Registration Dossier

Administrative data

Description of key information

Not a skin irritant

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)

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.

The test item was investigated for skin irritating property in rabbits using a guideline given by the U.S. Department of Agriculture (Fed. Reg 38, 187, 27019, 1973). A single dose was tested on the skin of six rabbits. The test item was applied to intact and wound skin of each animal. The degree of irritation/corrosion was read and scored for oedema and erythema reactions at intervals of 24 and 72 hours.

The test item caused no irritation in the skin of rabbits.

The test item was investigated for eye irritating property in rabbits using a guideline given by the US Department of Health, Education and Welfare (Fed Reg 37 (83), 8535, 1972).A single dose was applied into the eyes of six rabbits. The exposure was of 5 minutes and 24 hours. The degree of eye irritation/corrosion was evaluated by scoring lesions of conjunctiva, cornea, and iris, at specific intervals of 24, 48, 72 hours and 7, 14 and 21 days.

The test item was found not to be irritating to the eyes of rabbits.

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 (24/72 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 corneal opacity and iritis were not ≥ 1 and scores for conjunctival both redness and oedema (chemosis) were not ≥ 2. Therefore, the substance is not classified for Eye Irritation/corrosion, according to the CLP Regulation (EC) No. 1272/2008.


Route: .live2