Reaction products of 2-amino-4,6-dinitrophenol, 4-amino-5-hydroxy 2,7-naphthalenedisulfonic acid, 4-nitrobenzenamine and resorcinol, sodium salts

Endpoint summary

Description of key information

Skin: not irritating, not corrosive
Eye:  irritating, not corrosive

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

Skin irritation/corrosion

The irritation/corrosion property was tested on the Similar substances 01 and the Similar substance 02, according to the OECD404 and EU B.4, in GLP.

Under the conditions of the experiment, the tested substances were found to not cause corrosion or irritating effects.

Based on the read-across principle, the results can be considered for the skin irritation assessment of the registered substance.

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

Due to the results described above, the registered substance is considered non irritant for the skin.

 

Eye irritation/corrosion

The eye irritation/corrosion property was tested on the Similar substance 01, according to the OECD 405 and EU B.5, in GLP.

Under the conditions of this experiment, the substance was found to cause a primary irritation score or f 4.58, when applied to the conjunctival sac of the rabbit eye. An irritant effect was observed, but fully reversible after 14 days.

According to EEC Council Directive, 83/467/EEC, July 1983 and 67/548/EEC, May 1987, Brussels, Belgium, the mean value of the scores was calculated, indicating that the test article had to be classified as irritating to the eyes.

It should be noted that no rinsing of the eyes has been performed before the evaluation, therefore to confirm the outcome an additional study in read across on the Similar substance 02 was evaluated.

The Similar substance 02 is classified as irritant.

Based on the read-across principle, the results can be considered for the eye irritation assessment of the registered substance.

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

Due to the results described above, the registered substance is considered irritant for the eyes.

Justification for classification or non-classification

Skin irritation/corrosion

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

According to the CLP Regulation 1272/2008, the substance can be classify as a single irritant category (Category 2) according to the criteria, section 3.2, table 3.2.2.

If, when applied to the skin of an animal, the substance produces:

(1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from grading 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

(2) 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

(3) 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. Reversibility of skin lesions is the other decisive factor in evaluating responses in the animal test.

Under the conditions of the experiments, the tested substances (Similar substances 01 and 02) were found to cause a primary irritation score of 0.00 when applied to intact rabbit skin. No corrosive effect had occurred on the skin at any measuring interval.

Local signs (mean between 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.

Based on the read-across principle, the results can be considered for the skin irritation assessment of the substance.

According to the paragraph 3.2. of the CLP Regulation n. 1272/2008, the substance is not classified as a skin irritant/skin corrosive.

Eye irritation/corrosion

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.

The Similar substance 01 produced a positive responses

≥ 1 on corneal opacity,

= 2 on conjunctival redness

= 2 conjunctival oedema (chemosis)

in two or three animals, calculated as the mean of scores at 24, 48, 72 hours.

The damage was fully reversible after 14 days, therefore the substance should be classified, according to the CLP Regulation 1272/2008, as Irritant, Category 2, H319.

However, it should be noted that the tested eyes were not rinsed during the test, therefore an additional study in read across on similar substance 02 was evaluated.

The Similar substance 02 is irritant.

Based on the read-across principle, the results can be considered for the eye irritation/damage assessment of the substance.

According to the paragraph 3.3 of the CLP Regulation n. 1272/2008, the substance is classified

H319: Causes serious eye irritation.