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EC number: 202-803-3 | CAS number: 99-94-5
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In the Ames study, no increase in the number of revertant colonies was observed in either strain (S. typhimurium TA98, TA100, TA1535, TA1537, or E. coli WP2 uvrA/pKM101) at any concentrations of p-toluic acid and with or without metabolic activation (S9 mix). These results led to the conclusion that p-toluic acid is not a mutagen in the bacterial reverse mutation assay (Ames test) regardless of metabolic activation.
This chromosome aberration study found p-toluic acid to increase structural chromosomal aberrations.
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- other: Chromosome aberration study
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch:
- Purity test date:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
OTHER SPECIFICS: - Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Chinese hamster lung.
- Suitability of cells:
- Cell cycle length, doubling time or proliferation index:
- Sex, age and number of blood donors if applicable:
- Whether whole blood or separated lymphocytes were used if applicable:
- Number of passages if applicable:
- Methods for maintenance in cell culture if applicable:
- Modal number of chromosomes:
- Normal (negative control) cell cycle time:
MEDIA USED
- Type and identity of media including CO2 concentration if applicable:
- Properly maintained: [yes/no]
- Periodically checked for Mycoplasma contamination: [yes/no]
- Periodically checked for karyotype stability: [yes/no)
- Periodically 'cleansed' against high spontaneous background: [yes/no] - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 1242 ug/mL without S-9 mix (6 hr short-term treatment)
1005 ug/mL with S-9 mix (6 hr short-term treatment)
775 ug/mL without S-9 mix (24 hr continuous treatment) - Vehicle / solvent:
- - Vehicle(s) used:CMC (carboxymethyl cellulose);
- Justification for choice of solvent/vehicle: - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- mitomycin C
- Details on test system and experimental conditions:
- Two plates were used for each concentration. The cells were treated continuously with the test substance for 24 hr in the absence of metabolic activation (continuous treatment) or shortly for 6 hr (short-term treatment) in the presence or absence of metabolic activation. In the short-term treatment, cells were incubated for additional 18 hr in a fresh culture medium without the test substance. The co-factor-supplemented post-mitochondrial fraction (S9 mix) was prepared from the livers of male Sprague-Dawley rats treated with phenobarbital and 5,6-benzoflavon. Mytomycin C or Benzo[a]pyrene was used as a positive control for the assay.
Colcemid (0.1 ug/ml) was added to the culture medium 2 hr before cell harvesting and then chromosome preparations were made. A hundred well-spread metaphase plates were observed under a microscope for each plate. Incidence of polyploid cells and that of cells with structural aberrations such as chromatid breaks and exchanges, chromosome breaks, exchanges and gaps, and others were recorded.
The results were considered negative when the incidence was less than 5%, and considered positive when the incidence was more than 10%.
The results were considered equivocal when the incidence was 5-10%. - Evaluation criteria:
- The results were considered negative when the incidence was less than 5%, and considered positive when the incidence was more than 10%.
The results were considered equivocal when the incidence was 5-10%. - Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- In this study, an increase in structural chromosomal aberrations, attributed to a decrease of culture media pH, was observed. Therefore, the confirmation tests were conducted with or without a buffered medium, which was prepared with a double amount of sodium hydrogen carbonate.
In the main and confirmation tests conducted with buffered medium, the number of cells with structural chromosomal aberrations except gaps increased at dose of1000 ug/mL and higher after continuous treatment without metabolic activation (frequency: 5-12 %). - Remarks on result:
- mutagenic potential (based on QSAR/QSPR prediction)
- Conclusions:
- This chromosome aberration study found p-toluic acid to increase structural chromosomal aberrations.
Reference
Colcemid
(0.1 ug/ml) was added to the culture medium 2 hr before cell harvesting
and then chromosome preparations were made. A hundred well-spread
metaphase plates were observed under a microscope for each plate.
Incidence of polyploid cells and that of cells with structural
aberrations such as chromatid breaks and exchanges, chromosome breaks,
exchanges and gaps, and others were recorded.
The results were considered negative when the incidence was less than
5%, and considered positive when the incidence was more than 10%.
The results were considered equivocal when the incidence was 5-10%.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: DMSO
- Justification for choice of solvent/vehicle:
- Concentration of test material in vehicle:
- Amount of vehicle (if gavage or dermal):
- Type and concentration of dispersant aid (if powder):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- Twice with 24 hr interval
- Frequency of treatment:
- Twice with 24 hr interval
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Tissues and cell types examined:
- Micronuclei in red blood cells.from bone marrow.
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Additional information on results:
- Although there are no ADME studies, it can be predicted, based on physical chemical considerations and toxicokinetic prediction, that the substance is likely to reach the target tissue, the bone marrow. Based on these results, p-toluic acid is not anticipated to be genotoxic in vivo.
- Conclusions:
- Although there are no ADME studies, it can be predicted, based on physical chemical considerations and toxicokinetic prediction, that the substance is likely to reach the target tissue, the bone marrow. Based on these results, p-toluic acid is not anticipated to be genotoxic in vivo.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
No increase in the number of revertant colonies was observed in either strain (S. typhimurium TA98, TA100, TA1535, TA1537, or E. coli WP2 uvrA/pKM101) at any concentrations of p-toluic acid and with or without metabolic activation (S9 mix). These results led to the conclusion that p-toluic acid is not a mutagen in the bacterial reverse mutation assay (Ames test) regardless of metabolic activation.”
Justification for classification or non-classification
On the basis of the mouse micronucleus study, p-toluic acid will not be classified for genetic toxicity.
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