Health Canada
www.hc-sc.gc.ca
Common menu bar links
Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-4251
2. Registrant Information.
Registrant Reference Number: M-161496-01-1
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
3. Select the appropriate subform(s) for the incident.
Scientific Study
4. Date registrant was first informed of the incident.
5. Location of incident.
6. Date incident was first observed.
Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)PMRA Registration No. 20364 PMRA Submission No. EPA Registration No.
Product Name: ETHOFUMESATE TECHNICAL HERBICIDE
- Active Ingredient(s)
- ETHOFUMESATE
7. b) Type of formulation.
Application Information
8. Product was applied?
Unknown
9. Application Rate.
10. Site pesticide was applied to (select all that apply).
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform VII: Scientific Study
1. Study Reference
Title Ethofumesate: Dietary rat two-generation reproduction toxicity study
Date 22-AUG-90
2. a) Is an extension needed to translate the document?
No
3. Type of incident identified in the study
New health or environmental hazard
4. Describe the incident identified in the study (e.g. study demonstrates an increased risk to non-Hodgkin's Lymphoma after exposure to pesticide X)
Male and female rats, 25/sex/group (FO generation) of the OFA-SD (IOPS Caw) strain were dosed via the diet with ethofumesate at levels of 0, 3,000, 10,000, and 30,000 ppm. The achieved dosage ranges were 157 to 544mg/kg/day at 3,000 ppm, 540 to 1824mg/kg/day at 10,000 ppm, and 1621 to 5711 mg/kg/day at 30,000 ppm. At 30,000 ppm, pup body weights were reduced during lactation in the F1 and F2 generations and at 10,000 ppm, pup body weights were reduced in the F2 generation. In the F2 generation, litter size at birth was reduced at 30,000 ppm ethofumesate. At 30,000 ppm, the number of pups with eyes open at 15 days post-partum was lower than in controls in the F1 generation (not statistically significant), however, in the F2 generation, this incidence was significantly lower at 10,000 and 30,000 ppm. This delay in eye opening was consistent with the impact of ethofumesate on pup bodyweight.
5. a) Was the study discontinued before completion?
No
