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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report date:
1966

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
But-2-ene-1,4-diol
EC Number:
203-787-0
EC Name:
But-2-ene-1,4-diol
Cas Number:
110-64-5
Molecular formula:
C4H8O2
IUPAC Name:
2-Butene-1,4-diol
Constituent 2
Chemical structure
Reference substance name:
(Z)-2-butene-1,4-diol
EC Number:
228-085-1
EC Name:
(Z)-2-butene-1,4-diol
Cas Number:
6117-80-2
Molecular formula:
C4H8O2
IUPAC Name:
but-2-ene-1,4-diol
Details on test material:
- Name of test material (as cited in study report): Butenediol, 25% acqueous
- Purity: not reported

In vivo test system

Test animals

Species:
human
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
25% solution
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information