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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6695

2. Registrant Information.

Registrant Reference Number: 2019-170

Registrant Name (Full Legal Name no abbreviations): Monsanto Canada ULC

Address: 180 Kent Street, Suite 810

City: Ottawa

Prov / State: ON

Country: Canada

Postal Code: K1P 0B6

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. 32774      PMRA Submission No.       EPA Registration No.

Product Name: TIOXAZAFEN TECHNICAL

  • Active Ingredient(s)
    • TIOXAZAFEN

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 MON 102100: Local Lymph Node Assay (LLNA) in Mice

Date 24-OCT-19

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)

Two LLNAs (local lymph node assays) in mice were conducted with separate manufacturing batches of tioxazafen, based on OECD Test Guideline 429. Five concentrations of the tioxazafen (1%, 3%, 6.25%, 12.5%, and 25%) in acetone/olive oil (4:1 v/v) (AOO) or in 1% Pluronic┐┐┐┐ L92 Surfactant w/w in distilled water (1% Pluronic┐┐┐┐ L92) were topically applied to groups of healthy mice (five mice/treatment group) for three consecutive days. As a SI (stimulation index) of greater than or equal to 3 was observed in the tioxazafen treated groups,tioxazafen was considered positive for dermal sensitization potential in both studies.

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