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
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