Registration Dossier
Registration Dossier
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EC number: 201-126-0 | CAS number: 78-59-1
Skin sensitisation
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:
- guideline study with acceptable restrictions
- Remarks:
- no positive control group (not required by 1981 version of guideline)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Reference Type:
- other: OECD SIDS
- Title:
- 3,5,5-Trimethylcyclohex-2-enone (Isophorone), CAS No. 78-59-1
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 16
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An appropriate guinea pig maximisation test is available which would not justify conducting an additional LLNA due to animal welfare.
Test material
- Reference substance name:
- 3,5,5-trimethylcyclohex-2-enone
- EC Number:
- 201-126-0
- EC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Cas Number:
- 78-59-1
- Molecular formula:
- C9H14O
- IUPAC Name:
- 3,5,5-trimethylcyclohex-2-enone
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino, Bor: DHPW
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen (DE)
- Weight at study initiation: 314.2 g (mean)
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 10% (in Freund's Complete Adjuvant (FCA))
2nd challenge: undiluted
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- undiluted
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- undiluted
- No. of animals per dose:
- 20 (test)
10 (control) - Details on study design:
- 1st application: Induction 10 % intracutaneous
2nd application: Challenge undiluted occlusive epicutaneous
3rd application: Challenge undiluted occlusive epicutaneous - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: 1st and 2nd reading
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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