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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:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Three animals were applied 500 µl of the test substance (RESOLIN Rotviolett FBL fl. 3. Umstellung) under semiocclusive conditions for 4 hours. After 4 hours the skin areas were washed with water. After 1, 24, 48, 72 hours and 7 days the skin areas were scored for erythema and edema according to Draize.
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:
The animals were housed in wire cages typ III (high) at a room temperature of 22 ± 2° C and a relative humidity of ca. 50%. The dark/light cycle was 12 hours. The animals received a standard nutrition and water ad libitum.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 µl
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 animals
Details on study design:
One day before the application of the test substance, an area of 6 x 6 cm of the animals was clipped. Only animals with intact skin were used. 500 µl of the test substance was applied under semiocclusive conditions for 4 hours. Afterwards the skin areas were washed with water. After 1, 24, 48, 72 hours and 7 days the skin areas were scored for erythema and edema according to Draize.

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
Reversibility:
other: score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
The test substance was not irritating to the skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The erythema and edema score was 0 at 24, 48 and 72 hours.
Executive summary:

Three animals were applied 500 µl of the test substance (RESOLIN Rotviolett FBL fl. 3. Umstellung) under semiocclusive conditions for 4 hours. After 4 hours the skin areas were washed with water. After 1, 24, 48, 72 hours and 7 days the skin areas were scored for erythema and edema according to Draize. The erythema and edema score was 0 at 24, 48 and 72 hours.

RESOLIN Rotviolett FBL fl. was not irritating to the skin.