Perylene-3,4:9,10-tetracarboxydiimide

Eye irritation

Administrative data

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

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 405 (Acute Eye 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 / tissue source

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

Test system

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)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.8

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.