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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
Study period:
1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The use of secondary sources of data is acceptable when they are based on a critical evaluation of peer-reviewed data and a consequent selection of a reliable and representative value for the property under investigation. Therefore, although the method is unknown, the values presented here are acceptable as they are from a reliable secondary source of biological data.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No data on materials and methods are reported in the EMEA report. The use of secondary sources of data is acceptable when they are based on a critical evaluation of peer-reviewed data and a consequent selection of a reliable and representative value for the property under investigation.
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA102 and Escherichia coli WP2 uvrA
Additional strain / cell type characteristics:
not specified
Metabolic activation:
not specified

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA102 and Escherichia coli WP2 uvrA
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Negative results were obtained in this reviewed in vitro gene mutation assay.