Registration Dossier
Registration Dossier
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EC number: 928-472-1 | CAS number: 1184301-52-7
Toxicological information
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
- Study period:
- 04.08.2004 - 10.11.2004
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: There are concerns on study result outcome
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (6S)-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine 2,3-dihydroxybutanedioic acid trihydrate
- EC Number:
- 928-472-1
- Cas Number:
- 1184301-52-7
- Molecular formula:
- C11-H17-N3-O6-S x 3H2O
- IUPAC Name:
- (6S)-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine 2,3-dihydroxybutanedioic acid trihydrate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- In the study report is mentioned that a dihydrate was used for testing, this statement is not correct. After further evaluation of the substances it was found out that it is a trihydrate. The batch for testing was a typical production batch.
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Experiment 1:
TA98/TA1537: 5000, 4000, 2500, 2000, 1000, 316.2, 100 and 31.6 µg/plate
TA 100/TA1535/ Escherichia coli: 5000, 2500, 1000, 316.2, 100 and 31.6 µg/plate
Experiment 2:
TA 98: 5000, 4000, 2500, 2000, 1000, 316.2, 100 and 31.6 µg/plate
TA 1537: 5000, 4500, 4000, 3000, 2000, 1000, 316.2 and 100 µg/plate
TA 100/TA1535/ Escherichia coli: 5000, 2500, 1000, 316.2, 100 and 31.6 µg/plate - Vehicle / solvent:
- DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other:
- Details on test system and experimental conditions:
- The test system was suitably labeled to clearly identify the study number, bacterial strain, test article concentration (where appropriate) positive and vehicle controls, absence or presence of S-9 mix.
- Rationale for test conditions:
- The test is considered acceptable if for each strain:
- the bacteria demonstrate their typical responses to crystal violet and ampicillin
- the control plates without S9 mix are within the historical control data range
- corresponding background growth on both negative control and test plates occurs
- the positive control shows a distinct enhancement over the control plate - Evaluation criteria:
- A test item is considered mutagenic if:
- a dose-related increase in the number of revertants occur and/or
- a reproducible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation.
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the test points is considered non-mutagenic in this system. - Statistics:
- The biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 100, TA 1535 and Escherichia coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The reported data of this mutagenicity assay show that, under the experimental conditions reported, the test item induces gene mutations by
frameshifts in the genome of the strains used.
Therefore, SND 919 Precursor 3a is considered to be mutagenic in this bacterial reverse mutation assay.
However there is evidence that a genotoxic impurity was responsible for the positive outcome. An other AMES test was performed with a high purified substances of (S)-2,6-Diamino-4,5,6,7-tetrahydrobenzothiazol (CAS: 106092-09-5), the result of this test was negative. Therefore it is assumed that the tartrate salt is also negative and the positive result in this study was caused by an impurity.
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