### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D.C. 20460

OF FICE O F CH E MICAL SAFETY AND
POLLUTION PREVENTION



### MEMORANDUM

Date: March 11

, 20 14

SUBJECT: Metofluthrin: Review of Hum an Incidents for Pre l im inary Ri s k Assess men t

PC Code: I 09709 DP Barcode: 0418298

Deci s ion N o.: 488164

Pet it io n No.: NA Registration No.: NA Regulator y Act i o n : NA

Case No .: NA Risk Assess m e nt T y pe: NA

TXR No.: NA CAS No.: 240494-70-6

40CFR: NA MRID No.: NA



### FROM: Shanna Recore, In dustrial Hygienist

Toxicolo gy and Epidemio l ogy Branch

Health Effects Division (7509P)

and

Eliza beth Evans, En vi ronme nt a l Pro t ec t i on Specia li st
Toxico lo gy and E pidemiol ogy Branch

Health E ffects Division (7509P) Ver.Apr.08



### THROUGH: David J. Mill e r , Acting Branch Chief li

,. / 

# Y/t{**~** /d/hcJI' •

# ~i}l '/


### To xico l ogy and Epidemiology Branch

# Jz~;**_,** 'f .t

H ea lt h Effect s Division (7509P)

TO: Linnea Hansen, Risk Assessor
Risk Assessment Branch II

Heal t h Effects Di v ision (7509P)

and

Veronica Dutch, Chem i cal Review Manager
Risk Management & 

### Implementation Bran ch V
Pesticid e Re-evaluation Di vision (7 508P )

Page 1 of 19

### Summary and Conclusions

Metofluthrin was previously reviewed in 2012 (S. Recore, 09 / 06 / 2012, 0404998). It 

### was concluded that "overall the incident cases reported for metofluthrin were generally low frequency and low severity of incident." However because Registration No. 4822-542 (OFF! Clip-On Mosquito Repellent) was a relatively new delivery method and there were 39 moderate

incidents reported in Main IDS, HED concluded that these inc id ent data may warrant further analysis in the preliminary risk assessment phase of Registration Review.

There were 14 additional moderate incidents and one major incident reported to IDS since the previous review. I n addition, four low severity cases reported to SENSOR -Pe sticides were reviewed. This updated review concurs with the previous conclusion

. Overall the incident cases reported for metofluthrin were generally of low frequency and low severity in both IDS and

NIOSH SENSOR-Pesticides. There does not appear to be a concern at this time that would

warrant further investigation. The Agency will continue to monitor the incident information and

if a concern is triggered, additional analysis will be conducted.

Detailed Review



### I. ACTION REQUESTED

Metofluthrin is a pesticide being considered under the FQPA-mandated Registration Review

program established to review, on a 15 year cycle, pesticides for which a Re-registration

E ligibility Decision has been made. One component of the Agency's Registration Review Program is consideration of human incident data. In conjunction with a human health risk

assessment based on other data sources, such human incident data can assist the Agency in better defining and characterizing the risk of pesticides / pesticide products.

Metofluthrin was previously reviewed in 2012 (S. Recore, 09 / 06/2012, 0404998). It 

### was concluded that because Registration No. 4822-542 (OFF! Clip-On Mosquito Repellent) was a relatively new delivery method and there were 39 moderate incidents reported in Main IDS,

these incident data may warrant further ana l ysis in the preliminary risk assessment phase of Registration Review

.

Reports of adverse health effects alleged l y due to a specific pesticide exposure (i.e

. , 

### an "inc id ent") are largely self

- reported and therefore, generally speaking, neither exposu r e to a pesticide or reported symptom (or the connection between the two) is validated or otherwise

confirmed. Typically, causation cannot be determined based on incident data. However,

incident information can be an important source of feedback to the Agency: in cidents of severe

outcome

, or a suggested pattern or trend among less severe incidents, can signal the Agency to
further investigate a particular chemical or product. Observational epidemiology studies relate

the risk of disease, 

### e.g., cancer, and exposure to an agent such as a pesticide product in the general popu l at i on or specific sub

- groups like pesticide applicators.

Page 2 of 19

### Page 3 of 19

II. BACKGROUND

Metofluthrin is a Type 1 pyrethroid active ingredient used to control insects. The product of
concern in this review is a personal outdoor insect repellent product consisting of a holder attached to the individual’s clothing (such as a belt). The holder contains a replaceable cartridge

insert coated with u p to 50 mg of metofluthrin. The product is activated by turning on a battery powered fan to release the metofluthrin into the air surrounding the individual.

For this evaluation, both OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk

- Pesticides (SENSOR) datab ases were consulted for pesticide incident data on the active ingredient metofluthrin (PC Code : 109709 ).
The purpose of the database search is to identify potential patterns i n the frequency and se verity

of the health effects attributed to metofluthrin ex posure.

III. RESULTS/DISCUSSION

a. IDS (Incident Data System)

OPP’s IDS includes reports of alleged human health incidents from various sources, including mandatory Federal Insecticide, Fungicide and Ro denticide Act (FIFRA) Section 6(a) (2) reports
from registrants, other federal and state health and environmental agencies

, and individual consumers. Since 1992, OPP has compile d these reports in IDS. IDS contain s reports from across the U.S. and most incidents have all relevant product information recorde d. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report.

