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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4254

2. Registrant Information.

Registrant Reference Number: M-638527-01-1

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. 27526      PMRA Submission No.       EPA Registration No.

Product Name: TRIFLOXYSTROBIN TECHNICAL FUNGICIDE

• Active Ingredient(s)
  • TRIFLOXYSTROBIN

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 Trifloxystrobin - Acute toxicity test with Daphnia longispina, basic test conditions following OECD TG 202

Date 31-AUG-18

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)

This GLP acute study was conducted with Daphnia longispina generally following OECD TG 202. The EC50 is lower than that observed in previous studies.

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 EC50 of this study is daphnia acute study is 0.00242 mg ai/L, which is lower than that used in the 2004 Regulatory Note (REG2004-03) which used an endpoint of 0.015 mg ai/L for the active ingredient. This is similar to two formulation studies also used in this assessment with EC50 values of 0.0081 and 0.0050 mg ai/L.