Page 2 of 23

Table of Contents 

1.0 Executive Summary ........................................................................................................... 3

2.0 HED Recommendations .................................................................................................... 4

2.1 Data Deficiencies ............................................................................................................ 4

2.2 Tolerance Considerations .............................................................................................. 4

2.3 Label Recommendations................................................................................................ 4

3.0 Introduction ........................................................................................................................ 5

3.1 Chemical Identity and Physical/Chemical Characteristics ........................................ 5

3.2 Pesticide Use Pattern ...................................................................................................... 5

3.3 Anticipated Exposure Pathways ................................................................................... 6

3.4 Consideration of Environmental Justice ...................................................................... 6

4.0 Hazard Characterization and Dose-Response Assessment ............................................ 7

4.1 Toxicology Studies Available for Analysis ................................................................... 7

4.2 Absorption, Distribution, Metabolism, Excretion (ADME) ....................................... 7

4.3 Toxicological Effects ...................................................................................................... 8

4.4 Safety Factor for Infants and Children (FQPA Safety Factor) ................................. 9

4.5 Toxicity Endpoint and Point of Departure Selections .............................................. 10

5.0 Dietary Exposure and Risk Assessment ......................................................................... 11

6.0 Residential (Non-Occupational) Exposure/Risk Characterization ............................. 11

6.1 Spray Drift .................................................................................................................... 11

7.0 Aggregate Exposure/Risk Characterization .................................................................. 11

8.0 Cumulative Exposure/Risk Characterization ............................................................... 12

9.0 Occupational Exposure/Risk Characterization ............................................................ 12

10.0 Public Health and Pesticide Epidemiology Data ........................................................... 12

11.0 Literature References ...................................................................................................... 12

12.0 References ......................................................................................................................... 13

Appendix A. Toxicology Profile ................................................................................................ 14

Appendix B. Review of Human Research ................................................................................ 20

Appendix C. Endocrine Disruptor Screening Program ......................................................... 20

Appendix D. Picaridin Use Pattern .......................................................................................... 21
Page 3 of 23

1.0 Executive Summary 

Picaridin [hydroxyethyl isobutyl piperidine carboxylate] is an insect repellent (non-food 

pesticide) approved for use on human skin. There are several registered formulations containing 

5-20% picaridin as the active ingredient. Formulations are applied directly to the skin of adults 

and children (e.g., spray, wipes, cream). 

The Pesticide Re-evaluation Division (PRD) requested that the Health Effects Division (HED) 

conduct a review to identify any data gaps, and assessments needed to support the Registration 

Review of picaridin. Several sources of information were used for this evaluation, including the 

most recent human health risk assessments (D357835, D261567, D241258, D279005, and 

D323024). This memorandum contains HED’s review and risk assessment for picaridin, 

reflecting updated hazard assessment, science policies and procedures. 

HED identified data gaps for the required inhalation toxicity and immunotoxicity studies. 

However, the Hazard and Science Policy Council (HASPOC), using a weight of the evidence 

(WOE) approach, concluded that these studies are not required for picaridin (TXR# 0056905). 

HED evaluated additional dermal absorption data and data submitted to address kidney effects 

observed in dermal and oral toxicity studies. The previous assessment of picaridin, (2006) 

employed endpoints for dermal and incidental oral exposure based upon kidney and body weight 

effects. However, the new data indicate that the kidney effects observed in the rat are a result of 

accumulation of alpha 2-u globulin, which is a species specific effect seen in rats and is not 

relevant for humans. Therefore, the kidney effects are not considered appropriate for use in risk 

assessment. Outside of the kidney effects, limited toxicity consisting of body weight changes, 

was observed in the picaridin toxicological database. The body weight changes were seen at the 

limit dose (1000 mg/kg/day), and human exposure at this level is not anticipated. Due to the 

limited toxicity in the picaridin toxicological database, HED has determined that a quantitative 

risk assessment is not needed for picaridin. Therefore, a qualitative human health risk 

assessment has been conducted to support registration review for all registered uses of picaridin. 

