Appendix D - Dossier (PDF) - Tera

date: 20–JUL–2005
5. Toxicity Substance ID: 71–43–2
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Test substance: Laboratory reagent; 99.9% pure.
Flag: Risk Assessment
06–JUL–2005 (536) (537) (538)
Species: mouse Sex: male/female
Strain: B6C3F1
Route of administration: gavage
Exposure period: 17 weeks
Frequency of treatment: 5 days/week
Post exposure period: none
Doses: 25, 50, 100, 200, 400, 600 mg/kg bw/day; 10 or 15
mice/sex/dose
Control Group: yes, concurrent vehicle
NOAEL: 25 mg/kg bw
LOAEL: mg/kg bw
Method: other
GLP: yes
Remark: Groups of ten or 15 animals of each sex were used.
Benzene administered in corn oil. Animals were checked
twice daily and weights recorded weekly. Five animals of
each sex from the control, 200 and 600 mg/kg bw groups were
killed on day 60. Survivors from all groups killed at end
of the study period and haematologic analyses were performed
on five animals from each group. At necropsy, a large
number of organs from animals from the control, the
interim–kill and the top–dose groups were removed and
examined histopathologically; spleens were examined in all
dose groups.
Result: No compound–related deaths. Mean body weight gain was
dose–dependently decreased in both the males and females at
100 mg/kg bw or more. Tremors were observed intermittently
in the 400 and 600 mg/kg bw groups, those during the last 3
weeks of the study being more pronounced in the males than
females. At day 60, no changes in the white blood cell or
lymphocyte counts were seen in either the male or female
animals given 200 or 600 mg/kg bw. Both counts were
dose–dependently and significantly (p 99.7% pure.
Flag: Risk Assessment
07–JUL–2005 (540) (843)
Appendix D: Benzene SIDS Dossier
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