTS (GRAMS) 

1 

0 

179 

8.6 

20 

222 

13.4 

20 

237 

14.1 

20 

251 

17.7 

20 

259 

18.2 

20 

270 

17.0 

20 

277 

19.3 

20 

279 

20.0 

20 

289 

22.1 

20 

2 

2000 

179 

8.6 

10 

217 

14.2 

10 

236 

16.2 

10 

247 

21.1 

10 

259 

21.7 

10 

268 

19.5 

10 

272 

18.0 

10 

277 

20.5 

10 

286 

21.8 

10 

3 

10000 

179 

8.6 

10 

225 

20.6 

10 

243 

22.2 

10 

259 

21.3 

10 

266 

20.8 

10 

281 

24.2 

10 

289 

25.0 

10 

293 

26.7 

10 

303 

24.5 

10 

20

-----------------------------------------------------------------------------------------------------------------

No statistically significant differences 
25-SEP-2003 12:03 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 4 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 8 MEAN 

S.D. 

N 

WEEK 9 MEAN 

S.D. 

N 

WEEK 10 MEAN 

S.D. 

N 

WEEK 11 MEAN 

S.D. 

N 

WEEK 12 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN BODY WEIGHTS (GRAMS) 

1 

0 

294 

23.2 

20 

299 

21.8 

20 

305 

23.1 

20 

308 

22.9 

20 

310 

22.2 

20 

2 

2000 

291 

20.8 

10 

295 

21.8 

10 

302 

26.6 

10 

303 

22.8 

10 

308 

24.7 

10 

3 

10000 

307 

29.8 

10 

320 

30.8 

10 

324 

29.0 

10 

326 

30.5 

10 

328 

32.4 

ro 

20
25-SEP-2003 12:03 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 4 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 13 MEAN 

S.D. 

N 

WEEK 14 MEAN 

S.D. 

N 

WEEK 15 MEAN 

S.D. 

N 

WEEK 16 MEAN 

S.D. 

N 

WEEK 17 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN BODY WEIGHTS (GRAMS) 

1 

0 

303 

19.9 

10 

305 

20.1 

10 

308 

20.6 

10 

309 

22.3 

10 

309 

22.1 

10 

4 

20000 

301 

16.3 

10 

301 

16.5 

10 

308 

15.1 

10 

311 

16.2 

10 

315 

16.0 

10 

P
25-SEP-2003 12:05 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 4 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK -1 MEAN 

S.D. 

N 

WEEK 0 MEAN 

S.D. 

N 

WEEK 1 MEAN 

S.D. 

N 

WEEK 2 MEAN 

S.D. 

N 

WEEK 3 MEAN 

S.D. 

N 

WEEK 4 MEAN 

S.D. 

N 

WEEK 5 MEAN 

S.D. 

N 

WEEK 6 MEAN 

S.D. 

N 

WEEK 7 MEAN 

S.D. 

N 

MEAN BODY WEIGHTS (GRAMS) 

1 

0 

218 

11.0 

5 

299 

21.5 

5 

334 

30.1 

5 

363 

32.2 

5 

389 

39.5 

5 

411 

39.6 

5 

437 

45.6 

5 

457 

46.7 

5 

481 

55.0 

5 

2 

2000 

216 

15.2 

5 

298 

24.6 

5 

335 

34.2 

5 

369 

39.5 

5 

395 

41.3 

5 

419 

46.9 

5 

443 

49.1 

5 

461 

54.5 

5 

480 

59.0 

5 

3 

10000 

217 

13.6 

5 

302 

28.4 

5 

336 

25.0 

5 

373 

27.2 

5 

404 

30.1 

5 

430 

32.0 

5 

456 

37.3 

5 

478 

39.7 

5 

498 

40.1 

5 

20

-----------------------------------------------------------------------------------------------------------------

No statistically significant differences 

P
25-SEP-2003 12:05 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 4 

GASOLINE DIPE .VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 8 MEAN 

S.D. 

N 

WEEK 9 MEAN 

S.D. 

N 

WEEK 10 MEAN 

S.D. 

N 

WEEK 11 MEAN 

S.D. 

N 

WEEK 12 MEAN 

S.D. 

N 

WEEK 13 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN BODY WEIGHTS (GRAMS) 

1 

0 

492 

58.8 

5 

508 

64.3 

5 

521 

62.9 

5 

536 

66.8 

5 

549 

70.5 

5 

555 

72.5 

5 

2 

2000 

495 

59.9 

5 

513 

62.5 

5 

523 

59.8 

5 

541 

60.9 

5 

548 

62.0 

5 

555 

69.9 

5 

3 

10000 

512 

42.8 

5 

532 

46.6 

5 

543 

45.6 

5 

560 

49.8 

5 

575 

52.8 

5 

582 

54.0 

5 

20

P
25-SEP-2003 12:06 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 4 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK -1 MEAN 

S.D. 

N 

WEEK 0 MEAN 

S.D. 

N 

WEEK 1 MEAN 

S.D. 

N 

WEEK 2 MEAN 

S.D. 

N 

WEEK 3 MEAN 

S.D. 

N 

·wEEK 4 MEAN 

S.D. 

N 

WEEK 5 MEAN 

S.D. 

N 

WEEK 6 MEAN 

S.D. 

N 

WEEK 7 MEAN 

S.D. 

N 

MEAN BODY WEIGHTS (GRAMS) 

1 

0 

183 

7.7 

5 

230 

15.0 

5 

252 

13.9 

5 

268 

22.0 

5 

276 

19.7 

5 

286 

22.5 

5 

300 

25.6 

5 

302 

28.8 

5 

312 

28.0 

5 

2 

2000 

180 

10.0 

5 

225 

14.8 

5 

244 

9.8 

5 

257 

10.3 

5 

273 

19.9 

5 

276 

20.0 

5 

287 

15.3 

5 

288 

18.7 

5 

298 

21.1 

5 

3 

10000 

179 

9.0 

5 

225 

24.1 

5 

238 

29.2 

5 

252 

31.0 

5 

259 

36.0 

5 

272 

37.8 

5 

279 

41.0 

5 

285 

43.1 

5 

291 

45.9 

5 

20

-----------------------------------------------------------------------------------------------------------------

No statistically significant differences 

P
25-SEP-2003 12:06 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 4 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 8 MEAN 

S.D. 

N 

WEEK 9 MEAN 

S.D. 

N 

WEEK 10 MEAN 

S.D. 

N 

WEEK 11 MEAN 

S.D. 

N 

WEEK 12 MEAN 

S.D. 

N 

WEEK 13 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN BODY WEIGHTS (GRAMS) 

1 

0 

316 

29.8 

5 

321 

31.6 

5 

326 

35.8 

5 

330 

33.2 

5 

337 

38.1 

5 

332 

40.5 

5 

2 

2000 

298 

24.6 

5 

305 

20.8 

5 

310 

23.3 

5 

317 

25.3 

5 

324 

29.1 

5 

318 

23.7 

5 

3 

10000 

298 

46.0 

5 

302 

49.5 

5 

307 

49.7 

5 

311 

50.5 

5 

319 

50.9 

5 

317 

55.1 

5 

20

P
25-SEP-2003 12:07 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 5 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 TO 1 MEAN 

S.D. 

N 

WEEK 0 TO 2 MEAN 

S.D. 

N 

WEEK 0 TO 3 MEAN 

S.D. 

N 

WEEK 0 TO 4 MEAN 

S.D. 

N 

WEEK 0 TO 5 MEAN 

S.D. 

N 

WEEK 0 TO 6 MEAN 

S.D. 

N 

MEAN BODY WEIGHT CHANGE FROM BASELINE (GRAMS) 

1 

0 

36 

7.5 

20 

67 

10.6 

20 

94 

10.8 

20 

114 

14.0 

20 

133 

13.8 

20 

149 

15.0 

20 

2 

2000 

35 

6.3 

10 

66 

6.6 

10 

95 

8.8 

10 

120 

12.2 

10 

136 

10.8 

10 

155 

13.3 

10 

3 

10000 

31 

8.4 

10 

62 

10.2 

10 

84 

13.9 

10 

110 

14.3 

10 

128 

16.5 

10 

148 

17.6 

10 

20

-----------------------------------------------------------------------------------------------------------------

No statistically significant differences 

P
25-SEP-2003 12:07 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 5 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 TO 7 MEAN 

S.D. 

N 

WEEK 0 TO 8 MEAN 

S.D. 

N 

WEEK 0 TO 9 MEAN 

S.D. 

N 

WEEK 0 TO 10 MEAN 

S.D. 

N 

WEEK 0 TO 11 MEAN 

S.D. 

N 

WEEK 0 TO 12 MEAN 

S.D. 

N 

MEAN BODY WEIGHT CHANGE FROM BASELINE (GRAMS) 

1 

0 

173 

18.0 

20 

186 

18.8 

20 

202 

19.9 

20 

212 

19.3 

20 

227 

19.5 

20 

237 

20.8 

20 

2 

2000 

175 

15.2 

10 

190 

16.9 

10 

204 

19.3 

10 

212 

19.6 

10 

225 

22.6 

10 

229 

27.7 

10 

3 

10000 

172 

18.7 

10 

187 

20.7 

10 

201 

23.4 

10 

215 

25.6 

10 

226 

27.6 

10 

233 

29.8 

10 

20

-----------------------------------------------------------------------------------------------------------------

No statistically significant differences 

P
25-SEP-2003 12:09 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 5 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 TO 13 MEAN 

S.D. 

N 

WEEK 0 TO 14 MEAN 

S.D. 

N 

WEEK 0 TO 15 MEAN 

S.D. 

N 

WEEK 0 TO 16 MEAN 

S.D. 

N 

WEEK 0 TO 17 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN BODY WEIGHT CHANGE FROM BASELINE (GRAMS) 

1 

0 

232 

22.7 

10 

240 

23.7 

10 

250 

20.9 

10 

259 

25.0 

10 

263 

25.5 

10 

4 

20000 

227 

22.4 

10 

239 

20.1 

10 

254 

21.9 

10 

264 

23.0 

10 

270 

22.3 

10 

P
25-SEP-2003 12:11 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 5 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 TO 1 MEAN 

S.D. 

N 

WEEK 0 TO 2 MEAN 

S.D. 

N 

WEEK 0 TO 3 MEAN 

S.D. 

N 

WEEK 0 TO 4 MEAN 

S.D. 

N 

WEEK 0 TO 5 MEAN 

S.D. 

N 

WEEK 0 TO 6 MEAN 

S.D. 

N 

MEAN BODY WEIGHT CHANGE FROM BASELINE (GRAMS) 

1 

0 

15 

6.1 

20 29 

9.5 

20 

37 

10.6 

20 

48 

9.1 

20 

55 

13.1 

20 

57 

13.1 

20 

2 

2000 

19 

6.5 

10 

30 

12.5 

10 

41 

11.8 

10 

51 

8.9 

10 

55 

10.0 

10 

60 

15.2 

10 

3 

10000 

18 

9.2 

10 

34 

11.0 

10 

41 

13.9 

10 

56 

11.3 

10 

64 

14.2 

10 

69 

15.0 

10 

20

-----------------------------------------------------------------------------------------------------------------

No statistically significant differences 

P
25-SEP-2003 12:11 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 5 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 TO 7 MEAN 

S.D. 

N 

WEEK 0 TO 8 MEAN 

S.D. 

N 

WEEK 0 TO 9 MEAN 

S.D. 

N 

WEEK 0 TO 10 MEAN 

S.D. 

N 

WEEK 0 TO ll MEAN 

S.D. 

N 

WEEK 0 TO 12 MEAN 

S.D. 

N 

MEAN BODY WEIGHT CHANGE FROM BASELINE (GRAMS) 

1 

0 

67 

16.1 

20 

72 

17.6 

20 

77 

16.6 

20 

83 

17.1 

20 

86 

16.8 

20 

88 

17.1 

20 

2 

2000 

69 

12.9 

10 

74 

12.7 

10 

78 

14.2 

10 

85 

19.2 

10 

85 

15.5 

10 

91 

16.7 

10 

3 

10000 

78 

14.8 

10 

83 

16.5 

10 

95** 

17.5 

10 

99* 

17.0 

10 

101* 

20.4 

10 

103* 

19.3 

10 

20

-----------------------------------------------------------------------------------------------------------------

Statistical key: * = p<0.05 ** = p<0.01 

P
25-SEP-2003 12:11 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 5 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 TO 13 MEAN 

S.D. 

N 

WEEK 0 TO 14 MEAN 

S.D. 

N 

WEEK 0 TO 15 MEAN 

S.D. 

N 

WEEK 0 TO 16 MEAN 

S.D. 

N 

WEEK 0 TO 17 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN BODY WEIGHT CHANGE FROM BASELINE (GRAMS) 

1 

0 

81 

15.8 

10 

82 

15.2 

10 

86 

15.7 

10 

87 

16.8 

10 

87 

17.1 

10 

4 

20000 

79 

12.7 

10 

79 

13.9 

10 

86 

10.4 

10 

90 

11.6 

10 

94 

12.3 

10 

P
25-SEP-2003 12:12 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 5 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 TO 1 MEAN 

S.D. 

N 

WEEK 0 TO 2 MEAN 

S.D. 

N 

WEEK 0 TO 3 MEAN 

S.D. 

N 

WEEK 0 TO 4 MEAN 

S.D. 

N 

WEEK 0 TO 5 MEAN 

S.D. 

N 

WEEK 0 TO 6 MEAN 

S.D. 

N 

MEAN BODY WEIGHT CHANGE FROM BASELINE (GRAMS) 

1 

0 

34 

10.2 

5 

63 

11.5 

5 

90 

19.9 

5 

111 

22.7 

5 

138 

28.8 

5 

158 

30.3 

5 

2 

2000 

37 

10.2 

5 

71 

15.6 

5 

97 

17.5 

5 

121 

23.2 

5 

145 

24.7 

5 

163 

30.0 

5 

3 

10000 

35 

8.2 

5 

72 

7.9 

5 

103 

8.5 

5 

129 

14.5 

5 

155 

11.9 

5 

177 

14.2 

5 

20

-----------------------------------------------------------------------------------------------------------------

No statistically significant differences 

P
25-SEP-2003 12:12 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 5 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 TO 7 MEAN 

S.D. 

N 

WEEK 0 TO 8 MEAN 

S.D. 

N 

WEEK 0 TO 9 MEAN 

S.D. 

N 

WEEK 0 TO 10 MEAN 

S.D. 

N 

WEEK 0 TO 11 MEAN 

S.D. 

N 

WEEK 0 TO 12 MEAN 

S.D. 

N 

MEAN BODY WEIGHT CHANGE FROM BASELINE (GRAMS) 

1 

0 

181 

38.3 

5 

192 

42.8 

5 

209 

48.4 

5 

221 

47.1 

5 

236 

51.2 

5 

250 

54.6 

5 

2 

2000 

182 

34.9 

5 

197 

36.0 

5 

215 

38.7 

5 

225 

37.0 

5 

243 

37.6 

5 

250 

38.2 

5 

3 

10000 

197 

16.2 

5 

210 

19.4 

5 

230 

22.3 

5 

242 

21.3 

5 

258 

24.2 

5 

273 

26.2 

5 

20

-----------------------------------------------------------------------------------------------------------------

No statistically significant differences 

P
25-SEP-2003 12:16 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 5 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

WEEK 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

0 TO 13 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN BODY WEIGHT CHANGE FROM BASELINE (GRAMS) 

1 

0 

256 

55.2 

5 

2 

2000 

257 

45.6 

5 

3 

10000 

280 

26.4 

5 

20

P
25-SEP-2003 12:18 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 5 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 TO 1 MEAN 

S.D. 

N 

WEEK 0 TO 2 MEAN 

S.D. 

N 

WEEK 0 TO 3 MEAN 

S.D. 

N 

WEEK 0 TO 4 MEAN 

S.D. 

N 

WEEK 0 TO 5 MEAN 

S.D. 

N 

WEEK 0 TO 6 MEAN 

S.D. 

N 

MEAN BODY WEIGHT CHANGE FROM BASELINE (GRAMS) 

1 

0 

21 

3.1 

5 

37 

11.6 

5 

46 

10.9 

5 

56 

11.8 

5 

69 

15.5 

5 

71 

18.6 

5 

2 

2000 

19 

8.1 

5 

32 

8.2 

5 

48 

5.3 

5 

51 

8.9 

5 

61 

10.4 

5 

62 

5.5 

5 

3 

10000 

13 

7.9 

5 

27 

8.9 

5 

34 

13.1 

5 

47 

15.1 

5 

55 

18.1 

5 

60 

20.2 

5 

20

-----------------------------------------------------------------------------------------------------------------

No statistically significant differences 

P
25-SEP-2003 12:18 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 5 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 TO 7 MEAN 

S.D. 

N 

WEEK 0 TO 8 MEAN 

S.D. 

N 

WEEK 0 TO 9 MEAN 

S.D. 

N 

WEEK 0 TO 10 MEAN 

S.D. 

N 

WEEK 0 TO 11 MEAN 

S.D. 

N 

WEEK 0 TO 12 MEAN 

S.D. 

N 

MEAN BODY WEIGHT CHANGE FROM BASELINE (GRAMS) 

1 

0 

81 

18.5 

5 

86 

22.3 

5 

90 

22.6 

5 

96 

27.2 

5 

99 

26.0 

5 

106 

29.0 

5 

2 

2000 

73 

7.8 

5 

73 

12.9 

5 

80 

9.3 

5 

85 

9.5 

5 

92 

11.6 

5 

99 

16.0 

5 

3 

10000 

66 

23.6 

5 

73 

23.5 

5 

77 

26.3 

5 

82 

26.5 

5 

86 

28.1 

5 

94 

27.6 

5 

20

-----------------------------------------------------------------------------------------------------------------

No statistically significant differences 

P
25-SEP-2003 12:18 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 5 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

WEEK 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

0 TO 13 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN BODY WEIGHT CHANGE FROM BASELINE (GRAMS) 

1 

0 

102 

31.0 

5 

2 

2000 

93 

14.4 

5 

3 

10000 

92 

32.0 

5 

20

P
25-SEP-2003 12:22 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 6 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 MEAN 

S.D. 

N 

WEEK 1 MEAN 

S.D. 

N 

WEEK 2 MEAN 

S.D. 

N 

WEEK 3 MEAN 

S.D. 

N 

WEEK 4 MEAN 

S.D. 

N 

WEEK 5 MEAN 

S.D. 

N 

WEEK 6 MEAN 

S.D. 

N 

WEEK 7 MEAN 

S.D. 

N 

WEEK 8 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

1 

0 

97 

4.9 

20 

80 

4.6 

20 

71 

3.4 

20 

66 

3.7 

20 

62 

3.7 

20 

60 

4.2 

20 

60 

2.9 

20 

57 

2.5 

20 

53 

2.5 

20 

2 

2000 

96 

4.7 

10 

77 

3.2 

10 

71 

2.7 

10 

67 

3.0 

10 

63 

3.6 

10 

59 

1.8 

10 

59 

3.0 

10 

55 

3.5 

10 

52 

3.8 

10 

3 

10000 

96 

3.7 

10 

78 

6.9 

10 

71 

4.1 

10 

67 

2.5 

10 

64 

3.1 

9 

59 

3.3 

10 

61 

5.7 

10 

57 

3.9 

10 

54 

3.2 

10 

20

P
25-SEP-2003 12:22 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 6 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 9 MEAN 

S.D. 

N 

WEEK 10 MEAN 

S.D. 

N 

WEEK 11 MEAN 

S.D. 

N 

WEEK 12 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

1 

0 

52 

2.5 

20 

51 

3.2 

20 

so 

3. 6 

20 

48 

2.7 

20 

2 

2000 

51 

2.8 

10 49 

3.0 

10 48 

2.8 

10 

46 

3.9 

10 

3 

10000 

52 

3.4 

10 

51 

2.8 

10 

48 

2.3 

10 

47 

1.6 

10 

20

P
25-SEP-2003 12:23 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 6 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 13 MEAN 

S.D. 

N 

WEEK 14 MEAN 

S.D. 

N 

WEEK 15 MEAN 

S.D. 

N 

WEEK 16 MEAN 

S.D. 

N 

WEEK 17 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

1 

0 

46 

3.0 

10 

48 

3.9 

10 

48 

3.2 

10 

47 

2.9 

10 46 

3.5 

10 

4 

20000 

45 

2.2 

10 

so 

3.7 

10 

51 

4.3 

10 

49 

4.2 

10 48 

3.7 

10 

P
25-SEP-2003 12:23 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 6 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 MEAN 

S.D. 

N 

WEEK 1 MEAN 

S.D. 

N 

WEEK 2 MEAN 

S.D. 

N 

WEEK 3 MEAN 

S.D. 

N 

WEEK 4 MEAN 

S.D. 

N 

WEEK 5 MEAN 

S.D. 

N 

WEEK 6 MEAN 

S.D. 

N 

WEEK 7 MEAN 

S.D. 

N 

WEEK 8 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN FEED CONSUMPTION VALUES (GRAMS/KG/DAY). 

1 

0 

97 

5.3 

19 

81 

3.6 

19 

77 

3.7 

19 

73 

4.1 

20 

71 

3.9 

20 

67 

3.8 

19 

66 

4.5 

19 

65 

4.8 

20 

63 

3.8 

20 

2 

2000 

98 

8.0 

10 

83 

5.1 

10 

77 

6.9 

10 

75 

5.3 

10 

69 

3.5 

9 

64 

2.9 

10 

66 

4.5 

10 

64 

5.8 

10 

63 

4.6 

10 

3 

10000 

97 

4.4 

9 

78 

5.8 

9 

75 

5.0 

10 

71 

3.5 

10 

71 

3.9 

10 

64 

4.5 

10 

66 

3.1 

10 

65 

3 .3 

10 

64 

3.5 

10 

20

P
25-SEP-2003 12:23 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 6 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 9 MEAN 

S.D. 

N 

WEEK 10 MEAN 

S.D. 

N 

WEEK 11 MEAN 

S.D. 

N 

WEEK 12 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

1 

0 

63 

4.6 

20 

62 

3.6 

20 

58 

4.5 

20 

57 

3.8 

20 

2 

2000 

62 

5.0 

10 

63 

5.4 

10 

59 

4.5 

10 

61 

3.8 

10 

3 

10000 

63 

4.1 

10 

61 

4.5 

10 

58 

2.8 

10 

59 

3.1 

10 

20

P
25-SEP-2003 12:24 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

TABLE 6 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 13 MEAN 

S.D. 

N 

WEEK 14 MEAN 

S.D. 

N 

WEEK 15 MEAN 

S.D. 

N 

WEEK 16 MEAN 

S.D. 

N 

WEEK 17 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

1 

0 

56 

3.8 

10 

62 

7.5 

10 

58 

3.0 

10 

57 

2.7 

9 

59 

4.1 

10 

4 

20000 

56 

2.8 

10 

64 

13.0 

10 

62 

6.1 

9 

64 

9.8 

10 

60 

4.7 

10 

P
25-SEP-2003 12:25 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 6 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 MEAN 

S.D. 

N 

WEEK 1 MEAN 

S.D. 

N 

WEEK 2 MEAN 

S.D. 

N 

WEEK 3 MEAN 

S.D. 

N 

WEEK 4 MEAN 

S.D. 

N 

WEEK 5 MEAN 

S.D. 

N 

WEEK 6 MEAN 

S.D. 

N 

WEEK 7 MEAN 

S.D. 

N 

WEEK 8 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

1 

0 

98 

3.8 

5 

82 

3.2 

5 

73 

3.4 

5 

68 

3.3 

5 

63 

3.5 

5 

63 

3.2 

5 

60 

3.5 

5 

59 

3.3 

5 

53 

2.4 

5 

2 

2000 

97 

5.2 

5 

81 

4.4 

5 

74 

1.7 

4 

67 

2.2 

5 

62 

1.3 

5 

62 

1.5 

5 

58 

1.6 

5 

55 

1.7 

5 

52 

1.3 

5 

3 

10000 

96 

2.7 

5 

78 

5.7 

5 

73 

3.3 

5 

69 

2.6 

5 

64 

1.7 

5 

62 

2.5 

5 

58 

2.1 

5 

56 

3.0 

5 

52 

1.6 

5 

20

P
25-SEP-2003 12:25 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 6 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 9 MEAN 

S.D. 

N 

WEEK 10 MEAN 

S.D. 

N 

WEEK 11 MEAN 

S.D. 

N 

WEEK 12 MEAN 

S.D. 

N 

WEEK 13 MEAN 

S.D. 

N 

No statistically significant differences 

MEAN FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

1 

0 

53 

2.7 

5 

51 

1.1 

5 

49 

1.7 

5 

49 

2.0 

5 

46 

2.2 

5 

2 

2000 

52 

2.2 

5 

50 

1.8 

5 

49 

2.1 

5 

46 

4.8 

5 

44 

1.6 

5 

3 

10000 

52 

1.8 

5 

50 

2.0 

5 

50 

1.3 

5 

47 

0.6 

5 

44 

1.2 

5 

20

P
25-SEP-2003 12:26 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 6 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES MEAN FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 0 MEAN 

S.D. 

N 

WEEK 1 MEAN 

S.D. 

N 

WEEK 2 MEAN 

S.D. 

N 

WEEK 3 MEAN 

S.D. 

N 

WEEK 4 MEAN 

S.D. 

N 

WEEK 5 MEAN 

S.D. 

N 

WEEK 6 MEAN 

S.D. 

N 

WEEK 7 MEAN 

S.D. 

N 

WEEK 8 MEAN 

S.D. 

N 

Statistical key: * = p<0.05 ** = p<0.01 

1 

0 

98 

3.4 

5 

84 

3.5 

5 

79 

2.5 

5 

74 

4.0 

5 

68 

0.8 

5 

68 

3.4 

5 

64 

1.6 

5 

63 

2.8 

5 

58 

2.8 

5 

2 

2000 

97 

10.6 

5 

90 

8.4 

4 

84 

11.7 

5 

75 

4.0 

5 

68 

3.7 

5 

69 

3.6 

5 

66 

3.5 

5 

65 

2.8 

5 

59 

3.4 

5 

3 

10000 

96 

7.7 

5 

79 

5.8 

5 

74 

4.1 

4 

71 

3.5 

5 

68 

3.2 

5 

65 

2.6 

5 

65 

2.3 

4 

63 

1.1 

5 

59 

2.0 

5 

20

P
25-SEP-2003 12:26 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

TABLE 6 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES 

DOSE GROUP: 

DOSE LEVEL (MG/M3): 

WEEK 9 MEAN 

S.D. 

N 

WEEK 10 MEAN 

S.D. 

N 

WEEK 11 MEAN 

S.D. 

N 

WEEK 12 MEAN 

S.D. 

N 

WEEK 13 MEAN 

S.D. 

N 

Statistical key: * = p<0.05 

MEAN FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

1 

0 

60 

3.0 

5 

59 

3.0 

5 

58 

3.0 

5 

58 

1.8 

5 

51 

4.3 

5 

2 

2000 

61 

6.7 

5 

63 

2.5 

5 

61 

3.0 

5 

60 

3.2 

5 

52 

3.2 

5 

3 

10000 

59 

1.8 

5 

59 

2.5 

5 

57 

3.3 

5 

57 

3.7 

5 

52 

2.2 

5 

20

P
Huntingdon Life Sciences 00-6130 Page 127

211-DIPE-S Final Report

Summary of FOB and Motor Activity Analyses Table 7
Analysis of Data from Clean Air Act, Section 211, 

Huntingdon Life Sciences Study 00-6130 

Under a Contract with API 

This report details the statistical analysis of data from a series of behavioral observations using rats 

from Huntingdon Life Sciences Study 00-6130. There were 10 animals of each sex in each of four 

exposure groups (control, low, medium, and high exposure). 

The data were mailed to ExxonMobil Biomedical Sciences, Inc., by Huntingdon Life Sciences 

[Huntingdon Life Sciences, Inc., Mettlers Road, East Millstone, NJ 08875] on a data CD. The 

data were in Microsoft Excel® format and converted to a Statistical Analysis System (SAS) data 

base using a SAS program. The statistical analyses were done in SAS® version 8.02. The final 

report, computer output, and original data CD will be sent to Huntingdon Life Sciences, Inc. A 

copy of the final report will be sent to API [American Petroleum Institute, 1220 L St., NW, 

Washington, DC 20005-4070]. 

The behavioral observations were the Functional Observational Battery (FOB) and motor activity 

observations. The FOB consisted of 30 observations grouped in five areas (home cage, handling, 

open field, reflex, and other). The areas and variables are listed in Table I below. The FOB and 

motor activity data were collected on all animals prior to the start of the study and at 4th and 8th and 

13th weeks. 

Some of the FOB variables are measured on a continuous scale and some are nominal or count 

scale. The continuous data are printed in italics in Table I. The statistical analysis of the 

continuous FOB variables was by a mixed model analysis of covariance with a first order 

autoregressive error structure on the time points [Galecki, 1994, Pinheiro and Bates, 2002]. The 

pretest response was used as the covariate. The residuals from the model were tested for normality 

by the Shapiro-Wilk test. Those variables that did not exhibit normally distributed residuals at the 

0.01 level of significance were converted to a function of its percentile rank, then transformed by 

the inverse normal distribution (the transformation is known as Blom's transformation where the 

rank order is replaced by [rank-0. 375]/[n+0.25]), and reanalyzed [Blom, 1958]. 

The nominal and count data of the FOB were analyzed by a cumulative logit repeated measures 

analysis with contrast terms to test for differences between control and exposed groups [Agresti, 

1989]. For the measures that are count data (such as number ofrears or number of urinations), the 

count responses may be grouped into several data ranges to allow sufficient data in the cells. The 

statistical model partitions the variation of the response variable among the variables sex, exposure 

group, week number and their interactions. 

The motor activity experiment measured the number of beam breaks in an activity box during a 

five-minute interval. During a single session the experiment ran for 12 consecutive intervals (1 

hour total). Data were analyzed by a mixed model analysis of covariance with an unstructured 

error relationship among the five-minute periods, and a first order autoregressive error structure 

on weeks [Galecki, 1994, Pinheiro and Bates, 2002]. The pretest response was used as the 

covariate. The residuals from the model were tested for normality by the Kolmogorov-Smimov 

1 

Page 128
test. Those variables that did not exhibit normally distributed residuals at the 0.01 level of 

significance were converted to a function of its percentile rank, then transformed by the inverse 

normal distribution (the transformation is known as Blom's transformation where the rank order 

is replaced by [rank-0. 375]/[n+0.25]), and reanalyzed [Blom, 1958]. 

RESULTS: 

Table I 

Functional Observational Battery Areas and Measures 

(italics indicate a measure analyzed as a continuous variable) 

Home Cage Evaluations 

Posture 

Vocalization 

Palpebral closure 

Handling Evaluations 

Ease of removal 

Ease of handling 

Chromodacryorrhea 

Lacrimation 

Salivation 

Altered fur appearance 

Open Field Evaluations 

Gait and posture 

Locomotion 

Arousal level 

Exophthalmia 

Piloerection 

Defecation count 

Urination count 

Fasciculation 

Tremors 

Convulsions 

Reflex Assessments 

Response to visual stimuli 

Response to auditory stimuli 

Pain perception 

Pupillary response 

Sensitivity to light touch 

Proprioception 

Other 

Forelimb grip strength 

Hindlimb grip strength 

Air righting ability 

Landingfoot splay 

Body weight 

FOB Continuous 

None of the four continuous measures indicated statistically significant exposure related 

differences. The residuals from the forelimb grip strength, foot splay, and Blom transformed 

hindlimb grip strength were normally distributed. The residuals from body weight (both observed 

and Blom transformed data) and hindlimb grip strength (observed data) were not normally 

distributed. Because the significance levels for the observed and Blom transformed body weight 

were not near the 0.05 level of significance the deviation from normality was not considered crucial 

2 

Page 129
in these analyses. 

FOB Discrete 

For the 26 measures on a nominal or count scale only 6 measures showed any variation in response: 

posture, ease of removal, ease of handling, defecation count, urination count, and sensitivity to 

light touch. For these 6 measures none indicated statistically significant exposure related 

differences. For the remaining 20 variables all animals, or at most four responses (less than 1.5% 

of the observations), showed the same response in all groups at all time points and were not 

analyzed because of the lack of meaningful variation in response. 

Motor Activity 

The residuals from the motor activity data analysis and those from the Blom transformed data were 

not normally distributed as is required for the statistical analysis. A possible explanation for the 

non-normal distribution of the residuals is that approximately 27% of the observations are zero. It is 

difficult to have normally distributed residuals when a large percentage of the data have the same 

value. However, inspection of the residuals shows a reasonably symmetric distribution with 

slightly heavier tails than a normal distribution. Overall, these departures of the residuals from 

normality are not thought to effect the analysis conclusions. 

The results of the analyses indicated statistically significant differences in responses in exposure 

levels for both the original data and the Blom transformed data (p<0.002). 

Contrast analysis of the Blom transformed data showed that response from low and medium 

exposure groups were significantly different from the control group. Least squares means of the 

mean number of beam breaks across the three exposure groups are shown in Table II. The least 

squares means are the means accounting for initial activity (pre-test), sex, study week, replicates, 

and their interactions. There is no linear relationship between exposure levels and response, or any 

consistent change in activity related to exposure. The attached data plots do not suggest a 

consistent exposure related response, but show an increase in activity in the female control group 

and decrease in activity in the female mid exposure group only during study week 8 (there was not a 

statistically significant time by exposure effect). 

Table II. 

M ean B B earn re ak s ner In terva 1 

Exposure Least Squares Mean 

Groun (Breaks/interval) 

control 56.53 

low 46.23** 

medium 42.87** 

high 52.18 

**different from control p<O.Ol 

3 

Page 130
CONCLUSION: 

Based on these findings, administration of the test substance at the exposures tested is not 

associated with any change in counts of the 26 nominal FOB measures, or the 4 continuous FOB 

measures, or with consistent changes in motor activity. 

Mark 

~~__L/ J. Nicolich, ~' ~~-"" OC'-

Statistician 

ExxonMobil Biomedical Sciences, Inc 

1545 Route 22 East 

PO Box 971 

Annandale, NJ 08801-0971 

~--~ ~~ George Bukh~r, Ph.D. 

Consultant 

References: 

BLOM'S TRANSFORMATION 

r/?fftr 

July 24, 2009 

Blom, G., Statistical Estimates and Transformed Beta Variables, J. Wiley and Sons, NY, 1958. 

CUMULATIVE LOGIT 

Agresti, Alan, "A survey of models for repeated ordered categorical response data", Statistics in 

Medicine, vol8, 1989, pg 1209-1224. 

KOLMOGOROV -SMIRNOV TEST 

Stephens, M.A., 'EDF statistics for goodness of fit and some comparisons', Journal ofthe American 

Statistical Association, vol69, 1974, pg 730-737. 

MIXED MODEL ANALYSES 

Galecki, A.T., "General class of covariance structures for two or more repeated factors in 

longitudinal data analysis," Communications in Statistics-Theory and Methods, 23(11), 1994 pg 

3105 -3119. 

Pinheiro, J.C. and Bates, D.M., Mixed-Effects Models in S and S-PLUS, Springer-Verlag, NY, 

2002. 

SAS 

SAS/STAT, V8.02, copyright© 1999-2001, SAS Institute, Inc., Cary, NC. 

4 

Page 131
SHAPIRO-WILK TEST 

Shapiro, S.S. and Wilk, M.B., "An analysis of variance test for normality (complete samples)," 

Biometrika, 52, 1965, pg 591-611. 

5 

Page 132
225 

200 

ns c: 175 

Q) 

.... 

r::: 150 

-

.. f Q) \ c. 125 

tn 

ns 1oo 

Q) 

.... 

m 1s 

r::: 

ns 

Q) 50 

::?! 

25 

Pretest 

\ 

\ ... \ \ I . • -• -\ 

\

\1 ',\ :· "' . \ ,: ·. 

\ I ·. \ . . . . ,...., . I \ ··'=- ,·. '- /\ ,·. 

\ \· A (, 

Y, 

\o 

\ 

Motor Activitv Means 

Study 61!0 Sex= Female 

Week4 WeekS 

\ . 

\\ \ .... 

:. f-i. 

r. 

\ 1: I· 

\ 1: I• 

\

I'· 

I' 

\ 

1··. 

I• 

I • 

\ -· ....... ..... ' ·. \ ' ... . ' \.. "'. · .. 

0 '- '-.. i'·. .. 

_,..;><: .___../ ....... 

We

1 2 3 4 s 6 7 8 9 a 1 1 2 3 4 s 6 7 8 9 a 1 1 2 3 4 s 6 7 8 9 a 1 1 2 3 4 s 

Time Period 

Dose Group - 1 ---· 2 -- 3 ...... 4 
225 

- 2001 

cu c: 175 

(I) 

s:::: 150 

-

'-

8.125 

tJ) 

100 

(I) 

'-

m 75 

s:::: 

cu 

(I) 50 ::i 

Pretest 

\_ \. \ 

I I I I I I I I I I I I I 

1 2 3 4 5 6 7 8 9 1 1 1 0 1 2 

I 

I 

I 

I 

I 

Motor Activitv Means 

Study Sex=Male 

Week4 WeekS 

I •' 

I: 

I: 

I I' '\ 

\ \·. 

