Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3832

2. Registrant Information.

Registrant Reference Number: 822484

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.

19-JUL-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

17-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. 29313      PMRA Submission No.       EPA Registration No.

Product Name: OFF! familycare eucalyptus lotion Insect Repellent 118mL- Canada

• Active Ingredient(s)
  • P-MENTHANE,3-8-DIOL

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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 <=6 yrs / > 1 < = 6 ans

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Edema

4. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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.

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

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.)

7/19/2011 Caller reports that she applied the product all over her (age) yr old daughter's body on 7/17/2011, for the first time at 3 pm. She then bathed her at 6 pm and the child developed swelling involving her face starting at 7 pm. The swelling was worse an hour later and she took her to ER around 8 pm. The ER physician diagnosed her daughter with an atypical allergic reaction and gave her Benadryl. By morning the swelling was gone. Caller states she applied to other areas of body and had swelling only developed on her face. The child has an allergy to milk. No hives or rash were reported.

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 a skin or allergic condition of this nature would include multiple potential etiologies which, in addition to this product, include such factors as plant allergens, mold, food, infectious pathogens, medications, dietary supplements, etc.. Target allergy testing would be required before labeling this product as the causative agent. Also, it would be unusual for the allergic reaction to manifest in the form of swelling only on the face whereas other areas of the body where the product was applied show no adverse reaction.