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:
weight of evidence
Study period:
11 to 20 November 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
9 animals used.
Principles of method if other than guideline:
9 animals used (6 non rinsed, 3 rinsed).
GLP compliance:
no
Remarks:
Not-GLP but QA statement included.

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.
EC Number:
603-094-7
Cas Number:
125904-11-2
Molecular formula:
C8 H6 Br2
IUPAC Name:
Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Clerco Reasearch Farm, Cincinnati, Ohio, USA
- Age at study initiation: young adults
- Weight at study initiation: 1.85 to 3.65 kg
- Housing: individually in steel wire-bottomed cages suspended above cage board that was changed 3 times a week
- Diet: Purina Certified Rabbit Chow 5322 ad libitum
- Water: ad libitum
-Acclimation period: 10 to 32 days
ENVIRONMENTAL CONDITIONS
Animals were maintained in a temperature and humidity controlled room with 12-hour light/dark cycles
IN-LIFE DATES: from 11 to 20 November 1982

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
20-30 seconds for the 3 animals in which eyes were rinsed
Observation period (in vivo):
10 days
Duration of post- treatment incubation (in vitro):
Not applicable
Number of animals or in vitro replicates:
9 (6 non rinsed, 3 rinsed).
Details on study design:
Grading for irritation and injury were made at 24, 48 and 72 hours and 4, 7 and 10 days, using the standard scoring system of Draize. Fluorescein examinations were used to facilitate evaluation of potential corneal damage. The maximum score at any examination is 110 points. Classification is given on the basis of the primary eye irritation index (worst value obtained at each time point).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
11
Max. score:
110
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: non-rinsed group
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
10.67
Max. score:
110
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 4 Days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 4 Days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 4 Days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 4 Days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 4 Days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 4 Days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 4 Days
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 4 Days
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 4 Days
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 4 Days
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: 4 Days
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: 4 Days
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #4
Time point:
7 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #5
Time point:
7 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #6
Time point:
7 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #1
Time point:
10 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #2
Time point:
10 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #3
Time point:
10 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #4
Time point:
10 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #5
Time point:
10 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
iris score
Basis:
animal #6
Time point:
10 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 4 Days
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 4 Days
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 4 Days
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 4 Days
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 4 Days
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 4 Days
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
7 d
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
other: 4 Days
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
other: 4 Days
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
other: 4 Days
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #4
Time point:
other: 4 Days
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #5
Time point:
other: 4 Days
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #6
Time point:
other: 4 Days
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
chemosis score
Remarks:
Redness
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #4
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #5
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #6
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #4
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #5
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #6
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 4 Days
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Time point:
other: 4 Days
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Time point:
other: 4 Days
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #4
Time point:
other: 4 Days
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #5
Time point:
other: 4 Days
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #6
Time point:
other: 4 Days
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #4
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #5
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #6
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #4
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #5
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #6
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Not rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 4 Days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 4 Days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 4 Days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 4 Days
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 4 Days
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 4 Days
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
iris score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
iris score
Basis:
animal #1
Time point:
10 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
iris score
Basis:
animal #2
Time point:
10 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed
Irritation parameter:
iris score
Basis:
animal #3
Time point:
10 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Rinsed group
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Rinsed group
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Rinsed group
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 4 Days
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Rinsed group
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 4 Days
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Rinsed group
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 4 Days
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Rinsed group
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Rinsed group
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
10 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
other: 4 Days
Score:
2
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
other: 4 Days
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
other: 4 Days
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
7 d
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Time point:
other: 4 Days
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Time point:
other: 4 Days
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Time point:
other: 4 Days
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Time point:
10 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Rinsed group
Irritant / corrosive response data:
Mildly irritating
Other effects:
Thick white discharge, alopecia in area around eye and eschar fromation in area under eye with gradual exfoliation were also observed.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: US EPA pesticides
Conclusions:
Mildly irritating
Executive summary:

In a primary eye irritation study, 0.1 mL of the test substance were applied to the right eye of each of 9 rabbits. The left eye remained untreated and served as control. 20 to 30 seconds after instillation the treated eyes of 3 rabbits were rinsed for 1 minute with two 60cc syringes filled with lukewarm distilled water.

Based on maximal primary eye irritation indexes of 11 and 10.67, respectively, for the unrinsed and rinsed group, the test substance was classified as mildly irritating to the eye.