I\' I ' 

I ', 

I\', 

I : 

I: 

y, 

\:), 

v· 1 

•, I 

... 

\ \\ \ \-·. 

/ 

, .... \' 

''\.'· 

I I I I I I I I I I I I I I I I I I I I I I I I 

1 2 3 4 5 6 7 8 9 ! 1 2 3 4 5 6 7 8 9 1 1 1 0 1 2 

Time Period 

Dose Group --1 ---· 2 --3 ...... 4 

Week 

I I I 1- I I I 

1 2 3 4 5 6 
MALE 

Exposure 

Week Group 1 2 

0 c mean 116.20 143.60 

sd 85.30 37.27 

n 10 10 

L mean 119.80 172.20 

sd 89.14 46.06 

n 10 10 

M mean 136.70 140.10 

sd 67.30 79.16 

n 10 10 

H mean 120.90 142.60 

sd 92.68 68.96 

n 10 10 

4 c mean 193.60 167.40 

sd 32.12 46.75 

n 10 10 

L mean 186.00 144.90 

sd 39.89 48.78 

n 10 10 

M mean 158.00 168.40 

sd 92.75 31.25 

n 10 10 

H mean 167.00 179.40 

sd 72.81 32.98 

n 10 10 

8 c mean 159.10 121.70 

sd 28.92 65.69 

n 10 10 

8 L mean 150.80 119.90 

Study 00-6130 

Mean, sd, and Sample Size for Beam Breaks per Interval 

By Sex, Study Week, and Exposure Group 

Interval 

3 4 5 6 7 

149.30 127.90 109.40 105.50 82.70 

48.78 42.34 38.36 35.21 52.13 

10 10 10 10 10 

136.70 121.80 107.80 115.50 87.00 

42.97 59.72 53.76 52.85 55.21 

10 10 10 10 10 

107.20 119.10 111.80 73.00 56.80 

47.95 45.12 44.13. 53.95 62.41 

10 10 10 10 10 

126.80 121.60 102.60 87.70 51.60 

55.19 52.49 56.03 52.54 46.45 

10 10 10 10 10 

136.00 139.80 109.90 78.40 58.20 

42.37 46.41 62.49 57.02 56.33 

10 10 10 10 10 

111.30 86.40 85.40 72.00 46.20 

33.00 69.37 83.35 69.28 50.89 

10 10 10 10 10 

137.00 91.20 67.40 84.40 43.30 

38.53 47.70 53.60 85.90 65.18 

10 10 10 10 10 

127.40 108.70 72.90 62.40 43.70 

55.86 50.59 69.40 53.99 60.11 

10 10 10 10 10 

79.20 71.70 55.80 41.90 26.70 

55.27 51.84 59.66 54.02 48.32 

10 10 10 10 10 

55.70 43.00 25.50 23.00 19.00 

8 9 

69.40 57.90 39

55.51 55.69 44

10 10 10 

62.70 58.70 1

48.59 54.73 26

10 10 10 

43.60 17.60 1

50.64 38.00 1

10 10 10 

55.60 39.50 252.82 68.86 47

10 10 10 

56.60 37.00 36

61.99 54.44 55

10 10 10 

18.80 22.80 1

30.84 56.40 43

10 10 10 

31.70 18.40 1

57.68 29.99 34

10 10 1

21.40 26.50 7

37.09 41.30 1

10 10 1

15.30 1.20 1

23.09 2.82 22

10 10 1

1.20 7.60 1
Exposure Interval 

Week Group 1 2 3 4 5 6 7 8 9 

sd 54.26 54.59 40.94 38.21 41.09 45.58 21.96 1.48 14.18 15

n 10 10 10 10 10 10 10 10 10 10 

M mean 163.00 89.50 58.50 35.80 40.00 27.20 9.40 2.80 4.80 3.

sd 51.25 77.97 52.29 42.21 52.05 43.48 14.18 5.09 8.75 6.

n 10 10 10 10 10 10 10 10 10 10 

H mean 155.30 107.80 83.50 56.80 44.00 37.60 40.70 47.80 34.20 17

sd 60.74 45.84 42.04 49.96 42.62 48.13 43.80 75.81 56.91 34

n 10 10 10 10 10 10 10 10 10 10 

13 c mean 182.30 133.10 108.20 53.40 45.90 37.50 11.40 17.50 25.40 37

sd 56.86 44.10 31.55 40.36 31.40 49.49 10.73 33.04 49.15 44

n 10 10 10 10 10 10 10 10 10 10 

L mean 195.33 119.89 78.44 45.44 25.56 23.78 33.78 25.22 25.00 10

sd 29.17 30.59 60.78 47.55 20.99 27.01 59.14 38.91 47.86 28

n 9 9 9 9 9 9 9 9 9 9 

M mean 162.30 114.50 71.80 38.20 25.70 32.20 16.10 25.10 7.80 20

sd 61.02 57.63 49.13 49.36 39.07 38.84 28.46 41.72 13.34 44

n 10 10 10 10 10 10 10 10 10 10 

H mean 173.50 102.70 72.90 54.20 48.20 33.60 10.50 20.40 32.70 12

sd 41.93 22.83 39.83 49.40 59.48 43.47 15.31 33.73 46.02 30

n 10 10 10 10 10 10 10 10 10 10 
FEMALE 

Exposure Interval 

Week Group 1 2 3 4 5 6 7 8 9 

0 c mean 119.10 112.60 99.80 89.60 66.40 70.70 43.60 37.20 25.90 33

sd 39.82 26.68 35.18 53.12 49.16 55.59 44.85 50.04 33.39 57

n 10 10 10 10 10 10 10 10 10 10 

L mean 140.10 119.70 76.10 56.30 70.00 72.20 69.70 67.30 48.70 53

sd 30.58 35.45 49.21 45.67 58.99 61.28 64.57 56.81 43.92 54

n 10 10 10 10 10 10 10 10 10 10 

M mean 128.50 116.90 79.80 42.60 41.00 61.10 54.10 42.70 49.10 23

sd 40.88 40.98 39.19 34.37 56.79 59.69 64.38 46.33 60.33 44

n 10 10 10 10 10 10 10 10 10 10 

H mean 122.90 118.40 82.90 80.20 84.00 68.50 65.20 49.00 50.50 64

sd 52.82 32.27 40.84 37.58 40.90 35.15 46.88 45.91 53.30 70

n 10 10 10 10 10 10 10 10 10 10 

4 c mean 125.80 116.00 71.70 74.70 55.70 48.80 43.80 39.30 20.70 6.3

sd 32.78 35.74 34.55 57.24 49.25 42.31 51.13 50.19 27.07 15

n 10 10 10 10 10 10 10 10 10 10 

L mean 136.10 121.60 100.00 80.10 60.00 50.10 14.10 11.00 9.20 3.9

sd 25.77 17.81 38.96 49.25 49.30 64.21 28.73 22.30 25.97 10

n 10 10 10 10 10 10 10 10 10 10 

M mean 135.90 119.90 78.90 62.10 24.20 32.60 27.10 16.40 1.50 0.3

sd 24.58 53.95 53.42 56.04 36.86 32.22 47.21 33.19 2.46 0.6

n 10 10 10 10 10 10 10 10 10 10 

H mean 127.30 120.00 113.40 63.60 62.70 61.80 54.60 39.60 48.10 45

sd 50.50 40.14 29.66 45.49 44.06 55.43 55.11 45.60 54.37 61

n 10 10 10 10 10 10 10 10 10 10 

8 c mean 133.90 112.30 88.20 72.20 52.50 48.80 24.50 14.10 12.60 8.4

sd 38.23 46.23 52.20 41.22 42.24 48.09 36.92 22.97 24.53 25

n 10 10 10 10 10 10 10 10 10 10 

L mean 123.50 73.50 72.60 29.90 30.30 17.90 12.10 19.30 8.70 8.7

sd 31.87 36.90 29.60 34.09 41.05 32.07 26.31 43.18 24.20 27

n 10 10 10 10 10 10 10 10 10 10 
Exposure Interval 

Week Group 1 2 3 4 5 6 7 8 9 

8 M mean 123.90 67.20 46.70 9.10 3.70 0.10 0.00 1.30 10.50 9.1

sd 42.37 30.87 52.80 16.41 7.59 0.32 0.00 1.83 28.02 14

n 10 10 10 10 10 10 10 10 10 10 

H mean 136.30 104.30 75.30 40.20 25.80 29.90 19.70 12.10 8.60 6.0

sd 45.98 45.77 51.03 38.61 35.25 39.27 33.30 33.41 27.20 18

n 10 10 10 10 10 10 10 10 10 10 

13 c mean 137.50 103.50 89.50 65.10 38.60 22.60 14.50 14.00 11.90 18

sd 42.06 38.78 41.92 47.90 46.39 29.35 22.92 27.43 14.67 36

n 10 10 10 10 10 10 10 10 10 10 

L mean 140.00 68.30 53.10 23.80 14.30 7.20 23.90 23.00 23.40 34

sd 30.94 17.61 41.96 27.13 35.13 13.28 51.45 42.11 45.77 52

n 10 10 10 10 10 10 10 10 10 10 

M mean 128.80 87.40 53.00 48.60 15.60 23.40 13.50 11.50 7.70 14

sd 40.87 37.54 52.04 54.70 19.60 46.71 31.76 23.70 11.42 28

n 10 10 10 10 10 10 10 10 10 10 

H mean 148.10 96.20 70.80 43.30 42.00 19.70 4.40 9.60 23.30 2.4

sd 35.19 35.55 52.40 49.52 32.00 33.43 7.47 20.05 51.06 5.9

n 10 Hl 10 10 10 - 10 ..... 10 10 10 ---- 10 
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Males

Mean Motor Activity Valuesa

Pretest Table 8

a

Number of beam breaks per interval

Interval

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

Group I - 0 mg/m3

Mean 116.2 143.6 149.3 127.9 109.4 105.5 82.7 69.4 57.9 39.7 21.0 23.0

SD 85.30 37.27 48.78 42.34 38.36 35.21 52.13 55.51 55.69 44.88 45.69 42.26

N 10 10 10 10 10 10 10 10 10 10 10 10

Group II - 2000 mg/m3

Mean 119.8 172.2 136.7 121.8 107.8 115.5 87.0 62.7 58.7 16.0 15.3 9.3

SD 89.14 46.06 42.97 59.72 53.76 52.85 55.21 48.59 54.73 26.68 31.90 22.08

N 10 10 10 10 10 10 10 10 10 10 10 10

Group III - 10000 mg/m3

Mean 136.7 140.1 107.2 119.1 111.8 73.0 56.8 43.6 17.6 10.3 4.5 3.2

SD 67.30 79.16 47.95 45.12 44.13 53.95 62.41 50.64 38.00 18.19 13.19 7.74

N 10 10 10 10 10 10 10 10 10 10 10 10

Group IV - 20000 mg/m3

Mean 120.9 142.6 126.8 121.6 102.6 87.7 51.6 55.6 39.5 21.8 5.9 1.5

SD 92.68 68.96 55.19 52.49 56.03 52.54 46.45 52.82 68.86 47.55 12.62 2.46

N 10 10 10 10 10 10 10 10 10 10 10 10
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Females

Mean Motor Activity Valuesa

Pretest Table 8

a

Number of beam breaks per interval

Interval

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

Group I - 0 mg/m3

Mean 119.1 112.6 99.8 89.6 66.4 70.7 43.6 37.2 25.9 33.8 17.5 13.9

SD 39.82 26.68 35.18 53.12 49.16 55.59 44.85 50.04 33.39 57.64 38.87 30.05

N 10 10 10 10 10 10 10 10 10 10 10 10

Group II - 2000 mg/m3

Mean 140.1 119.7 76.1 56.3 70.0 72.2 69.7 67.3 48.7 53.8 41.9 23.4

SD 30.58 35.45 49.21 45.67 58.99 61.28 64.57 56.81 43.92 54.25 60.63 31.85

N 10 10 10 10 10 10 10 10 10 10 10 10

Group III - 10000 mg/m3

Mean 128.5 116.9 79.8 42.6 41.0 61.1 54.1 42.7 49.1 23.9 16.3 12.6

SD 40.88 40.98 39.19 34.37 56.79 59.69 64.38 46.33 60.33 44.17 33.57 26.31

N 10 10 10 10 10 10 10 10 10 10 10 10

Group IV - 20000 mg/m3

Mean 122.9 118.4 82.9 80.2 84.0 68.5 65.2 49.0 50.5 64.8 44.6 25.8

SD 52.82 32.27 40.84 37.58 40.90 35.15 46.88 45.91 53.30 70.02 43.64 29.78

N 10 10 10 10 10 10 10 10 10 10 10 10
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Males

Mean Motor Activity Valuesa

4th week of exposure Table 8

a

Number of beam breaks per interval

Interval

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

Group I - 0 mg/m3 

Mean 193.6 167.4 136.0 139.8 109.9 78.4 58.2 56.6 37.0 36.9 27.6 1.3

SD 32.12 46.75 42.37 46.41 62.49 57.02 56.33 61.99 54.44 55.63 42.38 2.06

N 10 10 10 10 10 10 10 10 10 10 10 10

Group II - 2000 mg/m3

Mean 186.0 144.9 111.3 86.4 85.4 72.0 46.2 18.8 22.8 16.5 21.3 15.9

SD 39.89 48.78 33.00 69.37 83.35 69.28 50.89 30.84 56.40 43.18 56.63 44.04

N 10 10 10 10 10 10 10 10 10 10 10 10

Group III - 10000 mg/m3

Mean 158.0 168.4 137.0 91.2 67.4 84.4 43.3 31.7 18.4 13.6 2.4 3.9

SD 92.75 31.25 38.53 47.70 53.60 85.90 65.18 57.68 29.99 34.56 4.06 8.27

N 10 10 10 10 10 10 10 10 10 10 10 10

Group IV - 20000 mg/m3

Mean 167.0 179.4 127.4 108.7 72.9 62.4 43.7 21.4 26.5 7.1 10.8 0.8

SD 72.81 32.98 55.86 50.59 69.40 53.99 60.11 37.09 41.30 11.42 18.69 1.40

N 10 10 10 10 10 10 10 10 10 10 10 10
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Females

Mean Motor Activity Valuesa

4th week of exposure Table 8

a

Number of beam breaks per interval

Interval

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

Group I - 0 mg/m3

Mean 125.8 116.0 71.7 74.7 55.7 48.8 43.8 39.3 20.7 6.3 4.4 0.5

SD 32.78 35.74 34.55 57.24 49.25 42.31 51.13 50.19 27.07 15.83 9.29 1.27

N 10 10 10 10 10 10 10 10 10 10 10 10

Group II - 2000 mg/m3

Mean 133.9 120.7 95.4 79.4 56.9 53.7 17.3 12.1 10.1 3.9 5.4 2.1

SD 25.00 18.61 37.31 48.27 45.89 66.66 30.92 22.62 25.77 10.69 16.73 4.20

N 10 10 10 10 10 10 10 10 10 10 10 10

Group III - 10000 mg/m3

Mean 135.9 119.9 78.9 62.1 24.2 32.6 27.1 16.4 1.5 0.3 0.7 2.6

SD 24.58 53.95 53.42 56.04 36.86 32.22 47.21 33.19 2.46 0.67 1.64 8.22

N 10 10 10 10 10 10 10 10 10 10 10 10

Group IV - 20000 mg/m3

Mean 127.3 120.0 113.4 63.6 62.7 61.8 54.6 39.6 48.1 45.6 23.6 18.3

SD 50.50 40.14 29.66 45.49 44.06 55.43 55.11 45.60 54.37 61.18 39.57 32.16

N 10 10 10 10 10 10 10 10 10 10 10 10
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Males

Mean Motor Activity Valuesa

8th week of exposure Table 8

a

Number of beam breaks per interval

Interval

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

Group I - 0 mg/m3

Mean 159.1 121.7 79.2 71.7 55.8 41.9 26.7 15.3 1.2 11.5 20.5 19.9

SD 28.92 65.69 55.27 51.84 59.66 54.02 48.32 23.09 2.82 22.31 54.39 44.76

N 10 10 10 10 10 10 10 10 10 10 10 10

Group II - 2000 mg/m3

Mean 150.8 119.9 55.7 43.0 25.5 23.0 19.0 1.2 7.6 10.9 20.9 20.7

SD 54.26 54.59 40.94 38.21 41.09 45.58 21.96 1.48 14.18 15.31 39.61 40.82

N 10 10 10 10 10 10 10 10 10 10 10 10

Group III - 10000 mg/m3

Mean 167.0 99.2 57.3 33.3 55.8 32.8 13.3 2.9 7.6 1.4 1.8 2.8

SD 56.84 89.93 51.85 38.35 62.50 43.48 16.48 5.04 11.19 2.07 3.46 2.49

N 10 10 10 10 10 10 10 10 10 10 10 10

Group IV - 20000 mg/m3

Mean 155.3 107.8 83.5 56.8 44.0 37.6 40.7 47.8 34.2 17.9 18.1 11.7

SD 60.74 45.84 42.04 49.96 42.62 48.13 43.80 75.81 56.91 34.83 41.87 20.27

N 10 10 10 10 10 10 10 10 10 10 10 10
Huntingdon Life Sciences 00-6130 Page 144

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Females

Mean Motor Activity Valuesa

8th week of exposure Table 8

a

Number of beam breaks per interval

Interval

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

Group I - 0 mg/m3

Mean 133.9 112.3 88.2 72.2 52.5 48.8 24.5 14.1 12.6 8.4 6.0 9.2

SD 38.23 46.23 52.20 41.22 42.24 48.09 36.92 22.97 24.53 25.52 12.66 24.96

N 10 10 10 10 10 10 10 10 10 10 10 10

Group II - 2000 mg/m3

Mean 123.5 73.5 72.6 29.9 30.3 17.9 12.1 19.3 8.7 8.7 4.9 4.4

SD 31.87 36.90 29.60 34.09 41.05 32.07 26.31 43.18 24.20 27.51 9.89 11.88

N 10 10 10 10 10 10 10 10 10 10 10 10

Group III - 10000 mg/m3

Mean 123.9 67.2 46.7 9.1 3.7 0.1 0.0 1.3 10.5 9.1 2.3 5.3

SD 42.37 30.87 52.80 16.41 7.59 0.32 0.00 1.83 28.02 14.11 3.95 14.74

N 10 10 10 10 10 10 10 10 10 10 10 10

Group IV - 20000 mg/m3

Mean 136.3 104.3 75.3 40.2 25.8 29.9 19.7 12.1 8.6 6.0 7.0 3.6

SD 45.98 45.77 51.03 38.61 35.25 39.27 33.30 33.41 27.20 18.62 12.17 8.59

N 10 10 10 10 10 10 10 10 10 10 10 10
Huntingdon Life Sciences 00-6130 Page 145

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Males

Mean Motor Activity Valuesa

13th week of exposure Table 8

a

Number of beam breaks per interval

b

Animal 2070 sacrificed for humane reason. 

Interval

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

Group I - 0 mg/m3

Mean 182.3 133.1 108.2 53.4 45.9 37.5 11.4 17.5 25.4 37.3 33.6 9.6

SD 56.86 44.10 31.55 40.36 31.40 49.49 10.73 33.04 49.15 44.09 43.01 16.83

N 10 10 10 10 10 10 10 10 10 10 10 10

Group II - 2000 mg/m3

Mean 195.3 119.9 78.4 45.4 25.6 23.8 33.8 25.2 25.0 10.6 4.8 18.3

SD 29.17 30.59 60.78 47.55 20.99 27.01 59.14 38.91 47.86 28.32 6.67 46.85

N 9b 9 9 9 9 9 9 9 9 9 9 9 

Group III - 10000 mg/m3

Mean 162.3 114.5 71.8 38.2 25.7 32.2 16.1 25.1 7.8 20.1 20.9 6.3

SD 61.02 57.63 49.13 49.36 39.07 38.84 28.46 41.72 13.34 44.91 37.80 7.85

N 10 10 10 10 10 10 10 10 10 10 10 10

Group IV - 20000 mg/m3

Mean 173.5 102.7 72.9 54.2 48.2 33.6 10.5 20.4 32.7 12.7 4.8 1.2

SD 41.93 22.83 39.83 49.40 59.48 43.47 15.31 33.73 46.02 30.42 10.28 2.10

N 10 10 10 10 10 10 10 10 10 10 10 10
Huntingdon Life Sciences 00-6130 Page 146

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Females

Mean Motor Activity Valuesa

13th week of exposure Table 8

Interval

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

Group I - 0 mg/m3

Mean 137.5 103.5 89.5 65.1 38.6 22.6 14.5 14.0 11.9 18.3 15.1 4.1

SD 42.06 38.78 41.92 47.90 46.39 29.35 22.92 27.43 14.67 36.03 22.20 8.36

N 10 10 10 10 10 10 10 10 10 10 10 10

Group II - 2000 mg/m3

Mean 140.0 68.3 53.1 23.8 14.3 7.2 23.9 23.0 23.4 34.0 22.5 7.2

SD 30.94 17.61 41.96 27.13 35.13 13.28 51.45 42.11 45.77 52.73 39.83 20.02

N 10 10 10 10 10 10 10 10 10 10 10 10

Group III - 10000 mg/m3

Mean 128.8 87.4 53.0 48.6 15.6 23.4 13.5 11.5 7.7 14.1 15.8 4.0

SD 40.87 37.54 52.04 54.70 19.60 46.71 31.76 23.70 11.42 28.71 41.27 8.63

N 10 10 10 10 10 10 10 10 10 10 10 10

Group IV - 20000 mg/m3

Mean 148.1 96.2 70.8 43.3 42.0 19.7 4.4 9.6 23.3 2.4 1.7 2.7

SD 35.19 35.55 52.40 49.52 32.00 33.43 7.47 20.05 51.06 5.93 4.69 4.45

N 10 10 10 10 10 10 10 10 10 10 10 10
Huntingdon Life Sciences 00-6130 Page 147

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Males

Summary of Functional Observational 

Battery Evaluations

Pretest Table 9

*Significantly different from control mean; p≤0.05.

**Significantly different from control mean; p≤0.01.

If no asterisks, no statistically significant differences from control mean.

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Body Weight (grams) Mean 256.8 256.5 254.3 260.8

S.D. 17.0 23.0 19.3 23.2

N 10 10 10 10

Forelimb Grip Strength (grams of force)

Mean 878.3 950.0 878.0 967.3

S.D. 116.8 128.0 84.9 105.7

N 10 10 10 10

Hindlimb Grip Strength (grams of force)

Mean 585.0 593.8 548.0 612.5

S.D. 114.9 143.4 100.4 134.5

N 10 10 10 10

Landing Foot Splay (centimeters)

Mean 6.2 6.2 6.3 6.9

S.D. 1.4 1.4 1.0 1.0

N 10 10 10 10
Huntingdon Life Sciences 00-6130 Page 148

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Males

Summary of Functional Observational 

Battery Evaluations

Pretest Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals 

Examined 

10 10 10 10 

Home Cage Evaluations

Posture Sitting or Standing Normally 9 10 10 10

Alert, Oriented Toward Observer 1 0 0 0 

Asleep 0 0 0 0

Lying on Side 0 0 0 0

Flattened 0 0 0 0

Crouched 0 0 0 0

Vocalizations Not Present 10 10 10 10

Present 0 0 0 0

Palpebral Closure Eyelids Open 10 10 10 10

Eyelids Completely Closed 0 0 0 0 

Eyelids Slightly Drooping 0 0 0 0

Eyelids Half Closed 0 0 0 0

Handling Evaluations

Ease of Removal Very Easy 10 9 10 8

Easy 0 1 0 2 

Moderately Difficult 0 0 0 0

Freezes 0 0 0 0

Difficult 0 0 0 0

Ease of Handling Very easy; totally limp 2 3 2 3

Normal 8 7 8 7 

Moderately Difficult 0 0 0 0

Freezes 0 0 0 0

Difficult 0 0 0 0

Chromodacryorrhea Not Present 10 10 10 10

Present 0 0 0 0 

Lacrimation No lacrimation 10 10 10 10

Some lacrimation 0 0 0 0

Extreme lacrimation 0 0 0 0

Salivation Not Present 10 10 10 10

Slight 0 0 0 0 

Moderate 0 0 0 0

Extreme 0 0 0 0

Coat Normal 10 10 10 10

Slightly Soiled 0 0 0 0

Moderately Soiled 0 0 0 0 

Extremely Soiled 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 149

211-DIPE-S Final Report

Males

Summary of Functional Observational 

Battery Evaluations

Pretest Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals 

Examined 

10 10 10 10 

Open Field Evaluations

Gait Normal 10 10 10 10

Ataxia 0 0 0 0 

Body Drags 0 0 0 0

Limbs splayed or dragging 0 0 0 0

Hunched posture 0 0 0 0

Locomotion Normal 10 10 10 10 

Increased movement 0 0 0 0

Decreased movement 0 0 0 0

None 0 0 0 0

Arousal Normal 10 10 10 10 

Low, Slight Stupor 0 0 0 0

Very Low, Stupor 0 0 0 0

High, Slight Excitement, Tense 0 0 0 0

Very High, Hyper-Alert 0 0 0 0

Exophthalmia Not Present 10 10 10 10

Present 0 0 0 0

Piloerection Not Present 10 10 10 10

Present 0 0 0 0 

Feces Number of pellets 9 3 6 10

Unformed Stool 0 0 0 0

Urine Number of Pools 3 4 17 8 

Polyuria 0 0 0 0

Fasciculation Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0 

Tremors Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0

Convulsions Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 150

211-DIPE-S Final Report

Males

Summary of Functional Observational 

Battery Evaluations

Pretest Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals 

Examined 

10 10 10 10 

Reflex Assessments

Visual Approach Normal, slowly approaches 10 10 10 10

No Reaction 0 0 0 0 

Freezes or pulls away slightly 0 0 0 0

Jumps or Turns Abruptly to Avoid, or 

attacks and/or bites

0 0 0 0

Audition Assessment Normal 10 10 10 10

No Reaction 0 0 0 0

Exaggerated, Jumps, Flips, Bite 0 0 0 0

Pain Perception Normal 10 10 10 10 

No Reaction 0 0 0 0

Increased Pain 0 0 0 0

Pupil Response Pupil Constricts Normally 10 10 10 10 

Pupil Size does not Change 0 0 0 0 

Miosis 0 0 0 0

Mydriasis 0 0 0 0

Proprioception Returns leg to original position 10 10 10 10 

Returns leg only partially to original 

position 

0 0 0 0 

No response 0 0 0 0

Pinna Reflex Ear flattens against head 0 0 0 0 

Animals shakes head 10 10 10 10

No response 0 0 0 0

Air Righting Reflex Lands on All Four Feet (Normal) 10 10 10 10 

Slightly Uncoordinated 0 0 0 0 

Lands on Side 0 0 0 0

Lands on Back 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 151

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Females

Summary of Functional Observational 

Battery Evaluations

Pretest Table 9

*Significantly different from control mean; p≤0.05.

**Significantly different from control mean; p≤0.01.

If no asterisks, no statistically significant differences from control mean.

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Body Weight (grams) Mean 197.0 194.6 195.5 195.1

S.D. 10.2 8.5 13.3 11.1

N 10 10 10 10

Forelimb Grip Strength (grams of force)

Mean 884.5 920.3 898.0 894.5

S.D. 108.8 136.1 84.7 129.8

N 10 10 10 10

Hindlimb Grip Strength (grams of force)

Mean 661.3 596.5 583.0 625.3

S.D. 94.5 73.7 108.3 88.5

N 10 10 10 10

Landing Foot Splay (centimeters)

Mean 4.9 5.2 5.1 5.3

S.D. 0.7 0.6 1.2 1.2

N 10 10 10 10
Huntingdon Life Sciences 00-6130 Page 152

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Females

Summary of Functional Observational 

Battery Evaluations

Pretest Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10 

Home Cage Evaluations 

Posture Sitting or Standing Normally 9 8 9 10

Alert, Oriented Toward Observer 1 2 1 0

Asleep 0 0 0 0

Lying on Side 0 0 0 0 

Flattened 0 0 0 0

Crouched 0 0 0 0

Vocalizations Not Present 10 10 10 10

Present 0 0 0 0 

Palpebral Closure Eyelids Open 10 10 10 10

Eyelids Completely Closed 0 0 0 0

Eyelids Slightly Drooping 0 0 0 0

Eyelids Half Closed 0 0 0 0 

Handling Evaluations

Ease of Removal Very Easy 10 10 10 10

Easy 0 0 0 0

Moderately Difficult 0 0 0 0 

Freezes 0 0 0 0

Difficult 0 0 0 0

Ease of Handling Very easy; totally limp 3 2 3 2

Normal 7 8 7 8 

Moderately Difficult 0 0 0 0

Freezes 0 0 0 0

Difficult 0 0 0 0

Chromodacryorrhea Not Present 10 10 10 10

Present 0 0 0 0 

Lacrimation No lacrimation 10 10 10 10

Some lacrimation 0 0 0 0

Extreme lacrimation 0 0 0 0

Salivation Not Present 10 10 10 10 

Slight 0 0 0 0

Moderate 0 0 0 0

Extreme 0 0 0 0

Coat Normal 10 10 10 10

Slightly Soiled 0 0 0 0 

Moderately Soiled 0 0 0 0

Extremely Soiled 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 153

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

Pretest Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10 

Open Field Evaluations

Gait Normal 10 10 10 10

Ataxia 0 0 0 0

Body Drags 0 0 0 0

Limbs splayed or dragging 0 0 0 0 

Hunched posture 0 0 0 0

Locomotion Normal 10 10 10 10

Increased movement 0 0 0 0

Decreased movement 0 0 0 0 

None 0 0 0 0

Arousal Normal 10 10 10 10

Low, Slight Stupor 0 0 0 0

Very Low, Stupor 0 0 0 0 

High, Slight Excitement, Tense 0 0 0 0

Very High, Hyper-Alert 0 0 0 0

Exophthalmia Not Present 10 10 10 10

Present 0 0 0 0 

Piloerection Not Present 10 10 10 10

Present 0 0 0 0

Feces Number of pellets 1 0 0 1 

Unformed Stool 0 0 0 0

Urine Number of Pools 3 0 7 2

Polyuria 0 0 0 0

Fasciculation Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0

Tremors Not Present 10 10 10 10 

Slight 0 0 0 0

Extreme 0 0 0 0

Convulsions Not Present 10 10 10 10

Slight 0 0 0 0 

Extreme 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 154

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

Pretest Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10 

Reflex Assessments 

Visual Approach Normal, slowly approaches 10 10 10 10

No Reaction 0 0 0 0

Freezes or pulls away slightly 0 0 0 0

Jumps or Turns Abruptly to Avoid, 

or attacks and/or bites 

0 0 0 0 

Audition Assessment Normal 10 10 10 10

No Reaction 0 0 0 0 

Exaggerated, Jumps, Flips, Bite 0 0 0 0

Pain Perception Normal 10 10 10 10

No Reaction 0 0 0 0

Increased Pain 0 0 0 0 

Pupil Response Pupil Constricts Normally 10 10 10 10

Pupil Size does not Change 0 0 0 0

Miosis 0 0 0 0

Mydriasis 0 0 0 0 

Proprioception Returns leg to original position 10 10 10 10

Returns leg only partially to original 

position

0 0 0 0

No response 0 0 0 0

Pinna Reflex Ear flattens against head 0 0 0 1

Animals shakes head 10 10 10 9 

No response 0 0 0 0 

Air Righting Reflex Lands on All Four Feet (Normal) 10 10 10 10

Slightly Uncoordinated 0 0 0 0

Lands on Side 0 0 0 0 

Lands on Back 0 0 0 0 
Huntingdon Life Sciences 00-6130 Page 155

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Males

Summary of Functional Observational 

Battery Evaluations

4th week of exposure Table 9

*Significantly different from control mean; p≤0.05.

**Significantly different from control mean; p≤0.01.

If no asterisks, no statistically significant differences from control mean.

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Body Weight (grams) Mean 397.1 396.3 410.1 405.5

S.D. 33.3 37.0 30.0 23.1

N 10 10 10 10

Forelimb Grip Strength (grams of force)

Mean 1270.3 1327.3 1328.0 1327.5

S.D. 139.0 139.1 218.0 137.5

N 10 10 10 10

Hindlimb Grip Strength (grams of force)

Mean 834.5 780.8 848.8 883.8

S.D. 126.7 181.3 273.2 206.9

N 10 10 10 10

Landing Foot Splay (centimeters)

Mean 7.1 6.5 6.4 7.0

S.D. 1.7 0.9 1.4 1.8

N 10 10 10 10
Huntingdon Life Sciences 00-6130 Page 156

211-DIPE-S Final Report

Males

Summary of Functional Observational 

Battery Evaluations

4th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10

Home Cage Evaluations

Posture Sitting or Standing Normally 9 9 8 9

Alert, Oriented Toward Observer 1 1 2 1 

Asleep 0 0 0 0

Lying on Side 0 0 0 0

Flattened 0 0 0 0

Crouched 0 0 0 0

Vocalizations Not Present 10 10 10 10

Present 0 0 0 0

Palpebral Closure Eyelids Open 10 10 10 10

Eyelids Completely Closed 0 0 0 0 

Eyelids Slightly Drooping 0 0 0 0

Eyelids Half Closed 0 0 0 0

Handling Evaluations

Ease of Removal Very Easy 10 10 7 10 

Easy 0 0 3 0

Moderately Difficult 0 0 0 0

Freezes 0 0 0 0

Difficult 0 0 0 0

Ease of Handling Very easy; totally limp 0 0 0 0

Normal 10 10 10 10

Moderately Difficult 0 0 0 0

Freezes 0 0 0 0

Difficult 0 0 0 0 

Chromodacryorrhea Not Present 10 10 10 10

Present 0 0 0 0

Lacrimation No lacrimation 10 10 10 10 

Some lacrimation 0 0 0 0

Extreme lacrimation 0 0 0 0

Salivation Not Present 10 10 10 10

Slight 0 0 0 0 

Moderate 0 0 0 0

Extreme 0 0 0 0

Coat Normal 10 10 10 10

Slightly Soiled 0 0 0 0 

Moderately Soiled 0 0 0 0

Extremely Soiled 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 157

211-DIPE-S Final Report

Males

Summary of Functional Observational 

Battery Evaluations

4th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10

Open Field Evaluations

Gait Normal 10 10 10 10

Ataxia 0 0 0 0 

Body Drags 0 0 0 0

Limbs splayed or dragging 0 0 0 0

Hunched posture 0 0 0 0

Locomotion Normal 10 10 10 10 

Increased movement 0 0 0 0

Decreased movement 0 0 0 0

None 0 0 0 0

Arousal Normal 10 10 10 10 

Low, Slight Stupor 0 0 0 0

Very Low, Stupor 0 0 0 0

High, Slight Excitement, Tense 0 0 0 0

Very High, Hyper-Alert 0 0 0 0

Exophthalmia Not Present 10 10 10 10

Present 0 0 0 0

Piloerection Not Present 10 10 10 10

Present 0 0 0 0 

Feces Number of pellets 10 5 25 14

Unformed Stool 0 0 0 0

Urine Number of Pools 12 18 9 8 

Polyuria 0 0 0 0

Fasciculation Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0 

Tremors Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0

Convulsions Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 158

211-DIPE-S Final Report

Males

Summary of Functional Observational 

Battery Evaluations

4th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10

Reflex Assessments

Visual Approach Normal, slowly approaches 9 10 10 10

No Reaction 1 0 0 0 

Freezes or pulls away slightly 0 0 0 0

Jumps or Turns Abruptly to Avoid, or 

attacks and/or bites

0 0 0 0

Audition Assessment Normal 10 10 10 10

No Reaction 0 0 0 0

Exaggerated, Jumps, Flips, Bite 0 0 0 0

Pain Perception Normal 10 10 10 10 

No Reaction 0 0 0 0

Increased Pain 0 0 0 0

Pupil Response Pupil Constricts Normally 10 10 10 10

Pupil Size does not Change 0 0 0 0 

Miosis (bilateral) 0 0 0 0

Mydriasis 0 0 0 0

Proprioception Returns leg to original position 10 10 10 10

Returns leg only partially to original 

position 

0 0 0 0 

No response 0 0 0 0

Pinna Reflex Ear flattens against head 0 1 0 0 

Animals shakes head 10 9 10 10

No response 0 0 0 0

Air Righting Reflex Lands on All Four Feet (Normal) 10 10 10 10 

Slightly Uncoordinated 0 0 0 0 

Lands on Side 0 0 0 0

Lands on Back 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 159

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

4th week of exposure Table 9

*Significantly different from control mean; p≤0.05.

**Significantly different from control mean; p≤0.01.

If no asterisks, no statistically significant differences from control mean.

