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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:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
data is from experimental reports

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)
Principles of method if other than guideline:
To determine the ocular irritation potential of the test chemical in rabbits
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs.
- Substance type: Organic
- Physical state: liquid

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:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
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:
24 hrs
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:
TEST PROCEDURE:
The test compound in the amount of 0.1 ml applied in the conjunctival sac of one eye of each animal after gentle pulling the lower eye lid away from the eye ball. The eye lids were then gently held together for about one second to prevent the loss of the material. The other eyes which remains untreated, served as control.
Irritation:
The eyes of the test animal did not washed for at least 24 hours following instillation of the test compound. At 24 hours a washout may be used if considered appropriate.

Results and discussion

In vivo

Results
Irritation parameter:
other: MMAS(Modified Maximum Average Draizes Test Score)
Basis:
mean
Score:
8.33
Reversibility:
not specified
Remarks on result:
other: not irritating
Irritant / corrosive response data:
The test compound when applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm produce slight redness and mild eye discharge after four hours of application of test compound. However, any lesions such as pannus, staining were not recorded throughout the observation period of 72 hours.

Any other information on results incl. tables

      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

1

0

0

0

1

1+0+1×5=10

B.       Chemosis

0

0

0

0

0

C.       Discharge 

0

1

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

1

0

0

0

1

1+0+0×5=5

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

1

0

0

0

1

1+0+1×5=10

B.       Chemosis

0

0

0

0

0

C.       Discharge 

0

1

0

0

0

Grand total

25

Mean

8.33

Eye Irritation Scoring index

2.08

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The Modified maximum average score (MMAS) of the test chemical was found to be 8.33.
Based on above results, it can be concluded that the test compound was practically non irritant when applied in the amount of 0.1 gm in the conjunctival sac of the New Zealand White rabbits.

Executive summary:

A study was performed to determine the ocular irritation potential of the test chemical in accordance with OECD 405 Guidelines.. 3 female New Zealand White rabbits were used for the study.

The test compound  in the amount of 0.1 ml applied in the conjunctival sac of one eye of each animal after gentle pulling the lower eye lid away from the eye ball.  The eye lids were then gently held together for about one second to prevent the loss of the material.  The other eyes which remains untreated, served as control.

The eyes of the test animal did not washed for at least 24 hours following instillation of the test compound. At 24 hours a washout may be used if considered appropriate. 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

The Modified maximum average score (MMAS) of the test chemical was found to be 8.33.

Based on above results, it can be concluded that the test compound was practically non irritant when applied in the amount of 0.1 gm in the conjunctival sac of the New Zealand White rabbits.