IDS records incidents in one of two modules: Main IDS and Aggregate IDS:

o Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specific. This system stores incident data for death, major and moderate incidents, and it includes information about the location, date and nature of the incident. Main IDS incidents involving only o ne pesticide are considered to provide more certain information about the potential effects of exposure from the pesticide.

o Aggregate IDS contains incidents resulting in less severe human incidents (minor, unknown, or no effects outcomes) . These are repo rted by registrants only as counts in what are aggregate summaries

.

For the M ain IDS, from January 1, 200 7 to January 7 , 201 4

, there were 5 4 incidents reported for single chemical only in the database involving metofluthrin. 1 

### One incident was classified as major severity and 53 incidents were classified as moderate severity . The incident narratives are summarized in Appendix 1

. In A ggregate IDS , from January 1, 200 7 to January 7, 2014, there

1 There were also four additional incidents reported that occurred in Canada. Foreign incidents are not reviewed in detail because of the potential differences in the exposure patterns, use practices, and product formulation.

### Page 4 of 19

were 5 reported incidents involving metofluthrin

. These inciden ts were classified as minor severity.

The number of incidents reported over time to IDS are listed in Table 1. There are approximately 12 incidents reported per year for metofluthrin to the IDS databases.

Table 1. Incidents Reported to Main and Aggregate

IDS Over Time 2009

- 2013*

Year Number of Incidents

2009 10

2010 13

2011 17

2012 10

2013 9

* Although the query did included years 2007 and 2008, no incidents were reported for metofluthrin before 2009

.



### The only product implicated in the incidents was Registration No. 4822

- 542 ( OFF! Clip

- O n

M osquito R epellent ) . This product is a personal outdoor insect repellent product consisting of a holder attached to the individual’s clothing (such as a belt).

Six of these incidents appeared to be due at allergic reaction s to the product s. Eleven of the incidents appeared to be due to potential misuse. Of these 11 incidents, five cases reported that

the individual wore the product clipped to their shirt (up around their face), three cases

reporte dly used the product indoors, and three case reported direct contact with the active ingredient. The other 43 cases appeared to use the product according to the label directions, either clipping the product to their belts or setting it on a table beside t hem.

Based on the IDS reports, dermal symptoms were reported most often (n=31) by the exposed individuals. Other symptoms reported included neurological (n=15) , respiratory (n=10)

, gastrointestinal (n=4)

, ocular (n=4) , and cardiovascular (n=3 ) . Note that a patient could exhibit multiple symptoms. Dermal symptoms reported include hives, itchiness, rash, blisters, welts, swelling, redness and skin irritation . Neurological symptoms reported include weakness, headache, lightheadedness, fainting, and memory lost . Respiratory symptoms reported included coughing, asthma, throat irritation, bronchitis, and shortness of breath . Ocular symptoms reported were redness, irritation, cloudy vision, and ocular discharge . Gastrointestinal symptoms reported were nausea, diarrhea, and vomiting. Cardiovascular symptoms reported include low chest pain

, heart palpitations , and heart attack

.

### Page 5 of 19 b. SENSOR

- Pesticides

The S ENSOR

- Pesticides database covers 11 states from 1998

- 2009

, although reporting varies from state to state. Cases of pesticide

- related illnesses are ascertained from a variety of sources, including: reports from local Poison Control Centers, state Department of Labor workers’ compensation claims when reported by phy sicians, reports from Stat e Departments of Agriculture, and physician reports to s tate Departments of Health . Although both occupational
and non

- occupational incidents are included in the database, SENSOR focuses on occupational pesticide incidents, and is of particular value in providing that information. A state SENSOR contact specialist attempts to follow

- up with cases and obtains medical records to verify symptoms, circumstances surrounding the exposure, severity, and outcome. Using standardized
protoc ol and case definitions derived from poison center reporting, SENSOR coordinators at State Departments of Health enter the incident interview description provided by the case , medical report, physician and patient into the SENSOR data system . The SENSOR da ta system
is accessible to participating states and EPA.

A query of SENSOR

- Pesticides from 1998

- 2010 identifies 4 single ai cases, stemming from 3 events, involving metofluthrin (pc code 109709). No multiple ai cases were found. These four

cases were no t work

- related. All four cases were low in severity. All cases were reported in

2010. Two of the cases involved children. Th ree cases involved the product OFF! Clip

- O n M osquito R epellent , EPA R eg # 4822

- 542 and case one involved OFF! Hangables, EPA R eg #
10308

- 31. One case experienced respiratory symptoms. One case experienced ocular
symptoms. Three cases reported nervous system symptoms including headache. Two cases had gastrointestinal symptoms including vomiting. The cases are described in Table 2.

Table 2. SENSOR

- Pesticides 1998

- 2010 Metofluthrin Case Reports

N=4

Case ID Case Description

FL03883 Caller states that his six year old son rubbed his eyes with off

clip on which he had in his grand parents' house.

