Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[(2-cyanoethyl)[2-(2-hydroxyethoxy)ethyl]amino]-1,3,5-triazine-4,2-diyl]imino]]bis[benzene-1,4-disulphonate]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August from the 26th to the 30th, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted on 12 May, 1981

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Optical Brightener 380

IUPAC Name:

Optical Brightener 380

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoering, AG.
- Age at start of treatment: ca. 12 weeks.
- Body weight at start of treatment: 2.3 - 3 kg.
- Diet: pelleted standard Kliba 23/341/1 rabbit maintenance diet, ad libitum.
- Water: tap water, ad libitum.
- Accomodation: individually in stainless steel cage.
- Acclimation period: 4 days.
- Health check: before testing, both eyes of each animal were examined and any animal with eye defect was rejected.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours light/dark.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g/rabbit

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

1 male and 2 females

Details on study design:

SCORING SYSTEM
The eye were examined and the grade of ocular reaction recorded at 1, 24, 48 and 72 hours after treatment.
Draize 1959; Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States.

Corneal opacity
No ulceration or opacity 0
Scattered or diffuse areas, details of iris clearly vsible 1
Easily discernible translucent area, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris not discernible through the opacity 4

Area of cornea affected
No ulceration or opacity 0
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

Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia 1
No reaction to light, haemorrhage, gross destruction 2

Conjuctival redness 
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

Conjunctival oedema (chemosis)
No swelling 0
Any swelling above normal 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4

Discarge
No discharge 0
Any amount different from normal 1
Discharge with moistening of the lids and hairs 2
Discharge with moistening of the lids and hairs, in a considerable area 3

In addition the colouration of sclera/cornea was recorded in connection with the colour of the test compound.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 1

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 1

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Reversibility:

fully reversible within: 72 hrs in 2 out of 3 animals; no information about the 3rd animal because the test was stopped at 72 hrs

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Reversibility:

fully reversible within: 48 hrs

Irritant / corrosive response data:

Under the conditions of the test, the substance was found to cause no irritation when applied to rabbit eye mucosa.
No discolouration of the cornea and conjunctivae which could be related to compound effects was observed.
The primary irritaiton index was found to be 3.3
No corrosion effect was observed at each of the measuring intervals.

Any other information on results incl. tables

Individual reactions

Animal No	Reaction	1 hr	24 hrs	48 hrs	72 hrs	Mean 24/48/72 hrs
374 M	Cornea opacity	0	0	0	0	0.00
375 F	Cornea opacity	0	0	0	0	0.00
376 F	Cornea opacity	0	0	0	0	0.00
374 M	Iris	0	0	0	0	0.00
375 F	Iris	0	0	0	0	0.00
376 F	Iris	0	0	0	0	0.00
374 M	Conjunctival redness	2	1	1	1	1.00
375 F	Conjunctival redness	1	0	0	0	0.00
376 F	Conjunctival redness	2	1	1	0	0.67
374 M	Conjunctival chemosis	1	1	0	0	0.33
375 F	Conjunctival chemosis	1	0	0	0	0.00
376 F	Conjunctival chemosis	1	0	0	0	0.00
374 M	Conjunctival discharge	2	2	0	0	-
375 F	Conjunctival discharge	1	0	0	0
376 F	Conjunctival discharge	1	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to CLP Regulation (EC) No1272/2008

Conclusions:

Not eye irritating

Executive summary:

The eye irritation potential of te test item was assessed in accordance with method and procedures outlined into the OECD guideline 405. 0.1 g of test substance were placed in the rabbit eyes, which were not rinsed. The eye were examined and the grade of ocular reaction recorded at 1, 24, 48 and 72 hours after treatment, according to the Draize system (1959) and in accordance with the Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States criteria.

Under the conditions of the test, the substance was found to cause no irritation when applied to rabbit eye mucosa. No discolouration of the cornea and conjunctivae which could be related to compound effects was observed. The primary irritaiton index was found to be 3.3

No corrosion effect was observed at each of the measuring intervals.

Conclusion

The mean values from grading at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for irtitis, lower than 2 for both conjunctival redness and oedema, in all animals. No corrosion effect was observed at each of the measuring intervals. In one case the recovery of the redness cannot be judged because the test was stopped before; nevertheless, based on the severity of the effect observed and the decrease over the test period, the lacking of this information can be considered as not critical and not impacting the test outcomes conclusion.

Thus, the substance can be considered as non irritating to eye, according to the CLP Regulation (EC) No 1272/2008.