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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-1166

2. Registrant Information.

Registrant Reference Number: 100002613

Registrant Name (Full Legal Name no abbreviations): Monsanto Canada Inc.

Address: 180 Kent St., Suite 810

City: Ottawa

Prov / State: ON

Country: CANADA

Postal Code: K1P 0B6

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

Domestic Animal

4. Date registrant was first informed of the incident.

19-FEB-10

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

07-JAN-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.       PMRA Submission No.       EPA Registration No. 71995-25

Product Name: Roundup Weed And Grass Killer Ready Super Concentrate

  • Active Ingredient(s)
    • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
      • Guarantee/concentration 50 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - Out Home / Rés - à l'ext.maison

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

2.7

kg

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Trembling
  • Gastrointestinal System
    • Symptom - Vomiting
  • Skin
    • Symptom - Hyperesthesia

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Other / Autre

specify Dog in yard after treatment was applied

17. Provide any additional details about the incident

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

Jan 07, 2010 at 10:32 PM CST (name) (veterinarian) interacted with Dr. (name) (emergency vet) for reason: obtain help. [Note : Spoke with erDVM about case. Owners brought in another dog about 2 hours ago that was having seizures; dog had history of seizures and was on phenobarbital. Dog did not respond to treatment and owners elected euthanasia. When owners got home, they found their second dog hyperesthetic, and tremoring, and brought her in for care. Gardener today put out coffee grounds and Roundup. Dog spend very little time outdoors; only go out to eliminate. The presence of only tremors/seizures does not fit very well with methylxanthines. Would expect agitation, tachycardia, and gi signs. Could there have been other potential exposures? Moldy food, compost could be sources. If organophosphate insecticides involved, would have expected SLUD signs. The surviving dog did have one bout of vomiting. Owners have been asked about strychnine, which is not a possibility. Suggested now that the dog is stable, have owners check with grandmother at home to see if there are medicaitons in the house. We can add these to case and provide more detailed managerment recommendations. (by AM on Jan 07, 2010 at 11:38 PM)]


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Roundup Weed and Grass Killer Super Concentrate Because the time course was poorly consistent, the amount was unknown consistent, and the findings were not consistent, this substance was considered to have doubtful likelihood of causing the clinical situation.

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Hyperthermia
    • Symptom - Fever

12. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Euthanised / Euthanasie

16. How was the animal exposed?

Other / Autre

specify Product applied in yard

17. Provide any additional details about the incident

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

Jan 07, 2010 at 10:32 PM CST (name) (veterinarian) interacted with Dr. (name) (emergency vet) for reason: obtain help. [Note : Spoke with erDVM about case. Owners brought in another dog about 2 hours ago that was having seizures; dog had history of seizures and was on phenobarbital. Dog did not respond to treatment and owners elected euthanasia. When owners got home, they found their second dog hyperesthetic, and tremoring, and brought her in for care. Gardener today put out coffee grounds and Roundup. Dog spend very little time outdoors; only go out to eliminate. The presence of only tremors/seizures does not fit very well with methylxanthines. Would expect agitation, tachycardia, and gi signs. Could there have been other potential exposures? Moldy food, compost could be sources. If organophosphate insecticides involved, would have expected SLUD signs. The surviving dog did have one bout of vomiting. Owners have been asked about strychnine, which is not a possibility. Suggested now that the dog is stable, have owners check with grandmother at home to see if there are medicaitons in the house. We can add these to case and provide more detailed managerment recommendations. (by AM on Jan 07, 2010 at 11:38 PM)]


To be determined by Registrant

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

Death

19. Provide supplemental information here

Coffee Grounds Because the time course was somewhat consistent, the amount was unknown consistent, and the findings were poorly consistent, this substance was considered to have low likelihood of causing the clinical situation. Roundup Weed and Grass Killer Super Concentrate Because the time course was poorly consistent, the amount was unknown consistent, and the findings were not consistent, this substance was considered to have doubtful likelihood of causing the clinical situation. Mycotoxins Because the time course was somewhat consistent, the amount was unknown consistent, and the findings were somewhat consistent, this substance was considered to have medium likelihood of causing the clinical situation.