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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
The genetic toxicity of the test item was determined in an Ames test. No genotoxic effects were observed during the study.
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature (handbook)
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: other: Ames test, no further information provided
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Test concentrations with justification for top dose:
no data
Species / strain:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
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'.
Conclusions:
Interpretation of results (migrated information):
negative

The genetic toxicity of the test item was determined in an Ames test. No genetic toxicity was observed in this test.
Executive summary:

The genetic toxicity of the test item was determined in an Ames test. Salmonella typhimurium strains (TA 1535, TA 1537 and TA1538) were used with and without metabolic activation. No genotoxicity effects were observed during this study.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Ames test

The genetic toxicity of the test item was determined in an Ames test. Salmonella typhimurium strains (TA 1535, TA 1537 and TA1538) were used with and without metabolic activation. No genotoxic effects were observed during this study.

Fungi

The gene mutation potential of the test item was examined on Saccharomyces cerevisiae in an in-vitro gene mutation assay in fungi. The test item was tested with and without metabolic activation. No genotoxic effects were found.


Justification for selection of genetic toxicity endpoint
Only study available

Justification for classification or non-classification

Self-Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the results the substance is not considered to be classified for developmental toxicity under Regulation (EC) No 1272/2008.