Reaction mass of 2,2'-(vinylenedi-p-phenylene)bis[5-methylbenzoxazole] and 2,2'-(vinylenedi-p- phenylene)bisbenzoxazole and 2-[4-[2-[4-(benzoxazol-2- yl)phenyl]vinyl]phenyl]-5-methylbenzoxazole

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January from 12 to 15, 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FDA guideline, federal register 38, No. 187, 27.9.1973, p 27019

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fluorescent Brightener 219

IUPAC Name:

Fluorescent Brightener 219

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 15 - 19 kg
- Housing: single cage.
- Diet. standard diet (ERKA 8300), ad libitum.
- Water: ad libitum.

Test system

Vehicle:

other: polyethyene glycol 400

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg of the substance powder-form (mixed with 0.25 ml of polyethyene glycol 400)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6 rabbits

Details on study design:

APPLICATION
- Treatment: test compound was instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second.

REMOVAL OF TEST SUBSTANCE
- Washing: physiological saline.
- Time after start of exposure: 24 hours.

TOOL USED TO ASSESS SCORE: magnifying glass and at 48 and 72 hours after additional installation of a drop of flurescein sodium in the dilution 1: 10000, i.e. 0.01%

SCORING SYSTEM
According to the FDA guideline, federal register 38, No. 187, 27.9.1973, p 27019.
The assessment was perfromed after 1, 7, 24, 48 and 72 hours after application.

Cornea
A Opacity-degree of density (area most dense taken for reading)
No opacity 0
Scattered or diffuse area, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris invisible 4

B Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4

A × B × 5 Total maximum = 80

Iris
A Values
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2

A × 5 Total maximum = 10

Conjunctivae

A Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

B Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids about half closed to completely closed 4

C Discharge
No discharge 0
Any amount different From normal (does not include small amounts observed in inner cunthas of normal animals) 1
Discharge with moistening oi the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, and considerable area around the eye 3

(A + B + C) × 2 Total maximum = 20

To determine the irritation index, the scores of the cornea (a), the iris (b) and the conjunctiva (c) were added for each rabbit at the respective reading time. From the values of all rabbits the mean value was formed at the respective reading time. The highest index determined at one of the readings was used for the classification according to the following verbal evaluation classes:
0 - 10 non irritant
11 - 25 slightly irritant
26 - 56 moderately irritant
57 - 110 severely irritant

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Remarks:

score reasonably expected < 1

Results 2

Irritation parameter:

iris score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Remarks:

score reasonably expected < 1

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Remarks:

score reasonably expected < 2

Results 4

Irritation parameter:

chemosis score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Remarks:

score reasonably expected < 2

Irritant / corrosive response data:

The highest irritation index was 10 after 1 hour.

Applicant's summary and conclusion

Interpretation of results:

other: non irritant

Conclusions:

Non irritant

Executive summary:

The test substance eye irritation potential was assayed in 6 rabbits. The test was carried out in accordance with FDA guideline, federal register 38, No. 187, 27.9.1973, p 27019. 100 mg of the substance powder-form (mixed with 0.25 ml of polyethyene glycol 400) were instilled into the conjunctival sac of the eye. After 24 hours, eyes were rinsed with physiological saline. The rabbits were examined at 1, 7, 24, 48 and 72 hours after application of the test compound.

The highest irritation index resulted to be 10 after 1 hour, thus substance can be considered as not eye irritating.

Conclusion

Non irritant