Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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
Remarks:
Predates GLP and OECD guidelines, minor restrictions, available as unpublished report

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
No method guideline specified
GLP compliance:
no
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Ethasan

In vivo test system

Test animals

Species:
human

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: Dimethylphtalate
Concentration / amount:
Tested as 50% w/v in Dimethylphtalate
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: Dimethylphtalate
Concentration / amount:
Tested as 50% w/v in Dimethylphtalate
No. of animals per dose:
50 human volunteers

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Skin changes accompanying application No. 1 through 15
Group:
test group
Dose level:
50%
No. with + reactions:
1
Total no. in group:
50
Clinical observations:
Slight erythema
Reading:
other: Challenge
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
50

Applicant's summary and conclusion