MI02241 Used product, developed symptoms

MI02242 Product was clipped to pants for 2 days. On the second day the

[5 year

- old] case developed symptoms

NC02713 Woman was exposed to clip on mosquito repellent and had

symptoms

### Page 6 of 19

IV. CONCLUSION

Metofluthrin was previously reviewed in 2012 (S. Recore, 09/06/2012, D404998). It was
concluded that “overall the incident cases reported for metofluthrin were generally low frequency and low severity of incident.” However because Registration No. 4822

- 542 ( OFF!
Cli p

- O n M osquito R epellent ) “is a relatively new delivery method and there were 39 moderate incidents reported in IDS Main, these incident data m ay warrant further analysis in the preliminary risk assessment phase of Registration Review.”

There were 14 add itional moderate incidents and one major incident reported to IDS since the previous review. In addition, four low severity cases reported to SENSOR

- Pesticides were reviewed. This updated review concurs with the prev ious conclusion. Overall the incident c ases reported for metofluthrin were generally of low frequency and low severity in both IDS and

NIOSH SENSOR

- Pesticides. There does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be conducted.

### Page 7 of 19

Appendix 1. Incident Narratives

Human Incidents Descriptions for OFF! CLIP

- ON MOSQUITO REPELLENT (Reg. No. 4822

- 542)

Chemical: Metofluthrin PC Code: 109709

Incident Package Report Incident

Date Location Country Exposure Severity Incident Description

020923

- 00020 6/19/2009 RICHMOND, TX US MODERATE A 6 3 year old female used the product as directed 1

- 2x within the past 2

- 3 weeks, the last time being about 2

- 3 days ago. L ast week she developed symptoms of red blotches and dryness on her face and arms. S he has been to a dermatologist and was gi ven a topica l steroid. H er MD was unable to determine the cause of the symptoms.

021075

- 00010 1/1/2009 SAN ANTONIO,
TX US MODERATE Caller states she is involved in the L TC care of a quadriplegic (72 year old male) that has had the product in his room with a fan circulating the air for approx the last 48 h ou rs. Caller states that 24 hrs ago he was noted to have blood glucose of 25 mg/dL. He was given one amp of dextrose and blood sugar increased to 173 mg/dL but then started to fall again and within one hr fell back to approx 25 mg/dL and another amp of dextrose was given with same results as previous. He is being evaluated by a physician now and the physician has been unable to determine the cause.

021075

- 00018 6/30/2009 COOKVILLE, TN US MODERATE A 53 year old femal e has been using the product over the past 3 weeks on a daily basis, and is noting a loss of memory over the past 3 weeks. S he is making mistakes and not realizing them. During use she clips the product to her belt and removes it when protection is no longer needed.

021075

- 00027 7/25/2009 EL PASO, TX US MODERATE Caller state that her mother

- in

- law (63 year old ) fell do wn while wearing the product. She was on the floor for an unknown period of time. 24 hours later
she was feeling 'chest pains, cannot swallow or talk'.

021075

- 00030 1/1/2009 CANTON, TX US MODERATE A 52 year old female used product 5 wks ago. Over the 1 week that the product was used, caller clipped it on her belt and on the collar of her shirt.
1 wk after use she complained of coughing, weakness, hoarseness and 'feels like it is difficult to get oxyge n'. Has not used product since and symptoms have persisted for the past 3 wks.

021187

- 00003 1/1/2009 PASO ROBLES,
CA US MODERATE An 85 year old female b egan using the product daily about I month ago, with her most recent use yesterday. About 3 weeks ago, she began to experience asthma attack that has worsened since. 3 days ago she was seen by MD, who prescribed prednisone pills. Symptoms have improved with this regimen.

021187

- 1/1/2009 WRIGHTSTOWN, US MODERATE Caller states that her 64 year old sister has been regularly using the product

### Page 8 of 19

Human Incidents Descriptions for OFF! CLIP

- ON MOSQUITO REPELLENT (Reg. No. 4822

- 542)

Chemical: Metofluthrin PC Code: 109709

Incident Package Report Incident

Date Location Country Exposure Severity Incident Description

00010 NJ for about the past month. For about the past 2 weeks, sister began to wear the product about her neck when using it. At about this time, she developed cough and throat irritation. Over the past several d ays, she has had a diminished voice and bloody saliva. She did not read label directions until after use, and is being seen by MD today. She went to the MD and was diagnosed with pneumonia. Caller stated that the MD determined that the product wasn't like ly the cause of the symptoms but could had exasperated them Caller stated that her sister has been taking antibiotics and is beginning to feel better.

021187

- 00017 1/1/2009 PORTSMOUTH,
NH US MODERATE A 61 year old female used the product 3 weeks ago, and wore it daily for 1 week; she discontinued use 2 weeks ago. She began to experience hair loss and lethargy about 2 weeks ago, prompting her to discontinue use of product. Caller went to MD due to symptoms , and had low RBCs on blood work, but MD did not feel it was of clinical significance.

021299

- 00001 1/1/2009 GROVES, TX US MODERATE An 83 year old female placed the product on her t

- shirt, near her waist on Thursday and Friday

. On Friday within 8 hours after beginning the use of the product, she developed symptoms of a rash, itching and hives/welts on her neck, under her chin. S he had the product facing away from her skin.
S he took oral Benadryl to help relieve the symptoms with no relief.
Y esterday she got two topical meds from her MD, Betamethasone and Eramosone 1% and that she began applying the meds last night and the symptoms are beginning to improve.

