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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: old study summary, only 1 page long, no test substance concentrations or dose volumes given

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Unpublished, submitted to Research Institute for Fragrance Materials, Inc.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

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
After pre-testing the Maximization Test was conducted according to Journal of Investigative Dermatology 47 (5): 393-409 (1966).
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl benzoate
EC Number:
202-284-3
EC Name:
Ethyl benzoate
Cas Number:
93-89-0
Molecular formula:
C9H10O2
IUPAC Name:
ethyl benzoate

Method

Type of population:
general
Ethical approval:
not applicable
Subjects:
- Number of subjects exposed: 25
- Sex: male
Clinical history:
- Other: no known diseases
Controls:
none
Route of administration:
dermal
Details on study design:
TYPE OF TEST USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Testing/scoring schedule: exposure time testing: patches were applied for five alternate-day 48 hour periods; challenge patches were applied after a 10 day rest period, exposure time challenge patch: 48 h
- Removal of test substance: no

EXAMINATIONS
- Grading/Scoring system: no data

Results and discussion

Results of examinations:
There were no signs of contact sensitization found on the skin of the volunteers.

Applicant's summary and conclusion

Conclusions:
As no skin reactions were observed, the Maximization test results did not indicate a sensitizing effect of the test substance to the skin.
Executive summary:

A Maximization Test was conducted on 25 male humans to determine the contact sensitizing potential of ethyl benzoate. The test substance was applied under occlusion to the volar forearms for five alternate-day 48 hour periods. The patch sites were pretreated for 24 hours with 5 % aqueous sodium lauryl sulfate under occlusion. Following a ten-day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one-hour applications of 10 % aqueous sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter. As no skin reactions were observed, the Maximization test results did not indicate a sensitizing effect of the test substance to the skin.