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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 standard plastic cages.<br />

Reliability: 4 (validity could not be judged)<br />

Original reference not yet available<br />

Result: Benzene caused a dose–dependent increase in the frequencies<br />

of hprt variant (mutant) lymphocytes in both male and female<br />

mice at concentrations of 40 and 100 ppb. At 1000 ppb, the<br />

frequency was also increase when compared with the controls<br />

but this was less than in the 40 and 100 ppb groups.<br />

Females were more sensitive than males.<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

06–JAN–1997 (1236)<br />

Type: Somatic mutation assay<br />

Species: Drosophila melanogaster Sex: male/female<br />

Strain: other: see method<br />

Route of admin.: oral feed<br />

Exposure period: up to 96 hours<br />

Doses: 0.88, 4.4, 8.8 mg/ml<br />

Method: other<br />

Year: 1983<br />

GLP: no data<br />

Test substance: other TS<br />

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

No standard test procedure, but in accordance with generally<br />

accepted scientific standards and described in sufficient<br />

detail<br />

one dose tested per experimental design<br />

The method of Wurgler F.E. et al. Mutation Res. 122,<br />

321–328, 1983 was followed. Benzene was administered to<br />

mei–9 and +/mei–9 strain Drosophila as a solution in 5%<br />

Tween 80 and 5% ethanol. Larvae aged 48 or 72 hours were<br />

exposed for 2 hours to benzene concentrations of 4.4 and<br />

0.88 mg/ml respectively. In some cases, larvae were treated<br />

during the entire larval life (96 hours) to 4.4 or 8.8<br />

mg/ml. After exposure, the wings of the surviving adults<br />

were mounted and scored for the presence of single and twin<br />

spots. The number of wings scored and the frequency and<br />

size of the spots were recorded. Control experiments were<br />

conducted by exposing larvae of the same age as those in the<br />

treatment groups to the 5% Tween 80 and 5% ethanol vehicle<br />

for the same length of time as the corresponding treated<br />

larvae.<br />

Result: A benzene concentration of 8.8 mg/ml was lethal and 4.4<br />

mg/ml toxic when given for the entire larval life. A<br />

significant increase in the frequency of small single spots<br />

and/or total single spots was seen in the acute (larvae aged<br />

72 h) and chronic studies in the excision–repair–defective<br />

larvae (mei–9 strain). The acute result was only marginally<br />

positive. No such effect was seen when benzene was given to<br />

excision–repair–proficient larvae (+/mei–9 strain).<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

Test substance: Laboratory reagent grade; 99% pure.<br />

06–JAN–1997 (1284)<br />

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

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