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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:
other: according to guideline study, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
only study available

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhex-2-enal
EC Number:
211-448-3
EC Name:
2-ethylhex-2-enal
Cas Number:
645-62-5
Molecular formula:
C8H14O
IUPAC Name:
2-ethylhex-2-enal
Details on test material:
purity: 96 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Induction

treated group: three pairs of intradermal injections of 0.1 ml
1. a 1:1 mixture of Freunds Complete Adjuvant / water
2. the test substance in corn oil at a concentration of 10 %
3. the test substance (10 %) in a mixture of corn oil / Freunds Complete Adjuvant 1:1

control group: three pairs of intradermal injections of 0.1 ml
1. a 1:1 mixture of Freunds Complete Adjuvant / water
2. corn oil
3. a mixture of corn oil / Freunds Complete Adjuvant 1:1

Challenge

treated and control group: 100 % test substance
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
corn oil
Concentration / amount:
Induction

treated group: three pairs of intradermal injections of 0.1 ml
1. a 1:1 mixture of Freunds Complete Adjuvant / water
2. the test substance in corn oil at a concentration of 10 %
3. the test substance (10 %) in a mixture of corn oil / Freunds Complete Adjuvant 1:1

control group: three pairs of intradermal injections of 0.1 ml
1. a 1:1 mixture of Freunds Complete Adjuvant / water
2. corn oil
3. a mixture of corn oil / Freunds Complete Adjuvant 1:1

Challenge

treated and control group: 100 % test substance
No. of animals per dose:
treatment group: 20
control group: 10
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
no data
No. with + reactions:
9
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: no data. No with. + reactions: 9.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
no data
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: no data. No with. + reactions: 6.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
2-Ethylhex-2-enal is sensitising in the Guinea-Pig Maximisation test.
Executive summary:

The sensitising potential of 2 -Ethylhex-2 -enal was investigated in the Guinea-Pig Maximisation test. The test animals were intradermally injected with an emulsion of Freund's complete adjuvant and the test substance in both the selected vehicle and an emulsion of Freund's complete adjuvant. One week later this was boosted by topical application of the test substance over the injection sites. Control group animals were treated in the same manner but the selected vehicle was used in place of the test substance. Two weeks after the second induction stage, all animals were challenged by topical application of both the vehicle and the test substance. The results indicate that the test substance does elicit a sensitisation response in the guinea pig.