(Z)-2-butene-1,4-diol

Endpoint summary

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).