Registration Dossier
Registration Dossier
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EC number: 205-406-3 | CAS number: 140-26-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 974
Materials and methods
- Principles of method if other than guideline:
- To assess the skin sensitizing potential of phenethyl isovalerate by Kligman human maximization assay
- GLP compliance:
- not specified
- Type of study:
- other: Maximization test
Test material
- Reference substance name:
- Phenethyl isovalerate
- EC Number:
- 205-406-3
- EC Name:
- Phenethyl isovalerate
- Cas Number:
- 140-26-1
- Molecular formula:
- C13H18O2
- IUPAC Name:
- 2-phenylethyl 3-methylbutanoate
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report):Phenethyl isovalerate- Molecular formula (if other than submission substance):C13H1802- Molecular weight (if other than submission substance): 206.28 g/mol- Substance type:Organic- Physical state:Liquid- Analytical purity: No data available.
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- petrolatum
- Concentration / amount:
- 2%
Challenge
- Concentration / amount:
- 2%
- No. of animals per dose:
- 26 human volunteers
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: not specified
- Dose level:
- 2% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 26
- Clinical observations:
- No positive reaction observed
- Remarks on result:
- other: Reading: other: not specified. Dose level: 2% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 26.0. Clinical observations: No positive reaction observed.
Any other information on results incl. tables
not specified
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- A maximization test was carried out on 26 volunteers. The test chemical was tested at a concentration of 2% in petrolatum and produced no sensitization reactions.
- Executive summary:
In skin sensitization study , maximization test was carried out on 26 volunteers. The test chemical was tested at a concentration of 2% in petrolatum and produced no sensitization reactions. Based on the above value ,the test material does not classify as an skin sensitizer.
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