Registration Dossier
Registration Dossier
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EC number: 272-211-8 | CAS number: 68783-88-0 Complex combination obtained by steam distillation of soybean oil followed by condensation of the steam. Contains fatty acids, sterols, aldehydes and ketones.
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:
- weight of evidence
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study meets generally accepted scientific principles and is acceptable for assessment.
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C8-18 and C18-unsatd.
- EC Number:
- 266-929-0
- EC Name:
- Fatty acids, C8-18 and C18-unsatd.
- Cas Number:
- 67701-05-7
- IUPAC Name:
- Fatty acids, C8-18 and C18-unsatd.
- Details on test material:
- - Name of test material (as cited in study report): Edenor K 8-18(CAS N° 67701-05-7, EC N° 266-929-0)
Constituent 1
Method
- Target gene:
- No data
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 4, 20, 100, 500 and 2,500 µg/plate
- Vehicle / solvent:
- Water with Tween 80
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
Results and discussion
Test resultsopen allclose all
- 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:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- 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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
ambiguous without metabolic activation
Under the test conditions, ‘Fatty acids, C8-18 and C18-unsatd.’ was found to be negative in a Salmonella typhimurium bacteria reverse mutation assay. - Executive summary:
‘Fatty acids, C8-18 and C18-unsatd.’ was tested for mutagenic activity in the bacterial gene mutation assay with Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100. The test was conducted on agar plates in the absence or presence of S-9 mix. Suspensions of the test material were freshly prepared in water with Tween 80 before use at concentrations of 4, 20, 100, 500 and 2,500 µg/plate.
Under the test conditions, ‘Fatty acids, C8-18 and C18-unsatd.’ was found to be negative.
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