021299

- 00026 9/19/2009 PRAIRIE VILLAGE, KS US MODERATE A 77 year old female wore the product on her belt outside 4 days ago and

4

- 5 hours later broke out into hives over her whole body. 7

- 8 hours after using the product, her throat began swelling and she experienced an episode of syncope. She had swelling of the ears and throat and swelling of both of her hands. The next day her hands were still swollen and over the next 24 hours the hand swelling improved.

022109

- 00010 6/1/2010 PERU, NY US MODERATE A 7 year old male used the product while camping 1week ago. W ithin several days of the first use the child became pruritic and developed a full body rash. The child was taken to the MD yesterday as well as the day
before and the child was prescribed Benadryl as well as a Cortisone
Ointment. The MD was unsure what ca used the rash.

### Page 9 of 19

Human Incidents Descriptions for OFF! CLIP

- ON MOSQUITO REPELLENT (Reg. No. 4822

- 542)

Chemical: Metofluthrin PC Code: 109709

Incident Package Report Incident

Date Location Country Exposure Severity Incident Description

022109

- 00013 6/4/2010 DETROIT, MI US MODERATE Caller used the product on herself. She developed a headache and cough about 4 hours later. Headache persisted through yesterday. Cough currently persists. She was seen at urgent care clinic yesterday and diagnosed with bronchitis. MD prescribed antibiotics.

022109

- 00014 6/5/2010 DETROIT, MI US MODERATE The product w as clipped onto the pants of a 4 year old male grandson while he was outside. That evening, child began to complain of headache and vomited. Child developed temperature of 102 and is currently at urgent care clinic.

022109

- 00016 6/6/2010 FAIRFAX STATION, VA US MODERATE A 56 year old female used the product. She experienced rash with welts and pruritis. She was unsure if rash was from product or poison ivy.

022109

- 00029 6/21/2010 SAN ANTONIO,
TX US MODERATE A 9 year old female used the product on her right side today for about 20 minutes. Then set it down on a table near her. She c/o itching and when she got home she has a raised rash on her right side, hip and back. She's been
bathed in an oatmeal bath and given Benadryl. Her pediatrician has been called. On call back, her rash and welts were subsiding and she is improving.

022109

- 00033 6/15/2010 PATERSON, NJ US MODERATE A 56 year old male used the product two weeks ago. He developed a neurological illness with visual disturbances such as double vision,
inflammation of the ocular nerve, and a spike in BP resulting in hospitalization. Since there is no obvious cause, caller is researching several products he used about the time he got sic k. He used tile product according to package instructions, and discontinued use of the product because he was in the hospital. MD was unable to determine cause of caller's symptoms. MD is treating caller with
unknown medications. Symptoms have resolved wit h treatment.

022224

- 00009 6/23/2010 DANVILLE, VA US MODERATE A 73 year old male states that he used the product for about 2 weeks. Caller states that at times he clipped the product to his chair. He said it’s possible that the product got onto his skin. He noticed a rash on the upper parts of both arms and thighs 1 week after using product. He discontinued using the product after about 2 weeks. The rash had not improved even after two days of discontinued use. Caller saw MD for evaluation that was unsu re of the cause of symptoms. MD gave a steroid injection, and symptoms cleared within a few days of treatment.

### Page 10 of 19

Human Incidents Descriptions for OFF! CLIP

- ON MOSQUITO REPELLENT (Reg. No. 4822

- 542)

Chemical: Metofluthrin PC Code: 109709

Incident Package Report Incident

Date Location Country Exposure Severity Incident Description

022224

- 00010 6/24/2010 WHIPPANY, NJ US MODERATE An adult male reports that he has been using the product for the last two weeks. He developed a rash sometime in that two week period of using the product per label directions. The rash has developed on his shins, back and arms. He saw MD for evaluation who suspected allergic reaction to something. MD prescribed prednisone, and symptoms have almost completely resolved.

022224

- 00012 7/9/2010 BOSQUE, NM US MODERATE A 54 year old female used the product and may have breathed some of it in. She woke up the next morning and her face was swollen, red, and irritated. Caller went to MD and was prescribed Prednisone. Symptoms have improved. MD said that site had an allergi c reaction to an ingredient in the product.

022224

- 00013 7/2/2010 DAYTON, OH US MODERATE A 72 year old male used the product. He used it for about 2 hrs on the first day and about 1 hour on the second day. By that evening he was exhibiting a few welts, and used Ben adryl cream for the itching. By the next morning,
he was covered in welts and especially around the area where the clip

- on was attached to his belt. He had taken a bath the night before and put on cream all night. He was taken to the hospital and given a shot for the welts and 3 prescriptions to calm the itching and take the welts d own.

022224

- 00018 7/4/2010 HAUPPAUGE,
NY US MODERATE A 78 year old female used product at a barbecue. She did not touch the product other than to set it up with her hands. Unsure if she washed her hands after touching product. She developed red marks that looked like hives on 'different parts of her body' 8 hours after use. The following day she had more hives, so she sprayed her bed with insecticide in case she had a bug in her bed. She consulted an MD 2 days after symptoms started. The MD kept her

o vernight in the hospital and gave her steroids. She was sent home with
Prednisone.

