Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
Allergic contact dermatitis due to nonylphenol ethoxylate (Nonoxynol-6)
Author:
Nethercott, J.R. and Lawrence, M.J
Year:
1984
Bibliographic source:
Contact Dermatitis, 10, 235-239

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
0, 1.7, 3, 9 and 27% (w/w) NPE6 in propylene glycol and complete Freund's adjuvant (1:1)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Concentration / amount:
0.1 mL
Challengeopen allclose all
Route:
epicutaneous, occlusive
Concentration / amount:
0.1 mL

Results and discussion

Any other information on results incl. tables

A maximization study of NPE6 sensitization was conducted in Hartley-Dalkin guinea pigs. A solution of 0, 1.7, 3, 9 and 27% (w/w) NPE6 in propylene glycol and complete Freund's adjuvant (1:1) was injected into the shoulder at a dose of 0.1 mL. After 7 days, undiluted NPE6 was applied and the application site was occluded for 48 hours for sensitization. After a 21-day interval without application, 2.7% NPE6, which induces no skin irritation, was applied and the application site was occluded for 24 hours to induce irritation, and 48 hours after, skin responses were observed. The positive response rates were 5/40, 2/5, 0/5, 1/4 and 2/5, respectively, and no significant differences were found among NPE6 concentrations. From these results, it is concluded that NPE6 causes no sensitization in guinea pig

Applicant's summary and conclusion