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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-5386

2. Registrant Information.

Registrant Reference Number: 518029

Registrant Name (Full Legal Name no abbreviations): S.C. Johnson and Son, Limited

Address: 1 Webster Street

City: Brantford

Prov / State: ON

Country: Canada

Postal Code: N3T 5R1

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

Domestic Animal

4. Date registrant was first informed of the incident.

14-AUG-09

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

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)

PMRA Registration No. 27325      PMRA Submission No.       EPA Registration No. 4822-415

Product Name: OFF! Skintastic Spray Insect Repellant Tropical Fresh 175mL

  • Active Ingredient(s)
    • DEET (N,N-DIETHYL-M-TOLUAMIDE) PLUS RELATED ACTIVE TOLUAMIDES (ORTHO & PARA ISOMERS)

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Personal use / Usage personnel

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Havanese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.6

7. Weight (provide a range if necessary )

8.50

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Blood
    • Symptom - Other
    • Specify - Abnormal lab value (can not be more specific)
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness

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?

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 Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

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

8/14/2009 Caller's (age) dog has been around children at a day care that have been applying the product for the last 2 weeks. The dog has had no witnessed exposure to the product. The dog was taken to a veterinarian and was found to have an abnormal blood value, but caller could not be more specific. Two days ago the dog developed lethargy and weakness in the hind legs.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. The product use history is extremely vague and lacks any description of a known or defined point of direct exposure to this product. Even had casual or incidental contact with this product occurred, such illness would be unexpected given the relatively low concentration and degree of toxicity of the pesticide used in this product that could have been conceivable transferred from treated children to the dog. Such illness from a secondary exposure off a child treated with a <10% DEET insect repellent lacks biological plausibility.