DRAFT REPORT 

Study Title 

In Vivo-In Vitro Rat Peripheral Lymphocyte Sister Chromatid Exchange Assay 

Test Substance 

Gasoline DEE Vapor Condensate 

Author 

Rarnadevi Gudi, Ph.D. 

Caren M. Brown, M.S. 

Study Completion 

(Pending final report) 

Performing Laboratov 

BioReliance 

9630 Medical Center Drive 

Rockville, Maryland 20850 

Laboratory Study Number 

AA4ONZ. 130.BTL 

Subcontractor's Sponsor Proiect Number 

00-6130 

Subcontractor's Sponsor 

Huntingdon Life Sciences 

Princeton Research Center (PRC) 

Mettlers Road 

East Millstone, New Jersey 08875-2360 

Page 1 of 
STATEMENT OF COMPLIANCE 

The Sister Chromatid Exchange BioReliance Study No. AA40NZ. 130.BTL was conducted in 

compliance with 79.60, CFR Vol. 59, No. 122,27 June 1994. This study was performed 

according to protocol and BioReliance7s Standard Operating Procedure for Sister Chromatid 

Exchange Assay with no exceptions. 

1 4&- 

Rarnadevi Gudi, Ph.D. Date 

Principal Investigator 

BioReliance 

Gary M. Hoffinan, B.A.; D.A.B.T. Date 

Study Director 

Huntingdon Life Sciences 

BioReliance Study No. : AA40NZ. 130.BTL 2 
Quality Assurance Statement 

Study Title: IN VIVO-IN VITRO RAT PERIPHERAL LYMPHOCYTE SISTER CHROMATID 

EXCHANGE ASSAY 

Study Number: AA40NZ. 130.BTL 

Study Director: Ramadevi Gudi, Ph.D. 

This study has been divided into a series of in-process phases. Using a random sampling approach, Quality 

Assurance monitors each of these phases over a series of studies. Procedures, documentation, equipment 

records, etc., are examined in order to assure that the study is performed in accordance with the U.S. FDA 

Good Laboratory Practice Regulations (21 CFR 58), the US. EPA GLPs (40 CFR 792 and 40 CFR 160), the 

UK GLP Regulations, the Japanese GLP Standard, and the OECD Principles of Good Laboratory Practice 

and to assure that the study is conducted according to the protocol and relevant Standard Operating 

Procedures. . 

The following are the inspection dates, phases inspected, and report dates of QA inspections of this study. 

Inspect On 12-Apr-02 - 12-Apr-02 To Study Dir 12-Apr-02 To Mgmt 12-Apr-02 

Phase Preparation of cultures 

Inspect On 05-Aug-02 - 06-Aug-02 To Study Dir 06-Aug-02 To Mgmt 15-Aug-02 

Phase Draft Report 

This report describes the methods and procedures used in the study and the reported results accurately reflect 

the raw data of the study. 

8hdb 

Joan M. ~l~owan, A.A.S. DATE 

QUALITY ASSURANCE 
SPONSOR'S QUALITY ASSURANCE STATEMENT 

Listed below are the dates that this study was inspected by the Quality Assurance Unit of 

Huntingdon Life Sciences, East Millstone, New Jersey, and the dates that findings were 

reported to the Study Director and Management. This report reflects the raw data as far as 

can be reasonably established. 

Reported to 

Date(s) of Study Director and 

Type of Inspection Inspection Management 

Date 

Quality Assurance Auditor 

BioReliance Study No. : AA40NZ. 130.BTL 
SIGNATURE PAGE 

SCIENTIST 

The following Scientist was responsible for the overall conduct of this study: 

Ramadevi Gudi, PbD. 

Principal Investigator 

BioReliance 

Date 

SCIENTIFIC REVIEW 

The following Scientists have reviewed and approved this report: 

David Jacobson-Kram, Ph.D., DABT 

Vice-president, Toxicology 

BioReliance 

Gary M. Hofkan, B.A., DABT 

Study Director 

Huntingdon Life Sciences 

BioReliance Study No. : AA40NZ. 130.BTL 

Date 

Date 
In Vivo-In Vitro Rat Peripheral Lymphocyte Sister Chromatid Exchange Assay 

DRAFT REPORT 

Subcontractor's Sponsor: 

Study Director: 

Performing Laboratory: 

Test Substance I.D.: 

Sponsor Project Number: 

BioReliance Study No. : 

Experimental Start Date for SCE: 

Experimental Completion Date for SCE: 

BioReliance Study No. : AA4ONZ. 130.BTL 6 

Huntingdon Life Sciences 

Princeton Research Center (PRC) 

Mettlers Road 

East Millstone, New Jersey 08875-2360 

Gary Hoffman, B.A., DABT 

BioReliance 

9630 Medical Center Drive 

Rockville, Maryland 20850 

Gasoline DIPE Vapor Condensate 

00-6130 

M40NZ.130.BTL 

April 11,2002 

June 24,2002 
TABLE OF CONTENTS 

Page 

SUMMARY .......................................................................................................................................................... 8 

PURPOSE ............................................................................................ - ........................................................... 9 

CHARACTERIZATION OF TEST AND CONTROL SUBSTANCES ........................................................ 9 

MATERIAIS AND METHODS .................................................................................................................... 9 

RESULTS AND DISCUSSION ....................................................................................................................... 11 

CONCLUSION .................................................................................................................................................. 12 

REF'ERENCES .................................................................................................................................................. 13 

DATA TABLES ........................................................................................................................................... 14 

APPENDIX A: CONTRACTING SPONSOR'S EXPOSURE DATA AND ANIMAL DATA ................... 21 

BioReliance Study No . : AA4ONZ . 130.BTL 
SUMMARY 

The test substance, Gasoline DIPE Vapor Condensate, was tested in the rat peripheral 

lymphocyte sister chromatid exchange (SCE) assay following inhalation exposure of rats. 

Information on test system, experimental design and methodology will be provided by 

Huntingdon Life Sciences. All in vivo portions of the study, including inhalation exposures 

were performed by Huntingdon Life Sciences. 

Rats were exposed by inhalation to negative (air) control, 2,000, 10,000 and 

20,000 mg/m3 of Gasoline DIPE Vapor Condensate for 4 weeks (5 days exposure per week). 

