Appendix D - Dossier (PDF) - Tera

date: 20–JUL–2005
5. Toxicity Substance ID: 71–43–2
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compared with 2%), hepatomas (incidence= 5.7 compared with
0.3%) and total malignant tumours (incidence = 31.4, 51.7
and 40.6% in the treated males, females and when combined
respectively compared with 18.5, 17.6 and 18.0 in the
control groups respectively). In the females, alone,
increases were seen in malignant mammary tumours (incidence
= 13.8 compared with 5.4%) and haemolymphoreticular
neoplasias other than thymomas (incidence = 6.9 compared
with 0.7%).
Tumor incidences in male and female offspring treated for 15
weeks followed by an observation period until week 150:
No. of animals with tumors were related to the No. of animals
at study begin:
Zymbal gland carcinoma:
offspring males 4/70 vs 2/158 controls
offspring females 1/59 vs 0/149 controls
oral cavity carcinomas:
offspring males 2/70 vs 0/158 controls
offspring females 6/59 vs 0/149 controls
nasal cavity carcinomas:
offspring males 1/70 vs0/158 controls
offspring females 1/59 vs 0/149 controls
hepatomas:
offspring males 2/70 vs 1/158 controls
offspring females 5/59 vs 0/149 controls
Source: BP Chemicals Ltd LONDON
Deutsche Shell Chemie GmbH Eschborn
German Rapporteur
Test substance: 99.93% pure.
Flag: Risk Assessment
01–JUL–2005 (734) (735) (736) (819)
Species: rat Sex: female
Strain: Sprague–Dawley
Route of administration: inhalation
Exposure period: 104 weeks
Frequency of treatment: see remarks
Post exposure period: until spontaneous death
Doses: 200, 300 ppm (converts to 0.65, 0.98 mg/l); 54 rats
Control Group: yes, concurrent no treatment
Method: other
GLP: no data
Test substance: other TS
Remark: Control group consisted of 60 female rats exposed from day
12 of pregnancy to air for a total of 104 weeks. The
benzene–treated group was exposed, from day 12 of pregnancy,
to 0.65 mg/l, 4 hours/day, 5 days/week for 7 weeks and then
for 7 hours/day, 5 days/week for 12 weeks and finally to
0.98 mg/l, 7 hours/day, 5 days/week for 85 weeks. The
animals were weighed every 2 weeks during the treatment
Appendix D: Benzene SIDS Dossier
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