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Administrative data

Description of key information

Skin Irritation: Non irritant
Eye Irritation: Non 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

Skin Irritation

The irritation potential for skin of the test substance was evaluated by means of two studies on the substance in itself.

The key study was conducted in 1981 on the substance in itself according to the Federal Register, 17 September, 1964,§ 191.11. During the experimental speriod 0.5 g of the test substance was applied on the inctact skin of six rabbits, after shaving, using gauze patches, then covered by impermeable material. After 24 hours the gauzes were removed and the skin observed for 72 hours.

The mean score after 24, 48 and 72 hours for each rabbits was considered for the classification pourpose. the calculated values were always under the limit for irritation potential set out in the CLP Regulation (EC n. 1272/2008), therefore the substance is considered to be not irritant.

The Supporting study was conducted in 1974 according to the guideline inserted into the Federal Register, 17 September, 1964,§ 191.11. During the experimental period, the substance was applied to six rabbits on intact skin. No sign of irritation was observed during the study.

Eye Irritation

The irritation potential for eye of the test substance was evaluated by means of two studies on the substance in itself.

The key study was conducted in 1981 on the substance in itself according to the guideline described in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" published for Food and Drug Officials of the United States, pag. 49-52, 1959.

After application of the substance the animals were observed for 72 hours.

The mean score after 24, 48 and 72 hours were calculated for classification pourpose for each rabbit, the value obtained were always under the limit for irritation classification set out in the CLP Regulation (EC n. 1272/2008), therefore the test item is considered to be not irritant.

The supporting study was conducted in 1974 on the substance in itself according to the Federal Register, 17 September 1964, § 191.12. Six rabbits are treated with 100 mg of substance.

After the observation period of 7 days all rabbits are fully recovered. In the group with rinsed eyes only one rabbit showed slight conjunctival effects (score 1), fully reversible within 2 days. No other effects were observed, therefore the substance was considered to be not irritant.

Justification for classification or non-classification

SKIN IRRITATION/CORROSION

In order to classify a substance as irritant, the major criterion is that at least 2 of 3 tested animals have a mean score of ≥ 2,3 - ≤ 4,0.

Category 2:

- Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from grading 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.

The substance is not classified as skin irritant because in the performed tests it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.

 

EYE IRRITATION

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.

Irritating to eyes (Category 2)

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 test substance does not meet the requirements to be classified in Category 2, therefore it is not classified.