Appendix D - Dossier (PDF) - Tera

date: 20–JUL–2005
5. Toxicity Substance ID: 71–43–2
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Species: mouse Sex: male
Strain: CD–1
Route of administration: inhalation
Exposure period: life–time
Frequency of treatment: 6 hours per day/5 days per week
Post exposure period: none
Doses: 300 ppm (converts to 0.98 mg/l); 40 mice
Control Group: yes, concurrent vehicle
Method: other
GLP: no data
Test substance: no data
Remark: Control group consisted of 40 mice exposed to air.
Semi–monthly haematologic studies were conducted on ten test
and ten control animals.
Reliability: 3 (not valid)
Significant methodological deficiencies
one sex, no data about measured benzene concentration and
test substance, insufficient documentation of methods, low
number of animals, one concentration tested, results limited
to leukaemia
Result: Three mice showed myeloproliferative disorders, including
one case of acute myelogenous leukaemia, one case of chronic
myelogenous leukaemia and a third in which granulocytic
hyperplasia was present. No such effects were seen in the
control group. Although the increased incidences are not
statistically significant when compared with the control
group, the fact that myelogenous leukaemia has not been
reported in historic control data on this strain of mouse is
suggestive of a causative role for benzene.
Source: Deutsche Shell Chemie GmbH Eschborn
German Rapporteur
Flag: Risk Assessment
01–JUL–2005 (424)
Species: mouse Sex: male
Strain: CBA
Route of administration: inhalation
Exposure period: 16 weeks
Frequency of treatment: 6 hours per day/5 days per week
Post exposure period: 18 months
Doses: 300 ppm (converts to 0.98 mg/l); 125 mice; mean
analytical chamber concentration 300+/–3 ppm
Control Group: yes, concurrent vehicle
Method: other
GLP: no data
Test substance: other TS
Remark: CBA/Ca strain mice were used. Control group consisted of
125 animals exposed to conditioned, filtered air. Benzene
concentrations in the exposure chambers were monitored twice
per hour during the exposures. The experiment was
terminated when the survival of the benzene–exposed group
reached 20% (22 months from the start of exposure). Blood
and bone marrow smears were examined from the 24
Appendix D: Benzene SIDS Dossier
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