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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:
1986
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:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
This is formulation of 49.2% of the test substance in water.

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100.
Metabolic activation:
with and without
Metabolic activation system:
liver microsome fraction of Aroclor-induced rats for metabolic activation (S9-mix)
Test concentrations with justification for top dose:
0, 0.31, 0.93, 2.78, 8.33 and 25 µg/plate.
Details on test system and experimental conditions:
Salmonella typhimurium reverse mutation assay

Results and discussion

Test results
Key result
Species / strain:
other: Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100.
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: >= 50.0 µg per plate

Applicant's summary and conclusion

Conclusions:
Under the study conditions, the test substance was not considered to be mutagenic in the presence and absence of exogenous metabolic activation.
Executive summary:

A study was conducted to determine the in vitro genetic toxicity of the test substance according to OECD Guideline 471 (Ames test), in compliance with GLP. The substance was examined for mutagenic activity in the Ames test using the histidine-requiring Salmonella typhimurium mutant strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100, and a liver microsome fraction of Aroclor-induced rats for metabolic activation (S9-mix). The substance was tested at doses of 0, 0.31, 0.93, 2.78, 8.33 and 25 µg/plate. Based on preliminary test in TA 98, 25 µg/plate was chosen as the highest dose level. The test was carried out twice. Under the study conditions, the substance was considered to be non-mutagenic in the presence and absence of exogenous metabolic activation (Wilmer, 1986).