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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-0076

2. Registrant Information.

Registrant Reference Number: M-501339-01-1

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. 19204      PMRA Submission No.       EPA Registration No.

Product Name: PHENMEDIPHAM TECHNICAL HERBICIDE

• Active Ingredient(s)
  • PHENMEDIPHAM

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 Acute toxicity of BCS-AU61245 (m-toluidine) to the waterflea Daphnia magna in a static laboratory test system - Final report

Date 30-OCT-14

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)

The minor metabolite of phenmedipham, BCS-AU61245 (m-toluidine), was tested on Daphnia magna for 48 hours in a static exposure system to nominal concentrations of 20, 40, 80, 160, 320 and 640 Aug pure metabolite / L (corresponding to mean-measured concentrations of 17.5, 34.2, 68.4, 142, 295 and 582 Aug pure metabolite / L) in comparison to a control. The study was performed according to OECD test guideline 202 and OCSPP test guideline 850.1010. Test conditions met all guideline validity criteria. The 48-hour EC50=100 Aug pure metabolite/L (95% C.L. = 83 to 119 Aug pure metabolite/L) was based on immobilization of the daphnids. These values were lower than the previously reported daphnia 48-hour endpoints used in the risk assessment, which were determined as EC50=2033 Aug phenmedipham/L, and EC50=1880 Aug desmedipham/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

Phenmedipham is moderately toxic to freshwater aquatic animals on an acute exposure basis. The aquatic invertebrate study with a phenmedipham metabolite met reportability criteria for Canada due to lower endpoints as compared to the acute daphnia study (Daphnia magna). The lower endpoints do not affect the risk assessment for phenmedipham as the level of concern was low for adverse effects to freshwater invertebrates.