Registration Dossier
Registration Dossier
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EC number: 500-236-9 | CAS number: 68920-66-1 1 - 2.5 moles ethoxylated
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Neither E.coli WP2 strains nor S. typhimurium TA102 were used.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Alcohols, C16-18, ethoxylated
- EC Number:
- 500-212-8
- EC Name:
- Alcohols, C16-18, ethoxylated
- Cas Number:
- 68439-49-6
- IUPAC Name:
- 68439-49-6
Constituent 1
Method
- Target gene:
- His-operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Plate incorporation: 0, 50, 160, 500, 1600, 5000 µg/plate
Preincubation (Test 1): 0, 50, 150, 300, 900, 1500 µg/plate
Preincubation (Test 2): 0, 10, 25, 50, 100, 150 µg/plate - Vehicle / solvent:
- acetone
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated cells
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9: 2-aminoanthracene (2.5 µg/plate); -S9: sodium azide (TA100 (5 µg/plate), TA1535 (2.5 µg/plate)), 2-nitrofluorene (TA98; 2.5 µg/plate), 9-aminoacridine (TA1537; 40 µg/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation & preincubation
- Evaluation criteria:
- According to Guideline.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: 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:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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