Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3092

2. Registrant Information.

Registrant Reference Number: 804311

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.

15-JUN-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

13-JUN-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. 24723      PMRA Submission No.       EPA Registration No.

Product Name: OFF! Deep Woods Insect Repellent 3 Aerosol 230g - 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

• Respiratory System
  • Symptom - Coughing
  • Symptom - Shortness of breath
  • Symptom - Sneezing

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.

Respiratory

11. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

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.)

Caller reports that on June 11, she developed sneezing which progressed to shortness of breath within 30 minutes of her application of the OFF! repellent to her face, arms and legs. Given the persistence of her breathing trouble, she eventually went to a local ER on June 13 where she was started on oral prednisone and a bronchodilator inhaler before being sent home. She was not admitted. She was noticeably better by the time she reported the incident on June 15. She has no prior history of asthma or respiratory problems. Follow-up with the consumer was completed on July 12. She states she developed shortness of breath again when she used the product again on July 7. She treated herself again with the leftover medications she had from her original illness in June. Her symptoms readily resolved within 3-4 days and she did not see a doctor. At this time she also reported that her father developed respiratory irritation within an hour of applying the product to his arms and legs the weekend of July 9. He bathed the following day and recovered without an specific treatments. He did not see a doctor.

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 an acute respiratory condition of this nature would include multiple potential etiologies which, in addition to this product, include multiple environmental factors. The routine application of this insect repellent is not typically associated with the sudden acute onset of upper respiratory symptoms.

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: Male

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

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Respiratory irritation

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.

No

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.

<=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.)

Caller reports that on June 11, she developed sneezing which progressed to shortness of breath within 30 minutes of her application of the OFF! repellent to her face, arms and legs. Given the persistence of her breathing trouble, she eventually went to a local ER on June 13 where she was started on oral prednisone and a bronchodilator inhaler before being sent home. She was not admitted. She was noticeably better by the time she reported the incident on June 15. She has no prior history of asthma or respiratory problems. Follow-up with the consumer was completed on July 12. She states she developed shortness of breath again when she used the product again on July 7. She treated herself again with the leftover medications she had from her original illness in June. Her symptoms readily resolved within 3-4 days and she did not see a doctor. At this time she also reported that her father developed respiratory irritation within an hour of applying the product to his arms and legs the weekend of July 9. He bathed the following day and recovered without an specific treatments. He did not see a doctor.

To be determined by Registrant

14. Severity classification.

Minor

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 an acute respiratory condition of this nature would include multiple potential etiologies which, in addition to this product, include multiple environmental factors. The routine application of this insect repellent is not typically associated with the sudden acute onset of upper respiratory symptoms.