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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:
July 1998 - September 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

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

Test material

Constituent 1
Details on test material:
none

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation:
- Weight at study initiation:
animal #1: 3138 g (at the start); 3155g (at conclusion of the test)
animal #2: 3768g (at the start); 3852 g (at conclusion of the test)
animal #3: 3832g (at the start): 3957g (at conclusion of the test)
- Housing: Cages of stainless stell with bottom grid of oval steel and with tub for faeces, dimenstions of the cages: 50x55x40 cm
Bedding: Altromin Type S8/15, granulated soft wood bedding, Batch 240798
- Diet (ad libitum): Altromin 2123, standard diet for rabbits, Batch 071198/1307
- Water (ad libitum): tap water (municipal supply), Makrolon bottles, changed daily
- Acclimation period: the animals wre housed approx. 4 month before administration to the testing facility

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 50-70%
- Air changes (per hr): air conditioned
- Photoperiod (hrs dark / hrs light): artificial light was set to give a cycle of 12 houer ligth and 12 hours dark; the light phase was from 6.30 a.m. - 6.30 p.m.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
The animals were monitored for general clinical condition continuously on the day of administration and once daily thereafter (in the morning).
The conjunctivae, cornea and iris of the eyes were examined at 1, 24, 48 and 72 hours and from day 4 until day 7 after instillation by means of a hand slit-lamp (Heine Optotechnik).
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed out with distilled water
- Time after start of exposure: 24 hours

SCORING SYSTEM:
see table 1

TOOL USED TO ASSESS SCORE:
hand-slit lamp (Heine Optotechnik)

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 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
1
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:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
3
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 h
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days

Any other information on results incl. tables

In the treated eye a briefly serous lacrimation was observed in all animals one hour after instillation. The control eyes of the animals showed no alterations at any observation time.

The Cornea of the treated eye showed a slight opacity in one animal only one hour after instillation. The iris was not affected.

The conjunctivae of the treated eyes were slightly red in one animal and clearly red in two animals one hour after instillation and clearly red 24 hours after instillation in all three animals. This clear redness continued in all animals until 48 hours after instillation. Then the redness faded in all animals and a redness was not more observed on day 7. One hour after instillation a clear swelling of conjunctivae was observed in two animals and a swelling with lids about half closed was observed in one animal. This swelling faded quickly and 24 hours (in two animals) or 48 hours (in one animal) after instillation a swelling was not more observed. 7 days after instillation no signs of irritation were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is non-irritant to the eye.
Executive summary:

The acute eye irritation/corrosion of the test item was tested in three albino rabbits. The test article was applied at a single dose of 0.1 g to one of the eyes in each animal. The eyes were washed out 24 hours after instillation of the test article using distilled water. The untreated eye was used for control. The animals were examined for clinical signs and the eyes were examined for lesions of the conjunctivae, cornea and iris 60 minutes, 24, 48 and 72 hoursand from day 4 until day 7 after instillation of the test article.

The instillation of the test article caused a clear redness for 48 hours and a briefly clear swelling of the conjunctivae in all 3 animals.

The cornea was only slight affected and the iris was not affected.

No Signs of systemic effects of the test article were observed in the course of testing.