06.02.2013 Views

Appendix D - Dossier (PDF) - Tera

Appendix D - Dossier (PDF) - Tera

Appendix D - Dossier (PDF) - Tera

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

date: 20–JUL–2005<br />

5. Toxicity Substance ID: 71–43–2<br />

______________________________________________________________________________<br />

reproductive performance had been revealed. A trend toward<br />

reduced mean fetal body weights during the lactation period<br />

and towards reduced mean organ weights (testes, liver,<br />

kidney) on postnatal day 21 was observed at the 30 and 300<br />

ppm level. Except for reduced body and liver weights in the<br />

female pups at 300 ppm, these changes were not statistically<br />

significantly different from controls. No treatment–related<br />

effects were seen in pup survival data during lactation or<br />

in the gross postmortem evaluation of these pups on Day 21<br />

of lactation. Thus exposure of dams to benzene levels as<br />

high as 300 ppm resulted in only minimal effects on the<br />

pups.<br />

NOAEL/rat,female: 300 ppm<br />

Source: German rapporteur; Deutsche Shell Chemie GmbH Eschborn;<br />

Flag: Risk Assessment<br />

17–JUN–2005 (646)<br />

Type: Fertility<br />

Species: rabbit<br />

Sex: female<br />

Strain: New Zealand white<br />

Route of administration: inhalation<br />

Exposure Period: gestation days 6–19<br />

Frequency of treatment: daily/24 hours per day<br />

Duration of test: gestation day 29<br />

Doses: 0.5, 1.0 mg/l; 11 and 15 rabbits respectively<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 60 dams exposed to air. Dams<br />

were killed on day 29 and foetuses examined as described by<br />

Ungvary G. Munkavédelem, Munka–és Uzemegészségügy 29,<br />

207–216, 1983.J. Hyg. Epidem. Microbiol. Immun. 24, 363–371,<br />

1980.<br />

Result: The top dose caused statistically significant decreases in<br />

maternal weight gain and mean foetal weight and a<br />

statistically significant increase in the number of dead or<br />

resorbed foetuses, mainly arising from abortion. At 0.5<br />

mg/l, a slight non–significant decrease in maternal weight<br />

gain and increase in the number of dead or resorbed foetuses<br />

was reported.<br />

Source: BP Chemicals Ltd LONDON<br />

17–OCT–2000 (1190)<br />

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

– 564/957 –

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!