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Description of key information

OECD 404, albino rabbits, Not a Skin Irritant or Skin Corrosive

OECD 405, NZW rabbits, Not an 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:
no adverse effect observed (not irritating)

Additional information

Skin irritation/corrosion: evaluated in an experimental study equivalent to the OECD Guideline 404 (1981). 0.5 g of undiluted, solid test item was applied to the clipped, dorsal area of 3 female New Zealand albino rabbits for 4 hours and then monitored for erythema (score out of 4), oedema (score out of 4), corrosion, clinical symptoms and discolouration at 1, 24, 48 and 72 hours after removal of the test item and dressing. 

Eye irritation/corrosion: evaluated in an experimental study equivalent to the OECD Guideline 405 (1981). 100 mg of moistened test item was administered inside the lower, left eyelid of 3 female New Zealand albino rabbits for 24 hours and then monitored for corneal capacity, iritis, conjunctival redness and oedema at 1, 24, 48 and 72 hours and 7 days.

The analogue substance resulted not skin and nor eye iritant. Based on the read across considerations, same results apply to the target substance

Justification for classification or non-classification

Skin Irritation/Corrosion Criteria

According to Annex I: 3.2.2.1.1 of the CLP Regulation (EC 1272/2008) for skin corrosion and irritation, a substance is classified in Category 1: Skin Corrosive if it produces irreversible damage to the skin; namely, visible necrosis through the epidermis and into the dermis, in at least 1 test animal following the application of a test substance for up to 4 hours. Corrosive reactions are typified by ulcers, bleeding, bloody scabs, discolouration due to blanching of the skin after 14 days, complete areas of alopecia, and scars. Skin corrosives can be further divided into 3 sub-categories:

- Sub-Category 1A: corrosive responses in at least one animal following exposure ≤ 3 min during an observation period ≤ 1 h

- Sub-Category 1B: corrosive responses in at least one animal following exposure > 3 min and ≤ 1 h and observations ≤ 14 days

- Sub-Category 1C: corrosive responses in at least one animal after exposures > 1 h and ≤ 4 h and observations ≤ 14 days

A substance is classified as Category 2: Skin Irritant if:

(i) it produces reversible damage (mean score of ≥ 2.3 and ≤ 4.0 for erythema and/or oedema at 24, 48 and 72 hours after removal) following the application of a test substance for ≤ 4 hours in at least 2 of 3 tested animals; or

(ii) it produces inflammation that persists to the end of an observation period of 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

(iii) very definite positive effects related to chemical exposure are apparent in a single animal but it does not meet the criteria above.

According to the study available, the mean irritation scores for the test item do not satisfy the abovementioned criteria for Category 1: Skin Corrosive or Category 2: Skin Irritant.

Eye Irritation/Corrosion Criteria

According to Annex I: 3.3.2.1.1 and Annex I: 3.3.2.1.2 of the CLP Regulation for serious eye damage and eye irritation, a substance is classified in Category 1: Serious Eye Damage if it produces:

(i) effects on the cornea, iris or conjunctiva which are not reversible within 21 days in at least one animal, and/or

(ii) a positive response of corneal opacity (mean score ≥ 3) or iritis (mean score > 1.5) in at least 2 of 3 animals following grading at 24, 48 and 72 hours after application of the test material to the anterior surface of the eye.

A substance is classified in Category 2: Eye Irritant if:

- it produces a positive response of corneal capaity (mean score 1), iritis (mean score 1), conjunctival redness (mean score 2) and/or chemosis (mean score 2) in at least 2 of 3 animals following grading at 24, 48 and 72 hours after application of the test material to the anterior surface of the eye which is fully reversed within 21 days.

According to the study available, the mean irritation scores of the test item did not meet the criteria for classification in Category 1: Serious Eye Damage or Category 2: Eye Irritant according to the CLP Regulation (EC 1272/2008) as the slightly elevated conjunctival redness was reversible within 7 days and was below the threshold for classification.

BAsed on the read across considerations same results apply to the target substance

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