022298

- 00030 8/23/2010 LAKESIDE, AZ US MODERATE An adult female used the product. She broke out in red blotches that itch wherever there was no clothing (where her neck, arms and legs were exposed). She used Benadryl and cortisone and alcohol on the areas where it continued to spread. She went to the ER and was given medication that was helping.

022376

- 9/5/2010 ZACHARY, LA US MODERATE A 13 year old female used the product for about an hour on her left side.

### Page 11 of 19

Human Incidents Descriptions for OFF! CLIP

- ON MOSQUITO REPELLENT (Reg. No. 4822

- 542)

Chemical: Metofluthrin PC Code: 109709

Incident Package Report Incident

Date Location Country Exposure Severity Incident Description

00006 She bathed afterwards for 15 minutes. About 5 hours later woke up with pruritic hives on her left side, left thigh and both arms. The hives seem to be spreading. They have used Swan Clear anti

- itch lotion on the areas. She went to the emergency room. They advised that it was probably an allergic reaction and recommended Benadryl and caladryl. The rash was improving, but then came back and spread on her leg and face. She was going to see a dermatologist.

023081

- 00001 5/28/2011 MIDDLEBURY,
VT US MODERATE An adult female used the product for the first time 4 days ago. After using the product while gardening for about 4 hours, caller began to feel her tongue swelling. Swelling worsened over the next 2 hours, and caller began coughing and felt short of breath. She began using her asthma nebulizer and administered an epi

- pen at home. Symptoms improved with treatment, but she continued to use her nebulizer over the next few days feeling so me tightness in her chest. She is just feeling better at the time of call. She did
not see MD for evaluation.

023081

- 00010 6/14/2011 HAMPDEN, MA US MODERATE A 60 year old female used the product yesterday (attached to her shirt) evening outdoors. Her face/neck became red and she found her BP to be about 240/110 and HR about 90. She showered and went to ER, where she was kept overnight. MD diagnosed her with an allergic reaction to the product. Within 24 hours her Sx dissipated.

023081

- 00015 6/18/2011 SHELTON, CT US MODERATE A 65 year old female used the product while camping in Maine. She did not realize tire batteries were dead. She was bitten by gnats and black flies and experienced redness and swelling under her eyes and on the left side o f her face and the back of her neck. She was taken to urgent care where she was given prednisone injection and Benadryl. Two day later, went to see her own doctor today, swelling was still present but resolving.

023081

- 00027 6/26/2011 MERRILL, WI US MODERATE Caller clipped the product on her 2 year old daughter's stroller 2 days ago in the evening for a few hours. The next morning she woke up and had a rash from head to toe. She went to MD that night for the rash. MD recommended ibuprofen for a fever. MD ruled out heat rash and chicken pox. Blood work to rule out platelet and WBC levels.

023081

- 00031 6/26/2011 KEWANEE, IL US MODERATE A 7 year old female was wearing the product on her belt loop. She began to widen her eyes as they looked off to the side. She was having neck 'ticks'

### Page 12 of 19

Human Incidents Descriptions for OFF! CLIP

- ON MOSQUITO REPELLENT (Reg. No. 4822

- 542)

Chemical: Metofluthrin PC Code: 109709

Incident Package Report Incident

Date Location Country Exposure Severity Incident Description

while she was looking away. The same symptoms occurred on and off the next day. The following day, she was taken to E.D. She had a CAT scan performed which was unremarkable. She saw her pediatrician who thinks the eye

mo vements are due to wearing the product and the ingredients in the product ClipOn.

023081

- 00032 6/24/2011 MOUNT LAUREL, NJ US MODERATE A 70 year old male used the product daily for about 2 weeks. He developed
a rash on his back and shoulder. He went to his MD and was diagnosed with shingles.

023228

- 00019 7/6/2011 HOUSTON, TX US MODERATE The caller stated that she used the product on 7/6 and accidentally touched the liquid and then touched her eye. Since then she has been experiencing
ocular redness and irritation. She did rinse not rinse her eye after the exposure but did rinse her eyes on 7/9. Symptoms did not improved and she was seen by her MD on 7/11 and was prescribed and ocular ointment (contained steroid and antibiotic) . She has been following the MD recommended treatment and she is wondering if anything else can be done
for treatment. Symptoms resolved.

023228

- 00025 7/10/2011 WINFIELD PARK, NJ US MODERATE Caller wore the product on her shirt. 2 or 3 days later, she noticed an itchy rash on her arms and torso. She contacted MD by phone (was not examined), who prescribed 'fungus cream.' She began applying this on 7/14 with relief of the itch, but the rash remains. S he has discontinued use of the cream and has appointment with MD fort moderate oming. Caller was evaluated by her MD , but does not recall MD diagnosis. MD prescribed oral Prednisone for treatment. Symptoms immediately began to improve and have almost complet ely resolved with treatment.

023228

- 00026 7/13/2011 NEW MEADOWS, ID US MODERATE Caller and family used the product 5 days ago while camping. Caller's son was bitten by mosquitoes on his arms and legs. The following day, son had severe itching on tile bug bites, and caller gave son Benadryl to try to ease symptoms. When they returned h ome from camping a few days ago, son was evaluated by MD. Son was given a steroid injection, and they used calamine lotion to help ease symptoms. Symptoms have resolved with

treatment.

