Reaction products of diazotised 3-amino-2-hydroxy-5-nitrobenzenesulphonic acid and 3-amino-4-hydroxy-5-nitrobenzenesulphonic acid, coupled with resorcinol, metalized with Ferric Chloride, condensed with Formaldehyde, sodium salts

Endpoint summary

Description of key information

not skin irritant

eye Irrit. 2

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:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The following data was obtained for Similar Substance 01. It is expected that Target substance will present similar acute oral toxicity. Justification for Read Across is given in Section 13 of IUCLID.

Skin irritation assessment

The assessment was based on a study made in 2000 according to the procedure inside the Spain Royal Decree 363/1995 and Royal Decree 1078/93.

Three male rabbits were tested with 0.5 g of test item to the shaved skin after 4 hours of patch treatment. Under the conditions of the present experiment the substance was found to cause no irritation when applied to intact rabbit skin.

Eye irritation assessment

The assessment was based on a study made in 2001 according to the procedure inside the Spain Royal Decree 363/1995 and Royal Decree 1078/93.

The eye irritation potential was investigated by instillation of the equivalent of 0.1 g/animal of the test substance. The scores of each animal at the reading times of 24, 48 and 72 hours was used in calculating the respective mean values for each type of lesion, as stated by the Regulation EC 1272/2008 (CLP).

Scores for corneal opacity and iritis were lower than the threshold value of 1 for 3/3 rabbits.

Scores for conjunctival redness and oedema were higher than the threshold value of 2 in 2/3 rabbits.

Every type of lesion was fully reversible within 21 days except the conjunctival redness response, which was identified in 2/3 rabbits on the 21th day of the test (graded as 1 according to the used scoring system).

From the present results the substance should be classified as corrosive to the eyes bacause the produced effects were not fully reversible within 21 days. However, the following considerations should be underlined.

Since the study did foresee the rising of eyes after the application of the test item in its solid form, the results of the test can be considered as an overestimation of the true irritating effects strictly related to the substance chemical/toxicological properties. Indeed, due to the intrinsic irritating nature of dusty materials, this overestimation is true especially for the conjunctival redness response and the fact that this lesion was not fully reversible within 21 days can be attributed to the lack of eye rinsing. Moreover, from the individual scoring of each animal, it can be observed a progressive reduction of this lesion, suggesting that the effect will most likely not be persistent.

Experimental data of skin and eye irritation potential of Target substance obtained in in vivo tests is available. Unfortunately, the reliability of the data cannot be judged because of the lacking of details about test material and testing procedures and conditions.

REFERENCE: details in attachment.

On the skin the substance dissolves no recognizable even after prolonged exposure primary irritation; its mucous membrane irritation on the eye is strong.

 

Skin irritation (rabbit)

-Application form: 50 % aqueous solution

-Exposure time: 20 h

-Findings:

after 24 hours : light brown substance residues; no irritating effects

after 8 days: no irritating effects

 

Eye irritation (rabbit)

-Application form: (1 x 50 mm^3 or 50 mg) unchanged

-Findings

after 1 h: light redness ; light oedema; black substance residues; opacity not recognizable; secretion

after 24 h: strong redness; light oedema; strong opacity; greasy pad

Findings after 8 days: no effects

-Reference – talc findings:

after 1 hour: light redness

after 24 hours: light redness

after 8 days: no effects

Justification for classification or non-classification

Skin irritation

According to the CLP Regulation (EC 1272/2008), 3.2 Skin corrosion/irritation section, skin Irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

In the available study, the mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in at least 2 of 3 animals for both erythema/eschar and oedema reactions.

Eye irritation

According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) 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 installation of the test material, and which fully reverses within an observation period of 21 days.

Scores for corneal opacity and iritis were lower than the threshold value of 1 for 3/3 rabbits.

Scores for conjunctival redness and oedema were higher than the threshold value of 2 in 2/3 rabbits.

Every type of lesion was fully reversible within 21 days except the conjunctival redness response, which was identified in 2/3 rabbits on the 21th day of the test (graded as 1 according to the used scoring system).

From the present results the substance should be classified as corrosive to the eyes bacause the produced effects were not fully reversible within 21 days. However, the following considerations should be underlined.

Since the study did foresee the rising of eyes after the application of the test item in its solid form, the results of the test can be considered as an overestimation of the true irritating effects strictly related to the substance chemical/toxicological properties. Indeed, due to the intrinsic irritating nature of dusty materials, this overestimation is true especially for the conjunctival redness response and the fact that this lesion was not fully reversible within 21 days can be attributed to the lack of eye rinsing. Moreover, from the individual scoring of each animal, it can be observed a progressive reduction of this lesion, suggesting that the effect will most likely not be persistent.

For the above mentioned reason, the substance does not meet the criteria for classification as Eye Damage 1. Instead, a classification as Eye Irrit 2, under the Regulation EC 1272/2008 (CLP), is warranted.