New incident report
Incident Report Number: 2024-1784
Registrant Reference Number: M-847216-01-1
Registrant Name (Full Legal Name no abbreviations): BAYER CROPSCIENCE INC.
Address: 160 QUARRY PARK BOULEVARD SE SUITE 130
City: CALGARY
Prov / State: AB
Country: CANADA
Postal Code: T2C 3G3
Scientific Study
PMRA Registration No. 35120 PMRA Submission No. EPA Registration No.
Product Name: DIFLUFENICAN TGAI
Unknown
Unknown
Title A 2-week dietary dose range finding study with diflufenican-acid in wistar han rats
Date 06-DEC-23
No
New health or environmental hazard
A 2-week dietary dose range finding study was conducted with the diflufenican metabolite, diflufenican-acid. Male and female rats were given carrier control item or 100, 320, or 1000 mg/kg/day diflufenican-acid via ad libitum access to diet for 14 days. Diflufenican-Acid-related decreased average body weight and/or average body weight gain were noted for animals given 1000 mg/kg/day. No alterations in body weight, compared to controls, was noted for females given 1000 mg/kg/day; however, minor body weight loss was noted on Days 1 to 4 and 11 to 14. Similar body weight loss effects were noted in the 28-day diflufenican technical dietary study (PMRA Number XXX). In this study, in the high dose male group, body weight and net body weight gain were lower when compared to the control group, but statistical significance was only achieved on week 1. For the female high dose group, the body weights were lower when compared to the control group, but statistical significance was only achieved during week 4. The body weight effects observed in the diflufenican-acid dietary study occurred in a shorter time period when compared to the diflufenican technical dietary study. It should be noted, however, that there was also an associated decrease in food consumption likely related to the palatability of the test item diet.
No
No impact expected to human health risk assessment.