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Body Weight (grams) Mean 271.5 262.3 254.4 253.3

S.D. 19.4 22.8 26.3 13.1

N 10 10 10 10

Forelimb Grip Strength (grams of force)

Mean 1179.0 1171.5 1172.8 1184.0

S.D. 74.1 107.9 196.8 106.4

N 10 10 10 10

Hindlimb Grip Strength (grams of force)

Mean 787.3 767.0 783.8 712.0

S.D. 128.9 141.9 104.8 112.3

N 10 10 10 10

Landing Foot Splay (centimeters)

Mean 5.4 5.2 5.5 6.0

S.D. 0.8 0.8 1.2 1.2

N 10 10 10 10
Huntingdon Life Sciences 00-6130 Page 160

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

4th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10

Home Cage Evaluations

Posture Sitting or Standing Normally 7 6 6 5

Alert, Oriented Toward Observer 2 3 4 5 

Asleep 1 1 0 0

Lying on Side 0 0 0 0

Flattened 0 0 0 0

Crouched 0 0 0 0

Vocalizations Not Present 10 10 10 10

Present 0 0 0 0

Palpebral Closure Eyelids Open 9 9 10 10

Eyelids Completely Closed 1 1 0 0 

Eyelids Slightly Drooping 0 0 0 0

Eyelids Half Closed 0 0 0 0

Handling Evaluations

Ease of Removal Very Easy 10 10 10 9 

Easy 0 0 0 1

Moderately Difficult 0 0 0 0

Freezes 0 0 0 0

Difficult 0 0 0 0

Ease of Handling Normal 0 1 2 0

Moderately Difficult 10 9 8 10

Freezes 0 0 0 0

Difficult 0 0 0 0

Totally limp 0 0 0 0 

Chromodacryorrhea Not Present 10 10 10 10

Present 0 0 0 0

Lacrimation No lacrimation 10 10 10 10 

Some lacrimation 0 0 0 0

Extreme lacrimation 0 0 0 0

Salivation Not Present 10 10 10 10

Slight 0 0 0 0 

Moderate 0 0 0 0

Extreme 0 0 0 0

Coat Normal 10 10 10 10

Slightly Soiled 0 0 0 0 

Moderately Soiled 0 0 0 0

Extremely Soiled 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 161

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

4th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10

Open Field Evaluations

Gait Normal 10 10 10 10

Ataxia 0 0 0 0 

Body Drags 0 0 0 0

Limbs splayed or dragging 0 0 0 0

Hunched posture 0 0 0 0

Locomotion Normal 10 10 10 10 

Increased movement 0 0 0 0

Decreased movement 0 0 0 0

None 0 0 0 0

Arousal Normal 10 10 10 10 

Low, Slight Stupor 0 0 0 0

Very Low, Stupor 0 0 0 0

High, Slight Excitement, Tense 0 0 0 0

Very High, Hyper-Alert 0 0 0 0

Exophthalmia Not Present 10 10 10 10

Present 0 0 0 0

Piloerection Not Present 10 10 10 10

Present 0 0 0 0 

Feces Number of pellets 4 0 1 0

Unformed Stool 0 0 0 0

Urine Number of Pools 2 0 3 0 

Polyuria 0 0 0 0

Fasciculation Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0 

Tremors Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0

Convulsions Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 162

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

4th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10

Reflex Assessments

Visual Approach Normal, slowly approaches 10 10 10 10

No Reaction 0 0 0 0 

Freezes or pulls away slightly 0 0 0 0

Jumps or Turns Abruptly to Avoid, 

or attacks and/or bites

0 0 0 0

Audition Assessment Normal 10 10 10 10

No Reaction 0 0 0 0

Exaggerated, Jumps, Flips, Bite 0 0 0 0

Pain Perception Normal 10 10 10 10 

No Reaction 0 0 0 0

Increased Pain 0 0 0 0

Pupil Response Pupil Constricts Normally 10 10 10 10

Pupil Size does not Change 0 0 0 0 

Miosis (bilateral) 0 0 0 0

Mydriasis 0 0 0 0

Proprioception Returns leg to original position 10 10 10 10

Returns leg only partially to 

original position 

0 0 0 0 

No response 0 0 0 0

Pinna Reflex Ear flattens against head 1 0 1 0 

Animals shakes head 9 10 9 10

No response 0 0 0 0

Air Righting Reflex Lands on All Four Feet (Normal) 10 10 10 10 

Slightly Uncoordinated 0 0 0 0 

Lands on Side 0 0 0 0

Lands on Back 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 163

211-DIPE-S Final Report

Males

Summary of Functional Observational 

Battery Evaluations

8th week of exposure Table 9

*Significantly different from control mean; p≤0.05.

**Significantly different from control mean; p≤0.01.

If no asterisks, no statistically significant differences from control mean.

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Body Weight (grams) Mean 485.1 463.1 504.9 501.8

S.D. 46.7 85.2 35.1 44.5

N 10 10 10 10

Forelimb Grip Strength (grams of force)

Mean 1207.3 1175.0 1138.0 1266.0

S.D. 175.9 230.0 228.6 192.2

N 10 10 10 10

Hindlimb Grip Strength (grams of force)

Mean 921.5 803.8 838.5 859.0

S.D. 195.1 172.6 351.5 170.4

N 10 10 10 10

Landing Foot Splay (centimeters)

Mean 7.1 6.3 5.9 6.3

S.D. 1.7 1.0 1.4 0.8

N 10 10 10 10
Huntingdon Life Sciences 00-6130 Page 164

211-DIPE-S Final Report

Males

Summary of Functional Observational 

Battery Evaluations

8th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals 

Examined 

10 10 10 10 

Home Cage Evaluations

Posture Sitting or Standing Normally 8 8 8 5

Alert, Oriented Toward Observer 2 2 2 5 

Asleep 0 0 0 0

Lying on Side 0 0 0 0

Flattened 0 0 0 0

Crouched 0 0 0 0

Vocalizations Not Present 10 10 10 10 

Present 0 0 0 0

Palpebral Closure Eyelids Open 10 10 10 10

Eyelids Completely Closed 0 0 0 0

Eyelids Slightly Drooping 0 0 0 0

Eyelids Half Closed 0 0 0 0 

Handling Evaluations

Ease of Removal Very Easy 7 8 10 8

Easy 3 2 0 2

Moderately Difficult 0 0 0 0

Freezes 0 0 0 0 

Difficult 0 0 0 0

Ease of Handling Very easy; totally limp 0 0 0 0

Normal 10 10 10 10

Moderately Difficult 0 0 0 0

Freezes 0 0 0 0 

Difficult 0 0 0 0

Chromodacryorrhea Not Present 10 9 10 10

Present 0 1 0 0

Lacrimation No lacrimation 10 9 10 10

Some lacrimation 0 1 0 0

Extreme lacrimation 0 0 0 0

Salivation Not Present 10 10 10 10 

Slight 0 0 0 0

Moderate 0 0 0 0

Extreme 0 0 0 0

Coat Normal 10 10 10 10 

Slightly Soiled 0 0 0 0

Moderately Soiled 0 0 0 0

Extremely Soiled 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 165

211-DIPE-S Final Report

Males

Summary of Functional Observational 

Battery Evaluations

8th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals 

Examined 

10 10 10 10 

Open Field Evaluations

Gait Normal 10 9 10 10

Ataxia 0 0 0 0 

Body Drags 0 0 0 0

Limbs splayed or dragging 0 0 0 0

Hunched posture 0 1 0 0

Locomotion Normal 10 9 10 10 

Increased movement 0 0 0 0

Decreased movement 0 1 0 0

None 0 0 0 0

Arousal Normal 10 9 10 10 

Low, Slight Stupor 0 1 0 0

Very Low, Stupor 0 0 0 0

High, Slight Excitement, Tense 0 0 0 0

Very High, Hyper-Alert 0 0 0 0

Exophthalmia Not Present 10 10 10 10

Present 0 0 0 0

Piloerection Not Present 10 10 10 10

Present 0 0 0 0 

Feces Number of pellets 9 11 14 12

Unformed Stool 0 0 0 0

Urine Number of Pools 8 9 13 6 

Polyuria 0 0 0 0

Fasciculation Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0 

Tremors Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0

Convulsions Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 166

211-DIPE-S Final Report

Males

Summary of Functional Observational 

Battery Evaluations

8th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals 

Examined 

10 10 10 10 

Reflex Assessments

Visual Approach Normal, slowly approaches 10 10 10 10

No Reaction 0 0 0 0 

Freezes or pulls away slightly 0 0 0 0

Jumps or Turns Abruptly to Avoid, or 

attacks and/or bites

0 0 0 0

Audition Assessment Normal 10 10 10 10

No Reaction 0 0 0 0

Exaggerated, Jumps, Flips, Bite 0 0 0 0

Pain Perception Normal 10 10 10 10 

No Reaction 0 0 0 0

Increased Pain 0 0 0 0

Pupil Response Pupil Constricts Normally 10 10 10 10 

Pupil Size does not Change 0 0 0 0 

Miosis 0 0 0 0

Mydriasis 0 0 0 0

Proprioception Returns leg to original position 10 10 10 10 

Returns leg only partially to original 

position 

0 0 0 0 

No response 0 0 0 0

Pinna Reflex Ear flattens against head 0 0 0 0 

Animals shakes head 10 10 10 10

No response 0 0 0 0

Air Righting Reflex Lands on All Four Feet (Normal) 10 10 10 10 

Slightly Uncoordinated 0 0 0 0 

Lands on Side 0 0 0 0

Lands on Back 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 167

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

8th week of exposure Table 9

*Significantly different from control mean; p≤0.05.

**Significantly different from control mean; p≤0.01.

If no asterisks, no statistically significant differences from control mean.

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Body Weight (grams) Mean 302.5 288.8 280.3 282.3

S.D. 29.3 26.5 33.7 18.9

N 10 10 10 10

Forelimb Grip Strength (grams of force)

Mean 1169.3 1029.8 1148.5 1018.0

S.D. 129.5 152.9 205.0 177.3

N 10 10 10 10

Hindlimb Grip Strength (grams of force)

Mean 774.8 775.0 803.5 741.3

S.D. 166.5 148.1 115.2 130.8

N 10 10 10 10

Landing Foot Splay (centimeters)

Mean 5.0 5.0 4.8 5.5

S.D. 0.4 0.8 0.9 0.9

N 10 10 10 10
Huntingdon Life Sciences 00-6130 Page 168

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

8th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10

Home Cage Evaluations

Posture Sitting or Standing Normally 4 5 6 5

Alert, Oriented Toward Observer 5 5 4 5 

Asleep 1 0 0 0

Lying on Side 0 0 0 0

Flattened 0 0 0 0

Crouched 0 0 0 0

Vocalizations Not Present 10 10 10 10

Present 0 0 0 0

Palpebral Closure Eyelids Open 9 10 10 10

Eyelids Completely Closed 1 0 0 0 

Eyelids Slightly Drooping 0 0 0 0

Eyelids Half Closed 0 0 0 0

Handling Evaluations

Ease of Removal Very Easy 10 10 10 10 

Easy 0 0 0 0

Moderately Difficult 0 0 0 0

Freezes 0 0 0 0

Difficult 0 0 0 0

Ease of Handling Very easy; totally limp 0 0 0 0

Normal 10 10 10 10

Moderately Difficult 0 0 0 0

Freezes 0 0 0 0

Difficult 0 0 0 0 

Chromodacryorrhea Not Present 10 10 10 10

Present 0 0 0 0

Lacrimation No lacrimation 10 10 10 10 

Some lacrimation 0 0 0 0

Extreme lacrimation 0 0 0 0

Salivation Not Present 10 10 10 10

Slight 0 0 0 0 

Moderate 0 0 0 0

Extreme 0 0 0 0

Coat Normal 10 10 10 10

Slightly Soiled 0 0 0 0 

Moderately Soiled 0 0 0 0

Extremely Soiled 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 169

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

8th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10

Open Field Evaluations

Gait Normal 10 10 10 10

Ataxia 0 0 0 0 

Body Drags 0 0 0 0

Limbs splayed or dragging 0 0 0 0

Hunched posture 0 0 0 0

Locomotion Normal 10 10 10 9 

Increased movement 0 0 0 1

Decreased movement 0 0 0 0

None 0 0 0 0

Arousal Normal 10 10 10 9 

Low, Slight Stupor 0 0 0 0

Very Low, Stupor 0 0 0 0

High, Slight Excitement, Tense 0 0 0 1

Very High, Hyper-Alert 0 0 0 0

Exophthalmia Not Present 10 10 10 10

Present 0 0 0 0

Piloerection Not Present 10 10 10 10

Present 0 0 0 0 

Feces Number of pellets 0 2 0 0

Unformed Stool 0 0 0 0

Urine Number of Pools 3 2 0 0 

Polyuria 0 0 0 0

Fasciculation Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0 

Tremors Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0

Convulsions Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 170

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

8th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10

Reflex Assessments

Visual Approach Normal, slowly approaches 10 10 10 10

No Reaction 0 0 0 0 

Freezes or pulls away slightly 0 0 0 0

Jumps or Turns Abruptly to Avoid, 

or attacks and/or bites

0 0 0 0

Audition Assessment Normal 10 10 10 10

No Reaction 0 0 0 0

Exaggerated, Jumps, Flips, Bite 0 0 0 0

Pain Perception Normal 10 10 10 10 

No Reaction 0 0 0 0

Increased Pain 0 0 0 0

Pupil Response Pupil Constricts Normally 10 10 10 10

Pupil Size does not Change 0 0 0 0 

Miosis 0 0 0 0

Mydriasis 0 0 0 0

Proprioception Returns leg to original position 10 10 10 10

Returns leg only partially to original 

position 

0 0 0 0 

No response 0 0 0 0

Pinna Reflex Ear flattens against head 0 1 0 0 

Animals shakes head 10 9 10 10

No response 0 0 0 0

Air Righting Reflex Lands on All Four Feet (Normal) 10 10 10 10 

Slightly Uncoordinated 0 0 0 0 

Lands on Side 0 0 0 0

Lands on Back 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 171

211-DIPE-S Final Report

Males

Summary of Functional Observational 

Battery Evaluations

13th week of exposure Table 9

*Significantly different from control mean; p≤0.05.

**Significantly different from control mean; p≤0.01.

If no asterisks, no statistically significant differences from control mean.

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Body Weight (grams) Mean 555.6 557.0 578.1 545.7

S.D. 59.6 49.3 44.9 53.7

N 10 9 10 10

Forelimb Grip Strength (grams of force)

Mean 1284.8 1196.4 1178.8 1309.3

S.D. 293.1 224.5 187.4 228.1

N 10 9 10 10

Hindlimb Grip Strength (grams of force)

Mean 1003.0 946.9 992.5 911.3

S.D. 225.8 226.3 328.0 325.9

N 10 9 10 10

Landing Foot Splay (centimeters)

Mean 6.3 6.2 5.7 5.7

S.D. 1.6 1.1 1.1 1.1

N 10 9 10 10
Huntingdon Life Sciences 00-6130 Page 172

211-DIPE-S Final Report

Males

Summary of Functional Observational 

Battery Evaluations

13th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 9 10 10

Home Cage Evaluations

Posture Sitting or Standing Normally 8 6 9 6

Alert, Oriented Toward Observer 2 3 1 4 

Asleep 0 0 0 0

Lying on Side 0 0 0 0

Flattened 0 0 0 0

Crouched 0 0 0 0

Vocalizations Not Present 10 9 10 10

Present 0 0 0 0

Palpebral Closure Eyelids Open 10 9 10 10

Eyelids Completely Closed 0 0 0 0 

Eyelids Slightly Drooping 0 0 0 0

Eyelids Half Closed 0 0 0 0

Handling Evaluations

Ease of Removal Very Easy 9 8 9 6 

Easy 0 1 1 3

Moderately Difficult 1 0 0 1

Freezes 0 0 0 0

Difficult 0 0 0 0

Ease of Handling Normal 0 1 0 0

Moderately Difficult 9 8 10 9

Freezes 1 0 0 1

Difficult 0 0 0 0

Totally limp 0 0 0 0 

Chromodacryorrhea Not Present 10 9 10 10

Present 0 0 0 0

Lacrimation No lacrimation 10 9 10 10 

Some lacrimation 0 0 0 0

Extreme lacrimation 0 0 0 0

Salivation Not Present 10 9 10 10

Slight 0 0 0 0 

Moderate 0 0 0 0

Extreme 0 0 0 0

Coat Normal 10 9 10 10

Slightly Soiled 0 0 0 0 

Moderately Soiled 0 0 0 0

Extremely Soiled 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 173

211-DIPE-S Final Report

Males

Summary of Functional Observational 

Battery Evaluations

13th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10

Open Field Evaluations

Gait Normal 10 9 10 10

Ataxia 0 0 0 0 

Body Drags 0 0 0 0

Limbs splayed or dragging 0 0 0 0

Hunched posture 0 0 0 0

Locomotion Normal 10 9 10 10 

Increased movement 0 0 0 0

Decreased movement 0 0 0 0

None 0 0 0 0

Arousal Normal 10 9 10 10 

Low, Slight Stupor 0 0 0 0

Very Low, Stupor 0 0 0 0

High, Slight Excitement, Tense 0 0 0 0

Very High, Hyper-Alert 0 0 0 0

Exophthalmia Not Present 10 9 10 10

Present 0 0 0 0

Piloerection Not Present 10 9 10 10

Present 0 0 0 0 

Feces Number of pellets 10 24 13 6

Unformed Stool 0 0 0 0

Urine Number of Pools 13 11 7 5 

Polyuria 0 0 0 0

Fasciculation Not Present 10 9 10 10

Slight 0 0 0 0

Extreme 0 0 0 0 

Tremors Not Present 10 9 10 10

Slight 0 0 0 0

Extreme 0 0 0 0

Convulsions Not Present 10 9 10 10

Slight 0 0 0 0

Extreme 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 174

211-DIPE-S Final Report

Males

Summary of Functional Observational 

Battery Evaluations

13th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 9 10 10

Reflex Assessments

Visual Approach Normal, slowly approaches 9 9 9 10

No Reaction 0 0 1 0 

Freezes or pulls away slightly 1 0 0 0

Jumps or Turns Abruptly to Avoid, or 

attacks and/or bites

0 0 0 0

Audition Assessment Normal 10 9 10 10

No Reaction 0 0 0 0

Exaggerated, Jumps, Flips, Bite 0 0 0 0

Pain Perception Normal 10 9 10 10 

No Reaction 0 0 0 0 

Increased Pain 0 0 0 0

Pupil Response Pupil Constricts Normally 10 9 10 10

Pupil Size does not Change 0 0 0 0 

Miosis (bilateral) 0 0 0 0 

Mydriasis 0 0 0 0

Proprioception Returns leg to original position 10 9 10 10

Returns leg only partially to original 

position

0 0 0 0 

No response 0 0 0 0

Pinna Reflex Ear flattens against head 0 0 0 0 

Animals shakes head 10 9 10 10

No response 0 0 0 0

Air Righting Reflex Lands on All Four Feet (Normal) 10 9 10 10

Slightly Uncoordinated 0 0 0 0 

Lands on Side 0 0 0 0

Lands on Back 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 175

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

13th week of exposure Table 9

*Significantly different from control mean; p≤0.05.

**Significantly different from control mean; p≤0.01.

If no asterisks, no statistically significant differences from control mean.

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Body Weight (grams) Mean 328.8 314.1 304.7 304.9

S.D. 36.3 29.2 35.5 23.7

N 10 10 10 10

Forelimb Grip Strength (grams of force)

Mean 1092.8 1022.8 1150.3 1038.0

S.D. 206.2 197.0 126.1 177.4

N 10 10 10 10

Hindlimb Grip Strength (grams of force)

Mean 877.8 782.3 849.5 804.3

S.D. 190.4 176.3 142.7 90.5

N 10 10 10 10

Landing Foot Splay (centimeters)

Mean 4.2 4.6 4.7 4.9

S.D. 0.7 0.9 0.5 0.5

N 10 10 10 10
Huntingdon Life Sciences 00-6130 Page 176

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

13th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10

Home Cage Evaluations

Posture Sitting or Standing Normally 8 3 9 6

Alert, Oriented Toward Observer 2 7 1 4 

Asleep 0 0 0 0

Lying on Side 0 0 0 0

Flattened 0 0 0 0

Crouched 0 0 0 0

Vocalizations Not Present 10 10 10 10

Present 0 0 0 0

Palpebral Closure Eyelids Open 10 10 10 10

Eyelids Completely Closed 0 0 0 0 

Eyelids Slightly Drooping 0 0 0 0

Eyelids Half Closed 0 0 0 0

Handling Evaluations

Ease of Removal Very Easy 10 9 10 10 

Easy 0 1 0 0

Moderately Difficult 0 0 0 0

Freezes 0 0 0 0

Difficult 0 0 0 0

Ease of Handling Very easy; totally limp 1 1 1 1

Normal 9 9 9 9

Moderately Difficult 0 0 0 0

Freezes 0 0 0 0

Difficult 0 0 0 0 

Chromodacryorrhea Not Present 10 10 10 10

Present 0 0 0 0

Lacrimation No lacrimation 10 10 10 10 

Some lacrimation 0 0 0 0

Extreme lacrimation 0 0 0 0

Salivation Not Present 10 10 10 10

Slight 0 0 0 0 

Moderate 0 0 0 0

Extreme 0 0 0 0

Coat Normal 10 10 10 10

Slightly Soiled 0 0 0 0 

Moderately Soiled 0 0 0 0

Extremely Soiled 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 177

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

13th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10

Open Field Evaluations

Gait Normal 10 10 10 10

Ataxia 0 0 0 0 

Body Drags 0 0 0 0

Limbs splayed or dragging 0 0 0 0

Hunched posture 0 0 0 0

Locomotion Normal 10 9 10 9 

Increased movement 0 1 0 1

Decreased movement 0 0 0 0

None 0 0 0 0

Arousal Normal 10 9 10 9 

Low, Slight Stupor 0 0 0 0

Very Low, Stupor 0 0 0 0

High, Slight Excitement, Tense 0 1 0 1

Very High, Hyper-Alert 0 0 0 0

Exophthalmia Not Present 10 10 10 10

Present 0 0 0 0

Piloerection Not Present 10 10 10 10

Present 0 0 0 0 

Feces Number of pellets 6 0 4 0

Unformed Stool 0 0 0 0

Urine Number of Pools 6 3 5 4 

Polyuria 0 0 0 0

Fasciculation Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0 

Tremors Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0

Convulsions Not Present 10 10 10 10

Slight 0 0 0 0

Extreme 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 178

211-DIPE-S Final Report

Females

Summary of Functional Observational 

Battery Evaluations

13th week of exposure Table 9

Group I Group II Group III Group IV

Exposure Level (mg/m3): 0 2000 10000 20000

Number of Animals Examined 10 10 10 10

Reflex Assessments

Visual Approach Normal, slowly approaches 10 10 10 10

No Reaction 0 0 0 0 

Freezes or pulls away slightly 0 0 0 0

Jumps or Turns Abruptly to Avoid, 

or attacks and/or bites

0 0 0 0

Audition Assessment Normal 10 10 10 10

No Reaction 0 0 0 0

Exaggerated, Jumps, Flips, Bite 0 0 0 0

Pain Perception Normal 10 10 10 10 

No Reaction 0 0 0 0

Increased Pain 0 0 0 0

Pupil Response Pupil Constricts Normally 10 10 10 10

Pupil Size does not Change 0 0 0 0 

Miosis (bilateral) 0 0 0 0

Mydriasis 0 0 0 0

Proprioception Returns leg to original position 10 10 10 10

Returns leg only partially to 

original position 

0 0 0 0 

No response 0 0 0 0

Pinna Reflex Ear flattens against head 0 0 0 1 

Animals shakes head 10 10 10 9

No response 0 0 0 0

Air Righting Reflex Lands on All Four Feet (Normal) 10 10 10 10 

Slightly Uncoordinated 0 0 0 0 

Lands on Side 0 0 0 0

Lands on Back 0 0 0 0
Huntingdon Life Sciences 00-6130 Page 179

211-DIPE-S Final Report

Mean Hematology Values

Preface Table 10

Reporting

Abbreviation Parameter Units 

HGB Hemoglobin Concentration g/dL

HCT Hematocrit percent

RBC Erythrocyte Count 106/μL 

RETIC Absolute Reticulocyte Count 109/L

PLT Platelet Count 103/μL 

MCV Mean Corpuscular Volume fL

MCH Mean Corpuscular Hemoglobin pg

MCHC Mean Corpuscular Hemoglobin

Concentration g/dL

WBC Total Leukocyte Count 103/μL 

ANEU Absolute Neutrophils 103/μL 

ALYM Absolute Lymphocytes 103/μL 

AMONO Absolute Monocytes 103/μL 

AEOS Absolute Eosinophils 103/μL 

ABASO Absolute Basophils 103/μL 

ALUC Absolute Large Unstained Cells 103/μL 

Key to Statistical Symbols:

*Significantly different from control mean; p≤0.05.

**Significantly different from control mean; p≤0.01.

If no asterisks, no statistically significant differences from control mean
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 10 

Mean Hematology Values - Week 4 

Group HGB HCT 

g/dL % 

1M 

0 mg/m(3) Mean 16.0 48.4 

SD 0.54 1. 43 

n 10 10 

2M 

2000 mg/m(3) Mean 15.8 48.4 

SD 0.36 1.47 

n 10 10 

3M 

10000 mg/m(3) Mean 15.5 47.2 

SD 0.42 2.02 

n 10 10 

4M 

** 20000 mg/m(3) Mean 15.4 46.9 

SD 0.51 1. 70 

n 10 10 

RBC 

X10A6/UL 

8.62 

0.294 

10 

8.73 

0.392 

10 

8.46 

0.481 

10 

8.55 

0.309 

10 

RETIC PLT MCV MCH MCHC WBC 

X10A9/L X10A3/UL fL pg g/dL X10

202.4 902 56.2 18.5 33.0 16

30.41 146.4 1. 39 0.47 0.50 2.1

10 10 10 10 10 

* 177.1 914 55.6 18.2 32.7 16

19.35 194.9 1.65 0.61 0.33 2.6

10 10 10 10 10 

** 168.8 915 55.8 18.4 32.9 17

25.48 215.0 1. 48 0.78 0.79 3.4

10 10 10 10 10 

** 155.8 930 54.9 18.0 32.7 14

26.41 287.2 1.15 0.46 0.46 2.3

10 10 10 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 10 

Mean Hematology Values - Week 4 

Group ANEU ALYM 

1M 

o mg/m(3) Mean 1. 94 13.21 

SD 0.437 2.022 

n 10 10 

2M 

2000 mg/m(3) Mean 1. 78 13.96 

SD 0.555 2.674 

n 10 10 

3M 

10000 mg/m(3) Mean 1. 67 14.69 

SD 0.605 2.744 

n 10 10 

4M 

20000 mg/m(3) Mean 2.02 11.81 

SD 0.824 2.062 

n 10 10 

AMONO AEOS ABASO ALUC 

0.42 0.22 0.14 0.07 

0.105 0.102 0.060 0.041 

10 10 10 10 

0.36 0.15 0.16 0.09 

0.152 0.050 0.045 0.026 

10 10 10 10 

0.39 0.17 0.15 0.11 

0.168 0.139 0.045 0.035 

10 10 10 10 

0.33 0.23 0.13 0.10 

0.160 0.174 0.035 0.040 

10 10 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 10 

Mean Hematology Values - Week 4 

Group HGB HCT 

g/dL % 

1F 

0 mg/m(3) Mean 15.6 46.6 

SD 0.47 1. 42 

n 10 10 

2F 

2000 mg/m(3) Mean 15.9 47.9 

SD 0.85 3.54 

n 10 10 

3F 

10000 mg/m(3) Mean 15.2 45.7 

SD 0.57 2.19 

n 10 10 

4F 

20000 mg/m(3) Mean 15.1 45.2 

SD 0. 71 2.51 

n 10 10 

RBC 

X10A6/uL 

8.38 

0.282 

10 

8. 71 

0.687 

10 

8.18 

0.464 

10 

8.27 

0.555 

10 

RETIC PLT MCV MCH MCHC W

X10A9/L x10A3/UL fL pg g/dL X

194.4 1000 55.6 18.6 33.5 

33.69 153.0 1.14 0.35 0.33 

10 10 10 10 10 

189.6 969 55.0 18.3 33.2 

30.79 190.6 1. 78 0.87 0.96 

10 10 10 10 10 

188.9 951 55.9 18.6 33.4 

35.92 297.8 1. 04 0.55 0.61 

10 10 10 10 10 

185.1 1048 54.7 18.3 33.4 

36.99 229.9 2.15 0.65 0.56 

10 10 10 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 10 

Mean Hematology Values - Week 4 

Group ANEU ALYM 

X10A3/uL X10A3/uL 

1F 

0 mg/m(3) Mean 1. 78 13.15 

SD 0.407 3.106 

n 10 10 

2F 

2000 mg/m(3) Mean 1.40 12.80 

SD 0.420 2.068 

n 10 10 

3F 

10000 mg/m(3) Mean 1. 79 12.87 

SD 0.535 2.790 

n 10 10 

4F 

20000 mg/m(3) Mean 1. 63 11.88 

SD 0.689 2. 096 

n 10 10 

AMONO AEOS ABASO ALUC 

X10A3/uL x10A3/uL x10A3/uL x10A3/UL 

0.39 0.15 0.15 0.10 

0.075 0.077 0.058 0.044 

10 10 10 10 

0.31 0.21 0.13 0.10 

0.112 0.197 0.036 0.025 

10 10 10 10 

0.31 0.21 0.12 0.10 

0.118 0.188 0.045 0.033 

10 10 10 10 

** 0.25 0.19 0.11 0.09 

0.100· 0.136 0.027 0.034 

10 10 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 10 

Mean Hematology Values - Termination 

Group HGB HCT 

g/dL % 

1M 

0 mg/m(3) Mean 16.2 48.1 

SD 0.58 1.63 

n 10 10 

2M 

2000 mg/m(3) Mean 16.2 47.8 

SD 0.55 1.67 

n 9 9 

3M 

10000 mg/m(3) Mean 15.7 46.8 

SD l. 08 2.90 

n 10 10 

4M 

20000 mg/m(3) Mean 16.0 47.7 

SD 0.79 2.76 

n 10 10 

RBC RBTIC 

X10A6/UL X10A9/L 

9.16 189.2 

0.367 30.69 

10 10 

9.15 169.9 

0.395 19.11 

9 9 

8.97 202.0 

0.655 94.13 

10 10 

9.26 150.1 ** 

0.477 18.81 

10 10 

PLT MCV MCH MCHC WBC 

X10A3/UL fL pg g/dL X10A3/UL 

855 52.6 17.7 33.7 12.08 

282.9 1.52 0.54 0.60 2.874 

10 10 10 10 10 

* 1125 52.2 17.7 33.9 13.28 

143.2 1.21 0.53 0.68 4.347 

9 9 9 9 9 

* 1123 52.2 17.5 33.6 11.10 

197.8 1.68 1.19 1.89 2.042 

10 10 10 10 10 

1044 * 51.5 17.3 33.6 11.31 

241.8 1.01 0.41 0.70 2.992 

10 10 10 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 10 

Mean Hematology Values - Termination 

Group ANEU ALYM 

1M 

0 mg/m(3) Mean 2.26 9.14 

SD 0.709 2.501 

n 10 10 

2M 

2000 mg/m(3) Mean 2.10 10.54 

SD 0.925 3.844 

n 9 9 

3M 

10000 mg/m (3) Mean 1. 77 8.81 

SD 0.566 1.713 

n 10 10 

4M 

20000 mg/m(3) Mean 1.80 8.95 

SD 0.537 2.672 

n 10 10 

AMONO AEOS ABASO ALUC 

0.33 0.19 0.11 0.05 

0.100 0.107 0.091 0.032 

10 10 10 10 

0.31 0.16 0.11 0.08 

0.161 0.069 0.059 0.054 

9 9 9 9 

0.27 0.14 0.07 0.05 

0.179 0.091 0.020 0.013 

10 10 10 10 

0.28 0.20 o.os 0.06 

0.167 0.122 0.052 0.039 

10 10 10 10 

P
Huntingdon Life sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 10 

Mean Hematology Values - Termination 

Group HGB HCT 

g/dL % 

1F 

0 mg/m(3) Mean 15.6 45.5 

SD 0.46 1.42 

n 10 10 

2F 

2000 mg/m(3) Mean 16.1 47.2 

SD 0.91 3.34 

n 10 10 

3F 

10000 mg/m(3) Mean 15.9 46.0 

SD 0.52 1.69 

n 10 10 

4F 

20000 mg/m(3) Mean 15.8 46.5 

SD 0.55 1. 81 

n 9 9 

RBC 

8.33 

0.278 

10 

8.69 

0.662 

10 

8.39 

0.415 

10 

8.61 

0.414 

9 

RETIC PLT MCV MCH MCHC WBC 

fL pg g/dL 

171.3 1024 54.6 18.7 34.2 9.90 

29.67 224.5 1.25 0.54 0.33 3.189 

10 10 10 10 10 10 

171.7 921 54.4 18.6 34.2 9.56 

22.32 158.2 1. 73 0.77 0.88 2.268 

10 10 10 10 10 10 

179.6 1013 54.8 19.0 34.6 9.88 

34.10 232.1 1.28 0.40 0.56 2.805 

10 10 10 10 10 10 

193.3 1020 54.0 18.4 34.0 9.23 

34.14 243.6 2.54 0.84 0.41 1. 807 

9 9 9 9 9 9 

P
Huntingdon Life sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 10 

Mean Hematology Values - Termination 

Group ANEU ALYM 

1F 

o rng/rn(3) Mean 1.88 7.54 

SD 1.070 2.575 

n 10 10 

2F 

2000 rng/rn(3) Mean 1.06 8.10 

SD 0.303 2. 021 

n 10 10 

3F 

10000 rng/rn (3) Mean 1.55 7.78 

SD 0.637 2.110 

n 10 10 

4F 

20000 rng/rn(3) Mean 1.34 7.46 

SD 0.559 1.406 

n 9 9 

AMONO AEOS ABASO ALUC 

0.24 0.15 0.05 0.04 

0.117 0.101 0.027 0.025 

10 10 10 10 

0.18 0.13 0.05 0.05 

0.079 0.049 0.025 0.032 

10 10 10 10 

0.21 0.22 0.07 0.05 

0.117 0.201 0.033 0.013 

10 10 10 10 

0.16 0.14 0.05 0.04 

0.053 0. 059 0.032 0.028 

9 9 9 9 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211- DIPE-S 

Table 10 

Mean Hematology Values - Recovery 

Group 

1M 

0 mg/m(3) Mean 

SD 

n 

4M 

20000 mg/m(3) Mean 

SD 

n 

HGB 

g/dL 

15.5 

0.55 

10 

15.5 

0.52 

10 

HCT 

% 

48.1 

2.23 

10 

47.2 

1. 84 

10 

RBC 

9.10 

0.446 

10 

8.99 

0.416 

10 

RETIC 

162.4 

34.81 

10 

** 126.8 

12.34 

10 

PLT 

983 

196.2 

10 

1020 

238.5 

10 

MCV 

fL 

52.9 

0.88 

10 

52.6 

1. 68 

10 

MCH 

pg 

17.1 

0.94 

10 

17.3 1. 22 

10 

MCHC 

g/dL 

32.4 

1. 50 

10 

32.9 

1.56 

10 

WB

3

1

3

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211- DIPE-S 

Table 10 

Mean Hematology Values - Recovery 

Group 

1M 

0 mg/m(3) Mean 

SD 

n 

4M 

20000 mg/m(3) Mean 

SD 

n 

ANEU 

X10A3/uL 

1.78 

0.508 

10 

1. 96 

0.834 

10 

ALYM 

X10A3/UL 

9.92 

2.938 

10 

9.32 

3.284 

10 

AMONO 

x10A3/uL 

0.46 

0.175 

10 

0.35 

0.116 

10 

AEOS 

X10A3/uL 

0.21 

0.185 

10 

0.17 

0.136 

10 

ABASO 

X10A3/uL 

0.20 

0.103 

10 

0.16 

0.060 

10 

ALUC X10A3/uL 

0.05 

0.034 

10 

0.06 

0.025 

10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211- DIPE-S 

Table 10 

Mean Hematology Values - Recovery 

Group 

1F 

0 mg/m(3) Mean 

SD 

n 

4F 

20000 mg/m(3) Mean 

SD 

n 

HGB 

g/dL 

15.3 

0.66 

10 

15.6 

0.44 

10 

HCT 

% 

45.8 

2.27 

10 

46.9 

1.96 

10 

RBC 

X10A6/UL 

8.26 

0.314 

10 

8.50 

0.355 

10 

RETIC x10A9/L 

133.0 

26.02 

10 

118.5 

24.25 

10 

PLT 

X10A3/UL 

1044 

180.1 

10 

878 

225.7 

10 

MCV 

fL 

55.4 

1.22 

10 

55.1 

1.27 

10 

MCH 

pg 

18.5 

0.51 

10 

18.3 

0.51 

10 

MCHC 

g/dL 

33.5 

0.57 

10 

33.2 

0.75 

10 

WBC 

x10

101.410

2.

