Registration Dossier
Registration Dossier
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EC number: - | CAS number: 1374859-51-4
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)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read-across was used. Hypothesis for the analogue approach: see files attached under section 13 assessment reports Read Across Justification. Test for source substance to genetic toxicity in vitro was performed according to EU Method B.13/14 and compliant with GLP.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium: TA 98, TA 100, TA102, TA 1535, TA 1537, et E.coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S 9 mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 321.5...5000 µg/plate
Concentration range in the main test (without metabolic activation): 321.5...5000 µg/plate - Vehicle / solvent:
- Solvent: acetone
Results and discussion
Test results
- Species / strain:
- other: as specified above
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Additional information on results:
- Observatons: no mutagenic activity
- Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The Ames-test for test substance indicated negative results with and without metabolic activation. The test substance (source substance) bis(hydrogenated tallow C16-C18-alkyl)hydroxylamine is a structurally very similar substance to target substance hydroxylamines, di-C16-18 (even numbered) alkyl. It can be reasonably assumed that target substance has also negative results with and without metabolic activation.
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