Registration Dossier
Registration Dossier
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EC number: 245-854-7 | CAS number: 23735-96-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N6-(1-oxooctyl)-L-lysine
- EC Number:
- 245-854-7
- EC Name:
- N6-(1-oxooctyl)-L-lysine
- Cas Number:
- 23735-96-8
- Molecular formula:
- CH3-(CH2)6-CO-NH-(CH2)4-CH(-NH2; -COOH)
- IUPAC Name:
- (2S)-2-amino-6-octanamidohexanoic acid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Additional strains: E. coli WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 19.5 - 78.1 - 313 - 1250 - 5000 µg/plate
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Additional information on results:
- Note: E. coli WP2 uvrA was also tested with and without metabolic activation; result: negative
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
The test item showed no bacterial reverse mutagenic activity in this test.
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