1,4-diamino-2,3-diphenoxyanthraquinone

Skin irritation / corrosion

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

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

Test material information

Constituent 1

Reference substance name:

1,4-diamino-2,3-diphenoxyanthraquinone

EC Number:

229-066-0

EC Name:

1,4-diamino-2,3-diphenoxyanthraquinone

Cas Number:

6408-72-6

Molecular formula:

C26H18N2O4

IUPAC Name:

1,4-diamino-2,3-diphenoxyanthraquinone

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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

Results

Results 1

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

Results 2

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

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.