Appendix D - Dossier (PDF) - Tera

date: 20–JUL–2005
5. Toxicity Substance ID: 71–43–2
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Type: other
Species: other: rat, mouse
Sex: male/female
Strain: other: Sprague–Dawley (rat); CD–1 (mouse)
Route of administration: inhalation
Exposure Period: 13 weeks
Frequency of treatment: 6 hours per day/5 days per week
Duration of test: 13 weeks
Doses: 1, 10, 30, 300 ppm (converts to 0.003, 0.033, 0.098,
0.98 mg/l); 50 rats/sex/dose; 150 mice/sex/dose
Control Group: yes, concurrent vehicle
Method: other
GLP: no data
Test substance: other TS: >99.9% pure
Remark: rat:
Control group consisted of 50 animals exposed to filtered
air. All animals were observed twice daily for mortality
and moribundity throughout the study and weekly for signs of
toxicity. On days 0, 7, 14, 28, 56 and 91, 10
rats/sex/group were sacrificed and complete necropsies
performed. Animals dying or sacrificed in a moribund
condition during the study were also necropsied. The testes
and ovaries were preserved in 10% neutral buffered formalin
and those from the control and high–dosed groups sectioned
and examined microscopically.
mouse:
Control group consisted of 150 animals exposed to filtered
air. All animals were observed twice daily for mortality and
moribundity throughout the study and weekly for signs of
toxicity. On days 0, 7, 14, 28, 56, and 91, 20 mice
/sex/group were sacrificed and complete necropsies
performed. Animals dying or sacrificed in a moribund
condition during this study were also necropsied. The testes
and ovaries were preserved in 10% neutral buffered formalin
and those from the control and high–dosed groups in the
interim kills and from all treated groups at the final
sacrifice sectioned and examined microscopically.
Result: rat:
No exposure related mortality, clinical observations or mean
body weight changes were seen. See section 5.4 for
explanation of other general systemic effects. No effects
were recorded on the testes or ovary weights and no
histological changes were seen on microscopic examination of
the tissues from these organs.
NOEL/rat: 300 ppm
Appendix D: Benzene SIDS Dossier
mouse:
No exposure related mortality , clinical observations or
mean body weight changes were seen. See section 5.4 for
explanation of other general systemic effects.
A statistically significant, exposure–time related decrease
in the mean testis weight was seen at the top–dose (300 ppm
level) on days 28, 56 and 91 , corresponding to a decreased
mean testis/body weight ratio on days 56 and 91. No effects
on the ovary weight was noted. The top–dose animals, dosed
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