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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2019-1034
2. Registrant Information.
Registrant Reference Number: M-295885-01-1
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.
Active(s)PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Prothioconazole + Tebuconazole EC 240 (80+160) G
- Active Ingredient(s)
- PROTHIOCONAZOLE
- TEBUCONAZOLE
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 LOCAL LYMPH NODE ASSAY IN MICE (LLNA/IMDS)
Date 10-DEC-07
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)
Prothioconazole + Tebuconazole EC 240 (80+160 g/L) was tested in the modified Local Lymph Node Assay (IMDS) to determine the skin sensitization potential of this formulated pesticide product. The test was conducted with 50%, 10% and 2% concentrations in Pluronic PE 9200 / 0.9% NaCl solution (1% v/v). Compared to control animals, there was a clear (statistically significant) increase in the weight of the draining lymph nodes in the high dose group, and increases in the cell counts of the mid and high dose groups. The 真真真positive真真真 level of the cell count index (1.4) was exceeded in both groups. This test shows that Prothioconazole + Tebuconazole EC 240 has a moderate sensitizing potential in mice after dermal application of a 10% concentration. No indication for a non-specific, irritating activation was detected.
5. a) Was the study discontinued before completion?
No
