1-hydroxy-4-(p-toluidino)anthraquinone

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:

1983

Report date:

1983

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 mg of the test substance 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:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-hydroxy-4-(p-toluidino)anthraquinone

EC Number:

201-353-5

EC Name:

1-hydroxy-4-(p-toluidino)anthraquinone

Cas Number:

81-48-1

Molecular formula:

C21H15NO3

IUPAC Name:

1-hydroxy-4-[(4-methylphenyl)amino]-9,10-anthraquinone

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three male rabbits with an average weight of 3.5 kg were used. The animals were housed in single cages at a room temperature of 19 - 25° C and a relative humidity of 40 - 60 %. The dark/light cycle was 12 hours. The animals received a standard nutrition and tap water ad libitum.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

500 mg

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 mg 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:

Erythema and edema score was = 0 at any time point (24/48/72 hours).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

1-Hydroxy-4-(p-toluidino)anthraquinone is not irritating. Erythema and edema score was = 0 at any time point (24/48/72 hours).

Executive summary:

Three animals were applied 500 mg of the test substance 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. 1-Hydroxy-4-(p-toluidino)anthraquinone is not irritating. Erythema and edema score was = 0 at any time point (24/48/72 hours).