Registration Dossier
Registration Dossier
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EC number: 811-711-8 | CAS number: 14952-06-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Open Epicutaneous Test
- GLP compliance:
- no
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- Sufficient data was collected from the Open Epicutaneos Test in order to conclude on the skin sensitization potential of Neofolione.
Test material
- Reference substance name:
- (E)-methyl non-2-enoate
- EC Number:
- 811-711-8
- Cas Number:
- 14952-06-8
- Molecular formula:
- C10H18O2
- IUPAC Name:
- (E)-methyl non-2-enoate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1ml
- Day(s)/duration:
- 20
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.025ml
- Day(s)/duration:
- 14
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 6-8
- Details on study design:
- To determine whether or not contact sensitization was induced, all groups of guinea pigs previously treated for 21 days for skin irritation testing, as well as 6 to 8 untreated or only with the vehicle pretreated controls are tested on days 21 and 35 on the contra-lateral flank with the test material at the minimal irritating and some lower concentrations.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 504
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 840
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 504
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 840
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Under OET-conditions no sensitizing potential of Neofolione was detected.
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