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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-1644

2. Registrant Information.

Registrant Reference Number: M-805922-01-1

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.

Active(s)

PMRA Registration No. 30358      PMRA Submission No.       EPA Registration No.

Product Name: PENFLUFEN TC

  • Active Ingredient(s)
    • PENFLUFEN

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 Penflufen tech. - Single Exposure of Honey Bee (Apis mellifera L.) Larvae under Laboratory Conditions (in vitro)

Date 23-MAR-22

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)

First instar honey bee larvae of Apis mellifera were exposed once (on day 4) via the diet to no (controls) and five concentrations of Penflufen tech (98.8%) and assessed for effects on mortality from days 4 through 7 of the study. The LD50/LC50 endpoint was more than 2x lower than the previously known LD50/LC50 for honey bees (i.e. 108g/bee).

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 values for LD10,20,50 (larval mortality on D7) were estimated to be beyond the tested range (15g a.s./larva). The LC10,20,50 were estimated to be beyond the tested range (440 mg a.s./kg food).