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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V, B13/14
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Method

Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
Liver S9 derived from phenobarbital/B-naphthoflavone-induced Sprague Dawley rats
Test concentrations with justification for top dose:
in main test (with metabolic activation): 100... 5000 ug/plate
in main test (without metabolic activation): 100... 5000 ug/plate
Vehicle:
solvent: dried dimethylsulphoxide
Details on test system and conditions:
Concentration of the test substance resulting in precipitation: 5000 ug/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
5000 ug/plate
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: preliminary test
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
5000 ug/plate
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: main test

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative