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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial reverse mutation assay (Ames assay) was performed to determine the mutagenic nature of (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS). The study was performed using Salmonella typhimurium strains TA1535, TA97, TA98, TA100, TA102 in the presence and absence of metabolic activation system. (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) did not induce gene mutation in Salmonella typhimurium strains TA1535, TA97, TA98, TA100, TA102 in the presence and absence of metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
Experimental study made available by ECHA
Qualifier:
according to
Guideline:
other: Annex V (Ames)
Principles of method if other than guideline:
Bacterial reverse mutation assay (Ames assay) was performed to determine the mutagenic nature of the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
- Name of test material (IUPAC name): (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS)
- Common name: Lokanol
- Molecular formula: C15H26O
- Molecular weight: 222.3694 g/mol
- InChl: 1S/C15H26O/c1-13(2)10(6-12-8-15(12,13)4)5-11-7-14(11,3)9-16/h10-12,16H,5-9H2,1-4H3
- Substance type: Organic
Species / strain / cell type:
other: TA1535, TA97, TA98, TA100, TA102
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
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): 5 ... 500 μg/plate
Concentration range in the main test (without metabolic activation): 1.6 ... 158 μg/plate
Vehicle / solvent:
Solvent: Dimethylsulphoxide
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 1580 μg/plate
Rationale for test conditions:
No data
Evaluation criteria:
No data
Statistics:
No data
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
158 μg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
True negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
50 μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 158 μg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
True negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 50 μg/plate)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
True negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Observations:
Appropriate revertant counts were obtained in the negative
and positive controls.
Remarks on result:
other: preliminary test Migrated from field 'Test system'.
Conclusions:
(1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) did not induce gene mutation in Salmonella typhimurium strains TA1535, TA97, TA98, TA100, TA102 in the presence and absence of metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Executive summary:

Bacterial reverse mutation assay (Ames assay) was performed to determine the mutagenic nature of (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS). The study was performed using Salmonella typhimurium strains TA1535, TA97, TA98, TA100, TA102 in the presence and absence of metabolic activation system. (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) did not induce gene mutation in Salmonella typhimurium strains TA1535, TA97, TA98, TA100, TA102 in the presence and absence of metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Gene mutation in vitro:

Data available for the target chemical was reviewed to determine the mutagenic nature of (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS). The studies are as mentioned below:

Bacterial reverse mutation assay (Ames assay) was performed to determine the mutagenic nature of (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS). The study was performed using Salmonella typhimurium strains TA1535, TA97, TA98, TA100, TA102 in the presence and absence of metabolic activation system. (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) did not induce gene mutation in Salmonella typhimurium strains TA1535, TA97, TA98, TA100, TA102 in the presence and absence of metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

In vitro chromosomal aberration study was performed to determine the mutagenic nature of (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS). The study was performed using human lymphocytes in the presence and absence of S9 fraction of rat liver treated with phenobarbital / β-naphtoflavone metabolic activation system at different dose levels with and without metabolic activation. DMSO was used as vehicle.(1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) did not induce chromosomal aberration in human lymphocytes in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Based on the available data for the target chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.

Justification for classification or non-classification

Based on the available data for the target chemical, (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS ) (CAS no 198404-98-7) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.