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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Gene mutation (bacterial reverse mutation assay / Ames test): negative with and without metabolic activation [McLain et al. 1990]
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:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: short abstract
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Target gene:
Histidine gene locus
Species / strain / cell type:
S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537 and TA 1538
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
no data
Test concentrations with justification for top dose:
16.7 - 3330 µg/plate
Vehicle / solvent:
no data
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
no data
Evaluation criteria:
no data
Statistics:
no data
Species / strain:
S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537 and TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
in all strains at 1670 and 3330 µg/plate
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'.
Executive summary:

The mutagenic potential of the test substance was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in the presence and absence of S9 mix. Evidence of mutagenic activity was not seen up to the maximum dose level of 3330 µg/plate. Cytotoxic effects were observed at 1670 and 3330 µg/plate in all strains. In addition, the test substance percipitated at these concentrations.

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

Additional information

Additional information from genetic toxicity in vitro:

The mutagenic potential of the test substance was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in the presence and absence of S9 mix (McLain et al, 1990). Evidence of mutagenic activity was not seen up to the maximum dose level of 3330 µg/plate. Cytotoxic effects were observed at 1670 and 3330 µg/plate in all strains. In addition, the test substance percipitated at these concentrations.


Justification for selection of genetic toxicity endpoint
Only one study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.