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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
