Arbejdsrapport fra Miljøstyrelsen, 23/1994

Health Assessment of Microbial Plant Protection Products


SURVEY OVER METHODS APPLICABLE FOR THE HEALTH ASSESSMENT OF MICROBIAL PLANT PROTECTION PRODUCTS AND MICROBIAL ACTIVE SUBSTANCES; INITIAL CONSIDERATIONS IN TOXICOLOGICAL TESTING OF MPPP'S AND MICROBIAL ACTIVE SUBSTANCES; GENERAL CONSIDERATIONS IN TOXICOLOGICAL TESTING OF A MICROBIAL PLANT PROTECTION PRODUCT/ACTIVE SUBSTANCE; GENERAL COMMENTS ON THE PRESENTED SURVEY; TOXICOLOGICAL, PATHOGENICITY AND INFECTIVITY STUDIES; BACTERIA, FUNGI, PROTOZA AND MYCOPLASMA; Toxicity and/or pathogenicity and infectivity : oral single dose : in cases where a single dose is not appropriate to assess pathogenicity, a set of range-finding tests must be carried out to reveal highly toxic agents and infectivity : percutaneous single dose : inhalation single dose : intraperitoneal single dose : skin and, where necessary, eye irritation : skin sensitization; Short-term toxicity (90 days exposure) : oral administration : other routes (inhalation, percutaneous as appropriate); Supplementary toxicological and/or pathogenicity and infecivity studies : oral long term toxicity and carcinogenicity : mutagenicity : teratogenicity studies : multigeneration study in mammals (at least two generations) : metabolic studies- absorption, distribution and excretion in mammals including elucidation of metabolic pathways : neurotoxicity, including where appropriate delayed neurotoxicity tests in adults hens : immunotoxicity, e.g. allergenicity : pathogenicity and infectivity under immunosuppression; Viruses, viroids : acute toxicity and/or pathogenicity and infectivity : short term toxicity and tests for infectivity carried out by bio-assay or on a suitable cell culture at least seven days after the last administration to the test animals; APPENDICES; Tests included in guidelines but not listed in the EEC directive under annex 2B, point 5; Overview of USEPA guidelines; Canadian guidelines; General remarks regarding UK test; WHO - basic principles

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