Registration Dossier
Registration Dossier
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EC number: 203-095-9 | CAS number: 103-28-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- 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 publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance material review on benzyl isobutyrate
- Author:
- D. McGinty , C.S. Letizia, A.M. Api
- Year:
- 2 012
- Bibliographic source:
- Food and Chemical Toxicology 50 (2012) S420
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Maximization test was conducted on humans to determine the sensitization potential of test chemical.
- GLP compliance:
- not specified
- Type of study:
- other: human Maximization test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The human Maximization test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- Benzyl isobutyrate
- EC Number:
- 203-095-9
- EC Name:
- Benzyl isobutyrate
- Cas Number:
- 103-28-6
- Molecular formula:
- C11H14O2
- IUPAC Name:
- benzyl 2-methylpropanoate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Benzyl isobutyrate
- Molecular formula: C11H14O2
- Molecular weight: 178.23 g/mol
- Smiles: c1(COC(C(C)C)=O)ccccc1
- InChl): -1S/C11H14O2/c1-9(2)11(12)13-8-10-6-4-3-5-7-10/h3-7,9H,8H2,1-2H3
-Substance type: organic
- Physical state: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- male
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4 % in petrolatum
- Day(s)/duration:
- 5 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4 % in petrolatum
- Day(s)/duration:
- 48 and 72 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 25 healthy male patients.
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:3 days
- Exposure period: 48 h periods.
- Test groups:25
- Control group:No
- Site:Forarms
- Frequency of applications: for five alternate days, 48 h periods
- Duration:5 days
- Concentrations:4% in petrolatum
B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge: 10 days after challenge exposure period
- Exposure period:48-hrs
- Test groups:25
- Control group:
- Site: applied to fresh sites on the back
- Concentrations: 4% in petrolatum
- Evaluation (hr after challenge): 48 and 72 h - Challenge controls:
- No data
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 4 %
- 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:
- 4%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No sensitization reactions were observed.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- Non-sensitising effects were known in maximisation study of test chemical exposed to 25 human volunteers.
- Executive summary:
Maximization test was conducted on 25 human volunteers to determine skin sensitization potential of test chemical.
The test chemical in petrolatum was applied on the skin of 25 healthy male patients. Application was under occlusion to the same site on the forearm of all subjects for five alternate day, 48 h periods. The patch sites were pretreated for 24 h with 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 10% SLS. The challenge site was evaluated at 48 and 72 h.
Since Non-sensitizing effects were known in maximization test, the test chemical was considered to be non-sensitizing on human skin.
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