Reaction mass of 1,5-diamino-4,8-dihydroxy(4-hydroxyphenyl)anthraquinone and 1,5-diamino-4,8-dihydroxy-2-(4-methoxyphenyl)anthraquinone

Endpoint summary

Description of key information

Skin irritation: non-irritant
Eye irritation: non-irritant

Additional information

The substance was tested for skin irritation potential using the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" 1959, the US Association of Food and Drug Officials (AFDO).

2.5 cm × 2.5 cm intact and abraded skin of 3 male and 3 female Himalayan rabbits were exposed to 0.5 ml of test substance in an occlusive preparation for 24 h. Skin reactions were recorded at 0 h and 48 h after patch removal. For the purpose of calculating erythema and edema scores at 24, 48 and 72 h after patch removal, the following method was adopted: scores at 0 h were taken as scores at 24 h and scores at 48 h were also taken as scores at 72 h.

Intact skin showed no skin reactions at all for erythema; 2/6 rabbits show very slight edema at 0h, but this skin reactions were reversible within 48h. No erythema was observed also in scarified skin. Slight edema was observed in scarified skin at 0 h. These skin reactions were reversible within 48 h.

For all animals, the calculation of mean skin reaction scores (24, 48 and 72 h) after patch removal gave the following values for intact skin: erythema score = 0 and oedema score = 0.1; and for abraded skin: erythema score = 0 and oedema score < 1.

Therefore, the test substance is a non-skin irritant.

As no detailed composition on the tested substance is available, the test is considered as a weight of evidence, supported by another test available on similar substance 1.

In this test (1980), the test substance was examined for irritation potential on intact and abraded skin in an occlusive preparation for 24 h. Skin reactions were scored at 24 h, 48 h, 72 h, 4 d and 7 d after patch removal. Abraded skin of 6/6 animals had the following mean reaction scores (24, 48 and 72 h): erythema score < 1 and oedema score < 1 while intact skin of 6/6 animals had the following mean reaction scores (24, 48 and 72 h): erythema score = 0 and oedema score = 0. All skin reactions were fully reversible within 48 h.

Therefore, also similar substance 1 is considered as a non-skin irritant.

 

The eye irritation potential of the test substance was investigated by the slit-lamp procedure on the basis of the 'Appraisal of the safety of chemicals in Food, Drugs and Cosmetics' 1959 of the US Association of Food and Drug officials.

0.1 ml of unchanged test substance was applied to the left eye of 3 male and 3 female New Zealand white rabbits for 30 s. The untreated right eye served as controls. Treated eyes of female rabbits were each flushed with 10 ml lukewarm water approximately 30 s after treatment. Eye reactions were scored at 1 d, 2 d, 3 d, 4 d and 7 d after exposure.

The mean irritation indexes (at 1, 2 and 3 d) for 6 out of 6 (6/6) animals were the following: corneal score = 0 and iris score = 0. and conjunctivae score = 0.

Therefore, the test substance is a non-eye irritant.

As no detailed composition on the tested substance is available, the test is considered as a weight of evidence, supported by another test available on similar substance 1.

This test (1980) examined eye irritation potential by the slit-lamp procedure. Unchanged test substance was applied to the left eye of 3 male and 3 female New Zealand white rabbits for 30 s. Treated eyes of three rabbits were each flushed with 10 ml physiological saline approximately 30 s after treatment. At 24 h, 48 h, 72 h, 4 d and 7 d after exposure, eye reactions were scored.

The mean irritation indexes (at 24, 48 and 72 h) for 6/6 animals were as follows: Cornea = 0, Iris = 0 and Conjunctivae = 0.

 Therefore, also similar substance 1 is considered as a non-eye irritant.

Justification for classification or non-classification

For skin irritation and eye irritation, the CLP Regulation (EC 1272/2008) was used for overall judgment.

In the CLP Regulation (EC 1272/2008), skin irritation is defined as "the production of reversible damage to the skin following the application of a test substance for up to 4 hours." The same regulation, defines a Category 2 skin irritant as "Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal."

In the two tests evaluated, edema and erythema scores on intact skin were equal to 0 or <1.

Therefore, the test substance is a non-skin irritant.

Moreover the CLP Regulation (EC 1272/2008), defines eye irritation as follows: "Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application." The same regulation defines a Category 2 eye irritant as, "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 gradings at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days."

Mean corneal, iris and conjunctivae scores (at 24, 48 and 72 h) were equal to 0 for 6/6 animals in both tests.

Therefore, based on these results, the test material is considered as a non-eye irritant.