Reaction products of 6-amino-4-hydroxynaphthalene-2-sulphonic acid and 7-amino-4-hydroxynaphthalene-2-sulphonic acid, condensed with Formaldehyde and Sodium hydrogensulfite, coupled with diazotised Sodium 2-amino-4,6-dinitrophenoxide, metalized with Sodium Dichromate, sodium salts

Endpoint summary

Additional information

The skin and eye irritation/corrosion potential of the substance was evaluated by considering data on the substance itself and data on Similar Substance 01. Justification for Read Across is given in Section 13 of IUCLID.

Skin irritation/corrosion

An acute dermal irritation study was performed with Target Substance in six male New Zealand rabbits, according to the OECD Guideline 404 (1981). No mortality was recorded during the study and no cutaneous reactions appeared during the observation period study. The erythema and oedema scores were 0 in all animals.

The skin irritation test with Similar Substance 01 was performed to rabbit skin according to the OECD guideline 404 (1981). The observed skin irritation consisted of very slight erythema (grade 1) in all animals. The irritation was reversible within 24 hours after exposure in two animals and within 48 hours in the third animal. In the area of application, black staining of the treated skin by test substance was observed. No corrosive effect occurred on the skin and no signs of systemic intoxication were observed in any of the rabbits.

Eye irritation/corrosion

An acute eye irritation study was performed with Target Substance after instillation into the conjunctival sac of six New-Zealand rabbits according to the OECD Guideline 405 (1981). The scores obtained related to the effects observed into the treated eye were used to calculate the mean scores 24/48/72 h. Corneal opacity were 0.67 in four animals (#1, #2, #3 and #6), 1 in animal #4 and 0 in animal #5. Iris scores were 0 in three animals (#1, #2 and #5), 0.33 in animal #3 and 0.67 in two animals (#4 and #6). Conjunctival erythema (redness) scores were 2 in two animals (#1 and #5), 1 in two animals (#2 and #5) and 1.33 in two animals (#3 and #4). Conjunctival oedema (chemosis) were 0 in four animals (#2, #4, #5 and #6), 1.33 in animal #1 and 0.33 in animal #3. All the effects observed were fully reversible within 5-day observation period after the test item application.

The eye irritation test with Similar Substance 01 was performed to rabbit eye according to the OECD Guideline 405 (1987). Under the conditions of this study, the substance resulted in a black staining and an adverse effect on the conjunctivae: mean values at 24, 48 and 72 h were 1, 1.7 and 1.3 for redness and 0.3 in all animals for chemosis. These effects were reversible within 72 h in one animal and within 7 d in the other two animals. The mean values at 24, 48 and 72 h for corneal opacity and iris were 0 in all animals. Neither corrosion nor signs of systemic intoxication were observed.

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/corrosion

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).