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Diss Factsheets
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EC number: 202-179-2 | CAS number: 92-69-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and GLP compliant study, completely adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Biphenyl-4-ol
- EC Number:
- 202-179-2
- EC Name:
- Biphenyl-4-ol
- Cas Number:
- 92-69-3
- Molecular formula:
- C12H10O
- IUPAC Name:
- biphenyl-4-ol
- Test material form:
- solid: flakes
- Details on test material:
- - Physical state: white flake or powder
- Analytical purity: 99.9%
- Purity test date: 17 July 2012
- Lot/batch No.: 20522
- Expiration date of the lot/batch: 3 July 2013
- Storage condition of test material: ambient temperature
:
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor 1254 treated rat liver S9
- Test concentrations with justification for top dose:
- 8.75, 17.5, 35, 70 and 90 ug/mL both in presence and absence of S9
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- cyclophosphamide (40 ug/mL +S9, mitomycin-C (0.3 ug/mL) -S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 48 hours
- Exposure duration: Phases I and III, 3 hours 30 mins; Phase II, 24 hours - Evaluation criteria:
- The test was considered to have shown clastogenic activity if the following criteria were met:
1. Increased frequency of metaphases with aberrant chromosomes observed at one or more test concentrations (concentration-related).
2. Increases were reproducible between replicate cultures and between tests (when treatment conditions are the same).
3. Increases in percent aberrant metaphases were statistically significant.
4. Increases in percent aberrant metaphases were not associated with large changes in pH and osmolality of the treatment medium.
Historical control data from the laboratory were also considered in the evaluation.
An increase in the number of polyploidy cells indicates that the test item has the potential to inhibit mitotic processes and to induce numerical chromosome aberration. Biological relevance was considered first. The test item was considered non-mutagenic if the results did not meet the above-mentioned criteria. - Statistics:
- Gaps and polyploidy were not included in the calculation of total aberration frequency. Data on mitotic index, polyploidy and percent aberrant cells were subjected to Bartlett's test to meet the homogeneity of variance before conducting Analysis of Variance (ANOVA) and Dunnett's t-test (Gad and Weil, 1994). Where the data did not meet the homogeneity of variance, Student's t-test was performed to determine the level of significance between the negative control and three selected test concentrations (selected based on the mitotic index data) and positive controls.
Results and discussion
Test results
- Species / strain:
- lymphocytes:
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- p-PP did not show any potential to induce chromosomal aberrations, both in the absence and presence (2 and 4% v/v S9) of metbolic activation system under the present experimental conditions.
- Executive summary:
p-PP did not show any potential to induce chromosomal aberrations, both in the absence and presence (2 and 4% v/v S9) of metbolic activation system under the present experimental conditions.
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