Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Currently viewing:

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Type of study / information:
The test substance was investigated for skin irritation in 20 healthy volunteers in an 24 hour occlusive patch test at a concentration of 1 % active
substance.
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Duhring-Kammer-Test method
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dehyquart AU 56
- Physical state: white paste
- Lot/batch No.: 3174133
- Expiration date of the lot/batch: 1994-01-23

Method

Details on study design:
The Duhring-Kammer-Test is an occlusive, epicutaneous test system, to determin skin irritation in human volunteers.
Scoring was performed according to the method of Kligman and Frosch (Contact Dermatitis 5, 1979, 73 - 81)

The test substance was investigated with the Duhring Kammer Test method according to the publication of Kligman and Frosch (Contact Dermatitis 5, 1979, 73 -81) for skin irritation in 20 healthy volunteers in a 24 hour occlusive patch test at a concentration of 1 % active substance.
70 µL of the test substance was applied via large finn chambers (12 mm Ø) on scanpor plaster to the back of the volunteers. Irritating effects were scored 6, 24, 48 and 72 hours after removal of patches.
Reference substances were aqua demin., phys. NaCl, cosmetic alcohol, SDS 0.5 % a.i. and Texapone N25 1.0 % a.i.

Details on exposure:
TYPE OF EXPOSURE: Large Finn Chambers (diameter 12 mm) on Scanpor plaster were placed on the back of the panalists.
EXPOSURE LEVELS: 10 % a.i.; 70 µL/ patch
EXPOSURE PERIOD: 24 hours
POSTEXPOSURE PERIOD: Scoring after 6, 24, 48 and 72 hours
DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: 20 healthy male and female volunteers (aged 20 to 56 years)

Results and discussion

Results:
In none of the 20 panelists a positive reaction for erythema, oedema, scaling or fissuring was observed for the test substance.

Applicant's summary and conclusion