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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4252

2. Registrant Information.

Registrant Reference Number: M-352015-01-1

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 Carcinogenicity study with ethofumesate technical in Swiss albino mice

Date 01-FEB-02

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 an 18-month mouse carcinogenicity study with ethofumesate technical, no carcinogencity was observed. However, at 10,000 ppm, uterine epithelial thickening and squamous metaplasia was observed in terminally sacrificed high dose females which was considered treatment-related. However, there were no associated histopathological or other changes in endocrine organs (ovaries, adrenals and pituitary) or in mammary glands.

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

This study does not report any carcinogenicity and the existing chronic POD is lower than the NOAEL for this study, so these results would not affect the current risk assessment.