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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
During June of 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study run to a method comparable with current guidelines and to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch No.: 19101-164-1
Purity: not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.79 to 2.96 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a dose (18.8 mg) equivalent to a volume of 0.1 mL
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
2 males, 1 female
Details on study design:
A dose of 18.8 mg (the amount of compound equivalent to a volume of 0.1 mL) of the test substance was instilled into the conjunctivasl sac of the left of each the three rabbits (2 males, 1 female); the right eye of each animal served as an untreated control. The eyes were not rinsed after dosing.
All animals were observed 3 days. on the day of dosing (day 1), the eyes were evaluated wuth minimal manipulation and without the use of fluorescein.
The scoring system used was that of Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: One animal appeared at 1 hour but fully reversible within 24 hours.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
ca. 0.11
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Two animals appeared, one fully reversible within 24 hours, the other one fully reversible within 48 hours.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Two animals appeared at 1 hour but fully reversible within 24 hours.
Irritant / corrosive response data:
Immediately after dosing, each rabbit blinked and rubbed the treated eye; however, none of the rabbits exhibited sign of obvious pain or discomfort. Within 1 hour of dosing, slight circumcorneal reddening was apperent in the treated eye of each rabbit. Slight comjuctival reddening and chemosis was also evident in two of the rabbits, and iritis was apperent in the treated eye of one of these animals. By 6 hours post dose, the ocular changes were subsiding, and at 24 hours, the only changes noted were slight circumcorneal reddening in one rabbit and slight reddening of the conjuctivae in another animal. By 48 hours post dose, the treated eye of each rabbit appeared normal.
Other effects:
All rabbits were asymptomatic throughout the 72-hour test period, and they all gained weight.

Any other information on results incl. tables

Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number

Time after

application

Cornea opacity

Iris

Conjunctivae

Redness

Chemosis

1

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

1

0

0

1

0

0

0

2

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3

1 hour

24 hours

48 hours

72 hours

0

0

0

0

1

0

0

0

1

0

0

0

1

0

0

0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test indicated that the test substance is not an ocular irritant in rabbits because a positive irritating effect was not apperent in any of the treated eyes at 24, 48, or 72 hours post dose.