Registration Dossier
Registration Dossier
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EC number: 218-129-8 | CAS number: 2051-78-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviwed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance Material Monograph for Allyl butyrate
- Author:
- Edited by D. L. J. Opdyke
- Year:
- 1 977
- Bibliographic source:
- Food and Cosmetics Toxicology, Volume 15, Issue 6, December 1977, Pages 613-614
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- A Human maximisation test was carried out in 28 volunteers to determine skin sensitization potential caused by the chemical Allyl butyrate (CAS No: 2051-78-7).
- GLP compliance:
- not specified
- Type of study:
- other: Human maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Allyl butyrate
- EC Number:
- 218-129-8
- EC Name:
- Allyl butyrate
- Cas Number:
- 2051-78-7
- Molecular formula:
- C7H12O2
- IUPAC Name:
- prop-2-en-1-yl butanoate
- Test material form:
- liquid
- Details on test material:
- - Name of test material : 2-Propen-1-yl butanoate
- Common name : Allyl butyrate
- Molecular formula : C7H12O2
- Molecular weight : 128.17 g/mol
- Smiles notation : C(OCC=C)(CCC)=O
- InChl : 1S/C7H12O2/c1-3-5-7(8)9-6-4-2/h4H,2-3,5-6H2,1H3
- Substance type: Organic
- Physical state: Liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (IUPAC name): Allyl butyrate
- Molecular formula: C7H12O2
- Molecular weight: 128.17 g/mol
- Smiles notation: C(OCC=C)(CCC)=O
- InChl: 1S/C7H12O2/c1-3-5-7(8)9-6-4-2/h4H,2-3,5-6H2,1H3
- Substance type: Organic
- Physical state: Liquid
In vivo test system
Test animals
- Species:
- other: human
- Strain:
- other: not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- 4%
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4%
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 28
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 4%
- No. with + reactions:
- 0
- Total no. in group:
- 28
- Clinical observations:
- No signs of sensitization were observed.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No signs of sensitization were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test material Allyl butyrate (CAS No: 2051-78-7) was considered to be not sensitizing to the skin of human volunteers.
- Executive summary:
A Human maximisation test was carried out in 28 volunteers to determine skin sensitization potential caused by the chemicalAllyl butyrate(CAS No: 2051-78-7).
Each subject was treated with 4% ofAllyl butyratein petrolatum dermally and later observed for any signs of contact allergy.
None of the volunteer showed any signs of contact sensitization. Hence the chemical Allyl butyrate(CAS No: 2051-78-7) wasconsidered to be not sensitizing to theskin of human volunteers.
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