Exposure Profile 

Since there are no registered food uses for picaridin, dietary exposure is not expected. Further, 

there are no registered uses of picaridin that could result in occupational exposure, so only 

residential exposure scenarios have been considered. 

Individuals (adults and/or children) are exposed to picaridin primarily via the dermal route when 

applying it as an insect repellent directly to their skin. However, inhalation exposure is possible 

when sprays are used. Also, incidental oral exposures are also expected for children if hands are 

not washed after application. 

 

Hazard Profile 

The toxicology database for picaridin is considered complete. The majority of the studies for 

picaridin were done via the dermal route; however, there are also a few oral studies available. 

Kidney effects were seen in the dermal and oral studies but were attributed to alpha 2-u globulin 

accumulation, which is species specific (i.e., seen only in the rat), and is not considered relevant 
Page 4 of 23

to humans. Body weight effects were seen in rats in oral studies, but only at the limit dose which 

is significantly higher than exposure expected from labeled use of products containing picaridin. 

There were some signs of skin irritation in a few dermal studies; however, no other effects were 

observed in the toxicological database. There was no evidence of neurotoxicity, developmental 

and/or reproductive toxicity, or carcinogenicity. 

In acute lethality oral, dermal, and inhalation studies, exposure to picaridin resulted in low 

toxicity (Categories III and IV). It is moderately irritating to the eye and not irritating to the 

skin; it is not a dermal sensitizer. 

Potential areas of environmental justice concerns, to the extent possible, were considered in this 

preliminary human health risk assessment for picaridin. However, there are no risks anticipated 

for picaridin due to the low toxicity observed in the toxicological database. For more 

information, see Section 3.5: Considerations of Environmental Justice. 

This risk assessment relies in part on data from studies in which adult human subjects were 

intentionally exposed to a pesticide or other chemical. Those studies are subject to ethics review, 

have received that review, and are compliant with applicable ethics requirements. 

A dermal absorption study with human volunteers is also available for picaridin. However, the 

study was not used in the current assessment. If EPA decides to use the study, EPA will ensure 

that all applicable regulatory requirements are met, including, but not limited to, the 

requirements for EPA ethics review and Human Studies Review Board review of certain 

research involving intentional exposure of human subjects (Appendix B).

2.0 HED Recommendations 

HED has not identified any risk concerns associated with the registered uses of picaridin as an 

insect repellent. There are no data gaps that would require submission of additional toxicity or 

exposure data. 

2.1 Data Deficiencies 

The currently available data are sufficient to support risk conclusions. 

2.2 Tolerance Considerations 

Picaridin is not a food-use chemical, and there are no established US tolerances. 

2.3 Label Recommendations 

None 
Page 5 of 23

3.0 Introduction

Picaridin is a widely used personal insect repellent that can be applied directly to the skin of 

adults and children. The structure and other identifiers are found in the chemical identity table 

below. 

3.1 Chemical Identity and Physical/Chemical Characteristics 

Chemical Structure: 

Chemical Class: piperidine derivative 

Empirical Formula: C12H23NO3

Molecular Weight: 229.3 g/Mol 

Vapor Pressure: 0.3 kPa (2.25 mm Hg) at 20 C 

Odor: nearly odorless 

Solubility: in water: insoluble 

in 2-propanol: miscible 

in ethanol: miscible 

3.2 Pesticide Use Pattern

Picaridin [hydroxyethyl isobutyl piperidine carboxylate] is an insect repellent (non-food 

pesticide) approved for use on human skin. There are 26 registered end-use products with 

formulations containing 5-20% picaridin as the active ingredient. Formulations are applied 

directly to the skin of adults and children (e.g., spray, aerosol, wipes, and lotion/cream) at a 

frequency of 1-3 applications per day depending on the product. There is also a registered 

product for use on all breeds of riding horses (horses not intended for human consumption). 

Labels contain instructions which prohibit application directly to the hands of children and limit 

the number of applications that can be made per day. Picaridin products can be used for several 

days or weeks or longer, depending on the activity pattern and geographic area as well as pest 

pressure. 

