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EC number: 202-785-7 | CAS number: 99-76-3
- 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:
- Sep-2018 to Feb-2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- Adopted on 29 th July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
Test material
- Reference substance name:
- Methyl 4-hydroxybenzoate
- EC Number:
- 202-785-7
- EC Name:
- Methyl 4-hydroxybenzoate
- Cas Number:
- 99-76-3
- Molecular formula:
- C8H8O3
- IUPAC Name:
- methyl 4-hydroxybenzoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- CAS No: 99-76-3
Melting point: 127 °C
Purity: 99.8 % (=<0.1 % p-HBA and =< 0.1 % unspecified impurity)
Date of Expiry: 29.11.2020
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Sodium phenobarbitone and ß-Naphthoflavone induced rat liver homogenate
- Test concentrations with justification for top dose:
- The test item was found soluble in DMSO at 200 mg/mL. Since the test item showed slight precipitation and no changes in pH up to 2 mg /mL, same concentration was considered as the highest concentration in the initial cytotoxicity test.
There was no excessive cytotoxicity up to 2 mg/mL, therefore 2 mg/mL was selcted as the highest concentration for testing in the gene mutation test.
For concentrations i.e. 0.25, 0.50, 1 and 2 mg/ml were selcted for gene mutation test based on initial cytotoxicity test. - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- benzo(a)pyrene
- Details on test system and experimental conditions:
- The derivative of the CHO-K1, CHO AA8 cells were used as the test system as recommended in teh OECD TG 476. CHO AA8 cells, Batch No. 5000062 procured fromAmerican Type Culture Collection (ATCC) was used for the test.
Benozo(a) pyrene and 4 Nitroquinoline N-oxide were used as positive controls for the gene mutation test.
Cytotoxicity was assessed by determining the adjusted cloning efficiency and relative survival in the test.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the results obtained, the test item is considerd as non-mutagenic and and up to the concentration of 2 mg/mL, both in the presence and absence of metabolic activation under the tested laboratory conditions.
- Executive summary:
The test item was evaluated for gene mutation test in CHO AA8 cells, according to OECD TG 476 " In vitro Mammalian cell genen mutation test using hprt and xprt genes" adopted on 29th july 2016.
The test item was found soluble in DMSO at 200 mg/mL. Slight precipitation was observed at 2 mg/ml. No change in pH and precipitate at and up to 2 mg/mL in culure medium. Based on the result of solubility, pH and precipitation test an initial cytotoxicity test was conducted at concentrations of 0.0625, 0.125, 0.25, 0.5 1 and 2 mg/mL using DMSO as vehicle in the presence and absence of metabolic activation (3 to 6 hours). The result of the initial cytotoxicity test indicated that the test item was not cytotoxic to CHO AA8 cells, as the relative survival of the treated CHO AA8 cellsat the test concentrations up to 2 mg/mL was in a range of 71.91 to 86.21 % when compared with the respective vehicle control, both in the presence and absence of metabolic activation. The gene mutation test was conducted at concentrations of 0.25, 0.5, 1 nd 2 mg/mL in for plates/groups in the presence and absence of metabolic activation (3 to 6 hours) Benozo(a) pyrene and 4 Nitroquinoline N-oxide were used as positive controls for the gene mutation test. Cytotoxicity was assessed by determining the adjusted cloning efficiency and relative survival in the test.
There was no statistically significant increase in number of mutant colonies at any of concentrations tested when compared with the vehicle control. Positive controls resulted in mutant frequencies, which were statistically significant when compared with the vehicle control.
Based on the results obtained, the test item is considerd as non-mutagenic and and up to the concentration of 2 mg/mL, both in the presence and absence of metabolic activation under the tested laboratory conditions.
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