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Consumer Product Safety

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


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: Dietary rat two-generation reproduction toxicity study

Date 22-AUG-90

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)

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?


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