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
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