Registration Dossier
Registration Dossier
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EC number: 204-442-7 | CAS number: 121-00-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- 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
- Species:
- human
- Sex:
- not specified
- Route:
- other: no data
- Vehicle:
- other: 2 % butylated hydroxyanisole
- Route:
- other: no data
- Vehicle:
- other: 2 % butylated hydroxyanisole
- Vehicle:
- not specified
- 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.
- 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.
Reference
Three patient observed with eczematous dermatitis patch
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
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.
The other authoritative supporting sources of information also indicates that the tert-butyl-4-methoxyphenol was not found to be sensitising.
Migrated from Short description of key information:
Tert-butyl-4-methoxyphenol was not found to be sensitizing to human, in the in vivo Patch test conducted.
Justification for classification or non-classification
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.
