Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-5215

2. Registrant Information.

Registrant Reference Number: 658991

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.

08-JUL-10

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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. 28648      PMRA Submission No.       EPA Registration No.

Product Name: OFF!Skintastic familycare Insect Repellant smooth and dry 113g-Canada

• 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.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Rash

4. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

12. Time between exposure and onset of symptoms.

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

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.)

7/8/2010 11:34:03 AM Caller states that she has applied the product to her arms, legs and chest 6 times in the past week while working in her garden. She developed a rash to her arms, legs and chest within a few hours of using the product the second day. Her local Pharmacist recommended topical Benadryl applied to the rash. She has also taken an oral antihistamine. Follow-up on 7/22/2010 Patient states that her symptoms persisted for about 2 weeks, and caller saw MD for evaluation. MD prescribed a steroid cream for treatment of allergic reaction. Caller used the cream for a week and her symptoms completely resolved. After patient stopped using the cream, her rash returned despite not using the repellent anymore. She has started using the cream again and the rash has dissipated. She is now thinking something else is the cause since the rash has returned despite not using the repellent anymore.

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. Also, given that the rash disappeared then reappeared again despite not using the insect repellent anymore there would appear to be another etiology involved.