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Toxicological information

Genetic toxicity: in vitro

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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:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
Deviations:
not specified
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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)

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.