Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Closed Epicutaneous Test
Author:
M. ISHIHARA et al.
Year:
1986
Bibliographic source:
Hifu 28: 230–240

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl salicylate
EC Number:
204-265-5
EC Name:
Ethyl salicylate
Cas Number:
118-61-6
Molecular formula:
C9H10O3
IUPAC Name:
ethyl 2-hydroxybenzoate
Test material form:
liquid

Method

Type of population:
general
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
Clinical history:
not specified
Route of administration:
dermal
Details on study design:
Induction phase:
- patches applied using 12% of test item

Challenge phase:
- a challenge patch was applied with 12 % of test item

Results and discussion

Results of examinations:
Observations remained negative throughout the test interval.

Applicant's summary and conclusion

Conclusions:
Under the condtions of the study, the test material indicated no potential for dermal irritation or allergic sensitization.
Executive summary:

The cutaneous sensitization potential of the test item has been assessed using maximization test in human, which was developed by Klingman and modified by Klingman and Epstein. 25 subjects received 12% (induction and challenge phase). The test material indicated no potential for dermal irritation or allergic sensitization.