Risk Assessment of the Insecticide Plenum 50 WG with the Active Substances Pymetrozine

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dc.contributor.authorSverdrup, L. E.en_US
dc.contributor.authorBjørge, C.en_US
dc.contributor.authorEklo, O. M.en_US
dc.contributor.authorGrung, M.en_US
dc.contributor.authorKällqvist, T.en_US
dc.contributor.authorKlingen, I.en_US
dc.contributor.authorLåg, M.en_US
dc.contributor.authorRopstad, E.en_US
dc.contributor.authorØvrebø, S.en_US
dc.contributor.authorRivedal, E.en_US
dc.date.accessioned2023-07-14T08:08:13Z
dc.date.available2023-07-14T08:08:13Z
dc.date.issued2022-10
dc.description.abstractPlenum is a new insecticide containing the new active substance pymetrozine. Plenum is an insecticide against different pests in ornamentals, lettuce, cucumber and tomato in greenhouse and against pollen beetles in oilseed- and turnip rapes. The risk assessment was finalized at a meeting Mai 29, 2012, by VKM’s Scientific Panel on plant protection products (VKM). The Panel is in particular asked by the Norwegian Food Safety Authority to look at the following: The human health risk for operators related to the properties of the active substance and the product. The Panel is in particular asked to look at the following: o The effects seen in studies on dog and if these effects warrant a classification for chronic toxicity. o The oncogenic effects in liver and lungs o The genotoxicity of metabolite CGA 300407. o The effects on reproduction and if the effects seen in teratology studies and developmental neurotoxicity study warrant a classification for developmental toxicity o The establishment of NOAELs and reference values (ADI, AOEL and ARfD). o The classification and labelling of the active substances and the product. VKM’s conclusion is as follows: The effects reported in the repeated dose toxicity studies with dogs should be considered as adverse. The increased incidence of liver and lung tumors should be considered as relevant for humans. It cannot be excluded that a genotoxic mechanism could be involved in the formation of the liver tumors, which would have implications for risk assessment. It should therefore be considered to test pymetrozine in more sensitive in vivo genotoxic endpoints in liver. The effects reported in the teratogenicity studies in rats and rabbits and in the developmental neurotoxicity study in rats should be considered for a classification of pymetrozine for developmental toxicity. Risk calculations with both the German model and the UK POEM show low risk if personal protection equipment is used. VKM propose: NOAEL of 0.6 mg/kg bw/day for pymetrozine based on the 1-year study in dogs. AOEL of 0.006 mg/kg bw/day for pymetrozine based on the NOAEL value at 0.6 mg/kg bw/day from the one year study in dogs and an UF of 100. ADI of 0.006 for pymetrozine based on the NOAEL value at 0.6 mg/kg bw/day from the one year study in dogs and an UF of 100. ARfD of 0.02 mg/kg bw/day for pymetrozine based on the LOAEL value at 8.1 mg/kg bw/day from the developmental neurotoxicity study and an UF of 500 (10 x interspecies difference, 10 x intraspecies difference, 3 x due to the use of a LOAEL value and 2 x due to the adversity of the neurodevelopmental effects). VKM supports the classification proposal from Norwegian Food Safety Authority.en_US
dc.identifier.affiliationsNorwegian Scientific Committee for Food Safety (VKM), Det Norske Veritas, Norwayen_US
dc.identifier.affiliationsNorwegian Scientific Committee for Food Safety (VKM), Norwegian Enviroment Agency, Norwayen_US
dc.identifier.affiliationsNorwegian Scientific Committee for Food Safety (VKM), Norwegian Institute of Bioeconomy Research, Norwayen_US
dc.identifier.affiliationsUniversity of Oslo / Norwegian Scientific Committee for Food Safety (VKM), Norwegian Institute for Water Research, Norwayen_US
dc.identifier.affiliationsNorwegian Scientific Committee for Food Safety (VKM),Norwegian Institute of Public Health (FHI), Norwayen_US
dc.identifier.affiliationsNorwegian Scientific Committee for Food Safety (VKM), Oslo University Hospital, Norwayen_US
dc.identifier.affiliationsNorwegian Scientific Committee for Food Safety (VKM), Norwegian University of Life Sciences, Norwayen_US
dc.identifier.affiliationsNorwegian Scientific Committee for Food Safety (VKM), National Institute of Occupational Health, Norwayen_US
dc.identifier.citationSverdrup L. E., Bjørge C., Eklo O. M., Grung M., Källqvist T., Klingen I., Låg M., Ropstad E., Øvrebø S.,Rivedal E.. Risk Assessment of the Insecticide Plenum 50 WG with the Active Substances Pymetrozine. European Journal of Nutrition & Food Safety. 2022 Oct; 14(10): 12-14en_US
dc.identifier.issn2347-5641
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/219615
dc.languageenen_US
dc.publisherSciencedomain Internationalen_US
dc.relation.issuenumber10en_US
dc.relation.volume14en_US
dc.source.urihttps://doi.org/10.9734/ejnfs/2022/v14i1030534en_US
dc.subjectVKMen_US
dc.subjectassessmenten_US
dc.subjectNorwegian Scientific Committee for Food Safetyen_US
dc.subjectinsecticide.en_US
dc.titleRisk Assessment of the Insecticide Plenum 50 WG with the Active Substances Pymetrozineen_US
dc.typeJournal Articleen_US
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