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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.

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.

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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