Nouvelle déclaration d'incident
No de la demande: 2013-0867
Numéro de référence du titulaire d'homologation: 112911
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer CropScience Inc.
Adresse: 295 Henderson Drive
Ville: Regina
État: SK
Pays: Canada
Code postal /Zip: S4N 6C2
Étude scientifique
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 264-746
Nom du produit: Baythroid
Inconnu
Inconnu
Titre Assessment of Pubertal Development and Thyroid Function in Juvenile/Peripubertal Male and Female Rats
Date 27-JUN-11
Non
Augmentation du risque sanitaire ou environnemental
Pursuant to the Agencys interpretation of requirements imposed on registrants by way of Section 6(a)(2) of FIFRA, Bayer CropScience LP (BCS), is conservatively submitting studies whose effects are potentially deemed reportable adverse effects associated with Cyfluthrin as per guidance offered by the EPA in 75 FR 70566-70567, and in correspondence as per their letter dated July 15, 2011. With the submission of the studies to PMRA, and concurrently a list of studies to OPPs 6(a)(2) Document Processing Office, BCS believes it has completed its reporting obligations in response to its understanding of PMRAs interpretation of Incident Reporting Regulation and EPAs interpretation of FIFRA 6(a)(2) requirements for EDSP screening assays and 40 C.F.R. 159.158(a) and 40 C.F.R. 159.195(a). This notice does not necessarily reflect a new adverse effect of the subject chemical, but may meet the criteria identified in 40 CFR 159.165(a) and 40 CFR 159.158(a).The Tier 1 EDSP test battery is intended for screening purposes only and should not be used for endocrine classification or risk assessment. Results of the Tier 1 screening battery, along with other scientifically relevant information, are to be used in a weight-of- evidence determination of a substances potential to interact with the androgen, estrogen, or thyroid systems. The fact that a substance may interact with a hormone system does not mean that when the substance is used, it will cause adverse effects in humans or ecological systems.
Non