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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 />

germinal epithelium) were noted. It is difficult to draw<br />

any conclusions from this study due to low numbers of<br />

animals tested and the single dose level used.<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

Test substance: 99.98% pure.<br />

24–OCT–2000 (1264)<br />

Type: other<br />

Species: rabbit<br />

Sex: male<br />

Strain: no data<br />

Route of administration: inhalation<br />

Exposure Period: 243 days<br />

Frequency of treatment: 7 hours per day/5 days per week<br />

Duration of test: 243 days<br />

Doses: 0.26 mg/l; 1 or 2 rabbits<br />

Control Group: yes, concurrent no treatment<br />

Method: other<br />

GLP: no data<br />

Test substance: other TS<br />

Remark: All animals were weighed at regular intervals during the<br />

study and frequent observations made of their general<br />

appearance and behaviour. Records were kept of food<br />

consumption and mortality. Various organs, including the<br />

testes, were weighed and examined grossly and<br />

microscopically.<br />

Result: See section 5.4 for general systemic effects. Slight<br />

histopathological testicular changes (degeneration of the<br />

germinal epithelium) were noted. It is difficult to draw<br />

any conclusions from this study due to low numbers of<br />

animals tested and the single dose level used.<br />

Source: BP Chemicals Ltd LONDON<br />

Test substance: 99.98% pure.<br />

24–OCT–2000 (1264)<br />

Type: other<br />

Species: rabbit<br />

Sex: female<br />

Strain: New Zealand white<br />

Route of administration: inhalation<br />

Exposure Period: 13 weeks<br />

Frequency of treatment: 6 hours per day/5 days/per week<br />

Duration of test: 13 weeks<br />

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

0.98 mg/l); 100 mice/sex/dose<br />

Control Group: yes, concurrent vehicle<br />

Method: other<br />

GLP: no data<br />

Test substance: no data<br />

Remark: Control group consisted of 100 animals exposed to filtered<br />

air. All animals were observed twice daily for mortality<br />

and moribundity throughout the study and weekly for signs of<br />

toxicity. On days 0, 7, 14, 28, 56 and 91, 20<br />

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

– 569/957 –

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