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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4249

2. Registrant Information.

Registrant Reference Number: M-161477-01-1

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: Suite 200, 160 Quarry Park Boulevard SE


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.


PMRA Registration No. 20364      PMRA Submission No.       EPA Registration No.


  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


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?


Subform VII: Scientific Study

1. Study Reference

Title Ethofumesate: Oral (capsule/gavage) maximum tolerated dose (MTD) and 28 day repeat dose rangefinding in the dog

Date 22-APR-94

2. a) Is an extension needed to translate the document?


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)

In a 28-day oral study in dogs with ethofumesate technical at 2,000 mg/kg/day, minimal glomerular vacuolar degeneration was observed in the kidneys of one male and one female dog.

5. a) Was the study discontinued before completion?


5. b) Provide the reason for discontinuation

6. If the study is ongoing, what is the expected completion date?

For Registrant use only

7. Provide supplemental information here

This finding in the kidney was not observed in a 13 week dog study with ethofumesate technical at up to 1500 mg/kg/day (4/sex/group) nor in a 104 week dog study with ethofumesate technical at a dose of up to 625 mg/kg/day (8/sex/group). These studies were conducted with more animals per treatment group and for a longer treatment duration. Taken together with the kidney finding in the 28-day study being of minimal severity, the kidney may not be a relevant target organ for ethofumesate.