Currently there are no registered uses of picaridin that could result in dietary or occupational 

exposures. There is no personal protective equipment (PPE) on the registered labels as these are 

considered residential uses. The use directions for the picaridin products are summarized in 

Appendix D. 

General use directions on the registered labels include the following: 

 Avoid applying excessive amounts of this product. Excess amounts or frequent 

applications are unnecessary. Use just enough repellent to cover exposed skin. Avoid 
Page 6 of 23

over-application of this product. 

 Do not use under clothing. 

 Do not apply over cuts, wounds, irritated or sunburned skin. 

 Do not allow children to handle this product. Do not apply on children’s hands. When 

using on children, apply to your own hands and then put it on the child. 

 Do not apply directly onto face, near eyes and mouth. Apply sparingly around ears. 

 After returning indoors, wash treated skin with soap and water. Wash treated clothing 

before wearing it again. 

These use directions are consistent with the directions on other insect repellent products and 

should remain on the labels to decrease the likelihood of any possible adverse health effects from 

misuse or overuse of these products. 

3.4 Anticipated Exposure Pathways 

Individuals (adults and/or children) are exposed to picaridin primarily via the dermal route when 

applying insect repellent directly to their skin; however, inhalation exposure is possible when 

sprays are used. Also, incidental oral exposures are also expected for children if hands are not 

washed after application. In the case of insect repellents, it is not appropriate to assess handler 

and post-application exposure separately. Instead, self-application and the subsequent exposure 

period are assessed as a single exposure event. 

3.5 Consideration of Environmental Justice 

Potential areas of environmental justice concerns, to the extent possible, were considered in the 

preliminary human health risk assessment for picaridin, in accordance with U.S. Executive Order 

12898, "Federal Actions to Address Environmental Justice in Minority Populations and LowIncome 

Populations,"http://www.epa.gov/compliance/resources/policies/ej/exec_order_12898.pdf. As a 

part of every pesticide risk assessment, OPP considers a large variety of consumer subgroups 

according to well-established procedures. In line with OPP policy, HED estimates risks to 

population subgroups from pesticide exposures that are based on patterns of that subgroup’s food 

and water consumption, and activities in and around the home that involve pesticide use in a 

residential setting. Extensive data on food consumption patterns are compiled by the USDA 

under the Continuing Survey of Food Intake by Individuals (CSFII) and are used in pesticide risk 

assessments for all registered food uses of a pesticide. These data are analyzed and categorized 

by subgroups based on age, season of the year, ethnic group, and region of the country. 

Additionally, OPP is able to assess dietary exposure to smaller, specialized subgroups and 

exposure assessments are performed when conditions or circumstances warrant. Whenever 

appropriate, non-dietary exposures based on home use of pesticide products and associated risks 

for adult applicators and for toddlers, youths, and adults entering or playing on treated areas 

post-application are evaluated. Further considerations are currently in development as OPP has 

committed resources and expertise to the development of specialized software and models that 

consider exposure to bystanders and farm workers as well as lifestyle and traditional dietary 

patterns among specific subgroups. However, there are no risks anticipated for picaridin due to 

the low toxicity observed in the toxicological database. 
Page 7 of 23

4.0 Hazard Characterization and Dose-Response Assessment 

Picaridin is an insect repellent belonging to the piperidine chemical family. Since the chemical 

is dermally applied, the Agency recommended that toxicological studies in support of this 

registration be conducted via the dermal route to reflect the use pattern and to provide route 

specific data for risk assessments. With the exception of the acute neurotoxicity study (ACN) 

and developmental toxicity study in rats, the majority of the dermal toxicity studies were 

conducted at a maximum dose of 200 mg/kg/day. This was done to prevent excessive spreading 

of the dose beyond the application site at high doses. The highest doses tested in the ACN and 

developmental toxicity study in rats were 2000 mg/kg and 400 mg/kg/day, respectively. It was 

in these studies that excessive spreading of the dermally applied dose was identified. In addition 

to dermal studies, there are a few oral rat studies available for picaridin (14 day, 5 week, and 14 

week subchronic studies). Since the last risk assessments (D279005, 2001; D323024, 2006), 

several in vitro dermal absorption studies with rat and human skin have been submitted and 

reviewed for picaridin. Additionally, more information regarding the kidney effects observed in 

oral and dermal studies has also been submitted (see 4.3). 

