Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: non irritant, non corrosive
Eye irritation/corrosion: irritant, non corrosive

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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

The skin irritation/corrosion test was performed on a similar substance (read-across from supporting substance -structural analogue or surrogate, following the OECD 404 and the EU B.4.

Three rabbits were exposed to 0.5 gram of the similar substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made at 1, 24, 48 and 72 hours.

No skin irritation was caused by 4 hours of exposure to the similar substance.

Brown remnants of the test substance were present on the skin from day 1 onwards until 48 hours after exposure.

Eye irritation/corrosion

The eye irritation/corrosion test was performed on a similar substance (read-across from supporting substance -structural analogue or surrogate, following the OECD 405 and the EU B.5.

Single samples of approximately 99.6 mg of the similar substance (a volume of approximately 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 and 14 days after instillation. 

Several fully reversible effects of the substance on cornea, iris and conjunctivae were observed, caused by the instillation of the substance.

In addition, brown staining of the conjunctivae and of the fur on the head and paws was noted during the observation period.

Justification for classification or non-classification

Skin irritation

Substances that have the potential to induce reversible skin irritation are classified in Category 2 (irritating to skin).

According to the CLP Regulation 1272/2008/EC, the substance can be classify as a single irritant category (Category 2) according to the criteria,section 3.2, table 3.2.2.

If, when applied to the skin of an animal, the substance produces:

(1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings 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

(2) 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

(3) 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.

Reversibility of skin lesions is the other decisive factor in evaluating responses in the animal test.

Observations at 1, 24, 48 and 72 hours revealed no skin irritation caused by 4 hours of exposure to the similar substance (mean scoring at 24, 48, 72 hours for oedema and erythema: 0)

Therefore, according to the paragraph 3.2. of the CLP Regulation n. 1272/2008, the similar substance shall be not classified as a skin irritant/skin corrosive.

According to the read-across from supporting substance-structural analogue evaluation, also the substance is not classified for this endpoint.

Eye irritation

Substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes).

According to the CLP Regulation 1272/2008/EC,using the results of animal testing the substance can be classify as a single irritant category (Category 2) according to the criteria, section 3.3, table 3.3.2

If, when applied to the eye of an animal, the 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 similar substance produced a positive response ≥ 2 on all the three rabbits, on conjunctival redness. The damage was fully reversible after 14 days, therefore the similar substance shall be classified, according to the CLP Regulation 1272/2008/EC,as Irritant, Category 2, H319.

According to the read-across from supporting substance-structural analogue evaluation, also the substance is classified as Irritant, Category 2, H319.