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EC number: 220-103-6 | CAS number: 2628-17-3
- 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 gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 January to 20 February 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
Test material
- Reference substance name:
- p-vinylphenol
- EC Number:
- 220-103-6
- EC Name:
- p-vinylphenol
- Cas Number:
- 2628-17-3
- Molecular formula:
- C8H8O
- IUPAC Name:
- p-vinylphenol
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Short-term treatment in the absence of metabolic activation (−S9 mix) Short-term treatment in the presence of metabolic activation (+S9 mix): 24-hour continuous treatment (−S9 mix): 1.32, 1.98, 2.96, 4.44, 6.67, 10.0 and 15.0 μg/mL
- Test concentrations with justification for top dose:
- In accordance with the specification of “Toxicity Study Guidelines”, the highest dose level was set at 1200 μg/mL (equivalent to 10 mM), and this was diluted using a common ratio of 2 to obtain a total of 9 concentrations (600, 300, 150, 75.0, 37.5, 18.8, 9.38 and 4.69 μg/mL).
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
Results and discussion
Test results
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- PHS has mutagenic potential in L5178Y TK+/-− -clone 3.7.2C cells under the conditions of this study.
- Executive summary:
A dose range finding test and a gene mutation test were conducted for PHS using the mutations in the thymidine kinase gene loci in the cultured mouse lymphocytes (L5178Y TK+/− -clone 3.7.2C) cells with the short-term treatment and 24-hour continuous treatment.
Observation and measurement were performed after the treatment with the test article or the control articles for 3 hours for the short-term treatment and for 24 hours for the continuous treatment. Dimethyl sulfoxide (DMSO), the vehicle, was used as the negative control article and methyl methanesulfonate (MMS) and cyclophosphamide (CP) as the positive control articles for the treatment without and with metabolic activation, respectively.
Since cytotoxicity was occurred in the dose range finding test, the concentrations for the gene mutation test was selected to cover the cytotoxicity range from that producing cytotoxicity and including concentrations at which there is moderate and little or no cytotoxicity.
– Short-term treatment in the absence of metabolic activation (−S9 mix):
5.27, 7.90, 11.9, 17.8, 26.7, 40.0 and 60.0 μg/mL (common ratio: 1.5)
– Short-term treatment in the presence of metabolic activation (+S9 mix):
8.78, 13.2, 19.8, 29.6, 44.4, 66.7 and 100 μg/mL (common ratio: 1.5)
– 24-hour continuous treatment (−S9 mix):
1.32, 1.98, 2.96, 4.44, 6.67, 10.0 and 15.0 μg/mL (common ratio: 1.5)
In the judgment of the results, the indices calculated by addition of the Global Evaluation Factor (GEF: 126 × 10−6) to the total mutant frequency (T-MF) of the negative control group were used for evaluation according to recommendation of "OECD Guidelines for Testing of Chemicals 490".
In the gene mutation test, precipitation was not observed in any test article treatment group. Color of the culture medium did not change for any test article treatment group.
In the short-term treatment without metabolic activation, the T-MFs were 65.95, 132.75, 206.79, 314.11, 401.39, 800.00 and 871.09 × 10−6 at 5.27, 7.90, 11.9, 17.8, 26.7, 40.0 and 60.0 μg/mL, respectively, and the T-MFs at the dose level of 11.9 to 60.0 μg/mL were increased more than the indices calculated by addition of the GEF to the T-MF of the concurrent negative control group (73.63 × 10−6). However, the T-MFs at the dose levels of 40.0 and 60.0 μg/mL were excluded from the statistical analysis and the evaluation of the results, since the RTG was not higher than 10%. This treatment with the test article showed a significant dose-dependent
T-G327
9
T-MF increase (p < 0.05). According to the judging criteria, the result of the short-term treatment without metabolic activation was evaluated as positive.
In the short-term treatment with metabolic activation, the T-MFs were 88.95, 152.61, 205.27, 236.46, 302.97, 309.96, 413.79 × 10−6 at the dose levels of 8.78, 13.2, 19.8, 29.6, 44.4, 66.7 and 100 μg/mL, respectively, and the T-MFs at the dose levels of 19.8 to 100 μg/mL were increased more than the indices calculated by addition of the GEF to the T-MF of the concurrent negative control group (65.20 × 10−6). However, the T-MFs at the dose levels of 66.7 and 100 μg/mL were excluded from the statistical analysis and the evaluation of the results, since the RTG was not higher than 10%. This treatment with the test article also showed a significant dose-dependent T-MF increase (p < 0.05). According to the judging criteria, the result of the short-term treatment without metabolic activation was evaluated as positive.
In the continuous treatment, the T-MFs were 93.00, 62.97, 108.92, 98.93, 155.00, 246.84 and 288.02 × 10−6 at the dose levels of 1.32, 1.98, 2.96, 4.44, 6.67, 10.0 and 15.0 μg/mL, respectively, and the T-MFs at the dose levels of 10.0 and 15.0 μg/mL were increased more than the indices calculated by addition of the GEF to the T-MF of the concurrent negative control group (109.29 × 10−6). This treatment with the test article also caused a significant dose-dependent T-MF increase (p < 0.05). According to the judging criteria, the result of the continuous treatment without metabolic activation was evaluated as positive.
For the negative control group, the T-MF was within 50×10-6 to 170×10-6, the CE was within 0.65 to 1.20, and the TSG was between 8 to 32-fold in the short-term treatment and 32 to 180-fold in the continuous treatment. For the positive control group, the RTG was more than 10% and the S-MF increased 150×10-6 above the concurrent negative control group. For all the treatment groups, the number of evaluable dose levels was 4 or more. Therefore, it was judged that the study was conducted appropriately.
Based on the above results, it was concluded that PHS has mutagenic potential in L5178Y TK+/-− -clone 3.7.2C cells under the conditions of this study.
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