Registration Dossier
Registration Dossier
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EC number: 428-970-4 | CAS number: 13595-25-0
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 February to 17 June 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- not specified
- 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:
- Bisphenol-M
- IUPAC Name:
- Bisphenol-M
- Details on test material:
- - Name of test material (as cited in study report): Bisphenol-M
- Substance type: Monomer
- Physical state: Solid
- Analytical purity: 99.5%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date: 27 January 1997
- Lot/batch No.: 681001
- Storage condition of test material: Room temperature (ca 15-25°C)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 S9-Mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 2.5 to 15 µg/ml
Concentration range in the main test (without metabolic activation): 5 to 25 µg/ml - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Tested at 20 - 60 µg / ml
Migrated to IUCLID6: Used in the presence of S9 mix
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Tested at 10 - 40 µg / ml
Migrated to IUCLID6: Used in the absence of S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 20 hours
- Expression time (cells in growth medium): 0-22 hours
SPINDLE INHIBITOR (cytogenetic assays): colcemid
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: A total of up to 100 metaphase cells per culture (up to 50 metaphase cells per slide, 2 - 3 slides per culture) - Evaluation criteria:
- Structural and Numerical Chromosomal Aberrations: from the results, 5 parameters were calculated, and judged as negative, suspicious or positive. These parameters were:
1. Lesions per cell
2. Percentage of aberrant cells including cells with gaps only
3. Percentage of aberrant cells excluding cells with gaps only
4. Percentage of aneuploid cells
5. Percentage ofpolyploid cells (normal and endoreduplicated) from additional assessment of ploidy.
The third parameter is considered the most important in judging the true clastogenicity of a test material.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 10 µg/ml)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 15 µg/ml)
- Positive controls validity:
- valid
- Remarks on result:
- other: other: main test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
It was concluded that Bisphenol-M was not clastogenic when tested with Chinese hamster ovary cells in vitro.
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