One additional group of animals (5 males and 5 females) was dosed with 

5 mgkg of cyclophosphamide (CP, positive control) by intraperitoneal injection 24 hours 

prior to blood collection. BioReliance personnel collected rat blood samples at 24 hours after 

the end of a 4 week (5 days per week) exposure period. Rat blood samples were cultured and 

processed for the SCE assay at a BioReliance facility. 

A minimum of 25 second division metaphases per animal were scored for SCEs. At least 

100 consecutive metaphases per animal were scored for the number of cells in first-, second-, 

or third-division metaphase for each animal as an indictor of toxicity (cell cycle delay). At 

least 1000 cells were scored for mitotic index per animal. A Dunnett's t test for multiple 

comparisons was performed to compare the SCE frequency of test exposure levels to the 

negative control fiequency. No statistically significant increase in SCE frequency was 

observed in males or females in any of the groups exposed to Gasoline DIPE Vapor 

Condensate. 

Based on the findings of this study, the test substance, Gasoline DIPE Vapor 

Condensate, was concluded to be negative for the induction of sister chromatid exchanges in 

rat peripheral lymphocytes. 

BioReliance Study No. : AA4ONZ. 130.BTL 
PURPOSE 

The purpose of this study was to evaluate the potential of Gasoline DIPE Vapor 

Condensate to induce SCEs in rat peripheral lymphocytes following inhalation exposures. 

CHARACTERIZATION OF TEST AND CONTROL SUBSTANCES 

Information regarding test substance and negative control and their characterizations will 

be provided by Huntingdon Life Sciences. 

Cyclophospharnide (CP, CAS No. 60%- 19-2, lot number 1 OSHO568, expiration date 30 

June 2002, white powder, storage 2-S°C, purity 99.2%), was obtained fiom the Sigma 

Chemical Company St. Louis, MO (responsible for its characterization) CP was shipped fiom 

BioReliance on 08 April 2002, received at Huntingdon Life Sciences on 09 April 2002 and 

was dissolved and diluted in sterile distilled water at Huntingdon Life Sciences to a stock 

concentration of 0.5 mg/mL for use as the positive control for the SCE study. 

CP has been characterized as per the Certificate of Analysis on file with the testing 

facility. The stability of CP and of the CP mixtures used in this assay was demonstrated by 

acceptable results that met the criteria for a valid test. 

MATERIALS AND METHODS 

Test System 

Information on the test system will be provided by Huntingdon Life Sciences. 

Sister Chromatid Exchange Assay 

Peripheral blood lymphocytes were obtained from Sprague-Dawley rats that were 

exposed with negative (air) control, 2000, 10,000 and 20,000 mg/m3 of Gasoline DIPE Vapor 

Condensate or positive control (5 mgkg of CP injected IP at 10 mL/kg, 24 hours prior to 

sacrifice). Animals were anesthetized with isoflurane by inhalation exposure. Blood samples 

were collected into sodium heparin tubes fiom the abdominal aorta by BioReliance personnel 

on site at Huntingdon Life Sciences. The blood samples were transported to BioReliance on 

the day of collection on ice packs. 

Cell Culture and Collection of Metaphase Cells 

Within 24 hours after blood collection, the whole blood samples were cultured in 

duplicates per animal in RPMI 1640 culture medium with 25 mM Hepes buffer 

supplemented, 10% fetal bovine serum, antibiotics (pencillin G, 100 u/mL and streptomycin 

sulfate, 0.1 mg/mL), 20 PglrnL phytohemagglutinin and an additional 2 rnM L-glutamine. 

Cultures were initiated by inoculating 0.5 mL of whole blood per 5 mL of complete medium 

BioReliance Study No. : AA40NZ. 130.BTL 9 
in T-25 sterile disposable tissue culture flasks and incubated at 37°C. Approximately 21 

hours after initiation of the cultures, the cells were exposed to 5 Pg/mL of 

bromodeoxyuridine (BrdU, Sigma Co., St. Louis, MO). At approximately 68 hours, 

0.2 PgIrnL of colcemid was added to each flask and incubated for approximately 4 hours. At 

approximately 72 hours, the cells were collected by centrifugation at approximately 1200 rpm 

for about 5 minutes. The cell pellet was resuspended in 5 mL 0.075 M KC1 and incubated at 

37*1°C for 20 minutes. At the end of the KC1 treatment and immediately prior to 

centrifbging, the cells were gently mixed and approximately 0.5 mL of fixative 

(methano1:glacial acetic acid, 3:l vlv) was added to each tube. The cells were collected by 

centrifugation, the supernatant aspirated, and the cells were fixed with two washes with 

approximately 3-5 mL of fixative and stored in fixative overnight or longer at approximately 

2-8°C. 

Slide Preparation 

To prepare slides, the fixed cells were centrifbged at approximately 1200 rpm for 5 

minutes, the supernatant was aspirated, and the cells were resuspended in 1 mL fresh fixative. 

The cells were collected by centrifugation and the supernatant aspirated, leaving 0.1 to 

0.3 mL fixative above the cell pellet. One to two drops of the cell suspension was dropped 

onto a glass slide and allowed to air dry overnight. Slides were identified by the study 

number, animal number, replicate tube designation and date prepared. The dried slides were 

then stained. 

Slide Staining 

The slides were stained by using a modified flourescence-plus-Giemsa technique. 

Hoechst 33258 stain, 5 &mL, was prepared fiesh by diluting 40 mL of Hoechst 33258 stock 

stain 50 Pg/mL in distilled water, with 360 mL phosphate buffer, pH 6.8. The slides were 

stained in Hoechst, 5 PgImL, for 10 minutes, rinsed in deionized water and dried between 

sheets of bibulous paper. Three drops of phosphate buffer was placed on each slide and the 

buffer covered with a coverslip. The slides were then placed on a slide warmer maintained at 

approximately 6W2'C and covered with a "Black Ray" lamp with 15 watt tubes for 4-6 

minutes. The coverslips were removed, the slides rinsed in deionized water and 

counterstained with 5% Giemsa solution (fieshly prepared by diluting 20 mL Giemsa in 380 

mL deionized water) for 6-10 minutes. The slides were rinsed in deionized water and left to 

air dry. 

