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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Not mutagenic in assays in vitro

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Target gene:
Histidine
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Key result
Species / strain:
S. typhimurium TA 1535
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Key result
Species / strain:
S. typhimurium TA 1537
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Key result
Species / strain:
S. typhimurium TA 98
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Key result
Species / strain:
S. typhimurium TA 100
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Conclusions:
The test substance did not cause mutations in a bacterial reverse mutation assay (Ames).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

In multiple in vitro genotoxicity assays of the analogue substance, there was no evidence of mutagenic or genotoxic effects. These data are applicable to the registered (target) substance; the criteria for classification are not met.