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EC number: 805-440-4 | CAS number: 22972-51-6
Toxicological information
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-03-14 to 2019-03-22
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol
- Cas Number:
- 22972-51-6
- Molecular formula:
- C10H16O
- IUPAC Name:
- (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol
- Test material form:
- liquid
- Details on test material:
- Test item: (1S,4R)-1-Methyl-4-(prop-1-en-2-yl)cyclohex-2-enol
CAS number: 22972-51-6
Physical state: Liquid
Storage: Room temperature
Constituent 1
- Specific details on test material used for the study:
- Test item: (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-en-1-ol (PMDOL)
CAS number: 22972-51-6
Physical state: Liquid
Storage: room temperature
Method
- Target gene:
- Histidine locus (histidine-dependent S. typhimurium strains)
Species / strain
- Species / strain / cell type:
- other: S. typhimurium: TA97a, TA98, TA100, TA102, TA1535
- Details on mammalian cell type (if applicable):
- not applicable
- Cytokinesis block (if used):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver enzyme solution (S9 mix)
- Test concentrations with justification for top dose:
- 0.625 µl/plate caused no significant toxicity and was highest dose tested in the study
Dose-rangeused in study: 0.625, 0.3125, 0.15625, 0.078125 and 0.0390625 μL/plate in with and without 5% S9-mix
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine (NPD)
- Remarks:
- Without S9-mix; 10 μg/plate (TA97a and TA98)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Without S9-mix; 0.5 μg/plate (TA102)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Without S9-mix; 0.4 μg/plate (TA100 and TA1535)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- Ethanol
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminofluorene
- Remarks:
- 4.0 μg/plate (TA97a with S9-mix)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- 4.0 μg/plate (TA98 with S9-mix)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- 4.0 μg/plate (TA100, TA102 and TA1535 with S9-mix)
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration (single, duplicate, triplicate): triplicate
METHOD: Plate incorporation method
The following solutions were added to 2 ml soft agar:
- 0.1 ml of a fresh bacterial culture (10^9 cells/ml) of one of the tester strains
- 0.1ml of the test article solution or control solution and
- either 0.5 ml S9-mix (in case of activation assays) or 0.5 ml 0.2 M sodium phosphate buffer (in case of nonactivation assays).
The mixtures was mixed thoroughly on a Vortex and was poured onto a minimal glucose agar plate and incubated at 37.0 °C for 48h. After this period revertant colonies were counted. - Evaluation criteria:
- A test article is considered negative (not mutagenic) in the test if:
The total number of revertants in the tester strain TA 97a, TA98, TA100 and TA102 was less than twice or thrice (TA1535) the concurrent negative control (Ethanol).
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA97a, TA98, TA100, TA102, and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the study results, no classification is proposed regarding genetic toxicity according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
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