4.1 Toxicology Studies Available for Analysis 

The toxicology database for picaridin is considered complete. Inhalation and immunotoxicity 

studies are not available; however, the Hazard and Science Policy Council (HASPOC), using a 

weight of the evidence (WOE) approach, concluded that these studies are not required for 

picaridin (TXR# 0056905). The available studies for picaridin include: 1) subchronic dermal 

and oral toxicity studies in rats, 2) dermal chronic studies in dogs and chronic/carcinogenicity 

studies in rats and mice, 3) dermal developmental studies in rats and rabbits, 4) a dermal 

reproduction study in rats 5) dermal acute and subchronic neurotoxicity studies, 6) dermal 

absorption (in vivo and in vitro) and dermal (and intravenous) metabolism studies in rats, 7) a 

mutagenicity battery, and 8) acute lethality (LD50) studies. In addition, data characterizing the 

etiology of the kidney effects seen in rats are also available. Subchronic mouse and dog studies 

are not available for picaridin; however, new studies are not needed since potential toxicity can 

be adequately characterized by the available cancer mouse and chronic dog studies. 

4.2 Absorption, Distribution, Metabolism, Excretion (ADME) 

The absorption, distribution, metabolism, and elimination (ADME) of picaridin have been 

examined in rats following dermal and intravenous (I.V.) administration with varying dose 

levels. Picaridin was rapidly absorbed, metabolized, and excreted in the urine. After dermal 

exposure, the onset of absorption was fast with half-lives of 0.8-3.4 hours and peak blood levels 

were reached within 6-8 hours of dosing; blood levels were higher in females. Approximately, 

60-66% of the administered dose was absorbed at the low dose and 40-55% at the high dose 

during the test duration of 7 days. The majority was absorbed (> 90%) within the first 24 hours 

after application. Following I.V. administration (within 48 hours of dosing), urinary elimination 

was 74-82% in males and 87-90% in females; fecal elimination was 12-17% in males and 5-6% 

in females; and 0.4-0.5% remained in the body for both sexes. The metabolite profile and 

relative distribution of metabolites was similar in urine and feces, and between dose groups and 

sexes. 

 
Page 8 of 23

4.2.1 Dermal Absorption 

Since the last risk assessment, several in vitro dermal absorption studies using rat and human 

skin with different formulations have been submitted for picaridin. The formulations with and 

without ethanol indicate similar absorption values, which addresses an uncertainty previously 

identified regarding the potential for ethanol to increase dermal absorption. Formulations with 

and without sunscreen were also tested and the absence of sunscreen resulted in a 2-fold higher 

absorption value. Additionally, the data demonstrates that dermal absorption in rat skin is 

approximately 2X higher than dermal absorption in human skin after exposure to picaridin. 

Technical/Formulations In vivo Rat 

(0.67 mg/cm2) 

168 hours* 

In vitro Rat 

(0.63mg/cm2) 

24 hours 

In vitro Human 

(0.63mg/cm2) 

24 hours 

KBR-3023 Technical 19.1% 25.2% 10.7% 

KBR 3023 15% in ethanol N/A 22.3% 9.8% 

Cutter Insect Repellant SS ( 

KBR3023 15% ethanol with 

sunscreen) 

N/A N/A 9.9% 

Cutter Insect Repellant 

Formulation A- (KBR3023 

15% ethanol without 

sunscreen) 

N/A N/A 18.9% 

 

* The 168 hour time point was used for the in vivo rat since there was continued absorption after 8 and 24 hours. 

