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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 />

In 1991 and 1992, when the benzene concentrations were<br />

brought down, there was a concomitant decrease in the<br />

frequencies of chromosomal aberrations.<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

06–JAN–1997 (1145)<br />

Type: Cytogenetic assay<br />

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

Strain: other: Swiss Lane Petter<br />

Route of admin.: gavage<br />

Exposure period: 24 hours<br />

Doses: 0, 10.2, 25.6, 64, 160, 400, 2500 ul/kg bw/day (converts to 0,<br />

8.96, 22.5, 56.3, 140, 352, 2198 mg/kg bw/day)<br />

Method: other: in compliance with OECD Guide–line 475<br />

Year: 1984<br />

GLP: no data<br />

Test substance: other TS<br />

Remark: Benzene was administered in peanut oil. Groups of ten male<br />

and ten female Swiss Lane Petter mice were exposed to each<br />

benzene dose. Control animals received peanut oil. The<br />

animals were given two administrations, of the same benzene<br />

dose, at 24–hour intervals. Animals received an<br />

intraperitoneal injection of colchicine 3 hours after the<br />

second dose and were killed 3 hours later. The femurs were<br />

removed and processed for metaphase analysis.<br />

Reliability: 2 (valid with restriction)<br />

Comparable to guideline study with acceptable restrictions<br />

no positive control, one sampling time<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 in males and females. The male<br />

animals were more sensitive than the females. At doses up<br />

to 56.3 mg/kg bw/day, the abnormalities consisted of<br />

chromatid gaps and single breaks. At 140 mg/kg bw/day,<br />

multiple breaks, as well as gaps and single breaks,<br />

occurred and at the higher doses, cells showing<br />

pulverisation of chromosomes were also seen. Chromosomal<br />

damage has also been reported in Swiss CD–1 mice<br />

administered benzene by gavage on two or three days by<br />

Gad–El–Karim M.M. et al. Mutation Res. 135, 225–243, 1984<br />

and Meyne J. & Legator M.S. Envir. Mutagen 2, 43–50, 1980.<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

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

06–JAN–1997 (1042)<br />

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

– 467/957 –

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