Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-6750

2. Registrant Information.

Registrant Reference Number: 3704597

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.

29-AUG-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

22-AUG-23

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. 23487      PMRA Submission No.       EPA Registration No.

Product Name: OFF! Deep Woods For Sportsmen I Insect Repellent, 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?

Unknown

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

• General
  • Symptom - Other
  • Specify - Nail polish melting off

• Nervous and Muscular Systems
  • Symptom - Numbness

4. How long did the symptoms last?

<=30 min / <=30 min

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

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)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

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.)

8/29/2023 Email from consumer: Hello. Me and my brother used a bottle of off yesterday going into the woods. We sprayed our arms legs back shoulders and faces. During our hike we noticed the paint from our phone cases colors where melting off. My electronic cigarette colors and materials melted off. My nail polish on my fingers and toes also melted off! I'm very concerned this happened not only ruined my items but how can this stuff be safe on people's skin if it melts paint and materials? 9/5/2023 Callback from consumer. Caller reports she and her brother used the product on about 08/26-08/27/2023. They both experienced numb lips with product use. They must have touched their mouth/lips when the product was on their hands. The symptoms happened several times between 08/26/2023-08/27/2023. Each time the symptoms resolved without treatment within about 5-15 minutes. They have not had symptoms since 08/27/2023.Her primary reason for calling was some property was damaged. She was at work and will callback with additional information. 9/19/2023 Consumer reporting that she and her brother experienced numbness when some of the product came into contact with their lips. She and her brother began using it for the first time on approximately 08/22/23. That day they both applied the product while outside for a deep woods nature hike by spraying the product on their body and face. Within a few minutes their lips began to go numb. She said it was pretty concerning and described it as feeling like her lips were numb from dental work. After hiking for about 10 minutes, the symptoms resolved on their own. As they continued to hike, if they rubbed their face or touched their lip, the sensation would return and resolve in the same way as before. She states this happened about 2-3 times in all. They have not used the product again and they have remained asymptomatic. They have used other Off! products in the past and have never experienced this before. No further information is available.

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.

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

• Nervous and Muscular Systems
  • Symptom - Numbness

4. How long did the symptoms last?

<=30 min / <=30 min

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

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)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

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.)

8/29/2023 Email from consumer: Hello. Me and my brother used a bottle of off yesterday going into the woods. We sprayed our arms legs back shoulders and faces. During our hike we noticed the paint from our phone cases colors where melting off. My electronic cigarette colors and materials melted off. My nail polish on my fingers and toes also melted off! I'm very concerned this happened not only ruined my items but how can this stuff be safe on people's skin if it melts paint and materials? 9/5/2023 Callback from consumer. Caller reports she and her brother used the product on about 08/26-08/27/2023. They both experienced numb lips with product use. They must have touched their mouth/lips when the product was on their hands. The symptoms happened several times between 08/26/2023-08/27/2023. Each time the symptoms resolved without treatment within about 5-15 minutes. They have not had symptoms since 08/27/2023.Her primary reason for calling was some property was damaged. She was at work and will callback with additional information. 9/19/2023 Consumer reporting that she and her brother experienced numbness when some of the product came into contact with their lips. She and her brother began using it for the first time on approximately 08/22/23. That day they both applied the product while outside for a deep woods nature hike by spraying the product on their body and face. Within a few minutes their lips began to go numb. She said it was pretty concerning and described it as feeling like her lips were numb from dental work. After hiking for about 10 minutes, the symptoms resolved on their own. As they continued to hike, if they rubbed their face or touched their lip, the sensation would return and resolve in the same way as before. She states this happened about 2-3 times in all. They have not used the product again and they have remained asymptomatic. They have used other Off! products in the past and have never experienced this before. No further information is available.

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.