New incident report
Incident Report Number: 2022-4250
Registrant Reference Number: M-161494-01-1
Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.
Address: Suite 200, 160 Quarry Park Boulevard SE
City: CALGARY
Prov / State: AB
Country: Canada
Postal Code: T2C 3G3
Scientific Study
PMRA Registration No. 20364 PMRA Submission No. EPA Registration No.
Product Name: ETHOFUMESATE TECHNICAL HERBICIDE
Unknown
Unknown
Title Ethofumesate: Dietary rat general reproductive performance dose ranging study
Date 09-MAR-89
No
New health or environmental hazard
In a dose range finding reproduction study, groups of six male and six female rats (FO generation) of the OFA-SD (IOPS Caw) strain were dosed via the diet with ethofumesate at levels of 0, 3750, 7500, 15000, and 30000/50000 ppm, corresponding to up to 3458/6345 mg/kg/day in males/females. At top dose, 4/6 females died or were sacrificed during lactation. These animals exhibited reduced body weight gain/food consumption and had adverse clinical observations including hunched posture, lethargy, piloerection, and emaciation. Two of these animals exhibited thoracic hemorrhage and one had gastrointestinal tract lesions. The high dose resulted in reduced pup survival during lactation and reduced pub body weights. Pups in this group were small, lethargic, and hypothermic.
No
These observations in pups occurred at the highest tested dose at which there was significant maternal toxicity. These findings are not anticipated to set the point of departure for human health risk assessment owing to the high doses at which adverse effects were noted.