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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-5654

2. Registrant Information.

Registrant Reference Number: 194063

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.

02-JUN-07

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW MEXICO

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 4822-399

Product Name: OFF! Deep Woods Insect Repellent Pump Spray 6 oz.

  • Active Ingredient(s)
    • DEET (N,N-DIETHYL-M-TOLUAMIDE) PLUS RELATED ACTIVE TOLUAMIDES (ORTHO & PARA ISOMERS)
      • Guarantee/concentration 25 %

7. b) Type of formulation.

Liquid

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: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Malaise
    • Symptom - Other
    • Specify - Brain tumor
  • Nervous and Muscular Systems
    • Symptom - Hallucination
    • Specify - Hallucinations/Delusion

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?

Yes

6. b) For how long?

4

Day(s) / Jour(s)

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?

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

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.)

Caller reported on 6/2/2007 that her husband developed confusion, disorientation, and general malaise over the previous 5 days. He had been using the insect repellent in an unspecified manner daily for the previous 10 days while working outside. He would shower at night before going to bed. He was seen by his doctor on 6/5/2007. Follow diagnostic testing consisting of a CT scan revealed that he was suffering from a brain tumor. He eventually had surgery to remove the tumor on 6/16/2007, after which his cognitive ability has shown gradual improvement. His treating doctors have indicated that as with most tumors, they will not be able to determine the cause. These doctors have not implicated the insect repellent.

To be determined by Registrant

14. Severity classification.

Major

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 acute use of an insect repellent over a 10 day period would not result in the formation of a brain tumor so quickly. The patient's tumor likely developed and progressed for several weeks, months, or even years prior to his use of this insect repellent and before the onset of clinical manifestations in early June 2007.There is no scientific data in the peer reviewed scientific literature that has shown that DEET containing insect repellents are carcinogenic or tumorgenic at levels equivalent to what is used in personal use insect repellents despite having such repellents used by millions of individuals over the past several decades.