Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-6096

2. Registrant Information.

Registrant Reference Number: PROSAR 1-27696864

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.

14-OCT-11

5. Location of incident.

Country: UNITED STATES

Prov / State: MONTANA

6. Date incident was first observed.

Unknown

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 100-1141

Product Name: Dividend Extreme treated barley seed

• Active Ingredient(s)
  • DIFENOCONAZOLE
    • Guarantee/concentration 7.73 %

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7. b) Type of formulation.

Other (specify)

Treated Barley seed

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 III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Horse / Cheval

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

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 - Diarrhea

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify No witnessed ingestion - the horse may have ingested the product (unknown if from container or pasture) several days prior to the call

17. Provide any additional details about the incident

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

1-27696864: The reporter, a veterinary clinic employee, notified the registrant on 10/14/11 of the possible exposure of 2 horses (breed, age, etc. unspecified) to barley seed which had been treated with the product Dividend Extreme. According to the reporter, a client had called the clinic indicating that the horses may have ingested some of the seed (unknown if from the container or pasture) several days previously. The first horse had developed severe diarrhea and had passed away earlier that same day (10/14/2011). The second horse had diarrhea and was acting depressed; the horse was en route to the clinic. The reporter stated she had the MSDS for the product but requested additional information regarding the exposure. It was discussed that the fungicide used to treat the barley seed had a low level of toxicity; however, large ingestions of the seed could possibly cause severe GI distress including impaction and colic. Such symptoms would be due to the physical bulk of the seed, not the fungicide. Treatment for any exposures to the treated seed would be supportive and symptomatic. A follow-up call on 10/17/11 revealed that the second horse never arrived at the clinic and they had not heard from the owner.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Note: The severity of symptoms up to and including death would not be typical from ingestion of the treated seed. Based on labelled rate of Dividend Extreme and assuming that the horse weighed 300 kg and ate an entire 25 kg bag of treated seed the horse would have been exposed to 10 mg/kg of difenconazole and 2.5 mg/kg of mefenoxam (metalaxyl M). These values are well below the LD50 of 1453 mg/kg for difenconazole and 667 mg/kg metalaxyl M.

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Horse / Cheval

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

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 - Diarrhea

• Nervous and Muscular Systems
  • Symptom - Depression

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Other / Autre

specify No witnessed ingestion - the horse may have ingested the product (unknown if from container or pasture) several days prior to the call

17. Provide any additional details about the incident

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

1-27696864: The reporter, a veterinary clinic employee, notified the registrant on 10/14/11 of the possible exposure of 2 horses (breed, age, etc. unspecified) to barley seed which had been treated with the product Dividend Extreme. According to the reporter, a client had called the clinic indicating that the horses may have ingested some of the seed (unknown if from the container or pasture) several days previously. The first horse had developed severe diarrhea and had passed away earlier that same day (10/14/2011). The second horse had diarrhea and was acting depressed; the horse was en route to the clinic. The reporter stated she had the MSDS for the product but requested additional information regarding the exposure. It was discussed that the fungicide used to treat the barley seed had a low level of toxicity; however, large ingestions of the seed could possibly cause severe GI distress including impaction and colic. Such symptoms would be due to the physical bulk of the seed, not the fungicide. Treatment for any exposures to the treated seed would be supportive and symptomatic. A follow-up call on 10/17/11 revealed that the second horse never arrived at the clinic and they had not heard from the owner.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Note: The severity of symptoms up to and including death would not be typical from ingestion of the treated seed.