Registration Dossier
Registration Dossier
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EC number: 239-346-4 | CAS number: 15307-79-6
Endpoint summary
Administrative data
Description of key information
Diclofenac Sodium Salt has been testd in mice, rats, rabbits, dogs and rhesus monkeys.
The LD50 oral in rats was 115 mg/kg.
The LD50 oral in rabbits was 213 mg/kg.
The LD50 oral in mice was 170 mg/kg.
The LD50 oral in rhesus monkeys was 3200 mg/kg.
Key value for chemical safety assessment
Additional information
A review of the results of studies with single administration by several routes to various animal species indicate that diclofenac sodium has a low to moderate degree of acute toxicity. Monkeys are a better model for man than rats in the toxicity evaluation of drugs with the given pharmacodynamics.
Based on a weight of evidence approach with respect to all available data the substance is classified in hazard class Acute Oral Toxicity Cat. 4 (H302).
Justification for classification or non-classification
Based on the present studies and according the classification criteria described in REGULATION (EC) No 1272/2008 (CLP), the product has has been classified in hazard Class Acute Oral Toxicity, Cat. 4.
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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