Registration Dossier
Registration Dossier
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EC number: 500-094-8 | CAS number: 37208-53-0 1 - 6.5 moles propoxylated
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: 1a GLP guideline study. Study was conducted in accordance to GLP and OECD guideline 471.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- TS: 2, 2', 2''-Nitrilotriethanol, propoxylated, (Mm = approx. 340 g/mol)
Lot No: 20104
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500, 5000 µg/plate
Controls
- Positive controls:
- yes
- Remarks:
- ENNG, 9AA, MMC and 4NQO
- Details on test system and experimental conditions:
- Type: Ames test
- Evaluation criteria:
- The test material should have induced a reproducible, dose related and statistically (Dunnett's method of linear regression) significant increase in the revertant count in at least one strain of bacteria.
Results and discussion
Test results
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: > 5000 µg/plate
- Additional information on results:
- No significant increase in the frequency of revertant colonies were recorded for any of the strains of Salmonella, at any dose level either with or without metabolic activation. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies.
- Remarks on result:
- other: other: Salmonella typhimurium
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
The test material was considered to be non-mutagenic under the test conditions.
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