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 substance was tested for skin irritation according to the guideline "Food end Drug Adrninistration of the U.S.A in The Federal Register (17 September, 1964 § 191.11)". Under the conditions of this experiment the test material was found to cause no irritation when applied to intact rabbit skin (erythema and oedema mean values at 24/48/72 h were 0 in all animals).

EYE IRRITATION

The substance was evaluated for eye irritation/corrosion according to the "Food and Drug Administration of the U.S.A. Federal Register (17 September, 1964 § 191. 12)". Six rabbits were treated with test material directly injected, three eyes of rabbits were rinsed and three eyes remaining untreated. The mean values at 24/48/72 hour were calculated for the effects on the rinsed eye. The cornea and iris values were 0 in all animals. The conjunctivae redness were 0.67 in two animals (#4 and #6) and 1 in one animal (#5); chemosis were 0.67 (animal #4), 0.33 (animal #5) and 0 (animal #6). All effects observed were reversible within the study period. The effects on the not rinsed eye were comparable to the rinsed one and reversible within the 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 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 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, the mean values (24/48/72 h) for corneal opacity and iritis were < 1 and for conjunctival redness and chemosis were <2. All effects observed were reversible. Therefore, the substance is not classified for Serious eye damage/eye irritation according to the CLP Regulation (EC n. 1272/2008).