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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-3652
2. Registrant Information.
Registrant Reference Number: 080632
Registrant Name (Full Legal Name no abbreviations): Syngenta Crop Protection Canada, Inc.
Address: 140 Research Lane, Research Park
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4Z3
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. 21208 PMRA Submission No. EPA Registration No.
Product Name: Fluazifop-P-Butyl
- Active Ingredient(s)
- FLUAZIFOP-P-BUTYL
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 Fluazifop-P-Butyl Technical-Local Lymph Node Assay (LLNA) in Mice
Date 23-APR-08
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)
In this study Fluazifop-P-Butyl was tested at 25% 50% and 100%. The values compared to control were in a dose response: 1.6 2.3 and 3.9. As the value at 100% is greater than 3 the material tested is considered a potential skin sensitizer. A previous sensitization study completed in Jun 1983 using the Maximization Test of Magnussom and Kligman supporting registration of Fluazifop-P-Butyl! Technical indicated that it was not a skin sensitizer in the guinea pig. Consequently Fluazifop-P-Butyl Technical is considered a potential skin sensitizer. This marginal positive result at highest concentration of 100% should be carefully evaluated considering the negative response of the in vivo test done previously. The in vivo test has not been accepted by the US EPA because there was no positive control, does not mean that the results in vivo should not still be valid.
5. a) Was the study discontinued before completion?
No
