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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-5514

2. Registrant Information.

Registrant Reference Number: M-805815-01-1

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.

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

Product Name:

• Active Ingredient(s)
  • OXADIAZON

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 Skin sensitization study of BCH-198SC in Hartley guinea pigs (Buehler test)

Date 18-FEB-22

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

No

3. Type of incident identified in the study

Increased health or environmental risk

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)

The purpose of this study was to evaluate the skin sensitization potential of the test substance, BCH-198SC, in male Hartley guinea pigs using the Buehler test. Test groups consisted of a test substance group (20 animals) and a control group (10 animals). In the test substance group, redness (score 1) was observed at 50% test substance in four animals at 24 hours after challenge patch removal and in nine animals at 48 hours after challenge patch removal. No skin reaction such as redness or swelling was observed in the other animals. The challenge sites with WFI did not reveal any evidence of skin reactions in any animal. In the control group, the 50% test substance and WFI challenge sites did not reveal any evidence of skin reactions in any animal at 24 and 48 hours after patch removal. During the observation period, no abnormal clinical signs or body weight gain was observed in any animal of any group. Based on the result of this study, the sensitization rate of BCH-198SC was 45% and the sensitization grade was Moderate. Therefore, BCH-198SC produced skin sensitization under the conditions of this study. The test substance was determined to be Sub-category 1B according to the GHS category.

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

The results of this study would not affect the current risk assessment for Canada.