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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-4566

2. Registrant Information.

Registrant Reference Number: 193275

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.

31-MAY-07

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

29-MAY-07

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. 22611      PMRA Submission No.       EPA Registration No.

Product Name: OFF! SKINTASTIC LOTION INSECT REPELLENT FAMILY WITH ALOE VERA

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

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).

See main notes on subform II

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: >1 <=6 yrs / > 1 < = 6 ans

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Hives

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

No

6. a) Was the person hospitalized?

Unknown

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?

>24 hrs <=3 days / >24 h <=3 jours

12. Time between exposure and onset of symptoms.

>24 hrs <=3 days / >24 h <=3 jours

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.)

5/31/2007 Caller's 3 year old grandson had product applied to his arms, legs, and neck 2 days ago. Child was not bathed after returning home or the following day. During the afternoon the day after application, child developed hives on his skin. Hives developed on arms, legs, torso, and face. Child was bathed after sxs developed, and has been given Benadryl and had hydrocortisone cream applied to help ease sxs. Caller was informed that this is not an expected reaction to product use. Would not anticipate sxs developing in areas that did not contact product. Recommended that she continue applying hydrocortisone cream to help ease sxs, and to see MD if sxs should persist or worsen. CB with any further questions. Follow-up 6/1/2007 Callback- Caller stated that her son's symptoms are still persisting but getting better. Caller stated that her son has not yet been seen by a doctor but she has spoken to her physician's office. They recommended to continue to use Benadryl to help relieve the symptoms and also recommended using a topical Benadryl as well. They did not feel the child needed to be seen by 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 a skin condition of this nature would include multiple potential etiologies such as plant allergens, food, infectious pathogens, heat exposure, insect bites, etc. Skin patch testing would be required before labeling this product as the causative agent. Given that the hives were most pronounced in regions not treated with the insect repellent makes the repellent an unlikely causative agent.