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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-6218

2. Registrant Information.

Registrant Reference Number: M-777972-01-2

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. 21903      PMRA Submission No.       EPA Registration No.


  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


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?


Subform VII: Scientific Study

1. Study Reference

Title Fenoxaprop-P-ethyl (AE F046360): An Oral (Gavage) Hershberger Assay in Peripubertal Orchidoepididymectomized Rats

Date 08-OCT-21

2. a) Is an extension needed to translate the document?


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)

Groups of peripubertal, orchidoepididymectomized male Crl:CD(SD) rats were dosed with fenoxaprop-P-ethyl via oral gavage once daily for 10 consecutive days at 10, 30, and 90 mg/kg/day level. All males survived to the scheduled necropsy. The seminal vesicle with coagulating gland and LABC muscle were statistically significantly decreased at 30 and 90 mg/kg/day. Higher mean liver weights were statistically significant in the 30 and 90 mg/kg/day test substance alone groups. Higher mean kidney weights were also noted at 90 mg/kg/day.

5. a) Was the study discontinued before completion?


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