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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-2095

2. Registrant Information.

Registrant Reference Number: PROSAR 1-22143003

Registrant Name (Full Legal Name no abbreviations): Syngenta Crop Protection Canada, Inc.

Address: 140 Research Lane, Research Park

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G4Z3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

04-APR-10

5. Location of incident.

Country: CANADA

Prov / State: MANITOBA

6. Date incident was first observed.

03-APR-10

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. 26638      PMRA Submission No.       EPA Registration No.

Product Name: Helix Xtra Treated Canola Seed

  • Active Ingredient(s)
    • DIFENOCONAZOLE
    • FLUDIOXONIL
    • METALAXYL-M (MEFENOXAM)
    • THIAMETHOXAM

7. b) Type of formulation.

Application Information

8. Product was applied?

No

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 III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

75

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • Nervous and Muscular Systems
    • Symptom - Staggering
    • Symptom - Muscle tremors
  • General
    • Symptom - Dehydration
  • Gastrointestinal System
    • Symptom - Bloody stool
    • Symptom - Anorexia

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-22143003: A reporter (dog owner) called on 04/04/2010 to report the possible exposure of his dog to treated Canola seeds coated with a fungicide containing the active ingredients Thiamethoxam, Difenoconazole, Metalaxyl-M, and Fludioxonil. According to the reporter, the dog may have ingested some seeds that had spilled on the floor of the shed at an unknown time. On 04/03/2010, the dog developed diarrhea, vomiting, staggering, and tremors. On the day of the report, the dog's stool contained what appeared to be seeds. At the time of the report, the dog was at the veterinary clinic and was being treated with IV fluids for dehydration. The reporter was advised that the signs described are not consistent with small ingestions of the product. While ingestions of seed may result in minor gastrointestinal upset, severe gastrointestinal signs and neurologic symptoms are not expected. A recommendation was made to have the dog's veterinarian rule out other potential causes for the dog's signs. On follow up, the reporter stated that the dog had developed some blood in its stool and she remained anorexic. The dog was still at the veterinary clinic at the time of the follow up, and the veterinarian was treating the dog for intestinal irritation. No further information was obtained.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

The symptoms as described are not consistent with exposure to the product.