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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 chemical
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).