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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A small quantity of each test substance was placed on the wetted (tap water) central gauze portion of 1 1/2-inch-square BandAid before application to a nonhairy region of the upper back. Strips of Dermicel hypoallergenic tape were used to occlude, cover and secure the patches. The patches were applied to the same areas on Mondays, Wednesdays and Fridays for 3 weeks ( 9 applications in total) for 24 hr and then removed by the subjects themselves, except for the first two occasions when the investigators removed the patches. The subjects did not expose their backs to sunlight during this procedure. Residual powder was gently removed from the skin with the soft alcohol pads. The reactions were graded and recorded during each visit. An additional visit for grading and observation took place on Monday of the 4th week.
Challenge applications were performed on Monday of the 6th week following the commencement of the sensitization procedure. Patches were applied to a previously untested area of the of the upper back skin using the method described above, except that they were left in situ for 48 hr before removal. The reactions were graded shortly after patches removal and then at 96 and 144 hr after application.
Additional 48 hr challenging applications were performed on certain subjects following the same procedures. - GLP compliance:
- no
- Type of study:
- Draize test
- Justification for non-LLNA method:
- Human study.
Test material
- Reference substance name:
- p-toluic acid
- EC Number:
- 202-803-3
- EC Name:
- p-toluic acid
- Cas Number:
- 99-94-5
- Molecular formula:
- C8H8O2
- IUPAC Name:
- 4-methylbenzoic acid
- Test material form:
- solid: crystalline
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: polystyrene or petrolatum
- Concentration / amount:
- p-toluic acid, 50% in polystyrene, and o-toluic acid, 50% in polystyrene
- Day(s)/duration:
- 2
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: polystyrene powder and petrolatum
- Concentration / amount:
- p-toluic, o-toluic and m-toluic acids, all three isomers at concentrations of 50% in polystyrene powder, 5% in petrolatum, and 1% in petrolatum.
- Day(s)/duration:
- 4
- Adequacy of challenge:
- other: Reactions were observed in all 4 subjects to all three isomers,
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 2 days
- Test groups: 1
- Control group: none
- Site:
- Frequency of applications: once
- Duration:
- Concentrations: 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 4
- Exposure period: 4
- Test groups: 1
- Control group: none
- Site:
- Concentrations:
- Evaluation (hr after challenge): 18 days
OTHER: - Challenge controls:
- none
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- Five of the subjects became sensitized to p-toluic. Sensitization reactions to p-toluic acid occurred days 15-18. In some subjects the challenge reactions were severe and necessitated removal of the patches before completion of 48-hr application time.
- Remarks on result:
- positive indication of skin sensitisation
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Under the conditions of this study, p-toluic acid was shown to be sensitising to human skin.
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