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EC number: 203-128-7 | CAS number: 103-61-7
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 reviewed journals
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Fragrance material review on cinnamyl butyrate
- Author:
- S.P. Bhatia, G.A. Wellington, J. Cocchiara, J. Lalko, C.S. Letizia, A.M. Api
- Year:
- 2 007
- Bibliographic source:
- Food and Chemical Toxicology, 45, (2007), S62–S65
- Reference Type:
- publication
- Title:
- A toxicologic and dermatologic assessment of related esters and alcohols of cinnamic acid and cinnamyl alcohol when used as fragrance ingredients
- Author:
- D. Belsito, D. Bickers , M. Bruze , P. Calow , H. Greim ,J.M. Hanifin, A.E. Rogers , J.H. Saurat, I.G. Sipesi, H. Tagami
- Year:
- 2 007
- Bibliographic source:
- Food and Chemical Toxicology, 45, (2007) S1–S23
- Reference Type:
- publication
- Title:
- Fragrance raw materials monographs: CINNAMYL BUTYRATE
- Author:
- D. L. J. Opdyke
- Year:
- 1 978
- Bibliographic source:
- Food and Cosmetics Toxicology,Volume 16, Supplement 1, 1978, Page 691
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the dermal sensitization potential of cinnamyl butyrate in humans
- GLP compliance:
- not specified
- Type of study:
- other: Human Maximization study
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Cinnamyl butyrate
- EC Number:
- 203-128-7
- EC Name:
- Cinnamyl butyrate
- Cas Number:
- 103-61-7
- Molecular formula:
- C13H16O2
- IUPAC Name:
- cinnamyl butyrate
- Test material form:
- liquid
- Details on test material:
- - Name of the test material: Cinnamyl butyrate
- IUPAC name: (2E)-3-phenylprop-2-en-1-yl butanoate
- Molecular formula: C13H16O2
- Molecular weight: 204.267 g/mol
- Substance type: Organic
- Smiles: c1(\C=C\COC(CCC)=O)ccccc1
- InChI : 1S/C13H16O2/c1-2-7-13(14)15-11-6-10-12-8-4-3-5-9-12/h3-6,8-10H,2,7,11H2,1H3/b10-6+
- Substance typy : Organic
- Physical State: Colorless to yellowish liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material: Cinnamyl butyrate
- IUPAC name: (2E)-3-phenylprop-2-en-1-yl butanoate
- Molecular formula: C13H16O2
- Molecular weight: 204.267 g/mol
- Substance type: Organic
- Smiles: c1(\C=C\COC(CCC)=O)ccccc1
- Physical State: Colorless liquid
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- no data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4% petrolatum, 2760 µg/cm2
- Day(s)/duration:
- five alternate-day 48-h periods
- Adequacy of induction:
- other: Patch sites were pre-treated for 24 h under occlusion with 5% aqueous sodium lauryl sulfate (SLS) for the initial patch only.
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- % (2760 µg/cm2) cinnamyl butyrate in petrolatum
- Day(s)/duration:
- 48 h
- Adequacy of challenge:
- other: Challenge applications were preceded by 30-min applications of 5% aqueous SLS under occlusion on the left side of the back.
- No. of animals per dose:
- 29 healthy male volunteers
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 48-h periods
- Test groups: 29 healthy volunteers
- Control group: no data available
- Site: forearms of all volunteers
- Frequency of applications: five alternate-day 48-h periods
- Duration: 48-h periods
- Concentrations: 4% (2760 µg/cm2) cinnamyl butyrate in petrolatum
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: Following a 10–14 day rest period
- Exposure period: 48 hours
- Test groups:
- Control group: A fifth site was challenged with SLS on the left and petrolatum controls on the right.
- Site: right side of the back
- Concentrations: undiluted
- Evaluation (hr after challenge): 48 hours
OTHER:
Patch sites were pre-treated for 24 h under occlusion with 5% aqueous sodium lauryl sulfate (SLS) for the initial patch only. Challenge applications were preceded by 30-min applications of 5% aqueous SLS under occlusion on the left side of the back. - Challenge controls:
- no data available
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 4% (2760 µg/cm2) cinnamyl butyrate in petrolatum .
- No. with + reactions:
- 0
- Total no. in group:
- 29
- Clinical observations:
- no sensitization reactions observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No sensitization reactions were observed in any of the volunteers. Hence, Cinnamyl butyrate can be considered to be not sensitizing to human skin.
- Executive summary:
A maximization test was carried out to assess the dermal sensitization potential of Cinnamyl butyrate. Application of 4% (2760µg/cm2) cinnamyl butyrate in petrolatum was made under occlusion to the same site on the forearms of 29 healthy, male volunteers for five alternate-day 48-h periods. Patch sites were pre-treated for 24 h under occlusion with 5% aqueous sodium lauryl sulfate (SLS) for the initial patch only. Following a 10–14 day rest period, challenge patches were applied under occlusion to fresh sites for 48 h. Challenge applications were preceded by 30-min applications of 5% aqueous SLS under occlusion on the left side of the back, whereas the test material without SLS treatment was applied on the right side. A fifth site was challenged with SLS on the left and petrolatum controls on the right.
No sensitization reactions were observed in any of the volunteers. Hence, Cinnamyl butyrate can be considered to be not sensitizing to human skin.
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