Registration Dossier
Registration Dossier
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EC number: 204-596-5 | CAS number: 123-05-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- 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:
- 1 989
- 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
Test material
- Reference substance name:
- 2-ethylhex-2-enal
- EC Number:
- 211-448-3
- EC Name:
- 2-ethylhex-2-enal
- Cas Number:
- 645-62-5
- IUPAC Name:
- 2-ethylhex-2-enal
- Details on test material:
- purity: 96 %
Constituent 1
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.
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