Registration Dossier

Administrative data

Description of key information

not skin irritating

not eye irritating

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 cm^2 sticking plaster. The degree of irritation/corrosion was read and scored for oedema and erythema reactions at intervals of 24 and 72 hours. As mean values from 24 to 72 hours consisted of grade 0 erythema and grade 0 oedema, the test substance was found to be not irritant when applied to intact and wound skin of rabbit.

EYE IRRITATION

The substance was tested for eye irritation according to an internal method: a single dose was applied into the eyes of six rabbits. After the exposure for each animal one eye was rinsed and the other one was not rinsed. 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 days.

Considering the rinsed eye, under this study conditions the substance resulted in no effects on cornea and iris (mean scores 0) except in animal #4 (mean cornea score 0.33) and in animal #3 (mean iris score 0.33). Three animals (#3, #5 and #6) showed no effects on conjunctivae (redness and chemosis mean scores 0). Effects on conjunctivae were observed in the other three animals: redness mean scores were 1.33 and 1 in animal #1 and animals #4 and #2 respectively; chemosis mean scores were 0, 1 and 0.67 in animals #1, #2 and #4 respectively. At the end of the observation period (7 days) all the irritation effects were fully reversible except from conjunctivae redness and chemosis scores that were observed in animal #1 and in animal #4 respectively (grade 1 after 7 days for both effects). Higher scores on cornea, iris and conjunctivae were observed in the unrinsed eye. The reversibility within 7 day-period of these effects was observed in all cases, except from cornea and chemosis (grade 3 and 1 respectively) in animal #4 and redness (grade 1) in animal #5.

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 scores (24/48/72h) of erythema and edema were 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 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 (or 4 out of 6) 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.

In the eye irritation test the substance caused some adverse effects: mean values at 24, 48 and 72 h on the unrinsed eye were lower than 2 for conjunctival redness and chemosis scores and lower than 1 for corneal opacity and iris scores in all animals. At the end of the observation period (7 days) all the irritation effects were fully reversible except from conjunctivae redness and chemosis scores that were observed in animal #1 and in animal #4 respectively (grade 1 for both effects). In these both cases, a decreasing trend of observed values occurred during the 7-day study period. This trend was also observed in the worst case for the unrinsed eye of the same two animals. Furthermore, the trend towards lower conjunctival scores was found in all other animals. Therefore, it is reasonable to think that reversibility within 21 days should occur even if at the present study it was not possible to observe the fully reversibility of all the effects within the 7-day study period.

The results show that the substance is not classified for both skin and eye irritation, according to the CLP Regulation (EC n. 1272/2008).