scholarly journals Brief communication: new perspectives on the calculation of bioaccumulation factors for active substances in living organisms

2020 ◽  
Author(s):  
Aude Ratier ◽  
Christelle Lopes ◽  
Gauthier Multari ◽  
Vanessa Mazerolles ◽  
Patrice Carpentier ◽  
...  
Keyword(s):  
Plant Protection ◽  
Plant Protection Products ◽  
Daily Work ◽  
Bioaccumulation Factors ◽  
On Line ◽  
Living Organisms ◽  
User Friendly ◽  
Data Requirements ◽  
Active Substances ◽  
Test Guideline

AbstractToday, there are no ready-to-use convenient tools in ecotoxicology to diagnose and predict the accumulation and effects of chemical substances on living organisms, accounting for exposure situations that are known to be complex (routes of exposure, metabolization processes, cocktail effects, etc.). Regarding plant protection products in marketing authorization applications, regulation No 283/2013 (EU) defines the data requirements for active substances with a bioaccumulation test on fish according to OECD Test guideline 305. This paper presents new perspectives on the estimation of the bioaccumulation factors via an innovative ready-to-use web tool providing these factors, associated with their uncertainty to facilitate the daily work of regulators, but also of any user, by benefiting of a freely available and user-friendly on-line interface avoiding to invest into underlying mathematical and statistical technicalities. This tool, MOSAICbioacc, is available at https://mosaic.univ-lyon1.fr/bioacc, and can be used by any environmental scientists, ecotoxicologists or managers when accumulation-depuration data are collected and need to be easily and quickly analysed.

scholarly journals A ready-to-use online tool to calculate the BCF of active substances: MOSAIC bioacc

2021 ◽  
Author(s):  
Aude Ratier ◽  
Christelle Lopes ◽  
Gauthier Multari ◽  
Marc Babut ◽  
Vanessa Mazerolles ◽  
...  
Keyword(s):  
Experimental Data ◽  
Plant Protection ◽  
Parent Compound ◽  
Plant Protection Products ◽  
Model Parameters ◽  
Individual Traits ◽  
Scientific Opinion ◽  
On Line ◽  
Toxicokinetic Model ◽  
Active Substances

Toxicokinetic/toxicodynamic (TKTD) models are used to describe and predict the toxicity and the effects of chemical substances on individual traits based on experimental data. The toxicokinetic (TK) part describes the relationship between the exposure medium and the organism, considering various processes such as ADME (accumulation, depuration, metabolization and excretion). Regulation laying down the data requirements for active substances for the placing of plant protection products on the market, a bioaccumulation study on fish is required for substances with a partition coefficient octanol / water greater than or equal to 3, following the OECD guideline 305. Such a TK test allows to define the bioconcentration factor (BCF), the biomagnification factor (BMF) or the bioaccumulation factor (BAF). These factors are decisive criteria for estimating the concentration of active substances present in food items of vertebrates and more particularly of piscivorous birds and mammals. In a recent study, a relevant inference framework (Bayesian inference) was proposed to estimate toxicokinetic model parameters accounting for their correlation, based on the experimental data from standard guidelines and leading to the calculation of BCF/BMF/BAF. Models underlying this framework can be directly integrated and used as TK parts of TKTD models. Achieved in agreement with EFSA's scientific opinion on good modeling practices, the objective of this project is to develop a ready-to-use on-line tool for easily estimating BCF/BMF/BAF in a regulatory framework, by taking into account bioaccumulation of a parent compound and its metabolites through biotransformation. We built a Shiny interface to make available the inference method and the BCF/BMF/BAF calculation from the MOSAIC platform, which may be used for research as well as by companies or regulatory agencies. This tool will be integrated more broadly into the development and widespread use of TKTD models within the risk assessment framework.

Toxicokinetic mixture effects of co-formulants and active substances in plant protection products in vitro

2021 ◽  
Vol 350 ◽  
pp. S237
Author(s):  
M. Karaca ◽  
B. Fischer ◽  
C.T. Willenbockel ◽  
P. Marx-Stoelting ◽  
D. Bloch
Keyword(s):  
Plant Protection ◽  
Plant Protection Products ◽  
Mixture Effects ◽  
Active Substances

scholarly journals Application of the Threshold of Toxicological Concern (TTC) in Food Safety: Challenges and Opportunities

2021 ◽  
Vol 3 ◽  
Author(s):  
Rositsa Serafimova ◽  
Tamara Coja ◽  
George E. N. Kass
Keyword(s):  
Food Safety ◽  
Plant Protection ◽  
Plant Protection Products ◽  
The European Union ◽  
Use Of Data ◽  
Challenges And Opportunities ◽  
Guidance Documents ◽  
Threshold Of Toxicological Concern ◽  
Active Substances

The safety assessment of chemicals added or found in food has traditionally made use of data from in vivo studies performed on experimental animals. The nature and amount of data required to carry out a risk assessment is generally stipulated either in the different food legislations or in sectoral guidance documents. However, there are still cases where no or only limited experimental data are available or not specified by law, for example for contaminants or for some minor metabolites from active substances in plant protection products. For such cases, the Threshold of Toxicological Concern (TTC) can be applied. This review explores the use of the TTC approach in food safety in the European Union, in relation to the different food sectors, legal requirements and future opportunities.

Regulatory aspects of RNAi in plant production.

2021 ◽  
pp. 154-158
Author(s):  
Werner Schenkel ◽  
Achim Gathmann
Keyword(s):  
Small Rna ◽  
Plant Protection ◽  
Plant Protection Products ◽  
Plant Production ◽  
The European Union ◽  
Relevant Aspect ◽  
Rna Molecules ◽  
Rnai Technology ◽  
Living Organisms ◽  
Intended Use

Abstract Technologies based on RNA interference (RNAi) may be used in plant production in different contexts. With respect to applicable regulations, a major distinction is to be made between plants producing small RNA molecules due to modifications of the genome and topically applied plant protection products (PPPs) based on double-stranded RNA (dsRNA). The first group may be further divided into those using RNAi technology to achieve changes in the plant's metabolism and those where plant-produced RNA molecules are intended to impact other organisms that interact with the plant. For PPPs, relevant aspects are whether the product contains living organisms or only purified molecules. The intended use of the product is another relevant aspect with respect to regulation. It is expected that PPPs will be among the first products utilizing the RNAi mechanism in the European Union. This chapter discusses the regulation of modified RNAi plants and the regulation of PPPs utilizing RNAi mechanisms.

Sign in / Sign up

Export Citation Format

Share Document