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211- DIPE-S 

Table 10 

Mean Hematology Values - Recovery 

Group 

1F 

o mg/m(3) Mean 

SD 

n 

4F 

20000 mg/m(3) Mean 

SD 

n 

ANEU 

1. 71 

0.574 

10 

1. 52 

0.685 

10 

ALYM 

8.30 

1. 345 

10 

8.36 

1. 425 

10 

AMONO 

0.34 

0.110 

10 

** 0.22 

0.049 

10 

AEOS 

0.11 

0.033 

10 

* 0.19 

0.155 

10 

ABA SO 

0.12 

0.040 

10 

0.16 

0.068 

10 

ALUC 

0.04 

0.012 

10 

0.04 

0.014 

10 

P
Huntingdon Life Sciences 00-6130 Page 192

211-DIPE-S Final Report

Mean Coagulation Values

Preface Table 11

Reporting

Abbreviation Parameter Units 

PT Prothrombin Time Seconds

APTT Activated Partial Thromboplastin Time Seconds

Key to Statistical Symbols:

*Significantly different from control mean; p≤0.05.

**Significantly different from control mean; p≤0.01.

If no asterisks, no statistically significant differences from control mean.
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 11 

Mean Coagulation Values - Week 4 

Group PT APTT 

Seconds Seconds 

1M 

o mg/m(3) Mean 11.9 17.7 

SD 0.50 2.67 

n 10 10 

2M 

* ** 2000 mg/m(3) Mean 12.5 20.4 

SD 0.34 1.50 

n 10 10 

3M 

* ** 10000 mg/m(3) Mean 12.6 20.4 

SD 0.64 1.69 

n 10 10 

4M 

* ** 20000 mg/m(3) Mean 12.5 21.1 

SD 0.74 2.04 

n 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 11 

Mean Coagulation Values - Week 4 

Group PT APTT 

Seconds Seconds 

1F 

o mg/m(3) Mean 11.4 19.8 

SD 0.46 1.26 

n 10 10 

2F 

2000 mg/m(3) Mean 11.5 19.2 

SD 0.58 1. 71 

n 9 9 

3F 

10000 mg/m(3) Mean 11.6 19.5 

SD 0.33 2.63 

n 10 10 

4F 

20000 mg/m(3) Mean 11.6 19.8 

SD 0.46 1.16 

n 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 11 

Mean Coagulation Values - Termination 

Group PT APTT 

Seconds Seconds 

1M 

0 mg/m(3) Mean 12.2 19.2 

SD 0.44 3.16 

n 10 10 

2M 

2000 mg/m(3) Mean 12.7 21.2 

SD 0.58 2.27 

n 9 9 

3M 

10000 mg/m (3) Mean 12.7 19.8 

SD 1. 06 3.03 

n 10 10 

4M 

20000 mg/m(3) Mean 12.5 20.5 

SD 0 0 72 2.67 

n 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 11 

Mean Coagulation Values - Termination 

Group PT APTT 

Seconds Seconds 

1F 

0 mg/m(3) Mean 11.2 18.2 

SD 0.27 2.99 

n 10 10 

2F 

2000 mg/m(3) Mean 11.1 16.6 

SD 0.37 1.45 

n 10 10 

3F 

10000 mg/m(3) Mean 11.2 17.2 

SD 0.29 2.21 

n 10 10 

4F 

20000 mg/m(3) Mean 11.2 16.9 

SD 0.38 1.78 

n 10 10 

P
Huntingdon Life Sciences 00-6130 Page 197

211-DIPE-S Final Report

Mean Clinical Chemistry Values

Preface Table 12

 Reporting

Abbreviation Parameter Units 

AST Aspartate Aminotransferase U/L

ALT Alanine Aminotransferase U/L

ALKP Alkaline Phosphatase U/L

LD Lactate Dehydrogenase U/L

SDH Sorbitol Dehydrogenase U/L

BUN Blood Urea Nitrogen mg/dL

CREAT Creatinine mg/dL

GLU Fasting Glucose mg/dL

CK Creatine Kinase U/L

CHOL Cholesterol (Enzymatic) mg/dL

TP Total Protein g/dL

ALB Albumin g/dL

GLOB Globulin (calculated) g/dL

A/G Albumin/Globulin Ratio (calculated)

TBILI Total Bilirubin mg/dL

DBILI Direct Bilirubin mg/dL

IBILI Indirect Bilirubin (calculated) mg/dL

Na+ Sodium mEq/L

K+ Potassium mEq/L

Cl- Chloride mEq/L

Ca++ Calcium mg/dL

PHOS Inorganic Phosphorus mg/dL

GGT Gamma-Glutamyl Transferase U/L

Bile Acids Bile Acids μmol/L

Key to Statistical Symbols:

*Significantly different from control mean; p≤0.05.

**Significantly different from control mean; p≤0.01.

If no asterisks, no statistically significant differences from control mean.
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry Values - Week 4 

Group AST ALT 

U/L U/L 

1M 

0 mg/m(3) Mean 81 44 

SD 9.7 6.9 

n 10 10 

2M 

2000 mg/m (3) Mean 75 39 

SD 2.8 6.2 

n 10 10 

3M 

10000 mg/m(3) Mean 78 40 

SD 11.7 7.7 

n 10 10 

4M 

** 20000 mg/m (3) Mean 7l 38 

SD 8.8 5.3 

n 10 10 

ALKP LD 

U/L U/L 

158 185 

35.8 31.4 

10 10 

* 

158 132 

21.3 24.5 

10 10 

** 156 118 

27.2 65.1 

10 10 

144 ** 89 

22.7 21.1 

10 10 

SOH BUN CREAT GLU CK 

U/L mg/dL mg/dL mg/dL U/L 

18.0 13 0.3 127 240 

2.90 2.1 0.05 9.1 191.8 

10 10 10 10 10 

* * 15.3 12 0.3 118 151 

2.77 1.8 0.03 8.7 28.3 

10 10 10 10 10 

* ** * 14.7 12 0.3 111 149 

3.76 1.8 0.06 7.6 62 .o 

10 10 10 10 10 

* ** ** 14.4 12 0.3 114 128 

2.78 1.4 0.03 7.5 30.8 

10 10 10 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry Values - Week 4 

Group CHOL TP 

mg/dL g/dL 

1M 

0 mg/m(3) Mean 66 6.5 

SD 9.1 0.27 

n 10 10 

2M 

2000 mg/m(3) Mean 61 6.4 

SD 11.2 0.21 

n 10 10 

3M 

10000 mg/m(3) Mean 57 6.4 

SD 10.3 0.33 

n 10 10 

4M 

20000 mg/m (3) Mean 59 6.4 

SD 9.6 0.30 

n 10 10 

ALB 

g/dL 

4.1 

0.20 

10 

4.1 

0.07 

10 

4.1 

0.16 

10 

4.1 

0.24 

10 

Glob A/G TBILI DBILI IBILI .. Na+ 

g/dL mg/dL mg/dL mg/dL mEq/L 

2.4 1.8 0.13 0.04 0.09 148 

0.17 0.17 0.025 0.008 0.023 1.0 

10 10 10 10 10 10 

2.3 1.8 0.12 0.03 0.09 148 

0.18 0.13 0.022 0.009 0.016 1.3 

10 10 10 10 10 10 

2.3 1.8 0.13 0.04 0.09 147 

0.21 0.15 0.025 0.007 0.022 1.1 

10 10 10 10 10 9 

2.3 1.8 0.11 0.03 0.08 148 

0.17 0.15 0.017 0.009 0.018 1.2 

10 10 10 10 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry Values - week 4 

Group K+ Cl- Ca++ PHOS GGT Bile 

Acids 

mEq/L mEq/L mg/dL mg/dL U/L umol/L 

1M 

0 mg/m(3) Mean 5.6 103 1.1.5 10.0 0 52 

SD 0.40 0.7 0.24 1.00 0.6 41.8 

n 10 10 1.0 1.0 10 10 

2M 

2000 mg/m(3) Mean 5.5 1.02 11.3 9.8 0 77 

SD 0.33 l.l. 0.23 0.41 0.0 85.1. 

n 1.0 1.0 10 10 10 10 

3M 

10000 mg/m(3) Mean 5.4 1.03 11.5 1.0.2 0 65 

SD 0.38 1.3 0.22 0.73 0.0 72.9 

n 9 9 9 9 10 9 

4M 

20000 mg/m(3) Mean 5.5 103 11.3 9.8 0 37 

SD 0.50 2.0 0.33 0.67 0.0 25.4 

n 10 10 10 10 10 1.0 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry Values - Week 4 

Group AST ALT 

U/L U/L 

1F 

0 mg/m(3} Mean 77 36 

SD 14.3 7.9 

n 10 10 

2F 

2000 mg/m(3} Mean 78 34 

SD 13 .a 7.6 

n 10 10 

3F 

10000 mg/m(3} Mean 70 33 

SD 6.3 4.0 

n 10 10 

4F 

20000 mg/m(3) Mean 69 29 * 

SD 3.9 3.7 

n 10 10 

ALKP LD 

U/L U/L 

95 87 

14.3 38.6 

10 10 

108 117 

21.7 88.0 

10 10 

99 68 

30.7 16.9 

10 10 

89 62 

15.0 23.2 

10 10 

SDH BUN CREAT GLU CK 

U/L mg/dL mg/dL mg/dL U/L 

15.3 15 0.5 122 128 

2.26 1.1 0.07 4.8 54.3 

10 10 10 10 10 

15.6 14 . 0.4 135 165 

5.97 2.3 0.08 28.5 64.6 

10 10 10 10 10 

11.5 * 13 0.4 117 108 2.17 1.8 0.06 6.2 22.0 

10 10 10 10 10 

12.0 * 14 0.4 116 * 125 

2.73 1.8 0.03 8.6 58.2 

10 10 10 10 10 

P
Huntingdon Life sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry Values - Week 4 

Group CHOL TP 

rng/dL g/dL 

lF 

0 rng/rn (3) Mean 81 7.4 

SD 12.7 0.59 

n 10 10 

2F 

2000 rng/rn(3) Mean 85 7.2 

SD 11.8 0.36 

n B 10 

3F 

10000 rng/rn(3) Mean 95 7.4 

SD 12.5 0.36 

n 8 10 

4F 

20000 rng/rn(3) Mean 92 7.3 

SD 18.8 0.49 

n 8 10 

ALB 

g/dL 

4.8 

0.42 

10 

4.7 

0.27 

10 

4.8 

0.23 

10 

4.8 

0.29 

10 

Glob A/G TBILI DBILI IBILI Na+ 

g/dL rng/dL rng/dL rng/dL rnEq/L 

2.6 1.9 0.18 0.04 0.13 148 

0.21 0.13 0.031 0 0 011 0.028 1.0 

10 10 10 10 10 10 

2.5 1.9 0.17 0.04 0.13 149 

0.21 0.20 0.040 0.014 0.027 3.3 

10 10 10 10 10 10 

2.6 1.9 0.17 0.04 0.13 152 ** 

0.19 0.12 0.033 0.016 0.023 1.1 

10 10 10 10 10 10 

** 2.5 1.9 0.15 0.03 0.11 152 

0.25 0.15 0.037 0.011 0.034 1.6 

10 10 10 10 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry Values - Week 4 

Group K+ Cl- Ca++ PHOS GGT Bile 

Acids 

mEq/L mEq/L mg/dL mg/dL U/L umol/L 

1F 

o mg/m {3) Mean 5.3 102 11.9 9.9 0 84 

SD 0.52 1.4 0.45 0.56 0.0 59.0 

n 10 10 10 10 10 9 

2F 

2000 mg/m{3) Mean 6.0 * 104 * 12.0 10.8 0 26 * 

SD 0.54 3.4 0.24 1.73 0.3 18.9 

n 10 10 10 10 10 9 

3F 

10000 mg/m {3) Mean 5.8 * 105 ** 12.0 10.2 0 45 * 

SD 0.31 1.8 0.20 0.85 0.0 51.1 

n 10 10 10 10 10 8 

4F 

20000 mg/m{3) Mean 5.6 * 106 ** 11.8 9.5 0 34 * 

SD 0.37 1.8 0.33 0.71 o.o 19.8 

n 10 10 10 10 10 9 

P
Huntingdon Life sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry values - Termination 

Group AST ALT 

U/L U/L 

1M 

o rng/m(3) Mean 85 44 

SD 11.4 6.4 

n 10 10 

2M 

2000 rng/rn(3) Mean 85 45 

SD 14.5 6.7 

n 9 9 

3M 

10000 rng/rn(3) Mean 84 41 

SD 14.5 7.4 

n 10 10 

4M 

20000 rng/rn(3) Mean 72 38 

SD 13.1 8.4 

n 10 10 

ALKP 

U/L 

90 

15.2 

10 

89 

14.8 

9 

93 

13.9 

10 

85 

16.9 

10 

LD SOH BUN CREAT GLU CK 

U/L U/L rng/dL rng/dL mg/dL U/L 

181 17.6 15 0.4 149 190 

117.6 4.48 2.0 0.07 24.9 124.4 

10 10 10 10 10 10 

246 17.0 15 0.5 165 234 

159.0 5.19 1.3 0.07 52.5 185.2 

9 9 9 9 9 9 

189 15.9 14 0.4 131 193 

128.5 5.13 1.4 0.12 20.4 121.8 

10 10 10 10 10 10 

113 15.4 15 0.4 136 135 

43.5 6.08 1.7 0.07 34.2 46.4 

10 10 10 10 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry values - Termination 

Group CHOL TP 

mg/dL g/dL 

1M 

0 mg/m(3) Mean 69 7.1 

SD 14.3 0.35 

n 10 10 

2M 

2000 mg/m (3) Mean 64 7.0 

SD 17.0 0.30 

n 9 9 

3M 

10000 mg/m(3) Mean 66 7.0 

SD 15.6 0.30 

n 10 10 

4M 

20000 mg/m(3) Mean 61 6.8 

SD 17.4 0.40 

n 10 10 

ALB Glob 

g/dL g/dL 

4.3 2.8 

0.23 0.19 

10 10 

4.3 2.7 

0.19 0.23 

9 9 

4.4 2.6 

0.08 0.25 

10 10 

4.2 2.6 

0.20 0.24 

10 10 

A/G TBILI DBILI IBILI Na+ 

mg/dL mg/dL mg/dL mEq/L 

1.5 0.11 0.03 0.08 148 

0.10 0.017 0.019 0.019 1.1 

10 10 10 10 10 

1.6 0.11 0.02 0.09 148 

0.16 0.025 0.009 0.019 0.7 

9 9 9 9 9 

1.7 * 0.10 0.03 0.07 148 

0.16 0.015 0.013 0.015 1.7 

10 10 10 10 10 

* 1.6 0.09 0.02 0.07 148 

0.13 0.021 0.009 0.018 1.4 

10 10 10 10 10 

P
Huntingdon Life Sciences Study No. 

Sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry Values - Termination 

Group K+ Cl- Ca++ PHOS GGT Bile 

Acids 

mEq/L mEq/L mg/dL mg/dL U/L umol/L 

1M 

o mg/m(3) Mean 5.9 11.3 8.4 0 27 

SD 0.37 2.8 0.65 0.96 0.0 17.2 

n 10 10 10 10 10 10 

2M 

2000 mg/m(3) Mean 5.7 101 11.1 8.9 0 23 

SD 0.53 2.2 0.61 2.29 0.0 16.5 

n 9 9 9 9 9 9 

3M 

10000 mg/m(3) Mean 5.8 102 11.1 8.6 0 28 

SD 0.58 1.8 0.32 2.04 0.0 17.2 

n 10 10 10 10 10 10 

4M 

20000 mg/m(3) Mean 5.9 102 10.9 8.8 0 21 

SD 0.58 3.0 0.21 1.52 0.6 7.9 

n 10 10 10 10 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry Values - Termination 

Group AST ALT 

U/L U/L 

1F 

0 mg/m(3) Mean 91 42 

SD 18.6 10.7 

n 10 10 

2F 

2000 mg/m(3) Mean 84 36 

SD 9.8 11.1 

n 10 10 

3F 

** 10000 mg/m(3) Mean 71 33 

SD 9.6 3.7 

n 10 10 

4F 

** 20000 mg/m(3) Mean 75 36 

SD 11.9 13.4 

n 10 10 

ALKP 

U/L 

43 

9.7 

10 

48 

11.2 

10 

43 

12.2 

10 

44 

5.9 

10 

LD SDH BUN CREAT GLU CK 

U/L U/L mg/dL mg/dL mg/dL U/L 

270 18.2 15 0.5 140 210 

114.3 4.67 1.8 0.06 25.9 96.5 

10 10 10 10 10 10 

318 15.1 17 0.5 135 184 

163.6 2.32 1.9 0.07 27.2 71.9 

10 10 10 10 10 10 

  123 15.1 14 0.5 136 124 

40.3 3.57 1.5 0.06 19.0 65.7 

10 10 10 10 10 10 

**  ** ** 86 12.7 16 0.5 129 87 

31.3 4.05 1.9 0.03 17.3 22.0 

10 10 10 10 10 10 

P
Huntingdon Life sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry Values - Termination 

Group CHOL TP 

mg/dL g/dL 

1F 

o mg/m(3) Mean 77 7.7 

SD 14.1 0.71 

n 10 10 

2F 

2000 mg/m(3) Mean 80 7.7 

SD 20.2 0.47 

n 10 10 

3F 

10000 mg/m(3) Mean 90 7.7 

SD 17.6 0.64 

n 10 10 

4F 

20000 mg/m(3) Mean 91 7.9 

SD 13.0 0.45 

n 10 10 

ALB 

g/dL 

5.1 

0.49 

10 

5.1 

0.44 

10 

5.1 

0.46 

10 

5.1 

0.39 

10 

Glob A/G TBILI DBILI IBILI Na+ 

g/dL mg/dL mg/dL mg/dL mEq/L 

2.7 1.9 0.14 0.03 0.11 148 

0.31 0.19 0.036 0.014 0.028 2.2 

10 10 10 10 10 10 

2.5 2.0 0.15 0. 03 0.12 148 

0.18 0.24 0. 039 0.013 0.031 1.8 

10 10 10 10 10 10 

2.7 1.9 * 0.13 0.02 0.11 150 

0.31 0.27 0.013 0.011 0.009 1.5 

10 10 10 10 10 10 

** 2.8 1.8 0.13 0.03 0.10 150 

0.17 0.15 0.022 0.008 0.021 2.1 

10 10 10 10 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry Values - Termination 

Group K+ Cl- Ca++ PHOS GGT Bile 

Acids 

mEq/L mEq/L mg/dL mg/dL U/L umol/L 

1F 

0 mg/m(3) Mean 4.8 103 11.3 6.8 0 37 

SD 0.63 3.3 0.39 1.41 o.o 27.9 

n 10 10 10 10 10 10 

2F 

2000 mg/m(3) Mean 5.7 ** 103 11.6 6.8 0 33 

SD 0.49 3.4 0.51 0.90 o.o 26.9 

n 10 10 10 10 10 10 

3F 

10000 mg/m(3) Mean 5.5 ** 103 11.6 7.2 0 25 

SD 0.47 2.4 0.26 1.32 0.0 14.5 

n 10 10 10 10 10 10 

4F 

20000 mg/m(3) Mean 6.0 ** 103 11.9 ** 7.1 0 54 

SD 0.48 3.7 0.46 0.91 0.4 54.0 

n 10 10 10 10 10 10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry Values - Recovery 

Group 

1M 

0 mg/m(3) 

4M 

20000 mg/m(3) 

Mean 

SD n 

Mean 

SD 

n 

AST 

U/L 

89 

40.7 

10 

72 * 

9.2 

10 

ALT 

U/L 

51 

22.7 

10 

43 

9.1 

10 

ALKP 

U/L 

83 

13.7 

10 

86 

6.3 

10 

LD 

U/L 

209 

175.3 

10 

** 94 

34.6 

10 

SDH 

U/L 

19.6 

5.38 

10 

* 14.7 

2.64 

10 

BUN 

mg/dL 

13 

1.0 

10 

13 

1.5 

10 

CREAT 

mg/dL 

0.4 

0.05 

10 

0.3 

o.os 

10 

GLU 

mg/dL 

118 

30.5 

10 

113 

27.6 

10 

CK 

U/L 

154 

85.6 

10 

100 

46.7 

10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPB-S 

Table 12 

Mean Clinical Chemistry Values - Recovery 

Group 

1M 

o mg/m(3) Mean 

SD 

n 

4M 

20000 mg/m(3) Mean 

SD n 

CHOL 

mg/dL 

67 

13.2 

10 

67 

19.0 

10 

TP 

g/dL 

7.0 

0.23 

10 

6.9 

0.16 

10 

ALB 

g/dL 

4.2 

0.17 

10 

4.2 

0.14 

10 

Glob 

g/dL 

2.8 

0.20 

10 

2.7 

0.18 

10 

A/G 

1.5 

0.14 

10 

1.6 

0.15 

10 

TBILI 

mg/dL 

0.13 

0.019 

10 

0.13 

0.013 

10 

DBILI 

mg/dL 

0.04 

0.011 

10 

0.03 

0.012 

10 

IBILI 

mg/dL 

0.09 

0.017 

10 

0.10 

0.015 

10 

Na+ 

mBq/L 

146 

1.8 

10 

** 148 

1.0 

10 

P
HUntingdon Life Sciences study No. oo-6130 

Sponsor Study No. 211-DIPB-S 

Table 12 

Mean Clinical Chemistry values - Recovery 

Group 

1M 

0 mg/m(3) 

4M 

20000 mg/m(3) 

Mean 

SD 

D 

Mean 

SD 

n 

K+ 

mBq/L 

6.1 

0.51 

10 

6.2 

0.24 

10 

ClmBq/L 

104 

1.5 

10 

105 ** 

1.3 

10 

C&++ 

mg/dL 

11.2 

0.28 

10 

11.1 

0.43 

10 

PHOS 

mg/dL 

7.8 

0.64 

10 

7.4 

0.39 

10 

GGT 

U/L 

0 

0.4 

10 

0 

0.3 

10 

Bile 

Acids 

umol/L 

39 

24.2 

10 

31 

11.2 

10 

P
Huntingdon Life Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPB-S 

Table 12 

Mean Clinical Chemistry values - Recovery 

Group 

1F 

0 mg/m(3l 

4F 

20000 mg/m(3l 

Mean 

SD 

n 

Mean 

SD 

n 

AST U/L 

109 

75.7 

10 

81 

29.6 

10 

ALT 

0/L 

62 

42.0 

10 

51 

26.3 

10 

ALKP 

U/L 

41 

11.8 

10 

40 

10.4 

10 

LD 

U/L 

149 

54.9 

10 

** 69 

19.9 

10 

SOH 

U/L 

19.4 

8.21 

10 

* 12.8 

5.25 

10 

BUN 

mg/dL 

14 

1.8 

10 

15 

2.3 

10 

CRBAT 

mg/dL 

0.4 

0.05 

10 

0.5 

o.os 

10 

GLU 

mg/dL 

99 

7.4 

10 

103 

10.9 

10 

CK 

0/L 

103 

20.4 

10 

* 77 

22.4 

10 

P
Huntingdon Life Sciences Study Mo. 00-6130 

Sponsor Study Mo. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry Values - Recovery 

Group 

1F 

0 mg/m(3) 

4F 

20000 mg/ml3) 

Mean 

SD 

n 

Mean 

SD n 

CHOL 

mg/dL 

96 

20.1 

10 

96 

19.2 

10 

TP 

g/dL 

7.6 

0.62 

10 

7.9 

0.44 

10 

ALB 

g/dL 

5.0 

0.47 

10 

5.1 

0.45 

10 

Glob 

g/dL 

2.6 

0.25 

10 

2.9 

0.34 

10 

A/G 

1.9 

0.21 

10 

1.9 

0.28 

10 

TBILI 

mg/dL 

0.19 

0.025 

10 

0.17 

0.040 

10 

DBILI 

mg/dL 

0.04 

0.014 

10 

0.04 

0.018 

10 

IBILI 

mg/dL 

0.13 

0.019 

10 

0.13 

0.025 

10 

Ma+ 

mEq/L 

149 

1.6 

10 

* 149 

1.4 

10 

P
HUntingdon Sciences Study No. 00-6130 

Sponsor Study No. 211-DIPE-S 

Table 12 

Mean Clinical Chemistry Values - Recovery 

Group 

1F 

0 mg/m(3) 

4F 

20000 mg/m(3) 

Mean 

SD 

n 

Mean 

SD 

n 

!!:+ 

5.7 

0.34 

10 

5.5 

0.36 

10 

Cl106 

2.9 

10 

107 

1.6 

10 

Ca++ 

11.6 

0.42 

10 

11.8 

0.44 

10 

PHOS 

6.5 

0.60 

10 

6.2 

0.71 

10 

GGT 

U/L 

0 

0.7 

10 

0 

0.7 

10 

Bile 

Acids 

umol/I. 

34 

21.6 

10 

54 

57.5 

10 

P
Huntingdon Life Sciences 00-6130 Page 216

211-DIPE-S Final Report

Mean Organ Weights and

Brain Measurements

Preface Table 13

Table of Contents

Absolute Organ Weights (Terminal Sacrifice - Main Study).............................. 217

% Organ to Body Weight (Terminal Sacrifice - Main Study)............................. 221

% Organ to Brain Weight (Terminal Sacrifice - Main Study)............................. 225

Neurotox Brain Measurements (Terminal Sacrifice)......................................... 229

Absolute Organ Weights (Recovery Sacrifice - Main Study) ............................ 231

% Organ to Body Weight (Recovery Sacrifice - Main Study)............................ 235

% Organ to Brain Weight (Recovery Sacrifice - Main Study)............................ 239

Note: Brain length and width were measured in centimeters.

Corresponding exposure levels for each group were as follows:

Group 1 - 0 mg/m3

Group 2 - 2000 mg/m3

Group 3 - 10000 mg/m3

Group 4 - 20000 mg/m3

Key to Abbreviations:

g = Grams

wt. = Weight

observ. = Observed
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Main Study - Terminal Sacrifice 

Group 

Summary statistics for absolute organ weights (g) 

Study number: 006130 

Terminal Brain Heart 

Body wt. (g) Adrenal Glands Epididymis Kidneys 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

2 

M e a n: 

Standard deviation: 

Number of observ. : 

3 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

528.9 

21.9 

(10) 

506.2 

35.2 

(9) 

514.4 

46.0 

(10) 

516.6 

58.7 

(10) 

0. 0725 0.0066 

(10) 

0.0726 0.0105 

(9) 

0.0680 0.0123 

(10) 

0.0701 0.0080 

(10) 

M a 1 e 

2.2155 

0.0985 

(10) 

2.1477 

0.1038 

(9) 

2.1674 

0.0766 

(10) 

2.1639 

0.0921 

(10) 

A n i m a 1 s 

1.5765 

0.1600 

(10) 

1.6347 

0.2308 

(9) 

1.4379 

0.4102 

(10) 

1. 6259 

0.1776 

(10) 

1.7422 

0.1418 

(10) 

1.6566 

0.1391 

(9) 

1.6614 

0.1786 

(10) 

1.6437 

0.2459 

(10) 

4.3464 

0.4963 

(10) 

4.2592 

0.3751 

(9) 

4.4738 

0.4413 

(10) 

4.5684 

0.4495 

(10) 

Live

15.83

1. 68

(1

14.70

1.93

(

15.04

1. 56

(1

15.53

2.55

(1

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%{$) = mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Summary statistics for absolute organ weights (g) 

Study number: 006130 

Table 13: Main Study - Terminal Sacrifice 

Group 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

2 

M e a n: 

Standard deviation: 

Number of observ. : 

3 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

Terminal 

Body wt. (g) 

528.9 

21.9 

(10) 

506.2 

35.2 

(9) 

514.4 

46.0 

(10) 

516.6 

58.7 

(10) 

Seminal vesicles 

Prostate 

M a 1 e 

1.1331 1. 7279 

0.2870 0.2915 

(10) (10) 

1.0766 1.4215 

0.1893 0.2231 

(9) (9) 

1. 2492 1.7506 

0.2533 0.5404 

(10) (10) 

1.1517 1.7414 

0.2388 0.3770 

(10) (10) 

Testes 

Spleen 

A n i m a 1 s 

0.7744 3.6093 0.1209 0.5810 

(10) (10) 

0.8419 3.4285 

0.1272 0.3058 

(9) (9) 

0.7951 3.4189 0.1315 0.8429 

(10) (10) 

0.7752 3.7369 

0.1536 0.2558 

(10) (10) 

Thymus 

0.3697 0.0893 

(10) 

0.3902 0.0750 

(9) 

0.3563 0.0638 

(10) 

0.3346 0.0674 

(10) 

P

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sign
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Main Study- Terminal Sacrifice 

Group 

Summary statistics for absolute organ weights (g) 

Study number: 006130 

Terminal Brain Kidneys 

Body wt. (g) Adrenal Glands Heart 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

2 

M e a n: 

Standard deviation: 

Number of observ. : 

3 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

294.0 

24.5 

(10) 

288.5 

25.2 

(10) 

309.1 

32.0 

(10) 

284.6 

28.3 

(10) 

0.0683 0.0078 

(10) 

0.0768 0.0118 

(10) 

0.0675 0.0151 

(10) 

0.0696 0.0115 

(10) 

F e m a l e 

2.0282 

0.0739 

(10) 

2.0683 

0.1021 

(10) 

2.1027 

0.0831 

(10) 

2.0794 

0.0692 

(10) 

A n i m a l s 

1.0565 

0.1207 

(10) 

1. 0822 

0.1119 

(10) 

1.1183 

0.1006 

(10) 

1.0079 

0.0943 

(10) 

2.3602 

0.1791 

(10) 

2.3957 

0.3473 

(10) 

2.6543 

0.2585 

(10) 

2.4240 

0.2768 

(10) 

Liver 

8.3127 

0.9646 

(10) 

8.3821 

1.0932 

(10) 

9.1685 

1. 5541 

(10) 

8.8250 

1.0968 

(10) 

P

Lung

1. 595

0.176

(10

1. 615

0.239

(10

1. 73

0.168

(10

1.605

0.202

(10

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sign
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Main Study- Terminal Sacrifice 

Group 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

2 

M e a n: 

Standard deviation: 

Number of observ. : 

3 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

Terminal 

Body wt. (g) 

294.0 

24.5 

(10) 

288.5 

25.2 

(10) 

309.1 

32.0 

(10) 

284.6 

28.3 

(10) 

Summary statistics for absolute organ weights (g) 

Study number: 006130 

Thymus 

Spleen Uterus 

F e m a 1 e A n i m a 1 s 

0.5768 0.3190 0.8984 

0.0557 0.0483 0.1815 

(10) (10) (10) 

0.5502 0.3337 0.6860$ 0.0889 0.0517 0.0609 

(10) (10) (10) 

0.5881 0.3392 1.0049 0.0874 0.0612 0.3861 

(10) (10) (10) 

0.5771 0.2991 0.8003 0.0755 0.0688 0.2566 

(10) (10) (10) 

P

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sign
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Main Study - Terminal Sacrifice 

Group 

Summary Statistics for % Organ to Body Weight 

Study number: 006130 

Terminal Brain Heart 

Body wt. (g) Adrenal Glands Epididymis 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

2 

M e a n: 

Standard deviation: 

Number of observ. : 

3 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

528.9 

21.9 

(10) 

506.2 

35.2 

(9) 

514.4 

46.0 

(10) 

516.6 

58.7 

(10) 

0.0137 

0.0012 

(10) 

0.0145 0.0027 

(9) 

0.0132 

0.0017 

(10) 

0.0136 0.0015 

(10) 

M a 1 e 

0.4190 0.0135 

(10) 

0.4258 0.0310 

(9) 

0.4234 0.0284 

(10) 

0.4230 0.0429 

(10) 

A n i m a 1 s 

0.2980 0.0268 

(10) 

0.3229 0.0390 

(9) 

0.2800 0.0837 

(10) 

0.3172 0.0419 

(10) 

0.3295 

0.0245 

(10) 

0.3277 0.0235 

(9) 

0.3232 

0.0235 

(10) 

0.3174 0.0167 

(10) 

Kidneys 

0. 8211 0.0801 

(10) 

0.8413 0.0437 

(9) 

0.8714 0. 0715 

(10) 

0.8866 0.0521 

(10) 

P

Liver 

2.991

0.279

(10

2.898

0.218

(9

2.926

0.193

(10

2.995

0.226

(10

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of signi

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sign
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Summary Statistics for % Organ to Body Weight 

Study number: 006130 

Table 13: Main Study- Terminal Sacrifice 

Group 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

2 

M e a n: 

Standard deviation: 

Number of observ. : 

3 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

Terminal 

Body wt. (g) 

528.9 

21.9 

(10) 

506.2 

35.2 

(9) 

514.4 

46.0 

(10) 

516.6 

58.7 

(10) 

Seminal vesicles 

Prostate 

M a 1 e 

0.2149 0.3268 0.0561 0.0537 

(10) (10) 

0.2137 0.2805 0.0410 0.0365 

(9) (9) 

0.2447 0.3423 0.0546 0.1093 

(10) (10) 

0.2230 0.3387 

0.0391 0.0722 

(10) (10) 

Testes 

Spleen 

A n i m a 1 s 

0.1466 0.6815 0.0229 0.0990 

(10) (10) 

0.1672 0.6800 0.0282 0.0737 

(9) (9) 

0.1552 0.6653 0.0259 0.1664 

(10) (10) 

0.1496 0.7320 0.0226 0.1040 

(10) (10) 

Thymus 

0.0695 0.0146 

(10) 

0.0767 0.0121 

(9) 

0.0694 0.0120 

(10) 

0.0646 0.0100 

(10) 

P

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of signi

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sign
Huntingdon Life Sciences Summary Statistics for % Organ to Body Weight 

Princeton Research Center Study number: 006130 

East Millstone, New Jersey 

Table 13: Main Study - Terminal Sacrifice 

Group Terminal Brain Kidneys 

Body wt. (g) Adrenal Glands Heart 

F e m a l e A n i m a l s 

1 

M e a n: 294.0 0.0234 0.6928 0.3596 0.8067 

Standard deviation: 24.5 0.0034 0.0463 0.0319 0.0829 

Number of observ. : (10) (10) (10) (10) (10) 

2 

M e a n: 288.5 0.0268 0.7206 0.3758 0.8300 

Standard deviation: 25.2 0.0045 0.0577 0.0314 0.0946 

Number of observ. : (10) (10) (10) (10) (10) 

3 

M e a n: 309.1 0.0219 0.6867 0.3629 0.8646 

Standard deviation: 32.0 0.0047 0.0761 0.0229 0.1009 

Number of observ. : (10) (10) (10) (10) (10) 

4 

M e a n: 284.6 0.0246 0.7363 0.3554 0.8542 

Standard deviation: 28.3 0.0044 0.0668 0.0283 0.0851 

Number of observ. : (10) (10) (10) (10) (10) 

Liver 

2.8332 

0.3111 

(10) 

2.8998 

0.1907 

(10) 

2.9582 

0.2915 

(10) 

3.1046 

0.2585 

(10) 

Lung

0.5430.045

(1

0.560.082

(1

0.5630.066

(1

0.5690.099

(1

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%{$) = mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Main Study - Terminal Sacrifice 

Group Terminal 

Body wt. (g) 

1 

M e a n: 294.0 

Standard deviation: 24.5 

Number of observ. : (10) 

2 

M e a n: 288.5 

Standard deviation: 25.2 

Number of observ. : (10) 

3 

M e a n: 309.1 

Standard deviation: 32.0 

Number of observ. : (10) 

4 

M e a n: 284.6 

Standard deviation: 28.3 

Number of observ. : (10) 

Summary Statistics for % Organ to Body Weight 

Study number: 006130 

Thymus 

Spleen Uterus 

F e m a l e A n i m a l s 

0.1974 0.1090 0.3067 

0.0252 0.0181 0.0645 

(10) (10) (10) 

0.1903 0.1166 0.2383% 0.0225 0.0214 0.0174 

(10) (10) (10) 

0.1904 0.1099 0.3285 

0.0225 0.0174 0.1320 

(10) (10) (10) 

0.2038 0.1055 0.2852 

0.0265 0.0270 0.0981 

(10) (10) (10) 

P

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sign
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Main Study- Terminal Sacrifice 

Group 

Summary Statistics for % Organ to Brain Weight 

Study number: 006130 

Terminal Brain Heart 

Body wt. (g) Adrenal Glands Epididymis 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

2 

M e a n: 

Standard deviation: 

Number of observ. : 

3 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

528.9 

21.9 

(10) 

506.2 

35.2 

(9) 

514.4 

46.0 

(10) 

516.6 

58.7 

(10) 

3.2751 

0. 3 068 

(10) 

3.3970 

0.5725 

(9) 

3.1407 

0.5634 

(10) 

3.2410 

0.3416 

(10) 

M a 1 e 

100.0000 

0.0000 

(10) 

100.0000 

0.0000 

(9) 

100.0000 

0.0000 

(10) 

100.0000 

0.0000 

(10) 

A n i m a 1 s 

71.1861 

6.7627 

(10) 

76.0754 

9.9999 

(9) 

66.4679 

19.1909 

(10) 

75.4128 

10.1435 

(10) 

78.7923 

7.5643 

(10) 

