Disodium 5-[[2,4-dihydroxy-5-[(4-nitrophenyl)azo]phenyl]azo]-4-hydroxy-3-[(2-hydroxy-3,5-dinitrophenyl)azo]naphthalene-2,7-disulphonate

Endpoint summary

Description of key information

Not skin irritant

Category 2 (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:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

SKIN IRRITATION/CORROSION

Experimental data for the Target Substance is available; since the documentation is insufficient for assessment, the reliability of the study is not assignable. The substance was tested for skin irritation according to the ETAD method No. 2. Six rabbits were exposed to 0.5 g of test item. The substance was found to be not irritating to the rabbit skin.

The potential of the substance to cause acute dermal irritation or corrosion was assessed also considering the following data obtained for the Similar Substance 01. It is expected that the Target substance will present similar potential for skin and eye irritation/corrosion. Justification for Read Across is given in Section 13 of IUCLID.

The substance was tested for skin irritation with three rabbits with an occlusive method, following a method similar to the OECD Guideline 404. The test item were applied to shaved skin for 4 hours and the readings were performed after 1, 24, 48 and 72 hours, 7and 14 days. The mean values 24/48/72 hours for erythema were 1.67 (animal #1) and 0.67 (animals #2 and #3); for oedema the scores were 0 in all animals. The effects observed were fully reversible within 7 days.

 

EYE IRRITATION/CORROSION

Experimental data for the Target Substance is available; since the documentation is insufficient for assessment, the reliability of the study is not assignable. The substance was tested for eye irritation according to the ETAD method No. 3. Six rabbits were treated with test substance directly injected into the conjunctival sac. One eye was rinsed, the other eye remain unrinsed. During the observation period no signs of irritation was found into the rinsed eyes. The test substance was found to be not irritating to the rabbit eye under the test condition.

The potential of the test substance to cause eye irritation or corrosion was assessed also considering the following data obtained for the Similar Substance 01. It is expected that the Target substance will present similar potential for skin and eye irritation/corrosion. Justification for Read Across is given in Section 13 of IUCLID.

The substance was tested on the eye of three rabbits for 24 hours following a method similar to the OECD guideline 405. Three male rabbits were treated with 100 mg of the test item placed into one eye, while the other untreated eye served as a control. The eyes were evaluated at 1, 24, 48 and 72 hours, 7, 14 and 21 days after the application of the test substance. The cornea and iris scores (mean values 24/48/72) were 1 in all animals. The mean values 24/48/72 h for conjunctivae for redness were 2.33 in two animals (#1 and #2) and 2.67 in one animal (#3); for chemosis were 2.33 in two animals (#1 and #2) and 3 in one animal (#3). All effects observed were fully reversible within the 21-day observation period.

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 mean scores (24/48/72h) of erythema and edema were not in the range of ≥ 2.3 - ≤ 4.0; therefore 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.

The mean scores obtained in the study conducted similarly to the OECD Guideline 405 suggest a classification of the substance in Category 2 according to the CLP Regulation (EC 1272/2008). On the contrary, data obtained in the study conducted according to the ETAD method 03 suggests a non-classification of the substance for eye irritation. However, considering the low purity of the test material used in the latter study and following a precautionary approach, the substance is classified Category 2 (eye irritation) according to the CLP Regulation (EC 1272/2008).