Health Canada
www.hc-sc.gc.ca
Common menu bar links
Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-2360
2. Registrant Information.
Registrant Reference Number: TKI201206
Registrant Name (Full Legal Name no abbreviations): Tessenderlo Kenley Inc
Address: 2255 N. 44th Street, Suite 300
City: Phoenix
Prov / State: AZ
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 A Pubertal Development and Thyroid Function Assay of Linuron Administered Orally in Intact Juvenile/Peripubertal Female Rats
Date 05-JUN-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)
Effects of Linuron in this study were limited to lower body weights and body weight gains at the high dosage level of 100 mg/kg/day and lower total T4 levels at dosage levels of 50 and 100 mg/kg/day. The significance of the lower T4 is not clear, because there was no statistically significant change in mean serum TSH levels, no change in thyroid gland weights, and no test substance-related microscopic findings in the thyroid gland. Based on the lack of effects on the attainment of vaginal patency, estrous cyclicity, organ weights, serum chemistry, and histopathology of the ovary, thyroid, uterus, pituitary, and kidney, Linuron was not considered to be a pubertal developmental toxicant when administered orally by gavage to juvenile/peripubertal female Crl:CD(SD) rats at dosage levels of 50 and 100 mg/kg/day.
5. a) Was the study discontinued before completion?
No
