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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-1033

2. Registrant Information.

Registrant Reference Number: M-557585-01-1

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name:

  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


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?


Subform VII: Scientific Study

1. Study Reference

Title Fenoxaprop-P-ethyl+Thiencarbazone-methyl +Mefenpyr-diethyl EC 117,5 Local Lymph Node Assay in the Mouse

Date 21-JUN-16

2. a) Is an extension needed to translate the document?


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)

Fenoxaprop-P-ethyl + Thiencarbazone-methyl + Mefenpyr diethyl EC 117.5 (80+7.5+30 g/L) was tested in the Local Lymph Node Assay (LLNA) to determine the skin sensitization potential of this formulated pesticide product. Following a preliminary irritation/toxicity test with the test item at 100%, the main test was conducted with 25%, 10% and 5% (w/v) concentrations in 1% aqueous Pluronic PE9200. The test item was applied to both ears of four animals per group on days 1-3, then not applied on days 4-6. Cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine and the values obtained were used to calculate stimulation indices (SI). The SI values were 4.3, 1.2 and 1.1 at concentrations of 25%, 10% and 5% test item, respectively. As the highest concentration resulted in an SI value above the threshold of 3.0, and there was a dose response, Fenoxaprop-P-ethyl + Thiencarbazone-methyl + Mefenpyr diethyl EC 117.5 was considered to have skin sensitization potential. The calculated EC3 value is 18.7%.

5. a) Was the study discontinued before completion?


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