Registration Dossier

Administrative data

Description of key information

Skin irritation: not irritating

Eye Irritation: not irritating

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 potential of the substance has been based on studies conducted on the Similar Substance 01. The complete hypothesis and justification for the read across approach has been attached in section 13.

The skin irritation test was performed to rabbit skin using a single administration, according to the "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

The test substance was found to be non irritant when applied to intact or abraded rabbit skin.

The eye irritation test was performed to rabbit eye using a single administration, according to the "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

The substance was found to cause minimal to slight irritation when applied to the rabbit eye mucosa. The substance was found to cause transient minimal to slight irritation in un-rinsed and minimal irritation in rinsed eyes, in both cases after 6 hours (during the test, the eyes of three animals were rinsed 1 minute after application, with physiologic saline solution). The irritation consisted of conjunctival reaction. Reflective hyperemia of the iris was observed 6 hours after installation in 1/3 unrinsed eyes only. After 24 hours, there was complete recovery in 2/3 unrinsed and 3/3 rinsed eyes.

The criteria for the evaluation of the eye irritation potential followed in the test are different from those reported into the OECD guideline. Nevertheless, the scoring system used for the cornea opacity and degree of density, for the iris and conjunctivae redness and chemosis is the same of that reported into the OECD. Since the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (1272/2008).

Justification for selection of skin irritation / corrosion endpoint:

The study was performed according to an internationally accepted testing guideline and it met the endpoint requirements fully.

Justification for selection of eye irritation endpoint:

The study was performed according to an internationally accepted testing guideline and it met the endpoint requirements fully.

Justification for classification or non-classification

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 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

- 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

- 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.

In the skin irritation test, the mean values at 24, 48 and 72 hours after patch removal were lower than 2.3 (explicitly, the mean values were zero) in all animals for both erythema/eschar and oedema reactions (in both intact and abraded skin).

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 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

In the eye irritation test, the mean values at 24, 48 and 72 hours for both rinsed and unrinsed eyes were lower than 1 for corneal opacity, lower than 1 for irtitis, lower than 2 for both conjunctival redness and oedema, in all animals.

The available experimental data were considered suitable for a classification and labelling, according to the CLP Regulation (EC 1272/2008). The results show that the substance is not classified for eye and skin irritation.