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

Endpoint summary

Description of key information

Skin irritation/corrosion: non-irritating, no guideline/GLP, 0.02 ml of the test substance (filtrate), intracuteanous injection, rabbit, 1967, K2
Eye irritation: non-irritating, no guideline/GLP, 0.1 ml of the test substance (filtrate), rabbit, 1967, K2

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

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

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.

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

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

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: not specified

Remarks on result:

other: not irritating

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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 tested.

Qualifier:

no guideline followed

Principles of method if other than guideline:

eye irritation study

GLP compliance:

no

Species:

rabbit

Strain:

other: yellow-silver breed

Details on test animals or tissues 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

Vehicle:

other: The pigment was digested in 0.9% NaCl solution tor 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.

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amounts applied: 0.1 mL

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:

one single application

Observation period (in vivo):

The animals were monitored for any signs of irritation 1, 3, 7 and 24 hours after application.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: none

Irritation parameter:

other: signs of irritation in the ocular mucous membrane

Basis:

mean

Time point:

24 h

Remarks on result:

other: not irritating

Irritant / corrosive response data:

The undiluted filtrate caused no signs of irritation in the ocular mucous membrane.

Interpretation of results:

GHS criteria not met

Conclusions:

The undiluted filtrate caused no signs of irritation in the ocular mucous membrane.

Executive summary:

The test article 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. The mucous membrane tolerability was tested by introducing 0.1 ml of the undiluted filtrate once into the conjunctival sac of the rabbit's eye. The animals were monitored tor any signs of irritation 1, 3, 7 and 24 hours after application (Hoechst, 1967). No signs of eye irritation were observed. Therefore, the test item was considered to be not irritating to the eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

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 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 (Hoechst, 1967).

 

Eye irritation

The test article 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. The mucous membrane tolerability was tested by introducing 0.1 ml of the undiluted filtrate once into the conjunctival sac of the rabbit's eye. The animals were monitored tor any signs of irritation 1, 3, 7 and 24 hours after application (Hoechst, 1967). No signs of eye irritation were observed. Therefore, the test item was considered to be not irritating to the eyes.

 

Further toxicological data of category members:

Reliable data from several studies on irritation are available for the test article and for other members of the "perylene based pigments" category (see attached category justification). All of these data are taken into account for the evaluation and assessment of the irritation potential of the test article. Studies concerning the irritating potential for skin and eyes are available for all category members. In no study evidence for irritating or corrosive effects of the substances was observed. The category members can therefore all considered as not irritating to the skin and eyes.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Studies for skin and eye irritation are available. In both studies, no signs of irritation were observed. As a result, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.