Appendix D - Dossier (PDF) - Tera

date: 20–JUL–2005
5. Toxicity Substance ID: 71–43–2
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after 30 min, 1 and 2 hours treatment in the absence of S9;
the increase being time–dependent. No such effect was noted
in the presence of S9.
Source: Deutsche Shell Chemie GmbH Eschborn
Test substance: Laboratory reagent grade; 99% pure.
06–JAN–1997 (655)
Type: other: DNA damage assay
System of testing: Chinese hamster ovary cells
Concentration: 0.39–7.81 mg/ml
Metabolic activation: with and without
Result: negative
Method: other
GLP: no data
Test substance: other TS
Remark: Benzene was dissolved in dimethylsulphoxide before addition
to the cells. Metabolic activation system was derived from
the liver of Aroclor–1254 induced Sprague–Dawley rats (S9
mix). Cells were treated for 1 hour with benzene, washed
and subjected to alkaline sucrose sedimentation analysis in
order to assess the DNA single–strand breaks. Prior to
testing benzene, its cytotoxicity was determined by
examining inhibition of cell growth.
Reliability: 2 (valid with restriction)
No standard test procedure, but in accordance with generally
accepted scientific standards and described in sufficient
detail
no positive control, single exposure time, no data on
negative control and 2nd independent experiment
results:
The cytotoxicity threshold, that is, the lower limit of
cytotoxicity as determined by visible inhibition of cell
growth, was found to be 0.781 ’g/ml when tested in the
presence and absence of S9. In the mutagenicity study,
benzene was tested at levels of 0.39–7.81 mg/ml. No
single–strand breaks were found at levels up to 2.34 mg/ml
tested with or without S9. Above this, single–strand breaks
increased but this was thought to be due to the toxic
effects of benzene. Other investigators have reported
similar negative results using the alkaline elution
technique in Chinese hamster V79 cells in the presence and
absence of metabolic activation (Swenberg J.A. et al.
Biochem. biophys. Res. Commun. 72, 732–738, 1976) and rat
hepatocytes in the absence of activation (Bradley M.O. Prog.
Mutation Res. 5, 353–357, 1985; Sina J.F. et al. Mutation
Res. 113, 357–391, 1983).
Source: Deutsche Shell Chemie GmbH Eschborn
Test substance: Laboratory reagent grade; purity unspecified.
06–JAN–1997 (305)
Appendix D: Benzene SIDS Dossier
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