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
Study period:
July 5th, 1983 - July 8th, 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
but QAU statement included

Test material

Constituent 1
Chemical structure
Reference substance name:
2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
EC Number:
226-866-1
EC Name:
2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
Cas Number:
5521-31-3
Molecular formula:
C26H14N2O4
IUPAC Name:
7,18-dimethyl-7,18-diazaheptacyclo[14.6.2.2²,⁵.0³,¹².0⁴,⁹.0¹³,²³.0²⁰,²⁴]hexacosa-1(22),2,4,9,11,13(23),14,16(24),20,25-decaene-6,8,17,19-tetrone
Details on test material:
- Physical state: solid (powder)
- Storage condition of test material: in the dark at room temperature
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:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG breed
- Weight at study initiation: 3.5 - 3.9 kg
- Housing: individually
- Diet (e.g. ad libitum): Altromin 2013 breedingdiat - rabbit (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): fully conditioned room
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
other: polyethylenglycol 400
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg in 0.01 mL polyethylenglycol 400
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with physiological NaCl solution of 37 °C (0.01%)
- Time after start of exposure: 24 hours

SCORING SYSTEM: According to OECD test guideline

TOOL USED TO ASSESS SCORE: magnifier, fluorescein solution (0.01%) and UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: fluorescent test
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: after 1 h of exposure the iris was brownish colored in two of the animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No signs of irritation were observed for the iris and the cornea at 24-72h timepoints. After 1 h of exposure the iris was brownish colored in two of the animals. A moderate (grade 1) redness and swelling of the conjunctival sac was observed after 1 h of exposure which both decreased gradually. No swelling was observed from 24 hours onwards and no redness was observed at 72 hours.

Any other information on results incl. tables

overview of results:

Animal 1 Animal 2 Animal 3
cornea 1 h 0 0 0
24 h 0 0 0
48 h 0 0 0
72 h 0 0 0
redness 1 h 1 1 1
24 h 1 1 0
48 h 1 0 0
72 h 0 0 0
chemosis 1 h 1 0 1
24 h 0 0 0
48 h 0 0 0
72 h 0 0 0
Iris 1 h 0 0 0
24 h 0 0 0
48 h 0 0 0
72 h 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was investigated for its potential to be irritant to eyes. All effects observed were fully reversible within 72 h and thus, it was concluded that the test substance is not irritating to eyes.