Reaction mass of sodium 3-[[4-[(4-ethoxy-m-tolyl)azo]-1-naphthyl]azo]benzenesulphonate and sodium 3-[[4-[(4-ethoxyphenyl)azo]-1-naphthyl]azo]benzenesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Remarks:

source of read across

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Principles of method if other than guideline:

Code of Federal Regulation, title 16, Section 1500.42

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: W. Ostrop, Meerbusch.
- Weight at study initiation: 3.2 kg
- Housing: single cages.
- Diet: "mümmel z" (ssniff / Soest), ad libitum.
- Water: ad libitum.
- Acclimation period: 7 - 14 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 16 - 18 °C
- Humidity: 40 %
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 µl of amorphous substance

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

6 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: the eye was not rinsed after the application.

TOOL USED TO ASSESS SCORE: the assessment was performed with the help of an ophthalmoscope. The corneal epithelium was detected with the fluorescein test: installation of 1 drop of fluorescein solution in ophthalmological preparation directly on the cornea. After rinsing with a physiological solution of hydrochloric acid, horny yellow-green appears. UV light or cobalt blue filter.

SCORING SYSTEM
The eyes were examined and the grade of ocular reaction was recorded at 24, 48, 72 hours and 8 days.
The ocular reactions were scored by the method described by "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" FDA, 1959.

Mean Draize score
0 - 10 non-irritant
11 - 25 slightly irritant
26 - 56 moderately irritant
57 - 110 severe irritant

CORNEA:
A Opacity and degree of density (most dense area scored) .
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 x B x 5; Maximum possible score = 80

IRITIS:
A Values
Normal: 0
Folds above normal, congestion, swelling, circumcornea 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 x 5; Maximum possible score = 10

CONJUNCTIVAE:
A Redness (refers to lids 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 cantus of normal animals): 1
Discharge with moistening of 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) x 2; Maximum possible score = 20

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 6/6

Time point:

24/48/72 h

Score:

< 1

Results 2

Irritation parameter:

iris score

Basis:

animal: 6/6

Time point:

24/48/72 h

Score:

< 1

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 6/6

Time point:

24/48/72 h

Score:

< 2

Reversibility:

fully reversible within: 48 hrs

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 6/6

Time point:

24/48/72 h

Score:

< 2

Reversibility:

fully reversible within: 48 hrs

Irritant / corrosive response data:

Primary irritation index: 0.8, thus the substance can be considered as non-irritating.

Any other information on results incl. tables

Reaction	Animal N.	24 hrs	48 hrs	72 hrs	Mean 24/48/72 hrs
Opacity	1	0	0	0	0.00
Opacity	2	0	0	0	0.00
Opacity	3	0	0	0	0.00
Opacity	4	0	0	0	0.00
Opacity	5	0	0	0	0.00
Opacity	6	0	0	0	0.00
Iris	1	0	0	0	0.00
Iris	2	0	0	0	0.00
Iris	3	0	0	0	0.00
Iris	4	0	0	0	0.00
Iris	5	0	0	0	0.00
Iris	6	0	0	0	0.00
Conjunctival Redness	1	1	0	0	0.33
Conjunctival Redness	2	1	0	0	0.33
Conjunctival Redness	3	1	0	0	0.33
Conjunctival Redness	4	1	0	0	0.33
Conjunctival Redness	5	1	0	0	0.33
Conjunctival Redness	6	1	0	0	0.33
Conjunctival Chemosis	1	0	0	0	0.00
Conjunctival Chemosis	2	0	0	0	0.00
Conjunctival Chemosis	3	0	0	0	0.00
Conjunctival Chemosis	4	1	0	0	0.33
Conjunctival Chemosis	5	0	0	0	0.00
Conjunctival Chemosis	6	0	0	0	0.00

Individual reaction scores

Time	24 hrs						48hrs						72 hrs						8 days
Animal N.	1	2	3	4	5	6	1	2	3	4	5	6	1	2	3	4	5	6	1	2	3	4	5	6
Cornea
A. Opacity	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
B. Area	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
a = AxBx5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Iris
Iris (A)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
b = Ax5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Conjuntival
A. Redness	1	1	1	1	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
B. Chemosis	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
C. Discharge	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
c = (A+B+C)x2	2	2	2	4	2	2	0	0	0	0	0	0	0	0	0	0	0	0
a+b+c	2	2	2	4	2	2	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

Non-irritating

Executive summary:

The procedures employed were that prescribed by Code of Federal Regulation, title 16, Section 1500.42. 100 µl of the test article were instilled into one eye of each animal, the other eye remaining untreated, served as a control.

The eyes were examined and the grade of ocular reaction was recorded at 24, 48, 72 hours and 8 days. The ocular reactions were scored by the method described by "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" FDA, 1959.

The orimary irritation index resulted to be 0.8, thus the substance can be considered as non-irritating.

Conclusion

Although the criteria for the evaluation of the eye irritation potential followed in the test are different from those reported into the OECD guideline, the scoring system is hte same. Because the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC) No 1272/2008.

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all the tested animals, thus the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.