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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 />

mg/kg bw/day.<br />

The number of polychromatic erythrocytes was reduced at 2198<br />

mg/kg bw/day and, therefore, the reading of smears was<br />

unsatisfactory. Male mice were more sensitive to<br />

micronucleus induction than the females. These<br />

investigators have previously reported positive micronuclei<br />

tests in mice (Siou G. & Conan L. Cah. Notes Doc. 89,<br />

443–444, 1977; Siou G. & Sourdeix D. ibid. 101, 531–534,<br />

1980).<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

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

06–JAN–1997 (1042)<br />

Type: Micronucleus assay<br />

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

Strain: other: Swiss CD–1<br />

Route of admin.: gavage<br />

Exposure period: 3 days<br />

Doses: 0, 0.1, 0.5, 1 ml/kg bw/day (converts to 0, 88, 440, 880 mg/kg<br />

bw/day)<br />

Method: other: nearly in compliance with OECD Guideline 474<br />

GLP: no data<br />

Test substance: other TS<br />

Remark: Benzene diluted in corn oil. Control animals received corn<br />

oil only. Groups of five males and five females were<br />

exposed at each dose level. The animals were sacrificed 4<br />

hours after the final dose (2 h after colchicine treatment,<br />

assay combined with metaphase analysis), the femurs removed<br />

and bone marrow used for cytogenetic preparations. 5 male<br />

and 5 female mice per group.<br />

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

Comparable to guideline study with acceptable restrictions<br />

no positive control, no toxicity data, one sampling time<br />

Result: Significant increase in frequency of micronuclei was seen in<br />

the in the mid– and high–dosed male and female mice.<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

Test substance: >99% pure.<br />

06–JAN–1997 (771)<br />

Type: Micronucleus assay<br />

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

Strain: CD–1<br />

Route of admin.: unspecified<br />

Exposure period: 0, 15, 30, 60, 90 days<br />

Doses: 1, 10, 30, 300 pmm<br />

Method: other: see ref.<br />

Year: 1985<br />

GLP: no data<br />

Test substance: as prescribed by 1.1 – 1.4<br />

Result: Exposure to 3000 ppm benzene caused a significant increase<br />

in micronucleated polychromatic and monochromatic<br />

erytrocytes in male and female mice at all simples times.<br />

Source: REPSOL PETROLEO, S.A. MADRID<br />

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

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