Evaluation of SCEs 

Slides were coded using random numbers by an individual not involved with the scoring 

process. Metaphase cells were examined under oil immersion without prior knowledge of 

treatment groups. Whenever possible, a minimum of 25 second division metaphases per 

animal were scored for SCEs. At least 100 consecutive metaphase cells were scored for the 

number of cells in first-, second- or third-division metaphase for each animal as an indicator 

of toxicity (cell cycle delay) (BioReliance SOP# OPGT0442 and OPGT0336). At least 1000 

cells were scored for mitotic index per animal. 

BioReliance Study No. : AA40NZ. 130.BTL 10 
Evaluation of Test Results 

The number of SCEs per second-division metaphase cell were presented for each group 

along with the range of SCEsImetaphase for animals within a group. SCE frequencies as the 

grand mean * standard deviation were presented for each group. The Average Generation 

Time (AGT) is estimated as: = Number of hours in BrdU X 100/ [(number MI cells x 

l)+(number Mz cells x 2)+(number M3 cells x 3)]. A Dunnett's t test for multiple comparisons 

was performed to compare the SCE fiequency of test exposure levels to the negative control 

frequency, and if ~50.05, that exposure level was considered significant. The conclusion of 

the study was based on the Principal Investigator's evaluation of all the data, including the 

biological as well as statistical significance. The following criteria were used as guidelines in 

evaluation of this study: 

The test substance was considered positive if an exposure-level responsive and 

statistically significant increase is observed over a minimum of two exposure levels. A 

statistically significant increase at the high exposure level with an exposure-level responsive 

although not statistically significant increase at lower exposure levels was assessed as 

suspect. A statistically significant increase at one or more exposure levels with no evidence 

of an exposure level response was assessed as equivocal or as negative according to the 

magnitude of the response and the number of exposure levels affected. 

Criteria for Determination of a Valid Test 

The mean SCEs/celVanimal for the positive control animals must be statistically 

increased relative to the negative control. 

Deviations 

No known deviations fiom the protocol or assay-method SOPS occurred during the 

conduct of this study. 

Archives 

All raw data, the protocol and all reports generated at BioReliance will be maintained 

according to Standard Operating Procedure OPQP3040 by the BioReliance RAQA unit 

headquartered at: BioReliance, 14920 Broschart Road, Rockville, MD 20850. After 

submission of the final report, all of the above will be shipped to Huntingdon Life Sciences 

to be archived. All study materials returned to Huntingdon Life Sciences will first be copied 

and the copy will be retained in the BioReliance archives for a minimum of 10 years. All 

specimens, such as microscope slides, will be held in storage as long as the quality affords 

evaluation at BioReliance until the final report is issued in accordance with the relevant Good 

Laboratory Practice Regulations. 

RESULTS AND DISCUSSION 

Sister chromatid exchanges involve a symmetrical exchange at one locus, between sister 

chromatids of the chromosomes. Giemsa method for the differential staining of sister 

chromatids by Peny and Wolff (1974a) Wolff and Perry (1974) hav made it possible to 

BioReliance Study No. : AA4ONZ. 130.BTL 11 $ BIORELIANCE. 
distinguish between sister chromatids. These techniques involve exposing cells to 

5-bromodeoxyuridine (BrdU) for at least 2 rounds of replication so that M2 chromosomes 

consist of one chromatid unifilarly substituted with BrdU and the other bifilarly substituted. 

The chromatids of such chromosomes stain differentially with Giemsa stain. The observed 

SCE represents a recombination between DNA helices in the replicating chromosomes and 

used as a sensitive cytological end point which correlates with DNA damage. The test 

substance, Gasoline DIPE Vapor Condensate, was tested in the rat peripheral lymphocyte 

sister chromatid exchange (SCE) assay following inhalation exposure of rats. 

Information on test system, experimental design and methodology will be provided by 

Huntingdon Life Sciences. All in vivo portions of the study, including inhalation exposures, 

were performed by Huntingdon Life Sciences. 

Rats were exposed by inhalation to negative (air) control, 2,000, 10,000 and 

20,000 mg/m3 of Gasoline DIPE Vapor Condensate for 4 weeks (5 days exposure per week). 

One additional group of animals (5 males and 5 females) was dosed with 5 mgkg 

cyclophosphamide (CP, positive control) by intraperitoneal injection 24 hours prior to blood 

collection. Animals dosed at 5 mgkg of CP were used as the positive control group for the 

SCE assay. BioReliance personnel collected rat blood samples at 24 hours after the end of a 4 

week (5 days per week) exposure period. Rat blood samples were cultured and processed for 

the SCE assay in a BioReliance facility. 

A minimum of 25 second division metaphases per animal were scored for SCEs. At least 

100 consecutive metaphases per animal were scored for the number of cells in first-, second-, 

or third-division metaphase for each animal as an indictor of toxicity (cell cycle delay). At 

least 1000 cells are scored for mitotic index per animal. The number of SCEs per 

second-division metaphase cell were presented for each animal (both males and females) in 

Tables 1 to 5. The number of MI, M2 and M3 cells out of 100 metaphases and the mitotic 

index out of 1000 cells per animal are also presented in Tables 1 to 5. The range and the 

average SCEs per animal and the SCE fi-equencies as the grand meamstandard deviation per 

group for males are presented in Table 6 and for females in Table 7. The Average Generation 

Time (AGT) and the mitotic index per group for males are presented in Table 6 and for females 

in Table 7. A Dunnett's t test for multiple comparisons was performed to compare the 

average SCE fi-equency of test exposure levels to the negative control fiequency. No 

statistically significant increase in average SCE fiequency was observed in males or females 

in any groups exposed to Gasoline DlPE Vapor Condensate. The positive control group 

(5 mgkg) induced statistically significant increases in SCE fi-equency in both males and 

females. No appreciable difference was observed in AGT and in mitotic index in the test 

substance groups relative to the negative control group. 

CONCLUSION 

The positive control fulfilled the requirements for a valid test. 

Under the conditions of the assay described in this report, based on the findings of this 

study, the test substance, Gasoline DlPE Vapor Condensate, was concluded to be negative for 

the induction of sister chromatid exchanges in rat peripheral lymphocytes. 

BioReliance Study No. : AA40NZ. 130.BTL 12 
REFERENCES 

Evans, H.J. (1976) Cytological methods for detecting chemical mutagens, in: A. Hollaender 

(Ed.), Chemical Mutagens, Principles and Methods for their Detection, vol. 4. Plenum Press, 

New York, NY. 

