Sodium 2,5-dichloro-4-[4-[[2-[(ethylphenylamino)sulphonyl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted on 12th May, 1981

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow 061 - Similar Substance 01

IUPAC Name:

Acid Yellow 061 - Similar Substance 01

Test material form:

not specified

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: breeder Interfauna U.K. Ltd.
- Age at study initiation: adult, age not specified.
- Weight at study initiation: 3.0 - 3.6 kg
- Housing: animals were maintained in individual wire cages type III.
- Diet: standard diet "ssniff K 4", ad libitum.
- Water: ad libitum.
- Health status: animals were routinely inspected for health status. The animal facilities were disinfected
by Zephirol (1% in water), twice a week. About 1 day before the administration, the rabbits were examine
d in order to assess the suitability for use.
- Quarantine: 14 days in testing laboratories.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Relative humidity: 45 - 65 %
- Air changes: ca 10 per hr.
- Photoperiod: 12 hrs dark / hrs light.

Test system

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 µl (apparent specific gravity ca 40 mg). After application, the eyelids were held together for about 1 second.

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

Three animals

Details on study design:

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

SCORING SYSTEM
Eye reacrions have been scored according to the Draize scale.

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: 2/3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

iris score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 1

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

2.3

Reversibility:

fully reversible within: 14 dyas

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

slightly irritating

Any other information on results incl. tables

Individual score

Animal N.	Effect	Score after						Mean 24, 48, 72 hrs
		1 h	24 hrs	48 hrs	72 hrs	7 d	14 d
T28	Cornea
	A: opacity	0	1	1	0	0	0	0.7
	B: area involved	0	1	1	0	0	0	-
	Iris	0	0	0	0	0	0	0.0
	Conjunctival
	Redness	3	3	2	2	1	0	2.3
	Chemosis	3	1	0	0	0	0	0.3
	Discharge	2	1	0	1	0	0	-
T76	Cornea
	A: opacity	0	1	1	1	0	0	1.0
	B: area involved	0	3	3	3	0	0	-
	Iris	0	0	0	0	0	0	0.0
	Conjunctival
	Redness	3	3	2	2	0	0	2.3
	Chemosis	3	2	1	0	0	0	1.0
	Discharge	2	0	0	1	0	0	-
T29	Cornea
	A: opacity	0	1	1	1	0	0	1.0
	B: area involved	0	3	3	3	0	0	-
	Iris	0	1	0	0	0	0	0.3
	Conjunctival
	Redness	3	3	2	2	0	0	2.3
	Chemosis	3	2	1	0	0	0	1.0
	Discharge	2	0	0	0	0	0	-

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 (irritating to eyes) based on CLP criteria

Conclusions:

Eye irritant

Executive summary:

A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit. The method followed OECD Guidelines No. 405. A single application 100 µl (apparent specific gravity ca 40 mg) of the test material was administered to eye of three rabbits. Ocular effects were recorded 1, 24, 48 and 72 hours, 7 and 14 days after administration.

Substance resulted slightly irritating.

Conclusion

The mean values from gradings at 24, 48 and 72 hours were equal to 1 for corneal opacity in two animals, lower than 1 for iritis in all rabbits, equal to 2.3 for conjunctival redness and lower than 2 for oedema in all animals.

Therefore, the substance meets the criteria to be classified as eye irritating, category 2 (H319), according to the CLP Regulation (EC 1272/2008).