Registration Dossier
Registration Dossier
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EC number: 204-442-7 | CAS number: 121-00-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- DOSE No.: B244
- Author:
- RSC Publishing
- Year:
- 2 011
- Bibliographic source:
- Dictionary of Substances and their effects (DOSE) : Roed-Petersen, J. et al Br. J. Dermatol. 1976, 94, 233.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Study is from handbook of 'DOSE (Dictionary of Substances and their effects)'
- GLP compliance:
- not specified
- Type of study:
- patch test
Test material
- Reference substance name:
- 2-tert-butyl-4-methoxyphenol
- EC Number:
- 204-442-7
- EC Name:
- 2-tert-butyl-4-methoxyphenol
- Cas Number:
- 121-00-6
- Molecular formula:
- C11H16O2
- IUPAC Name:
- 2-tert-butyl-4-methoxyphenol
- Details on test material:
- - Name of test material (as cited in study report): tert-butyl-4-methoxyphenol
- Substance type: Organic
- Physical state: Solid
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: no data
- Vehicle:
- other: 2 % butylated hydroxyanisole
Challenge
- Route:
- other: no data
- Vehicle:
- other: 2 % butylated hydroxyanisole
Study design: in vivo (LLNA)
- Vehicle:
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 3
- Total no. in group:
- 112
- Clinical observations:
- Three patient observed with eczematous dermatitis patch
- Remarks on result:
- other: Reading: 1st reading. Group: test group. No with. + reactions: 3.0. Total no. in groups: 112.0. Clinical observations: Three patient observed with eczematous dermatitis patch.
Any other information on results incl. tables
Three patient observed with eczematous dermatitis patch
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Three positive reactions observed from a total 112 patients with eczematous dermatitis patch-tested with 2% butylated hydroxyanisole.From this test result it is concluded that tert-butyl-4-methoxyphenol was not found to be sensitising to human skin.
- Executive summary:
Three positive reactions observed from a total 112 patients with eczematous dermatitis patch-tested with 2% butylated hydroxyanisole.From this test result it is concluded that tert-butyl-4-methoxyphenol was not found to be sensitising to human skin.
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