Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
existing in-vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited report, non GLP. The information in the report is limited to the information in the summary.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FHSLA, CFR, TitIe 21. para . 191. 12.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no details reported

Test system

Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 40%

Duration of treatment / exposure:
NA
Observation period (in vivo):
14 days, scored at 24, 48 and 72 hours and 4, 7 and 14 days after installation
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: not reported

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 1.5
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 1.1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 2.9
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 3.1
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
irritant
Other effects:
Not reported

Any other information on results incl. tables

Animal no

1

2

3

time

24

48

72

4

7

14

24

48

72

4

7

14

24

48

72

4

7

14

cornea

1

1

1

1

1

1

1

1

1

1

1

1

2

2

2

1

1

1

iris

1

1

1

1

1

1

1

1

1

1

1

1

2

1

1

1

1

1

conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

redness

3

3

3

3

3

3

3

3

3

2

2

2

3

3

3

3

3

3

chemosis

3

3

2

2

3

2

4

3

2

2

2

2

4

3

2

2

2

1

discharge

3

3

3

2

2

2

3

3

2

2

2

2

3

3

3

2

2

2

Animal no

4

 

 

 

 

 

5

 

 

 

 

 

6

 

 

 

 

 

time

24

48

72

4

7

14

24

48

72

4

7

14

24

48

72

4

7

14

cornea

2

2

2

1

1

1

2

2

2

2

2

2

1

1

1

1

1

1

iris

2

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

redness

3

3

3

3

3

2

3

3

3

3

3

3

3

3

3

3

3

3

chemosis

4

3

3

2

2

2

4

3

3

2

2

2

3

3

3

3

2

2

discharge

3

3

3

2

2

2

3

3

3

3

2

2

3

3

3

2

2

2

 

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is a severe eye irritant
Executive summary:

The test substance was installed in the eye of 6 rabbits. During the 14 day observation period severe eye irritation is observed. The test substance is considered to be an eye irritant category 1.