Nouvelle déclaration d'incident
No de la demande: 2022-1742
Numéro de référence du titulaire d'homologation: M-769030-02-1
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer CropScience Inc.
Adresse: Suite 200, 160 Quarry Park Boulevard SE
Ville: CALGARY
État: AB
Pays: Canada
Code postal /Zip: T2C 3G3
Étude scientifique
ARLA No d'homologation 30219 ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: INDAZIFLAM TECHNICAL HERBICIDE
Inconnu
Inconnu
Titre Indaziflam - Short-Term Reproduction Assay with Fathead Minnow (Pimephales promelas) - Amended Final Report -
Date 04-JUN-21
Non
Augmentation du risque sanitaire ou environnemental
There was a survival effect on the fish during this study at the test concentration of 190 ug/L. The next lowest concentration tested was 64 ug/L. This appears to be lower than the current chronic fish NOEC that PMRA is considering in their risk assessments, thus would meet the criteria for adverse effects reporting.
Non
However, this study is not considered appropriate for assessing chronic risk to fish because this is an endocrine screening study, and as such there are a limited number of test concentrations employed and a specific dose-spacing factor, and these constraints do not provide for the type of dose-response analysis that lends to a robust risk assessment endpoint. EPA has previously acknowledged the limitations of this guideline study type (OCSPP 890.1350) for use in risk assessment. The fish short-term reproduction study was conducted to meet endocrine testing requirements for activeingredients in the EU as was an amphibian metamorphosis assay [Snow, A; 2021; Indaziflam - Modified amphibian metamorphosis assay with African clawed frog (Xenopus laevis); M-761878-02-02]. The amphibian metamorphosis assay does not meet the criteria for adverse effects reporting, but we are providing it for completeness of the Indaziflam data package.