Acute dermal toxicity study waiver: H113-8/2017-2E-PDF

"In December 2013, Health Canada’s Pest Management Regulatory Agency (PMRA) published the Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests for Pesticides, which defined situations under which applicants and registrants could apply for a data waiver for specific acute studies. The PMRA also co-led the development of an OECD Guidance Document, published in 2016, that further addressed data waivers for acute studies. More recently, an initiative to develop guidance on waiving acute dermal toxicity tests for pesticide formulations was undertaken under the auspices of the Canada-United States Regulatory Co-operation Council (RCC). A regulatory partnership between the PMRA and the United States Environmental Protection Agency’s (USEPA) Office of Pesticide Programs (OPP) on this initiative has facilitated the alignment of both countries’ regulatory approaches, while advancing efforts to implement the 3Rs of animal testing, namely, to reduce, refine, or replace the need for animal studies.This document describes the retrospective analyses undertaken by Health Canada’s PMRA and its commitment, under the RCC initiative, to publish guidance that outlines the Agency’s position on the use of acute oral toxicity studies as an alternate predictor of dermal hazard for the purpose of dermal hazard labelling for pesticides"--Background, p. 1.

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Department/Agency Health Canada. Pest Management Regulatory Agency.
Title Acute dermal toxicity study waiver
Series Title Regulatory proposal,
Publication Type Series - View Master Record
Language [English]
Other Language Editions [French]
Format Electronic
Electronic Document

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Note Issued also in French under title: Exemption concernant les études de toxicité aiguë par voie cutanée. Cover title. “1 March 2017.”
Date c2017.
Number of Pages 4 p.
Catalogue Number
  • H113-8/2017-2E-PDF
Subject Terms Pesticides, Toxicology, Animal testing