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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0047

2. Registrant Information.

Registrant Reference Number: SSIR-IFT-04Jan2022

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: Suite 200, 160 Quarry Park Blvd S.E.

City: Calgary

Prov / State: Alberta

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. 26141      PMRA Submission No.       EPA Registration No. 264-566

Product Name: ISOXAFLUTOLE TECHNICAL

• Active Ingredient(s)
  • ISOXAFLUTOLE

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 Isoxaflutole - Short-term reproduction assay with fathead minnow (Pimephales promelas)

Date 29-APR-21

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)

There was a survival effect on the fish during this endocrine screening study at the test concentration of 110 ug/L. The next lowest concentration tested was 33 ug/L. This appears to be lower than the current chronic fish NOEC that PMRA is considering in their risk assessments, thus would meet the criteria for incident reporting (SSIR).

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 enclosed fish short-term reproduction study was conducted to meet endocrine testing requirements for active ingredients in the EU, as was an amphibian metamorphosis assay [Urann, K; 2021; Modified amphibian metamorphosis assay with African clawed frog (Xenopus laevis); M-763982-01-1]. The amphibian metamorphosis assay does not meet the criteria for SSIR, but has been included here as supplemental information for completeness of the IFT database. EPA has previously acknowledged the limitations of this study type (endocrine screening, guideline OCSPP 890.1350) for use in chronic risk assessment; there are a limited number of test concentrations employed and a specific dose-spacing factor and these constraints do not provide for the type of dose-response analysis that lends to a robust risk assessment endpoint. PMRA has a fathead minnow early-life stage fish toxicity study with isoxaflutole (tech.) on file (PMRA doc. # 2713648). The parent isoxaflutole is relatively short-lived in the environment, as such an early life stage fish toxicity study with the metabolite RPA202248 would be considered the most appropriate study from which to derive endpoints for a chronic aquatic risk assessment. For completeness of the IFT database, the fathead minnow early life stage fish toxicity study with the metabolite RPA202248 (MRID 49273702) has been included as supplemental information, as well.