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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-5119

2. Registrant Information.

Registrant Reference Number: M-049090-01-1

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: FLINT

• Active Ingredient(s)
  • TRIFLOXYSTROBIN (CGA 279202)

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 Micronucleus test for Flint

Date 26-AUG-99

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)

A group of 12 Swiss male mice received by intraperitonial administration 550 mg/kg of NVF 026-99, equivalent to 80% of the LD50 (687 mg/kg). Two concurrent control groups, negative and positive received the vehicle (deionized water, 5mL/kg) and cyclophosphamide (50 mg/kg), respectively. One animal of the experimental group died after the treatment with NVF 026-99 and one was scarified at random and taken out of the experimental group, so that 10 animals were analyzed per group.

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

An experimental animal died after the treatment of Flint at a dose that was 80% of the reported LD50. This is likely reportable since the death occurred below the reported LD50, and would be considered a new route of exposure. In this case, by IP (intraperitoneal) injection versus an oral exposure that would be used during the acute study. However, this information should not affect the risk assessment as IP injection is not considered a relevant route of exposure in humans.