2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

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

Remarks:

only a filtrate was tested.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

eye irritation study

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

EC Number:

225-590-9

EC Name:

2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone

Cas Number:

4948-15-6

Molecular formula:

C40H26N2O4

IUPAC Name:

2,9-bis(3,5-dimethylphenyl)isoquino[4',5',6':6,5,10]anthra[2,1,9-def]isoquinoline-1,3,8,10(2H,9H)-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: yellow-silver breed

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: animals were kept in individual cages
- Diet (e.g. ad libitum): ALTROMIN K, manufactured by Altromin GmbH in Lage/Lippe
- Water (e.g. ad libitum): tap water

Test system

Vehicle:

other: The pigment was digested in 0.9% NaCl solution tor 1 hour at 40 ºC in a heating cabinet, the amount being 2.5 g in 25 mL NaCl solution. The solution was then filtered off and the aqueous filtrate obtained.

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amounts applied: 0.1 mL

VEHICLE
- Concentration (if solution): pigment was digested in 0.9% NaCl solution for 1 hour at 40 ºC in a heating cabinet, the amount being 2.5 g in 25 ml NaCl solution. The solution was then filtered off and the aqueous filtrate obtained.

Duration of treatment / exposure:

one single application

Observation period (in vivo):

The animals were monitored for any signs of irritation 1, 3, 7 and 24 hours after application.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: none

Results and discussion

In vivo

Results

Irritation parameter:

other: signs of irritation in the ocular mucous membrane

Basis:

mean

Time point:

24 h

Remarks on result:

other: not irritating

Irritant / corrosive response data:

The undiluted filtrate caused no signs of irritation in the ocular mucous membrane.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The undiluted filtrate caused no signs of irritation in the ocular mucous membrane.

Executive summary:

The test article was digested in 0.9% NaCl solution for 1 hour at 40°C in a heating cabinet, the amount being 2.5 g in 25 ml NaCl solution. The solution was then filtered off and the aqueous filtrate obtained. The mucous membrane tolerability was tested by introducing 0.1 ml of the undiluted filtrate once into the conjunctival sac of the rabbit's eye. The animals were monitored tor any signs of irritation 1, 3, 7 and 24 hours after application (Hoechst, 1967). No signs of eye irritation were observed. Therefore, the test item was considered to be not irritating to the eyes.