Registration Dossier
Registration Dossier
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EC number: 201-108-2 | CAS number: 78-35-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- OET (Klecak 1977)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- OET (Klecak 1977)
- GLP compliance:
- no
- Remarks:
- study pre-dates the introduction of GLP
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- LLNA not available at the time of testing.
Test material
- Reference substance name:
- 1,5-dimethyl-1-vinylhex-4-enyl isobutyrate
- EC Number:
- 201-108-2
- EC Name:
- 1,5-dimethyl-1-vinylhex-4-enyl isobutyrate
- Cas Number:
- 78-35-3
- Molecular formula:
- C14H24O2
- IUPAC Name:
- 1,5-dimethyl-1-vinylhex-4-enyl isobutyrate
- Reference substance name:
- Unknown impurities
- Molecular formula:
- not applicable
- IUPAC Name:
- Unknown impurities
- Test material form:
- liquid
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Material: Linalyl Isobutyrate
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)
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- No. of animals per dose:
- One to six experimental groups and one control group of six to eight guinea pigs are used.
- Details on study design:
- Induction consisted of 21 daily open applications to the shaved flank of 6-8 guinea pigs per group. One to six experimental and one control group of six to eight guinea pigs ware used. Open challenge applications were made on days 21 and 35. Reactions were read at 24, 48 and 72 hours. No further details were provided.
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Linalyl Isobutyrate was found to be non-sensitizing in the Open Epicutaneous test (OET) in the Guinea Pig.
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