Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3661

2. Registrant Information.

Registrant Reference Number: 640070

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.

Human

4. Date registrant was first informed of the incident.

01-JUN-10

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

18-MAY-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)

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PMRA Registration No. 27325      PMRA Submission No.       EPA Registration No.

Product Name: OFF familycare Insect Repellant For Use on Kids Tropical Fresh 175mL

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

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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 II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Female

Age: <=1 yr / < = 1 an

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Rash

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Application

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

6-1-2010 Caller reports that she applied the product to her (age) year old child two weeks ago. Caller sprayed her hands and patted the product on child's arms, legs, and cheeks. Within minutes, the child developed a rash where the product was applied. Caller bathed the child within ten minutes of application. The child was evaluated by a doctor, and was prescribed an unspecified lotion. The child continues to suffer from the rash two weeks later.

To be determined by Registrant

14. Severity classification.

Moderate

15. 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 differential diagnosis for dermatological disorders, especially during the warm weather months, would include multiple potential etiologies such as heat rash, sunburn, insect bites, viral infection, allergic reaction to sunscreens, allergic reaction to a consumed food or medication, and allergic reaction to a naturally occurring environmental allergen such as a component of a plant like poison ivy or poison oak. Typically, if an individual is allergic to an insect repellent, the rash would be most severe or limited to the areas of product application, as was evident in this case, but other etiologies must be considered, since contact allergic dermatitis does not typically last 2 weeks or longer.