Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
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 irritation test was performed according to GLP and OECD 405. In both studies the test item 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, 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. DADPM/DEG-PO 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 the test item, 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. DADPM/DEG-PO was found to be non-irritating to the eye of rabbits (Calvert Laboratories, Inc, 2009d).
Effect level: empty Endpoint conclusion: No 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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