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Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2022-5973

2. Registrant Information.

Registrant Reference Number: M-464613-01-1

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 Zebra fish (Danio rerio), life cycle test, flow through conditions - Ethofumesate

Date 20-AUG-13

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

No

3. Type of incident identified in the study

Increased health or environmental risk

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 160-day full life cycle (FLC) study of the freshwater Zebrafish (Danio rerio) with TGAI, the no observed adverse effect concentration (NOAEC) was non-definitive (i.e., NOAEC 306 g a.i./L) and was based on a 5-8% reduction in F0 spawning male and female length, 13% reduction in F0 spawning female weight, and 9% reduction in F0 4-week post-hatch length at the LOAEC of 306 g a.i./L (the lowest test concentration). The aim was to assess the effects of continuous exposure to ethofumesate technical on different life stages of zebrafish (Danio rerio) during a life cycle, including early life stages, juvenile growth, reproduction of the parental generation (P generation) and the early life stages of the filial generation (F1-generation). However, this study (MRID 50279402) was classified as supplemental in the EPA risk assessment since it did not test low enough and the NOAEC was established as 306 g a.i./L.

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

The endpoint values in the fish full life cycle study were originally evaluated in the EPA risk assessment for ethofumesate. Therefore, this study information does not impact the current risk assessment for Canada.