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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test item: Levodione
CAS number: 21800-83-9
Batch number: 242027N
Physical state: Solid, crystalline powder
Colour: White
Storage: At a temperature of 15 to 30 °C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species and strain: New Zealand white rabbit
Source: S&K LAP Kft.
Hygienic level during the study: good conventional
Number of animal: 3 males
Age of animals: adult rabbits, 11 weeks old
Body weight range at the beginning of the study: 2366 - 3178 g
Body weight range at the end of the study: 2370 - 3284 g
Acclimatisation time: 7 days in first animal, 8 days in second animal and 9 days in third animal
Animal health: Only animals in acceptable health condition were used for the test.

Housing: Animals were housed individually in metal cage.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20 ± 3 °C
Relative humidity: 30-70 %
Ventilation: 10-15 air exchanges/hour by central air-condition system

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye served as control.
Amount / concentration applied:
0.1 g of the finely grounded test item was used for the study, as a single dose.
Duration of treatment / exposure:
The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours after the application.
Number of animals or in vitro replicates:
3 male
Details on study design:
In the first step an initial test was performed using one animal. The test item was placed into the conjunctival sac of the left eye. The eyelids were held closed gently for about one second to prevent any loss of the test item. The contralateral eye served as control.
In the initial test slight irritant effect was observed 24 hours after treatment. The confirmatory test was conducted using a second animal. Slight irritant effect was observed in second animal 24 hours after treatment. The confirmatory test was conducted using a third animal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
0.33
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Remarks:
(conjunctival oedemea)
Basis:
mean
Time point:
24/48/72 h
Score:
0 - 0.33
Max. score:
0.33
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
conjunctival discharge
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Treated and control eyes were examined at 1, 24, 48 and 72 hours after the application.
One hour after treatment some hyperemic blood vessels (score 1) of the conjunctivae were observed in all animals. The swelling of the conjunctivae was different from normal (score 1) in one animal. The amount of discharge was different from normal (score 1) in same animal. The obvious swelling with partial eversion of lids (score 2) of the conjunctivae was detected in two animals. Discharge with moistening of the lids and hairs just adjacent to lids (score 2) of the conjunctivae was recorded in one animal. Discharge of the conjunctivae moistened lids and hairs on considerable area around the treated eye (score 3) were found in one animal.
24 hours after treatment some hyperemic blood vessels (score 1) of the conjunctivae were observed in all animals. The swelling of the conjunctivae was different from normal (score 1) in two animals.
48 hours after treatment all animals became free of symptoms.
72 hours after treatment all animals were free of symptoms.

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
In conclusion, test item levodione (CAS 21800-83-9) applied to the rabbits' eye mucosa caused slight to severe conjunctival irritant effects which were fully reversible within 48 hours. The test item can be classified into GHS category 2B.