Registration Dossier
Registration Dossier
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EC number: 412-450-9 | CAS number: 131766-73-9 CLARYCET
Genetic toxicity: in vitro
Administrative data
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducting according to OECD method by a GLP accredited laboratory.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline for Testing of Chemicals No's 471 and 472, and the following Japanese Ministries: Ministry of labour, Ministry of Health and Welfare, Ministry of International Trade and Industry, and Ministry of Agriculture, Forestry and Fisheries.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
- EC Number:
- 412-450-9
- EC Name:
- A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
- Cas Number:
- 131766-73-9
- Molecular formula:
- C11H20O3
- IUPAC Name:
- reaction mass of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix from the liver of Aroclor induced rats.
- Test concentrations with justification for top dose:
- 0 (solvent control), 312.5, 625, 1250, 2500, or 5000 µg/plate of the test substance in DMSO with and without metabolic activation (S9).
- Vehicle / solvent:
- DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see details on test system and conditions
- Details on test system and experimental conditions:
- Salmonella typhimurium strains TA1537, TA1535, TA1538, TA100, and TA98: Positive controls used for cultures without S9 were N-ethyl-N’-nitro-N-nitrosoguanidine (TA1535 and TA100), 9-aminoacridine (TA1537), and 2-nitrofluorene (TA98 and TA1538). For cultures with S9, 2- aminoanthracene was used for all strains.
E. coli strain WP2 uvrA: Positive control used for cultures without S9 was N-ethyl-N’-nitro-N-nitrosoguanidine. For cultures with S9, 2 aminoanthracene was used. - Evaluation criteria:
- If exposure to test substance produces an increase in the number of revertant colonies at least twice that of the solvent control with some evidence of dose-response in 2 separate experiments, the test substance is considered to show evidence of mutagenic activity.
- Statistics:
- No statistical analysis is performed unless no clear “positive” response is obtained.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Concentrations of the test substance resulting in precipitation is >5000µg/plate.
No substantial increase in revertant colonies numbers of any of the tester strains were observed following treatment with the test substance at any dose level, either in the presence or absence of S-9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance showed no evidence of mutagenic activity when tested in this bacterial system. - Executive summary:
The mutagenic potential of the test substance was assessed in the AMES test using histidine dependent auxotrophic mutants of Salmonella typhimurium (strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100) and tryptophan dependent auxotrophic mutant of Escherichia coli (WP2 uvrA). The bacteria were exposed to the test substance at 0 (solvent control), 312.5, 625, 1250, 2500, or 5000 µg/plate, with dimethylsulphoxide as vehicle.The test substance showed no evidence of mutagenic activity.
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