77.3440 

8.0110 

(9) 

76.7095 

8.2462 

(10) 

76.0710 

11.9499 

(10) 

Kidneys 

196.3874 

23.1171 

(10) 

198.4332 

16.3400 

(9) 

206.5097 

19.8247 

(10) 

211.0862 

18.7674 

(10) 

P

Liver 

714.107

63.330

(10

686.091

94.182

(9

694.302

66.463

(10

718.637

120.296

(10

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of signi

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sign
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Summary Statistics for % Organ to Brain Weight 

Study number: 006130 

Table 13: Main Study- Terminal Sacrifice 

Group 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

2 

M e a n: 

Standard deviation: 

Number of observ. : 

3 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

Terminal 

Body wt. (g) 

528.9 

21.9 

(10) 

506.2 

35.2 

(9) 

514.4 

46.0 

(10) 

516.6 

58.7 

(10) 

Seminal vesicles 

Prostate 

M a 1 e 

51.2043 78.0026 

12.8696 12.6975 

(10) (10) 

50.1626 65.9880% 

8.7842 8.2619 

(9) (9) 

57.4743 81.1189 

10.5286 25.8248 

(10) (10) 

53.4552 80.4902 

11.9996 17.0347 

(10) (10) 

Testes 

Spleen 

A n i m a 1 s 

35.0394 163.2256 

5.8600 27.5023 

(10) (10) 

39.2541 159.7528 

6.0887 13.3620 

(9) (9) 

36.7023 158.0105 

5.9544 39.5019 

(10) (10) 

35.8259 173.2907 

6.9513 17.9686 

(10) (10) 

Thymus 

16.6305 

3.6458 

(10) 

18.1942 

3.6350 

(9) 

16.5036 

3.2765 

(10) 

15.4663 

3.0664 

(10) 

P

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of signi

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sign
Huntingdon Life Sciences Summary Statistics for % Organ to Brain Weight 

Princeton Research Center Study number: 006130 

East Millstone, New Jersey 

Table 13: Main Study - Terminal Sacrifice 

Group Terminal Brain Kidneys Lun

Body wt. (g) Adrenal Glands Heart Liver 

F e m a 1 e A n i m a 1 s 

1 

M e a n: 294.0 3.3732 100.0000 52.0429 116.3003 409.4997 78.5

Standard deviation: 24.5 0.4254 0.0000 4.9719 6.7233 40.3534 6.8

Number of observ. : (10) (10) (10) (10) (10) (10) (

2 

M e a n: 288.5 3. 7110 100.0000 52.3417 115.7209 404.9260 77.9

Standard deviation: 25.2 0.5346 0.0000 4.9064 15.0587 44.9891 9.5

Number of observ. : (10) (10) (10) (10) (10) (10) (

3 

M e a n: 309.1 3.2164 100.0000 53.2591 126.2977 436.4908 82.3

Standard deviation: 32.0 0.7397 0.0000 5.2692 11.8921 75.6905 7.8

Number of observ. : (10) (10) (10) (10) (10) (10) (

4 

M e a n: 284.6 3.3459 100.0000 48.4561 116.3956 423.9828 77.1

Standard deviation: 28.3 0.5434 0.0000 4.0461 11.1258 46.3470 9.0

Number of observ. : (10) (10) (10) (10) (10) (10) (

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sig

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of si
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Main Study- Terminal Sacrifice 

Group 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

2 

M e a n: 

Standard deviation: 

Number of observ. : 

3 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

Terminal 

Body wt. (g) 

294.0 

24.5 

(10) 

288.5 

25.2 

(10) 

309.1 

32.0 

(10) 

284.6 

28.3 

(10) 

Summary Statistics for % Organ to Brain Weight 

Study number: 006130 

Thymus 

Spleen Uterus 

Female A n i m a l s 

28.4970 15.7873 44.4148 

3.2283 2.7791 9.7483 

(10) (10) (10) 

26.6826 16.1213 33.1895$ 

4.5465 2.2483 2. 7911 

(10) (10) (10) 

28.0501 16.1643 47.7500 

4.6431 2.9250 17.8805 

(10) (10) (10) 

27.8128 14.3506 38.6511 

4.0235 3.2323 13.0661 

(10) (10) (10) 

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sig

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Summary statistics for absolute organ weights (g) 

Study number: 006130N 

Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Terminal Sacrifice - Neurotox Brain Measurement 

Group 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

2 

M e a n: 

Standard deviation: 

Number of observ. : 

3 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

Terminal 

Body wt. (g) 

558.6 

72.5 

(5) 

561.2 

72.2 

(5) 

583.6 

52.4 

(5) 

542.5 

68.1 

(5) 

Length 

weight Width 

M a 1 e A n i m a 1 s 

1.6818 2.1 1.5 

0.1482 0.0 0.0 

(5) (5) (5) 

1.7532 2.2 1.5 

0.0710 0.1 0.0 

(5) (5) (5) 

1.7896 2.2 1.5 

0.1189 0.1 0.0 

(5) (5) (5) 

1.7512 2.1 1.5 

0.0876 0.1 0.0 

(5) (5) (5) 

P

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%{$) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sign
Summary statistics for absolute organ weights (g) 

Study number: 006130N 

Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Terminal Sacrifice - Neurotox Brain Measurements 

Group 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

2 

M e a n: 

Standard deviation: 

Number of observ. : 

3 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

Terminal 

Body wt. (g) 

330.5 

40.3 

(5) 

318.5 

24.5 

(5) 

315.9 

53.5 

(5) 

316.7 

29.6 

(5) 

Length 

Weight Width 

F e m a 1 e A n i m a 1 s 

1. 6494 2.1 1.5 

0.0340 0.0 0.0 

(5) (5) (5) 

1. 6998 2.1 1.5 

0.0309 0.0 0.0 

(5) (5) (5) 

1.6786 2.1 1.4 

0.1498 0.0 0.1 

(5) (5) (5) 

1.7058 2.1 1.4 

0.0678 0.0 0.0 

(5) (5) (5) 

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Recovery Sacrifice- Main Study 

Group 

Summary statistics for absolute organ weights (g) 

Study number: 006130 

Terminal Brain Heart 

Body wt. (g) Adrenal Glands Epididymis Kidneys 

M a 1 e A n i m a 1 s 

1 

M e a n: 540.5 0.0686 2.2416 1.5543 1.6989 4.3624 

Standard deviation: 36.8 0.0107 0.1002 0.0751 0.1729 0.4534 

Number of observ. : (10) (10) (10) (10) (10) (10) 

4 

M e a n: 543.6 0.0691 2.2632 1.6357 1.7284 4.6263 

Standard deviation: 29.8 0.0089 0.0920 0.1361 0.1421 0.5443 

Number of observ. : (10) (10) (10) (10) (10) (10) 

P

Liver 

14.865

1.293

(10

15.766

1.373

(10

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of signi

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sign
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Summary statistics for absolute organ weights (g) 

Study number: 006130 

Table 13: Recovery Sacrifice -Main Study 

Group 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

Terminal 

Body wt. (g) 

540.5 

36.8 

(10) 

543.6 

29.8 

(10) 

Seminal vesicles 

Prostate 

M a 1 e 

1.2788 1.8435 

0.2642 0.5598 

(10) (10) 

1.1843 2.1906 

0.1831 0.5179 

(10) (10) 

Testes 

Spleen 

A n i m a 1 s 

0.8687 3.4205 0.1458 0.2335 

(10) (10) 

0.8902 3.7421* 0.1834 0.2829 

(10) (10) 

Thymus 

0.2751 0.0973 

(10) 

0.3001 0.0782 

(10) 

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Recovery Sacrifice -Main Study 

Group 

Summary statistics for absolute organ weights (g) 

Study number: 006130 

Terminal Brain Kidneys 

Body wt. (g) Adrenal Glands Heart 

F e m a 1 e A n i m a 1 s 

1 

M e a n: 288.9 0.0746 2 .1420 1.0282 2.3961 

Standard deviation: 22.2 0.0103 0.0764 0.0617 0.1492 

Number of observ. : (10) (10) (10) (10) (10) 

4 

M e a n: 294.5 0.0783 2.0981 1.1821 2.4379 

Standard deviation: 17.1 0.0065 0.0504 0.3198 0.1904 

Number of observ. : (10) (10) (10) (10) (10) 

Liver 

8.8277 

0.5781 

(10) 

8.9586 

1.2645 

(10) 

Lun

1.5

0.0

(

1.6

0.2

(

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sig

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of si
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Recovery Sacrifice -Main Study 

Group 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

Terminal 

Body wt. (g) 

288.9 

22.2 

(10) 

294.5 

17.1 

(10) 

Summary statistics for absolute organ weights (g) 

Study number: 006130 

Thymus 

Spleen Uterus 

F e m a 1 e A n i m a 1 s 

0.6031 0.2543 0.9948 

0.0757 0.0586 0.2960 

(10) (10) (10) 

0.5987 0.2655 0.8199 

0.0916 0.0399 0.3129 

(10) (10) (10) 

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%($) = mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Recovery Sacrifice -Main Study 

Group 

Summary Statistics for % Organ to Body Weight 

Study number: 006130 

Terminal Brain Heart 

Body wt. (g) Adrenal Glands Epididymis 

M a 1 e A n i m a 1 s 

1 

M e a n: 540.5 0.0128 0.4159 0.2889 0.3144 

Standard deviation: 36.8 0.0024 0.0261 0.0256 0.0254 

Number of observ. : (10) (10) (10) (10) (10) 

4 

M e a n: 543.6 0.0128 0.4173 0.3020 0.3181 

Standard deviation: 29.8 0.0022 0.0255 0.0336 0.0225 

Number of observ. : (10) (10) (10) (10) (10) 

Kidneys 

0.8073 0.0661 

(10) 

0.8520 0.0977 

(10) 

Liv

2.75

0.21

(

2.90

0.21

(

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Summary Statistics for % Organ to Body Weight 

Study number: 006130 

Table 13: Recovery Sacrifice- Main Study 

Group 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

Terminal 

Body wt _ (g) 

540.5 

36.8 

(10) 

543.6 

29.8 

(10) 

Seminal vesicles 

Prostate 

M a 1 e 

0.2390 0.3386 0.0593 0.0915 

(10) (10) 

0.2191 0.4034 0.0409 0.0946 

(10) (10) 

Testes 

Spleen 

A n i m a 1 s 

0.1603 0.6343 

0.0222 0.0466 

(10) (10) 

0.1629 0.6898* 0-0272 0.0600 

(10) (10) 

Thymus 

0.0507 

0.0177 

(10) 

0.0550 0.0129 

(10) 

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%{$) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Recovery Sacrifice- Main Study 

Group 

Summary Statistics for % Organ to Body Weight 

Study number: 006130 

Terminal Brain Kidneys 

Body wt. (g) Adrenal Glands Heart 

F e m a 1 e A n i m a 1 s 

1 

M e a n: 288.9 0.0259 0.7451 0.3574 0.8320 

Standard deviation: 22.2 0.0042 0.0595 0.0302 0.0612 

Number of observ. : (10) (10) (10) (10) (10) 

4 

M e a n: 294.5 0.0266 0. 7149 0.4016 0.8286 

Standard deviation: 17.1 0.0021 0.0507 0.1059 0.0585 

Number of observ. : (10) (10) (10) (10) (10) 

Liver 

3.0710 

0.3050 

(10) 

3.0381 

0.3681 

(10) 

P

Lung

0.5340.057

(10

0.5450.060

(10

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%($) = mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Recovery Sacrifice- Main Study 

Group 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

Terminal 

Body wt. (g) 

288.9 

22.2 

(10) 

294.5 

17.1 

(10) 

Summary Statistics for % Organ to Body Weight 

Study number: 006130 

Thymus 

Spleen Uterus 

F e m a 1 e A n i m a 1 s 

0.2087 0.0884 0.3452 0.0197 0.0202 0.1004 

(10) (10) (10) 

0.2033 0.0901 0.2775 0.0280 0.0125 0.1000 

(10) (10) (10) 

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Recovery Sacrifice -Main Study 

Group 

Summary Statistics for % Organ to Brain Weight 

Study number: 006130 

Terminal Brain Heart 

Body wt. (g) Adrenal Glands Epididymis 

M a l e A n i m a l s 

1 

M e a n: 540.5 3.0693 100.0000 69.5118 75.7644 

Standard deviation: 36.8 0. 5371 0.0000 5.3618 6.6130 

Number of observ. : (10) (10) (10) (10) (10) 

4 

M e a n: 543.6 3.0600 100.0000 72.4622 76.4156 

Standard deviation: 29.8 0.4430 0.0000 7.4811 6.1973 

Number of observ. : (10) (10) (10) (10) (10) 

Kidneys 

194.4783 

16.4682 

(10) 

204.1324 

19.2810 

(10) 

Live

664.405

63.734

(1

696.840

55.86

(1

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Summary Statistics for % Organ to Brain Weight 

Study number: 006130 

Table 13: Recovery Sacrifice -Main Study 

Group 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

Terminal 

Body wt. (g) 

540.5 

36.8 

(10) 

543.6 

29.8 

(10) 

Seminal vesicles 

Prostate 

M a 1 e 

57.2014 81.6144 

12.0790 23.0587 

(10) (10) 

52.3306 97.3335 

7.6983 24.8323 

(10) (10) 

Testes 

Spleen 

A n i m a 1 s 

38.8754 152.6653 

6.9694 9.1502 

(10) (10) 

39.3058 165.7971* 

7.6661 16.6181 

(10) (10) 

Thymus 

12.3440 

4.6503 

(10) 

13.2347 

3.2593 

(10) 

P

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Recovery Sacrifice -Main Study 

Group 

Summary Statistics for % Organ to Brain Weight 

Study number: 006130 

Terminal Brain Kidneys 

Body wt. (g) Adrenal Glands Heart 

Female A n i m a 1 s 

1 

M e a n: 288.9 3.4780 100.0000 48.0365 111.9848 

Standard deviation: 22.2 0.4327 0.0000 3.0277 8. 0711 

Number of observ. : (10) (10) (10) (10) (10) 

4 

M e a n: 294.5 3.7344 100.0000 56.2085 116.2735 

Standard deviation: 17.1 0.3260 0.0000 14.1922 9.7910 

Number of observ. : (10) (10) (10) (10) (10) 

Liver 

412.2083 

24.5428 

(10) 

426.6188 

56.1668 

(10) 

Lung

71.785

5.372

(1

76.664

9. 729

(1

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%($) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 13: Recovery Sacrifice - Main Study 

Group 

1 

M e a n: 

Standard deviation: 

Number of observ. : 

4 

M e a n: 

Standard deviation: 

Number of observ. : 

Terminal 

Body wt. (g) 

288.9 

22.2 

(10) 

294.5 

17.1 

(10) 

Summary Statistics for % Organ to Brain Weight 

Study number: 006130 

Thymus 

Spleen Uterus 

F e m a 1 e A n i m a 1 s 

28.2112 11.9131 46.4072 

3. 9161 2.8620 13.5217 

(10) (10) (10) 

28.5218 12.6689 39.1512 

4.1761 1.9629 15.1460 

(10) (10) (10) 

*(+) =mean value of group was significantly different from control at P = 0.05(0.01) with Dunnett's test of sign

%{$) =mean value of group was significantly different from control at P = 0.05(0.01) with Modified T test of sig
Huntingdon Life Sciences 00-6130 Page 243

211-DIPE-S Final Report

Incidence Summary Report

for Gross Necropsy Observations

Preface Table 14

Table of Contents

Main Study - Terminal Sacrifice........................................................................ 244

Main Study - Recovery Sacrifice....................................................................... 245

Neuropathology Sacrifice.................................................................................. 246

Key to Abbreviations 

LN = Lymph Node

Submandib/Max = Submandibular/Submaxillary

Corresponding exposure levels for each group were as follows:

Group 1 - 0 mg/m3

Group 2 - 2000 mg/m3

Group 3 - 10000 mg/m3

Group 4 - 20000 mg/m3
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 14: Main Study - Terminal Sacrifice 

Group: 

Number in group: 

Within normal limits .............. 

Epididymis 

Small ••••••••• 0 ••••• 0 •••••••••• 

Kidneys 

Dilated Pelvis ................. 

Cyst ........................... 

Lungs 

Discolored ..................... 

Seminal vesicles 

Small • 0 ••••• 0 0. 0 0 0 •• 0 •••••••••• 

Submandib/Max LN 

Discolored ..................... 

Enlarged ....................... 

Testes 

Small •••• 0 0 •••• 0 •••••••• 0 0 0 •••• 

Soft ........................... 

Thymus 

Discolored ..................... 

Skin-protocol 

Hair Thin/Absent 0 •••• 0. 0 •••••• 0 

1 

10 

3 

1 

2 

1 

2 

0 

1 1 1 

0 

0 

0 

Incidence Summary Report for Gross Necropsy Observations 

Study number: 006130 

Males 

2 3 

9 10 

7 7 

0 1 0 0 0 0 

2 2 

0 1 

0 0 0 0 0 1 0 1 0 1 0 0 

4 

10 

5 

0 

1 

0 3 

1 

0 0 

0 0 

0 0 

I I 

I I 

I 

1 

10 

7 

0 0 0 

1 

0 

0 0 0 0 0 

2 

Females --

2 3 

10 10 

8 8 

0 0 0 0 0 0 

1 1 

0 0 

0 0 0 0 0 0 0 0 

0 0 

1 1 

4 

10 

9 

0 0 0 

1 

0 

0 0 0 0 0 0 
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Incidence Summary Report for Gross Necropsy Observations 

Study number: 006130 

Table 14: Main Study - Recovery Sacrifice 

Group: 

Number in group: 

Within normal limits •••• 0 0 •••••••• 

Lungs 

Discolored ••••• 0 0 0 ••••• 0. 0 0 •••• 

Thymus 

Discolored ..................... 

Skin-protocol 

Hair Thin/Absent • 0 ••••••••••••• 

Vagina 

Nodule •• 0 ••••••• 0 0 ••• 0 0. 0 0 0 0. 0. 

Males 

1 

10 

7 

1 

2 

0 

0 

4 

10 

8 

1 1 

0 0 

1--

1 

I I 

I 

I 

Females --

1 4 

10 10 

8 9 

1 1 

0 0 

1 0 1 0 
Huntingdon Life Sciences 

Princeton Research Center 

East Millstone, New Jersey 

Table 14: Neurotox 

Group: 

Number in group: 

Within normal limits ••• 0. 0. 0 •• 0 0 0 0 

Lungs 

Discolored •••• 0 0 0 0 ••••••••••• 0. 

Kidneys 

Discolored ..................... 

Thymus 

Discolored 0 •• 0 0 •••••••••• 0 0 0 0 •• 

Skin-protocol 

Hair Thin/Absent 0 0 0 ••• 0 0 0 •••• 0 0 

Scab 0 0. 0 •••••••••• 0 0 ••••••• 0 0. 0 

1 

5 

3 

1 

1 

0 0 0 

Incidence Summary Report for Gross Necropsy Observations 

Study number: 006130N 

Males 

2 3 

5 5 

5 5 

0 0 

0 0 

0 0 0 0 0 0 

4 

5 

3 

0 

1 

1 

1 1 

I I 

I 

I 

I 

1 

5 

5 

0 

0 

0 0 0 

Females 

2 3 

5 5 

4 3 

1 2 

0 0 

0 0 0 0 0 0 

4 

5 

4 

1 

0 

0 

0 

0 
Huntingdon Life Sciences 00-6130 Page 247

211-DIPE-S Final Report

Incidence Summary of Microscopic 

Findings with Severity Levels

Preface Table 15

Table of Contents

Main Study - Terminal Sacrifice........................................................................ 248

Main Study - Recovery Sacrifice....................................................................... 257

Neuropathology Sacrifice.................................................................................. 264

Key to Abbreviations 

Fibr = Fiber

Gang = Ganglia

LN = Lymph Node

Nad = No abnormal diagnoses

Nose/Turb Sec 1 = Nose/Turbinates Section 1 

Nose/Turb Sec 2 = Nose/Turbinates Section 2

Nose/Turb Sec 3 = Nose/Turbinates Section 3

Nose/Turb Sec 4 = Nose/Turbinates Section 4

SC = Spinal Cord

Submandib/Max = Submandibular/Submaxillary

V-DVTC = Ventral Diverticulum

V-SM-G = Ventral Seromucinous Glands

Corresponding exposure levels for each group were as follows:

Group 1 - 0 mg/m3

Group 2 - 2000 mg/m3

Group 3 - 10000 mg/m3

Group 4 - 20000 mg/m3
15-Dec-11; 17:43 

Huntingdon Life Sciences 006130 

Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Terminal Sacrifice 

-- A n i m a l s 

Controls from group(s): 1 Animal sex: -- M a l e s --

Dosage group: Ctls 2 3 4 

T i s s u e s W i t h D i a g n o s e s No. in group: 10 9 10 10 I 

Adrenal Glands ................................. Number examined: 10 0 0 10 I 

CONGESTION 

Nad> 

Minimal> 

............................ Total Incidence of Finding Observed: 

Aorta .......................................... Number examined: 

Brain .......................................... Number examined: 

Cecum .......................................... Number examined: 

Cervical SC .................................... Number examined: 

Colon ................ . LUMEN: NEMATODE(S) ......................... Number examined: 

Nad> 

Present> 

............................ Total Incidence of Finding Observed: 

Duodenum ....................................... Number examined : 

Epididymis ..................................... Number examined: 

Esophagus ...................................... Number examined: 

Femur .......................................... Number examined : 

Heart .......................................... Number examined: 

MONONUCLEAR CELL INFILTRATE WITH MYOFIBER DEGENERATION/LOSS 

Nad> 

Minimal> 

............................ Total Incidence of Finding Observed: 

Ileum .......................................... Number examined: 

Jejunum ........................................ Number examined: 

All Diagnoses; Phases: P2; Death types: Scheduled FS; Date of death 

10 

0 0 

10 10 10 

10 

10 

9 

1 1 

10 10 

9 

10 10 

6 

4 4 

10 10 

0 0 0 

0 

0 0 

0 0 0 0 0 0 0 0 

0 0 

0 

0 

0 

0 0 

0 

0 0 

0 0 0 0 0 0 0 0 

0 0 0 

0 0 0 0 0 

0 

0 

10 

0 0 

10 10 10 

10 10 

10 

0 0 

10 10 10 

10 10 

9 

1 1 

10 10 

I 

I I 

range: 13-May-02 To 14-May-02 

A f f e c t e 

-- F e m 

Ctls 

10 10 

9 

1 1 

10 

10 10 

10 10 

9 

1 1 

10 10 

10 10 

8 

2 2 

10 10 

2 

10 

0 

0 0 0 

0 

0 0 

0 0 0 0 0 

0 

0 

0 0 0 0 0 0 0 
15-Dec-11; 17:43 

Huntingdon Life Sciences 006130 Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Terminal Sacrifice 

-- A n i m a l s 

Controls from group(s): 1 Animal sex: -- M a l e s -- I 

Dosage group: Ctls 2 3 4 I 

T i s s u e s W i t h D i a g n o s e s No. in group: 10 9 10 10 I 

Kidneys ........................................ Number examined: 10 0 0 10 I 

CORTEX: PROXIMAL CONVOLUTED TUBULAR 

-EPITHELIUM-EOSINOPHILIC/HYALINE DROPLETS 

Nad> 

Minimal> 

Slight> 

............................ Total Incidence of Finding Observed: 

BASOPHILIC TUBULES 

Nad> 

Minimal> 

Slight> 

............................ Total Incidence of Finding Observed: 

CORTEX: LYMPHOID CELL AGGREGATE(S) 

Nad> 

Minimal> 

............................ Total Incidence of Finding Observed: 

CORTEX/CORTICO-MEDULLARY JUNCTION: MINERAL DEPOSIT(S) 

Nad> 

Minimal> 

Slight> 

............................ Total Incidence of Finding Observed: 

CORTEX/CORTICO-MEDULLARY JUNCTION: TUBULE(S) DILATED 

Nad> 

Minimal> 

............................ Total Incidence of Finding Observed: 

10 

0 0 

0 

7 

2 

1 

3 6 

4 4 

10 

0 0 0 

9 

1 

1 

0 0 

0 

0 

0 

0 0 

0 0 0 0 

0 0 

0 

0 

0 0 0 

0 0 0 

0 

0 

0 0 

0 0 0 0 

0 0 

0 

0 

0 0 0 

0 

1 

9 

10 

3 

5 

2 

7 

2 

8 8 

10 

0 

0 0 

10 

0 0 

All Diagnoses; Phases: P2; Death types: Scheduled FS; Date of death range: 13-May-02 To 14-May-02 

A f f e c t e 

-- F e m 

Ctls 2 

10 10 

10 

10 

0 0 

0 

10 

0 0 

0 

8 

2 

2 

4 

5 

1 

6 

10 

0 0 

0 

0 0 0 

0 0 0 0 

0 

0 0 

0 

0 0 0 0 0 0 0 
15-Dec-11; 17:43 

Huntingdon Life Sciences 006130 Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Terminal Sacrifice 

-- A n i m a 1 s 

Controls from group(s): 1 Animal sex: M a 1 e s -- I 

Dosage group: Ctls 2 3 4 I 

T i s s u e s W i t h D i a g n o s e s No. in group: 10 9 10 10 I 

Kidneys ........................................ Number examined: 10 0 0 10 

UROTHELIAL HYPERPLASIA 

Nad> 

Minimal> 

............................ Total Incidence of Finding Observed: 

PELVIS: DILATED 

Nad> 

Minimal> 

Slight> 

............................ Total Incidence of Finding Observed: 

CORTICAL CYST 

Nad> 

Present> 

............................ Total Incidence of Finding Observed: 

Larynx: V-DVTC ................................. Number examined: 

SUBMUCOSAL LYMPHOCYTIC AGGREGATE 

Nad> 

Minimal> 

............................ Total Incidence of Finding Observed: 

SUBMUCOSAL CYSTS WITH EOSINOPHILIC CRYSTALS 

Nad> 

Present> 

............................ Total Incidence of Finding Observed: 

Larynx: V-SM-G ................................. Number examined: 

GRANULOMATOUS CHONDROPATHY 

Nad> 

Minimal> 

Slight> 

............................ Total Incidence of Finding Observed: 

10 

0 

0 

8 

1 

1 

2 

9 

1 

1 

10 

5 5 5 

8 

2 

2 

10 10 

0 0 

0 

0 0 

0 

0 0 0 0 0 

0 0 0 

0 

0 0 

0 

0 

0 0 0 0 0 

0 

0 0 0 

0 

0 0 0 

0 0 0 0 

0 

0 0 

0 0 

0 0 

0 0 0 

0 

9 

1 1 

9 

1 

0 

1 

10 

0 0 

10 

5 5 5 

10 

0 

0 

10 10 

0 0 

0 

All Diagnoses; Phases: P2; Death types: Scheduled FS; Date of death range: 13-May-02 To 14-May-02 

A f f e c t e 

-- F e m 

Ctls 2 

10 10 

10 0 

10 

0 

0 

10 

0 0 0 

10 

0 0 

10 

8 

2 2 

7 

3 

3 

10 

7 

1 

2 

3 

0 0 0 0 0 0 0 

0 

0 

0 

0 

0 0 

0 

0 0 

0 0 0 0 

0 

0 
15-Dec-11; 17:43 

Huntingdon Life Sciences 006130 

Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Terminal Sacrifice 

-- A n i m a 1 s 

Controls from group(s): 1 Animal sex: -- M a 1 e s I 

Dosage group: Ctls 2 3 4 I 

T i s s u e s w i t h D i a g n o s e s No. in g:rou12: 10 9 10 10 I 

Larynx: V-SM-G ................................. Number examined: 10 0 0 10 I 

SUBMUCOSAL LYMPHOCYTIC AGGREGATE 

Nad> 6 0 0 8 

Minimal> 4 0 0 1 

Slight> 0 0 0 1 

............................ Total Incidence of Finding Observed: 4 0 0 2 

Liver .......................................... Number examined: 10 0 0 10 

MONONUCLEAR CELL AGGREGATES 

Nad> 1 0 0 2 

Minimal> 9 0 0 8 

............................ Total Incidence of Finding Observed: 9 0 0 8 

Lumbar SC ...................................... Number examined : 10 0 0 10 I Lungs .......................................... Number examined : 10 9 10 10 

ALVEOLAR/INTRAALVEOLAR MACROPHAGES 

Nad> 10 9 10 10 I 

Minimal> 0 0 0 0 I 

............................ Total Incidence of Finding Observed: 0 0 0 0 I 

HEMORRHAGE 

Nad> 9 9 10 9 

Minimal> 1 0 0 1 

............................ Total Incidence of Finding Observed: 1 0 0 1 

VISCERAL PLEURA/CAPSULE: FIBROSIS 

Nad> 10 9 10 10 I 

............................ Total Incidence of Finding Observed: 0 0 0 0 I 

All Diagnoses; Phases: P2; Death types: Scheduled FS; Date of death range: 13-May-02 To 14-May-02 

A f f e c t e 

-- F e m 

Ctls 2 

10 10 10 0 

6 0 

4 0 

0 0 

4 0 

10 0 

4 0 

6 0 

6 0 

10 0 

10 10 10 10 

0 0 

0 0 

10 10 

0 0 

0 0 

10 10 

0 0 
15-Dec-11; 17:43 

Huntingdon Life Sciences 006130 

Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Terminal Sacrifice 

-- A n i m a l s 

Controls from group(s): 1 Animal sex: M a l e s 

Dosage group: Ctls 2 3 4 

T i s s u e s W i t h D i a g n o s e s No. in group: 10 9 10 10 I 

Mediastinal LN ................................. Number examined: 9 0 0 9 I 

SINUSES: FREE ERYTHROCYTES 

Nad> 

Minimal> 

Slight> 

............................ Total Incidence of Finding Observed: 

Mesenteric LN .................................. Number examined: 

Nose/Turb Sec 1 ................................ Number examined: 

ODONTOPATHY 

Nad> 

Minimal> 

Moderate> 

............................ Total Incidence of Finding Observed: 

SEPTAL DEVIATION 

Nad> 

Present> 

............................ Total Incidence of Finding Observed: 

NASOLACRIMAL DUCT(S): LUMEN-HEMORRHAGE(S) 

Nad> 

Minimal> 

Slight> 

............................ Total Incidence of Finding Observed: 

Nose/Turb Sec 2 ................................ Number examined: 

SEPTAL DEVIATION 

Nad> 

Present> 

............................ Total Incidence of Finding Observed: 

3 

5 

1 

6 

10 10 10 

0 0 0 

10 

0 

0 

10 

0 0 0 

10 

10 

0 0 

0 0 0 0 

0 0 0 

0 

0 

0 

0 0 

0 

0 0 0 0 

0 

0 0 0 

0 0 0 0 

0 0 0 

0 

0 0 

0 0 

0 0 0 

0 

0 

0 0 0 0 

6 

3 

0 

3 

10 10 

9 

0 

1 

1 

10 

0 

0 9 0 

1 1 

10 10 

0 0 

All Diagnoses; Phases: P2; Death types: Scheduled FS; Date of death range: 13-May-02 To 14-May-02 

A f f e c t e 

-- F e m 

Ctls 2 

10 10 10 

7 

3 

0 

3 

10 10 

9 

1 

0 

1 

10 

0 

0 

10 

0 

0 

0 

10 

9 

1 1 

0 

0 0 0 0 

0 0 0 

0 0 0 

0 0 

0 0 0 

0 0 

0 0 

0 

0 
15-Dec-11; 17:43 

Huntingdon Life Sciences 006130 Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Terminal Sacrifice 

-- An i m a l s 

Controls from group(s): 1 Animal sex: M a l e s --

Dosage group: Ctls 2 3 4 

T i s s u e s W i t h D i a g n o s e s No. in group: 10 9 10 10 

Nose/Turb Sec 2 ................................ Number examined: 10 0 0 10 

ODONTOPATHY 

Nad> 

Minimal> 

Slight> 

Moderate> 

............................ Total Incidence of Finding Observed: 

NASOLACRIMAL DUCT(S): LUMEN-EOSINOPHILIC MATERIAL 

Nad> 

Slight> 

............................ Total Incidence of Finding Observed: 

NASOLACRIMAL DUCT(S): LUMEN-HEMORRHAGE(S) 

Nad> 

Minimal> 

Slight> 

............................ Total Incidence of Finding Observed: 

Nose/Turb Sec 3 ................................ Number examined: 

NASOLACRIMAL DUCT(S): LUMEN-EOSINOPHILIC MATERIAL 

Nad> 

Minimal> 

............................ Total Incidence of Finding Observed: 

Nose/Turb Sec 4 ................................ Number examined: 

Ovaries ........................................ Number examined: 

MINERALIZATION 

Nad> 

Minimal> 

............................ Total Incidence of Finding Observed: 

Pancreas ....................................... Number examined: Parathyroid .................................... Number examined: 

10 

0 0 0 

0 

8 

2 

2 

10 

0 0 

0 

10 

9 

1 

1 

10 

10 

10 

0 0 0 0 

0 

0 

0 0 0 0 0 0 

0 

0 

0 0 0 

0 0 

0 0 0 0 

0 0 0 

0 

0 0 

0 

0 

0 0 0 0 0 

0 

0 

9 

0 

1 

0 

1 

10 

0 0 

9 

0 

1 

1 

10 10 

0 0 

10 

10 10 

All Diagnoses; Phases: P2; Death types: Scheduled FS; Date of death range: 13-May-02 To 14-May-02 

A f f e c t e 

-- F e m 

Ctls 2 

10 10 

10 0 

8 

1 1 

0 

2 

10 

0 0 

10 

0 0 

0 

10 

10 

0 0 

10 10 10 

0 

0 

10 

10 

0 

0 

0 0 

0 

0 0 0 

0 0 

0 

0 

0 0 

0 0 0 0 0 

0 0 

0 

0 
15-Dec-11; 17:43 

Huntingdon Life Sciences 006130 

Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Terminal Sacrifice 

-- An i m a 1 s 

Controls from group(s): 1 Animal sex: -- M a 1 e s -- I 

Dosage group: Ctls 2 3 4 I 

T i s s u e s w i t h D i a g n o s e s No. in grouQ: 10 9 10 10 I 

Prostate ....................................... Number examined : 10 0 0 10 I 

LYMPHOID CELL AGGREGATE(S) 

Nad> 8 0 0 10 

Minimal> 2 0 0 0 

............................ Total Incidence of Finding Observed: 2 0 0 0 

Rectum/Low Colon ............................... Number examined: 10 0 0 10 

LUMEN: NEMATODE(S) 

Nad> 7 0 0 9 I 

Present> 3 0 0 1 I 

............................ Total Incidence of Finding Observed: 3 0 0 1 I 

Salivary glands ................................ Number examined: 10 0 0 10 

Sciatic Nerve .................................. Number examined: 10 0 0 10 I 

Seminal vesicles ............................... Number examined: 10 0 1 10 

SECRETORY PRODUCT: DECREASED 

Nad> 10 0 0 9 

Minimal> 0 0 0 1 

Slight> 0 0 1 0 

............................ Total Incidence of Finding Observed: 0 0 1 1 

Skin ........................................... Number examined: 0 0 0 0 I 

EPITHELIUM: SQUAMOUS CELL HYPERPLASIA 

Nad> 0 0 0 0 I 

Minimal> 0 0 0 0 I 

............................ Total Incidence of Finding Observed: 0 0 0 0 I 

EPITHELIUM: HYPERKERATOSIS 

Nad> 0 0 0 0 

Minimal> 0 0 0 0 

............................ Total Incidence of Finding Observed: 0 0 0 0 

All Diagnoses; Phases: P2; Death types: Scheduled FS; Date of death range: 13-May-02 To 14-May-02 

A f f e c t e 

-- F e m 

Ctls 2 

10 10 

10 0 

9 0 

1 0 

1 0 

10 0 

10 0 

2 1 

1 1 

1 0 1 0 

1 1 

1 0 1 0 
15-Dec-11; 17>43 

Huntingdon Life Sciences 006130 Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Terminal Sacrifice 

-- A n i m a 1 s 

Controls from group(s): 1 Animal sex: -- M a 1 e s -- I 

Dosage group: Ctls 2 3 4 I 

T i s s u e s W i t h D i a g n o s e s No. in group: 10 9 10 10 I 

Skin ........................................... Number examined : 0 0 0 0 I 

HYPOTRICHOSIS 

Minimal> 

............................ Total Incidence of Finding Observed: 

Spleen ......................................... Number examined: 

Sternum ........................................ Number examined: 

Stomach ........................................ Number examined: 

GLANDULAR ECTASIA 

Nad> 

Minimal> 

............................ Total Incidence of Finding Observed: 

Submandib/Max LN ............................... Number examined: 

SINUSES: FREE ERYTHROCYTES 

Nad> 

Minimal> 

Slight> 

............................ Total Incidence of Finding Observed: 

Testes ......................................... Number examined: 

SEMINIFEROUS TUBULES: DILATED 

Nad> 

Minimal> 

............................ Total Incidence of Finding Observed: 

GERMINAL EPITHELIUM: DEGENERATION/ATROPHY 

Nad> 

Severe> 

............................ Total Incidence of Finding Observed: 

