Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only 7 days of observation
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Lix 860 N I
- Physical state: brown viscous liqid
- Analytical purity: ca. 90% (ca. 84 % AS+ ca. 5 % Nonylphenol + ca. 1 % Etheraldehyde) based on similar test material
- Solvent: ca. 10 % Kerosene based on similar test material.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: LSR Industries, Union Grove, WI
no further information

ENVIRONMENTAL CONDITIONS : no data

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: second eye served as negative control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with 0.9% Saline
- Time after start of exposure: 24 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 4 d
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
7 d
Score:
2
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 4 d
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
7 d
Score:
1
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 4 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
7 d
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 4 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
7 d
Score:
3
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 4 d
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 4 d
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 4 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
7 d
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 h
Score:
3
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 4 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
7 d
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 4 d
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 4 d
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 4 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
7 d
Score:
2
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle seen
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 4 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
7 d
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 1 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24 h
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
48 h
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
72 h
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 4 d
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
7 d
Score:
2
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 1 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 4 d
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
7 d
Score:
1
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 1 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
48 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 4 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
7 d
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 1 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
48 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
72 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 4 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
7 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 4 d
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: 1 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: 4 d
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 1 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
48 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 4 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
7 d
Score:
2
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 1 h
Score:
3
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
48 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
72 h
Score:
4
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 4 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
7 d
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 4 d
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
7 d
Score:
1
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: 1 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #6
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #6
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: 4 d
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #6
Time point:
7 d
Score:
1
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 1 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
48 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 4 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
7 d
Score:
2
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 1 h
Score:
3
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
48 h
Score:
4
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
72 h
Score:
4
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 4 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
7 d
Score:
2
Max. score:
4
Remarks on result:
other: vesicle formation

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Conclusions:
Based on the results of a study according to OECD Test Guideline 405, the test substance is considered as severly irritating to the eye (applying the evaluation system of the EU regulation 1272/2008).
Executive summary:

The eye irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 405.

The amount of 0.1 ml of the substance was applied unchanged for 24 hours to the eyes of six New Zealand White rabbits, which were observed for 7 days post application. Over the first three days, clear effects (cornea, iris, conjunctivae and chemosis) were observed, which did not fully reverse within 7 days.

Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered as severely eye irritating as at the end of the observation period effects still persisted.