Registration Dossier
Registration Dossier
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EC number: 203-883-2 | CAS number: 111-57-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Refer to section 13 of IUCLID for details on the category justification.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- other: read-across from similar mixture/product (migrated information)
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Not reported
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The study was conducted according to 'Mutation Research 31, 347 - 364 (1975)'
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Not reported
- Species / strain / cell type:
- other: TA 1535, TA 100, TA 1537, TA 1538 and TA 98
- Details on mammalian cell type (if applicable):
- Type and identity of media: Agar plates
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Postmitochondrial supernatant fluids from the liver of male rats treated with Aroclor 1254 (S-9 mix)
- Test concentrations with justification for top dose:
- 4, 20, 100, 500 and 2500 µg/plate test material per plate
- Vehicle / solvent:
- No data
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Remarks:
- None
- Details on test system and experimental conditions:
- No data
- Evaluation criteria:
- No data
- Statistics:
- Not reported
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- Under the study conditions, test susbtance was considered to be non-mutagenic in an in vitro Ames test.
- Executive summary:
A study was conducted to evaluate the in vitro genotoxic toxicity of the test substance, C12-18 and C18-unsatd. MEA, in a Ames test. Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 were treated with the test substance using the Ames plate incorporation method at up to five dose levels (4, 20, 100, 500 and 2500 µg/plate test material per plate) both with and without metabolic activation. Under the test conditions, test susbtance was found to be non-mutagenic (Wallat, 1981).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Not reported
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The study was conducted according to 'Mutation Research 31, 347 - 364 (1975)'.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(2-hydroxyethyl)stearamide
- EC Number:
- 203-883-2
- EC Name:
- N-(2-hydroxyethyl)stearamide
- Cas Number:
- 111-57-9
- Molecular formula:
- C20H41NO2
- IUPAC Name:
- N-(2-hydroxyethyl)octadecanamide
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- Not reported
Species / strain
- Species / strain / cell type:
- other: TA 1535, TA 100, TA 1537, TA 1538 and TA 98
- Details on mammalian cell type (if applicable):
- Type and identity of media: Agar plates
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Postmitochondrial supernatant fluids from the liver of male rats treated with Aroclor 1254 (S-9 mix)
- Test concentrations with justification for top dose:
- 4, 20, 100, 500 and 2500 µg/plate test material per plate
- Vehicle / solvent:
- No data
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Remarks:
- None
- Details on test system and experimental conditions:
- No data
- Evaluation criteria:
- No data
- Statistics:
- Not reported
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, test susbtance was considered to be non-mutagenic in an in vitro Ames test.
- Executive summary:
A study was conducted to evaluate the in vitro genotoxic toxicity of read across substance, C12-18 and C18-unsatd. MEA, in the Ames test. Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 were treated with the read across substance using the Ames plate incorporation method at up to five dose levels (4, 20, 100, 500 and 2500 µg/plate test material per plate) both with and without metabolic activation. Under the test conditions, the test substance was found to be non-mutagenic (Wallat, 1981).
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