Thoracic SC .................................... Number examined: 

0 0 

10 10 10 10 

0 0 

10 

8 

1 

1 

2 

10 

9 

1 

1 

10 

0 0 

10 

0 0 0 0 0 

0 

0 0 

0 

0 0 

0 0 0 

0 0 

0 

0 0 

0 

0 

0 

0 0 

0 

0 

0 0 

0 

0 0 0 

0 

0 

1 

1 

0 0 0 

1 1 

0 

0 

0 

10 

10 

10 

10 

0 

0 

10 

9 0 

1 

1 

10 

10 

0 0 

10 

0 0 

10 

I 

I 

All Diagnoses; Phases: P2; Death types: Scheduled FS; Date of death range: 13-May-02 To 14-May-02 

A f f e c t e 

-- F e m 

Ctls 2 

10 10 

2 1 

2 2 

10 

10 10 10 

0 0 

10 

10 

0 

0 0 

10 

1 

1 

0 0 0 

0 

0 0 

0 0 

0 

0 0 

0 
15-Dec-11; 17:43 

Huntingdon Life Sciences 006130 Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Terminal Sacrifice 

-- An i m a l s 

Controls from group(s): 1 Animal sex: M a l e s -- I 

Dosage group: Ctls 2 3 4 I 

T i s s u e s w i t h D i a g n o s e s No. in grouj;:>: 10 9 10 10 I Thymus ......................................... Number examined: 10 0 1 10 I 

CONGESTION 

Nad> 9 0 0 8 

Minimal> 1 0 1 2 

............................ Total Incidence of Finding Observed: 1 0 1 2 

MEDULLARY HYPERPLASIA 

Nad> 10 0 1 10 I 

Minimal> 0 0 0 0 I 

............................ Total Incidence of Finding Observed: 0 0 0 0 I 

Thyroid gland .................................. Number examined: 10 0 0 10 I 

Trachea ........................................ Number examined: 10 0 0 10 I 

Urinary bladder ................................ Number examined: 10 0 0 10 I Uterus ......................................... Number examined: I 

LUMEN: DILATED 

Nad> 

Slight> 

............................ Total Incidence of Finding Observed: 

CERVIX: LYMPHANGIECTASIA 

Nad> I 

Present> I 

............................ Total Incidence of Finding Observed: I 

Vagina ......................................... Number examined: 

CYST 

............................ Total Incidence of Finding Observed: I 

All Diagnoses; Phases: P2; Death types: Scheduled FS; Date of death range: 13-May-02 To 14-May-02 

A f f e c t e 

-- F e m 

Ctls 2 

10 10 

10 0 

10 0 

0 0 

0 0 

9 0 

1 0 1 0 

10 0 

10 0 

10 0 10 0 

8 0 

2 0 

2 0 

9 0 

1 0 

1 0 

0 0 

0 0 
15-Dec-11- 17:44 

Huntingdon Life Sciences 006130 Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Recovery Sacrifice 

-- A n i m a 1 s 

Controls from group(s): 1 Animal sex: -- M a 1 e s -- I 

Dosage group: Ctls 4 I 

T i s s u e s W i t h D i a g n o s e s No. in group: 10 10 I 

Adrenal Glands ................................. Number examined: 0 0 I 

CONGESTION 

............................ Total Incidence of Finding Observed: 

Aorta .......................................... Number examined: 

Brain .......................................... Number examined: 

Cecum .......................................... Number examined: 

Cervical SC .................................... Number examined: 

Colon .......................................... Number examined: 

LUMEN: NEMATODE(S) 

............................ Total Incidence of Finding Observed: 

Duodenum ....................................... Number examined: 

Epididymis ..................................... Number examined: Esophagus ...................................... Number examined: 

Femur .......................................... Number examined : 

Heart .......................................... Number examined: 

MONONUCLEAR CELL INFILTRATE WITH MYOFIBER DEGENERATION/LOSS 

............................ Total Incidence of Finding Observed: 

Ileum .......................................... Number examined: 

Jejunum ........................................ Number examined: 

All Diagnoses; Phases: P3; Death types: Scheduled FS; Date of death 

0 0 0 0 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 0 

range: 14-Jun-02 To 14-Jun-02 

A f f e c t e 

F e m 

Ctls 

10 

0 0 0 

0 

0 0 

0 0 0 

0 0 0 

0 

0 

0 
15-Dec-11- 17:44 

Huntingdon Life Sciences 006130 Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Recovery Sacrifice 

-- An i m a l s 

Controls from group(s): 1 Animal sex: -- M a l e s 

Dosage group: Ctls 4 

T i s s u e s W i t h D i a g n o s e s No. in group: 10 10 I 

Kidneys ........................................ Number examined: 0 0 

CORTEX: PROXIMAL CONVOLUTED TUBULAR 

-EPITHELIUM-EOSINOPHILIC/HYALINE DROPLETS 

............................ Total Incidence of Finding Observed: 

BASOPHILIC TUBULES 

............................ Total Incidence of Finding Observed: 

CORTEX: LYMPHOID CELL AGGREGATE(S) 

............................ Total Incidence of Finding Observed: 

CORTEX/CORTICO-MEDULLARY JUNCTION: MINERAL DEPOSIT(S) 

............................ Total Incidence of Finding Observed: 

CORTEX/CORTICO-MEDULLARY JUNCTION: TUBULE(S) DILATED 

............................ Total Incidence of Finding Observed: 

UROTHELIAL HYPERPLASIA 

............................ Total Incidence of Finding Observed: 

PELVIS: DILATED 

............................ Total Incidence of Finding Observed: 

CORTICAL CYST 

............................ Total Incidence of Finding Observed: 

Larynx: V-DVTC ................................. Number examined: 

SUBMUCOSAL LYMPHOCYTIC AGGREGATE 

............................ Total Incidence of Finding Observed: 

SUBMUCOSAL CYSTS WITH EOSINOPHILIC CRYSTALS 

............................ Total Incidence of Finding Observed: 

All Diagnoses; Phases: P3; Death types: Scheduled FS; Date of death 

0 0 0 0 0 0 0 0 0 0 0 0 

0 0 0 0 

0 0 0 0 0 0 

range: 14-Jun-02 To 14-Jun-02 

A f f e c t e 

F e m 

Ctls 

10 

0 0 0 0 

0 0 

0 

0 0 

0 0 0 
15-Dec-11- 17:44 

Huntingdon Life Sciences 006130 

Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Recovery Sacrifice 

-- A n i m a 1 s 

Controls from group(s): 1 Animal sex: -- M a 1 e s --

Dosage group: Ctls 4 

T i s s u e s W i t h D i a g n o s e s No. in group: 10 10 

Larynx: V-SM-G ................................. Number examined: 0 0 

GRANULOMATOUS CHONDROPATHY 

............................ Total Incidence of Finding Observed: 

SUBMUCOSAL LYMPHOCYTIC AGGREGATE 

............................ Total Incidence of Finding Observed: 

Liver .......................................... Number examined: 

MONONUCLEAR CELL AGGREGATES 

............................ Total Incidence of Finding Observed: 

Lumbar SC ...................................... Number examined: 

Lungs .......................................... Number examined: 

ALVEOLAR/INTRAALVEOLAR MACROPHAGES 

Nad> 

............................ Total Incidence of Finding Observed: 

HEMORRHAGE 

Nad> 

............................ Total Incidence of Finding Observed: 

VISCERAL PLEURA/CAPSULE: FIBROSIS 

Nad> 

Minimal> 

............................ Total Incidence of Finding Observed: 

Mediastinal LN ................................. Number examined: 

SINUSES: FREE ERYTHROCYTES 

............................ Total Incidence of Finding Observed: 

Mesenteric LN .................................. Number examined: 

All Diagnoses; Phases: P3; Death types: Scheduled FS; Date of death 

0 0 0 0 

0 0 

0 0 

0 0 

1 1 

1 1 

0 0 

1 1 

0 0 

1 1 

0 0 0 0 

0 0 

0 0 0 0 

range: 14-Jun-02 To 14-Jun-02 

A f f e c t e 

F e m 

Ctls 

10 

0 

0 0 

0 0 0 

1 1 

0 

1 

0 0 

1 

1 

0 

0 0 
15-Dec-11- 17:44 

Huntingdon Life Sciences 006130 Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Recovery Sacrifice 

-- A n i m a 1 s 

Controls from group(s): 1 Animal sex: -- M a 1 e s -- I 

Dosage group: Ctls 4 I 

T i s s u e s W i t h D i a g n o s e s No. in group: 10 10 I 

Nose/Turb Sec 1 ................................ Number examined: 0 0 I 

ODONTOPATHY 

............................ Total Incidence of Finding Observed: 

SEPTAL DEVIATION 

............................ Total Incidence of Finding Observed: 

NASOLACRIMAL DUCT(S): LUMEN-HEMORRHAGE(S) 

............................ Total Incidence of Finding Observed: 

Nose/Turb Sec 2 ................................ Number examined: 

SEPTAL DEVIATION 

............................ Total Incidence of Finding Observed: 

ODONTOPATHY 

............................ Total Incidence of Finding Observed: 

NASOLACRIMAL DUCT(S): LUMEN-EOSINOPHILIC MATERIAL 

............................ Total Incidence of Finding Observed: 

NASOLACRIMAL DUCT(S): LUMEN-HEMORRHAGE(S) 

............................ Total Incidence of Finding Observed: 

Nose/Turb Sec 3 ................................ Number examined: 

NASOLACRIMAL DUCT(S): LUMEN-EOSINOPHILIC MATERIAL 

............................ Total Incidence of Finding Observed: 

Nose/Turb Sec 4 ................................ Number examined: 

Ovaries ........................................ Number examined: 

All Diagnoses; Phases: P3; Death types: Scheduled FS; Date of death range: 

0 0 0 0 0 0 0 0 

0 0 0 0 

0 0 

0 0 0 0 0 0 

0 0 

14-Jun-02 To 14-Jun-02 

A f f e c t e 

F e m 

Ctls 

10 

0 0 0 

0 0 0 0 0 

0 0 

0 

0 0 
15-Dec-11- 17:44 

Huntingdon Life Sciences 006130 

Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Recovery Sacrifice 

-- A n i m a 1 s 

Controls from group(s): 1 Animal sex: -- M a 1 e s -- I 

Dosage group: Ctls 4 I 

T i s s u e s w i t h D i a g n o s e s No. in group: 10 10 I 

Ovaries ........................................ Number examined: 

MINERALIZATION 

............................ Total Incidence of Finding Observed: 

Pancreas ....................................... Number examined: 

Parathyroid .................................... Number examined: Prostate ....................................... Number examined: 

LYMPHOID CELL AGGREGATE(S) 

............................ Total Incidence of Finding Observed: 

Rectum/Low Colon ............................... Number examined: 

LUMEN: NEMATODE(S) 

............................ Total Incidence of Finding Observed: 

Salivary glands ................................ Number examined: 

Sciatic Nerve .................................. Number examined: 

Seminal vesicles ............................... Number examined: 

SECRETORY PRODUCT: DECREASED 

............................ Total Incidence of Finding Observed: 

Skin ........................................... Number examined: 

EPITHELIUM: SQUAMOUS CELL HYPERPLASIA 

Nad> 

............................ Total Incidence of Finding Observed: 

EPITHELIUM: HYPERKERATOSIS 

Nad> 

............................ Total Incidence of Finding Observed: 

All Diagnoses; Phases: P3; Death types: Scheduled FS; Date of death 

0 0 

0 0 

0 0 0 0 0 0 

0 0 0 0 0 0 

0 0 0 0 0 0 

0 0 0 0 

0 0 0 0 

range: 14-Jun-02 To 14-Jun-02 

A f f e c t e 

F e m 

Ctls 

10 

0 0 0 

0 

0 

0 

0 

0 

1 

1 

0 

1 

0 
15-Dec-11- 17:44 

Huntingdon Life Sciences 006130 

Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immuno.toxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Recovery Sacrifice 

-- A n i m a 1 s 

Controls from group(s): 1 Animal sex: -- M a 1 e s 

Dosage group: Ctls 4 

T i s s u e s W i t h D i a g n o s e s No. in group: 10 10 

Skin examined: 0 0 I 

Minimal> 

............................ Total Incidence of Finding Observed: 

Spleen ......................................... Number examined: 

Sternum ........................................ Number examined: 

Stomach ........................................ Number examined: 

GLANDULAR ECTASIA 

............................ Total Incidence of Finding Observed: 

Submandib/Max LN ............................... Number examined: 

SINUSES: FREE ERYTHROCYTES 

............................ Total Incidence of Finding Observed: 

Testes ......................................... Number examined: 

SEMINIFEROUS TUBULES: DILATED 

............................ Total Incidence of Finding Observed: 

GERMINAL EPITHELIUM: DEGENERATION/ATROPHY 

............................ Total Incidence of Finding Observed: 

Thoracic SC .................................... Number examined: 

Thymus ......................................... Number examined : 

CONGESTION 

Minimal> 

............................ Total Incidence of Finding Observed: 

All Diagnoses; Phases: P3; Death types: Scheduled FS; Date of death 

0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 0 0 

0 0 

0 0 0 0 

2 1 2 1 2 1 

range: 14-Jun-02 To 14-Jun-02 

A f f e c t e 

F e m 

Ctls 

10 

1 1 1 

0 

0 0 0 0 0 

0 

0 

0 0 
15-Dec-11- 17:44 

Huntingdon Life Sciences 006130 Main Study 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Recovery Sacrifice 

-- A n i m a 1 s 

Controls from group(s): 1 Animal sex: -- M a 1 e s -- I 

Dosage group: Ctls 4 I 

T i s s u e s W i t h D i a g n o s e s No. in group: 10 10 I Thymus ......................................... Number examined: 2 1 

MEDULLARY HYPERPLASIA 

Nad> 

............................ Total Incidence of Finding Observed: 

Thyroid gland .................................. Number examined: 

Trachea ........................................ Number examined: 

Urinary bladder ................................ Number examined: Uterus ......................................... Number examined: 

LUMEN: DILATED 

............................ Total Incidence of Finding Observed: 

CERVIX: LYMPHANGIECTASIA 

............................ Total Incidence of Finding Observed: 

Vagina ......................................... Number examined: 

CYST 

Present> 

............................ Total Incidence of Finding Observed: 

2 

0 0 0 0 

1 

0 0 

0 

0 

All Diagnoses; Phases: P3; Death types: Scheduled FS; Date of death range: 14-Jun-02 To 14-Jun-02 

A f f e c t e 

F e m 

Ctls 

10 

0 0 0 0 0 0 0 

0 0 

1 1 1 
15-Dec-11; 17:58 

Huntingdon Life Sciences 006130N 

Neurotox 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Terminal Sacrifice 

-- A n i m a l s 

Controls from group(s): 1 Animal sex: -- M a l e s -- I 

Dosage group: Ctls 2 3 4 I 

T i s s u e s w i t h D i a g n o s e s No. in grou12: 5 5 5 5 I 

Brain .......................................... Number examined: 5 0 0 5 I 

Cervical SC .................................... Number examined: 5 0 0 5 

Dorsal Root Fibr ............................... Number examined: 5 0 0 5 

Dorsal Root Gang ............................... Number examined: 5 0 0 5 

Eyes ........................................... Number examined : 5 0 0 5 

CILIARY BODY: MONONUCLEAR CELL INFILTRATE 

Nad> 5 0 0 5 I 

Minimal> 0 0 0 0 I 

............................ Total Incidence of Finding Observed: 0 0 0 0 I 

Kidneys ........................................ Number examined : 1 0 0 1 I 

PROXIMAL TUBULAR EPITHELIUM: EOSINOPHILIC CRYSTALS 

Nad> 1 0 0 0 I 

Slight> 0 0 0 l I 

............................ Total Incidence of Finding Observed: 0 0 0 1 I 

DILATED TUBULES 

Nad> 0 0 0 1 I 

Slight> 1 0 0 0 I 

............................ Total Incidence of Finding Observed: l 0 0 0 I 

Lumbar SC ...................................... Number examined: 5 0 0 5 I 

Lungs .......................................... Number examined: 5 5 5 5 I 

HEMORRHAGE(S) 

Nad> 5 4 5 3 I 

Minimal> 0 1 0 2 I 

............................ Total Incidence of Finding Observed: 0 1 0 2 I 

All Diagnoses; Phases: P2; Death types: Scheduled FS; Date of death range: 16-May-02 To 17-May-02 

A f f e c t e 

-- F e m 

Ctls 2 

5 5 

5 0 

5 0 

5 0 

5 0 

5 0 

4 0 

1 0 1 0 

0 0 

0 0 

0 0 

0 0 

0 0 

0 0 

0 0 

5 0 

5 5 5 5 

0 0 

0 0 
15-Dec-11; 17:58 

Huntingdon Life Sciences 006130N 

Neurotox 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Terminal Sacrifice 

-- A n i m a 1 s 

Controls from group(s): 1 Animal sex: --Mal e s -- I 

Dosage group: Ctls 2 3 4 I 

T i s s u e s W i t h D i a q n o s e s No. in qroup: 5 5 5 5 I 

Lungs .......................................... Number examined: 5 5 5 5 

ALVEOLAR MACROPHAGES 

Nad> 

Minimal> 

............................ Total Incidence of Finding Observed: 

Optic nerve .................................... Number examined: 

Sciatic Nerve .................................. Number examined: 

Skin ....... . examined: 

Marked> 

............................ Total Incidence of Finding Observed: 

SURFACE BACTERIA 

Present> 

............................ Total Incidence of Finding Observed: 

DERMAL GRANULATION TISSUE 

Moderate> 

............................ Total Incidence of Finding Observed: 

NEUTROPHILIC INFILTRATE 

Moderate> 

............................ Total Incidence of Finding Observed: 

HYPOTRICHOSIS 

Slight> 

............................ Total Incidence of Finding Observed: 

Sural Nerve .................................... Number examined: 

Thoracic SC .................................... Number examined: 

5 

0 0 

5 5 

0 

0 

0 0 0 

0 0 

0 0 

0 

0 

5 

5 

5 

0 0 

0 0 0 

0 

0 0 0 

0 0 0 0 

0 0 0 

0 

4 

1 

1 

0 0 

0 0 

0 0 0 

0 0 0 0 

0 0 0 

0 

5 

0 

0 

5 5 

1 1 

1 

1 

1 

1 

1 

1 

1 

1 1 

5 

5 

All Diagnoses; Phases: P2; Death types: Scheduled FS; Date of death range: 16-May-02 To 17-May-02 

A f f e c t e 

-- F e m 

Ctls 2 

5 5 

5 5 

0 0 

5 5 

0 

0 

0 0 0 

0 0 0 0 

0 0 

4 

5 

5 5 

0 0 

0 0 0 0 0 0 0 

0 0 0 0 

0 

0 0 

0 
15-Dec-11; 17:58 

Huntingdon Life Sciences 006130N 

Neurotox 

Gasoline DIPE Vapor Condensate: A 13-Week Whole-Body Inhalation 

Toxicity Study in Rats with Neurotoxicity Assessments and 4-Week 

In Vivo Genotoxicity and Immunotoxicity Assessments 

Incidence Summary of Microscopic Findings with Severity Levels 

Terminal Sacrifice 

-- A n i m a l s 

Controls from group(s): 1 Animal sex: -- M a l e s --

Dosage group: Ctls 2 3 4 I 

T i s s u e s W i t h D i a g n o s e s No. in group: 5 5 5 5 I Thymus ......................................... Number examined: 0 0 0 1 

CONGESTION 

Slight> 

............................ Total Incidence of Finding Observed: 

Tibial Nerve ................................... Number examined: 

Trachea ........................................ Number examined: Trigeminal Gang ................................ Number examined: 

Ventrl Root Fibr ............................... Number examined: 

All Diagnoses; Phases: P2; Death types: Scheduled FS; Date of death 

0 0 

5 5 5 

5 

range: 

0 0 1 0 0 1 

0 0 5 

5 5 5 

0 0 5 0 0 5 

16-May-02 To 17-May-02 

A f f e c t e 

-- F e m 

Ctls 2 

5 5 

0 0 0 0 0 0 

5 0 

5 5 

5 0 

5 0 
Huntingdon Life Sciences 00-6130 Page 267

211-DIPE-S Final Report

Chamber Monitoring Results

Preface Appendix A

Key to Abbreviations

MMAD = Mass Median Aerodynamic Diameter

GSD = Geometric Standard Deviation

TMC = Total Mass Concentration
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number Mean 

(mg/m3) (mg/m3) 

0 12-Feb-02 1 0 0 

1 13-Feb-02 2 0 0 

2 14-Feb-02 3 0 0 

3 15-Feb-02 4 0 0 

6 18-Feb-02 5 0 0 

7 19-Feb-02 6 0 0 

8 20-Feb-02 7 0 0 9 21-Feb-02 8 0 0 

10 22-Feb-02 9 0 0 

13 25-Feb-02 10 0 0 

14 26-Feb-02 11 0 0 

15 27-Feb-02 12 0 0 16 28-Feb-02 13 0 0 17 01-Mar-02 14 0 0 

20 04-Mar-02 15 0 0 

21 05-Mar-02 16 0 0 

22 06-Mar-02 17 0 0 

23 07-Mar-02 18 0 0 

24 08-Mar-02 19 0 0 

27 11-Mar-02 20 0 0 

28 12-Mar-02 21 0 0 

29 13-Mar-02 22 0 0 

30 14-Mar-02 23 0 0 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group lA - 0 mg/m3 (Air Control) 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) 

0 0 0 0 0 0 0 0 

0 0 0 0 

0 0 0 0 1.209 

0 0 0 0 

0 0 0 0 

0 0 0 0 

0 0 0 0 

0 0 0 0 

0 0 0 0 4.471 

0 0 0 0 

0 0 0 0 

0 0 0 0 

0 0 0 0 

0 0 0 0 2.303 

0 0 0 0 

0 0 0 0 

0 0 0 0 

0 0 0 0 

0 0 0 0 1.520 

0 0 0 0 

0 0 0 0 

0 0 0 0 

Particle Size 

Determinations 

GSD TMC 

(mg/m3) 

1.495 1.94E-03 

2.682 7.37E-03 

2.369 3.03E-03 

1.876 3.20E-03 

--

Te
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

31 15-Mar-02 24 0 

32 16-Mar-02 25 0 34 18-Mar-02 26 0 

35 19-Mar-02 27 0 36 20-Mar-02 28 0 

37 21-Mar-02 29 0 38 22-Mar-02 30 0 

41 25-Mar-02 31 0 

42 26-Mar-02 32 0 

43 27-Mar-02 33 0 44 28-Mar-02 34 0 45 29-Mar-02 35 0 48 1-Apr-02 36 0 49 2-Apr-02 37 0 

50 3-Apr-02 38 0 

51 4-Apr-02 39 0 

52 5-Apr-02 40 0 

55 8-Apr-02 41 0 

56 9-Apr-02 42 0 

57 10-Apr-02 43 0 58 11-Apr-02 44 0 59 12-Apr-02 45 0 

62 15-Apr-02 46 0 63 16-Apr-02 47 0 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group lA- 0 mg/m3 (Air Control) 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (.urn) 

0 0 0 0 0 0 0 0 0 0 0.9053 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 2.495 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 2.357 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 2.187 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 1.413 

0 0 0 0 0 0 0 0 0 0 

C

Particle Size 

Determinations Te

GSD TMC 

(mg/m3) 

2.137 1.20E-02 

2.130 4.91E-03 

2.501 7.60E-03 

2.049 2.32E-03 

1.998 8.01 E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

64 17-Apr-02 48 0 

65 18-Apr-02 49 0 

66 19-Apr-02 50 0 

69 22-Apr-02 51 0 

70 23-Apr-02 52 0 

71 24-Apr-02 53 0 

72 25-Apr-02 54 0 73 26-Apr-02 55 0 76 29-Apr-02 56 0 

77 30-Apr-02 57 0 

78 1-May-02 58 0 79 2-May-02 59 0 

80 3-May-02 60 0 

83 6-May-02 61 0 84 7-May-02 62 0 85 8-May-02 63 0 86 9-May-02 64 0 87 10-May-02 65 0 

89 12-May-02 66 0 

90 13-May-02 67 0 

91 14-May-02 68 0 

92 15-May-02 69 0 93 16-May-02 70 0 

Mean 0 

S.D. 0 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group lA- 0 mg/m3 (Air Control) 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (pm) 

0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 1.767 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2.130 0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 1.325 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 1.594 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 

0 1.975 

0 0.899 

C

Particle Size 

Determinations Te

GSD TMC 

(mg/m3) 

2.858 5.16E-03 

1.927 4.07E-03 

1.605 1.29E-03 

2.093 2.01E-03 

2.132 4.84E-03 

0.392 3.13E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

0 12-Feb-02 1 0 

1 13-Feb-02 2 0 

2 14-Feb-02 3 0 

3 15-Feb-02 4 0 

6 18-Feb-02 5 0 

7 19-Feb-02 6 0 

8 20-Feb-02 7 0 9 21-Feb-02 8 0 

10 22-Feb-02 9 0 

13 25-Feb-02 10 0 

14 26-Feb-02 11 0 

15 27-Feb-02 12 0 16 28-Feb-02 13 0 17 1-Mar-02 14 0 

20 4-Mar-02 15 0 

21 5-Mar-02 16 0 

22 6-Mar-02 17 0 23 7-Mar-02 18 0 24 8-Mar-02 19 0 27 11-Mar-02 20 0 28 12-Mar-02 21 0 

29 13-Mar-02 22 0 

30 14-Mar-02 23 0 

31 15-Mar-02 24 0 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IB - 0 mg/m3 (Air Control) 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (.urn) 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 1.230 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 3.222 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 2.090 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 1.465 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3) 

1.627 1.72E-03 

2.309 7.63E-03 

1.807 3.69E-03 

1.966 2.72E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

32 16-Mar-02 25 0 

34 18-Mar-02 26 0 

35 19-Mar-02 27 0 

36 20-Mar-02 28 0 

37 21-Mar-02 29 0 38 22-Mar-02 30 0 

41 25-Mar-02 31 0 

42 26-Mar-02 32 0 

43 27-Mar-02 33 0 44 28-Mar-02 34 0 

45 29-Mar-02 35 0 48 1-Apr-02 36 0 

49 2-Apr-02 37 0 

50 3-Apr-02 38 0 

51 4-Apr-02 39 0 

52 5-Apr-02 40 0 

55 8-Apr-02 41 0 

56 9-Apr-02 42 0 57 10-Apr-02 43 0 

58 11-Apr-02 44 0 

59 12-Apr-02 45 0 

62 15-Apr-02 46 0 

63 16-Apr-02 47 0 

64 17-Apr-02 48 0 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group 18 - 0 mg/m3 (Air Control) 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (pm) 

0 0 0 0 0 0.9933 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3.236 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 1.240 

0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 2.023 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 1.877 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3) 

2.559 1.41E-02 

2.579 3.65E-03 2.374 4.86E-03 

1.994 2.81E-03 

2.932 9.96E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

65 18-Apr-02 49 0 

66 19-Apr-02 50 0 69 22-Apr-02 51 0 

70 23-Apr-02 52 0 

71 24-Apr-02 53 0 

72 25-Apr-02 54 0 

73 26-Apr-02 55 0 76 29-Apr-02 56 0 

77 30-Apr-02 57 0 78 1-May-02 58 0 

79 2-May-02 59 0 

80 3-May-02 60 0 

83 6-May-02 61 0 

84 7-May-02 62 0 85 8-May-02 63 0 

86 9-May-02 64 0 

87 10-May-02 65 0 89 12-May-02 66 0 90 13-May-02 67 0 

91 14-May-02 68 0 

Mean 0 

S.D. 0 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IB - 0 mg/m3 (Air Control) 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (.urn) 

0 0 0 0 0 

0 0 0 0 0 1.879 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 11.62 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 1.503 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1.708 

0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 

0 2.622 0 2.790 

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3) 

2.460 5.66E-03 

2.643 1.06E-02 

1.759 1.54E-03 

1.749 2.43E-03 

2.212 5.49E-03 

0.417 3.94E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

0 12-Feb-02 1 1940 

1 13-Feb-02 2 1990 

2 14-Feb-02 3 1950 

3 15-Feb-02 4 2150 

6 18-Feb-02 5 2010 

7 19-Feb-02 6 2090 

8 20-Feb-02 7 2060 

9 21-Feb-02 8 2130 

10 22-Feb-02 9 2000 13 25-Feb-02 10 2090 14 26-Feb-02 11 1970 

15 27-Feb-02 12 1990 

16 28-Feb-02 13 2030 

17 1-Mar-02 14 2030 

20 4-Mar-02 15 2050 21 5-Mar-02 16 1900 22 6-Mar-02 17 2100 

23 7-Mar-02 18 2090 24 8-Mar-02 19 2150 27 11-Mar-02 20 2020 

28 12-Mar-02 21 2010 29 13-Mar-02 22 2010 

30 14-Mar-02 23 2080 

31 15-Mar-02 24 2160 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IIA - 2,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (pm) 

1985 1990 1860 2020 2070 

1930 1770 1910 2020 2020 

1953 2000 1990 2020 1800 

2085 1900 2170 2150 2120 1.422 

1995 1980 2000 1980 2020 

2025 1920 2010 2070 2100 

1985 1920 1980 2020 2020 

1998 2000 1940 2030 2020 1950 2300 1610 1940 1950 

1995 1920 1900 2050 2110 1.182 

1998 2080 1910 2000 2000 

1958 1920 1960 2010 1940 

2010 2050 1980 1990 2020 

2035 2040 2050 2050 2000 

1998 2090 1980 2000 1920 1.832 1865 1940 1730 1800 1990 

2000 2010 1990 2000 2000 

1915 2020 1750 1970 1920 

1983 1900 2030 2020 1980 

1928 2020 1820 1970 1900 1.506 1883 1850 2130 1790 1760 1988 1950 2020 1980 2000 

1905 1860 1840 1900 2020 

1968 1870 1920 1950 2130 

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3) 

1.933 3.09E-03 

2.060 4.38E-03 

2.321 2.65E-03 

2.053 3.51 E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

32 16-Mar-02 25 2190 

34 18-Mar-02 26 2190 

35 19-Mar-02 27 2160 

36 20-Mar-02 28 2130 

37 21-Mar-02 29 2180 

38 22-Mar-02 30 2050 

41 25-Mar-02 31 2090 

42 26-Mar-02 32 2030 

43 27-Mar-02 33 2170 

44 28-Mar-02 34 2110 

45 29-Mar-02 35 2110 

48 1-Apr-02 36 2090 

49 2-Apr-02 37 2030 

50 3-Apr-02 38 2130 

51 4-Apr-02 39 2060 

52 5-Apr-02 40 2220 

55 8-Apr-02 41 1980 

56 9-Apr-02 42 2040 

57 10-Apr-02 43 2050 

58 11-Apr-02 44 2060 

59 12-Apr-02 45 2060 

62 15-Apr-02 46 2060 

63 16-Apr-02 47 1910 

64 17-Apr-02 48 2000 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IIA- 2,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (pm) 

2068 1900 2050 2100 2220 0.7940 

2205 2330 2190 2280 2020 

2095 2100 2060 2110 2110 

2040 2020 2030 2070 2040 

2108 2170 2040 2110 2110 

1913 1950 1940 1840 1920 

1918 1900 1900 1830 2040 3.911 

1913 2080 1760 1830 1980 

2133 2220 2130 2150 2030 2090 2130 2030 2020 2180 

2028 2040 2040 2010 2020 0.8422 

1843 2120 1630 1830 1790 

1845 1900 1790 1810 1880 1875 1790 1890 1890 1930 

2093 2240 2130 2010 1990 

2150 1860 2030 2340 2370 1.438 

1950 2010 1810 1730 2250 

1938 1980 2030 1720 2020 

1955 2010 1950 1920 1940 

1960 2010 2030 1960 1840 1820 1870 1890 1730 1790 1.154 

1958 2010 2110 1730 1980 

2040 2220 2020 1920 2000 2080 2240 2020 2010 2050 

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3) 

1.908 1.19E-02 

2.446 4.72E-03 

2.224 4.56E-03 

2.053 1.53E-03 

2.045 5.62E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

65 18-Apr-02 49 2010 66 19-Apr-02 50 2140 69 22-Apr-02 51 1930 

70 23-Apr-02 52 1970 

71 24-Apr-02 53 2060 

72 25-Apr-02 54 1970 

73 26-Apr-02 55 2060 

76 29-Apr-02 56 2060 77 30-Apr-02 57 1900 78 1-May-02 58 2090 

79 2-May-02 59 2040 

80 3-May-02 60 2070 

83 6-May-02 61 2060 84 7-May-02 62 2120 85 8-May-02 63 2190 86 9-May-02 64 1990 

87 10-May-02 65 2080 

89 12-May-02 66 2130 

90 13-May-02 67 2230 

91 14-May-02 68 2330 

92 15-May-02 69 2150 93 16-May-02 70 2100 

Mean 2068 

S.D. 83 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IIA- 2,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) {tim) 

2000 2040 2020 1920 2020 

2108 2030 2130 2180 2090 1.072 

1885 1700 1970 2020 1850 

1963 2010 1870 2020 1950 

2045 1950 2390 1880 1960 

1875 1920 1970 1730 1880 

2020 2010 2020 2040 2010 12.34 

1985 2030 1970 2020 1920 

1898 1880 1930 1920 1860 

2163 2290 2210 2110 2040 

2065 2150 2120 1980 2010 

2010 2020 1990 2000 2030 1.351 

1958 2150 2000 1850 1830 1935 1920 1950 1910 1960 

1890 1880 2010 1750 1920 

1808 1880 1790 1830 1730 

1915 2170 2020 1750 1720 1.631 

1943 2010 1660 1820 2280 1945 1920 1950 1970 1940 

2015 2070 2010 1970 2010 

2023 2160 1900 2010 2020 

1883 1900 1890 1790 1950 

1981 2.344 

129 3.103 

-

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3) 

1.803 3.00E-03 

2.875 6.96E-03 

1.783 1.34E-03 

1.870 2.36E-03 

2.106 4.28E-03 

0.303 2.79E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

0 12-Feb-02 1 1940 

1 13-Feb-02 2 1990 

2 14-Feb-02 3 1950 

3 15-Feb-02 4 2150 

6 18-Feb-02 5 2010 

7 19-Feb-02 6 2090 

8 20-Feb-02 7 2060 

9 21-Feb-02 8 2130 

10 22-Feb-02 9 2000 

13 25-Feb-02 10 2090 

14 26-Feb-02 11 1970 15 27-Feb-02 12 1990 

16 28-Feb-02 13 2030 

17 1-Mar-02 14 2030 

20 4-Mar-02 15 2050 

21 5-Mar-02 16 1900 

22 6-Mar-02 17 2100 

23 7-Mar-02 18 2090 

24 8-Mar-02 19 2150 

27 11-Mar-02 20 2020 

28 12-Mar-02 21 2010 29 13-Mar-02 22 2010 

30 14-Mar-02 23 2080 

31 15-Mar-02 24 2160 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group liB - 2,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (.um) 

1963 2100 1810 1980 1960 

1943 2060 1950 1900 1860 1983 2020 1920 1880 2110 

2178 2400 2030 2130 2150 1.589 

2135 2010 2170 2210 2150 

2063 2180 1990 2000 2080 

1943 1980 1930 1920 1940 

2035 2090 2120 1980 1950 

1903 1910 1710 2000 1990 

2070 2160 2170 1960 1990 1.378 

1938 1730 1920 2000 2100 

1993 1920 2000 2010 2040 

1975 2060 2000 2000 1840 

2050 1920 2150 2210 1920 

2113 2210 2080 2040 2120 3.380 

1918 2000 1860 1860 1950 1998 2010 1980 2000 2000 

2028 2190 1890 2020 2010 

1958 1910 2020 1950 1950 

2023 1760 1960 2180 2190 1.174 

1963 2080 2210 1850 1710 

1973 2040 2000 1920 1930 

1985 1960 1950 1940 2090 

2020 1920 1980 2160 

Particle Size 

Determinations 

GSD TMC 

(mg/m3) 

2.321 3.46E-03 

2.273 5.03E-03 2.827 3.14E-03 

1.633 2.54E-03 

- -- -

C

Tem
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

32 16-Mar-02 25 2190 

34 18-Mar-02 26 2190 35 19-Mar-02 27 2160 36 20-Mar-02 28 2130 37 21-Mar-02 29 2180 38 22-Mar-02 30 2050 

41 25-Mar-02 31 2090 

42 26-Mar-02 32 2030 

43 27-Mar-02 33 2170 

44 28-Mar-02 34 2110 

45 29-Mar-02 35 2110 48 1-Apr-02 36 2090 49 2-Apr-02 37 2030 

50 3-Apr-02 38 2130 

51 4-Apr-02 39 2060 

52 5-Apr-02 40 2220 

55 8-Apr-02 41 1980 

56 9-Apr-02 42 2040 57 10-Apr-02 43 2050 

58 11-Apr-02 44 2060 

59 12-Apr-02 45 2060 

62 15-Apr-02 46 2060 63 16-Apr-02 47 1910 

_64 17-Apr-02 48 2000 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group 118 - 2,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) {tim) 

