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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:
February 25 - August 10, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
GLP compliance:
yes

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
New-Zealand White hybrid rabbits, vaccinated against myxomatosis (Lyomyxovax N.D. - Rhone Merieux - 17, rue Bourgelat - 69223 Lyon -France)
from :Charles River - Saint Aubin les Elbeuf - 76410 Cleon - France
Husbandry
- Cages : individual housing, in polystyrene cages, with internal dimensions 560 x 355 x 315 mm, with a perforated floor.
- Environment :
Temperature : 20 + 3• C .
. Humidity : 30 to 7o% R.H.
Lighting : a 12-hour light-dark cycle was maintained (photoperiod = 7h30 - 19h30).
Diet and water
- Rabbit complete pelleted maintenance food, ad libitum {U.A.R. formule "112" - U.A.R., Villemoisson Sur Orge - 91360 Epinay Sur Orge - France).
- Softened and filtered drinking water {15 \lm), ad libitum (automatic watering). Bacteriological and chemical controls every six months.
Pretreatment procedures
- Acclimatization period : 19 days at least before the beginning of treatment.
- Clinical examinations : on arrival, then before the beginning of the treatment to keep only healthy animals for the test ; in particular, any rabbit showing ocular lesions will not be used.
- Identification : metal ear tag on arrival in the animal house.
- Allocation to group : animals allocated randomly to group as they came to hand.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
The test article was applied once.
Methods of administration : each animal was immobilised in a
polyethylene restraining box (Iffa Credo - Les Oncins - 69210 L'Arbresle -
France). Using a hundredth graduated sterile polypropylene syringe of 1 ml
the test article was instilled into the inferior conjunctival sac of the
right eye of each of the 6 rabbits, the left eye serving as a control.
1'he lower and upper eyelids were kept in contact for a few seconds to
prevent any loss of the test article.
The animals were restrained for 1 hour to prevent them from scratching
their eyes, then replaced in individual cages after the first observation.
Methods of administration : each animal was immobilised in a polyethylene restraining box (Iffa Credo - Les Oncins - 69210 L'Arbresle - France). Using a hundredth graduated sterile polypropylene syringe of 1 ml the test article was instilled into the inferior conjunctival sac of the right eye of each of the 6 rabbits, the left eye serving as a control.
The lower and upper eyelids were kept in contact for a few seconds to prevent any loss of the test article.
The animals were restrained for 1 hour to prevent them from scratching their eyes, then replaced in individual cages after the first observation.
Observation period (in vivo):
1 h
Number of animals or in vitro replicates:
6 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal: #1-#6
Time point:
other: 1 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
chemosis score
Basis:
animal: #7 with rinsing
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Basis:
animal: #1-#6
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Basis:
animal: #7 with rinsing
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
cornea opacity score
Basis:
animal: #1-#6
Time point:
other: 1 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
cornea opacity score
Basis:
animal: #7 with rinsing
Time point:
other: 1 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritant / corrosive response data:
The ocular examinations were performed in the order of treatment of the animals, 1 hour after administration of the test article.
Taking into account the severity of the lesions observed and in accordance with the Study Monitor, the readings were not continued and the animals were sacrificed.
After a single ocular application followed by a water rinsing carried out 30 seconds later and lasting 30 seconds, the test article PNCL2 provoked at 1 hour severe ocular lesions characterized in particular by absence of secretions, of any reaction to light or to touch, and by severe (but not total) corneal opacity, with ulceration.
Taking into account the severity of the irritation observed, the animal was killed after the reading.
The lesions observed are not very different from those noted during the study performed without rinsing.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
After administration with or without rinsing, the test article provoked severe ocular lesions characterized in particular by absence of secretions, of any reaction to light or to touch, and by corneal opacity with ulceration. The degree of this opacity was less severe with a rinsing (degree 3) than without rinsing (degree 4).
Executive summary:

The test for acute eye irritation/corrosion according to OECD Guideline No. 405 was performed with the test item. The test article was administered as supplied (under the form of a paste), without rinsing and at the dose level of 0.1 ml per animal, into the inferior conjunctival sac of the right eye of 6 New-Zealand White hybrid male rabbits. It was also administered in one single animal at the same dose level with a water rinsing carried out 30 seconds later and lasting 30 seconds.

The ocular examinations were performed, in the conjunctiva, iris and cornea, according to the Draize scale, 1 hour after administration of the test article.

After administration with or without rinsing, the test article provoked severe ocular lesions characterized in particular by absence of secretions, of any reaction to light or to touch, and by corneal opacity with ulceration. The degree of this opacity was less severe with a rinsing (degree 3) than without rinsing (degree 4).

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