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EC number: 946-283-2 | CAS number: 1864727-96-7
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:
- From 05 January 2017 to 09 February 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- The Joint Notification Yakusyoku 0331 No. 8 of the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, H23·03·29 seikyoku No. 6 of the Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry, kanpoki No. 110331010 of the Environmental Policy Bureau, Ministry of the Environment (March 31, 2011) and the Joint Notification Yakusyoku 0331 No. 7 of the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare , H23·03·29 seikyoku No. 5 of the Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry, kanpoki No. 110331009 of the Environmental Policy Bureau, Ministry of the Environment (March 31, 2011).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JAPAN: Industrial Safety and Health Law
- Version / remarks:
- The Notifications of Ministry of the Labour, No. 76 (September 1, 1988) and No. 13 (revised March 29, 2000) and the Notifications of Ministry of the Labour, No. 77 (September 1, 1988) and No. 67 (revised June 2, 1997).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD Principles of Good Laboratory Practice (as revised in 1997) and OECD Guideline for Testing of Chemicals (21st July 1997), 471: Bacterial Reverse Mutation Test.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (cyclohex-3-en-1-yl)methyl 2-hydroxypropanoate
- EC Number:
- 946-283-2
- Cas Number:
- 1864727-96-7
- Molecular formula:
- C10H16O3
- IUPAC Name:
- (cyclohex-3-en-1-yl)methyl 2-hydroxypropanoate
Constituent 1
- Specific details on test material used for the study:
- -Name of test substance (as cited in study report): Kurimate
-Lot No. MB10-55
-Purity: >99%
-CAS No. 1864727-96-7
-Molecular weight: 184.23
-Appearance at ordinary temperature: Colorless liquid
-Stability: Stable at room temperature
-Storage condition: Room temperature
Method
- Target gene:
- his operon (for S. typhimurium strains)
trp operon (for E.coli strain)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and 5,6-benzoflavone.
- Test concentrations with justification for top dose:
- Dose-determination test: 4.88, 19.5, 78.1, 313, 1250 and 5000 μg/plate
Mutagenicity test 1 and 2: 156, 313, 625, 1250, 2500 and 5000 μg/plate - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of solvent/vehicle: the test substance was not soluble in water at 50 mg/mL, but was soluble in DMSO at 50 mg/mL.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-aminoanthracene (2-AA), 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2)
- Remarks:
- +S9: 2-AA (1 µg/plate, TA100; 2 µg/plate, TA1535, TA1537; 10 µg/plate, WP2uvrA; 0.5 µg/plate, TA98) -S9: AF-2 (0.01 µg/plate, TA100, WP2uvrA; 0.1 µg/plate, TA98); 9-AA (80 µg/plate, TA1537); NaN3 (0.5 µg/plate, TA1535)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: pre-incubation method
DURATION
- Pre-incubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: A dose-determination test was carried out in a single plate, and mutagenicity tests were carried out in triplicate plates for each dose.
DETERMINATION OF CYTOTOXICITY
- Method: growth inhibition and test substance precipitation - Evaluation criteria:
- When the test substance induces a dose-dependent increase in the number of revertant colonies to at least twice as many as that of the negative control and the increase is reproducible, the test substance is judged positive in this test system.
- Statistics:
- Any statistical method was not used for the data analysis.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above dose levels of 2500 μg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above dose levels of 2500 μg/plate without metabolic activation, and at 5000 μg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above dose levels of 2500 μg/plate without metabolic activation, and at 5000 μg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above dose levels of 2500 μg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above dose levels of 2500 μg/plate without metabolic activation, and at 5000 μg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- PRECIPITATION: precipitation on the plates was not observed.
RANGE-FINDING/SCREENING STUDIES: growth inhibition by the test substance was observed in all strains with and without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Throughout the tests, Kurimate did not induce any increases in the number of revertant colonies to at least twice as that of the negative control for any of the bacterial strains.
The test substance was concluded to be non-mutagenic under the conditions of this test.
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