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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
From experimental studies it is concluded that the test substance 2-cyclohexylidene-2-phenylacetonitrile is non genotoxic.
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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from test report
Qualifier:
according to guideline
Guideline:
other: 92/69/EEC (Ames)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium, other: Salmonella typhimurium TA1535, TA97, TA98, TA100, TA102
Additional strain / cell type characteristics:
not specified
Metabolic activation:
not specified
Metabolic activation system:
Phenobarbital and beta-naphthoflavone-induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): .33 ... 333 μg/plateConcentration range in the main test (without metabolic activation): .33 ... 333 μg/plate
Vehicle / solvent:
Solvent: Dimethylsulfoxide
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
not specified
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 100 μg/plate
Evaluation criteria:
No data
Statistics:
No data
Species / strain:
S. typhimurium, other: TA1535, TA97, TA98, TA100, TA102
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 333 μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium, other: TA1535, TA97, TA98, TA100, TA102
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 333 μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium, other: TA1535, TA97, TA98, TA100, TA102
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 333 μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Positive and negative controls responded as expected. There was no increase in the numbers of revertants in any strain at any dose level.
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):negative negative with and without metabolic activationIn bacterial reverse mutation assay (Ames test) on Salmonella typhimurium TA1535, TA97, TA98, TA100, TA102 at dose concentration Concentration range in the main test (with metabolic activation): .33 ... 333 μg/plate and Concentration range in the main test (without metabolic activation): .33 ... 333 μg/plate show negative genetic toxicity with and without metabolic activity.
Executive summary:

In bacterial reverse mutation assay (Ames test) on Salmonella typhimurium TA1535, TA97, TA98, TA100, TA102 at dose concentration Concentration range in the main test (with metabolic activation): .33 ... 333 μg/plate and Concentration range in the main test (without metabolic activation): .33 ... 333 μg/plate show negative genetic toxicity with and without metabolic activity.

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

Additional information

Additional information from genetic toxicity in vitro:

Genetic toxicity in vitro:

In bacterial reverse mutation assay (Ames test) for test chemical 2-cyclohexylidene-2-phenylacetonitrile on Salmonella typhimurium TA1535, TA97, TA98, TA100, TA102 at dose concentration Concentration range in the main test (with metabolic activation): .33 ... 333 μg/plate and Concentration range in the main test (without metabolic activation): .33 ... 333 μg/plate show negative genetic toxicity with and without metabolic activity.

Other experimental studies also indicate that the test substance is non genotoxic.


Justification for selection of genetic toxicity endpoint
In bacterial reverse mutation assay (Ames test) for test chemical 2-cyclohexylidene-2-phenylacetonitrile on Salmonella typhimurium TA1535, TA97, TA98, TA100, TA102 at dose concentration Concentration range in the main test (with metabolic activation): .33 ... 333 μg/plate and Concentration range in the main test (without metabolic activation): .33 ... 333 μg/plate show negative genetic toxicity with and without metabolic activity.

Justification for classification or non-classification

Overall reported genetic toxicity studies of 2-cyclohexylidene-2-phenylacetonitrile, indicate2-cyclohexylidene-2-phenylacetonitrileis not likely to exhibit genetic toxicity can be classified as 'non-hazardous' as per the CLP classification criteria.