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EC number: 202-200-5 | CAS number: 92-88-6
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- Short-term toxicity to fish
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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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted in accordance with OECD TG 473 and GLP
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Principles of method if other than guideline:
- Test method was in accordance with the OECD 473 Test Guideline and the Guidelines for Screening Mutagenicity Testing of Chemicals (Chemical Substances Control Law of Japan)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Biphenyl-4,4'-diol
- EC Number:
- 202-200-5
- EC Name:
- Biphenyl-4,4'-diol
- Cas Number:
- 92-88-6
- Molecular formula:
- C12H10O2
- IUPAC Name:
- [1,1'-biphenyl]-4,4'-diol
- Details on test material:
- No further details.
Constituent 1
- Specific details on test material used for the study:
- - Analytical purity:99.96
Method
- Target gene:
- Chromosomal aberrations in Chinese hamster lung cells (CHL/u)
Species / strain
- Species / strain / cell type:
- other: Chinese hamster lung cells (CHL/u)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver induced with phenobarbital and 5,6-benzoflavone S-9
- Test concentrations with justification for top dose:
- 0.03; 0.06 and 0.12 mg/mL with and without S-9
- Vehicle / solvent:
- dimethyl sulphoxide (DMSO)
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S-9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S-9
- Details on test system and experimental conditions:
- No further information
- Evaluation criteria:
- According to criteria set out in OECD Test Guidelines No 473 and Guidelines for Screening Mutagenicity Testing of Chemicals (Chemical Substances Control Law of Japan)
- Statistics:
- Chromosome analysis conducted using one-sided Fisher's exact probability test. Significant results tabulated for p<0.01
Results and discussion
Test results
- Key result
- Species / strain:
- other: chinese hamster lungs cells (CHL/U)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- clastogenicity and polyploidy with or without metabolic activation at 0.03 or 0.06 mg/mL and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- A significant increase in frequency of cells with chromosomal aberrations was noted at all three treatments, 0.03, 0.06, 0.12 mg/mL, without metabolic activation and in the two higher dose levels with metabolic activation (Chromosome analysis conducted using one-sided Fisher's exact probability test. Significant results tabulated for p<0.01). A significant increase in polyploidy was also observed at 0.06 or 0.12 mg/mL, with and without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: positive
A statistically significant (p<0.01: Fisher's Exact Test) increase in frequency of cells with chromosomal aberrations was noted at all three treatments, 0.03, 0.06, 0.12 mg/mL, without metabolic activation and in the two higher dose levels with metabolic activation.
A statistically significant increase in polyploidy (p<0.01: Fisher's Exact Test) was also observed at 0.06 or 0.12 mg/mL, with and without metabolic activation.
A positive response for induction of chromosomal aberrations was observed in chinese hamster lung cells treatd with 4,4'-biphenyldiol, typically at dose levels of 0.06 mg/mL and above, the response was typified by clastogenic and polyploidy effects. - Executive summary:
The cytogenicity of biphenyl-4,4'-diol (biphenol) was investigated in Chinese Hamster cells (CHL/IU) cells in vitro. A significant (p<0.01) increase in frequency of cells with chromosomal aberrations was noted at all three treatments, 0.03, 0.06, 0.12 mg/mL, without metabolic activation and in the two higher dose levels with metabolic activation. A significant increase in polyploidy was also observed at 0.06 or 0.12 mg/mL, with and without metabolic activation.
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