Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Adopted according to OECD SIDS (public available peer reviewed source). The original source is not available and has not been reviewed. The test was considered invalid because of the following reasons: limited documentation; no guideline study, use of the crude material that could be possibly influence the irritant action of dichlorobutene.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
1,4-Dichlorobut-2-ene- CAS No: 764-41-0
Author:
OECD SIDS
Year:
2006
Bibliographic source:
SIDS Initial Assessment Report for 22th SIAM, UNEP Publications
Reference Type:
study report
Title:
Unnamed
Year:
1956
Report Date:
1956

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A 1 % solution of crude dichlorobutene in acetone was applied on the shaved skin of 10 guinea pigs.
GLP compliance:
no
Remarks:
GLP was mandatory at the time of the study
Type of study:
open epicutaneous test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Crude preparation A 9949 containing 20% cis-1,4-dichlorobut-2-ene, 45% trans-1,4-dichlorobut-2-ene, and 35% 3,4-dichlorobut-1-ene as well as 4% foreshots and 5% tails. Composition of foreshot: 80% dichlorobutenes and small amounts of alpha-, beta- and isochloroprene, crotyl chloride, 3-chlorobut-1-ene, dichloropropene, and 1,2-dichloro-2-methylpropane. Composition of tails: 50% dichlorobutenes and small amounts of trichlorobutene, tetrachlorobutane, and a C8 chloro compound.

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
other: acetone
Concentration / amount:
1% of crude dichlorobutene in acetone was applied during the induction exposure. First challenge: 1% solution. Second challenge: 10% solution.
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: acetone
Concentration / amount:
1% of crude dichlorobutene in acetone was applied during the induction exposure. First challenge: 1% solution. Second challenge: 10% solution.
No. of animals per dose:
10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
Series of 6 sensitizing treatments were performed over a period of 2 weeks (1% of crude dichlorobutene in acetone was applied during the induction exposure). Afterwards the animals were allowed to rest for 2 weeks.

B. CHALLENGE EXPOSURE
After 2 weeks the animals were challenged by the application of a drop of a 1 % solution of dichlorobutene in acetone. A week later the animals were challenged by application of a drop of a 10 % solution of dichlorobutene in acetone.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
strongly and developed erythema
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: strongly and developed erythema .

Any other information on results incl. tables

When a 1 % solution of crude dichlorobutene in acetone was applied on the shaved skin of 10 guinea pigs, 3/10 animals reacted within 24 hours with a mild erythema. After a series of 6 sensitizing treatments over a period of 2 weeks the animals were allowed to rest for 2 weeks and then were challenged by the application of a drop of a 1 % solution of dichlorobutene in acetone. The response was negative. A week later the animals were challenged by application of a drop of a 10 % solution of dichlorobutene in acetone. All 10 guinea pigs reacted strongly and developed erythema within 24 hours.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information