Registration Dossier

Toxicological information

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:
2006
Report Date:
2006

Materials and methods

Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

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