Registration Dossier
Registration Dossier
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EC number: 939-582-4 | CAS number: 1471315-26-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance CAS 112-85-6. In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Docosanoic acid
- EC Number:
- 204-010-8
- EC Name:
- Docosanoic acid
- Cas Number:
- 112-85-6
- IUPAC Name:
- docosanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Docosanoic acid
- Physical state: white solid
- Analytical purity: 85.9 %
- Lot/batch No.: 60805X
- Storage condition of test material: at room temperature
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Chinese hamster lung (CHL) cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM (Eagle)
- Metabolic activation:
- with and without
- Metabolic activation system:
- post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- 6 h: 875, 1750 and 3500 µg/mL, with and without metabolic activation
24 h: 350, 700, 1400 and 2800 µg/mL, without metabolic activation
48 h: 288, 575, 1150 and 2300 µg/mL, without metabolic activation - Vehicle / solvent:
- Carboxymethylcellulose sodium (1.0% )
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: long term exposure: mitomycin C (0.05 µg/mL (24 h exp) or 0.025 µg/mL (48 h exp)); short term exposure: cyclophosphamide 12.5 µg/mL (6 h exp)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 3 days
- Exposure duration: 6, 24 and 48 h
STAIN (for cytogenetic assays): Giemsa
NUMBER OF CELLS EVALUATED: 200
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- The frequency of polyploid cells or cells with abnormal structure of each test group were determined according to the criteria of Ishidate.
- Statistics:
- Probit test
Results and discussion
Test results
- Species / strain:
- mammalian cell line, other: Chinese hamster lung (CHL) cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: the test material was insoluble in water and soluble in alcohol, ether, chloroform and acetone.
- Precipitation: in the high dose group on the slide of continuous exposure precipitation was observed.
RANGE-FINDING/SCREENING STUDIES:
No cytotoxicity was observed in a preliminary test at concentrations of 4.05, 13.5, 45.0, 150 and 500 μg/mL. Therefore, cytotoxicity was tested at: (6 h exposure): 272, 453, 756, 1260, 2100, 3500 μg/mL with and without metabolic activation, (24 and 48 h exposure): 272, 453, 756, 1260, 3500 µg/mL without metabolic activation.
Result of cytotoxicity test 50 % cytotoxicity concentration:
24 h exposure: 2703 μg/mL
48 h exposure: 2248 μg/mL
6 h exposure: not observed
Based on this cytotoxicity test, test concentration of the main test were determined. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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