Registration Dossier

Administrative data

Description of key information

Non irritant to intact rabbit skin.

Non irritant to rabbit eye.

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

No information is available on the substance itself, i.e. Solvent Red 122. However, a study on a read across substance, i.e. Similar Substance 01, was available and used for the assessment. A detailed description of the read across process was attached in section 13.

Skin irritation

The substance was tested for skin irritation according to OECD guideline 404. Under test conditions, no signs of skin irritation were noted. In the area of application a marked to slight orange discolouration of the skin was observed in all rabbits within 1 to 72 hours after removal the bandage. No acute toxicological signs were seen in animals during the test period.

Eye irritation

The substance was tested for eye irritation/corrosion according to OECD guideline 405. During the test, the eye was not rinsed, however, no signs of irritation were noted. No discolouration of the cornea and conjunctivae, related to compound effects, was observed. No acute toxicological signs were seen in animals during the test period.

Justification for classification or non-classification

Skin Irritation

According to the CLP Regulation (EC 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 it produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to a 4 hour duration.

 

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.

 

Under the test condition, no signs of irritation were observed, thus no classification applied. Based on the read across approach, Solvent Red 122 was considered as non irritant to skin.

 

Eye Irritation

According to the CLP Regulation (EC 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.

The substance did not show any effect on eye, thus no classification applied. Based on a read across approach, Solvent Red 122 was considered as non irritant to eye.