Appendix D - Dossier (PDF) - Tera

date: 20–JUL–2005
5. Toxicity Substance ID: 71–43–2
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Summary SMRs for leukaemia in white males declined from 3.37
(95% CI 1.54–6.41) in the previous update to 2.56 (95% CI
1.43–4.22) in the current study.
The relationship between benzene exposure and leukaemia
mortality appeared to be best modelled using a linear
cumulative exposure with no lag.
Four new multiple myeloma deaths occurred since the 1981
update bringing the total to 8, however 3 of the 4 new cases
were in workers judged to be unexposed and were not included
in the SMR calculations. Of the remainder, 4 occurred in the
lowest exposure category (1 ppm–day to 30.99 ppm–years of
exposure) and the fifth was in the highest exposure category
(>400 ppm–years).
Source: A.K. Mallett Surrey
Conclusion: The results reaffirm the leukemogenic effects of benzene
exposure and suggest that excess risk had diminished with
time (possibly reflecting a decline in benzene exposure).
19–MAR–2004 (942)
5.8.1 Toxicity to Fertility
Type: other: Reproductive toxicity of vapor recovery unit
gasoline.
Species: rat
Sex: male/female
Strain: Sprague–Dawley
Route of administration: inhalation
Exposure Period: 6 hr/day
Frequency of treatment: 6 hr/day, 7 days/wk
Duration of test: 10 wk exposure prior to mating. Females continued to
be exposed until gestation day 20.
Doses: 0, 5000, 10000, 20000 mg/m3
Control Group: yes, concurrent no treatment
Method: other
Year: 2000
GLP: yes
Test substance: other TS: Vapor Recovery Unit Gasoline
Remark: Gasoline (CAS 86290–81–5) is one of the world’s largest
volume commercial products. Although numerous toxicology
studies have been conducted, the potential for reproductive
toxicity has not been directly assessed. Accordingly, a
two–generation reproductive study in rats was conducted to
provide base data for hazard assessment and risk
characterization. The test material, vapor recovery unit
gasoline (68514–15–8), is the volatile fraction of
formulated gasoline and the material with which humans are
most likely to come in contact. The study was of standard
design. Exposures were by inhalation at target
concentrations of 5000, 10000 and 20000 mg/m3. The highest
exposure concentration was approximately 50% of the lower
explosive limit and several orders of magnitude above
anticipated exposure during refueling. There were no
Appendix D: Benzene SIDS Dossier
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