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Appendix D - Dossier (PDF) - Tera

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date: 20–JUL–2005<br />

5. Toxicity Substance ID: 71–43–2<br />

______________________________________________________________________________<br />

removed and processed for metaphase analysis.<br />

Result: The frequency of chromosome aberrations was increased in the<br />

benzene treated animals, this being significant at 56.3<br />

mg/kg bw/day and above. The male animals were more<br />

sensitive than the females. At doses up to 56.3 mg/kg<br />

bw/day, the abnormalities consisted of chromatid gaps and<br />

single breaks. At 140 mg/kg bw/day, multiple breaks, as<br />

well as gaps and single breaks, occurred and at the higher<br />

doses, cells showing pulverisation of chromosomes were also<br />

seen. Chromosomal damage has also been reported in Swiss<br />

CD–1 mice administered benzene by gavage on two or three<br />

days by Gad–El–Karim M.M. et al. Mutation Res. 135,<br />

225–243, 1984 and Meyne J. & Legator M.S. Envir. Mutagen 2,<br />

43–50, 1980.<br />

Source: BP Chemicals Ltd LONDON<br />

Test substance: "chemically pure" benzene tested.<br />

10–AUG–2000 (1042)<br />

Type: Cytogenetic assay<br />

Species: hamster Sex: male/female<br />

Strain: other<br />

Route of admin.: gavage<br />

Exposure period: 24 hours<br />

Doses: 0, 2.5, 10 ml/kg bw/day (converts to 0, 2.2, 8.8 g/kg bw/day)<br />

Method: other<br />

GLP: no data<br />

Test substance: other TS<br />

Remark: Groups of ten male and ten female Chinese hamsters were<br />

administered benzene in peanut oil. Control animals<br />

received peanut oil. The animals were given two<br />

administrations, of the same benzene dose, at 24–hour<br />

intervals. Animals received an intraperitoneal injection of<br />

colchicine 3 hours after the second dose and were killed 3<br />

hours later. The femurs were removed and processed for<br />

metaphase analysis.<br />

Result: In the males, a dose of 8.8 g/kg bw/day induced a<br />

significant increase in the frequency of chromosome<br />

aberrations, including gaps. In the low–dose group, the<br />

frequency of aberrations did not differ significantly from<br />

the controls. No significant effect was seen in the females<br />

at either dose level.<br />

Source: BP Chemicals Ltd LONDON<br />

Test substance: "Chemically pure" benzene tested.<br />

13–DEC–1996 (1042)<br />

<strong>Appendix</strong> D: Benzene SIDS <strong>Dossier</strong><br />

– 456/957 –

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