Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
The Freund’s Complete Adjuvant Test and the Open Epicutaneous Test
Author:
Klecak, G.
Year:
1985
Bibliographic source:
Current Problems in Dermatology

Materials and methods

Principles of method if other than guideline:
In an open epicutaneous test in 6–8 guinea pigs, 0.1 ml of 100, 30, 10, 3, 1, or 0.3% 1,1-dimethyl-2-phenylethyl acetate was applied daily for 3 weeks with the site uncovered. Suitable vehicles were suggested as ethanol, acetone, water, petrolatum, and/or PEG. Following induction, the animals were challenged on days 21 and 35 with 0.025 ml of 4% 1,1-dimethyl-2-phenylethyl acetate. The sites were scored 24, 48 and 72 h after exposure.
GLP compliance:
not specified
Type of study:
open epicutaneous test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Results and discussion

In vitro / in chemico

Results
Remarks on result:
no indication of skin sensitisation
Remarks:
A challenge concentration of 4% 1,1-dimethyl-2-phenylethyl acetate did not cause any reactions. 1,1-Dimethyl-2-phenylethyl acetate was not sensitizing to guinea pigs

Applicant's summary and conclusion