Print | Need Larger Text?

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-1236

2. Registrant Information.

Registrant Reference Number: M-800867-01-1

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.

PMRA Registration No. 19535      PMRA Submission No.       EPA Registration No.

Product Name: GLYPHOSATE TECHNICAL GRADE

• Active Ingredient(s)
  • GLYPHOSATE

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 Imino-bis-methylene-bis-phosphonic acid (IMINOBIS): Micronucleus Test in Human Lymphocytes in vitro

Date 06-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 manufacturing impurity of glyphosate, iminobis (imino-bis-methylene-bis-phosphonic acid, CAS 17261-34-6) was tested in an in vitro micronucleus assay. Preliminary data for the high dose group with 4-hours exposure and metabolic activation (+S9) demonstrated a stastically significant increase in the percentage of binucleated cells containing micronuclei when compared with the negative controls. A follow up in vivo study is planned to provide context to this in vitro finding.

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

Glyphosate technical acid together with its manufacturing impurities has been robustly evaluated across genotoxicity testing batteries and has consistently demonstrated a lack of genotoxic potential, including a lack of clastogenicity/aneugenicity.