Registration Dossier

Administrative data

Description of key information

A skin irritation test was performed accoring to GLP and OECD guideline 404, using New Zealand White rabbits. The eye iriitation test was performed according to GLP and OECD 405. In both studies Daltolac 159 was considered not- irritating. 

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

The skin irritating study was perfoemd according to GLP and OECD guideline 404.The purpose of this study was to determine the potential irritant and/or corrosive effects of the test articles on the skin of rabbits.

The test article Daltolac XR 159, was initially applied to three sites on the clipped dorsal trunk of one New Zealand White rabbit. The exposure periods were 3 and 60 minutes and 4 hours, respectively. Observations for dermal irritation were recorded for each site immediately after patch removal, 30-60 minutes post-dose and daily through 72 hours. The four-hour site was scored at 24, 48 and 72 hours after unwrap.Grading of irritation was according to the method of Draize. Daltolac XR 159 was found to be non-irritating to the skin of rabbits (Calvert Laboratories, Inc, 2009c).

The eye irritation study was performed according to GLP and OECD guideline 405. In the animals receiving Daltolac XR 159, iritis was observed in one of three rabbits at 1 hour post treatment. Scores for conjuctival redness, chemosis and/or discharge were observed at 1, 24, 48 and/or 72 hour post-dose. There was no irritation present on Day 5 and the in-life study was terminated. Daltolac XR 159 was found to be non-irritating to the eye of rabbits (Calvert Laboratories, Inc, 2009d).

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

According to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the scores in the irritation studies do not warrant classification and labelling.