Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Adult albino rabbits, Hra:(NZW)SPF
- Source:Hazleton Research Products, Inc., Denver PA
- Weight at study initiation: 2032 - 2116 g
- Housing: individually in screen-bottom cages,
- husbandry and housing: addording to "Guide for the Care and Use of Laboratory Animals" (NIH Publication No. 86-23 (revised 1985)).
- Diet (e.g. ad libitum): measured, High Fiber Rabbit Chow® 5326, Purina Mills, Inc.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Temperature (°C): 18.9-23.3
- Humidity (%):48 to 55

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0,5 g test material (moistened with 0,9% saline)

VEHICLE
- Concentration (if solution): 0,9% saline
Duration of treatment / exposure:
4 hours
Observation period:
30 minutes = 4 hours; 24, 48, and 72 hours after patch removal
Number of animals:
6 (3 male, 3 female)
Details on study design:
TEST SITE
- Area of exposure: 2,5 cm x 2,5 cm
- Type of wrap if used: gauze patch secured with paper tape, loosely overwrapped with Saran Wrap® and secured with Elastoplast® tape to provide a
semiocclusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure: 4 h

SCORING SYSTEM:according to the Draize technique (Draize, J.H. 1975)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
over 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
over 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
no erythema, no edema observed

Applicant's summary and conclusion

Interpretation of results:
other: not irritant