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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: PK 95/222

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerated

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: Young adult animals
- Housing: Single housing in fully air-conditioned rooms.
- Diet (ad libitum): Kliba-Labordiaet 341 (Klingentakmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day.
- Water (ad libitum): tap water, about 250 mL per animal per day.
- Acclimation period: for at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal.
Amount / concentration applied:
The test patch (2.5 cm x 2.5 cm) was moistened with a dose of 0.5 mL of the unchanged liquid test substance.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Upper third of the back or flanks
- Type of wrap: The test substance was covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, kaiserslautern) and fixomull stretch (adhesive fleece), Beiersdorf AG.

REMOVAL OF TEST SUBSTANCE
- Washing: The substance was removed at the end of the exposure with lutrol and lutrol/water (1:1)

READING TIME POINTS
- at 1, 24, 48 and 72 hours after removal of the dressing.

SCORING SYSTEM
- As recommended by OECD Guideline 404, the Draize scoring system was used.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
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 local effects were observed in any of the treated animals. Therefore, the study was terminated at 72 hours after removal of the patches. Under the test conditions, the test substance did not give indications of an irritant property to the skin.
Other effects:
No clinical symptoms were observed in any of the treated animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met