2098 1950 2200 2190 2050 0.8998 2020 2080 2010 1980 2010 

2028 2150 1930 2010 2020 2040 2110 2060 1980 2010 

2073 2240 2020 2020 2010 

1960 2040 1990 1890 1920 

1968 1980 2050 2080 1760 0.9819 

1960 1640 2000 2220 1980 

1978 2030 1980 1950 1950 

1915 2020 1920 1890 1830 

1998 2020 1980 1960 2030 0.8897 

2130 1810 2400 2180 2130 

1960 2130 1840 1850 2020 

1970 1900 2020 2040 1920 

2098 2170 2220 2020 1980 

2055 2270 1890 2110 1950 1.403 

1858 1790 1790 1730 2120 

1868 1770 1780 2150 1770 1943 1790 1980 1980 2020 

1985 2100 2020 1960 1860 

1970 2050 2020 1830 1980 1.101 

2000 1930 2180 1790 2100 

1903 2140 1840 1790 1840 

1920 2050 1920 1730 1980 

- ----· 

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3) 

2.47 1.47E-02 

1.762 1.76E-03 

1.926 5.04E-03 

1.989 1.74E-03 

1.755 6.24E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

65 18-Apr-02 49 2010 66 19-Apr-02 50 2140 69 22-Apr-02 51 1930 

70 23-Apr-02 52 1970 

71 24-Apr-02 53 2060 

72 25-Apr-02 54 1970 

73 26-Apr-02 55 2060 

76 29-Apr-02 56 2060 77 30-Apr-02 57 1900 78 1-May-02 58 2090 79 2-May-02 59 2040 

80 3-May-02 60 2070 

83 6-May-02 61 2060 84 7-May-02 62 2120 85 8-May-02 63 2190 86 9-May-02 64 1990 

87 10-May-02 65 2080 

89 12-May-02 66 2130 

90 13-May-02 67 2230 

91 14-May-02 68 2330 

Mean 2067 

S.D. 83 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group liB - 2,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) {tim) 

1913 1860 2150 1720 1920 

2133 2250 2180 2050 2050 0.9187 2055 2300 1960 2050 1910 

2043 2240 2040 2020 1870 

2133 2090 2400 1990 2050 

2083 2310 2180 1920 1920 

2168 2280 2130 2180 2080 1.358 2085 2100 2060 2110 2070 

1828 2210 1730 1700 1670 

2068 2030 2050 2090 2100 

1983 2000 1870 2020 2040 

2083 2110 2180 2020 2020 1.314 

2048 1940 2000 2120 2130 

1995 2020 2000 1980 1980 1973 2000 2170 1740 1980 

2015 1920 1930 2090 2120 

1963 2250 2040 1770 1790 1.510 

2043 2030 1940 1930 2270 

2095 2130 2090 2110 2050 

2075 2160 2100 2020 2020 

2009 1.377 

134 0.647 

Particle Size 

Determinations Te

GSD TMC 

(mg/m3) 

1.558 2.74E-03 

1.692 2.33E-03 

1.631 1.16E-03 

1.720 2.23E-03 

1.966 4.01E-03 

0.390 3.54E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

0 12-Feb-02 1 9470 

1 13-Feb-02 2 9450 

2 14-Feb-02 3 9540 

3 15-Feb-02 4 9890 

6 18-Feb-02 5 9830 

7 19-Feb-02 6 9740 

8 20-Feb-02 7 10800 

9 21-Feb-02 8 9910 

10 22-Feb-02 9 9950 13 25-Feb-02 10 9840 

14 26-Feb-02 11 9990 

15 27-Feb-02 12 9920 16 28-Feb-02 13 10100 

17 1-Mar-02 14 10100 

20 4-Mar-02 15 9200 

21 5-Mar-02 16 9890 

22 6-Mar-02 17 9730 23 7-Mar-02 18 9860 24 8-Mar-02 19 9960 

27 11-Mar-02 20 9810 28 12-Mar-02 21 9890 

29 13-Mar-02 22 9700 

30 14-Mar-02 23 10100 

31 15-Mar-02 24 9980 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group lilA- 10,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (tim) 

9685 10000 9580 9580 9580 9850 9290 10200 9910 10000 

9295 9650 8630 9350 9550 

10400 9910 11500 10200 10000 0.9889 10310 10600 10400 9940 10300 

9925 10100 9650 9650 10300 9680 9910 9190 9420 10200 

10380 9910 10600 10600 10400 

9758 10200 7730 10200 10900 

10480 11400 10200 9910 10400 1.043 

9823 9940 10500 9910 8940 

9943 10600 9420 9910 9840 

10650 10700 10300 10700 10900 10700 11200 10500 10200 10900 

9935 11200 8840 10600 9100 1.708 

10200 9580 10600 10500 10100 10480 10200 10700 10700 10300 10420 10000 11100 10700 9870 10240 9650 10100 10800 10400 10480 10800 10200 10700 10200 2.245 

10280 9910 10800 10200 10200 

9968 10900 9580 9810 9580 

10030 8300 10300 11500 10000 

9973 10200 9580 9910 10200 

Particle Size 

Determinations Te

GSD TMC 

(mg/m3) 

1.852 3.59E-03 

2.151 5.74E-03 

2.183 2.65E-03 

2.622 4.77E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

32 16-Mar-02 25 9530 34 18-Mar-02 26 10000 

35 19-Mar-02 27 10200 

36 20-Mar-02 28 10100 37 21-Mar-02" 29 10300 38 22-Mar-02 30 9370 

41 25-Mar-02 31 9690 

42 26-Mar-02 32 9940 43 27-Mar-02 33 9390 44 28-Mar-02 34 9540 45 29-Mar-02 35 9670 48 1-Apr-02 36 9830 49 2-Apr-02 37 10000 

50 3-Apr-02 38 10600 

51 4-Apr-02 39 10000 

52 5-Apr-02 40 9470 

55 8-Apr-02 41 10000 

56 9-Apr-02 42 9880 

57 10-Apr-02 43 10100 

58 11-Apr-02 44 9960 

59 12-Apr-02 45 9840 

62 15-Apr-02 46 9950 

63 16-Apr-02 47 9950 64 17-Apr-02 48 9460 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group lilA- 10,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (pm) 

10260 10800 10600 11900 7720 0.7927 10000 10000 10100 9910 10000 

10320 10800 9740 11100 9650 10010 9840 10400 9580 10200 

9970 9580 10000 10300 10000 

9475 9420 10300 8440 9740 

9450 9740 9350 9520 9190 1.316 

9773 10700 9190 9910 9290 

9670 10000 9910 9420 9350 

9930 8620 10000 10500 10600 

10010 9580 10400 9870 10200 0.7720 

9790 9840 9740 9580 10000 

9970 10000 9840 9740 10300 

9730 9320 10300 9780 9520 

9745 10200 9520 9740 9520 9098 9100 8550 8930 9810 1.490 

10450 10300 10400 10600 10500 

9828 10600 10000 9290 9420 

9945 9780 10000 10000 10000 

10730 10900 10700 10500 10800 

9475 9260 8260 10600 9780 0.9063 

9743 10000 10500 8170 10300 

10590 10700 10300 11700 9650 

10830 11200 10200 11200 10700 

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3) 

2.452 2.41 E-02 

2.451 2.91E-03 

1.889 5.54E-03 

2.249 1.78E-03 

1.662 7.08E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

65 18-Apr-02 49 10100 

66 19-Apr-02 50 9470 69 22-Apr-02 51 9550 

70 23-Apr-02 52 9780 

71 24-Apr-02 53 9780 

72 25-Apr-02 54 9940 

73 26-Apr-02 55 9680 76 29-Apr-02 56 9620 

77 30-Apr-02 57 9680 78 1-May-02 58 10200 79 2-May-02 59 9730 

80 3-May-02 60 10100 

83 6-May-02 61 10000 84 7-May-02 62 9670 85 8-May-02 63 9460 

86 9-May-02 64 9690 

87 10-May-02 65 9300 

89 12-May-02 66 9860 

90 13-May-02 67 9810 

91 14-May-02 68 9710 

92 15-May-02 69 9500 93 16-May-02 70 9390 

Mean 9821 

S.D. 286 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group lilA- 10,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (tim) 

10090 10100 10500 9910 9840 

9633 9910 9260 9680 9680 1.618 

10280 10200 11700 9100 10100 

11100 10700 10800 10900 12000 

9233 9130 8470 9680 9650 9770 9910 10100 9420 9650 

10090 10100 10100 10900 9260 1.285 

9488 9060 8810 9580 10500 9468 9870 9350 10200 8450 

10010 9740 10100 10100 10100 

9400 9680 9910 9290 8720 

10380 10200 10000 11000 10300 1.243 

9840 10000 9810 10000 9550 9318 10000 9650 9190 8430 

9658 9130 8400 10800 10300 

9240 8740 9610 8770 9840 

9490 9420 9520 8620 10400 4.537 

9940 9680 10200 9580 10300 9693 10700 9260 9260 9550 

9365 8740 9290 10200 9230 

10790 9650 10400 11700 11400 

10210 10000 9740 10900 10200 

9973 1.534 

701 0.992 

C

Particle Size 

Determinations Te

GSD TMC 

(mg/m3) 

2.006 6.01E-03 

1.701 1.84E-03 

1.646 1.17E-03 

2.571 3.25E-03 

2.110 5.42E-03 

0.347 5.91E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

0 12-Feb-02 1 9470 

1 13-Feb-02 2 9450 

2 14-Feb-02 3 9540 

3 15-Feb-02 4 9890 

6 18-Feb-02 5 9830 

7 19-Feb-02 6 9740 

8 20-Feb-02 7 10800 

9 21-Feb-02 8 9910 

10 22-Feb-02 9 9950 

13 25-Feb-02 10 9840 

14 26-Feb-02 11 9990 15 27-Feb-02 12 9920 

16 28-Feb-02 13 10100 

17 1-Mar-02 14 10100 

20 4-Mar-02 15 9200 

21 5-Mar-02 16 9890 

22 6-Mar-02 17 9730 

23 7-Mar-02 18 9860 

24 8-Mar-02 19 9960 

27 11-Mar-02 20 9810 

28 12-Mar-02 21 9890 

29 13-Mar-02 22 9700 

30 14-Mar-02 23 10100 

31 15-Mar-02 24 9980 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IIIB- 10,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (.urn) 

9930 10200 9740 9580 10200 

9925 10400 9840 9550 9910 

10650 10500 10600 10800 10700 

10270 10900 9160 10400 10600 1.351 

9998 10400 9710 9580 10300 

10010 10100 9740 9780 10400 

10150 9780 10000 10000 10800 

10150 10700 10000 9910 10000 

10240 11000 8440 11300 10200 

9480 8460 9580 9480 10400 1.013 

10120 9480 9910 10500 10600 

10740 9940 10300 11200 11500 

10650 10800 10800 10700 10300 

10010 10200 10100 9520 10200 

9955 9580 9940 10000 10300 1.729 

10140 10900 10300 10100 9260 

9743 10100 10000 9520 9350 

10170 9350 10800 10600 9910 

9590 9100 9480 10200 9580 

9655 10200 9580 9420 9420 1.443 

9995 10000 10200 9910 9870 

9168 8140 10400 9100 9030 

10100 10000 9580 10600 10200 

9983 10300 9420 9910 10300 

--- -

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3) 

2.364 4.54E-03 2.207 6.20E-03 2.339 2.53E-03 

1.826 3.34E-03 

-
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

32 16-Mar-02 25 9530 

34 18-Mar-02 26 10000 

35 19-Mar-02 27 10200 

36 20-Mar-02 28 10100 

37 21-Mar-02 29 10300 

38 22-Mar-02 30 9370 

41 25-Mar-02 31 9690 

42 26-Mar-02 32 9940 

43 27-Mar-02 33 9390 44 28-Mar-02 34 9540 

45 29-Mar-02 35 9670 

48 1-Apr-02 36 9830 

49 2-Apr-02 37 10000 

50 3-Apr-02 38 10600 

51 4-Apr-02 39 10000 

52 5-Apr-02 40 9470 

55 8-Apr-02 41 10000 56 9-Apr-02 42 9880 

57 10-Apr-02 43 10100 

58 11-Apr-02 44 9960 

59 12-Apr-02 45 9840 

62 15-Apr-02 46 9950 63 16-Apr-02 47 9950 

64 17-Apr-02 48 9460 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group 1118- 10,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) {tim) 

9325 9580 9520 10200 8000 0.7866 9980 10200 10300 9680 9740 

9548 9350 9100 9740 10000 

9510 9160 9650 9230 10000 

10110 9520 10000 10300 10600 

9188 9650 10000 8550 8550 9573 9650 9350 10000 9290 4.191 

10430 11100 10400 10000 10200 

9818 10200 9840 9580 9650 9493 9580 9230 9580 9580 

10070 10900 10100 9190 10100 0.7259 

10260 10500 10100 9940 10500 

9033 8100 9350 8940 9740 

10630 9910 11500 10400 10700 10680 11000 10700 10800 10200 10250 10400 10200 10400 10000 1.767 

9763 9910 9810 9910 9420 

10130 10600 9940 10300 9680 

10780 10300 11100 10600 11100 

9203 9520 8360 9350 9580 

9775 10400 8500 10200 10000 0.8941 

9888 9780 10700 9230 9840 

10310 10600 9650 11000 10000 

10240 10600 9740 10400 10200 

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3) 

2.330 2.44E-02 

3.203 5.14E-03 

1.633 5.49E-03 

2.194 3.29E-03 

1.837 8.92E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

65 18-Apr-02 49 10100 

66 19-Apr-02 50 9470 69 22-Apr-02 51 9550 

70 23-Apr-02 52 9780 

71 24-Apr-02 53 9780 

72 25-Apr-02 54 9940 

73 26-Apr-02 55 9680 

76 29-Apr-02 56 9620 

77 30-Apr-02 57 9680 

78 1-May-02 58 10200 

79 2-May-02 59 9730 

80 3-May-02 60 10100 

83 6-May-02 61 10000 84 7-May-02 62 9670 85 8-May-02 63 9460 

86 9-May-02 64 9690 87 10-May-02 65 9300 89 12-May-02 66 9860 

90 13-May-02 67 9810 

91 14-May-02 68 9710 

Mean 9832 

S.D. 282 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group 1118- 10,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (pm) 

11000 11500 11300 10600 10600 

10070 9940 9740 10400 10200 0.8013 

10090 10200 10400 9450 10300 

9758 9130 9480 9320 11100 

10650 10700 10200 11000 10700 10240 9740 10200 10500 10500 10530 10100 10400 11200 10400 2.013 

9885 9840 9420 9580 10700 

11250 11400 11100 11400 11100 11130 10900 11500 11000 11100 10480 10800 10100 10600 10400 

10650 10400 10200 11600 10400 1.661 

11180 11300 11100 11100 11200 

10350 10600 10700 10400 9710 

9923 9290 9480 11600 9320 

10500 10200 10500 10000 11300 

10180 10400 9420 9910 11000 1.736 

10550 11500 9810 10100 10800 

9650 10200 10100 8650 9650 

9218 8710 8580 10000 9580 

10090 1.547 

682 0.909 

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3) 

1.904 7.49E-03 

2.546 5.59E-03 

2.332 3.48E-03 

1.967 2.83E-03 

2.206 6.40E-03 

0.402 5.73E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

0 12-Feb-02 1 18400 

1 13-Feb-02 2 17700 

2 14-Feb-02 3 18400 

3 15-Feb-02 4 20500 

6 ' 18-Feb-02 5 20000 

7 19-Feb-02 6 19600 

8 20-Feb-02 7 20000 

9 21-Feb-02 8 19700 

10 22-Feb-02 9 19600 

13 25-Feb-02 10 19600 

14 26-Feb-02 11 19900 15 27-Feb-02 12 19400 16 28-Feb-02 13 19100 17 1-Mar-02 14 18900 

20 4-Mar-02 15 20000 

21 5-Mar-02 16 19600 

22 6-Mar-02 17 18500 

23 7-Mar-02 18 19200 24 8-Mar-02 19 19000 

27 11-Mar-02 20 18800 

28 12-Mar-02 21 19500 

29 13-Mar-02 22 19300 

30 14-Mar-02 23 19100 

31 15-Mar-02 24 19100 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IVA- 20,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (tim) 

19680 19400 19200 19700 20400 

19880 20100 18900 19300 21200 19480 20100 18700 19200 19900 

20430 20300 20300 20700 20400 1.779 20600 19700 22200 20500 20000 20130 19800 20300 19300 21100 

20650 20900 20900 20700 20100 

20550 20300 20300 20500 21100 21400 21200 22300 21000 21100 20480 21600 20400 20400 19500 3.198 20500 20000 20800 20400 20800 20600 19700 20700 20900 21100 

20030 20700 20600 20700 18100 20300 20400 20400 20100 20300 

20750 20800 20900 20800 20500 1.192 20950 20900 21300 20800 20800 

20500 21100 20100 20400 20400 

19900 19500 20100 20100 19900 

20050 19800 20500 19900 20000 

19680 18900 18100 21000 20700 1.358 

20130 20300 20100 20100 20000 20950 21200 21300 20900 20400 

19380 18200 19500 20500 19300 19100 18200 18500 20100 19600 

C

Particle Size 

Determinations Te

GSD TMC 

(mg/m3) 

2.630 4.97E-03 

3.812 1.15E-02 

1.779 1.83E-03 

2.170 4.54E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

32 16-Mar-02 25 19400 

34 18-Mar-02 26 19000 

35 19-Mar-02 27 19300 

36 20-Mar-02 28 19800 

37 '21-Mar-02 29 19000 

38 22-Mar-02 30 19500 

41 25-Mar-02 31 19300 

42 26-Mar-02 32 19300 

43 27-Mar-02 33 19600 

44 28-Mar-02 34 18400 

45 29-Mar-02 35 18600 

48 1-Apr-02 36 18700 49 2-Apr-02 37 18900 

50 3-Apr-02 38 18800 

51 4-Apr-02 39 18900 

52 5-Apr-02 40 19100 55 8-Apr-02 41 18800 

56 9-Apr-02 42 17600 

57 10-Apr-02 43 19700 

58 11-Apr-02 44 18400 

59 12-Apr-02 45 19400 

62 15-Apr-02 46 18700 63 16-Apr-02 47 18900 64 17-Apr-02 48 18700 65 18-Apr-02 49 18800 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IVA- 20,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (tim) 

19980 19600 20500 20100 19700 0.7739 19880 18900 20300 19800 20500 

19250 19500 19000 19500 19000 19650 18200 20400 19900 20100 

19350 19600 19500 19000 19300 

20280 19900 20300 20400 20500 

19550 19500 19700 20100 18900 2.346 

20330 20400 20100 20700 20100 20250 19800 19700 21000 20500 

19780 19500 19800 20200 19600 

19480 19400 18900 20300 19300 0.8053 

20080 20100 19700 20000 20500 20450 20800 20200 20300 20500 

20300 20100 19800 20400 20900 

19480 19300 19000 20000 19600 

20100 19700 19500 20800 20400 1.220 

19830 19900 19500 19300 20600 19050 18900 18800 19000 19500 

20780 20200 20800 21300 20800 

20330 20500 20500 20100 20200 

20680 20400 21100 21100 20100 1.373 

20580 20200 20400 20400 21300 

20900 20800 21000 21000 20800 

20100 20400 20000 20700 19300 

20650 20400 20800 20400 21000 

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3) 

1.949 2.44E-02 

3.191 4.30E-03 

2.004 7.67E-03 

1.549 1.09E-03 

3.011 1.12E-02 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

66 19-Apr-02 50 18400 69 22-Apr-02 51 18600 

70 23-Apr-02 52 18900 

71 24-Apr-02 53 18700 

72 25-Apr-02 54 19000 73 26-Apr-02 55 18800 

76 29-Apr-02 56 19000 

77 30-Apr-02 57 19000 

78 1-May-02 58 18900 79 2-May-02 59 18800 

80 3-May-02 60 18800 

83 6-May-02 61 19000 84 7-May-02 62 19100 

85 8-May-02 63 19100 

86 9-May-02 64 18600 

87 10-May-02 65 18900 

89 12-May-02 66 19100 

90 13-May-02 67 19500 

91 14-May-02 68 19100 

92 15-May-02 69 18700 

93 16-May-02 70 19300 

Mean 19070 

S.D. 510 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IVA- 20,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (pm) 

20430 20500 21100 19700 20400 0.9267 20330 19800 20500 20100 20900 

21200 21200 21100 21200 21300 

20480 19800 20300 20600 21200 20630 20500 21700 20100 20200 

21080 21200 20100 22200 20800 1.413 

19830 19300 20300 19600 20100 

20800 20600 21200 20200 21200 20350 20400 20200 20100 20700 

20230 20600 20300 20300 19700 

20100 20900 19700 19900 19900 3.580 

20930 20300 20900 21600 20900 20100 20700 19000 20000 20700 

20130 20700 20000 20400 19400 

18550 17200 19100 18900 19000 19180 18900 18700 19800 19300 1.597 

18830 18300 18000 19300 19700 

19580 19000 19300 19600 20400 

19450 20000 19800 19300 18700 19900 20000 20100 19500 20000 

20300 20200 20300 20300 20400 

20140 1.659 

770 

_ ____!!;878 

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3) 

1.578 2.63E-03 1.826 1.91E-03 

2.863 6.05E-03 

1.681 1.85E-03 

2.311 6.46E-03 

0.719 6.38E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

0 12-Feb-02 1 18400 

1 13-Feb-02 2 17700 

2 14-Feb-02 3 18400 

3 15-Feb-02 4 20500 

6 18-Feb-02 5 20000 7 19-Feb-02 6 19600 

8 20-Feb-02 7 20000 

9 21-Feb-02 8 19700 

10 22-Feb-02 9 19600 13 25-Feb-02 10 19600 

14 26-Feb-02 11 19900 

15 27-Feb-02 12 19400 16 28-Feb-02 13 19100 

17 1-Mar-02 14 18900 

20 4-Mar-02 15 20000 

21 5-Mar-02 16 19600 

22 6-Mar-02 17 18500 

23 7-Mar-02 18 19200 24 8-Mar-02 19 19000 

27 11-Mar-02 20 18800 

28 12-Mar-02 21 19500 29 13-Mar-02 22 19300 

30 14-Mar-02 23 19100 

31 15-Mar-02 24 19100 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IVB - 20,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (pm) 

20000 21700 20100 18800 19400 

19200 18200 19200 19300 20100 19900 19800 21100 17900 20800 

22680 23300 22600 22600 22200 1.134 

21680 22500 20900 22500 20800 

21300 19200 22000 21400 22600 20400 20000 20700 20200 20700 

20030 19600 19600 20100 20800 

20530 20400 21400 20200 20100 

21200 20500 21300 21500 21500 1.041 

21380 21700 22600 21700 19500 

20530 20900 19900 20500 20800 

20450 20700 20500 20200 20400 

20900 21300 21700 20200 20400 

21100 20700 21200 21100 21400 1.147 

21450 21400 21700 22000 20700 

19950 20000 19700 20000 20100 

21000 21700 20700 20900 20700 

19650 19400 19900 19500 19800 19350 19300 17400 20700 20000 1.182 

20350 20700 20500 20000 20200 

19400 19400 19500 19200 19500 

21080 20700 20700 21200 21700 

20430 20800 19600 20600 20700 

C

Particle Size 

Determinations Tem

GSD TMC 

(mg/m3j 

1.917 4.00E-03 

2.111 7.73E-03 

1.782 1.69E-03 

2.056 4.70E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

32 16-Mar-02 25 19400 

34 18-Mar-02 26 19000 35 19-Mar-02 27 19300 

36 20-Mar-02 28 19800 37 21-Mar-02 29 19000 38 22-Mar-02 30 19500 

41 25-Mar-02 31 19300 

42 26-Mar-02 32 19300 

43 27-Mar-02 33 19600 

44 28-Mar-02 34 18400 

45 29-Mar-02 35 18600 

48 1-Apr-02 36 18700 

49 2-Apr-02 37 18900 

50 3-Apr-02 38 18800 

51 4-Apr-02 39 18900 

52 5-Apr-02 40 19100 

55 8-Apr-02 41 18800 

56 9-Apr-02 42 17600 

57 10-Apr-02 43 19700 58 11-Apr-02 44 18400 

59 12-Apr-02 45 19400 

62 15-Apr-02 46 18700 

63 16-Apr-02 47 18900 64 17-Apr-02 48 18700 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IVB - 20,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (.um) 

20680 20300 21200 20500 20700 0.7578 

20980 20700 21300 20300 21600 20580 20700 20400 20700 20500 20800 20500 20800 20800 21100 20730 20300 20600 21100 20900 20750 20700 20700 21100 20500 

21030 21000 21200 20700 21200 0.9018 

19850 20000 20000 19900 19500 

20380 20000 20300 20800 20400 

19930 18900 20400 20400 20000 19650 19400 20800 19900 18500 0.7779 18930 18500 18900 19200 19100 18830 17900 19000 19100 19300 19250 19700 18900 18900 19500 19900 19600 19000 20700 20300 

19700 19600 20600 19300 19300 1.517 

19880 19600 19300 20000 20600 

18230 18300 18200 18100 18300 

20350 20100 20800 20800 19700 

20150 20500 20100 20000 20000 20200 19800 20800 20200 20000 1.301 

19650 19600 19200 19800 20000 

20450 20100 20800 20800 20100 

19300 18100 19200 20200 19700 

C

Particle Size 

Determinations Te

GSD TMC 

(mg/m3) 

1.842 2.31 E-02 

2.195 3.14E-03 

2.114 9.04E-03 

2.038 2.38E-03 

2.253 9.39E-03 
Huntingdon Life Sciences 00-6130 

Day Date Exposure Nominal 

Number 

(mg/m3) 

65 18-Apr-02 49 18800 66 19-Apr-02 50 18400 

69 22-Apr-02 51 18600 

70 23-Apr-02 52 18900 

71 24-Apr-02 53 18700 

72 25-Apr-02 54 19000 

73 26-Apr-02 55 18800 

76 29-Apr-02 56 19000 

77 30-Apr-02 57 19000 78 1-May-02 58 18900 

79 2-May-02 59 18800 

80 3-May-02 60 18800 83 6-May-02 61 19000 84 7-May-02 62 19100 

85 8-May-02 63 19100 

86 9-May-02 64 18600 

87 10-May-02 65 18900 

89 12-May-02 66 19100 

90 13-May-02 67 19500 

91 14-May-02 68 19100 

Mean 19070 

S.D. 515 

Mean 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IVB - 20,000 mg/m3 

Analytical Chamber Concentration 

Individual MMAD 

(mg/m3) (mg/m3) (tim) 

20080 20400 20400 19700 19800 

18850 18500 19400 18300 19200 0.7490 19780 19000 20000 19400 20700 19850 20500 19900 20500 18500 19430 19200 19800 19000 19700 19480 19400 20400 19600 18500 19930 20800 19200 19200 20500 1.357 

19300 18800 19400 19300 19700 

19030 18400 19200 18400 20100 

19900 20200 20100 19300 20000 18800 17900 19200 19400 18700 

19200 19000 19500 19300 19000 6.591 

19750 19500 20400 19700 19400 19680 20400 18600 19700 20000 

20330 20900 20200 20700 19500 20000 20200 20100 19700 20000 

20000 20000 20100 19900 20000 1.699 

20350 20000 20000 20800 20600 

20100 20000 20000 19800 20600 

18880 20000 19000 18300 18200 

20100 1.550 

Particle Size 

Determinations 

GSD TMC 

(mg/m3) 

1.593 5.03E-03 1.997 3.45E-03 

3.086 3.95E-03 

2.025 2.97E-03 

2.078 6.20E·03 

--------

967 - 1.§42 - 0.351 5.64E-03 - - -

C

Tem
Huntingdon Life Sciences 00-6130 Page 292

211-DIPE-S Final Report

Individual Clinical Observations

Preface Appendix B

For summarization purposes, descriptive comments [i.e., location of scab(s) 

and/or sore(s), etc.] are not presented in this table. These data are contained in 

the study raw data if needed.

Corresponding exposure levels for each group were as follows:

 

Group I – 0 mg/m3 

Group II – 2000 mg/m3

Group III – 10000 mg/m3

Group IV – 20000 mg/m3
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 1 0 MG/M3 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 -

1 1 1 1 

1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

ANIMAL# 

1051 

1052 

1053 

1054 

1055 

1056 

1057 1058 1059 1060 

OBSERVATIONS 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE DERMAL GENERAL: ALOPECIA - EXTREMITIES/SNOUT 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

OCULAR: CHROMODACRYORRHEA - UNILATERAL 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p 

p 

3 3 3 3 3 3 3 3 3 3 3 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p p p p 

p 

p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

MALES 

ANIMAL# 

1061 

1062 

1063 1064 1065 

1066 1067 1068 

GROUP 1 0 MG/M3 

OBSERVATIONS 

DAY OF 

STUDY 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

OCULAR: CHROMODACRYORRHEA - UNILATERAL 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

DERMAL GENERAL: SCABS 

OCULAR: CHROMODACRYORRHEA - UNILATERAL 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

DERMAL GENERAL: SCABS 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

1 1 1 1 

1 - 1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p 

p p p p p p 

p p p p 

p p 

p p 

p p p p p p p p 

p p 

p p p p p p p 

p p p p p p p p p p p p p p 

p p p p p p p p p p p p p p 

p p 

p 

p p 

p p p p p p p p p p p p p p p p p p p p p p p p p p p p p p 

p p p p p p p p p p p 

p p p p 

p p 

p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES GROUP 1 0 MG/M3 

ANIMAL# OBSERVATIONS 

1069 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

1070 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 -

1 1 1 1 

1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p 

p 

p p p p p p 

p p p p p p p p p p p p 

p 

p p p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

MALES 

ANIMAL# 

2051 

2052 2053 

2054 

2055 2056 2057 

2058 

GROUP 2 2000 MG/M3 

OBSERVATIONS 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

DAY OF 

STUDY 

DERMAL GENERAL: ALOPECIA - EXTREMITIES/SNOUT 

OCULAR: CHROMODACRYORRHEA - UNILATERAL 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

1 -

1 1 1 1 

1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p 

p 

3 3 3 3 3 3 3 3 

p 

p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p 

p 

p 

p p p p p p p p p p p p p p 

p 

p p p p p p p 

p 

p p p p p p p 

p p p p p p p p p p p p p p 

p 

p 

p p p p p 

p 

p p p p p p p p p p 

p p p p p p p p p p p p 

p 

p p p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

ANIMAL# 

2059 2060 

GROUP 2 2000 MG/M3 

OBSERVATIONS 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

REASSIGNED TO SATELLITE GROUP 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 1 1 1 

1 - 1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p 

p 

p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

ANIMAL# 

3051 

3052 3053 3054 

3055 

3056 

3057 3058 

3059 

GROUP 3 10000 MG/M3 

OBSERVATIONS 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

DERMAL GENERAL: SCABS DERMAL GENERAL: ALOPECIA - GENERAL 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

/ 

1 -

1 1 1 1 

1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p 

p 

p 

p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p 

p p 

p p p p p p 

2 2 2 

p 

p p p p 

p p p 

p p p p p p p p p p p p p p p 

p p p p p p p p p p p p p p 

p 

p 

p 

p p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

ANIMAL# 

3060 

GROUP 3 10000 MG/M3 

OBSERVATIONS 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 -

1 1 1 1 

1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p p 

p 

p p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES GROUP 4 20000 MG/M3 

ANIMAL# OBSERVATIONS 

4051 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

4052 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

4053 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

4054 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

4055 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

4056 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

OCULAR: CHROMODACRYORRHEA - BILATERAL 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

4057 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

4058 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 -

1 1 1 1 

1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p p p p p p 

p 

p p 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p p p 

p 

p p 

p p p p p p p p p p p p p p p p p p 

p 

p 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p 

p 

p p 

p p 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p 

p 

p p p p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 4 20000 MG/M3 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

ANIMAL# OBSERVATIONS 

DAY OF 

STUDY 

1 1 1 1 

1 - 1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

4059 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

4060 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE DERMAL GENERAL: ALOPECIA - EXTREMITIES/SNOUT 

ORAL/BUCCAL: NASAL DISCHARGE - CLEAR 

4061 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

4062 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

DERMAL GENERAL: ALOPECIA - EXTREMITIES/SNOUT 

OCULAR: CHROMODACRYORRHEA - BILATERAL 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

ORAL/BUCCAL: INCISORS MALOCCLUDED 

4063 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4064 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

4065 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p 

p 

3 3 3 3 3 3 3 3 

p 

p p p p p p p p p p p p 

p 

p p 

p p p 

p 

3 3 3 3 3 3 3 3 3 3 

p p p p p p 

p 

p p p p p p p p p 

p p p p p p p p p p p p p p 

p 

p p p p p 

p 

p p p p p p p p p 

p p p p p p p p p p p p p 

p 

p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

MALES 

ANIMAL# 

4066 

GROUP 4 20000 MG/M3 

OBSERVATIONS 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4067 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

4068 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

4069 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4070 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

OCULAR: CHROMODACRYORRHEA - UNILATERAL 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 1 1 1 

1 - 1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p 

p 

p p 

p p p p p p p p p p p 

p 

p p p p 

p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p 

p 

p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 1 0 MG/M3 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 -

1 1 1 1 

1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

ANIMAL# 

1551 

1552 

1553 

1554 1555 

1556 1557 1558 1559 

OBSERVATIONS 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE DERMAL GENERAL: ALOPECIA - EXTREMITIES/SNOUT 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p 

p 

p p p p 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p 

p 

2 2 2 2 2 2 2 2 

p p p p p p p p p p p p p p p p p p 

p 

p 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p p p p p 

p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 1 0 MG/M3 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 -

1 1 1 1 

1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

ANIMAL# 

1560 

OBSERVATIONS 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

1561 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

OCULAR: CHROMODACRYORRHEA - UNILATERAL 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

1562 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

1563 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1564 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1565 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

1566 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

DERMAL GENERAL: ALOPECIA - EXTREMITIES/SNOUT 

OCULAR: CHROMODACRYORRHEA - UNILATERAL 

1567 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

DERMAL GENERAL: ALOPECIA - EXTREMITIES/SNOUT 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p p p p p p 

p 

p p 

p p p p p p p p p p 

p 

p p 

p p p 

p p p p p p p p p 

p 

p p p p p 

p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p 

p 

p p p p p 

p 

p p p p p p p p p 

p p p p p p p 

p 

3 3 3 3 3 3 3 3 

p p p 

p p p p p 

p 

3 3 3 3 3 3 3 3 3 3 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES GROUP 1 0 MG/M3 

ANIMAL# OBSERVATIONS 

1568 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1569 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

1570 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 1 1 1 

1 - 1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p 

p 

p p p 

p p p p p p p p p p p p p p p 

p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

FEMALES GROUP 2 2000 MG/M3 

ANIMAL# 

2551 2552 2553 

2554 

2555 2556 2557 2558 2559 

OBSERVATIONS 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

DERMAL GENERAL: ALOPECIA - GENERAL 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

DAY OF 

STUDY 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

OCULAR: CHROMODACRYORRHEA - UNILATERAL 

ORAL/BUCCAL: INCISORS MALOCCLUDED 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

1 -

1 1 1 1 

1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p 

p 

p p 

p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p 

p 

p p p 

p 

2 2 2 2 2 2 2 2 2 2 2 

p p p p p p p p p p 

p 

p p p p 

p p p p p p p p p p p p p 

p p 

p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p p p p p p p p p p p 

p p p p p p p p p p 

p p p 

p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 2 2000 MG/M3 

ANIMAL# 

2560 

OBSERVATIONS 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 1 1 1 

1 - 1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 1 1 6 3 0 7 4 1 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p p p p 

p 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

FEMALES GROUP 3 10000 MG/M3 

ANIMAL# 

3551 

OBSERVATIONS 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

3552 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

DAY OF 

STUDY 

DERMAL GENERAL: ALOPECIA - EXTREMITIES/SNOUT 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

3553 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3554 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3555 

3556 3557 3558 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

1 -

1 1 1 1 

1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p 

p 

p p p p 

p p p p p p 

p 

3 3 3 3 3 3 3 3 

p p 

p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p 

p 

p 

p p p p p p p p p p p p 

p 

p p p 

p p p p p p p p p p p p p p 

p 

p 

p p p p p p p p p p p p 

p 

p p p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

FEMALES GROUP 3 10000 MG/M3 

ANIMAL# OBSERVATIONS 

3559 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

3560 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

DAY OF 

STUDY 

DERMAL GENERAL: ALOPECIA - EXTREMITIES/SNOUT 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

1 1 1 1 

1 - 1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p p 

p 

p p 

p p p 

p 

2 2 

p p p p p p p p p p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 4 20000 MG/M3 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 -

1 1 1 1 

1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

ANIMAL# OBSERVATIONS 

4551 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

4552 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

4553 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

DERMAL GENERAL: YELLOW ANO-GENITAL STAINING 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

4554 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

4555 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

4556 WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

4557 

ORAL/BUCCAL: NASAL DISCHARGE - RED ORAL/BUCCAL: INCISORS MALOCCLUDED 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

