Non-relevance of acute dermal toxicity testing for assessing human health protection in the regulatory decision-making for agrochemical formulated products.

Autor: Latorre AO; Bayer S.A., Rua Domingos Jorge, 1100, Sao Paulo, SP, Brazil. Electronic address: andreia.latorre@bayer.com., Floresta PVM; Corteva, Alameda Itapecuru, 506, Alphaville, Barueri, SP, Brazil., Boff MM; IHARABRAS S.A. INDUSTRIAS QUIMICAS, Avenida Liberdade, Sorocaba, SP, Brazil., Fagundes PM; Syngenta Crop Protection, Avenida das Nacoes Unidas, 18001, Sao Paulo, SP, Brazil., Martins AP; FMC Química do Brasil LTDA, Av. Dr. Jose Bonifacio Coutinho Nogueira, 150, Campinas, SP, Brazil., Ihlaseh-Catalano SM; BASF S.A., Avenida das Nacoes Unidas, 12997, 17279, Sao Paulo, SP, Brazil., Cazarin KCC; BASF S.A., Avenida das Nacoes Unidas, 12997, 17279, Sao Paulo, SP, Brazil., Romeo LL; Bayer S.A., Rua Domingos Jorge, 1100, Sao Paulo, SP, Brazil.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2019 Aug; Vol. 106, pp. 105-110. Date of Electronic Publication: 2019 Apr 25.
DOI: 10.1016/j.yrtph.2019.04.014
Abstrakt: Compared to oral toxicity tests, dermal toxicity tests offer little or no additional scientific information or public health protection for agrochemical-formulated products (US EPA, 2016). Based on that, a retrospective analysis of the results of acute oral and dermal LD 50 studies of agrochemical products registered in Brazil was carried out by the Technical Group on Toxicological Risk Assessment (GT-ART) of the Brazilian Crop Protection Association (ANDEF). The data were obtained from 6 agrochemical industries that are associated to ANDEF, following these considerations: only rat studies were selected; only paired studies were chosen; only studies performed with top doses ≥2,000 mg/kg were selected; biological products were excluded. The dataset includes 342 formulated products in 21 formulation types. Among these 342 formulated products, 228 have a single active ingredient, 107 have 2 and 7 have 3 or more. The comparison of acute oral to dermal toxicity studies of agrochemical-formulated products registered in Brazil corroborates the United States Environmental Protection Agency (US EPA) conclusion on waiving acute dermal toxicity tests, which will result in avoiding unnecessary use of time and resources, data generation costs and animal testing.
(Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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