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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:
Sep 1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.42
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-ethyl-2-[1,2,3,4-tetrahydro-1-(2-hydroxyethyl)-2,2,4-trimethyl-6-quinolyl]benz[cd]indolium chloride
EC Number:
264-497-8
EC Name:
1-ethyl-2-[1,2,3,4-tetrahydro-1-(2-hydroxyethyl)-2,2,4-trimethyl-6-quinolyl]benz[cd]indolium chloride
Cas Number:
63817-45-8
Molecular formula:
C27H31N2O.Cl
IUPAC Name:
2-ethyl-3-[1-(2-hydroxyethyl)-2,2,4-trimethyl-1,2,3,4-tetrahydroquinolin-6-yl]-2-azatricyclo[6.3.1.0^{4,12}]dodeca-1(11),2,4(12),5,7,9-hexaen-2-ium chloride
Test material form:
solid
Details on test material:
Basic Blue 147 Cl

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: W. Ostrop, Meerbusch, Germany
- Weight at study initiation: average 2.4 kg
- Housing: individually
- Diet (e.g. ad libitum): "mümmel z" ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: 7d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18°C
- Humidity (%): 40%
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL of the test substance
Duration of treatment / exposure:
1 treatment at 0 h
Observation period (in vivo):
1, 24, 48, 72 h and 8 d
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein after 24 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1; 2; 4; 5; 6
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
probability of severe irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
probability of moderate irritation
Irritation parameter:
iris score
Basis:
animal: 1;4;5
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Remarks on result:
probability of moderate irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 d
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Max. score:
3
Remarks on result:
not determinable
Remarks:
test item caused strong corrosive effects that do not allow to determine redness
Irritation parameter:
chemosis score
Basis:
animal: all animals
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
probability of severe irritation
Irritant / corrosive response data:
Strong corrosive effects visible on cornea and iris. Significant edema observed. Not reversible within observation period.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test substance was found to be corrosive to rabbit eyes under the conditions of the test. The substance is classified as Category 1 according to CLP criteria.