023313

- 7/28/2011 CEDAR KNOLLS, US MODERATE An adult female had the product under her seat at a concert last Thursday.

### Page 13 of 19

Human Incidents Descriptions for OFF! CLIP

- ON MOSQUITO REPELLENT (Reg. No. 4822

- 542)

Chemical: Metofluthrin PC Code: 109709

Incident Package Report Incident

Date Location Country Exposure Severity Incident Description

00001 NJ She touched the inside of the product. She did not wash her hands immediately. Later on that night she developed a rash to her chest, back and scalp. The product did not have direct contact with t hese areas. She went to MD and was put on oral prednisone and she is to take oatmeal
baths. On callback she is doing better but her rash is still healing. She still has the rash on her chest a bit, it is worst at night. Her scalp also itches a lot at night . She is following up with her MD and used the prednisone as prescribed.

023313

- 00002 7/19/2011 SUSSEX, NJ US MODERATE The caller reports that he used the product 2 weeks ago and developed a headache for 1 week. He discontinued use and sought medical care. He had a CT scan performed which shown no significant findings. They prescribed Naproxen for the discomfort which did help alleviate the symptoms. He used the product again tonight and developed the same headache. On call back, Richard was feeling better and doing fine. He has discontinued use of the product and that seems to be helping a lot. He only gets severe headache s when he was using the product and he's sure that there is some ingredient in the product that is causing these severe
headaches.

023313

- 00004 7/29/2011 MALVERN, AR US MODERATE Caller's husband started using product on 7/28/2011. Caller does not have packaging with her. She states that her husband developed 'rashes and hives' on 7/29/2011 and that he was just seen by a dermatologist. Dermatologist treated husband with unknown injection, and symptoms have been improving with treatment. Caller said she w as very busy and did not wish to talk further.

023313

- 00025 8/22/2011 LIVONIA, MS US MODERATE Caller was using the product 2 days ago. She had the area clipped on to the neckline of her shirt. About 24 hrs later, she developed 3 hive

- like bumps on
her chest. She applied some Cortisone cream to the site. Caller also thinks that the product wasn’t working and that the welts/hives might actually be mosquito bites.

023409

- 00004 7/26/2011 DENVER, CO US MODERATE Caller reports he used product about 6 weeks ago and about immediately developed a cough. Caller sought MODERATE P care and was hospitalized and told he had a heart problem caused by lung issues that developed as a result of product use. Caller was hospital ized for about I week and is now

### Page 14 of 19

Human Incidents Descriptions for OFF! CLIP

- ON MOSQUITO REPELLENT (Reg. No. 4822

- 542)

Chemical: Metofluthrin PC Code: 109709

Incident Package Report Incident

Date Location Country Exposure Severity Incident Description

recuperating.

023409

- 00016 9/10/2011 SAN ANTONIO,
TX US MODERATE Caller used the product on Friday. When he inserted the product into the unit, some of the green fluid got on his hands, and then he proceeded to eat without washing his hands. The next day, he became ill with nausea, diarrhea, malaise and muscle cramps. This has lasted for the past 2 days.

023409

- 00018 9/2/2011 CHAPLE HILL,
NC US MODERATE The caller stated that she used the product for the first time on 9/2/11 and that evening she developed hives on her stomach, legs and back. She was seen by her MD and was prescribed Prednisone and was diagnosed with having an allergic reaction.

023409

- 00026 9/16/2011 ALBANY, LA US MODERATE Caller states her husband used the product on Friday and within an hour,
she noticed that her husband's face and neck were red and his back was red and blotchy. That night, they called poison control and they told him to shower. After his shower, he had re d raised hives on back, chest and neck and some of them were peeling. Husband has doctor's appt tomorrow.

024299

- 00013 6/14/2012 NEW ALEXANDRIA,
PA US MODERATE Caller states that her 35 year old daughter attached the product to her waist 1 hour ago. Within a few minutes she developed irritation in her left eye. Caller is thinking she got product on her hand and then rubbed her eye. Caller's daughter flushed the eye for 5 minutes, applied cool compresses and took Tylenol. No eye drops were applied. Cal ler is concerned because her daughter had 2 eye surgeries in the past so she has sensitive eyes. Daughter is still experiencing a burning sensation. She is not sure that her daughters symptoms had anything to do with the Off! Product

. Went to

emergency ro om later that night due the fact that she was so much pain. They found scratches on her corneas. Symptoms lasted about 3 days. Daughter is doing fine now.

024299

- 00017 6/2/2012 SUMMERVILLE,
SC US MODERATE Caller states that he has been using the product on a table next to him for about 2 weeks. Two weeks later, he felt hand tingling and his lips felt numb. He called his V .A. nurse and was told to go to the hospital. He went to E.D and got a Ct scan. CT sca n was unremarkable. He was diagnosed 'Complicated migraine headaches'. He was not given any medications. Caller has a doctor appointment follow up this week.

