Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No GLP defined. Cross reactivity with other substance investigated.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1990

Materials and methods

Principles of method if other than guideline:
Method: other: In a skin sensitisation study in 4 human volunteers, 1 % benzylamine in vaseline was applied to the back, covered with a plaster. The exposition time was 24 h and the reading took place after 24, 48 and 72 h post exposure. 4 Patients with allergic contact dermatitis due to m-Xylylene diamine revealed allergic cross reactions to benzylamine.
GLP compliance:
no
Type of study:
other: epicutaneous test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Benzylamine

In vivo test system

Test animals

Species:
human
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: epicutaneous, covered with a plaster (no further information)
Vehicle:
no data
Concentration / amount:
no data
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
no data
No. of animals per dose:
4 humans

Results and discussion

Any other information on results incl. tables

Four patients with allergic contact dermatitis due to m-Xylylene diamine revealed allergic cross reactions to benzylamine.

Applicant's summary and conclusion