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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 />

Species: mouse Sex: female<br />

Strain: Swiss Webster<br />

Route of administration: inhalation<br />

Exposure period: gestation days 6–15<br />

Frequency of treatment: daily/6 hours per day<br />

Duration of test: 2–day–old neonates<br />

Doses: 5, 10, 20 ppm/day (converts to 0.017, 0.033, 0.066<br />

mg/l/day); 5–10 mice/dose<br />

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

Method: other<br />

GLP: no data<br />

Test substance: no data<br />

Remark: Control group consisted of five to ten females exposed to<br />

filtered conditioned air. Exposed, pregnant mice were<br />

allowed to proceed through normal parturition. Two male and<br />

two female neonates/litter were selected at 2 days of age,<br />

weighed and examined for any external gross morphological<br />

malformations. Livers were removed for enumeration of<br />

haematopoietic colony forming cells.<br />

Result: No difference in CFU–E numbers were noted between the<br />

low–dose offspring and the controls. Offspring exposed, in<br />

utero, to 0.033 mg/l had either increased or decreased CFU–E<br />

numbers and those in male offspring exposed in utero to<br />

0.066 mg/l were increased. The numbers of<br />

granulocytic/macrophage colony forming cells were increased<br />

in the male and female offspring from the top–dosed group<br />

and decreased in the male offspring in the mid–dosed group.<br />

Source: BP Chemicals Ltd LONDON<br />

25–OCT–2000 (607)<br />

Species: mouse Sex: female<br />

Strain: Swiss Webster<br />

Route of administration: inhalation<br />

Exposure period: gestation days 6–15<br />

Frequency of treatment: daily/6 hours per day<br />

Duration of test: 6–week–old offspring<br />

Doses: 5, 10, 20 ppm/day (converts to 0.017, 0.033, 0.066<br />

mg/l/day); 5–10 mice/dose<br />

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

Method: other<br />

GLP: no data<br />

Test substance: no data<br />

Remark: Control group consisted of five to ten females exposed to<br />

filtered conditioned air. Exposed, pregnant mice were<br />

allowed to proceed through normal parturition. At 6 weeks<br />

of age, one male and one female offspring were selected from<br />

each litter, sacrificed and their spleens and femurs removed<br />

for enumeration of haematopoietic colony forming cells.<br />

Result: CFU–E numbers were equivalent to the control values except<br />

in the males exposed to 0.033 mg/l in utero which displayed<br />

significant variations from the controls.<br />

Source: BP Chemicals Ltd LONDON<br />

25–OCT–2000 (607)<br />

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

– 583/957 –

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