Registration Dossier
Registration Dossier
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EC number: 203-106-7 | CAS number: 103-38-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting 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
Reference
- Reference Type:
- publication
- Title:
- Fragrance material review on benzyl butyrate
- Author:
- D. McGinty , C.S. Letizia, A.M. Api
- Year:
- 2 012
- Bibliographic source:
- Food and Chemical Toxicology, 50 , S407–S411,2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- A maximization test was carried out to assess the dermal sensitization potential of test chemical in humans
- GLP compliance:
- not specified
- Type of study:
- other: Maximization test
Test material
- Reference substance name:
- Benzyl butyrate
- EC Number:
- 203-105-1
- EC Name:
- Benzyl butyrate
- Cas Number:
- 103-37-7
- Molecular formula:
- C11H14O2
- IUPAC Name:
- benzyl butyrate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Benzyl butyrate
- Molecular formula : C11H14O2
- Molecular weight: 178.2296 g/mol
- Substance type: Organic
- Physical state: liquid
Constituent 1
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% (2760 µg/cm2)
- Day(s)/duration:
- 5 alternate days, 48 hours exposure
- Adequacy of induction:
- other: The patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4% (2760 µg/cm2)
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: The challenge site was pretreated for 1 h with 10% SLS.
- No. of animals per dose:
- 25 humans
- Details on study design:
- Details on study design
RANGE FINDING TESTS:no data available
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: No data available
- Exposure period: five alternate day at 48 h periods.
- Test groups: 25
- Control group: No data available
- Site: forearm
- Frequency of applications: 5 alternate days
- Duration: 48 hrs
- Concentrations: No data available
B. CHALLENGE EXPOSURE
- No. of exposures: No data available
- Day(s) of challenge: 10 days
- Exposure period: No data available
- Test groups: 25
- Control group: No data available
- Site: On the fresh sites of back
- Concentrations: No data available
- Evaluation (hr after challenge): 48 and 72 hrs
OTHER:
A. INDUCTION EXPOSURE
The patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion.
B. CHALLENGE EXPOSURE
The challenge site was pretreated for 1 h with 10% SLS. - 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:
- 72
- Group:
- test chemical
- Dose level:
- 4% (2760 µg/cm2)
- 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 sensitizing
- Conclusions:
- No sensitization reactions were observed. Hence, the test chemical can be considered to be not sensitizing to the skin of humans
- Executive summary:
A maximization test was carried out with 4% (2760µg/cm2) test chemical in petrolatum on 25 healthy male patients.
Application was under occlusion to the same site on the forearms 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.
No sensitization reactions were observed. Hence, the test chemical can be considered to be not sensitizing to the skin of humans
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