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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to internationally accepted testing guidelines, well documented and the results scientifically acceptable. Some minor details missing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Principles of method if other than guideline:
The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
GLP compliance:
no
Remarks:
Pre GLP.

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium sodium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
EC Number:
275-031-8
EC Name:
Potassium sodium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
Cas Number:
70942-01-7
Molecular formula:
C40H44KN12NaO10S2
IUPAC Name:
potassium sodium 2,2'-ethene-1,2-diylbis[5-({4-anilino-6-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt Sulzfeld, Germany.
- Age at study initiation: adult.
- Weight at study initiation: 1.5 to 2.
- Housing: individually housed in metal cages.
- Diet: ad libitum, standard rabbit food NAFAG, Gossau SG.
- Water: ad libitum.
- Acclimation period: for a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: constant room temperature of 22 ± 1 °C
- Humidity: relative humidity of 55 ± 5 %
- Photoperiod: 10 hrs light cycle day.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
Six animals
Details on study design:
APPLICATION
The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control.

REMOVAL OF TEST SUBSTANCE
- Washing: in 3 of the 6 rabbits the treated eye was flushed with 10 ml of physiological saline.
- Time after start of exposure: approximately 30 seconds after treatment.

SCORING SYSTEM
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

IRIS:
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 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 canthus 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

TOOL USED TO ASSESS SCORE: eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 6/6
Time point:
24/48/72 h
Score:
< 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: rinsed and unrinsed eyes
Irritation parameter:
iris score
Basis:
animal: 6/6
Time point:
24/48/72 h
Score:
< 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: rinsed and unrinsed eyes
Irritation parameter:
conjunctivae score
Basis:
animal: 6/6
Time point:
24/48/72 h
Score:
< 2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: rinsed and unrinsed eyes
Irritation parameter:
chemosis score
Basis:
animal: 6/6
Time point:
24/48/72 h
Score:
< 2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: rinsed and unrinsed eyes
Irritant / corrosive response data:
The primary irritation index in unrinsed eyes was estimated to be 0.
The primary irritation index in rinsed eyes was estimated to be 0.

Any other information on results incl. tables

Rabbit eye irritation scores

Animal Eye Parameter hrs days
24 48 72 4 7

Cornea
1 Rinsed Opacity 0 0 0 0 0
Area involved 0 0 0 0 0
Unrinsed Opacity 0 0 0 0 0
Area involved 0 0 0 0 0
2 Rinsed Opacity 0 0 0 0 0
Area involved 0 0 0 0 0
Unrinsed Opacity 0 0 0 0 0
Area involved 0 0 0 0 0
3 Rinsed Opacity 0 0 0 0 0
Area involved 0 0 0 0 0
Unrinsed Opacity 0 0 0 0 0
Area involved 0 0 0 0 0
4 Rinsed Opacity 0 0 0 0 0
Area involved 0 0 0 0 0
Unrinsed Opacity 0 0 0 0 0
Area involved 0 0 0 0 0
5 Rinsed Opacity 0 0 0 0 0
Area involved 0 0 0 0 0
Unrinsed Opacity 0 0 0 0 0
Area involved 0 0 0 0 0
6 Rinsed Opacity 0 0 0 0 0
Area involved 0 0 0 0 0
Unrinsed Opacity 0 0 0 0 0
Area involved 0 0 0 0 0

Iris
1 Rinsed 0 0 0 0 0
Unrinsed 0 0 0 0 0
2 Rinsed 0 0 0 0 0
Unrinsed 0 0 0 0 0
3 Rinsed 0 0 0 0 0
Unrinsed 0 0 0 0 0
4 Rinsed 0 0 0 0 0
Unrinsed 0 0 0 0 0
5 Rinsed 0 0 0 0 0
Unrinsed 0 0 0 0 0
6 Rinsed 0 0 0 0 0
Unrinsed 0 0 0 0 0

Conjunctiva
1 Rinsed Redness 0 0 0 0 0
Chemosis 0 0 0 0 0
Discharge 0 0 0 0 0
Unrinsed Redness 0 0 0 0 0
Chemosis 0 0 0 0 0
Discharge 0 0 0 0 0
2 Rinsed Redness 0 0 0 0 0
Chemosis 0 0 0 0 0
Discharge 0 0 0 0 0
Unrinsed Redness 0 0 0 0 0
Chemosis 0 0 0 0 0
Discharge 0 0 0 0 0
3 Rinsed Redness 0 0 0 0 0
Chemosis 0 0 0 0 0
Discharge 0 0 0 0 0
Unrinsed Redness 0 0 0 0 0
Chemosis 0 0 0 0 0
Discharge 0 0 0 0 0
4 Rinsed Redness 0 0 0 0 0
Chemosis 0 0 0 0 0
Discharge 0 0 0 0 0
Unrinsed Redness 0 0 0 0 0
Chemosis 0 0 0 0 0
Discharge 0 0 0 0 0
5 Rinsed Redness 0 0 0 0 0
Chemosis 0 0 0 0 0
Discharge 0 0 0 0 0
Unrinsed Redness 0 0 0 0 0
Chemosis 0 0 0 0 0
Discharge 0 0 0 0 0
6 Rinsed Redness 0 0 0 0 0
Chemosis 0 0 0 0 0
Discharge 0 0 0 0 0
Unrinsed Redness 0 0 0 0 0
Chemosis 0 0 0 0 0
Discharge 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
Not irritating
Executive summary:

Method

The eye irritation potential was assessed following the procedure of the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

Results

The primary irritation index in unrinsed eyes was estimated to be 0.

The primary irritation index in rinsed eyes was estimated to be 0.

Therefore, the substance resulted not irritating.

Discussion and conclusion

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 used for the corea opacity and degree of density, for the iris and conjunctivae redness and chemosis is the same of that reported into the OECD, but the timing for the removal of the substance are very different (30 seconds in the current study and 1 hours in the OECD). Nevertheless, because the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC 1272/2008).

The mean values from gradings at 24, 48 and 72 hours for both rinsed and unrinsed eyes were 0 in all animals for all the reactions scored.

In conclusion, the test item can be classified as NON irritating, according to the CLP (EC 1272/2008) Regulation.