Registration Dossier
Registration Dossier
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EC number: 207-668-4 | CAS number: 488-10-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study not GLP and no guideline stated.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No guideline is stated in the study report.
- GLP compliance:
- no
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- Alternative in vivo testing method available
Test material
- Reference substance name:
- 3-methyl-2-pent-2-enylcyclopent-2-enone
- EC Number:
- 207-668-4
- EC Name:
- 3-methyl-2-pent-2-enylcyclopent-2-enone
- Cas Number:
- 488-10-8
- Molecular formula:
- C11H16O
- IUPAC Name:
- 3-methyl-2-pent-2-enylcyclopent-2-enone
- Reference substance name:
- (E)-3-methyl-2-(pent-2-enyl)cyclopent-2-en-1-one
- EC Number:
- 228-410-7
- EC Name:
- (E)-3-methyl-2-(pent-2-enyl)cyclopent-2-en-1-one
- Cas Number:
- 6261-18-3
- Molecular formula:
- C11H16O
- IUPAC Name:
- 3-methyl-2-pent-2-en-1-ylcyclopent-2-en-1-one
- Test material form:
- liquid
Constituent 1
impurity 1
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:
- intradermal
- Vehicle:
- other: FCA
- Concentration / amount:
- 3%
- Day(s)/duration:
- 2days
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: petrolatum
- Concentration / amount:
- 25%
- Day(s)/duration:
- 2days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- other: petrolatum
- Concentration / amount:
- 3%
- Day(s)/duration:
- 2 and 3 weeks
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 4
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- The highest non irritant concentration of Jasmone Cis after one and after repeated applications is 3%. The preparation does not sensitise the guinea pig in the OET.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
The highest non irritant concentration of Jasmone Cis after one and after repeated applications is 3%. The preparation does not sensitise the guinea pig in the OET.
From a dermatological point of view, one may gather the following from the results for the dermatological tests in man:
1) The preparation may well be tolerated in man up to a concentration of 10%
2) Therefore an allergic sensitisation in man is most unlikely up to this concentration.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- The highest non irritant concentration of Jasmone Cis after one and after repeated applications is 3%. The preparation does not sensitise the guinea pig in the OET.
- Executive summary:
The highest non irritant concentration of Jasmone Cis after one and after repeated applications is 3%. The preparation does not sensitise the guinea pig in the OET.
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