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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-1728

2. Registrant Information.

Registrant Reference Number: M-505517-01-1

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.

Active(s)

PMRA Registration No. 19205      PMRA Submission No.       EPA Registration No.

Product Name: TECHNICAL ETHEPHON

  • Active Ingredient(s)
    • ETHEPHON

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 Lemna gibba G3 - Growth inhibition test with Ethephon SL 480 A G under semi-static conditions

Date 03-DEC-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 NOEC for this study (based on measured values, ~0.013 mg a.i./L) is less than the current PMRA freshwater vascular plant endpoint for Ethephon.

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 current PMRA freshwater vascular plant endpoint for Ethephon is 70.7 mg a.i./L, indicating no effects seen. Since effects were seen in this study, it is reportable but we believe the study chosen for the PMRA risk assessment is valid for that purpose and this finding does not impact the risk determinations.