Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 251-132-2 | CAS number: 32634-68-7
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Allergic Contact Dermatitis to the test chemical
- Author:
- Edward Emmett et.al
- Year:
- 1 973
- Bibliographic source:
- Journal of Investigative Dermatology, 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Modification of the Draize method
- Principles of method if other than guideline:
- The procedure used for sensitization was a modification of the method proposed by Draize.
- GLP compliance:
- not specified
- Type of study:
- other: Modification of the Draize method
- Justification for non-LLNA method:
- not specified
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
- Details on test material:
- - Name of test material (as cited in study report): 4-Methylbenzoic acid
- Molecular formula: C8H8O2
- Molecular weight : 136.1492 g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Department of Environmental Health , Kettering Laboratory, University of Cincinnati
- Age: 19-49 years old
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 50% polystyrene
- Concentration / amount:
- 50% in polystyrene
- Day(s)/duration:
- 24 hours
- Adequacy of induction:
- other: non irritating concentration
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 50% polystyrene
- Concentration / amount:
- 50% in polystyrene
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: non irritating concentration
- No. of animals per dose:
- 10 - test
- Details on study design:
- MAIN STUDY
Range finding study: A single 48 hour application of the test chemical in 50% polystyrene was made to the backs of atleast 10 normal subjects to ensure that concentrations used were non-irritating
A. INDUCTION EXPOSURE
- No. of exposures: 9 applications
- Exposure period: 24 hours
- Test groups: 5
- Control group: 10, vehicle control
- Site: non hairy region of the back
- Frequency of applications: Patches were applied to the same sites on Monday, Wednesday, and Friday for 3 weeks , a total of 9 applications.
- Duration: 3 weeks
- Concentrations: small amount in 50% polystyrene
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge:
- Exposure period: 48 hours
- Test groups: 10
- Control group: 10, vehicle control
- Site: untested site on the back
- Concentrations: test chemical, 50% in polystyrene
- Evaluation (hr after challenge): 48 and 96 hours after removal of the patch
OTHER:
Grading of the reactions was performed using the scale recommended by the International Contact Dermatitis League. They are:
NT = not tested
- = Negative reaction
?+ = Doubtful reaction
+ = weak (nonvesicular) reaction
++ = strong (edematous and vesicular reaction)
+++ = extreme reactions - Challenge controls:
- Also these 10 subjects were challenged with non irritating concentrations of undiluted polystyrene.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- test chemical,50% in polystyrene
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- Sensitization reactions were observed in 5 of the 10 patients
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: vehicle control
- Dose level:
- polystyrene
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no reactions were observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 96
- Group:
- test chemical
- Dose level:
- 50% in polystyrene
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- sensitization was observed in 5 of the 10 patients
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table: Simultaneous application of test chemical, 50% in polystyrene
Subject |
*Reactions to the test chemical |
||||
Third week of sensitizing application |
Challenge application
|
||||
Mon |
Wed |
Fri |
48 hours |
96 hours |
|
P.C |
- |
+ |
++ |
++ |
++ |
S.H |
- |
++ |
++ |
+++ |
+++ |
R.W |
- |
- |
+ |
++ |
++ |
M.S |
- |
- |
- |
++ |
++ |
C.M |
- |
+ |
++ |
++ |
++ |
Grading of the reactions was performed using the scale recommended by the International Contact Dermatitis League. They are:
NT = not tested; - = Negative reaction; ?+ = Doubtful reaction; + = weak (nonvesicular) reaction; ++ = strong (edematous and vesicular reaction); +++ = extreme reactions
Applicant's summary and conclusion
- Interpretation of results:
- other: sensitizing
- Conclusions:
- Sensitization reactions were observed in 5 of the 10 patients. In some subjects, the challenge reactions were so reactive to necessitate removal of patches before the completion of 48 hour period.
Hence, the test chemical was considered to have potential to cause dermal sensitization. - Executive summary:
The procedure used for sensitization was a modification of the method proposed by Draize.
25 healthy human volunteers, 14 males, 11 females (23 Caucasians and 2 Negroes), aged 19-49 were used in the study. None of the subjects gave positive past history of atopy or contact sensitivity.
A single 48 hour application of the test chemical in 50% polystyrene was made to the backs of atleast 10 normal subjects to ensure that concentrations used were non-irritating.
In the induction exposure, a small quantity of test material 50% in polystyrene was placed on the wetted central gauze portion of 1.5 inch square J&J BANDAID before application to a non hairy region of the upper back. Dermicel hypoallergic tape was used to occlude, cover and secure the patches. Patches were applied to the same sites on alternate days for 3 weeks, a total of 9 applications. They were left in place for 24 hours and then removed. The subjects were told not to expose their backs to sunlight. Residual powder was gently removed from skin using soft pads wetted with water or 70% alcohol. Challenge exposure was performed on Monday of the 6thweek following a rest period of 14 days.
Patches were applied to the untreated sites of the skin of back and were left in situ for 48 hours. Reactions were graded after removal of patches and again at 96 and 144 hours. Also these 10 subjects were challenged with non irritating concentrations of undiluted polystyrene. No significant reactions were observed to the vehicle.
Sensitization reactions were observed in 5 of the 10 patients. In some subjects, the challenge reactions were so reactive to necessitate removal of patches before the completion of 48 hour period.
Hence, the test chemical was considered to have potential to cause dermal sensitization.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.