Health Canada
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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-1682
2. Registrant Information.
Registrant Reference Number: TKI201204
Registrant Name (Full Legal Name no abbreviations): Tessendero Kenley Inc
Address: 2255 N. 44th Street, Suite 30
City: Phonenix
Prov / State: Arizona
Country: USA
Postal Code: 85008
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. 19696 PMRA Submission No. EPA Registration No. 61842-24
Product Name: Linuron
- Active Ingredient(s)
- LINURON
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 Linuron - Fish Short-Term Reproduction Assay with Fathead Minnow (Pimephales promelas)
Date 03-APR-12
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)
A short-term fish reproduction study with fathead minnow (Pimephales promelas) was conducted for linuron following OPPTS 890.1350 and OECD 229 guidelines. Nominal concentrations tested were 0.09, 0.9 and 9.0 mg/L. Mean measured concentrations closely matched the targets. No abnormal behavior or notable changes in secondary sex characteristics were observed throughout the 21-day study at the 0.09 and 0.9 mg/L treatment levels. Mortality of 25% and 6% was observed for the male and female fish, respectively (12% combined) at the 9.1 mg/L treatment level. Changes in coloration and lethargy were observed in fish exposed to the 9.1 mg/L treatment level. Therefore, the reductions of the core endpoints at this exposure concentration can be attributed to general toxicity as opposed to effects related to endocrine activity which were also observed (lack of spawns, reduced nuptial tubercle scores in males, reduction in male and female gonadosomatic indexes and histopathological findings in both males and females).
5. a) Was the study discontinued before completion?
No
