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EC number: 292-282-9 | CAS number: 90583-79-2
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:
- 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:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- In accordance with the guideline set forth in the "Standards for Mutagenicity Tests using Microorganisms" (Notification No. 77, September 1, 1988 & Notification No. 67, June 2, 1997, Ministry of Labour, Japan) and the "Amendment of the Reporting Form of the Results of the Mutagenicity Tests using Microorganisms" (Notification No. 653, September 29, 1997, Labour Standards Bureau, Ministry of Labour, Japan), and the "Guidelines for Toxicity Testings of New Chemical Substances" (Notification No. 1121002 of Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, No. 2 of the Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry, & No. 031121002 of Environmental Policy Bureau, Ministry of the Environment, Japan, November 21, 2003). And it was conducted in compliance with the "Standards to be observed by Mutagenicity Testing Institutions" (Notification No. 76, September 1, 1988 & Notification No. 13, March 29, 2000, Ministry of Labour, Japan) and the "GLP Standards for the Test Facility on New Chemical Substances" (Notification No. 1121003 of Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, No. 3 of Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry, & No. 031121004 of Environmental Policy Bureau, Ministry of the Environment, Japan, November 21, 2003).
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- L-Threonine, N-coco acyl derivs., monosodium salts
- Cas Number:
- 90583-79-2
- Molecular formula:
- n/a
- IUPAC Name:
- L-Threonine, N-coco acyl derivs., monosodium salts
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Name: Sodium Cocoyl Threoninate
BML-CODE: BML-10672
Lot No.: TCS-070717-3
Purity: 98% (w/w)
Impurities: Water (2% w/w)
Method
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:
- S9 mix
- Test concentrations with justification for top dose:
- Without S9 mix: 2.4, 4.9, 10, 20, 39, 78, 156 and 313 µg/plate
With S9 mix: 10, 20, 39, 78, 156, 313, 625, 1250, 2500 and 5000 µg/plate
Doses were based on a dose-finding study. - Vehicle / solvent:
- water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide; 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)aminopropylamino]acridine 2HCl; 2-Aminoanthracene
- Details on test system and experimental conditions:
- According to guideline
- Evaluation criteria:
- In the dose-finding test and the main tests, if the number of revertant colonies an the test plates increased significantly in comparison with that an the control plates (based on twice as many as that of the negative control), and dose-response and reproducibility were also observed, the test substance was to be judged positive.
- Statistics:
- Statistical analysis was not done.
Results and discussion
Test results
- Key result
- Species / strain:
- other: all strains tested
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Sodium Cocoyl Threoninate was not mutagenic under the described study conditions.
- Executive summary:
The mutagenic potential of Sodium Cocoyl Threoninate was assessed with Salmonella typhimurium TA 100, TA 1535, TA 98, TA 1537 and Escherichia coli WP2 uvrA. In this study, neither an increase in the number of revertant colonies more than twice in comparison with that of the negative control nor a dose-related response was observed in any strains of base-pair substitution type or frame-shift type, with or without metabolic activation.
Therefore, it is judged that Sodium Cocoyl Threoninate was not mutagenic under the described study conditions.
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