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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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: diiodohydroxyquinoline
- Molecular formula: C9H5I2NO
- Molecular weight: 396.95
- Substance type: organic
- Physical state: solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Age : 10 to 12 weeks
Sex : Female
Body weight range : 1.80kg ±200g
No. of animals : Three
Acclimatization : The rabbit was acclimatized to standard laboratory condition for 24 hours in experimental room before study.
Environmental conditions : Air conditioned room with 10-15 air changes per hour, temperature between 22-250C, relative humidity 40-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.

Test system

Vehicle:
water
Amount / concentration applied:
A dose of 0.1gm of test substance was applied into the one eye of the rabbits. The other eye, which remains untreated, serves as a control
Duration of treatment / exposure:
21 days
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours after test substance application. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. After recording the observations at 24 hours, the eyes were further examined with the aid of fluorescein. Individual animal weight before and during the study was also observed
Number of animals or in vitro replicates:
No. of animals : Three
Details on study design:
Two healthy rabbits of body weight 1.80 kg ±200 gm was selected for study after acclimatization. Both eyes of rabbits were examined for any abnormal discharge such as eye irritation, ocular defects or pre-existing corneal injury from eye 24 hours prior to application of test compound.
Test compound Diiodohydroxyquinoline was applied in the amount of 0.1 g in the conjunctival sac of rabbit after gently pulling the lower lid away from the eyeball. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hours after the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animals were observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp.

Results and discussion

In vivo

Results
Irritation parameter:
other: MMAS(Modified Maximum Average Draizes Test Score)
Basis:
mean
Time point:
21 d
Score:
0
Reversibility:
not specified
Remarks on result:
other: not specified
Irritant / corrosive response data:
The test compound Diiodohydroxyquinoline applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm did not produce any clinical signs of eye irritation. Furthermore, any lesions such as pannus, staining were not recorded throughout the observation period
Other effects:
The test compound Diiodohydroxyquinoline applied in conjunctival sac of rabbits did not show any observable clinical signs such as cage side activity and pain or stress etc. throughout the observation period of 21 days.

Any other information on results incl. tables

TABLE- 1     GRADING OF OCULAR LESIONS

 

S.NO/

SEX

 

OBSERVATION

Score

Total

Total Score

1/F

 

1 hour

24hours

48 hours

72 hours

Cornea

A.       Opacity-Degree of Density

0

0

0

0

0

0×0×5=0

B.       Area of Cornea Involved

0

0

0

0

0

Iris

A.       Values

0

0

0

0

0

0

Conjunctivae

A.       Redness

0

0

0

0

0

0+0+0×5=00

B.       Chemosis

0

0

0

0

0

C.       Discharge 

0

0

0

0

0

2/F

Cornea

A.       Opacity-Degree of Density

0

0

0

0

0

0×0×5=0

B.       Area of Cornea Involved

0

0

0

0

0

Iris

A.       Values

0

0

0

0

0

0

Conjunctivae

A.       Redness

0

0

0

0

0

0+0+0×5=00

B.       Chemosis

0

0

0

0

0

C.       Discharge 

0

0

0

0

0

3/F

Cornea

A.       Opacity-Degree of Density

0

0

0

0

0

0×0×5=0

B.       Area of Cornea Involved

0

0

0

0

0

Iris

A.       Values

0

0

0

0

0

0

Conjunctivae

A.       Redness

0

0

0

0

0

0+0+0×5=00

B.       Chemosis

0

0

0

0

0

C.       Discharge 

0

0

0

0

0

Grand total

00

Mean

0.00

Eye Irritation Scoring index

0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
MMAS(Modified Maximum Average Draizes Test Score) for Diiodohydroxyquinoline was found to be 0. From this it can be concluded that the test compound Diiodohydroxyquinoline is non-irritating when applied in the amount of 0.1 g in the conjunctival sac of the rabbits under test condition
Executive summary:

MMAS(Modified Maximum Average Draizes Test Score) for Diiodohydroxyquinoline was found to be 0. From this it can be concluded that the test compound Diiodohydroxyquinoline is non-irritating when applied in the amount of 0.1 g in the conjunctival sac of the rabbits under test condition