MTNITAB User's guide 2: data Analysis and Quality Tools, Release 12 for Windows@ 95 

WndowsNTTM February 1998 Chapter 3: Analysis of Variance, 3- 1 to3-7. 

Perry P. and Wolff S. (1974a) New Giemsa method for the differential staining of sister 

chromatid, Nature (London) 25 1, 156- 158 

Wolff S. and Perry P. (1974) Differential Giemsa staining of sister chromatid and the study of 

sister chromatid exchanges without autoradiography. Chromosoma 48,341-353 

BioReliance Study No. : AA4ONZ. 130.BTL 13 
TABLE 1 

Number of Sister Chromatid Exchanges per cell in Negative Air Control Group 

Air only 

Male and Female Rats 

Number of SCE's Counted 

I Animal Number 

1 Animal numbers 1081-1085 are males and 1591-1595 are females. 

2 Number of MI, M2 and M3 cells are obtained from 100 metaphases. 

Mitotic index; number mitotic figures x 100/1000 cells countedlanimal. 

BioReliance Study No. : AA4ONZ. 130.BTL 
TABLE 2 

Number of Sister Chromatid Exchanges per cell at 2000 mg/m3 of 

Gasoline DIPE Vapor Condensate 

Male and Female Rats 

I Number of SCE's Counted I 

I I Animal Number I 

' Animal numbers 2071-2075 are males and 2581-2585 are females. 

Number of MI, M2 and M3 cells are obtained from 100 metaphases. 

Mitotic index; number mitotic figures x 100/1000 cells countedanimal. 

BioReliance Study No. : AA4ONZ. 130.BTL 
TABLE 3 

Number of Sister Chromatid Exchanges per cell at 10,000 mglm3 of 

Gasoline DIPE Vapor Condensate 

Male and Female Rats 

I Number of SCE's Counted I 

I Animal numbers 3071-3075 are males and 358 1-3585 are females. 

2 Number of MI, M2 and M3 cells are obtained Erom 100 metaphases. 

Mitotic index; number mitotic figures x 100/1000 cells countedlanimal. 

BioReliance Study No. : AA40NZ. 130.BTL 
TABLE 4 

Number of Sister Chromatid Exchanges per cell at 20,000 mg/m3 

of Gasoline DIPE Vapor Condensate 

Male and Female Rats 

Number of SCE's Counted 

I AnimalNumber 

CellNo. 4081 4082 4083 4084 4085 4591 4592 4593 4594 4595 

1 67103669869 

2 991212875867 

3 78103958678 

4 768510678109 

#~lCells 32 35 37 38 30 42 37 30 36 30 

#M2Cells 35 36 30 32 35 38 33 34 30 36 

#M3 Cells 33 29 33 30 35 20 30 36 24 34 

Mitotichdex 6.0 3.0 6.0 10.0 6.0 3.0 8.0 4.0 9.0 6.0 

1 Animal numbers 4081-4085 are males and 4591-4595 are females. 

2 Number of MI, M2 and M3 cells are obtained from 100 metaphases. 

Mitotic index; number mitotic figures x 100/1000 cells counted/animal. 

BioReliance Study No. : AA40NZ. 130.BTL 
TABLE 5 

Number of Sister Chromatid Exchanges per cell at 5 mgkg Cyclophosphamide 

Male and Female Rats 

Number of SCE's Counted 

' Animal numbers 505 1-5055 are males and 5561-5565 are females. 

2 Number of MI, M2 and M3 cells are obtained from 100 metaphases. 

Mitotic index; number mitotic figures x 100/1000 cells countedlanimal. 

BioReliance Study No. : AA40NZ. 130.BTL 
TABLE 6 

Summary of Sister Chromatid Exchange Data - Gasoline DIPE Vapor Condensate Male Rats 

Total Range of 

# of # of SCEs Mean Group Group 

Treatment Animal Metaphases SCEs per per Animal SCEs Range Mean 

# Scored Animal Min Max per cell Min Max + Std. Dev.* 

Air 1081 25 

1082 25 

1083 25 

1084 25 

1085 25 

Gasoline DIPE Vapor Condensate 

2000 mg/rn3 2071 25 

2072 25 

2073 25 

2074 25 

2075 25 

Gasoline DIPE Vapor Condensate 

10,000 mg/m3 

307 1 25 

3072 25 

3073 25 

3074 25 

3075 25 

Gasoline DIPE Vapor Condensate 

20,000 rng/m3 

4081 . 25 

4082 25 

4083 25 

4084 25 

4085 25 

Cyclophosphamide 

5 mg/kg 

505 1 25 

5052 25 

5053 25 

5054 25 

per per per 

4nimal Group Group 

* The standard deviation was calculated using the data of all 125 metaphases scored. 

$ = Dunnett's t test (p 50.05) 

Mitotic Index: (Number of cells in mitosis out of 1000 cells) 

AGT=Average generation time: Number of hours in BrdU X 1001 (number MI cells x l)+(number M2 cells x 2)+(number M3 cells x 3) 

BioReliance Study No. : AA4ONZ. 130.BTL 
TABLE 7 

Summary of Sister Chromatid Exchange Data - Gasoline DIPE Vapor Condensate Female Rats 

Sister Chromatid Exchange data 

Total Range of 

Air 1591 25 

1592 25 

1593 25 

1594 25 

1595 25 

Gasoline DIPE Vapor Condensate 

2000 mglm3 258 1 25 

2582 25 

2583 25 

2584 25 

. 2585 25 

Gasoline DIPE Vapor Condensate 

10,000 mg/m3 

3581 25 

3582 25 

3583 25 

3584 25 

3585 25 

Gasoline DIPE Vapor Condensate 

20,000 mg/m3 

4591 25 

4592 25 

4593 25 

4594 25 

4595 25 

&T MI 

# of # of SCES Mean Group Group 

Treatment Animal Metaphases SCEs per per Animal SCEs Range Mean 

# Scored Animal Min Max per cell Min Max + Std. Dev.* 

Cyclophosphamide 

5 mgk 

5561 25 576 18 - 31 23.0 

5562 25 65 1 20 - 33 26.0 

5563 25 522 18 - 28 20.9 18 to 40 24.3$ f 4.3 

5564 25 609 18 - 30 24.4 

5565 25 679 19 - 40 27.2 

per per per 

Animal Group Group 

* The standard deviation was calculated using the data of all 125 metaphases scored. 

