2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Only a filtrate was used.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test for skin tolerability was carried out using the Barail test by intracutaneous injection. In a further test the undiluted aqueous filtrate was applied 5 times in 5 days in a quantity of 0.5 ml each time to the depilated and intact flank skin of rabbits.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

EC Number:

225-590-9

EC Name:

2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

Cas Number:

4948-15-6

Molecular formula:

C40H26N2O4

IUPAC Name:

2,9-bis(3,5-dimethylphenyl)isoquino[4',5',6':6,5,10]anthra[2,1,9-def]isoquinoline-1,3,8,10(2H,9H)-tetrone

Details on test material:

Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Specific details on test material used for the study:

Technically pure substance
The pigment was digested in 0.9% NaCl solution tor 1 hour at 40 ºC in a heating cabinet. The solution was then filtered off and the aqueous filtrate obtained.

Test animals

Species:

rabbit

Strain:

other: yellow-silver breed

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: animals were kept in individual cages
- Diet (e.g. ad libitum): ALTROMIN K, manufactured by Altromin GmbH in Lage/Lippe
- Water (e.g. ad libitum): tap water

Test system

Type of coverage:

occlusive

Preparation of test site:

other: depilated and intact skin

Vehicle:

physiological saline

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amounts applied: 0.5 mL
- Concentration applied: 2.5 g in 25 mL NaCl solution.

VEHICLE
- Concentration (if solution): pigment was digested in 0.9% NaCl solution for 1 hour at 40 ºC in a heating cabinet, the amount being 2.5 g in 25 ml NaCl solution. The solution was then filtered off and the aqueous filtrate obtained.

Duration of treatment / exposure:

applied 5 times in 5 days

Observation period:

No data

Number of animals:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: none

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: not specified

Remarks on result:

other: not irritating

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: not specified

Remarks on result:

other: not irritating

Irritant / corrosive response data:

All the injections were tolerated without reaction. No signs of irritation were observed after dermal application.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

All the injections were tolerated without reaction. No signs of irritation were observed after dermal application.

Executive summary:

To test the skin and mucous membrane tolerability the test substance was digested in 0.9% NaCl solution for 1 hour at 40°C in a heating cabinet, the amount being 2.5 g in 25 ml NaCl solution. The solution was then filtered off and the aqueous filtrate obtained. Three rabbits of the yellow-silver breed were used as the experimental animals in each test. The test for skin tolerability was carried out using the Barail test by intracutaneous injection of in each case 0.02 ml of the undiluted filtrate or the filtrate diluted 1:10, 1:100 or 1:1000 into the depilated flank skin. 0.02 ml of 0.9% NaCl solution was injected for control purposes. All the injections were well tolerated without reaction. In a further test the undiluted aqueous filtrate was applied 5 times in 5 days in a quantity of 0.5 ml each time to the depilated and intact flank skin of rabbits. No signs of irritation were observed. Based on these results, the substance was considered to be not irritating.