Registration Dossier
Registration Dossier
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EC number: 205-572-7 | CAS number: 142-92-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: handbook
- Adequacy of study:
- key study
- 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 Procedure 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:
- study was done before LLNA method was first choice
Test material
- Reference substance name:
- Hexyl acetate
- EC Number:
- 205-572-7
- EC Name:
- Hexyl acetate
- Cas Number:
- 142-92-7
- Molecular formula:
- C8H16O2
- IUPAC Name:
- hexyl acetate
- Reference substance name:
- acetic acid hexyl ester
- IUPAC Name:
- acetic acid hexyl ester
- Test material form:
- not specified
- Details on test material:
- No details provided
Constituent 1
Constituent 2
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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: OET - open and FCAT - intradermal injection
- Vehicle:
- no data
- Concentration / amount:
- 0.4%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- no data
- Concentration / amount:
- 0.4%
- No. of animals per dose:
- No details available
- Details on study design:
- refer to "any other information on materials and methods" field below
- Challenge controls:
- No details
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- Not reported
In vivo (non-LLNA)
Results
- Reading:
- other: overall assessment at challenge
- Group:
- test chemical
- Dose level:
- 4%
- No. with + reactions:
- 0
- Total no. in group:
- 6
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 n-hexyl actate 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 hexyl 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 for hexyl acetate.
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