Registration Dossier

Toxicological information

Eye irritation

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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

Constituent 1
Chemical structure
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)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-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 (if done): 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.