Registration Dossier
Registration Dossier
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EC number: 203-113-5 | CAS number: 103-45-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- other: handbook
- Adequacy of study:
- weight of evidence
- Study period:
- Published in 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The comparative assessment of two sensitisation methods includes limited results for hexyl acetate but is sufficient to support a conclusion that the substance is not a skin sensitiser.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- The Freund's Complete Adjuvant Test and the Open Epicutaneous Test A Complementary Test Pro cedure for Realistic Assessment of Allergenic Potential
- Author:
- G. Klecak
- Year:
- 1 985
- Bibliographic source:
- Curr. Probl. Derm., vol.14, pp.152-171
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Comparative assessment of skin sensitising potential in an adjuvant method (Freund’s Complete Adjuvant Test FCAT) and a non-adjuvant method (Open Epicutaneous Test).
- GLP compliance:
- no
- Type of study:
- other: Comparison of open epicutaneous test and Freund’s Complete Adjuvant Test (FCAT)
- Justification for non-LLNA method:
- Existing data.
Test material
- Reference substance name:
- Phenethyl acetate
- EC Number:
- 203-113-5
- EC Name:
- Phenethyl acetate
- Cas Number:
- 103-45-7
- Molecular formula:
- C10H12O2
- IUPAC Name:
- 2-phenylethyl acetate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data provided
Results and discussion
- Positive control results:
- Not reported
In vivo (non-LLNA)
Results
- Remarks on result:
- other: Specific results not detailed in report
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Complementary testing of phenyl ethyl acetate in two guinea pig models, one with and one without adjuvant, indicate the absence of sensitising potential.
- Executive summary:
No evidence of skin sensitisation was seen with phenyl ethyl acetate, either in the Freund's Complete Adjuvant Test (FCAT: an adjuvant method) or in the Open Epicutaneous Test (OET: a non-adjuvant method). Although the studies are of non-standard design, the constently negative results are considered to be sufficient to conclude an absence of sensitising potential.
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