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:
supporting study
Study period:
2000-05-08 to 2000-05-12
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Type of study / information:
Skin irritation (human study): 24 h patch test
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
according to
Guideline:
other: COLIPA guideline
GLP compliance:
yes
Remarks:
GCP Compliance

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
- Number of subjects exposed: 20 volunteer
- Sex: female and male
- Age: not age-restricted
- Race: caucasian
- Other: volunteers represent population with average, normal skin
Exposure assessment:
not specified
Details on exposure:
TYPE OF EXPOSURE: dermal (patch test: epicutaneous test)

EXPOSURE PERIOD: 24 h

ADMINISTRATION
- Type of application: occlusive
- Part of the body: back
- Description of patch: Finn Chamber on Scanpor, 12 mm
- Vehicle / solvent: eutanol, ethanol
- Concentrations:
Cetiol CC CB906900001 test concentration: 10 % in eutanol G 16, pH: 6.0;
Cetiol CC CB906900001, test concentration: 20 % in ethanol, pH: 8.86.

POSTEXPOSURE PERIOD:
- 6, 24, 48 and 72 h after removal of test substance

EXAMINATIONS
- Grading/Scoring system: according to P.J. Frosch, A.M. Kligman, J. Am. Acad. Dermatol. 1, 1989, 35-41.

Results and discussion

Results:
SYMPTOMS:
Cetiol CC (10 % PV) induced light erythema.
Cetiol CC (20 % PV) caused light erythema and light flaking.

Concerning the parameters erythem and flaking the comparison of the test substance with the standard tenside (Texapon N28) showed that Cetiol CC (10 % PV) has a significant better skin compatibility.
Concerning the parameters erythema the sum-weighted scoring system refered to the standard tenside Texapon 28 could show that Cetiol CC (10 % PV) has 3.3 % and Cetiol CC (20 % PV) has 6.7 %.

The reference substance Texapon N28 (1 % AS) caused light and medium erythema, light oedema and light and medium flaking.
The control substance aqua demin. induced slight flaking.

Applicant's summary and conclusion