$ = Dunnett's t test @ 10.05) 

Mitotic Index: (Number of cells in mitosis out of 1000 cells) 

AGT=Average generation time: Number of hours in BrdU X 1001 (number MI cells x l)+(number M1 cells x 2)+(number M3 cells x 3) 

BioReliance Study No. : AA4ONZ. 130.BTL 20 
Appendix A: Contracting Sponsor's Exposure Data and Animal Data 

BioReliance Study No. : AA4ONZ. 130.BTL 2 1 
Huntingdon Life Sciences 00-6130 Page 1 - 

21 1-DIPE-S Draft Final Report 

Animal Exposure and Animal Data 

Preface I Appendix A I 

INTRODUCTION: The following is data generated at Huntingdon Life Sciences, East 

Mdlstone, NJ. The separately issued main study report should be referenced for details of 

the procedures used for test atmosphere generation/characterization and animal 

evaluations. 

STUDY DATES: Date of Animal Receipt: 4 March 2002 

Experimental Initiation Date: 15 March 2002 (in-life) 

Experimental Completion Date: 11 April 2002 (in-life) 

Draft Report Date: 6 March 2003 

EXPOSURES AND IN-LIFE SUMMARY: The actual measured results during the 

exposures were comparable to the targeted exposure levels. There were no exposurerelated effects seen in the test animals with regards to body weights and feed 

consumption. 

TABLE OF CONTENTS 

TABLES 

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

B. Summary of Clinical Observations .................................................................................. 

C. Mean Body Weights (grams) ........................................................................................... 

D. Mean Body Weight Change fromBaseline (grams) ........................................................ 

E. Mean Feed Consumption Values (gramslkglday) ............................................................ 

F. Individual Clinical Observations ..................................................................................... 

G. Individual Body Weights (grams) .................................................................................... 

H. Individual Body Weight Change from Baseline (grams) ................................................. 

I. Individual Feed Consumption Values (gramskglday). .................................................... 

J. Animal Termination History ............................................................................................ 
Table A GASOLINE DlPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

00-61 30 

PAGE 1 

Date Exposure 

Number 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

Mean 

S.D. 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IA - 0 mglm3 (Air Control) 

Nominal 

(mglm3) 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

Mean 

(mg/m3) 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

Analvtical Chamber Concentration 

Individual MMAD 

Cum) 

0.9053 

2.495 

2.357 

2.187 

1.986 

0.731 

Particle Size 

Determinations 

GSD TMC 

(mglm3) 

1.20E-02 

4.91 E-03 

7.60E-03 

2.32E-03 

6.71 E-03 

4.1 3E-03 

Chamber 

l\i 

Tem~eraturs 

wironment 

In 

Humiditv 
Table A GASOLINE DlPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

00-61 30 

PAGE 2 

Date Ixposure 

Number 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

Mean 

S.D. 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group I9 - 0 mg/m3 (Air Control) 

Nominal 

(mg/m3) 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1 

Mean 

(mg/m3) 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

alytical Chamber Concentration 

Individual MMAD 

Olm) 

0.9933 

3.236 

1.240 

2.023 

1.873 

1 .OO9 

Particle Size 

?terminal 

GSD 

1s 

TMC 

(mg1m3) 

1.41 E-02 

3.65E-03 

4.86E-03 

2.81 E-03 

6.36E-03 

5.23E-03 

Chamber I 

M 

remperature 

("C) 

23 

26 

24 

24 

24 

24 

24 

24 

23 

24 

24 

24 

24 

24 

24 

24 

24 

24 

24 

24 

24.0 

0.6 

~vironment 

in 

Humidity 

("4 

55 

53 

5 1 

55 

53 

53 

58 

54 

55 

54 

58 

56 

52 

56 

53 

56 

56 

52 

56 

55 

54.6 

1.9 
Table A GASOLINE DlPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Date Exposure 

Number 

~ -- - 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

Mean 

S.D. 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IIA - 2,000 mg/m3 

Nominal 

(mg/m3) 

2160 

21 90 

21 90 

21 60 

21 30 

2180 

2050 

2090 

2030 

2170 

21 10 

2110 

2090 

2030 

2130 

2060 

2220 

1980 

2040 

2050 

21 09 

67 

1 

Mean 

(mgfm3) 

1968 

2068 

2205 

2095 

2040 

2108 

1913 

1918 

1913 

21 33 

2090 

2028 

1843 

1845 

1875 

2093 

21 50 

1950 

1938 

1955 

alytical Chamber Concentration 

Individual MMAD 

bm) 

0.794 

3.91 1 

0.8422 

1.438 

1.746 

1.473 

Particle Size 

!terminai 

GSD 

1s 

TMC 

(mgfm3) 

1.1 9E-02 

4.72E-03 

4.56E-03 

1.53E-03 

5.68E-03 

4.40E-03 

Chamber 

M 

Temperature 

("'4 

23 

26 

23 

23 

23 

23 

23 

23 

24 

24 

24 

24 

24 

23 

23 

23 

23 

23 

24 

24 

23.5 

0.8 

00-61 30 

PAGE 3 

vironment 

n 

Humidity 

(%) 

50 

50 

48 

50 

49 

50 

54 

5 1 

48 

48 

52 

50 

47 

52 

48 

51 

51 

48 

47 

49 

49.7 

1.8 
Table A GASOLINE DlPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Date Exposure 

Number 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

Mean 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IIB - 2,000 mglm3 

Nominal 

(mglm3) 

21 60 

21 90 

21 90 

2160 

21 30 

21 80 

2050 

2090 

2030 

21 70 

21 10 

21 10 

2090 

2030 

21 30 

2060 

2220 

1980 

2040 

2050 

21 09 

67 

Analytical Chamber Concentration 

Mean I Individual MMAD 

Olm) 

0.8998 

0.9819 

0.8897 

1.403 

1.044 

0.243 

Particle Size 

Determinations 

GSD TMC 

(mglm3) 

1.47E-02 

1.76E-03 

5.04E-03 

1.74E-03 

5.81 E-03 

6.13E-03 

00-61 30 

PAGE 4 

Chamber Environment 

Mean 
Table A GASOLINE DlPE VAPOR CONDENSATE: A 13-WEEK 00-61 30 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS PAGE 5 

Date Exposure 

Number 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

Mean 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group IIIA - 10,000 mg/m3 

