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Skin sensitisation

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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:
2012
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

Constituent 1
Chemical structure
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

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.