024438

- 00001 7/2/2012 GREENFIELD,
MA US MODERATE Caller states he inadvertently touched refill/disk about 2 hours ago. Caller states he feels 'strange with not clear thinking' and a 'different' breathing

### Page 15 of 19

Human Incidents Descriptions for OFF! CLIP

- ON MOSQUITO REPELLENT (Reg. No. 4822

- 542)

Chemical: Metofluthrin PC Code: 109709

Incident Package Report Incident

Date Location Country Exposure Severity Incident Description

pattern but not quite SOB. Caller states he has had previous Sx of fatigue.

024438

- 00002 6/30/2012 CHESTER, PA US MODERATE Caller states she used the product in the evening of 6

- 30

- 12. It was sitting on her lap on top of her sweater while running for a half hour. She put her jacket back on. She woke up with beet red skin and welts on her arms, chest, and legs, leg weakness, neck and throat irritation, lethargy, heart palpitations. One day ago she went to dermatologist who gave prednisone, Claritin, and cream to apply. He took blood. She is to call him today for
results. Skin is not as red and s he is feeling much better today. Caller states it was her fault, she did not read the instructions.

024438

- 00004 7/1/2012 OK US MODERATE Caller states that she began using the product 1

- 2 times per day by clipping
it to her shirt about 2

- 3 weeks ago. On 6/30/12 or 7/1/12, she developed itchy red rash on her neck, which spread to her chest. She was seen by MD on 7/2. MD advised her to discontinue use of Nopolea and Ambien, and prescribed triamcin olone cream. No diagnosis was made. Caller has showered. Itching has improved with the cream. Today, it occurred to caller that perhaps she should not have clipped the product to her shirt.

024438

- 00012 6/29/2012 WINNIPEG CN MODERATE Caller used the product in the evening while camping. Caller estimates that she used the product for 5 min total, 2

- 3 min then turned the product off
then used for another 2

- 3 min. The next morning (6

- 8 hours after use) she experienced extreme itching on the palms of her hands and soles of her feet. Caller states that shortly after she woke up she passed out for a short period of time. When she woke back up she felt nauseous and had some
diarrhea. The caller tried to walk to the car but found that she was unable to
move he r legs. The caller was carried to the car and taken to an emergency room. Several tests were done including EKG monitoring, unspecified blood work and CT scan. Caller states the physician was concerned that she had
a mild stroke. All tests came back normal Caller was kept for observation and unknown medications during the day and was released early in the evening with no medication. Caller states that the intense itching resolved approx 1 hour after arriving at the hospital. Caller states that she was

a symp tomatic within 24 hours of initial exposure. Her physician informed her that the intense itching could be related to her inhaling a poisonous gas.

024438

- 7/31/2012 PHILIPSBURG, US MODERATE Caller states that 4hrs prior to the call she turned the product on with her

### Page 16 of 19

Human Incidents Descriptions for OFF! CLIP

- ON MOSQUITO REPELLENT (Reg. No. 4822

- 542)

Chemical: Metofluthrin PC Code: 109709

Incident Package Report Incident

Date Location Country Exposure Severity Incident Description

00035 MT right hand. She states she did not touch any of the product inside the clip

on. 45min after turning it on, her hand became itchy and started to swell. 45min after symptoms began, she took a Benadryl She states the Benadryl has resolved her itching, but her hand remains very swollen at the time of
the call

. She has washed the hand for an unknown amt of time and has tried applying ice.

024514

- 00009 8/6/2012 POINT
PLEASANT BEACH, NJ US MODERATE Caller states that 2wks prior to the call she was sitting in her gazebo with the product and states she was still getting mosquito bites. Caller states that because she was still getting mosquito bites she held the product blowing at her leg s 3

- 4in away from her legs. Caller states that that same day around each of the mosquito bites she developed pink spots. Caller states her symptoms spread over her legs. She tried applying caladryl for her symptoms but they persisted and she went for a der matology consult and was told she has contact dermatitis. She was given a topical ointment to apply, but states her symptoms have gotten worse and her legs are now blistered with dark red spots that itch, burn and 2days prior to the call have spread down t o her feet.

024514

- 00012 8/16/2012 SMITHVILLE, TX US MODERATE An adult male was at a picnic and the product was clipped onto the back of his lawn chair. While sitting out for a few hours, he developed watery, irritated left eye. They left the party and went to the gas station for saline solution to rinse his eye. His eye was now red and irritated. He went home
and he removed his left contact lens. He had a 'cloudiness' to his vision. The symptoms persisted and he developed a swollen left eye by the next morning. He went to Optometrist and was given steroid eye drops. The Optometrist said there was 'bumps' of the OFF! ClipOn ingredients on his cornea. The eye doctor stated that his soft contact absorbed the product ingredient and caused the symptoms. On 8/19 he went to the E.D because his vision was not improving and sy mptoms seemed to worsen. The E.D doctor gave him antibiotic eye ointment and a pain medication. Several days later he had another appointment with Optometrist who examined his left eye and still saw cloudiness to the cornea. He has future appointments with eye doctor.

