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Diss Factsheets

Administrative data

Description of key information

Skin and eye irritation studies have been conducted on HFE-7300.  The results of the studies are: 
Eye irritation: Non-irritating
Skin irritation: Non-irritating

Key value for chemical safety assessment

Additional information

The eye irritation potential of the test material was evaluated in New Zealand White rabbits. The study was conducted in compliance with OECD GLP (1997) regulations. The test method was based on OECD No 405 (2002); EC Directive 67/548/EEC, An. V, B.5 (2004); OPPTS 870.2400 (1998); JMAFF guidelines (2000). Single samples of 0.1 ml of the test article (liquid - dosed undilluted) were instilled into one eye of each of three rabbits. Observations were made at 1, 24, 48, and 72 hours after instillation. Conjunctival redness (Grade 1) was observed in all animals at 1 hour, and persisted in a single animal at 24 hours. No other scores were observed at any other time point. Based on the results of the study, the test article is considered non-irritating to the eye.

 

The skin irritation potential of the test material was evaluated in New Zealand White rabbits. The study was conducted in compliance with OECD GLP (1997) regulations. The test method was based on OECD No. 404 (2002); EC Directive 67/548/EEC, An.V, B.4 (2004); OPPTS 870.2500 (1998); JMAFF Guidelines (2000) Three rabbits were exposed to 0.5 ml of the test article (liquid - dosed undiluted) applied to clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed at 1, 24, 48, and 72 hours after exposure. Exposure to the test article resulted in very slight edema in the treated skin areas of 2 rabbits which resolved by 24 hours. Based on these result of the study, the test article is considered non-irritating to the skin.

Justification for classification or non-classification

Criteria for classifying as a skin or eye irritant are not met.