Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Does not meet criteria of today standard methods. No official test guideline has been developed for this test; the reliability of the result can therefore not be judged.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1960
Report date:
1960

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to guideline
Guideline:
other: method of Shelanski and Shelanski (Proceedings of the Toilet Goods Association, Number 10, May 1953).
Principles of method if other than guideline:
50 volunteeers were treated repeatedly with insult patches containing a 5% suspension of the test substance in corn oil.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Etocrilene
EC Number:
226-029-0
EC Name:
Etocrilene
Cas Number:
5232-99-5
Molecular formula:
C18H15NO2
IUPAC Name:
etocrilene

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 50
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Vehicle / solvent: corn oil
- Concentrations: 5%

Results and discussion

Results of examinations:
None of the fifty subjects reacted to any of the 15 applications or to the challenge application.

Applicant's summary and conclusion

Conclusions:
From the results obtained, in this study on the fifty subjects used, the test article, tested as a 5% w/v solution in corn oil, was found to be neither a primary irritant nor a fatiguing agent to any of the subjects tested. This material did not produce sensitization in any of the subjects tested.