Registration Dossier
Registration Dossier
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EC number: 434-850-2 | CAS number: 1680-31-5
Exposure related observations in humans: other data
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:
- 2 000
- 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
- Guideline:
- other: COLIPA guideline
- GLP compliance:
- yes
- Remarks:
- GCP Compliance
Test material
Constituent 1
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
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