Registration Dossier

Administrative data

Description of key information

The test substance was corrosive in an OECD 404 guideline study and has (assumed) irreversible effects on the eye, as shown in an OECD guideline 405 study.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an in vivo skin irritation study, performed according to OECD guideline 404, two male New Zealand white rabbits were exposed to approx. 0.5 mL undiluted test substance on the dorsal shaved skin under semi-occlusive conditions for 4 hours. Severe erythema was observed at 1 hour after removal of the test substance. One of the animals showed slight edema at this time point. Both animals showed beginning necrosis. After 24, 48 and 72 hours severe erythema, slight edema and necrosis were observed in both animals. The study was aborted after 72 hours because of the strong reactions in both studies.

In an in vivo eye irritation study, performed according to methods that were comparable to OECD guideline 405, one New Zealand white rabbit was exposed to 0.1 mL undiluted test substance in the eye, which remained unwashed. Observations were performed 1, 24, 48 and 72 hours after application of the test material, after which the rabbit was sacrificed. Administration of the test substance resulted in corneal effects (opacity) and iridal effects. Conjunctival redness, chemosis and discharge was observed after 1 hour. The corneal opacity, iridal and conjunctival effects remained during the 72-hour period.

Justification for classification or non-classification

Based on the available information the test substance needs to be classified as Skin Corrosive 1: H314: Causes severe skin burns and eye damage, in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.

Based on the available information the test substance needs to be classified as Eye Damage 1: H318: Causes serious eye damage, in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.