Print | Need Larger Text?

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0075

2. Registrant Information.

Registrant Reference Number: SSIR-TFA-29Dec2021

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. 26232      PMRA Submission No.       EPA Registration No. 264-764

Product Name: FOE 5043 TECHNICAL HERBICIDE

• Active Ingredient(s)
  • FLUFENACET

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 Sodium trifluoroacetate: Study for effects on embryo-fetal development in the New Zealand white rabbit by oral gavage administration

Date 27-OCT-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 developmental toxicity study in pregnant New Zealand white rabbits was conducted with the sodium salt of trifluoroacetic acid, based on OECD Test Guideline 414. Twenty-four pregnant rabbits per dose level received daily treatment of 99.9% sodium salt of trifluoracetic acid by oral gavage from gestational days 6 to 28 at dose levels of 0, 180, 375 and 750 mg/kg bw/day. A detailed summary of the maternal and fetal findings is included in the summary document (DACO 4.5/4.8) submitted as supplemental file with this incident report.

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

Follow-up studies in-vitro/in-vivo are underway. The available study database for TFA/DevTox is included as supplementary files with this incident report; EOGRTS in rats - experimental phase completed, final report will be submitted upon completion.