2,9-bis[4-(phenylazo)phenyl]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, similar to OECD TG 404, non-GLP, the test substance in water (50 %), rabbit, 1978, K2
Eye irritation: non-irritating, similar to OECD TG 405, non-GLP, 100 µl of the test substance, rabbit, 1978, 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 50% aqueous substance preparation was tested.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

A 50% aqueous preparation of the substance has been applied on the back and ear of rabbits for 20 hours, observations were reported after 24, 48, 72h and 8 days.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Average weight at study initiation: 2.9 kg

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

50% aqueous preparation

Observation period:

8 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: back of the animals. The skin on the left side of the exposure are was abraded, the right side remained intact.

Irritation parameter:

erythema score

Remarks:

intact and damaged skin

Basis:

mean

Time point:

24 h

Remarks on result:

other: could not be scored due to coloration of the skin from the pigment

Irritation parameter:

erythema score

Remarks:

intact and damaged skin

Basis:

mean

Time point:

48 h

Remarks on result:

other: 48 h time point not evaluated

Irritation parameter:

erythema score

Remarks:

intact and damaged skin

Basis:

mean

Time point:

72 h

Remarks on result:

other: could not be scored due to coloration of the skin from the pigment

Irritation parameter:

erythema score

Remarks:

intact and damaged skin

Basis:

mean

Time point:

other: 8 d

Score:

0

Max. score:

4

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

48 h

Remarks on result:

other: 48h time point not evaluated

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Remarks:

damaged skin

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Remarks:

damaged skin

Basis:

mean

Time point:

48 h

Remarks on result:

other: 48h time point not evaluated

Irritation parameter:

edema score

Remarks:

damaged skin

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The test item was found to have no irritation potential, however the erythema reactions could not be scored due to coloring effects of the test substance. Erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Foi. Cosm. Tox. 13, 355, 1975). Mild edema reactions (score = 1) were reported in all animals at the 24 hours observation time point, abraded skin only. This effect reverted back to normal after 72 hours. On the eighth day the staining effect had cleared; all animals were free of any irritation signs. The test item was found to cause no irritation when applied to intact rabbit skin.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was found to have no irritation potential.

Executive summary:

The test substance was applied to the skin of rabbits as a 50% aqueous preparation (amount applied not specified) in an irritation study, comparable to OECD guideline 404 (using 6 animals) and observed for 8 days. Application caused no edema to intact skin, but forming of edema (mean score of 1) was observed at the damaged skin after 24 hours which was fully reversible within 72 hours. Determination of erythema was not possible at 24 and 72 hours, due to substance induced coloration of the skin. At day 8 no erythema was observed. The test article was judged to be not irritating to the skin.

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

other: Federal Register 38, No. 187, 1500.42, S. 27019 vom 27.09.73

Principles of method if other than guideline:

The substance is applied in the eye of the rabbit undiluted. Observations are recorded 1 hour, 24 hours, 48 hours, 72 hours after application.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: average weight 3.46 kg

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

undiluted, 100 µl

Duration of treatment / exposure:

one single application without washing was performed

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.4

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Minimal erythema reactions were reported (maximum score = 1), reversible within 72 hours. One hour after instillation discharge was reported in all animals and in 2/6 rabbits edema formation was observed. These effects were reversible within the first 24 hours.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was concluded not to be irritating to the eye.

Executive summary:

100 µl of the test substance was applied to the eyes of 6 rabbits in an eye irritation study comparable to OECD guideline 405. The animals were observed after 24, 48 and 72 hours after the treatment. The cornea, iris and chemosis scores were 0 at time points 24, 48 and 72 hours. The application caused a mean (24, 48 and 72 hours) conjunctivae redness score of 0.4 which was reversible within 72 hours. The test article was determined to be not irritating to the rabbit eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

The test substance was applied to the skin of rabbits as a 50% aqueous preparation (amount applied not specified) in an irritation study, comparable to OECD guideline 404 (using 6 animals) and observed for 8 days (BASF, 1978). Application caused no edema to intact skin but forming of edema (mean score of 1) was observed at the damaged skin after 24 hours which was fully reversible within 72 hours. Determination of erythema was not possible at 24 and 72 hours, due to substance induced coloration of the skin. At day 8 no erythema was observed. The test article was judged to be not irritating to the skin.

In a supporting irritation study comparable to OECD guideline 404, the test article (80% aqueous preparation, amount applied not specified) was applied to the back and ear of two rabbits for 20 hours under occlusive conditions and observed for 8 days (BASF, 1966). Determination of erythema was not possible at 24 hours, due to substance induced coloration of the skin. No effects (erythema and edema) were reported after 8 days. The test item was judged to be not irritating to the skin.

 

Eye irritation

100 µl of the test substance was applied to the eyes of 6 rabbits in an eye irritation study comparable to OECD guideline 405 (BASF, 1978). The animals were observed after 24, 48 and 72 hours after the treatment. The cornea, iris and chemosis scores were 0 at time points 24, 48 and 72 hours. The application caused a mean (24, 48 and 72 hours) conjunctivae redness score of 0.4 which was reversible within 72 hours. The test article was determined to be not irritating to the rabbit eye.

In a supporting irritation study comparable to OECD guideline 405, the test substance (50 µl) was applied to the conjunctival sac of the right eyes of two rabbits (BASF, 1966). The left eyes were treated with talcum powder and served as controls. The substance was not washed out. Animals were observed 1 and 24 hours and after 8 days after the treatment. After 1 and 24 hours remaining substance was observed. The application caused slight redness of the conjunctivae and slight chemosis at 1 hour (scores of 2 for both parameters). Both redness of the conjunctivae and chemosis was fully reversible within 24 hours. The initial irritation response was similar to that caused by the control substance talcum powder. Based on the results of this study, the test substance was considered to be not irritating to the eye.

 

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. A non-GLP study similar to OECD 404 is available for skin irritation. A non-GLP study similar to OECD 405 is available for eye irritation. In both studies, the scores for the test item treated tissues were below the thresholds for classification as an irritant. 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.