Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3833

2. Registrant Information.

Registrant Reference Number: 823811

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.

21-JUL-11

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

14-JUL-11

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. 28058      PMRA Submission No.       EPA Registration No.

Product Name: OFF! Active Pump Spray Insect Repellent 85 mL - 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 - Blister
  • Symptom - Itchy skin
  • Symptom - Rash

4. How long did the symptoms last?

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

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?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

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

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.)

7/21/2011 Caller states that she used the product daily during her travels over the past week. About 4-5 days ago, she noticed bumps on her ankles that she thought were bug bites. She continued to use the repellent daily but the bumps continued to spread up her legs and worsen into what appeared to be a vesicular rash. She indicated she plans on seeing a doctor. Follow-up on 7/28/2011 She eventually saw a physician who diagnosed her with a skin infection and prescribed oral antibiotics. The skin condition has begun to clear up.

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. allergy testing would be required before labeling this product as the causative agent. Furthermore, the skin condition appears to be caused by an infectious etiology rather than suspected contact dermatitis.