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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: 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 peer reviewed journal

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
FRAGRANCE RAW MATERIAL MONOGRAPHS
Author:
D.L.J. Opdyke
Year:
1974
Bibliographic source:
Food and Cosmetics Toxicology,1974
Reference Type:
publication
Title:
A toxicological assessment of aryl alkyl alcohol
Author:
Belsito et al.
Year:
2012
Bibliographic source:
Food and Chemical Toxicology

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To determine the skin irritation potential of test chemical.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
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 butanoate
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report):Benzyl butyrate
- Substance type: Organic
- Physical state:Liquid
-Molecular formula-C11H14O2
-Molecular weight- 178.2296 g/mol

Test animals

Species:
human
Strain:
other: not applicable
Details on test animals or test system and environmental conditions:
Sex: male

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: Petrolatum
Controls:
not specified
Amount / concentration applied:
4%
Duration of treatment / exposure:
48 hours
Observation period:
48 hours
Number of animals:
five adult male patients
Details on study design:
- Area of exposure: Back of humans
- Type of wrap if used: closed occlusive patch

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There was no irritation seen in any subjects.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The test chemical was tested at a concentration of 4 % in petrolatum which produced no irritation in a 48-hr closed-patch test in human subjects.
Executive summary:

Skin irritation study for test chemical was conducted on five adult male patients as in a preliminary study of a maximization test. The test chemical was applied at a 4% concentration under occlusion for 48 h to the back each patients. There was no irritation seen in any subjects. Hence the test chemical considered to be not irritating to the skin of treated subjects.

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