Registration Dossier
Registration Dossier
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EC number: 922-363-2 | CAS number: -
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:
- 98 days
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (2Z)-but-2-enedioic acid; N-[2-(dimethylamino)ethyl]-5-(1,2-dithiolan-3-yl)pentanamide
- EC Number:
- 922-363-2
- Cas Number:
- 865661-00-3
- Molecular formula:
- C16H28N2O5S2
- IUPAC Name:
- (2Z)-but-2-enedioic acid; N-[2-(dimethylamino)ethyl]-5-(1,2-dithiolan-3-yl)pentanamide
- Test material form:
- solid: particulate/powder
Constituent 1
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- S. typhimurium TA 98, TA 100, TA1535, TA1537 and TA102)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Non- mutagenic
Applicant's summary and conclusion
- Conclusions:
- Bacterial Reverse mutation test for Thioctamidoethyl Dimethylamine Maleate in Salmonella typhimurium tester strains
confirms it is non-mutagenic. The study is performed in compliance with OECD Guidelines No. 471.
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