Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD 405. GLP study.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Pale yellow powder
- Analytical purity: 99.04%
- Lot/batch No.: 5/87; Indent 9200/9622
- Storage condition of test material: Following its arrival in Compound Control this test substance was stored in the dark at ambient temperature.
- Stability: Infra-red spectra of the test substance were taken. There were no significant differences between the spectra and so, on this basis, the test substance was judged to have been stable for the duration of this study.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Sittingbourne Research Centre Breeding unit
- Age at study initiation: 4-9 months old
- Weight at study initiation: males: 3872-4184 g; females: 3276-4806 g
- Housing: Animals were singly housed in hanging, stainless-steel cages with all-mesh floors and tops and half-mesh fronts; each cage measured 67 cm x 43 cm x 45 cm.
- Diet (e.g. ad libitum): Standard Rabbit Diet, S.Q.C., Special Diet Services Ltd., Essex, ad libitum.
- Water (e.g. ad libitum): Filtered from the public supply , ad libitum.
- Acclimation period: At least, two weeks.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19 ºC
- Humidity (%): Not documented.
- Air changes (per hr): Not documented.
- Photoperiod (hrs dark / hrs light): Lighting was automatically switched on for the day (06.00 to 18.00 hours GMT) and off for the night (18.00 to 06.00 hours GMT).


Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg
Duration of treatment / exposure:
The eyes were not washed.
Observation period (in vivo):
A visual assessment of eye irritancy was made at 1, 4, 24, 48 and 72 hours and 7 days after instillation.
Number of animals or in vitro replicates:
Three per sex
Details on study design:
SCORING SYSTEM: Irritancy was scored for the cornea, iris and conjunctivae using the standard scores included in the study report.


TOOL USED TO ASSESS SCORE: At 24 hours and in the event of any corneal damage visualization was aided by the instillation of one drop of 2% fluorescein solution.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
other: Conjunctivae redness
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Irritant / corrosive response data:
The instillation of the test substance powder into the conjunctival sac of one eye of each of six rabbits resulted in slight initial pain. The only occular effect was slight conjunctival redness in all rabbits within 1 hour of dosing which had cleared by 24 hours.

Any other information on results incl. tables

Table 7.3.2: Mean eye irritation scores

Redness

Chemosis

Discharge

Opacity

Iris

24 hours

0

0

0

0

0

48 hours

0

0

0

0

0

72 hours

0

0

0

0

0

7 days

0

0

0

0

0

Mean score

24-72 h

0.0

0.0

0.0

0.0

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the rabbit eye irritancy test, the test material caused slight conjunctival redness within 1 hour of dosing which had cleared by 24 hours. The test material is therefore not an eye irritant in rabbits.
Executive summary:

The test material (25 mg) was applied to the eyes of six New Zealand White rabbits (3 per sex). A visual assessment of eye irritancy was made at 1, 4, 24, 48 and 72 hours and 7 days after instillation. The test material caused slight conjunctival redness within 1 hour of dosing which had cleared by 24 hours.