Registration Dossier

Administrative data

Description of key information

slightly irritant when administered by dermal and ocular route in rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

The potential of the test item was evaluated following a single topical applications to rabbits according to OECD (No. 404, 24th April 2002) and Council Regulation (EC) (No. 440/2008, B.4, 30 May 2008) guidelines (Rokh, 2009). The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. The test item was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit. Since the test item was neither severely irritant nor corrosive on this first animal, it was then applied simultaneously for 4 hours to two other animals. A single dose of 0.5 mL of the undiluted test item was applied to the closely-clipped skin of one flank. The test item was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until reversibility of cutaneous reactions (at least day 8). The mean values of the scores for erythema and edema were calculated for each animal. After a 3-minute exposure (one animal), a well-defined then very slight erythema was noted from day 1 until day 7. A very slight edema was observed on days 1 and 2. After a 1-hour exposure (one animal), a very slight erythema was noted from day 1 until day 7. After a 4-hour exposure (three animals), a very slight or well-defined erythema was noted in all animals on day 1. A very slight erythema persisted in two of them until day 5 (No. 938) or 6 (No. 935). Dryness of the skin was noted in animal No. 938 on days 5 and 6. Mean scores over 24, 48 and 72 hours for each animal were 1.0, 0.0 and 1.0 for erythema and 0.0, 0.0 and 0.0 for edema. The test item was slightly irritant when applied topically to rabbits.

Eye irritation

The potential of the test item to induce ocular irritation was evaluated following a single topical applications to rabbits according to OECD (No. 405, 24th April 2002) and Council Regulation (EC) (No. 440/2008, B.5, 30 May 2008) guidelines (Rokh, 2010). The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. The test item was first administered to a single male New Zealand White rabbit. Since the test item was not severely irritant on this first animal, it was then evaluated simultaneously in two other animals. A single dose of 0.1 mL of the undiluted test item was instilled into the left conjunctival sac. The right eye was not treated and served as control. The eyes were not rinsed after administration of the test item. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal. A slight or moderate chemosis was noted in all animals from day 1 until day 3 (2/3 animals) or 5 (1/3 animals). A slight or moderate redness of the conjunctiva was observed in all animals from day 1 until day 4 (2/3 animals) or 5 (1/3 animals). A clear to whitish purulent discharge was observed in all animals on days 2 and 3. Iris lesions were noted in 2/3 animals on day 2. Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 2.0 and 1.0 for chemosis, 1.7, 2.0 and 1.3 for redness of the conjunctiva, 0.3, 0.3 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity. Under these experimental conditions, the test item was slightly irritant when administered by ocular route to rabbits.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

No classification is warranted for skin and eye irritation under EU Dangerous Substances Directive 67/548/EEC or CLP EU Regulation 1272/2008.