Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Docosanoic acid
- EC Number:
- 204-010-8
- EC Name:
- Docosanoic acid
- Cas Number:
- 112-85-6
- Molecular formula:
- C22H44O2
- IUPAC Name:
- docosanoic acid
- Details on test material:
- The test substance provided by Nippon Oil & Fats (NOF) Corporation was used. The test substance was stored at room temperature until use.
Constituent 1
- Specific details on test material used for the study:
- The test substance provided by NOF Corporation was used. The test substance was stored at room temperature until use. After the test was completed, the residual test substance was analyzed by the test substance provider, and as a result, there was no problem with stability.
Method
- Target gene:
- his operon (S. typhimurium strains), trp operon (E. coli strain)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix was prepared from the liver of male Sprague-Dawley rats treated with phenobarbital and 5,6-benzoflavone as inducers.
- Test concentrations with justification for top dose:
- 156, 313, 625, 1250, 2500, 5000 µg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: -S9: 2-(2 Furyl)-3-(5-nitro-2-furyl)acrylamide (0.01 µg/plate);Sodium azide(0.5 µg/plate);Aminoacridine hydrochloride(80 µg/plate);+S9: 2-Aminoanthracene(1.0 µg/plate;TA100),(2 µg/plate;TA1535;TA1537),(10 µg/plate;WP2 uvrA),(0.5 µg/plate;TA98)
- Remarks:
- These positive control substances were dissolved using DMSO, dispensed in small portions, and then cryopreserved (-20 ° C).
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 minutes at 37 °C
- Exposure duration: 48 hours; after that, the growth state of the test strain on the plate was observed using a stereomicroscope (× 60) in order to confirm the growth inhibitory effect of the test substance on the test strain
NUMBER OF REPLICATIONS: 2 times (3 plates/concentration/test)
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- An increase twice the number of revertant colonies in test concentration plates compared to the solvent control plates and an observable dose-dependency is considered as a positive result.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative
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