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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4250

2. Registrant Information.

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

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.

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 general reproductive performance dose ranging study

Date 09-MAR-89

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)

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.

5. a) Was the study discontinued before completion?

No

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

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.