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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 />

Type: Cytogenetic assay<br />

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

Strain: Sprague–Dawley<br />

Route of admin.: inhalation<br />

Exposure period: 13 weeks<br />

Doses: 0, 1, 10, 30, 300 ppm (converts to 0, 0.003, 0.033, 0.098,<br />

0.98 mg/l)<br />

Method: other<br />

GLP: no data<br />

Test substance: no data<br />

Remark: Report of a study conducted for the American Petroleum<br />

Institute.<br />

Result: No increase in chromosomal damage was observed at<br />

concentrations of 0.098 mg/l or less. Slight increases in<br />

aberrations were seen at 0.98 mg/l but these were not<br />

statistically significant.<br />

Source: BP Chemicals Ltd LONDON<br />

13–DEC–1996 (321) (490)<br />

Type: Cytogenetic assay<br />

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

Strain: DBA<br />

Route of admin.: inhalation<br />

Exposure period: 4 hours<br />

Doses: 0, 3130 +/–170 ppm (converts to 0, 10.2 +/–0.55 mg/l)<br />

Method: other<br />

GLP: no data<br />

Test substance: no data<br />

Remark: Groups of ten male and eleven female DBA/2 mice were exposed<br />

to benzene. The control group consisted of six animals/sex.<br />

A further group of six males and seven females were injected<br />

intraperitoneally with sodium phenobarbital, twice daily for<br />

3 days prior to benzene exposure. Benzene concentration was<br />

measured at half–hour intervals. Control and exposed mice<br />

were treated with bromodeoxyuridine 1 hour after exposure<br />

and colcemid was injected intravenously 2 hours before<br />

termination. The animals were killed, femurs removed,<br />

marrow flushed out, slides prepared and chromosomal<br />

aberration frequency assessed.<br />

Result: Benzene alone did not increase the frequency of chromosomal<br />

aberrations. Treatment with phenobarbital before benzene<br />

exposure caused a statistically significant increase in<br />

chromatid–type aberrations. This was not seen in control<br />

mice pretreated with phenobarbital.<br />

Source: BP Chemicals Ltd LONDON<br />

13–DEC–1996 (1138)<br />

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

– 457/957 –

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