Registration Dossier
Registration Dossier
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EC number: 203-742-5 | CAS number: 110-16-7
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:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- Chromosome aberration tests with Chinese Hamster cells in vitro with and without metabolic activation - a comparative study on mutagens and carcinogens
- Author:
- Ishidate M
- Year:
- 1 980
- Bibliographic source:
- Arch. Toxicol. Suppl 4., 41-44, Springer Verlag
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- CHL cells were treated at different doses for 24 and 48 hours without a metabolic activation system and for 3 hours with S-9 mix from liver homogenate of Wistar rats preterated with PCB. After an additional culture for 24 hours, chromosome preparations were made.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Maleic anhydride
- EC Number:
- 203-571-6
- EC Name:
- Maleic anhydride
- Cas Number:
- 108-31-6
- Molecular formula:
- C4H2O3
- IUPAC Name:
- furan-2,5-dione
- Details on test material:
- See also SIDS Initial Assessment.
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix from liver homogenated of Wistar rats treated with PCB
- Test concentrations with justification for top dose:
- no data
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- not specified
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- D20 = ca. 10E-1 mg/mL
D20: dose (mg/mL) at which chromosome aberrations were detected in 20 % of metaphases observed. - 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): Ambiguous
In Chinsese hamster lung fibroblast cells chromosome aberrations were detected in 20 % of metaphases observed at a concentration range of ca. 10E-1 mg/mL.
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