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Registration Dossier
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EC number: 943-279-2 | CAS number: -
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 July 2007 - 03 September 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Labor, "Standards for testing of mutagenicity study in bacteria" Notification No.77, 1988
- Version / remarks:
- Partially revised, Notification No. 67, 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,2-bis(2-methylpropyl) (1R,2R,3R,6S)-3,6-dimethylcyclohexane-1,2-dicarboxylate; 1,2-bis(2-methylpropyl) (1S,2S,3R,6S)-3,6-dimethylcyclohexane-1,2-dicarboxylate
- EC Number:
- 943-279-2
- Molecular formula:
- C18H32O4
- IUPAC Name:
- 1,2-bis(2-methylpropyl) (1R,2R,3R,6S)-3,6-dimethylcyclohexane-1,2-dicarboxylate; 1,2-bis(2-methylpropyl) (1S,2S,3R,6S)-3,6-dimethylcyclohexane-1,2-dicarboxylate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: KU0704
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability: stable at room temperature
- Stability in solvent: insoluble in water; soluble (stable) in DMSO and acetone
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Japan bioasay research centre
Reason for selection of bacterial strains:
The selected bacterial strains are hypersensitive to mutagenic chemicals and generally used in the bacterial mutation test.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Japan bioasay research centre
Reason for selection of bacterial strains:
The selected bacterial strains are hypersensitive to mutagenic chemicals and generally used in the bacterial mutation test.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Dose range-finding assay: 1.2, 4.9, 20, 78, 313, 1250, 5000 µg/plate
Main assay: 313, 625, 1250, 2500 and 5000 µg/plate
Precipitation of test material was observed at 5000 µg/plate and at 2500 µg/plate in the absence of S9 mix - Vehicle / solvent:
- - Vehicle used: DMSO;
- Justification for choice of vehicle: substance was soluble and stable, the preliminary test on solvent selection in the testing facility revealed that the test substance was uniformly dispersed and stable but was undissolved at 5% in DMSO.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide, 6-Chloro-9-[3-(2-chloroethylamino)-propylamino]-2-methoxyarcidine dihydrochloride, A-Aminoanthracene
- Details on test system and experimental conditions:
- S9-mix preparation:
Prepared on: 20 April 2007
Lot No.: 07042001
A pre-incubation step was employed which involved a 20-minute incubation (37°C) with shaking of the test solution with the bacterial culture (plus S9 mix in the case of metabolic activation assays) prior to the addition of agar. Cultures were incubated for 48 hours at 37°C. Dose levels were analysed in duplicate and solvent controls were analysed in triplicate.
An automatic colony counter was used to count the number of revertant colonies. - Evaluation criteria:
- When the number of relevant colonies on test substance treatment plates is statistically significant increased compared to the spontaneous rate of mutation and the increase is a dose-dependent and reproducible between the dose-finding assay and the main study, the test substance is judged to be positive for mutagenicity. Otherwise, the test substance is judged as negative.
- Statistics:
- No statistical analysis is performed for 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the results, it was concluded that DMCHIBU was negative for mutagenicity under the test conditions of this study.
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