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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4248

2. Registrant Information.

Registrant Reference Number: M-155495-01-1

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 technical powder: Acute dermal toxicity (limit test) in the rat

Date 31-AUG-88

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)

A rat dermal toxicology study (OECD 402) resulted in a LD50 2,000 mg/kg body weight. The previous dermal toxicity study in rabbits had an LD50 20,050 mg/kg. No toxicity was identified in this new species but the LD50 value was considerably lower, owing to dose selection.

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

LD50 2,000 mg/kg. Should not require PMRA or GHS categorization. Likely not reportable but lower LD50 in new species.