Registration Dossier

Administrative data

Description of key information

Not a 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

The following data was 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 the use of a read-across approach is provided in Section 13 of IUCLID.

SKIN IRRITATION/CORROSION

The skin irritation potential was evaluated in an in vivo experimental study, according to a method similar to the OECD Guideline 404. The test item was applied to the shaved dorsal region of 3 male New Zealand White rabbits for a duration of 4 hours with an occlusive bandage, after which the bandage was removed and skin was evaluated for erythema and oedema after 1, 24, 48 and 72 hours, and 7 and 14 days.

The mean (24/48/72 hours) erythema scores for each animal were 1.67 (animal #1) and 0.67 (animals #2 and #3); the mean (24/48/72 hours) oedema scores were were 0 in all animals. The effects observed were fully reversible within 7 days.

EYE IRRITATION/CORROSION

The potential to induce eye irritation or serious damage was evaluated in an in vivo experimental study, according to a method similar to the OECD Guideline 405. Three male rabbits were administered 100 mg of unchanged test item to one eye for a duration of 24 hours; the untreated eye served as a negative control. Corneal opacity, iritis, conjunctival redness and chemosis were evaluated 1, 24, 48 and 72 hours and 7, 14 and 21 days after application.

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 animal #1, 3.33 in animal #2 and 3 in 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) No. 1272/2008, substances that have the potential to induce reversible damage to the skin following the application of a 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 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.

Based on the available experimental data of skin irritation, the mean (24/48/72 hours) scores for erythema and oedema were not in the range of ≥ 2.3 - ≤ 4.0; therefore, the substance is not classified as a skin irritant according to the CLP Regulation (EC) No. 1272/2008.

 

EYE IRRITATION/DAMAGE

According to the CLP Regulation (EC) No. 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 the following reactions in at least in 2 of 3 tested animals, and which fully reverses within an observation period of 21 days:

- corneal opacity ≥ 1; and/or

- iritis ≥ 1; and/or

- conjunctival redness ≥ 2; and/or

- conjunctival oedema (chemosis) ≥ 2,

Scores are calculated as the mean scores following grading at 24, 48 and 72 h for each animal after installation of the test item.

Based on the available experimental data of the eye irritation, the mean (24/48/72 hours) scores for both corneal opacity and iritis were ≥ 1 and scores for conjunctival both redness and oedema (chemosis) were ≥ 2. Therefore, the substance is classified in Category 2: Eye Irritation, according to the CLP Regulation (EC) No. 1272/2008.