I 

Nominal 

(mg/m3) 

9980 

9530 

10000 

10200 

10100 

10300 

9370 

9690 

9940 

9390 

9540 

9670 

9830 

10000 

10600 

10000 

9470 

10000 

9880 

101 00 

9880 

321 

Analvtical Chamber Concentration 

GSD 

Particle Size 

Determinations 

Mean I Individual TMC 

(mg/m3) 

2.41 E-02 

2.91 E-03 

5.54E-03 

1.78E-03 

8.58E-03 

1.05E-02 

MMAD 

Chamber Environment 

Mean 

Temperature 

("C) 

24 

23.6 

0.8 

Humidity 

("A) 

49 

48.7 

1.1 
Table A GASOLINE DlPE VAPOR CONDENSATE: A 13-WEEK 00-61 30 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS PAGE 6 

Chamber Monitoring Results 

Cumulative Exposure Record 

Group lllB -10,000 mg/m3 

Date 

Number 

56 9-Apr-02 

57 10-Apr-02 20 10100 10780 

Mean 9880 

S.D. 321 

alytical Chamber Concentration 

Individual 

Chamber Environment 

in 

Humidity 

("w 

49 

49 

46 

46 

46 

46 

46 

45 

46 

46 

46 

47 

44 

47 

' 46 

45 

45 

45 

48 

46 

46.2 

1.3 

Particle Size 

ns 

TMC 

(m9/m3) 

2.44E-02 

5.14E-03 

5.49E-03 

3.29E-03 

9.58E-03 

9.93E-03 

Temperature I 

("C) 

23 

23.8 

0.7 
Table A GASOLINE DlPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Exposure 

Number 

Day 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

Mean 

Date 

S.D. 

Cumulative Exposure Record 

Group IVA - 20,000 mg/m3 

Nominal 1 Mean , alytical Chamber Concentration 

Individual 

Particle Size 

Determinations 

TMC 

(m9/m3) 

2.44E-02 

4.30E-03 

7.67E-03 

1.09E-03 

9.37E-03 

1.04E-02 

MMAD 

Olm) 

0.7739 

2.346 

0.8053 

1.220 

1.286 

0.735 

Chamber Environment 

GSD 

1.949 

3.191 

2.004 

1.549 

2.173 

0.708 

Temperature 

("C) 

25 

28 

25 

24 

24 

25 

25 

25 

25 

25 

25 

26 

26 

25 

24 

24 

24 

25 

25 

26 

25.1 

0.9 

00-61 30 

PAGE 7 

In 

Humidity 

("4 

52 

52 

48 

5 1 

50 

50 

5 1 

49 

49 

49 

48 

49 

47 

50 

52 

50 

50 

49 

50 

5 1 

49.9 

1.4 
Table A GASOLINE DlPE VAPOR CONDENSATE: A 13-WEEK 

WHOLE-BODY INHALATION TOXICITY STUDY IN RATS 

Chamber Monitoring Results 

Number 

16-Mar-02 

57 1 10-Apr-02 1 20 

Mean 

Cumulative Exposure Record 

Group IVB - 20,000 mglm3 

Nominal 

(mglm3) 

191 00 

19400 

19000 

19300 

19800 

19000 

19500 

19300 

19300 

19600 

18400 

18600 

18700 

18900 

18800 

18900 

19100 

18800 

17600 

19700 

19040 

504 

Particle Size 

I 

Mean 

(mg/m3) 

20430 

20680 

20980 

20580 

20800 

20730 

20750 

21 030 

19850 

20380 

19930 

19650 

18930 

18830 

19250 

19900 

19700 

19880 

18230 

20350 

Chamber Environment 

Mean 

alytical Chamber Concentration 

Individual MMAD 

Olm) 

0.7578 

0.901 8 

0.7779 

1.517 

0.989 

0.358 

Humidity 

("h) 

5 1 

52 

49 

50 

49 

49 

50 

48 

5 1 

50 

50 

50 

48 

49 

50 

49 

48 

48 

52 

50 

49.7 

1.2 

00-61 30 

PAGE 8 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 1 

TABLE 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 SUMMARY OF CLINICAL OBSERVATIONS 

------------------------------------------------------------------------.-------

DAY OF STUDY 

GROUP# -4 27 TOTAL 

NORMAL 

WITHIN NORMAL LIMITS 

DEAD 

TERMINAL SACRIFICE 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 2 

TABLE 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 SUMMARY OF CLINICAL OBSERVATIONS 

-------------------------------------------------.-------------------------------

DAY OF STUDY 

GROUP# -4 27 TOTAL ................................................................................................................................... 

# OF ANIMALS EXAMINED 155 

255 

355 

455 

5 5 5 

NORMAL 

WITHIN NORMAL LIMITS 

DEAD 

TERMINAL SACRIFICE 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 1 

TABLE 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 

MALES MEAN BODY WEIGHTS (GRAMS) ................................................................................................................................... 

DOSE GROUP: 1 2 3 4 5 

DOSE LEVEL (MG/M3) : 0 2000 10000 20000 SCE+CONTROL ---------------------------------------------------------------------------------

WEEK 0 MEAN 

S.D. 

N 

WEEK 1 MEAN 

S.D. 

N 

MEAN 

S.D. 

N 

WEEK 2 

WEEK 3 MEAN 

S.D. 

N 

WEEK 4 MEAN 350 349 346 

S.D. 6.3 16.5 16.4 

N 5 5 5 .......................................................................................... 

No statistically significant differences 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 2 

TABLE 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 

FEMALES MEAN BODY WEIGHTS (GRAMS) ................................................................................................................................... 

DOSE GROUP: 1 2 3 4 5 

DOSE LEVEL (MG/M~) : 0 2000 10000 20000 SCEtCONTROL ................................................................................................................................... 

WEEK 

WEEK 

WEEK 

WEEK 

WEEK 

MEAN 

S.D. 

N 

MEAN 

S.D. 

N 

MEAN 

S.D. 

N 

MEAN 

S.D. 

N 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 1 

TABLE 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 

MALES MEAN BODY WEIGHT CHANGE FROM BASELINE (GRAMS) ------------------------------------------------------------.--------------------

DOSE GROUP: 1 2 3 4 5 

DOSE LEVEL (MG/M~) : 0 2000 10000 20000 SCE+CONTROL ................................................................................................................................... 