4.3 Toxicological Effects 

In the majority of the toxicity studies for picaridin, no treatment related effects were seen up to 

the highest doses tested. However, kidney effects were seen in oral and dermal toxicity studies 

in rats at ≥ 500 mg/kg/day; body weight changes were seen in oral studies at the limit dose. The 

kidney effects observed included increased kidney weights, slight hyaline degeneration, an 

increased incidence of foci of tubular regeneration, chronic kidney inflammation, and protein 

droplet nephropathy. 

The kidney effects observed in the picaridin database are consistent with nephrotoxicity resulting 

from alpha 2 u globulin (a2u-g) accumulation. The first morphological manifestation of alpha 2 u 

globulin nephropathy is the rapid accumulation of hyaline droplets in proximal tubule cells, 

developing within 24 hours of dosing with some compounds (Webb, et al 1989); exposure to 

picaridin resulted in protein droplets in oral subchronic rat studies at the limit dose. In order to 

confirm that the apparent nephrotoxicity seen with picaridin was related to a2u-g accumulation, 

the registrant submitted pathology slides and droplet staining information. The protein droplets 

observed in the oral studies with picaridin were stained with Mallory’s Heidenhain (MH) and 

Periodic Acid Schiff (PAS). The droplets were negative with PAS and positive with MH stains. 

The observation is consistent with what is seen for a2u-g hyaline droplets. The droplets stain 

positively with MH stain but are negative for PAS, indicating their protein composition (Alden et 

al., 1984). 

 
Page 9 of 23

Since a2u-g is a male rat specific protein, acute and chronic renal effects induced in male rats are 

unlikely to occur in any species not producing a2u-g, or a very closely related protein, in the large 

quantities typically seen in the male rat (Alden, 1989; Borg hoff et al., 1990; Green et al., 1990; 

Olson et al., 1990; Flamm and Lahman-McKeeman, 1991; Swanberg, 1991). Therefore, 

nephropathy induced by a2u-g accumulation would not be expected to occur in female rats, mice 

(either sex) or other species, including humans. As a result, the a2u-g nephropathy in male rats is 

not an appropriate endpoint to determine noncancer (systemic) effects potentially occurring in 

humans. Likewise, quantitative estimates of noncancer risk (e.g., reference doses) and marginof-exposure determinations) should be based on other endpoints (USEPA, 1991). Therefore, the 

kidney effects were not considered appropriate for risk assessment. 

In addition to kidney effects, a decrease in body weight was noted at the limit dose (1000 

mg/kg/day) following oral exposures for 5 weeks or longer. It is noteworthy that no progression 

of toxicity was observed, since body weight decrements were lower after 14 weeks of oral 

exposure (↓11%) vs 5 weeks (↓16%). 

There was no evidence of increased quantitative or qualitative susceptibility in dermal 

developmental toxicity studies in rats or rabbits or in a reproduction study in rats. No maternal 

or fetal/offspring effects were observed in the studies. There was no evidence of neurotoxicity in 

dermal acute and subchronic neurotoxicity studies, or in any other studies in the toxicology 

database. 

Although the tissue receiving the highest dose in the dermal studies was the skin, no skin tumors 

or precursor lesions were observed in the rat, mouse, or dog. Also, there is no evidence of 

carcinogenicity in dermal carcinogenicity studies in rats and/or mice and picaridin is classified as 

“not likely to be a carcinogenic to humans via the dermal route." Additionally, there is no 

mutagenicity concern for picaridin. 

In acute lethality oral, dermal, and inhalation studies, exposure to picaridin resulted in low 

toxicity (Categories III and IV). It is moderately irritating to the eye and not irritating to the 

skin; it is not a dermal sensitizer. 

4.4 Safety Factor for Infants and Children (FQPA Safety Factor) 

4.4.1 Food Quality Protection Act (FQPA) considerations 

Food Quality Protection Act (FQPA) considerations do not apply to picaridin since the registered 

uses are non-food, and dietary exposure is not anticipated. However, HED’s risk assessment has 

considered toxicity and exposure to sensitive populations, including infants and children.

