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Administrative data

Description of key information

SKIN IRRITATION: Not irritant

EYE IRRITATION: Not 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

The evaluation of the irritation and corrosion propreties of the Acid Red 249:1 has been based on the Read Across approach:

Acid Red 249:1 is a multiconstituent substance composed by the acidic and the sodium salt forms of the same structure (72.7 % and 14.95 % of the substances respectively).

The tests was performed on the Similar Substance 01 which is the major component of the multiconstituent substance. Considering the high similarity between the structures and the composition of the substance the Read Across approach is considered as acceptable. See section 13.

 

Skin irritation

The determination of skin irritation was determined in an a Primary Skin Irritation test. No guideline is available and the test was not performed on GLP. The test substance was tested in albino rats for 72 h. Erythema and oedema formation were observed.

Slight erythema was seen on 2/6 abraded sites and slight to moderate oedema was seen on all sites, 24 hours after application of the compound. All sites were normal by 72 hours. The primary irritation score was 1.2.

Eye irritation

An Eye Irritation test was performed on the substance. No guideline is available and the test was not performed on GLP. The reaction on the test substance was observed in albino rats for 10 days after the instillation. Reactions on Cornea, Conjunctivae and Iris were evaluated.

Conjunctival reaction: a mild to moderate reaction was seen in all treated eyes one hour after application of the compound.

This had subsided very slightly by 24 hours and thereafter continued to do so until all eyes had returned to normal by day 6 (1/3 unwashed, 3/3 washed) and 10 (2/3 unwashed). Staining of the conjunctivae by the compound was seen in the unwashed eyes at 24 hours.

Corneal reaction: slight opacity and damage to the surface epithelium was seen in all treated eyes at one hour. This was still present at 24 hours. These returned to normal by 48 hours (2/3 washed), 72 hours (1/3 washed) and 6 days (3/3 unwashed).

IRIS: increased folding of the iris was seen in 2/3 unwashed eyes, (no. 11) at 24 hours and (no. 13) at 40 hours only.

Justification for selection of skin irritation / corrosion endpoint:

The test was performed on the major component of the multiconstituent substance

Justification for selection of eye irritation endpoint:

The test was performed on the major component of the multiconstituent substance

Justification for classification or non-classification

Skin Irritation

According to the CLP Regulation (EC n. 1272/2008), skin corrosion means the production of irreversible damage to the skin, and skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

A substance has to be classified as Category 1 (Corrosive) if there is the production of irreversible damage to the skin in more than 1 of three animals.

 

A substance has to be classified as Category 2 (Irritant) if shows:

(1) 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 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.

 

The scores recorded during the primary skin Irritation test on the substance to be registered less than 2.3 and the reactions was fully reversible after 72 hours.

Therefore, according to the paragraph 3.2. of the CLP Regulation n. 1272/2008, the substance shall be non classified as a skin irritant. 

Eye Irritation

According to the CLP Regulation (EC n. 1272/2008), Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application

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.

 

A substance has to be classified as Category 1 (Irreversible effects on the eye), If, when applied to the eye of an animal, a substance produces:

— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or

— at least in 2 of 3 tested animals, a positive response of:

— corneal opacity ≥ 3 and/or

— iritis > 1,5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

 

A substance has to be classified as Category 2 (irritating to eye) 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 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

 

Detailed results were evaluated in order tho define the classification and for every point no more than 4 rabbits fullfilled the requirement for the irritation (Category 2):

Corneal opacity: 3 of 6 animals =1 (everage of 24,48,72 h), fully reversible after 10 days;

Iris: 2 of 6 animals =1 (everage 24,48,72 h), fully reversible after 10 days;

Redness Conjuntivae: 3 of 6 animals =2 (everage 24,48,72 h), fully reversible after 10 days;

Chemosis Conjuntivae: 1 su 6 animals =2 (everage 24,48,72 h), fully reversible after 10 days.

According to the paragraph 3.3. of the CLP Regulation n. 1272/2008, the substance shall be considered as non classified for eye irritation.