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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: 12–week–old offspring<br />

Doses: 10 ppm/day (converts to 0.033 mg/l/day); 5–10<br />

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 10 weeks<br />

of age, the offspring [numbers unspecified] were re–exposed<br />

for 2 weeks to 0.033 mg/l. After the 2 weeks, the animals<br />

were sacrificed and their spleens and femurs removed for<br />

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

offspring exposed in utero to air were similarly exposed at<br />

10 weeks of age to 0.033 mg/l benzene for 2 weeks.<br />

Result: The in utero benzene–exposed offspring showed a marked<br />

reduction in the numbers of bone marrow CFU–E on<br />

re–exposure. No such effect was seen in the in utero<br />

air–exposed animals. Both groups of offspring had decreased<br />

splenic granulocyte/macrophage colony forming unit–culture<br />

numbers on re–exposure but this was more severe in the in<br />

utero benzene–exposed offspring.<br />

Source: BP Chemicals Ltd LONDON<br />

25–OCT–2000 (607)<br />

Species: mouse Sex: female<br />

Strain: other<br />

Route of administration: inhalation<br />

Exposure period: gestation days 5–14<br />

Frequency of treatment: daily/three 4–hour exposures per day<br />

Duration of test: gestation day 17<br />

Doses: 0.5, 1.0 mg/l; 15 mice/dose<br />

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

Method: other<br />

GLP: no data<br />

Test substance: no data<br />

Remark: CFLP (LATI–Gödöllö, Hungary) strain mice were used. Control<br />

group consisted of 115 females exposed to air. Dams were<br />

killed on day 17 and foetuses examined as described by Hudak<br />

A. & Ungvary G. Toxicology 11, 55–63, 1978.<br />

Result: No effects were seen on the numbers of live or dead or<br />

resorbed foetuses or on the incidence of minor anomalies or<br />

total malformations. The incidences of weight and skeletal<br />

retarded foetuses were increased, this being statistically<br />

significant.<br />

Source: BP Chemicals Ltd LONDON<br />

24–OCT–2000 (1188)<br />

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

– 584/957 –

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