Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion study:

The study was carried out based on the guidelines described in: OECD No.404, "Acute Dermal Irritation/Corrosion" (2002)

EC, Council Directive 67/548/EEC, An.V, B.4 (2004), "Acute Toxicity: Dermal Irritation/ Corrosion" US EPA, OPPTS 870.2500 (1998), Acute Dermal Irritation

JMAFF Guidelines (2000) including the most recent partial revisions.

Three rabbits were exposed to 0.5 grams of the test substance, moistened with 50% watery ethanol, by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.

Exposure to the test substance resulted in scattered very slight erythema in the treated skin-areas of the rabbits, which had resolved within 24 hours. The results did not meet the classification criteria

Eye irritation/corrosion study:

The study was carried out based on the guidelines described in:

OECD No.405 (2002) "Acute Eye Irritation I Corrosion"

EC, Council Directive 67/548/EEC, An. V, B.5, (2004) "Acute Toxicity: Eye Irritation I Corrosion" EPA, OPPTS 870.2400 (1998): "Acute Eye Irritation"

JMAFF guidelines (2000); including the most recent partial revisions.

Single samples of approximately 30 mg of the test substance (a volume of approximately 0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours (all animals) and 7 days (two animals) after instillation.

Instillation of the test substance resulted irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 72 hours in two animals and within 7 days in the other animal. The results did not meet the classification criteria

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)

Additional information

Justification for classification or non-classification

The present studies did not meet the classification criteria according to CLP Regulation (EC) No 1272/2008 for skin or eye irritation.