OCULAR: CHROMODACRYORRHEA - UNILATERAL 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

ORAL/BUCCAL: INCISORS BROKEN/MISSING 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p p p p p 

p 

p 

p p p p p p p p p p p p p 

p 

1 

p p p p p 

p p p p p p p p p p p p p p p p 

p 

p p p 

p p p p p p p p p p p p p p p p p 

p 

p p 

p p p p p p 

p 

p p p p p p p p p p p p p 

p 

p p p p p p p p 

p 

p p 

p p p p p p p p p 

p p p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

FEMALES GROUP 4 20000 MG/M3 

ANIMAL# 

4558 4559 

4560 4561 

OBSERVATIONS 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

RECOVERY SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - CLEAR 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4562 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4563 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

OCULAR: CHROMODACRYORRHEA - BILATERAL OCULAR: CHROMODACRYORRHEA - UNILATERAL 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

ORAL/BUCCAL: INCISORS MALOCCLUDED 

4564 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4565 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

OCULAR: LACRIMATION - UNILATERAL 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 -

1 1 1 1 

1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p p p p p p p p p p 

p 

p 

p p p p p p p p p p p p p p p p p 

p 

p p 

p p p p p p p p p p p p p p 

p 

p p p p p 

p p p p p p p p p p p p p p 

p 

p p p p p p p p p p p p p p 

p 

p p p p p p p 

p 

p p 

p p p p 

p p 

p p p p p p 

p p p p p p p p p p p p p p 

p 

p p p p p p p p p 

p 

2 

p p p p 

P
25-SEP-2003 13:51 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

FEMALES GROUP 4 20000 MG/M3 

ANIMAL# OBSERVATIONS 

4566 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4567 4568 4569 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

DAY OF 

STUDY 

DERMAL GENERAL: YELLOW ANO-GENITAL STAINING 

OCULAR: CHROMODACRYORRHEA - UNILATERAL 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

4570 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

ORAL/BUCCAL: NASAL DISCHARGE - RED 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

1 -

1 1 1 1 

1 2 2 3 4 4 5 6 6 7 8 9 9 9 0 1 1 2 

1 1 6 3 0 7 4 1 8 5 2 9 6 3 0 1 7 4 1 8 2 

p p p p p p p p p 

p 

p p p p p p 

p p p p p p p p p p p 

p 

p p p p 

p p p p p p p p p p 

p 

p p p p p 

p p p p p p p p 

p 

1 1 1 1 1 

p 

p p p 

p p p p p p p p p p 

p 

p p p p p 

P
25-SEP-2003 13:52 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 1 0 MG/M3 

ANIMAL# OBSERVATIONS 

1071 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1072 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1073 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1074 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1075 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 9 9 1 3 4 

p 

p 

p 

p 

p 

p 

p 

p 

p 

p 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

P
25-SEP-2003 13:52 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 2 2000 MG/M3 

ANIMAL# OBSERVATIONS 

2061 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2062 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2063 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2064 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2065 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 9 9 

1 3 4 

p 

p 

p 

p 

p 

p 

p 

p 

p 

p 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

P
25-SEP-2003 13:52 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 3 10000 MG/M3 

ANIMAL# OBSERVATIONS 

3061 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3062 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3063 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3064 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3065 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 9 9 

1 3 4 

p 

p 

p 

p 

p 

p 

p 

p 

p 

p 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

P
25-SEP-2003 13:52 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 4 20000 MG/M3 

ANIMAL# OBSERVATIONS 

4071 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4072 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4073 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4074 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4075 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 9 9 

1 3 4 

p 

p 

p 

p 

p 

p 

p 

p 

p 

p 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

P
25-SEP-2003 13:52 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 1 0 MG/M3 

ANIMAL# OBSERVATIONS 

1571 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1572 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1573 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1574 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1575 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 9 9 

1 3 4 

p 

p 

p 

p 

p 

p 

p 

p 

p 

p 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

P
25-SEP-2003 13:52 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 2 2000 MG/M3 

ANIMAL# OBSERVATIONS 

2561 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2562 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2563 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2564 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2565 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 9 9 1 3 4 

p 

p 

p 

p 

p 

p 

p 

p 

p 

p 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

P
25-SEP-2003 13:52 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 3 10000 MG/M3 

ANIMAL# OBSERVATIONS 

3561 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3562 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3563 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3564 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3565 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 9 9 1 3 4 

p 

p 

p 

p 

p 

p 

p 

p 

p 

p 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

P
25-SEP-2003 13:52 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 4 20000 MG/M3 

ANIMAL# OBSERVATIONS 

4571 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4572 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4573 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4574 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4575 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

APPENDIX B 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL CLINICAL OBSERVATIONS 

DAY OF 

STUDY 

1 9 9 1 3 4 

p 

p 

p 

p 

p 

p 

p 

p 

p 

p 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 1 0 MG/M3 

ANIMAL# PART OF EYE 

1051 

1052 

1053 1054 

1055 1056 1057 1058 

1059 1060 1061 1062 1063 1064 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 1 0 MG/M3 

ANIMAL# PART OF EYE 

1065 1066 

1067 1068 

1069 1070 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 2 2000 MG/M3 

ANIMAL# PART OF EYE 

2051 2052 2053 2054 

2055 

2056 

2057 2058 2059 2060 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 3 10000 MG/M3 

ANIMAL# PART OF EYE 

3051 3052 3053 3054 3055 3056 3057 3058 3059 3060 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 4 20000 MG/M3 

ANIMAL# PART OF EYE 

4051 

4052 4053 4054 

4055 

4056 

4057 

4058 

4059 

4060 4061 4062 4063 4064 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 4 20000 MG/M3 

ANIMAL# PART OF EYE 

4065 

4066 

4067 

4068 4069 

4070 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 1 0 MG/M3 

ANIMAL# PART OF EYE 

1551 

1552 

1553 1554 

1555 

1556 1557 

1558 

1559 

1560 

1561 

1562 

1563 

1564 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 1 0 MG/M3 

ANIMAL# PART OF EYE 

1565 1566 1567 

1568 1569 1570 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 2 2000 MG/M3 

ANIMAL# PART OF EYE 

2551 2552 2553 2554 2555 2556 2557 

2558 

2559 2560 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 3 10000 MG/M3 

ANIMAL# PART OF EYE 

3551 

3552 3553 3554 

3555 3556 3557 3558 3559 

3560 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 4 20000 MG/M3 

ANIMAL# PART OF EYE 

4551 4552 4553 4554 

4555 

4556 

4557 4558 

4559 

4560 4561 4562 4563 4564 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 4 20000 MG/M3 

ANIMAL# PART OF EYE 

4565 4566 4567 4568 4569 4570 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
2S-SEP-2003 13:SS 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 1 0 MG/M3 

ANIMAL# PART OF EYE 

10Sl 

10S2 10S3 

10S4 

lOSS 

10S6 

10S7 

10S8 

10S9 

1060 1061 

1062 

1063 

1064 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 1 0 MG/M3 

ANIMAL# PART OF EYE 

1065 1066 

1067 1068 1069 

1070 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 2 2000 MG/M3 

ANIMAL# PART OF EYE 

2051 CONJUNCTIVA 

2052 2053 

2054 

2055 2056 2057 2058 2059 2060 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

CONJUNCTIVITIS; LEFT 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 3 10000 MG/M3 

ANIMAL# PART OF EYE 

3051 

3052 3053 3054 3055 

3056 3057 3058 3059 3060 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 4 20000 MG/M3 

ANIMAL# PART OF EYE 

4051 4052 4053 4054 4055 4056 4057 4058 4059 4060 4061 4062 CONJUNCTIVA 4063 

4064 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

CONJUNCTIVITIS; RIGHT 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 4 20000 MG/M3 

ANIMAL# PART OF EYE 

4065 

4066 4067 4068 4069 4070 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 1 0 MG/M3 

ANIMAL# PART OF EYE 

1551 1552 1553 

1554 

1555 1556 1557 1558 1559 1560 1561 1562 1563 1564 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 1 0 MG/M3 

ANIMAL# PART OF EYE 

1565 1566 CONJUNCTIVA 1567 1568 1569 1570 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

CONJUNCTIVITIS; RIGHT 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 2 2000 MG/M3 

ANIMAL# PART OF EYE 

2551 

2552 

2553 2554 2555 

2556 2557 2558 

2559 CONJUNCTIVA 

2560 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

CONJUNCTIVITIS; LEFT 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 3 10000 MG/M3 

ANIMAL# PART OF EYE 

3551 

3552 

3553 3554 3555 

3556 3557 3558 3559 

3560 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 4 20000 MG/M3 

ANIMAL# PART OF EYE 

4551 4552 4553 4554 

4555 

4556 IRIS 4557 

4558 4559 4560 4561 

4562 4563 CONJUNCTIVA 4564 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

ANTERIOR UVEITIS (IRITIS); RIGHT 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

CONJUNCTIVITIS; LEFT 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:55 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 4 20000 MG/M3 

ANIMAL# PART OF EYE 

4565 

4566 

4567 4568 

4569 

4570 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 1 0 MG/M3 

ANIMAL# PART OF EYE 

1071 

1072 

1073 1074 

1075 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 2 2000 MG/M3 

ANIMAL# PART OF EYE 

2061 

2062 2063 

2064 

2065 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 3 10000 MG/M3 

ANIMAL# PART OF EYE 

3061 3062 3063 3064 3065 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 4 20000 MG/M3 

ANIMAL# PART OF EYE 

4071 

4072 4073 4074 4075 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 1 0 MG/M3 

ANIMAL# PART OF EYE 

1571 1572 

1573 

1574 1575 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 2 2000 MG/M3 

ANIMAL# PART OF EYE 

2561 

2562 

2563 2564 

2565 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 3 10000 MG/M3 

ANIMAL# PART OF EYE 

3561 

3562 3563 

3564 

3565 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 4 20000 MG/M3 

ANIMAL# PART OF EYE 

4571 4572 

4573 

4574 4575 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 1 0 MG/M3 

ANIMAL# PART OF EYE 

1071 

1072 

1073 1074 1075 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 2 2000 MG/M3 

ANIMAL# PART OF EYE 

2061 2062 

2063 2064 2065 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 3 10000 MG/M3 

ANIMAL# PART OF EYE 

3061 3062 3063 3064 3065 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 4 20000 MG/M3 

ANIMAL# PART OF EYE 

4071 

4072 

4073 4074 

4075 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 1 0 MG/M3 

ANIMAL# PART OF EYE 

1571 1572 1573 1574 1575 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 2 2000 MG/M3 

ANIMAL# PART OF EYE 

2561 

2562 2563 2564 

2565 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 3 10000 MG/M3 

ANIMAL# PART OF EYE 

3561 

3562 

3563 

3564 

3565 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

NO VISIBLE LESIONS NO VISIBLE LESIONS 

NO VISIBLE LESIONS 

P
25-SEP-2003 13:59 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 4 20000 MG/M3 

ANIMAL# PART OF EYE 

4571 

4572 4573 4574 4575 

APPENDIX C 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL OPHTHALMOLOGY OBSERVATIONS 

OBSERVATION 

NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS NO VISIBLE LESIONS 

P
25-SEP-2003 14:01 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES 

ANIMAL# 

MEAN 

S.D. 

N 

1051 1052 1053 1054 1055 1056 1057 1058 1059 1060 

1061 

1062 1063 1064 1065 1066 1067 

1068 1069 1070 

GROUP 1 0 MG/M3 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

WEEK OF STUDY 

-1 0 1 

223 

211 230 211 212 

223 

220 228 228 210 

236 206 

218 216 

213 

222 219 

226 224 229 220 

8.1 

20 

317 305 308 

296 288 

322 

296 

322 314 

292 

338 

284 

309 307 

299 

313 

291 

296 299 

319 306 

13.7 

20 

359 347 348 334 320 365 329 370 336 

330 

382 323 344 351 331 349 

318 322 321 358 342 

18.5 

20 

2 

394 382 

380 

370 

342 

399 

359 

405 

362 369 

412 

358 382 380 

364 367 352 346 352 385 

373 

19.6 

20 

3 

418 

400 405 

395 374 

423 

378 

433 

383 389 

443 

391 

410 406 

392 

401 

381 373 377 

416 

399 

19.8 

20 

4 

434 428 435 417 

378 

439 406 434 

397 

400 463 

399 

445 434 413 445 401 

390 397 

436 420 

22.6 

20 

5 

450 

437 

448 434 400 467 424 461 419 435 486 424 443 

461 435 458 422 411 404 

453 439 

22.4 

20 

6 

460 

446 

466 445 412 480 438 483 434 448 

505 

442 

474 469 459 482 436 429 422 

471 455 

23.7 

20 

7 

481 467 

483 466 432 490 457 

518 

454 486 

531 

461 497 495 483 

512 

466 449 

447 

505 

479 

25.9 

20 

8 

491 480 

500 

472 

444 

504 

464 

527 

474 494 

543 

477 

521 512 501 

526 

481 457 459 

507 

492 

26.5 

20 

9 

508 

490 

520 

488 456 

514 

481 

542 

491 

510 563 

498 

535 

528 513 543 

498 472 471 

524 507 

27.3 

20 

10 

514 

503 

541 

500 

468 

529 

489 

553 505 

487 

571 518 

550 539 516 552 506 

492 492 

540 518 

27.5 

20 

11 

535 

511 

554 505 

483 

544 507 569 520 510 587 533 

562 560 533 563 518 507 

503 548 533 

27.6 

20 

12 

544 516 568 505 

491 

558 518 576 524 

515 591 544 574 564 548 576 

530 521 514 567 542 

28.5 

20 

P
25-SEP-2003 14:01 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 2 

ANIMAL# 

2051 2052 2053 

2054 2055 2056 2057 2058 2059 2060 

MEAN 

S.D. 

N 

2000 MG/M3 

WEEK OF STUDY 

-1 0 

212 293 230 311 222 306 

219 299 229 317 211 302 210 292 226 322 224 317 217 310 220 307 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

1 2 3 4 5 6 7 8 9 10 

330 364 387 407 418 443 456 477 492 498 337 364 391 407 436 445 464 473 482 486 344 368 398 421 433 453 478 491 505 519 

329 360 392 418 427 440 460 472 486 492 344 380 400 430 450 477 496 504 518 533 347 376 407 440 451 470 491 501 515 521 328 357 387 413 429 443 460 475 492 496 360 392 431 458 479 500 527 543 564 571 349 385 411 440 456 475 496 521 538 540 353 385 412 439 454 475 494 511 519 533 342 373 402 427 443 462 482 497 511 519 

7.5 10.4 11.0 12.0 13.9 16.9 18.0 20.2 22.7 23.8 25.8 26.5 

10 10 10 10 10 10 10 10 10 10 10 10 

11 12 

510 474 

496 504 

532 537 

500 509 

546 555 

530 539 507 515 

588 591 562 575 548 558 532 536 

29.7 35.6 

10 10 

P
25-SEP-2003 14:01 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 3 

ANIMAL# 

10000 MG/M3 

WEEK OF STUDY 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

-1 0 1 2 3 4 5 6 7 8 9 10 11 12 

-----------------------------------------------------------------------------------------------------------------

3051 226 306 330 358 377 403 419 440 467 482 493 513 521 527 3052 220 307 337 378 409 441 460 483 505 525 532 546 549 563 3053 224 306 323 361 378 413 430 444 480 484 496 512 519 522 3054 217 307 340 371 397 426 441 461 490 502 523 530 547 556 3055 213 292 325 364 392 409 428 452 473 498 508 521 533 541 3056 208 283 308 333 350 373 383 407 427 444 454 467 480 483 3057 233 351 399 432 455 481 504 528 552 570 596 621 640 650 3058 229 316 355 377 397 423 438 454 474 491 504 516 521 529 3059 223 308 337 368 389 408 433 455 469 485 495 512 526 531 3060 211 293 322 345 366 395 412 431 449 463 473 482 494 502 

MEAN 220 307 337 369 391 417 435 455 479 494 507 522 533 540 

S.D. 8.1 18.4 24.9 26.3 28.3 29.1 31.6 32.1 33.4 34.6 38.3 41.3 43.2 45.2 

N 10 10 10 10 10 10 10 10 10 10 10 10 10 10 

P
25-SEP-2003 14:01 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES 

ANIMAL# 

4051 

4052 

4053 4054 4055 4056 4057 4058 4059 4060 4061 

4062 4063 4064 4065 4066 4067 4068 4069 4070 

MEAN 

S.D. 

N 

GROUP 4 20000 MG/M3 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

WEEK OF STUDY 

-1 

228 215 

211 

204 

212 

216 

230 218 210 227 217 211 

222 

230 225 221 225 235 224 

223 

220 

8.1 

20 

0 

317 307 

296 

277 285 

300 325 304 

281 

306 

298 

298 

305 302 302 304 308 343 

297 

307 303 

14.5 

20 

1 

342 335 322 308 311 333 367 

339 300 336 331 326 343 337 331 331 347 

390 316 349 335 

20.1 

20 

2 

368 367 349 330 342 363 393 

375 

330 367 356 353 

380 

361 

360 365 378 

430 

337 378 364 

22.9 

20 

3 

392 392 

373 357 362 388 

425 401 

349 

400 

383 376 

416 

384 

384 

392 

400 459 

359 

406 

390 

25.5 

20 

4 

421 416 

398 379 378 

405 434 414 

368 

418 407 

367 

444 406 411 

428 

427 491 

377 

425 411 

29.3 

20 

5 

442 

436 425 

399 399 

427 459 428 

390 

445 

416 

375 

461 419 425 442 441 

517 

386 

444 429 

31.7 

20 

6 

459 455 439 420 408 443 482 448 410 458 

436 

392 

482 441 438 460 459 

539 

404 466 447 

33.0 

20 

7 

487 478 466 446 427 471 

505 

481 435 

483 459 407 

511 

475 461 492 480 

574 

425 489 

472 

36.4 

20 

8 

501 

483 478 461 441 458 

518 

491 452 

500 

476 415 

526 

488 475 

502 

489 

591 

442 

503 

484 

37.2 

20 

9 

518 

495 

497 470 461 482 

535 

496 471 

527 

489 

431 

543 507 

493 

518 506 

619 

454 

528 502 

39.7 

20 

10 

534 503 516 

485 470 

494 

541 509 

482 

545 505 

445 

553 515 

498 

526 515 

638 

462 

543 514 

41.1 

20 

11 

553 

514 532 

493 471 

503 551 525 

481 

557 518 

450 

569 534 520 543 525 

659 

470 

562 526 

45.4 

20 

12 

553 526 539 

495 476 

509 556 

528 

490 

570 531 

458 

572 533 527 550 537 

676 

481 

571 534 

46.6 

20 

P
25-SEP-2003 14:15 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 1 0 MG/M3 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

WEEK OF STUDY 

ANIMAL# 13 14 15 16 17 

1051 560 573 581 589 591 

1052 524 525 537 538 546 

1053 575 574 581 588 589 

1054 497 511 526 535 537 1055 497 515 524 537 547 1056 569 577 597 610 619 1057 514 522 528 533 535 

1058 589 607 604 627 631 

1059 541 537 554 565 564 1060 516 516 526 531 537 1061 TS 1062 TS 

1063 TS 

1064 TS 1065 TS 

1066 TS 

1067 TS 1068 TS 1069 TS 1070 TS 

MEAN 538 546 556 565 569 

S.D. 33.2 33.8 31.9 35.7 35.9 

N 10 10 10 10 10 

TS=Terminal Sacrifice 

P
25-SEP-2003 14:18 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

MALES GROUP 4 20000 MG/M3 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

WEEK OF STUDY 

ANIMAL# 13 14 15 16 17 

4051 553 570 585 586 594 4052 526 541 551 562 566 

4053 542 557 567 577 592 4054 502 517 543 556 558 4055 469 488 505 506 514 4056 514 521 536 543 546 4057 556 571 581 595 594 4058 537 542 555 571 578 

4059 495 503 518 532 544 4060 575 577 603 611 611 4061 TS 4062 TS 4063 TS 4064 TS 

4065 TS 4066 TS 

4067 TS 4068 TS 4069 TS 4070 TS 

MEAN 527 539 554 564 570 

S.D. 32.3 30.7 30.6 31.3 29.6 

N 10 10 10 10 10 

TS=Terminal Sacrifice 

P
25-SEP-2003 14:19 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 1 

ANIMAL# 

MEAN 

S.D. 

N 

1551 1552 

1553 1554 

1555 1556 1557 1558 1559 1560 1561 1562 1563 1564 

1565 1566 

1567 

1568 1569 1570 

0 MG/M3 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

WEEK OF STUDY 

-1 0 1 

188 167 

180 

183 

181 

185 170 

185 

178 176 

177 

188 

196 191 167 177 

165 189 175 

172 

179 

8.6 

20 

250 217 

220 234 224 209 

213 

224 221 

213 

216 234 232 227 

207 206 

204 252 224 

213 

222 

13.4 

20 

259 231 

222 253 233 228 225 235 233 228 232 252 259 235 229 230 

218 

272 236 233 237 

14.1 

20 

2 

265 

242 

236 

262 250 236 

233 

252 245 249 241 

261 

273 

259 

235 248 

231 

308 

244 247 251 

17.7 

20 

3 

271 252 248 

271 256 249 238 264 242 250 247 

274 

280 265 255 

243 

246 

319 

255 261 259 

18.2 

20 

4 

281 264 

257 292 

273 

259 247 268 258 266 260 

283 

285 270 257 

256 

259 

323 

268 269 270 

17.0 

20 

5 

281 275 

260 

302 

279 268 250 272 264 269 270 289 294 

273 

276 

263 

269 

343 

273 273 277 

19.3 

20 

6 7 

288 290 272 283 

256 267 

304 317 

288 297 270 281 255 267 

275 282 

265 268 

269 271 

276 276 

289 297 295 296 279 298 258. 282 

269 274 

274 283 

344 365 

268 286 

282 .301 279 289 

20.0 22.1 

20 20 

8 

295 290 

269 

328 301 

277 267 287 276 

284 

286 

304 

299 289 

280 274 

302 370 

291 

309 

294 

23.2 

20 

9 

304 

295 

273 

333 302 

281 276 

293 

281 292 297 

302 314 

288 288 

281 

311 

369 

294 

305 

299 

21.8 

20 

10 

310 304 

283 

333 

315 

293 284 

299 

282 

300 

299 

308 

316 

300 

280 288 

307 384 

296 

315 305 

23.1 

20 

11 

314 308 

286 

338 319 

297 280 

302 

281 

315 

294 

315 317 305 300 

277 

308 381 305 

309 308 

22.9 

20 

12 

311 305 

287 

347 321 

298 287 

306 

291 

301 320 313 314 304 

296 282 

319 380 

302 

311 310 

22.2 

20 

P
25-SEP-2003 14:19 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 2 2000 MG/M3 

WEEK OF STUDY 

ANIMAL# -1 0 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

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

-----------------------------------------------------------------------------------------------------------------

2551 186 222 239 253 263 271 279 279 293 293 298 309 313 307 2552 178 217 235 237 255" 267 270 269 283 288 288 289 292 296 

2553 188 233 246 245 259 275 273 266 282 289 290 290 296 304 2554 169 206 233 243 246 256 266 273 277 285 294 301 304 306 2555 176 208 231 242 259 268 272 285 285 288 294 2·99 304 301 2556 181 220 240 253 266 272 278 284 290 303 312 321 314 325 

2557 193 247 270 296 308 310 309 318 334 332 337 352 345 356 2558 166 202 206 212 222 238 237 237 251 256 255 257 263 269 2559 173 203 223 238 246 248 260 268 268 270 275 277 277 284 2560 184 215 239 255 263 277 280 289 301 309 307 324 319 333 

MEAN 179 217 236 247 259 268 272 277 286 291 295 302 303 308 

S.D. 8.6 14.2 16.2 21.1 21.7 19.5 18.0 20.5 21.8 20.8 21.8 26.6 22.8 24.7 

N 10 10 10 10 10 10 10 10 10 10 10 10 10 10 

P
25-SEP-2003 14:19 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 3 

ANIMAL# 

10000 MG/M3 

WEEK OF STUDY 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

-1 0 1 2 3 4 5 6 7 8 9 10 11 12 

-----------------------------------------------------------------------------------------------------------------

3551 186 237 260 278 281 300 307 309 321 324 334 341 340 342 3552 184 210 238 257 266 269 283 285 298 302 316 323 327 323 

3553 176 221 221 242 242 255 259 264 274 270 281 291 281 279 3554 189 255 266 280 291 313 312 318 327 341 354 360 372 376 3555 177 216 224 239 253 268 270 270 286 286 299 297 305 312 3556 181 219 247 270 284 290 304 311 316 323 339 348 350 346 3557 166 205 221 230 232 247 255 257 265 275 284 287 285 294 3558 173 201 219 237 254 260 270 278 286 277 293 301 305 303 3559 169 263 284 291 292 314 328 340 337 356 372 364 356 374 3560 192 223 248 267 270 291 302 302 320 322 330 325 335 331 

MEAN 179 225 243 259 266 281 289 293 303 307 320 324 326 328 

S.D. 8.6 20.6 22.2 21.3 20.8 24.2 25.0 26.7 24.5 29.8 30.8 29.0 30.5 32.4 

N 10 10 10 10 10 10 10 10 10 10 10 10 10 10 

P
25-SEP-2003 14:19 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 4 

ANIMAL# 

4551 4552 

4553 4554 4555 4556 4557 4558 4559 

4560 

4561 4562 4563 4564 4565 4566 

4567 

4568 

4569 4570 

MEAN 

S.D. 

N 

20000 MG/M3 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

WEEK OF STUDY 

-1 

186 176 

190 188 185 172 175 

188 

179 

170 

182 164 178 196 

166 

177 190 168 

183 

175 179 

8.7 

20 

0 

220 220 

237 

234 220 218 220 218 

203 

226 231 

192 

216 249 

195 

226 

250 

217 234 216 222 

15.0 

20 

1 

233 

219 

243 

238 226 235 244 234 216 

241 

244 

200 228 274 215 

243 

266 228 

248 226 235 

17.0 

20 

2 

244 230 

269 250 240 

244 

257 

250 228 

255 254 

207 240 

288 227 255 

280 245 259 

243 

248 

18.4 

20 

3 

250 239 

273 253 

249 250 277 260 232 

263 

263 219 252 

301 

225 

262 

282 

255 259 

253 

256 

19.1 

20 

4 

252 247 

282 264 258 

263 

261 265 241 

279 

278 

227 255 

307 

230 278 295 256 272 253 

263 

20.0 

20 

5 

259 

258 

286 267 265 

273 

277 278 249 

287 

285 230 271 

319 

234 277 

303 

270 

282 268 

272 

20.7 

20 

6 

264 

253 

293 

271 

268 276 

279 287 

255 

294 290 235 269 

320 

242 285 

308 

279 286 

272 276 

20.9 

20 

7 

271 261 

304 

277 278 280 

276 293 

258 

291 292 245 257 

334 

251 

292 

316 

283 

281 286 281 

21.7 

20 

8 

273 

265 

306 

286 281 

288 

296 288 259 

305 301 

246 274 

333 

246 293 

322 

293 

296 275 286 

22.5 

20 

9 

281 266 

307 

295 287 297 298 299 

266 

310 309 

245 278 

337 

253 

299 

338 301 301 

291 

293 

23.6 

20 

10 

285 271 

312 

297 289 

304 

292 

309 

274 

317 315 

247 291 

332 

255 

303 337 

297 

305 

298 296 

22.6 

20 

11 

292 

273 

322 304 

291 

301 

290 

309 

274 

310 318 

253 

285 

345 

262 

307 

336 300 

301 

299 299 

22.9 

20 

12 

284 

279 

317 311 

291 

311 301 309 

272 

320 322 

256 285 

341 

260 

310 

339 

308 313 

294 

301 

23.3 

20 

P
25-SEP-2003 14:19 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

FEMALES GROUP 1 0 MG/M3 

WEEK OF STUDY 

ANIMAL# 13 14 15 16 17 

1551 315 321 325 327 322 1552 308 311 315 314 311 

1553 283 287 297 289 298 1554 348 344 346 356 361 1555 317 319 328 325 324 1556 291 296 301 300 301 1557 290 276 277 280 285 1558 301 309 308 308 305 

1559 285 287 289 293 301 

1560 292 297 296 298 287 1561 TS 1562 TS 1563 TS 1564 TS 1565 TS 1566 TS 

1567 TS 1568 TS 1569 TS 1570 TS 

MEAN 303 305 308 309 309 

S.D. 19.9 20.1 20.6 22.3 22.1 

N 10 10 10 10 10 

TS=Terminal Sacrifice 

P
25-SEP-2003 14:21 

Huntingdon Life Sciences 00-6130 

Toxicity Sub-Group (Main and Recovery) 

FEMALES GROUP 4 20000 MG/M3 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

WEEK OF STUDY 

ANIMAL# 13 14 15 16 17 

4551 287 294 302 297 304 4552 281 275 286 294 295 

4553 314 321 327 329 328 4554 308 306 320 317 328 4555 291 302 304 315 311 4556 309 311 314 318 325 4557 302 283 300 305 305 4558 313 315 318 321 322 4559 275 282 284 282 294 

4560 325 319 323 333 342 4561 TS 4562 TS 4563 TS 4564 TS 4565 TS 4566 TS 

4567 TS 

4568 TS 4569 TS 4570 TS 

MEAN 301 301 308 311 315 

S.D. 16.3 16.5 15.1 16.2 16.0 

N 10 10 10 10 10 

TS=Terminal Sacrifice 

P
25-SEP-2003 14:23 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 1 

ANIMAL# 

0 MG/M3 

WEEK OF STUDY 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

-1 0 1 2 3 4 5 6 7 8 9 10 11 12 

----------------------------------------------------------------------------------------------------------------

1071 228 325 377 406 450 475 510 532 567 584 608 619 642 660 1072 214 283 315 343 367 396 429 450 477 492 512 524 538 552 

1073 229 316 348 385 406 414 441 461 487 495 510 521 533 551 1074 203 275 299 327 349 368 386 406 417 425 433 447 461 469 1075 219 297 330 352 375 399 421 436 457 462 478 494 504 513 

MEAN 218 299 334 363 389 411 437 457 481 492 508 521 536 549 

S.D. 11.0 21.5 30.1 32.2 39.5 39.6 45.6 46.7 55.0 58.8 64.3 62.9 66.8 70.5 

N 5 5 5 5 5 5 5 5 5 5 5 5 5 5 

P
25-SEP-2003 14:23 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 2 2000 MG/M3 

WEEK OF STUDY 

ANIMAL# -1 0 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

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

-----------------------------------------------------------------------------------------------------------------

2061 208 284 315 346 367 389 411 427 435 454 469 478 497 506 2062 221 299 330 362 389 408 443 463 484 508 530 544 562 560 

2063 229 309 351 386 414 441 471 492 517 535 555 568 582 592 2064 194 266 295 323 350 368 383 392 410 415 430 444 458 465 2065 229 331 384 426 455 487 508 532 555 562 582 583 604 616 

MEAN 216 298 335 369 395 419 443 461 480 495 513 523 541 548 

S.D. 15.2 24.6 34.2 39.5 41.3 46.9 49.1 54.5 59.0 59.9 62.5 59.8 60.9 62.0 

N 5 5 5 5 5 5 5 5 5 5 5 5 5 5 

P
25-SEP-2003 14:23 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 3 

ANIMAL# 

10000 MG/M3 

WEEK OF STUDY 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

-1 0 1 2 3 4 5 6 7 8 9 10 11 12 

-----------------------------------------------------------------------------------------------------------------

3061 223 313 350 389 424 457 482 506 523 546 569 575 596 607 3062 235 330 351 389 422 444 482 506 519 532 558 565 588 609 

3063 219 302 338 376 403 419 452 472 495 504 522 541 555 574 3064 212 309 351 387 420 452 472 496 524 535 556 570 583 601 3065 198 254 293 326 353 380 393 412 430 440 455 465 475 484 

MEAN 217 302 336 373 404 430 456 478 498 512 532 543 560 575 

S.D. 13.6 28.4 25.0 27.2 30.1 32.0 37.3 39.7 40.1 42.8 46.6 45.6 49.8 52.8 

N 5 5 5 5 5 5 5 5 5 5 5 5 5 5 

P
25-SEP-2003 14:23 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

MALES GROUP 4 

ANIMAL# 

20000 MG/M3 

WEEK OF STUDY 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

-1 0 1 2 3 4 5 6 7 8 9 10 11 12 

----------------------------------------------------------------------------------------------------------------

4071 218 304 335 360 386 406 430 442 468 465 485 496 505 522 

4072 217 319 367 406 438 460 492 520 537 563 578 600 615 631 

4073 231 325 362 396 425 446 465 484 503 514 535 553 565 577 4074 221 311 354 387 408 429 450 443 447 441 449 450 458 444 4075 203 271 309 344 368 392 413 427 448 469 481 494 509 518 

MEAN 218 306 345 379 405 427 450 463 481 490 506 518 531 538 

S.D. 10.0 21.1 23.7 25.8 28.2 27.7 30.7 38.1 38.8 48.3 51.1 58.6 60.7 70.2 

N 5 5 5 5 5 5 5 5 5 5 5 5 5 5 

P
25-SEP-2003 14:23 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 1 0 MG/M3 

WEEK OF STUDY 

ANIMAL# -1 0 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

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

----------------------------------------------------------------------------------------------------------------

1571 192 246 262 276 281 293 309 309 314 315 323 326 325 336 1572 180 218 241 260 269 276 292 294 302 319 316 327 332 335 1573 188 246 268 294 301 318 327 335 348 352 358 368 369 386 

1574 184 229 252 274 284 289 312 313 323 325 334 339 344 348 

1575 172 214 235 235 248 256 260 257 272 269 272 270 278 280 

MEAN 183 230 252 268 276 286 300 302 312 316 321 326 330 337 

S.D. 7.7 15.0 13.9 22.0 19.7 22.5 25.6 28.8 28.0 29.8 31.6 35.8 33.2 38.1 

N 5 5 5 5 5 5 5 5 5 5 5 5 5 5 

P
25-SEP-2003 14:23 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 2 

ANIMAL# 

2000 MG/M3 

WEEK OF STUDY 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

-1 0 1 2 3 4 5 6 7 8 9 10 11 12 

----------------------------------------------------------------------------------------------------------------

2561 184 209 229 241 251 249 262 263 269 260 273 279 282 280 2562 191 249 255 268 305 302 299 315 328 327 331 345 353 362 

2563 177 222 250 263 270 284 296 291 295 304 308 312 317 325 2564 182 221 241 257 267 266 282 282 292 294 305 308 310 325 2565 164 224 245 257 274 281 294 287 305 305 310 307 323 329 

MEAN 180 225 244 257 273 276 287 288 298 298 305 310 317 324 

S.D. 10.0 14.8 9.8 10.3 19.9 20.0 15.3 18.7 21.1 24.6 20.8 23.3 25.3 29.1 

N 5 5 5 5 5 5 5 5 5 5 5 5 5 5 

P
25-SEP-2003 14:23 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 3 

ANIMAL# 

10000 MG/M3 

WEEK OF STUDY 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

-1 0 1 2 3 4 5 6 7 8 9 10 11 12 

----------------------------------------------------------------------------------------------------------------

3561 181 219 220 240 252 258 264 270 281 290 288 299 315 313 3562 166 206 216 223 222 237 242 241 238 250 254 255 254 271 

3563 173 201 217 230 231 245 250 255 262 265 265 268 268 276 

3564 188 242 257 270 283 292 300 312 324 318 329 337 342 344 3565 185 257 280 298 308 328 341 346 352 366 374 376 375 393 

MEAN 179 225 238 252 259 272 279 285 291 298 302 307 311 319 

S.D. 9.0 24.1 29.2 31.0 36.0 37.8 41.0 43.1 45.9 46.0 49.5 49.7 50.5 50.9 

N 5 5 5 5 5 5 5 5 5 5 5 5 5 5 

P
25-SEP-2003 14:23 

Huntingdon Life Sciences 00-6130N 

Neurotoxicity Sub-Group 

FEMALES GROUP 4 20000 MG/M3 

WEEK OF STUDY 

ANIMAL# -1 0 

APPENDIX D 

GASOLINE DIPE VAPOR CONDENSATE: A 13-WEEK WHOLE-BODY 

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMUNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHTS (GRAMS) 

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

----------------------------------------------------------------------------------------------------------------

4571 191 235 261 275 282 292 310 318 331 329 346 355 362 362 4572 172 215 243 257 271 270 279 283 289 289 292 297 309 318 

4573 184 221 224 245 258 268 275 287 289 291 289 303 305 310 4574 188 228 241 241 255 261 267 261 274 279 279 277 290 293 4575 177 211 234 253 259 261 281 287 293 294 308 315 309 311 

MEAN 182 222 241 254 265 270 282 287 295 296 303 309 315 319 

S.D. 7.7 9.6 13.5 13.4 11.5 12.5 16.4 20.3 21.4 19.1 26.2 29.0 27.5 25.8 

N 5 5 5 5 5 5 5 5 5 5 5 5 5 5 

P