4.4.2 Completeness of the Toxicology Database 

The toxicology database for picaridin is adequate and considered complete for characterizing 

toxicity. 
Page 10 of 23

4.4.2 Evidence of Neurotoxicity 

 

Dermal acute and subchronic neurotoxicity studies are available for picaridin. No evidence of 

neurotoxicity was observed in the acute neurotoxicity study in rats up to 2000 mg/kg/day (limit 

dose) or in the subchronic neurotoxicity study up to 200 mg/kg/day. Additionally, no evidence 

of neurotoxicity was seen in the other available toxicity studies for picaridin. 

4.4.3 Evidence of Sensitivity/Susceptibility in the Developing or Young Animal 

No evidence of quantitative or qualitative susceptibility was observed in the dermal 

developmental and reproduction studies. 

 

4.4.4 Residual Uncertainty in the Exposure Database 

A quantitative risk assessment was not performed for picaridin. Therefore, there are no residual 

uncertainties regarding exposure. 

4.5 Toxicity Endpoint and Point of Departure Selections 

4.5.1 Dose-Response Assessment 

Toxicity endpoints and points of departure were not selected for picaridin. A qualitative human 

health risk assessment was conducted in lieu of a quantitative assessment, due to the limited 

toxicity seen in the database. Although kidney effects were seen in rats in dermal and oral 

toxicity studies, the effects are a result of accumulation of alpha 2-u globulin. Since a2u-g is a 

male rat specific protein, kidney toxicity induced by its accumulation is not be expected to occur 

in female rats, mice, or in any other species, including humans. Therefore, the kidney effects 

observed in male rats are not considered appropriate for use in human health risk assessment. 

Outside of the kidney effects, toxicity was limited to body weight changes seen only at the limit 

dose (1000 mg/kg/day); human exposure at this level is not anticipated in conjunction with the 

use of products containing picaridin in accordance with registered labels. 

4.5.2 Recommendation for Combining Routes of Exposures for Risk Assessment 

A quantitative risk assessment was not performed for picaridin. Therefore, there are no exposure 

routes to combine. 

4.5.3 Classification of Carcinogenic Potential 

Picaridin is classified as “not likely to be a carcinogenic to humans”, via the dermal route. No 

treatment-related increase in tumors was observed in dermal carcinogenicity studies in rats 

and/or mice. Picaridin was negative in the majority of mutagenicity studies. Clastogenicity was 

observed in in vitro chromosomal aberration studies in Chinese Hamster Ovary (CHO K1) cells. 

However, the effect was not expressed in vivo. Therefore, there is no mutagenic concern for 

picaridin. 
Page 11 of 23

5.0 Dietary Exposure and Risk Assessment 

Picaridin is a non-food active ingredient; therefore, dietary exposure is not expected. 

 

6.0 Residential (Non-Occupational) Exposure/Risk Characterization

The residential exposure database is adequate to support the registration review process for 

picaridin. Picaridin is registered for use as an insect repellent applied directly to the skin of 

adults and children. There is also a registered picaridin product for use on horses (i.e., a readyto-use spray “Ride Together” to protect the rider and the horse). Picaridin products are available 

in multiple formulations, including aerosol sprays, creams, and lotions containing 5-20% 

picaridin. Labels contain instructions which prohibit application directly to the hands of 

children, among other use directions, to decrease the likelihood of adverse health effects from 

possible misuse or overuse of insect repellent products. Picaridin products can be used for 

several days or weeks or longer, depending on the activity pattern and geographic area. 

Exposure is expected to be of short- and intermediate- term exposure duration; however, longterm exposures are possible for some individuals in some climates. 

Insect repellents are used on people of all ages. Adults are assumed to experience both dermal 

and inhalation handler exposures, as well as post-application dermal and, potentially, inhalation 

exposure. Adults are assumed to apply repellents to themselves or to others. Additionally, for 

aerosol and spray repellents, individuals to whom the products are being applied can experience 

indirect inhalation exposure during the application. For children, post-application exposure 

consists of dermal, (potentially) inhalation, and incidental oral (hand-to-mouth) exposure. 

