Registration Dossier
Registration Dossier
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EC number: 269-047-4 | CAS number: 68186-85-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77377.
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:
- Peer reviewed authority database (Peer review was conducted by a Japanese toxicological expert group at March 5, 2001. However, detailed information were not available). Furthermore test results were taken for the OECD SIDS Intital assessment report for C.I. Pigment Yellow 53.
Data source
Referenceopen allclose all
- Reference Type:
- other: Peer-reviewed database
- Title:
- Unnamed
- Year:
- 2 002
- Reference Type:
- other: OECD Substance initial assessment report (SIAR)
- 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:
- not specified
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- C.I. Pigment Yellow 53
- IUPAC Name:
- C.I. Pigment Yellow 53
- Reference substance name:
- Antimony nickel titanium oxide yellow
- EC Number:
- 232-353-3
- EC Name:
- Antimony nickel titanium oxide yellow
- Cas Number:
- 8007-18-9
- IUPAC Name:
- 8007-18-9
- Details on test material:
- - Purity 100 %
- Lot/Batch No.: 4879
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- other: Chinese hamster lung (CHL/IU) cells
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- short-term treatment (-S9 mix): 4.88, 9.77, 19.5, 39.1, 78.1 µg/mL;
short-term treatment (+S9 mix): 19.5, 39.1, 78.1, 156, 313, 625, 1250 µg/mL;
continuous treatment (-S9 mix): 4.88, 9.77, 19.5, 39.1, 78.1 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: Mitomycin C; +S9: Cyclophosphamide
- Details on test system and experimental conditions:
- NUMBER OF CELLS EVALUATED: 200
Results and discussion
Test results
- Species / strain:
- other: Chinese hamster lung (CHL/IU) cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity was observed at more than 39.1, 78.1, and 19.5 µg/ml in -S9mix, +S9mix and continuous treatments, respectively
- 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'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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