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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:
other information
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Annex V, Method B13/B14
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA1535, TA1537, TA98, TA100 Escherichia coli WP2 (pKM101), WP2 uvrA (pKM101)
Metabolic activation system:
Liver S9 derived from phenobarbital/ß-naphthoflavone-induced Sprague Dawley rats
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 100 - 5000 µg/plate
Concentration range in the main test (without metabolic activation): 100 - 5000 µg/plate
Vehicle / solvent:
Solvent: DMSO
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 0 µg/plate

Results and discussion

Test results
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 5000 µg/plate)
Additional information on results:
Observations:
none
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

Under the condition of this assay C3RO gave a negtive, i.e. non -mutagenic, response in Salmonella typhimurium TA1537, TA98, TA100 Escherichia coli WP2 (pKM101), WP2 uvrA (pKM101), in both the presence and absence of S9-mix.