Registration Dossier

Administrative data

Description of key information

The test item was tested for skin irritation/corrosion properties in a non-GLP study according to OECD 404 with rabbits. The test item was classified as not irritating to the skin.
The test item was tested for eye irritation properties in a GLP study according to OECD 405 with rabbits and was found to cause serious damage to the rabbit eye.

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)

Additional information

Skin:

Pyruvaldehyde was tested for skin irritation/corrosion properties in a non-GLP study with rabbits according OECD 404. A test patch was soaked with the undiluted test item. It was estimated in the study report that 0.5 mL of liquid was absorbed. The patch was applied to the dorsal skin and ear of three Vienna white rabbits. Exposure duration was 4 hours. The test substance caused slight (one animal, reversible) or no (two animals) erythema and no edema in all animals. After the 8 days observation, no effects were visible on the dorsal exposure sites. The test item was classified non irritating to the skin (BASF AG, 1987).

Eye:

Pyruvaldehyde was tested for eye irritation properties in a GLP study according to OECD 405 using rabbits. The test item was applied unchanged (30%) at a dose of 0.1 mL to the right eye of three Vienna white rabbits. Necropsy of one animal found dead on day 3 diagnosed a coccidia infection, and in consequence only data from 24 and 48 h were available from this animal. Both remaining rabbits were euthanased on day 15 due to severe irritation at the cornea (Draize score cornea: 3 or 4) and the conjunctiva (redness score: both 2; chemosis score: both 1). The test item was therefore classified as an eye irritant (BASF, 1987).


Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the results, classification for skin irritation is not warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.

Based on the results of the in vivo eye irritation study, the test substance is classified as Xi, R41 (risk of serious damage to eyes) according to the criteria of EU Directive 67/548/EEC and as eye damage cat. 1, H318 (Causes serious eye damage) according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.