Registration Dossier
Registration Dossier
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EC number: 485-390-4 | CAS number: -
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:
- key study
- Study period:
- 2006-10-03 to 2006-10-06
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
Test material
Constituent 1
Method
- Ethical approval:
- not specified
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: a 3/4" x 3/4" absorbent pad portion of an adhesive dressing
- Vehicle / solvent: mineral oil
- Concentrations: 10%, 50%, 100%
- Volume applied: 0.2 mL
- Testing/scoring schedule: patch remained onto the skin for a total of 48 hours. The sites were examined directly after patch removal and re-evaluated after 72 hours.
- Removal of test substance: no data
EXAMINATIONS
- Grading/Scoring system:
0 = No visible skin reaction
+ = Barely perceptible or spotty eithema
1 = Mild erytherna covering most ofthe test site
2 = Moderate erythemra, possible presence ofmild edema
3 = Marked erytherna, possible edema
4 = Severe erythema, possible edema, vesiculation, bullae and/or ulceration
- Statistical analysis: None - Exposure assessment:
- not specified
- Details on exposure:
- TYPE OF EXPOSURE: epidermal, occlusive
TYPE OF EXPOSURE MEASUREMENT: Exposure pads
EXPOSURE LEVELS: 10%, 25%, 50%, 100%
EXPOSURE PERIOD: 48 hours
POSTEXPOSURE PERIOD: 72 hours
DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES:
- Number of subjects exposed: 23
- Sex: 3males, 20 females
- Age: 34 - 78 years old
Results and discussion
- Results:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: No symptoms were observed
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
None of the test persons developed positive, equivocal or irritating reactions
RESULT OF CASE REPORT: The substance is not irritating.
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.
