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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
Study period:
13 Mar - 21 Mar 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: 15 weeks
- Weight at study initiation: male: 2.6 kg, females: 2.7 and 3.0 kg
- Housing: stainless steel cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 40 - 70% rh
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: powder slightly moistened with H2O bidest.
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
1 male, 2 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: 9 cm²
- Type of wrap if used: gauze, elastic bandage

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

OBSERVATION TIME POINTS
1, 24, 48, 72 h after removal

SCORING SYSTEM:
- Method of calculation: Draize system

Results and discussion

In vivo

Results
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No corrosive effects were noted on treated skin at any time.
No erythema score could be derived since the test item caused light red to red staining. Erythema is not assessable on red skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not cause any signs of irritation/corrosion on rabbit skin. Erythema could not be assessed due to red staining of skin caused by the test item. The substance is classifiable according to the CLP Regulation.