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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-1923
2. Registrant Information.
Registrant Reference Number: M-761798-01-2
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.
Active(s)PMRA Registration No. 26232 PMRA Submission No. EPA Registration No.
Product Name: FOE 5043 TECHNICAL HERBICIDE
- Active Ingredient(s)
- FLUFENACET
- Guarantee/concentration 97.9 %
- 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 A Hershberger Assay of Flufenacet Technical Substance Administered Orally in Peripubertal Orchidoepididymectomized Rats
Date 09-NOV-20
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)
Groups of peripubertal, orchidoepididymectomized male Crl:CD(SD) rats were dosed with flufenacet via oral gavage once daily for 10 consecutive days. The doses administered were 0, 62.5, 125, or 250 mg/kg/day flufenacet; additional groups included 0.2 mg/kg/day testosterone propionate (TP) and 3 mg/kg/day flutamide. In the 250 mg/kg/day groups, 4 animals were found dead on Study Day 0 (at the 10-hour postdosing observations) or Study Day 1. These deaths were considered likely treatment-related by the study director. Lower mean body weight gains and body weight losses were also noted and were considered a test substance effect by the study director; however, these differences had no effect on mean absolute body weights at any dose level. Androgenic antagonism, evidenced by lower mean levator ani bulbocavernosus (LABC) and seminal vesicle with coagulating gland weights, was noted in the 62.5, 125, and 250 mg/kg/day groups co-administered with TP. Furthermore, test substance-related higher mean liver weights were noted in the 62.5, 125, and 250 mg/kg/day groups.
5. a) Was the study discontinued before completion?
No