Several previous risk assessments have been conducted to evaluate human exposure to picaridin 

in support of its proposed use as a repellent. However, based on current policies and an updated 

evaluation of the available toxicity data, no toxicological endpoints and points of departure (for 

either the dermal, incidental or inhalation route of exposure) have been selected for picaridin risk 

assessment. Therefore, an updated quantitative residential exposure and risk assessment is not 

required to support registration review. 

6.1 Spray Drift 

Registered picaridin uses were evaluated as part of the Registration Review process to ensure 

that the potential for spray drift has been considered in the risk assessment. Based on the use 

pattern, HED determined that picaridin is not registered on use sites that would result in spray 

drift. Therefore, a quantitative spray drift assessment was not conducted. 

7.0 Aggregate Exposure/Risk Characterization

Based on the non-food use pattern, for picaridin, as well as a lack of toxicity associated with 

exposure to picaridin, HED concludes that aggregate risks are not of concern. 
Page 12 of 23

8.0 Cumulative Exposure/Risk Characterization

The Agency has not determined that picaridin shares a common mechanism of toxicity with 

other chemical substances; therefore, a cumulative risk assessment to support registration review 

is not required. 

9.0 Occupational Exposure/Risk Characterization

There is no occupational exposure associated with registered uses of picaridin. 

10.0 Public Health and Pesticide Epidemiology Data 

For this evaluation, the Agency consulted both the 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) databases were consulted for pesticide incident data on the active ingredient picaridin 

(D417724, S. Recore, 2/11/2014). The purpose of the database search is to identify potential 

patterns in the frequency and severity of the health effects attributed to picaridin exposure. 

Picaridin is not included in the AHS, and therefore this study does not provide information for 

this document. 

For the Main IDS, from January 1, 2009 to January 15, 2014, there were 26 incidents reported 

for the single chemical only in the database. These incidents were classified as moderate 

severity, not life threatening and the person returned to his/her pre-exposure state of health with 

no additional residual disability. There were no additional incidents reported involving more 

than one chemical. In the Aggregate IDS, from January 1, 2009 to January 15, 2014, there were 

214 reported incidents involving picaridin. These incidents were classified as minor severity and 

the symptoms resolved rapidly and usually involved skin, eye or respiratory irritation. 

A query of SENSOR-Pesticides 1998-2010 identifies 22 cases involving picaridin, 19 involving 

a single active ingredient and three involving multiple active ingredients. Of the 19 cases 

involving the single active ingredient, eighteen cases were low in severity, largely involving 

dermal or eye irritation; one case was moderate in severity, and involved direct application of a 

product containing picaridin to the face of an infant. 

Based on the low frequency and low severity of incident cases reported for picaridin in both IDS 

and SENSOR-Pesticides, there does not appear to be a concern at this time that would warrant 

further investigation. 

11.0 Literature References

A literature search was performed for picaridin. The search did not reveal information that 

would impact the current risk assessment. 
Page 13 of 23

12.0 References 

Alden, C.L., Kanerva, R.L., Ridder, G., and Stone, L.C. (1984) The pathogenesis of the 

nephrotoxicity of-volatile hydrocarbons in the male rat: Mehlman, M.A., Hemstreet, G.P., 

Thorpe, J.J., and Weaver, N.K.(eds.), Advances in Modern Environmental Toxicology. Vol. VII. 

Renal Effects of Petroleum Hydrocarbons. Princeton Scientific Publishers,Inc., Princeton, New 

Jersey, pp. 107-120. 

Figueroa, Z., Vogel, D. (2006) Re-Evaluation of Exposure Assumptions for KBR 3023 

(Picaridin). PC Code: 070705. DP 323024. 

Figueroa, Z. (2008) Picardin: Evaluation of in vitro dermal penetration study using human and 

rat skin for KBR 3023. PC Code: 070705. DP 357835. 

Leshin, J. (2014) KBR 3023 (Picaridin): Summary of the Hazard and Science Policy Council 

(HASPOC): Recommendations on the Need for Additional Oral, Inhalation and Immunotoxicity 

Studies. TXR# 0056905. 