WEEK 0 TO 1 

WEEK 0 TO 2 

WEEK 0 TO 3 

MEAN 

S.D. 

N 

MEAN 

S.D. 

N 

MEAN 

S.D. 

WEEK 0 TO 4 MEAN 225 225 

S.D. 12.4 22.3 

N 5 5 ............................................................................... 

No statistically significant differences 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 2 

TABLE 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 

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 

No statistically significant differences 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 1 

TABLE E 

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 

WEEK 1 MEAN 

S.D. 

N 

WEEK 2 MEAN 

S.D. 

N 

WEEK 3 MEAN 

S.D. 

N 

WEEK 4 MEAN 

S.D. 

N 

No statistically significant differences 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 2 

TABLE E 

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 

WEEK 1 

WEEK 2 

WEEK 3 

MEAN 

S.D. 

N 

MEAN 

S.D. 

N 

MEAN 

S.D. 

N 

No statistically significant differences 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 1 

TABLE F 

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 GROUP 1 0 MG/M3 

1081 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1082 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1083 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1084 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1085 WITHIN NORMAL LIMITS P 

TERMINAL SACRIFICE P ................................................................................................................................... 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 2 

TABLE F 

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 GROUP 2 2000 MG/M3 

ANIMAL# OBSERVATIONS 

DAY OF - 2 

STUDY 4 7 

2071 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2072 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2073 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2074 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2075 WITHIN NORMAL LIMITS P 

TERMINAL SACRIFICE P ................................................................................................................................... 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 3 

TABLE F 

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 GROUP 3 10000 MG/M3 

3071 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3072 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3073 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3074 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3075 WITHIN NORMAL LIMITS P 

TERMINAL SACRIFICE P ................................................................................................................................... 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

MALES GROUP 4 

TABLE F 

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 

00 MG/M3 

PAGE 4 

4081 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4082 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4083 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4084 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4085 WITHIN NORMAL LIMITS P 

TERMINAL SACRIFICE P ................................................................................................................................... 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 5 

TABLE F 

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 GROUP 5 SCE+CONTROL ................................................................................................................................... 

ANIMAL# OBSERVATIONS 

DAY OF - 2 

STUDY 4 7 

5051 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

5052 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

5053 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

5054 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

5055 WITHIN NORMAL LIMITS P 

TERMINAL SACRIFICE P ................................................................................................................................... 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 6 

TABLE F 

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 1 0 MG/M3 

ANIMAL# OBSERVATIONS 

DAY OF - 2 

STUDY 4 7 

1591 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1592 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1593 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1594 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

1595 WITHIN NORMAL LIMITS P 

TERMINAL SACRIFICE P ................................................................................................................................... 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 7 

TABLE F 

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 

2581 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2582 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2583 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2584 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

2585 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 8 

TABLE F 

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 

DAY OF - 2 

STUDY 4 7 

3581 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3582 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3583 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3584 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

3585 WITHIN NORMAL LIMITS P 

TERMINAL SACRIFICE P ................................................................................................................................... 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 9 

TABLE F 

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 

4591 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4592 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4593 WITHIN NORMAL LIMITS 

' TERMINAL SACRIFICE 

4594 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

4595 WITHIN NORMAL LIMITS P 

TERMINAL SACRIFICE P ................................................................................................................................... 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 10 

TABLE F 

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 5 SCE+CONTROL ................................................................................................................................... 

DAY OF - 2 

ANIMAL# OBSERVATIONS STUDY 4 7 

................................................................................................................................... 

5561 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

5562 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

5563 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

5564 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

5565 WITHIN NORMAL LIMITS 

TERMINAL SACRIFICE 

CODE: 1-SLIGHT 2-MODERATE 3-MARKED P-PRESENT 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 1 

TABLE G 

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 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 2 

TABLE G 

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 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 3 

TABLE G 

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) 

MALES GROUP 3 10000 MG/M3 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 4 

TABLE G 

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 

WEEK OF STUDY 

ANIMAL# 0 1 2 3 4 

................................................................................................................................... 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 5 

TABLE G 

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) 

MALES GROUP 5 SCE+CONTROL ................................................................................................................................... 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 6 

TABLE G 

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 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 7 

TABLE G 

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 

WEEK OF STUDY 

ANIMAL# 0 1 2 3 4 ................................................................................................................................... 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 8 

TABLE G 

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 3 10000 MG/M~ ................................................................................................................................... 

WEEK OF STUDY 

ANIMAL# 0 1 2 3 4 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 9 

TABLE G 

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 4 20000 MG/M3 

-------------------------------------------.------------------------------------

WEEK OF STUDY 

ANIMAL# 0 1 2 3 4 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 10 

TABLE G 

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 

WEEK OF STUDY 

ANIMAL# 0 1 2 3 4 

----------------------..---------------------------------------------------------

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 1 

TABLE H 

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 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 2 

TABLE H 

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 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 3 

TABLE H 

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 WEIGHT CHANGE FROM BASELINE (GRAMS) 

MALES GROUP 3 10000 MG/M3 

WEEK OF STUDY 

ANIMAL# 0-1 0-2 0-3 0-4 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 4 

TABLE H 

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 WEIGHT CHANGE FROM BASELINE (GRAMS) 

MALES GROUP 4 20000 MG/M3 -------------------------------------------------------------------------------

WEEK OF STUDY 

ANIMAL# 0-1 0-2 0-3 0-4 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 5 

TABLE H 

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 WEIGHT CHANGE FROM BASELINE (GRAMS) 

MALES GROUP 5 SCE+CONTROL 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 6 

TABLE H 

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 WEIGHT CHANGE FROM BASELINE (GRAMS) 

FEMALES GROUP 1 0 MG/M3 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 7 

TABLE H 

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

INHALATION TOXICITY STUDY IN RATS WITH NEUROTOXICITY ASSESSMENTS 

AND 4-WEEK IN VIVO GENOTOXICITY AND IMMLJNOTOXICITY ASSESSMENTS 

INDIVIDUAL BODY WEIGHT CHANGE FROM BASELINE (GRAMS) 

FEMALES GROUP 2 2000 MG/M3 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 8 

TABLE H 

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 WEIGHT CHANGE FROM BASELINE (GRAMS) 

FEMALES GROUP 3 10000 MG/M3 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 9 

TABLE H 

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 WEIGHT CHANGE FROM BASELINE (GRAMS) 

FEMALES GROUP 4 20000 MG/M3 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 10 

TABLE H 

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 WEIGHT CHANGE FROM BASELINE (GRAMS) 

FEMALES GROUP 5 SCE+CONTROL ................................................................................................................................... 

