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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

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

Method

Target gene:
Histidine locus
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
Concentration range in the main test:
-With metabolic activation: 0.5, 0.15, 0.1, 0.05, 0.015, 0.005 mg/plate
-Without metabolic activation: 0.5, 0.15, 0.1, 0.05, 0.015, 0.005 mg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
5 mg test materiall / ml DMSO

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100, TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Concentration of the test substance observed to be toxic to bacteria: no toxicity observed.
Concentration of the test substance resulting in precipitation: No precipitation
Other observations: None

Applicant's summary and conclusion

Conclusions:
The test material was considered to be non-mutagenic under the conditions of the test. No indication was observed of the mutagenic potential of the test material with or withour metabolic activation in this bacterial reverse mutation assay.