024514

- 8/17/2012 ANNISTON, AL US MODERATE Caller reports that she was wearing the product when she came into the

### Page 17 of 19

Human Incidents Descriptions for OFF! CLIP

- ON MOSQUITO REPELLENT (Reg. No. 4822

- 542)

Chemical: Metofluthrin PC Code: 109709

Incident Package Report Incident

Date Location Country Exposure Severity Incident Description

00014 house this past Friday evening. She had worn it outside without incident, and that she switched the product off and left it on her bedside table. She woke up six hours later and noticed that the product had been switched on. On Saturday morning, she noticed that her throat felt irritated, and since then she has felt lightheaded, and has not gotten out of bed since then. She developed diarrhea this morning. She tried to sit on her front p orch to get fresh air, and that she has taken Maalox and Benadryl, with no relief of her symptoms. She does have a ceiling and tower fan in her bedroom, and that
the room is well

- ventilated. She did not think that the product had a strong odor, and that sh e has called a poison center, and was told that the product active ingredient has a wide margin of safety, but she can see that the product has a warning label on It that indicates that it can be hazardous to
humans.

024514

- 00033 7/30/2012 BARRIE CN MODERATE Caller states that over a month ago while out to eat at a restaurant the product was used. Pt had looked at product and then had a syncopal episode, ambulance was called and pt was transported to hospital, pt's EKG was normal, MRI was fine, chest X

- ray was fine. Pt had a cardiac follow up with a specialist where he wore a heart monitor for 48 hours and that was
also fine.

024745

- 00009 10/2/2012 RENO, NV US MAJOR Caller and her husband felt ill following use of the product. Nausea, coughing, vomiting, and sweats symptoms started a couple of hours later. Went to the ER 1 days later. MD stated this may have caused the heart attack but were not certain, had to have br eathing treatments (unknown what kind). Caller was not certain what treatments were done for her husband. Husband was in the hospital for 7 days. Had a stress test done, angiogram, echocardiogram. Has been started on Plavix since being in the hospital is d oing better now. She became nauseous the following day. She noted that she did not like the smell of the product and did not use it as long. They have discontinued use of the product She has also remained asymptomatic.

025483

- 00018 6/14/2013 LINCOLN, NE US MODERATE An adult female used the product while camping

. She had the product clipped onto her shirt near her cleavage. She woke up the next morning after having the product attached to her and realized their skin was itchy.

### Page 18 of 19

Human Incidents Descriptions for OFF! CLIP

- ON MOSQUITO REPELLENT (Reg. No. 4822

- 542)

Chemical: Metofluthrin PC Code: 109709

Incident Package Report Incident

Date Location Country Exposure Severity Incident Description

Her chest and stomach red, itchy and painful. She diaper rash cream, calamine cream, and cortisone cream to the rash. She went to the MD and

was treated with Prednisone and Kejlex.

025483

- 00019 6/14/2013 LINCOLN, NE US MODERATE An adult male used the product while camping

. He has the product cli pped onto his belt loop. He woke up the next morning after having the product
attached him and realized his skin was itchy. He states that his skin near his groin was very itchy, red and painful. He used diaper rash cream, calamine

crea m, and cortisone cream to the rash. H is symptoms are beginning to
resolve

.

025628

- 00013 5/25/2013 ANCHORAGE,
AK US MODERATE An 82 year old female with some recent complaints of eye problems that seem to have developed over the past 30

- 45 days on an intermittent basis. The pt companies of some occasional eye irritation and crustiness around the eyes in the morning as well discharge and wateriness. She had reported
to them that she has worn one of the clip

- on products up near her collar
several times o ver the past few months and believes that she may have been exposed to it that way triggering these issues.

025628

- 00020 7/13/2013 WAUBAUSHENE CN MODERATE Caller had product clipped in the v

- neck of her shirt two days ago in the afternoon. Late that afternoon caller noticed bumps on her neck. She originally thought the bump was from a bite. The symptoms have spread and the area is now pimply. There is no ope n skin. Caller has used cortisone cream on the area but that has not helped. Putting something wet on the affected area makes it itchy. Caller is going to the doctor this afternoon for a Bl2 injection and plans to ask the nurse about the rash.
Call er has p reviously used the product but it has been on a table or on her lap, not clipped to her shirt. Caller also said she does not see the ingredients on the package and would like to know what they are.

025628

- 00038 7/29/2013 TORONTO CN MODERATE Caller used the product five times so far, this summer. I had started getting inexplicable tremors, dizzy spells, and nausea. I am in my early thirties, and healthy. She realized these symptoms, had only been present after the use of OFF. She stopped usi ng it, and has not felt that way again.

025763

- 00024 8/14/2013 EXETER, NH US MODERATE A 26 year old female used the product overnight indoors 2 nights ago. It was 6 feet from her face. She woke up 1 day ago with an abscess under her lower lip that is the size of a half dollar and swollen. She also had an open

### Page 19 of 19

Human Incidents Descriptions for OFF! CLIP

- ON MOSQUITO REPELLENT (Reg. No. 4822

- 542)

Chemical: Metofluthrin PC Code: 109709

Incident Package Report Incident

Date Location Country Exposure Severity Incident Description

sore on outside bottom edge of her nostril , and a boil on the back of her leg. She has applied witch hazel to both areas 2x. S he went to the ED

. She was given 2 prescription antibiotics. Dr said it was a 'massive allergic reaction to the bug spray. '