Registration Dossier
Registration Dossier
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: 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.
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.
