Registration Dossier

Administrative data

Description of key information

Not skin irritant

Not 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

SKIN IRRITATION/CORROSION

The skin irritation test was performed to rabbit skin according to an internal method: a single dose was tested on the skin of six rabbits. 0.5 g of test substance was applied to intact and wound skin of each animal using a 25 cm2sticking plaster. The degree of irritation/corrosion was read and scored for oedema and erythema reactions at intervals of 24 and 72 hours. The erythema and the oedema scores were calculated following the mean values after 24/48/72 h. For the scores at 48 h the greater value observed during the test was considered, as no observation was performed at this time-point. The erythema and oedema scores (mean values 24/48/72 hours) were 0 in all animals.

EYE IRRITATION

The substance has been tested for eye irritation according to the OECD guideline 405 and EEC Directive 79/381, annex V, Part B. During the test 2 male and 1 female rabbits are treated with 0.1 g of the test compound.

Mean values at 24, 48 and 72 hours corneal opacity were 0.00 in two animals (#1 and #2) and 0.67 in one animal (#3). Mean values at 24, 48 and 72 hours for iris were 0.00 in all three animals. The conjunctivae scores as mean values at 24, 48 and 72 hours were: for redness 0.67 in animals #1 and #3 and 1 in animal #2; for chemosis 0.33 in animal #1 and 1 in animals #2 and #3. All effects observed were fully reversible within the end of the 72 -hour study period, except in one animal (animal #2 showed a redness score 1 at 72 hours). None of the treated eyes was rinsed after the test item application. Moreover, the substance is a powder and thus it is even more necessary to rinse the eye in order to exclude any effects that could occur due to its physical state. In addition, a fully reversibility was observed within 72 hours in all animals besides one animal (#2). Therefore, it is reasonable to expect that reversibility within 21 days will occur also in animal #2 even if it a fully reversibility was not possible to be observed within the 72 hours study period.

Justification for classification or non-classification

SKIN IRRITATION/CORROSION

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 (or 4 out of 6) tested animals from gradings 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 d 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 results of irritation skin study conducted on the test substance, the mean score (24/48/72h) of erythema and edema was not in the range of ≥ 2.3 - ≤ 4.0; therefore the substance is not classified for skin irritation according to the CLP Regulation (EC 1272/2008).

 

EYE IRRITATION

According to the CLP Regulation (EC 1272/2008) substances that have the potential to seriously damage the eyes are classified in Category 1 (irreversible effects on the eye) if, when applied to the eye of an animal, a substance produces:

- at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or

- at least in 2 of 3 tested animals, a positive response of: corneal opacity ≥ 3 and/or iritis > 1,5

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

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

 

Based on the results obtained in the eye irritation study performed, for the substance no classification is warranted for Serious eye damage/eye irritation according to the CLP Regulation (EC n. 1272/2008).