Registration Dossier
Registration Dossier
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EC number: 249-769-6 | CAS number: 29676-71-9
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-aminothiazol-4-acetic acid
- EC Number:
- 249-769-6
- EC Name:
- 2-aminothiazol-4-acetic acid
- Cas Number:
- 29676-71-9
- Molecular formula:
- C5H6N2O2S
- IUPAC Name:
- (2-amino-1,3-thiazol-4-yl)acetic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix prepared from the livers of male rats treated with phenobarbital and beta-naphthoflavone
- Test concentrations with justification for top dose:
- Pre-experiment: 3.16, 10, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate (tested in strains TA98 and TA100)
Main experiment 1 and 2: 31.6, 100, 316, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent is compatible with the survival of the bacteria and the S9 activity
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenyllene-diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- Preparation of bacteria:
Samples of each tester strain were grown by culture for 12 hours at 38.5°C in Nutrient broth to the late exponential or early stationary phase of growth (approximately 10^9 cells/mL). A solution containing ampicillin was added in order to retain the phenotypic characteristics of the strain.
Pre-experiment: The toxicity of the test substance was determined with tester strains TA98 and TA100 in a pre-experiment. Eight concentrations were tested for toxicity and induction of mutations with three plates each. the experimental conditions in this pre-experiment were the same as the main experiment. Toxicity may be detected by a clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately < 0.5 in relation to the solvent control.
Main phase:
For the plate incorporation method the following materials were mixed in a test tube and poured over the surface of a minimal agar plate:
100 µL: test solution at each dose level, solvent control, negative control or reference mutagen solution.
500 µL: S9 mix (for testing with metabolic activation) or S9 mix substitution buffer (for testing with metabolic activation).
Counting:
The colonies were counted using a Protocol counter. If precipiation of the test substance precluded automatic counting the revertant colonies were counted by hand. In addition, tester strains with a low spontaneous mutation frequency like TA1535 and TA1537 were counted manually.
Cytotoxicity:
Assessed as per the preliminary test.
- Rationale for test conditions:
- Standard as per OECD guideline.
- Evaluation criteria:
- A test substance is considered mutagenic if:
- a clear and dose related increase in the number of revertants occurs and/or
- a biologically relevan positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation.
A biologically relevant increase is as follows:
- If in tester strains TA98, T100 and TA102 the number of reversions is at least twice as high.
- If in test strains TA1535 and TA 1537 the number of reversions is at least three times higher than the reversion rate of the solvent control.
A test substance producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system. - Statistics:
- Not required or conducted.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: None noted
- Effects of osmolality: None noted
- Evaporation from medium: None noted
- Water solubility: None noted
- Precipitation: None noted
Applicant's summary and conclusion
- Conclusions:
- The test substance was deemed not mutagenic in any of the strains tested both with and without metabolic activation under the conditions of the test.
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