Disodium [N-[7-hydroxy-8-[(2-hydroxy-5-mesylphenyl)azo]-1-naphthyl]acetamidato(2-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(2-)

Endpoint summary

Description of key information

 non-irritant to the skin and eye of rabbits.

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)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

A study was performed to determine the acute irritation, provoked by the Similar substance 01, on the skin of the rabbits according to the procedure employed was that prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 & 191 .11).

6 rabbits (3 males and 3 females), Albino White breed, were shaved and the test substance applied on abraded and intact skin of the animals. 0.5 g of the solid was mixed to a paste with 0.5ml of water before application to each treatment site for the 24-hour period of exposure.

There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings.Therefore the similar substance 01 is to be considered as a non-irritant to the skin of rabbits.

 

Eye irritation/corrosion

In a study performed to determine the eye irritation potential of the Similar substance 01, test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1 hour, 6 hours, 1 day, 2 days, 3 days, 4 days, 7 days, 14 days and 21 days. One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1. Based on these findings, it is considered to be a non-irritant to the eyes.

Based on the read across principle(read-across from supporting substance -structural analogue or surrogate), the results can be considered assessment of the registered substance.

Justification for read across is detailed in the report attached to the IUCLID section 13.

Justification for classification or non-classification

Skin irritation/corrosion

A study was performed to determine the acute irritation, provoked by the Similar substance 01, on the skin of the rabbits according to the procedure prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 & 191 .11).

Typically, up to 3 rabbits may be used. The basis for a positive response is the individual rabbit value averaged over days 1, 2, and 3. The mean score for each individual animal is used as a criterion for classification. The Skin Irritant Category 2 is used if at least 2 animals show a mean score of 2.3 or above. Other test methods, however, have been using up to 6 rabbits.

For existing test data with more than three animals, specific guidance adopted at UN level in June 2011

In case of 6 rabbits the following applies:

a. Classification as skin corrosive – Category 1 if destruction of skin tissue (visible necrosis through the epidermis and into the dermis) occurs in at least one animal after exposure up to 4 hours.

b. Classification as skin irritation – Category 2 if at least 4 out of 6 rabbits show a mean score per animal of ≥ 2.3 ≤ 4.0 for erythema/eschar or for oedema;

There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings for the Similar substance 01.

Based on the read across principle(read-across from supporting substance -structural analogue or surrogate), the results can be considered for the evaluation of the the registred substance.

Justification for read across is detailed in the report attached to the IUCLID section 13.

The substance is not classified as skin irritant, according to CLP (Regulation (EC) No 1272/2008).

Eye irritation/corrosion

In a study performed to determine the eye irritation potential of the Similar substance 01, test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1 hour, 6 hours, 1 day, 2 days, 3 days, 4 days, 7 days, 14 days and 21 days.

Substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes).

According to the CLP Regulation 1272/2008, using the results of animal testing the substance can be classify as a single irritant category (Category 2) according to the criteria, section 3.3, table 3.3.2

If, when applied to the eye of an animal, the 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 installation of the test material, and which fully reverses within an observation period of 21 days.

In this case the irritant categories 1 and 2 are used if 4 of 6 rabbits show a mean score per animal as outlined in the criteria.

A maximum group mean reaction of 6 was established on day 1. Based on these findings, it is considered to be a non-irritant to the eyes.

Based on the read across principle(read-across from supporting substance -structural analogue or surrogate), the results can be considered for the evaluation of of the registered substance. Justification for read across is detailed in the report attached to the IUCLID section 13.

The substance can be considered not classified as eye irritant, according to CLP (Regulation (EC) No 1272/2008).