Appendix D - Dossier (PDF) - Tera

date: 20–JUL–2005
5. Toxicity Substance ID: 71–43–2
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Type: Cytogenetic assay
Species: rat Sex: male
Strain: Wistar
Route of admin.: inhalation
Exposure period: 6 hours
Doses: 0, 1, 10, 100, 1000 ppm (converts to 0, 0.003, 0.033, 0.33,
3.26 mg/l)
Method: other: in compliance with OECD Guide–line 475
Year: 1984
GLP: no data
Test substance: other TS
Remark: Only male animals were tested (justified by the authors).
Groups of eight rats were exposed at each benzene
concentration and the control group contained 12 animals.
Controls were exposed to clean dry air. The benzene
exposure concentrations were measured. Animals received
colchicine intra–peritoneally 2 hours before sacrifice, they
were then killed, their femurs removed and the bone marrow
harvested. Slides were prepared and examined for
abnormalities.
Reliability: 2 (valid with restriction)
Comparable to guideline study with acceptable restrictions
no positive control, single sampling time
Result: Analysis of the test atmospheres gave benzene concentrations
of 0.0026 ñ 0.0006, 0.032 ñ 0.006, 0.44 ñ 0.12 and 3.56 ñ
0.34 mg/l. The breathing of animals at the top dose was
very rapid immediately after the exposure period. This was
not reported at the lower doses. There was a statistically
significant increase in the percentage of cells with
abnormalities, including or excluding gaps, in animals
exposed to 0.33 and 3.26 mg/l. Elevated levels of abnormal
cells were seen at 0.003 and 0.033 mg/l, these being
dose–related but not statistically significant. Positive
results in rats inhaling benzene have been reported by other
investigators (Anderson D. & Richardson C.R. Mutation Res.
90, 261–272, 1981.
Source: Deutsche Shell Chemie GmbH Eschborn
Test substance: analytical reagent grade; purity not specified.
06–JAN–1997 (1098)
Appendix D: Benzene SIDS Dossier
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