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

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:

1972

Report date:

1972

Materials and methods

Test guideline

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, 72 hours, 4 days and 8 days after application.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

204-905-3

EC Name:

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

Cas Number:

128-69-8

Molecular formula:

C24H8O6

IUPAC Name:

7,18-dioxaheptacyclo[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.

Specific details on test material used for the study:

- Physical state: solid (pellets)

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2,95 and 3,0 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: talcum powder was applied into the left eyes and served as control

Amount / concentration applied:

1x 50 mm³ / 50 mg

Duration of treatment / exposure:

one single application 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).

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

0

Max. score:

4

Remarks on result:

other: minimal effects to the cornea after one hour, reversible within 24 hours

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0.5

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 anf 72 h

Score:

0

Max. score:

4

Remarks on result:

other: minimal chemosis in one animal after 1 hour of instillation, reversible within 24 hours

Irritant / corrosive response data:

1 hour after application, slight reddening, slight taint and slight cloudiness of the eyes, the eyes were also dyed by the substance, after 24 hours the eyes showed still some slight reddening, after 72 hours no signs of irritation were reported. The initial slight signs of irritation were comparable with the effects of the control, talcum powder, in the eyes of rabbits.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions chosen, 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 of the test substance was applied undiluted into the conjunctival sac of the right eye of two rabbits. 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.