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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:
other: Study in full compliance with OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lupranol VP 9234
- Physical state: fluid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
sex of the test animals: males and/or females

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:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after patch removal.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): carefully washed with water

EXPOSURE PROCEDURE:
Due to a possible irritant potential of the test substance, in the first step only one animal was used and three patches were applied simultaneous. The first patch then was removed after three minutes. If no serious skin reactions were observed, the second patch was removed after one hour. If again no serious skin reactions were observed, the exposure was allowed to extend to four hours. Testing was then completed using two additional animals exposed for four hours.


SCORING SYSTEM: Draize; any serious lesions or toxic effects other than dermal irritation were also recorded and fully described.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 - #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: after 1h: score 1
Irritation parameter:
edema score
Basis:
animal: #1 - #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Other effects:
no other cutaneous reactions were observed.

Applicant's summary and conclusion

Executive summary:

An acute dermal irritation/corrosion test (OECD 404) was performed and no irritant effects were observed at any time point.