Registration Dossier

Administrative data

Description of key information

Test substance was found to be non-irritant to skin or eyes as tested in rabbits in protocols equivalent or similar to OECD 404 and 405.

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

Test substance was evaluated for its irritating properties on skin and eyes of rabbits (Ciba-Geigy, 1975). The procedures used was the test for skin and eye irritants described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). This is more stringent than the current OECD testing guideline case of the skin irritation study and comparable in the case of the eye irritation study.

Two days before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on the left side was slightly abraded. For treatment gauze patches of 2.5 x 2.5 cm soaked with the test substance were applied to the prepared abraded and non abraded skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour exposure. The skin irritation was scored immediately and 48 hours after removal of the dressings (24 and 72 hours after initiation of treatment). The primary skin irritation index in this experiment was established to be 0.

The test material in amounts of 0.1 g was inserted into the conjunctival sac of the left eye of 6 rabbits and the lids were gently held open for one second. The right eye remained untreated and served as a control. In 3 rabbits about 30 seconds after administration the treated eyes were flushed with 10 ml lukewarm water. The eye irritation was appraised with a slit-lamp at day 1, 2, 3, 4 and 7. The primary eye irritation index represents the sum of the mean values for cornea, iris and conjunctivae at day 1, 2, 3, 4 and 7. The irritation index was established to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.

No data are available for respiratory irritation. In the absence of adverse findings on skin and in eyes, respiratory irritation is not expected.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin and eye irritation under Regulation (EC) No. 1272/2008.