Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-4695
2. Registrant Information.
Registrant Reference Number: M-161486-01-1
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. 20364
PMRA Submission No.
EPA Registration No.
Product Name: ETHOFUMESATE TECHNICAL HERBICIDE
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 Chromosome analysis of Chinese hamster ovary cells treated in vitro with Ethofumesate
Date 08-MAY-87
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)
Ethofumesate induced structural chromosome aberrations in cultured CHO cells at the highest dose tested, 175 ug/mL only in the presence of the S-9 mix. Although considered a positive response, this dose was cytotoxic.
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
Ethofumesate induced structural chromosome aberrations in cultured CHO cells at a cytotoxic dose, the highest dose tested of 175 ug/mL and only in the presence of the S-9 mix. Although considered a positive response, the dose was high and considered cytotoxic. Ethofumesate is not considered genotoxic and testing of ethofumesate in human lymphoctyes was negative for chromosomal aberrations.