1,4-bis(mesitylamino)anthraquinone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP compliant OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-bis(mesitylamino)anthraquinone

EC Number:

204-155-7

EC Name:

1,4-bis(mesitylamino)anthraquinone

Cas Number:

116-75-6

Molecular formula:

C32H30N2O2

IUPAC Name:

1,4-bis(mesitylamino)anthraquinone

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rosemead Rabbits, Waltham Abbey, Essex, U.K.
- Age at study initiation: 12 - 17 weeks
- Weight at study initiation: 2.23 - 2.34 kg
- Housing: individually housed in suspended metal cages
- Diet: Rabbit Diet, Preston Farmers, Limited, New Leake, Boston, Lincolnshire, U.K.) ( ad libitum)
- Water: drinking water (ad libitum)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 60 - 65
- Air changes (per hr): PPROX: !%
- Photoperiod: 12 hrs dark /12 hrs light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

the test material was moistened with distilled water

Controls:

no

Amount / concentration applied:

A quantity of 0.5g of the test material, moistened with 0.5 ml of distilled water

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 (2 females, 1 male)

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm (gauze patch)
- Type of wrap if used: surgical adhesive tape (2.5 cm x 4 cm) additionally fixed with an elastic corset

REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing with cotton wool soaked in diethyl ether.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0; Very slight erythema (barely perceptible) 1; Well-defined erythema 2; Moderate to severe erythema 3;
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema Formation
No oedema 0; Very slight oedema (barely perceptible) 1; Slight oedema (edges of area well-defined by definite raising) 2;
Moderate oedema (raised approximately 1 millimetre) 3; Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean of 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: initial signs of slight irritation were fully reversible within 24 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean of 24, 48, 72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean of 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: Reversibility: no signs of irritation at any time

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean of 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Very slight erythema was noted at all treated skin sites one hour after patch removal, at two treated skin sites at the 24-hour observation and at one treated skin site at the 48-hour observation.

Very slight oedema was noted at two treated skin sites at the 24-hour observation. No other adverse skin reactions were noted.

All treated skin sites appeared normal 72 hours after treatment.

Other effects:

No other effects reported.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the test result, it is concluded thatthe test substance is not irritating to skin.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as Method B.4. in Commission Directive 84/449/EEC.

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. All treated skin sites appeared normal 72 hours after treatment. No corrosive effects were noted.

Based on these findings it is concluded that the test item is not irritating to skin.