Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EEC (Ames)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
other: Salmonella typhimurium: TA1535, TA1537, TA1538, TA98, TA100
Metabolic activation system:
Aroclor-induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 μg/plate
Vehicle:
Solvent: Dimethylsulfoxide

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
other: not available
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
other: not available
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
other: not available
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Additional information on results:
Observations:
No substantial increases in revertant colony numbers were
observed in any strain following treatment with the test
substance at any dose level, either in the presence or
absence of S-9 mix.

Applicant's summary and conclusion

Conclusions:
negative with metabolic activation
negative without metabolic activation