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 degree of skin irritation caused by the substance was determined after its application to shaved rabbit skin, according to the OECD Guideline No. 404 (1992) and the method B.4 of the EEC Guidelines of 31st July 1992 (92/69/EEC). The substance was applied using a semi-occlusive patch, left for 4 hours.

The mean values (24/48/72 h) for edema scores were 0 in all animals; for erythema scores were 0.67, 1 and 0 in animals #1, #2 and #3 respectively. All the effects observed were fully reversible within the 7day-study period.

 

EYE IRRITATION/CORROSION

The test substance was tested in order to evaluate the primary eye irritation, according to the OECD Guideline No. 405 (1987) and to the method B.5 of the EEC Directive of 31st July 1992 (92/69/EEC).

The mean values (24/48/72 h) for corneal opacity and iris scores were 0 in all animals; for conjunctivae redness were 1.33 all animals. The mean scores for conjunctivae edema were 0.33 in one animal (#1) and 0 the other two animals (#2 and #3). In the observations performed at 14 days after treatment, the said alterations were observed to be reversible.

Justification for classification or non-classification

SKIN IRRITATION/CORROSION

According to the CLP Regulation (EC) no. 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 tested animals from readings 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 available experimental data of skin irritation, 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) no. 1272/2008.

 

EYE IRRITATION

According to the CLP Regulation (EC) no. 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 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 available experimental data of eye irritation, the mean scores (24/48/72h) of corneal opacity and iritis were not ≥ 1 and conjunctival redness and conjunctival oedema (chemosis) were not ≥ 2. Moreover, all effects observed were fully reversible within the 14 day-study period. Therefore, the substance is not classified for eye irritation according to the CLP Regulation (EC) no. 1272/2008.