Registration Dossier
Registration Dossier
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EC number: 939-249-3 | CAS number: 97926-05-1
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
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:
- Alcohols, C12-14-secondary, β-(2-hydroxyethoxy)
- EC Number:
- 308-219-6
- EC Name:
- Alcohols, C12-14-secondary, β-(2-hydroxyethoxy)
- Cas Number:
- 97926-05-1
- IUPAC Name:
- 97926-05-1
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 1st test: 8, 40, 200, 1000, 5000 microg/plate
2nd test: without S9: TA 100, 1535, 1537 and 98: 12.5, 25, 50, 100, 200 microg/plate
TA 1538: 6.25, 12.5, 25, 50, 100 microg/plate
2nd test: with S9: TA 100, 1535, 1537 and 98: 62.5, 125, 250, 500, 1000 microg/plate
TA 1538: 12.5, 25, 50, 100, 200 microg/plate - Vehicle / solvent:
- Ethanol
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- other: 4-nitro-phenylendiamine
- Details on test system and experimental conditions:
- according to guideline
- Evaluation criteria:
- according to guideline
- Statistics:
- according to guideline
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item did not show any indication for genotoxic toxicity in this assay.
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