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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-5204

2. Registrant Information.

Registrant Reference Number: M-772398-01-1

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. 29068      PMRA Submission No.       EPA Registration No.

Product Name: THIENCARBAZONE-METHYL TECHNICAL HERBICIDE

• Active Ingredient(s)
  • THIENCARBAZONE-METHYL

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 BYH 18636- N-desmethyl (M07): Micronucleus Test in Human Lymphocytes in vitro

Date 14-JUL-21

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 minor plant metabolite (N-desmethyl) of thiencarbazone methyl herbicide tested positive in an in vitro micronucleus assay at 2000 ug/mL. Follow up fluorescence in situ hybridization indicated a clastogenic response.

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

In vitro clastogencity test on this metabolite was negative. Follow up in vivo study will be conducted to evaluate biological relevance. In vivo results are not necessarily predictive of in vivo results. The weight of the evidence can be used to evaluate potential genotoxicity.