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Toxicological information

Skin sensitisation

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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 peerreviewed journal.

Data source

Reference
Reference Type:
publication
Title:
Fragrance Raw Materials Monographs: 3-methylbutyl benzoate
Author:
Weir
Year:
1979
Bibliographic source:
A Collection of Monographs Originally Appearing in Food and Cosmetics Toxicology, 1979, Pages 78

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To evaluate the skin sensitizing potential of 3-methylbutyl benzoate in Human by Human Maximisation test.
GLP compliance:
not specified
Type of study:
other: Human Maximisation test.
Justification for non-LLNA method:
Not specified.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SMILES:CC(C)CCOC(=O)c1ccccc1
Specific details on test material used for the study:
- Name of test material (as cited in study report): Isoamyl benzoate (3-methylbutyl benzoate)
- Molecular formula: C12H16O2
- Molecular weight: 192.256 g/mol
- Substance type: Organic
- Physical state: Liquid

In vivo test system

Test animals

Species:
other: Human
Strain:
other:
Remarks:
Not applicable.
Sex:
not specified
Details on test animals and environmental conditions:
No data available.

Study design: in vivo (non-LLNA)

Induction
Route:
other: Topical application
Vehicle:
petrolatum
Concentration / amount:
6%
Challenge
Route:
other: Topical application
Vehicle:
petrolatum
Concentration / amount:
6%
No. of animals per dose:
25 human volunteers
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: No data available.
- Exposure period: No data available.
- Test groups: 25
- Control group: No data available.
- Site: Topical
- Frequency of applications: No data available.
- Duration: No data available.
- Concentrations: 6%in petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: No data available.
- Day(s) of challenge: No data available.
- Exposure period: No data available.
- Test groups: 25
- Control group: No data available.
- Site: Topical
- Concentrations: 6%in petrolatum
- Evaluation (hr after challenge): No data available.

OTHER:
Challenge controls:
No data available.
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: challenge
Group:
test group
Dose level:
6% in Petrolatum
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
No skin sensitization reaction observed.
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

No skin sensitization reaction observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing.
Conclusions:
Skin sensitization potential for 3-methylbutyl benzoate (94-46-2) was observed in human. The 3-methylbutyl benzoate (94-46-2) was considered to be not sensitizing to humans by human maximization test.
Executive summary:

Skin sensitization potential for 3-methylbutyl benzoate (94-46-2) was observed in human by human maximization test. A group of 25 human volunteers were tested by maximization test at a concentration of 6% in petrolatum. No reaction was observed .Therefore, 3-methylbutyl benzoate(94-46-2) was considered to be not sensitizing to humans.