Registration Dossier
Registration Dossier
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EC number: 252-038-4 | CAS number: 34452-51-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
1. HYPOTHESIS FOR THE CATEGORY APPROACH
This scenario covers the category approach for which the hypothesis is based on transformation to a common compound. For the REACH information requirement under consideration, the effects obtained in studies conducted with different source substances are used to predict the effects that would be observed in a study with the target substance if it were to be conducted. The same type of effect is observed for the different source substances; this may include absence of effects for every member of the category. No relevant differences in strengths of effect are observed for several source substances.
There are no relevant variations in properties among source substances and the same potency is predicted for all target substances. This corresponds to Scenario 5 of the RAAF (ECHA, 2017). The substances ATG, MEATG, KTG, CaTG, and NaTG are different inorganic salts of a common acid, thioglycolic acid (TGA; synonym: 2-mercaptoacetic acid). They dissociate rapidly in aqueous media to the common thioglycolate anion and to their different counter ions. The water solubility of all category members is high.
This approach serves to use existing data on aquatic toxicity endpoints for substances in this category.
It can be predicted with high confidence that the target substances will display the same mode of action and lead to the same type and strength of effects as observed with the source substances.
2. CATEGORY APPROACH JUSTIFICATION
For details, refer to Justification for read-across attached to Iuclid section 13
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Materials and methods
Test material
- Reference substance name:
- (2-hydroxyethyl)ammonium mercaptoacetate
- EC Number:
- 204-815-4
- EC Name:
- (2-hydroxyethyl)ammonium mercaptoacetate
- Cas Number:
- 126-97-6
- Molecular formula:
- C2H7NO.C2H4O2S
- IUPAC Name:
- 2-hydroxyethanaminium sulfanylacetate
Constituent 1
Method
- Target gene:
- Histidine reversion
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- btw. 1000 - 5000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 - 5000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 - 5000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 - 5000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 - 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In analogy to ATG and NaTG, KTG is considered non-mutagenic in bacteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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