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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:
1986-01-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:
Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation:
12 to 16 weeks
- Weight at study initiation: 2.10 - 2.54 kg
- Housing:
individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:
min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 19 °C
- Humidity: 50 %
- Air changes: apporx. 15 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:
single administration without rinsing of afterwards
Observation period (in vivo):
Assessment of damage/irritation was made 1 , 24, 48 and 72 hours following treatment
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not performed

SCORING SYSTEM:
according to Draize J.H. , 1959 Association of Food and Drug 0fficials of the United States, Austin' Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No evidence of corneal opacity was noted during the study period. Iridial inflammation was noted in 2/3 treated eyes at the one hour observation only. Conjunctivitis was noted in all treated eyes one hour after treatment. This irritation regressed and all treated eyes were normal 48 hours after treatment.

Any other information on results incl. tables

Table 1 Individual and mean scores for cornea, iris and conjunctivae

 

Animal no

Time after treatment

Cornea

Iris

Conjunctival redness

Conjunctival chemosis

1

1

0

1

2

2

24

0

0

1

0

48

0

0

0

0

72

0

0

0

0

Mean 24, 48, 72 h

0

0

0.3

0

 

2

1

0

1

1

1

24

0

0

1

0

48

0

0

0

0

72

0

0

0

0

Mean 24, 48, 72 h

0

0

0.3

0

 

3

1

0

0

1

1

24

0

0

1

0

48

0

0

0

0

72

0

0

0

0

Mean 24, 48, 72 h

0

0

0.3

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the test item is not considered to be eye irritating.
Executive summary:

The study was performed in order to assess irritancy potential of a test material following a single application to the rabbit eye. The study was designed to comply with the recommendations of the OECD Guidelines for Testing Chemicals (1981) No. 405 "Acute Eye Irritation /Corrosion". Three New Zealand White rabbits were administered 0.1 mL of the unchanged test item in the right eye. The contralateral left eye of the same animal served as negative control. Eyes were examined 1, 24, 48 and 72 h after application and findings were scored according to Draize scoring system. Based on the findings in this study the test item is not considered to be irritating to rabbit eye.