Registration Dossier
Registration Dossier
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EC number: 202-423-8 | CAS number: 95-48-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: insufficient for assessment: o-cresol only used in the re-challenge experiment
Data source
Reference
- Title:
- No information
- Author:
- Bruze M (1986). Sensitizing capacity of 2-methylolophenol 4-methylol phenol and 2,4,6-trimethylol phenol in the guinea pig. Contact Dermatitis 14, 32-38
Materials and methods
- Principles of method if other than guideline:
- GPMT was first performed with 2-methylolphenol, then re-challenge was performed with 13.1 w/w% o-cresol in ethanol.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- o-cresol
- EC Number:
- 202-423-8
- EC Name:
- o-cresol
- Cas Number:
- 95-48-7
- Molecular formula:
- C7H8O
- IUPAC Name:
- o-cresol
- Details on test material:
- o-cresol, no data on purity
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: ethanol
- Concentration / amount:
- intradermal : 5.0 % w/v: SLS: 10 %% w/v; Topical 25 %w/v; Challenge (I)15 % (II) o-cresol 13.1 %w/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- intradermal : 5.0 % w/v: SLS: 10 %% w/v; Topical 25 %w/v; Challenge (I)15 % (II) o-cresol 13.1 %w/v
- No. of animals per dose:
- no data
- Details on study design:
- According to Magnusson and Kligman, J. Invest Dermatol. (1969), 52, 268-276.
- Challenge controls:
- yes
- Positive control substance(s):
- not specified
Results and discussion
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Executive summary:
Guinea pigs sensitized with 2-methylol phenol showed skin effects also with o-cresol (13.1%).
Control group animals also showed skin effects, therefore the used test concentration was probably irritating.
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