Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt

Endpoint summary

Description of key information

not skin irritant

not eye 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)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

SKIN IRRITATION/CORROSION

The skin irritation test was evaluated in an in vivo test performed following a method similar to the OECD Guideline 404 method. 1 mL of test item solution were applied on the intact clipped skin of three male rabbits. The following observation period was of 72 hours.

No signs of skin irritation were noted. The erythema and edema scores (mean values at 24/48/72 h) were 0 in all animals.

 

EYE IRRITATION/CORROSION

Two in vivo studies are available for the substance: one performed in 1985 following a method similar to the OECD Guideline 405 method and the other one performed in the 1984 accoring to the OECD Guideline 405 (1981).

In the study of 1985 three rabbits were treated with 100 mg of test material directly injected into the conjunctival sac; the left eye served as control. The evaluation of eye reactions were performed without washing the treated eyes. The observation period had to be 21 days but the end was anticipated at 72 hours since no signs of eye irritation were observed. The scores for corneal opacity, iritis, conjunctival redness and oedema (mean values at 24/48/72 h) were 0 in all animals.

In the study of 1984 a single dose of 0.1 g of test item was applied unchanged into the left eye of three rabbits; the untreated right eye was used as a control. The evaluation of eye reactions were performed without washing the treated eyes during a 72 h-observation period.

In the area of application a yellow to brown discoloration of the conjunctivae which could be related to effects of the test article was observed during observation period. No corrosion of the cornea was observed at each of the measuring intervals. The mean values (24/48/72 h) for corneal opacity and iris scores were 0 in all animals. The mean values for conjunctivae redness were 1 in two animals (#1 and #3) and 1.33 in the other one (#2); the mean values for conjunctivae chemosis were 0.67, 0.33 and 1 in animals #1, #2 and #3 respectively. At the end of the observation period (72 h) all the irritation effects were fully reversible except from conjunctivae scores that were observed in animals #2 and #3 (redness) and in animal #3 (chemosis).

The higher values observed in the study performed in the study of 1984 and the reversibility not observed in all animals for conjunctivae effects observed can be reasonably explained compared with the study performed in 1985.

In fact it is worth saying that in the study performed in 1984 the test item used had a significantly lower organic content (dye) compared to the test item used in the study performed in 1985. Moreover, only the test item used in the 1984 study included in its content Sodium Carbonate that is classified Eye Irrit. 2 according to “Harmonised classification - Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation)”.

Justification for classification or non-classification

SKIN IRRITATION/CORROSION

According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible damage to the skin following the application of a test substance for up to 4 hours are classified in Category 2 (irritating to the skin) if:

-mean value of ≥ 2.3 ≤ 4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from readings at 24, 48 and 72 h 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 d 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.

Based on the available experimental data of skin irritation, the substance is not classified for skin irritation according to the CLP Regulation (EC 1272/2008).

 

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 h after installation of the test material, and which fully reverses within an observation period of 21 d.

Based on the available experimental data of eye irritation, the substance is not classified for eye irritation according to the CLP Regulation (EC 1272/2008).