Registration Dossier

Administrative data

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)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
A chemical product with multiple components including Butenediol was tested for sensitivity in adult males in accordance with the maximatization technique. The males that developed a sensitivity to the product were challenged patch tested with the individual components and the percentage of males showing sensitivity was recorded.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Study performed in year 1966
Species:
human
Sex:
male
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
25% solution
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
25% solution
No. of animals per dose:
15
Details on study design:
A chemical product with multiple components including Butenediol was tested for sensitivity in adult males in accordance with the maximatization technique. Fifteen of the males that developed a sensitivity to the product mixture were re-challenged patch tested with the individual components of the mixture and the percentage of males showing sensitivity was recorded.
Positive control substance(s):
yes
Remarks:
Butynediol (CASRN: 110-65-6) and, seperately, 1% formalin
Reading:
rechallenge
Hours after challenge:
504
Group:
test group
Dose level:
25% aqueous solution
No. with + reactions:
0
Total no. in group:
15
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 504.0. Group: test group. Dose level: 25% aqueous solution. No with. + reactions: 0.0. Total no. in groups: 15.0.
Group:
negative control
Remarks on result:
not measured/tested
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
not sensitising
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A chemical product / mixture containing butenediol was found to be a sensitiser, but the re-challenge patch test with butenediol alone did not cause sensitisation in any of the 15 males that showed a positive response to the product mixture. Given these results, butenediol was not found to be sensitising.


Migrated from Short description of key information:
not sensitising

Justification for classification or non-classification

Based on the results of a Human patch test (Kligman, 1966), 1,4-butenediol is judged not to be a skin sensitizer under the EU DSD criteria (EU Directive 67/548/EEC) or the EU CLP criteria (EU Regulation 1272/2008).