Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4098

2. Registrant Information.

Registrant Reference Number: 1833688

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.

01-JUN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

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.       PMRA Submission No.       EPA Registration No. 4822-397

Product Name: OFF! Deep Woods Sportsmen Insect Repellent 11 6oz

• Active Ingredient(s)
  • DEET (N,N-DIETHYL-M-TOLUAMIDE) PLUS RELATED ACTIVE TOLUAMIDES (ORTHO & PARA ISOMERS)
    • Guarantee/concentration 30 %

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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: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Other
  • Specify - Basal Cell Carcinoma

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?

No

6. b) For how long?

Unknown

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Application

What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

12. Time between exposure and onset of symptoms.

>2 mos <=6 mos / > 2 mois < = 6 mois

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.)

6/1/2016 Caller has used product for many years. About 3 years ago, caller got product into a scratch on his upper thigh. He was diagnosed with basal cell carcinoma in the same area. The shape of the carcinoma is the same as the scratch. Two dermatologists have told him it is related to N,N-Diethyl-meta-toluamide. He had surgery in May 2014 to remove the carcinoma. The site remained swollen after surgery and had misformed tissue. He saw a second physician in November 2015 and they thought it was scar tissue. He followed up again in November 2016 and the physician indicated it was scar tissue. A biopsy was performed in April 2016. It has returned, and he will be having another surgery in a few weeks. 6/21/2016 Attempted call back to the original caller. A message was left requesting follow up information. 6/23/2016 Attempted call back to the original caller. A message was left requesting follow up information. Caller is returning the previous message. Caller had another surgery performed by a mole surgeon on 6/15/2016, and a biopsy was performed during the surgery. There is a 5 inch incision on his leg due to the carcinoma which went down to his muscle. The incision is slowly healing.

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. Any relationship between the use of this product and the delayed development of the complications reported in this case is inconceivable and lacks biological plausibility. When considering the body of regulatory data and post-marketing data as well as the weight of scientific peer reviewed evidence on the active ingredients used in this product such a causal relationship appears to be scientifically implausible.