Perylene-3,4:9,10-tetracarboxydiimide

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 50% aqueous substance preparation was tested.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Perylene-3,4:9,10-tetracarboxydiimide

EC Number:

201-344-6

EC Name:

Perylene-3,4:9,10-tetracarboxydiimide

Cas Number:

81-33-4

Molecular formula:

C24H10N2O4

IUPAC Name:

7,18-diazaheptacyclo[14.6.2.2²,⁵.0³,¹².0⁴,⁹.0¹³,²³.0²⁰,²⁴]hexacosa-1(23),2,4,9,11,13,15,20(24),21,25-decaene-6,8,17,19-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.

Test animals

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

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

Irritation parameter:

erythema score

Remarks:

intact and abraded skin

Basis:

mean

Time point:

other: 6d and 8 d

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.