Risk Assessment of the Insecticide/Acaricide Milbeknock with the Active Substance Milbemectin

Simple item page
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.authorRivedal, E.en_US
dc.contributor.authorRopstad, E.en_US
dc.contributor.authorØvrebø, S.en_US
dc.date.accessioned2023-07-14T08:08:11Z
dc.date.available2023-07-14T08:08:11Z
dc.date.issued2022-05
dc.description.abstractMilbeknock is a new insecticide/acaricide containing the new active substance milbemectin, which is a microbial fermentation product of Streptomyces. It is applied for control of mites and leafminers. The intended use is as a foliar spray in fruits (apples/pears), strawberries (only after harvest) and in ornamental plants growing in greenhouse and outdoors. The risk assessment was finalized at a meeting November 24, 2011, by VKM’s Scientific Panel on plant protection products (Panel 2). Panel 2 is in particular asked by the Norwegian Food Safety Authority to look at the following: 1) The human health risk for operators related to the properties of the active substance and the product. 2) The degree of oral absorption. 3) Acute toxicity. 4) The reproduction and developmental toxicity. 5) Establishment of reference values (ADI, AOEL and ARfD). 6) The fate and behaviour in the environment and environmental risk with regard to the properties of Milbeknock and milbemectin. 7) Bioavailability of milbemectin. 8) The microcosm study. VKM Panel 2’s conclusion is as follows: Health: Panel 2 proposes to set the absorption to 50%, which is in agreement with the EU DAR report (propose 47%). For acute toxicicity, Panel 2 concludes that milbemectin probably has a LD50 for dogs between 100 and 200 mg/kg body weight (bw)/day. Dogs seem to be the most sensitive experimental species and should be considered for hazard classification purposes. With respect to reproduction and developmental toxicity, Panel 2 concludes that the documentation of the role of the P-glycoprotein transporter is not convincing, and that the CF1 mice study cannot be used to support the argumentation of no developmental toxicity put forward by the applicant. The following reference values have been estimated: ADI of 0.03 mg/kg bw/day; AOEL of 0.015 mg/kg bw/day and ARfD of 0.067 mg/kg bw/day for milbemectin. Provided that personal protection equipment is used, the AOEL for operators is not exceeded. Environment: With respect to environmental fate, the opinion of the Panel is that the relatively rapid degradation in soil indicates a significant bioavailability in both soil and water-sediment systems. Further it concludes that 0.058µg/L should be regarded as NOECpopulation for the microcosm study. Panel 2 concludes that there is a medium risk of toxic effects on aquatic organisms due to exposure of milbemectin sprayed in fruits with the proposed application regime, provided that a buffer zone of 30 meters to surface water is applied. There are minimal risks of toxic effects on aquatic organisms with sufficient buffer zones in other applied crops. Panel 2 further considers the risk for foliage dwelling non-target predators and parasitoids to be high, and the risk to earthworms to be medium. The strong sorption to soil suggests that the bioavailability in soil may be limited. However, the opinion of the Panel is that the relatively rapid degradation in soil indicates a significant bioavailability. Also, for a substance with such a high log Kow the reported water solubility is relatively high, which will contribute to the availability for biological uptake. The toxicity observed in the microcosm study indicates high bioavailability also in a water/sediment system.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., Rivedal E., Ropstad E., Øvrebø S. . Risk Assessment of the Insecticide/Acaricide Milbeknock with the Active Substance Milbemectin. European Journal of Nutrition & Food Safety. 2022 May; 14(5): 1-3en_US
dc.identifier.issn2347-5641
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/219576
dc.languageenen_US
dc.publisherSciencedomain Internationalen_US
dc.relation.issuenumber5en_US
dc.relation.volume14en_US
dc.source.urihttps://doi.org/10.9734/ejnfs/2022/v14i530494en_US
dc.subjectVKMen_US
dc.subjectassessmenten_US
dc.subjectNorwegian scientific committee for food safetyen_US
dc.subjectmilbeknock.en_US
dc.titleRisk Assessment of the Insecticide/Acaricide Milbeknock with the Active Substance Milbemectinen_US
dc.typeJournal Articleen_US
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
EJNFS2022v14n5p1.pdf
Size:
199.02 KB
Format:
Adobe Portable Document Format
Download
Collections
European Journal of Nutrition & Food Safety