Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2019-6331
2. Registrant Information.
Registrant Reference Number: M-251515-01-1
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.
PMRA Submission No.
EPA Registration No. Unknown
Product Name: Mefenpyr-diethyl
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 IN VITRO CHROMOSOME ABERRATION TESTWITH CHINESE HAMSTER V79 CELLS
Date 18-APR-05
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)
In an in vitro assay, an increase in chromosome aberrations was observed for AE F094270 at 2200 ug/ml in the absence and presence of S9. In a second trial with S9, an increase in chromosome aberrations was seen at 1800 and 2000 ug/ml. Other assays, in vivo mouse micronucleus, Ames assay, and a forward mutation assay (V79/HPRT) were negative for genotoxicity. The parent compound is also negative for genotoxicity.
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
Study was conducted on AE F094720, a plant, animal and soil metabolite of mefenpyr-diethyl.