Registration Dossier
Registration Dossier
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EC number: 203-119-8 | CAS number: 103-52-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- review article or handbook
- Title:
- Fragrance material review on phenethyl butyrate
- Author:
- D. McGinty, C.S. Letizia, A.M. Api
- Year:
- 2 012
- Bibliographic source:
- Food and Chemical Toxicology, 50 (2012) S398–S401
- Reference Type:
- review article or handbook
- Title:
- A toxicological and dermatological assessment of aryl alkyl alcohol simple acid ester derivatives when used as fragrance inl and dermatological assessment of aryl alkyl alcohol simple acid ester derivatives when used as fragrance ingredients
- Author:
- The RIFM Expert Panel,D. Belsito , D. Bickers , M. Bruze , P. Calow , M.L. Dagli , A.D. Fryer ,H. Greim , Y. Miyachi , J.H. Saurat , I.G. Sipes
- Year:
- 2 012
- Bibliographic source:
- Food and Chemical Toxicology 50 (2012) S269–S313
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- A human maximization assay was conducted to evaluate the sensitization potential of test chemical.
- GLP compliance:
- not specified
- Type of study:
- other: Human Maximization test
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- Phenethyl butyrate
- EC Number:
- 203-119-8
- EC Name:
- Phenethyl butyrate
- Cas Number:
- 103-52-6
- Molecular formula:
- C12H16O2
- IUPAC Name:
- 2-phenylethyl butanoate
- Reference substance name:
- phenethyul butyrate
- IUPAC Name:
- phenethyul butyrate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Phenethyl butyrate
- Molecular formula: C12H16O2
- Molecular weight: 192.106 g/mol
- Substance type: Organic
- Physical state: Liquid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8% (5520µg/cm2)
- Day(s)/duration:
- 5 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8% (5520µg/cm2)
- Day(s)/duration:
- 72 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 25 healthy patients
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:5
- Exposure period: 48 h
- Test groups: 25 healthy patients
- Control group: no data
- Site: Application was under occlusion to the same site on the forearm or back of all subjects
- Frequency of applications: for five alternate day
- Duration: 5 days
- Concentrations: 8%(5520 µg/cm2) test chemical in petrolatum
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge:Following a 10 day rest period
- Exposure period: 48 hours
- Test groups: 25 healthy patients
- Control group: no data
- Site: challenge patches were applied to fresh sites on the back for 48 h under occlusion
- Concentrations: 8%(5520 µg/cm2) in petrolatum
- Evaluation (hr after challenge): The challenge site was evaluated at 48 and 72 h. - Challenge controls:
- no data
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 8% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No sensitization reactions were observed.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 8%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No sensitization reactions were observed.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Not sensitizing
Any other information on results incl. tables
No skin reactions were observed on humans.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- No reaction was observed in any human volunteers during the assay.Hence the test chemical was considered to be not sensitizing to human skin.
- Executive summary:
A human maximization assay was conducted to evaluate the sensitization potential of test chemical.
The assay was carried out with 8% (5520µg/cm2) of test chemical in petrolatum on 25 healthy patients. Application was under occlusion to the same site on the forearm or back of all subjects for five alternate day 48 h periods. The patch sites were pretreated for 24 h with 2.5% or 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, challenge patches were applied to fresh sites on the back for 48 h under occlusion. The challenge site was pretreated for 1 h with 5–10% SLS. The challenge patches were applied to fresh sites on the back for 48 h under occlusion. The challenge site was evaluated at 48 and 72 h.
No reaction was observed in any human volunteers during the assay. Therefore the test chemical was considered to be not sensitizing to human skin.
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