Registration Dossier
Registration Dossier
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EC number: 289-124-6 | CAS number: 86014-76-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: expert assessment
- Adequacy of study:
- key study
- Study period:
- 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: expert assessment
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- epxert statement
- GLP compliance:
- no
- Type of assay:
- other: expert statement
Test material
- Reference substance name:
- Similar substance #2
- IUPAC Name:
- Similar substance #2
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- in addition to traditional bacteria strain, nitro-reductase deficient strains for TA98 an TA100 are used, namely TA98NR and TA100NR
- Metabolic activation:
- with and without
- Metabolic activation system:
- uninduced rat hamster liver S9 mix
- Test concentrations with justification for top dose:
- 0,5,16,50,150, 500, 1600 and 5000 micro/plate
- Vehicle / solvent:
- water
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
Results and discussion
Test results
- Species / strain:
- other: refer to attached expert statament
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the expert statament, the substance is not considerd as genotoxic in gene mutation studieis on bacteria
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