Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 September 1997 - 06 February 1998
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
92/69/EEC
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:
Six male rabbits from Covance Research Products Inc, Kalamazoo, Michigan weighing 2- 2.5 kg (approx. 14 weeks old) on arrival were allowed to acclimatise for 14 days before treatment. 5 animals were assigned to the study.
The animals were housed in individual stainless steel ventilated hanging cages. 100 -130g Certified High Fibre Rabbit Chow was provided each day and water ad libitum. The temperature was maintained at 67 - 70°F. The animal room was on a 12 hour daily light cycle.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other: right eye of each animal was untreated
Amount / concentration applied:
53mg (which, when gently compacted, occupied approx.0.1ml)
Duration of treatment / exposure:
53mg test material was instilled into the lower everted lid of the left eye. The material was placed in the conjuctival sac of the left eye after gently pulling the lower eye lid away from the eyeball. The upper and lower eyelid were held closed for about one or two second after treatment to prevent loose of material and then released. The right eye was left untreated to serve as the control.
Observation period (in vivo):
After the 24hr observation period the eyes of all rabbits were washed with lukewarm water.
All animals were observed daily forsurvival and general body condition.
Evaluations made at 1, 24, 48, 72 hrs and days 4, 7, 14 and 21 after treatments.
Number of animals or in vitro replicates:
5 male rabbits
Details on study design:
Prior to treatment the eyes were checked by a veterinarian.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: na
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: max irritation observed
Score:
> 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: na
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: na
Score:
>= 2 - <= 4
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: na
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: na
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
21 d
Score:
ca. 1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
21 d
Score:
ca. 1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
21 d
Score:
ca. 1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
21 d
Score:
ca. 1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
21 d
Score:
ca. 1
Max. score:
1
Reversibility:
not specified
Irritant / corrosive response data:
The maximum irritation grades observed in the treated eye of rabbits in this study were: corneal opacity (grades 1 or 2), involving at least ¾ of the cornea was observed in the treated eye of 3 rabbits; iritis (grade 1), in 1 of the above 3 rabbits; conjunctival redness (grades 2 or 3), conjunctival chemosis (grades 2, 3 or 4) and conjuctival discharge (grades 2 or 3).
Signs of irritation were completely reversible by 72 hrs after initial instillation in two rabbits and by day 7 in a third rabbit.
Corneal opacity (grade 1), conjunctival chemosis (grade 1) and conjunctival discharge (grade 1) were observed in the eye of the remaining 2 rabbits on day 21. In addition, grade 1 conjunctival redness wase noted in one of the same two rabbits on day 21.

Any other information on results incl. tables

Body weights ranged from 2.2 to 2.6kg on the day of treatment. No apparent treatment-related body weight changes were observed during the observation period following treatment.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
Abbott-164220 produced irritation in the treated eye of rabbits in this study.
Executive summary:

Abbott-164220 produced irritation in the eye of rabbits in this study.