Perylene-3,4:9,10-tetracarboxylic dianhydride

Endpoint summary

Description of key information

Skin irritation/corrosion: non-irritating, compareable to OECD TG 404, non-GLP, application of test substance in water (50%), rabbit, 1976, K2

Eye irritation: non-irritating, compareable to OECD TG 405, non-GLP, 50 mg of the test substance, rabbit, 1972, 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 mixture has been applied on the back of rabbits for 20 hours, observations were reported after 24, 48, 72 hours and after 6 and 8 days.

GLP compliance:

no

Specific details on test material used for the study:

- Physical state: solid

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2,49 kg and 2,84 kg

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

water

Controls:

no

Amount / concentration applied:

- Concentration (if solution): 50% aqueous preparation

Duration of treatment / exposure:

20 hours

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2,5 x 2,5 cm on the backs
- Substance was applied with a cotton tissue soaked with the test article.

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lukewarm tap water
- Time after start of exposure: 20 h after application

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 8 d

Score:

0

Max. score:

4

Remarks on result:

other: Until day 6 scoring for erythema was not possible due to the skin coloring.

Irritant / corrosive response data:

The test article did not cause apparent dermal reactions, however the exact determination of erythema scores at 24, 48 and 72 hours was not possible due to coloring by the test substance. Remaining colored test substance was observed until day 8. No edema was reported at all time point. From the 6 days observation time point, no erythema were reported. Erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Foi. Cosm. Tox. 13, 355, 1975). 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 substance was found to be not irritating to skin.

Executive summary:

In a non-GLP study according to a method comparable to OECD guideline 404, the test substance was applied as moistened powder (50% in water) for 20 hours to the rabbit skin on the back. Remaining colored test substance was observed at both observation time points (24 hours and 8 days). No edema was reported at the 24 hours observation time point. At this time point, scoring for erythema was not possible (due to skin coloring). At the 8 days observation time point, no edema and erythema were reported. The test 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:

supporting 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)

Deviations:

not specified

Principles of method if other than guideline:

The substance is applied in the eye of the rabbit undiluted (1x 50 mm3 / 50 mg). Observations are recorded 1 hour, 24 hours, 48 hours, 5, 7 and 8 days after application.

GLP compliance:

no

Specific details on test material used for the study:

- Physical state: solid

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2,71 and 2,46 kg

Vehicle:

unchanged (no vehicle)

Controls:

other: talcum powder applied into the left eye served es control.

Amount / concentration applied:

1x 50 mm^3 / 50 mg

Duration of treatment / exposure:

one single appliaction into the right eye

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

The substance is applied in the right eye of the rabbit undiluted (1x 50 mm3 / 50 mg).

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

0.5

Max. score:

3

Reversibility:

fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

1 hour after application, slight reddening of the conjunctivae and secretion was observed. These effects reverted back to normal within one day in animal number 1. In the second animal, the reddening also reversed to normal after one day, but reappeared on day 2 and persisted until day 7. On day 8 both animals were free of any irritational signs. The eyes were also dyed dark red by the substance. The initial slight signs of irritation were comparable with the effects of the control, talcum powder, in the eyes of rabbits. However the effects of talcum powder in rabbit eyes were becoming stronger after 24 hours, while the effects of the substance have disappeared. After 8 days also the effects of the talcum powder have disappeared.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was found not to be irritating to eyes.

Executive summary:

In a non-GLP study according to a method comparable to OECD guideline 405, 50 mg the test substance was applied undiluted into the right eye of two rabbits. The left eyes were treated with talcum powder and served as control. One hour after application, slight reddening and secretion were reported. These effects were reversible within 24 hours. The eyes were also dyed dark red by the substance. The control eyes showed redness of the conjunctivae and slight edema, the redness was still present at the 24 hour time point and completely resolved after 8 days. The substance was considered 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

In a non-GLP study according to a method comparable to OECD guideline 404, the test substance was applied as moistened powder (50% in water) for 20 hours to the rabbit skin on the back (BASF, 1976). Remaining colored test substance was observed at both observation time points (24 hours and 8 days). No edema was reported at the 24 hours observation time point. At this time point, scoring for erythema was not possible (due to skin coloring). At the 8 days observation time point, no edema and erythema were reported. The test substance was considered to be not irritating.

In a supporting non-GLP study according to a method comparable to OECD guideline 404, the test substance was applied as moistened powder (50% in water) for 20 hours to the back and the ear of two rabbits (BASF, 1972). At the observation time points 24 hours and 8 days, red/brown remains of the substance on the skin were observed, but no irritative/corrosive response. The test substance was found to be not irritating.

 

Eye irritation

In a non-GLP study according to a method comparable to OECD guideline 405, 50 mg of the test substance was applied undiluted into the conjunctival sac of the right eye of two rabbits (BASF, 1972). The left eyes were treated with talcum powder and served as controls. One hour after application, slight erythema, slight edema and slight cloudiness of the cornea were observed. The eyes were also dyed by the substance. After 24 hours the eyes showed still some slight reddening, after 8 days no signs of irritation were reported. The initial slight signs of irritation were comparable with the effects of the control. The test article was considered to be not irritating to the rabbit eyes.

In a supporting non-GLP study according to a method comparable to OECD guideline 405, 50 mg the test substance was applied undiluted into the right eye of two rabbits (BASF, 1976). The left eyes were treated with talcum powder and served as control. One hour after application, slight reddening and secretion were reported. These effects were reversible within 24 hours. The eyes were also dyed dark red by the substance. The control eyes showed redness of the conjunctivae and slight edema, the redness was still present at the 24 hour time point and completely resolved after 8 days. The substance was considered to be not irritating to the rabbit 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. 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.