Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: old summary of a study, sufficient for assessment with restrictions (only 1 page long)

Data source

Reference
Reference Type:
publication
Title:
The contact-sensitization potential of fragrance materials by maximization testing in humans
Author:
Kligmann, A.
Year:
1972
Bibliographic source:
Unpublished, submitted to Research Institute for Fragrance Materials, Inc.

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 5
- Sex: male
- Known diseases: none
Ethical approval:
not applicable
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
not specified
Details on exposure:
A patch (containing an unspecified amount of the substance) was applied to normal sites on the backs for 48 hours under occlusion.
Examinations:
The tested skin sites were examined after emoval of the patch.
Medical treatment:
none

Results and discussion

Clinical signs:
none
Results of examinations:
No signs of irritation were found on the volunteers' skin after removal of the patches.
Effectivity of medical treatment:
not applicable
Outcome of incidence:
not applicable

Applicant's summary and conclusion

Conclusions:
After 48 hours under occlusion the test substance did not cause irritations on the back skin of 5 volunteers. Therefore it was concluded that it was not irritating to the skin.
Executive summary:

Ethyl benzoate was applied to the back skin of 5 volunteers. The substance was applied on a patch, the test duration was 48 hours (under occlusion). Afterwards, no signs of irritation were found on the skin. On the basis of these results the substance was considered to be non irritating to the skin.