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Toxicological information

Skin sensitisation

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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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information