Perylene-3,4:9,10-tetracarboxydiimide

Endpoint summary

Description of key information

Skin irritation/corrosion: non-irritating, similar to OECD TG 404, non-GLP, test substance in water (50 %), occlusive, rabbit, 1978, K2
Eye irritation: non-irritating, similar to OECD TG 405, non-GLP, 0.1 ml 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)

GLP compliance:

no

Species:

rabbit

Strain:

other: Weißer Wiener

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: average weight 3.0 kg

Type of coverage:

occlusive

Preparation of test site:

other: intact and damaged skin

Vehicle:

water

Controls:

no

Amount / concentration applied:

The test substance was given as a 50% aqueous preparation. The amount applied is not specified.

Duration of treatment / exposure:

not specified

Observation period:

8 days

Number of animals:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: on the first day after instillation

Irritation parameter:

erythema score

Remarks:

intact and abraded skin

Basis:

mean

Time point:

24 h

Remarks on result:

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

Irritation parameter:

erythema score

Remarks:

intact and abraded skin

Basis:

mean

Time point:

48 h

Remarks on result:

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

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Remarks on result:

other: except for animal #1 (score 0), reactions could not be scored due to coloration of the skin

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

mean

Time point:

72 h

Remarks on result:

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

Irritation parameter:

erythema score

Remarks:

intact and abraded skin

Basis:

mean

Time point:

other: 6d and 8 d

Score:

0

Max. score:

4

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Remarks:

damaged skin

Basis:

mean

Time point:

24/48/72 h

Score:

0.55

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

The test item was found to have no irritation potential, however the exact determination of erythema scores at 24, 48 and 72 hours (except animal #1 intact skin) was not possible due to coloring by 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). The test item was found to cause no irritation when applied to intact rabbit skin.

Summary of results:

Score	Skin Type	Timepoint	Animal 1	Animal 2	Animal 3
Erythema Score	Intact skin	24h	#	#	#
		48h	#	#	#
		72h	0	#	#
		6 days	0	0	0
		8 days	0	0	0
	Scarified Skin	24h	#	#	#
		48h	#	#	#
		72h	#	#	#
		6 days	0	0	0
		8 days	0	0	0
Edema Score	Intact skin	24h	0	0	0
		48h	0	0	0
		72h	0	0	0
		6 days	0	0	0
		8 days	0	0	0
	Scarified Skin	24h	1	0	2
		48h	1	0	1
		72h	0	0	0
		6 days	0	0	0
		8 days	0	0	0

# Score not readable due to coloring by the test substance

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance did not induce adverse effects to the skin and thus, was found to be not irritating to skin.

Executive summary:

In a skin irritation study similar to OECD guideline 404, the test substance was applied to the skin of 3 rabbits as a 50% aqueous preparation (amount applied not specified) and observed for 8 days. Application caused no edema to intact skin, but formation of edema (in one animal a score of 1 and in one animal a score of 2) was observed when applied to damaged skin 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 substance 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)

GLP compliance:

no

Species:

rabbit

Strain:

other: Weißer Wiener

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: average weight 2.8 kg

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
The substance was applied undiluted
- Amount(s) applied (volume or weight with unit): 100 µl test material

Duration of treatment / exposure:

single application, no washing was performed

Observation period (in vivo):

24 hours, 48 hours and 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

TOOL USED TO ASSESS SCORE: fluorescein (last observation day)

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:

0.8

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 redness of the conjunctivae observed in 2/3 animals, reversible after 72 hours. One animal still showed redness on day 3 (the last day of observation), which is expected to be reversible upon longer observation.

Details on results:

Score	Timepoint	Animal 1		Animal 2		Animal 3
		Test substance	Talcum (control)	Test substance	Talcum (control)	Test substance	Talcum (control)
Conjunctiva Score	1 h	1	2	2	2	2	2
	24 h	1	1	1	1	1	1
	48 h	1	1	1	1	1	0
	72 h	0	1	0	0	1	0
Chemosis Score	1 h	1	0	1	0	0	1
	24 h	0	0	0	0	0	0
	48 h	0	0	0	0	0	0
	72 h	0	0	0	0	0	0
Iris Score	1 h	0	0	0	0	0	0
	24 h	0	0	0	0	0	0
	48 h	0	0	0	0	0	0
	72 h	0	0	0	0	0	0
Cornea Score	1 h	0	0	0	0	0	0
	24 h	0	0	0	0	0	0
	48 h	0	0	0	0	0	0
	72 h	0	0	0	0	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

In an eye irritation study similar to OECD guideline 405, 100 µl of the test article was applied to the eyes of three rabbits. Animals were observed after 24, 48 and 72 hours and 8 days 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 0.8 which decreased from day 3 onwards. As a result, the test item was considered to be not irritating to the 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 skin irritation study similar to OECD guideline 404, the test substance was applied to the skin of 3 rabbits as a 50% aqueous preparation (amount applied not specified) and observed for 8 days (BASF AG, 1978). Application caused no edema to intact skin, but formation of edema (in one animal a score of 1 and in one animal a score of 2) was observed when applied to damaged skin 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 substance was judged to be not irritating to the skin.

In a supporting skin irritation study comparable to OECD guideline 404, 50 µl of the test substance (50% aqueous preparation) was applied to the skin of rabbits for 20 hours (using 2 animals) under occlusive conditions and observed for 8 days (BASF AG, 1976). Determination of erythema was not possible at 24 hours, due to substance induced purple coloration of the skin. No effects (erythema and edema) were reported after 8 days. The test substance was therefore regarded as not irritating to the skin.

 

Eye irritation

In an eye irritation study similar to OECD guideline 405 (BASG, 1978), 100 µl of the test article was applied to the eyes of three rabbits. Animals were observed after 24, 48 and 72 hours and 8 days 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 0.8 which decreased from day 3 onwards. As a result, the test item was considered to be not irritating to the eye.

In a supporting eye irritation study (BASF, 1976), 50 µl of the test article was instilled into the conjunctival sac of one eye in a total of two animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account. The substance caused mild reactions of the conjunctiva, the mean irritation scores (24 and 72 h) for chemosis and redness were 0.25 and 1, respectively. These effects were reversible within 7 days, except for the redness in one animal (reversibility is expected after longer observation). The irritation observed caused by the test substance was not clearly different from the control substance talcum powder. The assessment of the substance based on the results of this study is not irritating.

 

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 GLP-compliant OECD 404 study is available for skin irritation. A GLP-compliant OECD 405 study 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.