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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-1783

2. Registrant Information.

Registrant Reference Number: M-847000-01-1

Registrant Name (Full Legal Name no abbreviations): BAYER CROPSCIENCE INC.

Address: 160 QUARRY PARK BOULEVARD SE SUITE 130

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. 35120      PMRA Submission No.       EPA Registration No.

Product Name: DIFLUFENICAN TGAI

• Active Ingredient(s)
  • DIFLUFENICAN

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 A 2-week dietary dose range finding study with diflufenican-amide in rats

Date 06-DEC-23

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 2-week dietary dose range finding study was conducted with the diflufenican metabolite, diflufenican-amide. Male and female rats were given carrier control item or 100, 320, or 1000 mg/kg/day diflufenican-amide via ad libitum access to diet for 14 days. Males and females given 320 mg/kg/day were noted with decreased average body weight on Days 4, 8, 11, and 14, compared to controls. Males and females given 1000 mg/kg/day were noted with decreased average body weight on Days 4, 8, 11, and 14, compared to controls. Similar body weight loss effects were noted in the 28-day diflufenican technical dietary study (PMRA Number XXX). In this study, in the high dose male group, body weight and net body weight gain were lower when compared to the control group, but statistical significance was only achieved on week 1. For the female high dose group, the body weights were lower when compared to the control group, but statistical significance was only achieved during week 4. The body weight effects observed in the diflufenican-amide dietary study occurred in a shorter time period when compared to the diflufenican technical dietary study. It should be noted, however, that there was also an associated decrease in food consumption likely related to the palatability of the test item.

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

No impact expected to the human health risk assessment.