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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-2259
2. Registrant Information.
Registrant Reference Number: 851008IR
Registrant Name (Full Legal Name no abbreviations): Tessenderlo Kerley, Inc.
Address: 2255 North 44th Street, Suite 300
City: Phoenix
Prov / State: Arizona
Country: United States
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. 27852 PMRA Submission No. EPA Registration No. 61842-22
Product Name: Linurex Technical
- 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 Study Director
Date 04-JAN-13
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)
TKI conducted an OCSPP Guideline 870.6200 Acute Neurotoxicity study in response to an EPA Data Call-In as part of the Agency's Registration Review process, for a Neurotoxicity Screening Battery for linuron. The acute neurotoxicity study was conducted at 0, 20, 100 or 500 mg/kg body weight. The effects of exposure were generally dose dependent with the most severe effects only observed in the highest dose group. Onset began within approximately 30 minutes depending on the dose, with time to peak effect occurring at 7 hours post-dose. One female rat at the highest dose (500 mg/kg body weight) was euthanized in extremis. Neurohistopathological observations did not reveal any lesions to the neurological system. All other animals recovered by the conclusion of the study. The following effects, not before reported for linuron, were observed in a dose dependent manner, with greatest severity at the highest dose (500 mg/kg) and minimal to no effects at the lowest dose (20 mg/kg), depending on the endpoint: Decreased motor activity; Altered gait and arousal; Ataxia; Walking on tiptoes, body dragging, swaying or lurching; Altered righting reflex and limb splay; Altered response in functional observational battery; Clinical signs of stress and toxicity (deposits or crusting on fur and around mouth/nose, lethargy, lack of resistance to handling).
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?
04-JAN-13