WEEK OF STUDY 

ANIMAL# 0-1 0-2 0-3 0-4 ................................................................................................................................... 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

MEAN 

S.D. 

N 

TABLE I 

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 

PAGE 1 

--------------------------------.--------------------------------------

WEEK OF STUDY 

1 2 3 4 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 2 

TABLE I 

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 FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

MALES GROUP 2 2000 MG/M3 ................................................................................................................................... 

WEEK OF STUDY 

ANIMAL# 1 2 3 4 ----------------------------.----------------------------------------------------

2071 131 106 9 3 83 

2072 138 123 105 91 

2073 136 120 99 8 9 

2074 131 110 95 81 

2075 145 126 111 9 9 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 3 

TABLE I 

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 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 4 

TABLE I 

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 FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

MALES GROUP 4 20000 MG/M3 ................................................................................................................................... 

WEEK OF STUDY 

ANIMAL# 1 2 3 4 

MEAN 

s .D'. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 5 

TABLE I 

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 FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

MALES GROUP 5 SCE+CONTROL 

WEEK OF STUDY 

1 2 3 4 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 6 

TABLE I 

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 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 7 

TABLE I 

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 

MEAN 

S.D. 

N 

SF=Spilled Feeder 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 8 

TABLE I 

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 FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

FEMALES GROUP 3 10000 MG/M3 ................................................................................................................................... 

MEAN 

S.D. 

N 

SF=Spilled Feeder 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 9 

TABLE I 

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 FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

FEMALES GROUP 4 20000 MG/M3 ................................................................................................................................... 

WEEK OF STUDY 

ANIMAL# 1 2 3 4 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 10 

TABLE I 

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 FEED CONSUMPTION VALUES (GRAMS/KG/DAY) 

FEMALES GROUP 5 SCE+CONTROL 

MEAN 

S.D. 

N 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 1 

TABLE J 

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 

ANIMAL TERMINATION HISTORY 

MALES GROUP 1 0 MG/M3 ................................................................................................................................... 

TYPE OF DATE OF WEEK OF STUDY 

ANIMAL# DEATH DEATH STUDY DAY ................................................................................................................................... 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 2 

TABLE J 

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 

ANIMAL TERMINATION HISTORY 

MALES GROUP 2 2000 MG/M3 -------------------------------------------------------------.------------------

TYPE OF DATE OF WEEK OF STUDY 

ANIMAL# DEATH DEATH STUDY DAY ................................................................................................................................... 

2071 TERMINAL SACRIFICE 11-APR-02 4 27 

2072 TERMINAL SACRIFICE 11-APR-02 4 27 

2073 TERMINAL SACRIFICE 11-APR-02 4 27 

2074 TERMINAL SACRIFICE 11-APR-02 4 27 

2075 TERMINAL SACRIFICE 11-APR-02 4 27 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 3 

TABLE J 

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 

ANIMAL TERMINATION HISTORY 

MALES GROUP 3 10000 MG/M3 

TYPE OF 

DEATH 

DATE OF WEEK OF STUDY 

DEATH STUDY DAY 

3071 TERMINAL SACRIFICE 

3072 TERMINAL SACRIFICE 

3073 TERMINAL SACRIFICE 

3074 TERMINAL SACRIFICE 

3075 TERMINAL SACRIFICE 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 4 

TABLE J 

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 

ANIMAL TERMINATION HISTORY 

MALES GROUP 4 20000 MG/M3 --------------------------------------------------------------------------------

TYPE OF DATE OF WEEK OF STUDY 

ANIMAL# DEATH DEATH STUDY DAY --------------------.---.------------------------------------------------.-------

4081 TERMINAL SACRIFICE 11-APR-02 4 27 

4082 TERMINAL SACRIFICE 11-APR-02 4 27 

4083 TERMINAL SACRIFICE 11-APR-02 4 2 7 

4084 TERMINAL SACRIFICE 11-APR-02 4 27 

4085 TERMINAL SACRIFICE 11-APR-02 4 27 

................................................................................................................................... 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 5 

TABLE J 

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 

ANIMAL TERMINATION HISTORY 

MALES GROUP 5 SCE+CONTROL 

TYPE OF 

DEATH 

DATE OF WEEK OF STUDY 

DEATH STUDY DAY 

TERMINAL SACRIFICE 

TERMINAL SACRIFICE 

TERMINAL SACRIFICE 

TERMINAL SACRIFICE 

TERMINAL SACRIFICE --------------.-------------------------------- 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 6 

TABLE J 

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 

TYPE OF DATE OF WEEK OF STUDY 

ANIMAL# DEATH DEATH STUDY DAY ................................................................................................................................... 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 7 

TABLE J 

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 

ANIMAL TERMINATION HISTORY 

FEMALES GROUP 2 2000 MG/M3 

2581 TERMINAL SACRIFICE 

2582 TERMINAL SACRIFICE 

2583 TERMINAL SACRIFICE 

2584 TERMINAL SACRIFICE 

2585 TERMINAL SACRIFICE 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 8 

TABLE J 

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 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 9 

TABLE J 

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 

ANIMAL TERMINATION HISTORY 

FEMALES GROUP 4 20000 MG/M3 

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

TYPE OF DATE OF WEEK OF STUDY 

ANIMAL# DEATH DEATH STUDY DAY 
Huntingdon Life Sciences 00-6130G 

211-DIPE-S 

PAGE 10 

TABLE J 

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 

ANIMAL TERMINATION HISTORY 

FEMALES GROUP 5 SCE+CONTROL -------------------------.-------------------------------------------------------

TYPE OF DATE OF WEEK OF STUDY 

ANIMAL# DEATH DEATH STUDY DAY ................................................................................................................................... 

5561 TERMINAL SACRIFICE 11-APR-02 4 27 

5562 TERMINAL SACRIFICE 11-APR-02 4 27 

5563 TERMINAL SACRIFICE 11-APR-02 4 27 

5564 TERMINAL SACRIFICE 11-APR-02 4 27 

5565 TERMINAL SACRIFICE 11-APR-02 4 27