Disodium 4,4'-bis[(4-anilino-6-methoxy-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate

Endpoint summary

Description of key information

Skin irritation: non irritant

Eye irritation: non irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

The skin and eye irritating potential OB 134 was assessed using a test sample with composition: 33 % OB 134, 38 % water and coupage as for the remaining. Based on information reported in study reports, the sample is liquid.

As for skin irritation, OB 134 was applied in amount of 0.5 ml and resulted as non irritant to rabbit skin, upon 24 -hour of exposure at observation times of 24 and 72 hours from start of exposure.

Further studies were available and are summarised in the table below:

test material	composition	method	results	date
FAT 65006/E	33 % a.i., 38 % water, coupage - solid	3 rabbit/sex; 0.5 g test material; intact and abraded skin	non irritant	1976
Rylux PRS	70 - 80 % a.i, 20 - 30 % non coloured components	0.5 g test material; intact and abraded skin	intact skin: no response at 24 and 72 hours observation time	1988
Rylux PRS	70 - 80 % a.i, 20 - 30 % non coloured components	0.5 g test material	slight response at 24; at 48 h no response in one rabbit and slight response the second rabbit; at 6 d no response	1980

The first study followed the same test procedure as the key study; however, physical state of test sample was solid. The last 2 studies could only be qualitatively interpreted, as no details on test procedure and results were available. Overall, the substance appeared as non irritant to the rabbit skin.

OB 134 resulted as non irritant to the rabbit eye, rinsed 30 seconds after application of 0.1 ml of test sample. Treated eyes were observed for responses 1, 2, 3, 4 and 7 days after application. Irritation of cornea and conjunctivae was noted in unrinsed eye, but disappear within 4 days after application.

Further studies were available and are summarised in the table below:

test material	composition	method	results	date
FAT 65006/E	33 % a.i., 38 % water, coupage - solid	3 rabbit/sex; 0.1 g test material; rinsed and unrinsed eye	no effects from rinsing; signs of cornea and conjunctivae irritation	1976
Rylux PRS	70 - 80 % a.i.; 20 - 30 % coloured components	rabbit; 0.1 g test sample	corneal opacity at 24 h, less evident at 72 h; very swollen, very strong swelling, strong discharge of mucous membrane at 24 h; after 72 hours swelling and discharge is significantly smaller.	1988
Rylux PRS	70 - 80 % a.i.; 20 - 30 % coloured components	rabbit; 0.02 g test sample	swirling of mucous; cornea unchanged	1980
		rabbit; 0.1 g test sample	swirling, swelling, discharge; corneal opacity

The first study followed the same test procedure as the key study; however, physical state of test sample was solid. Almost no difference between rinsed and unrinsed eye was noted, likely suggesting that residues of solid sample remained into the eye upon rinsing.

Few details on test procedure and results of the last 2 studies were available. Available data was indicative of dose-dependent effects on cornea and mucous membrane. No indication of rinsing was reported, thus it was reasonably assumed that it was not done. As currently accepted testing guidelines recommends to remove solid test substance from the eye, the significance of the study outcome was limited by the lack of rinsing.

Overall, no signs of eye irritation were noted in rinsed eye, whereas unrinsed eye showed signs of irritation, decreasing in time.

Justification for classification or non-classification

Skin Irritation

According to the CLP Regulation (EC 1272/2008), skin corrosion means the production of irreversible damage to the skin, and skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

A substance has to be classified as category 1 (corrosive) if it produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to a 4 hour duration.

 

A substance has to be classified as category 2 (irritant) if it shows:

- mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

- inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

- in some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

 

Under the test condition, no signs of irritation were observed, thus no classification applied.

Eye Irritation

According to the CLP Regulation (EC 1272/2008), serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application .

Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

 

A substance has to be classified as category 1 (Irreversible effects on the eye), if, when applied to the eye of an animal, a substance produces:

- at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or

- at least in 2 of 3 tested animals, a positive response of:

- corneal opacity ≥ 3 and/or

- iritis > 1,5 calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material.

 

A substance has to be classified as category 2 (irritating to eye) if, when applied to the eye of an animal, a substance produces:

at least in 2 of 3 tested animals, a positive response of:

- corneal opacity ≥ 1 and/or

- iritis ≥ 1, and/or

- conjunctival redness ≥ 2 and/or

- conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material, and which fully reverses within an observation period of 21 days.

The substance did not show any effect on eye, thus no classification applied.