Figueroa, Z. (2008) Picardin: Evaluation of in vitro dermal penetration study using human and 

rat skin for KBR 3023. PC Code: 070705. DP 357835. 

U.S. EPA. Alpha2u-Globulin: Association with Chemically Induced Renal Toxicity and 

Neoplasia in the Male Rat. U.S. Environmental Protection Agency, Risk Assessment Forum, 

Washington, DC, EPA/625/3-91/019F (NTIS PB92143668), 1991. 

Webb, D.R., Ridder, G.M., and Alden, C.L. (1989) Acute and subchronic nephrotoxicity of dlimonene in Fischer 344 rats. Fd. Chern. Toxicol. 27: 639-649. 

Weiss, S. (1999) Human Health Risk Assessment for KBR 3023 All Family Insect Repellent 

Spray & Cream. PC Code: 070705. DP 259708. 

Whalan, J. (2000) Human Health Risk Assessment for KBR 3023 All Family Insect Repellent 

Spray & Cream. PC Code: 070705. DP 261567. 

Whalan, J. (2001) Human Health Risk Assessment for KBR 3023 All Family Insect Repellent 

Spray & Cream. PC Code: 070705. DP 279005. 
Page 14 of 23

Appendix A. Toxicology Profile 

Table A.1. Acute Toxicity Profile of KBR 3023 (Picaridin) Technical. 

Guideline 

Number 

Study Type 

Classification 

MRID 

Number 

Results Toxicity 

Category 

870.1100 Acute Oral – Rat (w/ 

2% Cremophor EL) 

44408705 

44408706

LD50 = 4743 mg/kg 

(Males) 

LD50 = 2236 mg/kg 

(Females) 

III

870.1200 Acute Dermal - Rat 44408707 LD50 >2000 mg/kg (limit 

test) 

NOEL = 2000 mg/kg 

NOAEL >2000 mg/kg 

III 

870.1300 Acute Inhalation - 

Rat 

44408709 LC50 >4.364 mg/L 

NOAEL = 4.364 mg/L 

(slight body weight 

anomalies) 

IV 

870.2400 Primary Eye 

Irritation - Rabbit 

44408710 Moderate ocular irritant III 

870.2500 Primary Skin 

Irritation - Rabbit 

44408712 Not a dermal irritant IV 

870.2600 Dermal Sensitization 

- Guinea Pig 

44408713 

44408714 

44408752 

44408758 

Not a dermal sensitizer* -- 

* There is no evidence of dermal sensitization in a Buehler test of KBR 3023; this study was classified unacceptable 

because there was no positive control group (MRID 44408713). Two of five trace components of KBR 3023 tested 

in a maximization test were significant dermal sensitizers (MRID 44408714). No dermal sensitization was observed 

in Buehler tests of the 20% alcoholic and cream formulations (MRID 44408752 and 44408758).
Page 15 of 23

Table A.2. KBR 3023 (Picaridin) Subchronic, Chronic, and Other Toxicity. 

GUIDELINE 

NO. 

STUDY TYPE MRID NO. (YEAR)/ 

CLASSIFICATION /DOSES 

RESULTS 

870.3100 14-Day Feeding - Rat 

[Range finding 

study] 

45227601 

0, 1000, 1500, 2000, 20,000 ppm 

Males:0, 90, 141, 183, 731 mg/kg/day 

Females: 0, 109, 163, 202, 1826 

mg/kg/day 

Although this was a range-finding study, 

it was performed in compliance with the 

GLPs and was patterned after guideline 

OPPTS 870.3100 (90-day oral toxicity in 

rodents). 

NOAEL = 20,000 ppm (1731/1826 

mg/kg/day, M/F) which exceeds the 

limit dose of 1000 mg/kg/day. 

LOAEL - not determined 

870.3100 5-Week Feeding - 

Rat 

45387901 

0, 100, 150, 300, 1000 mg/kg/day 

This study was a satellite to subchronic 

study MRID 45387902 (below). 

 

NOAEL = 308 mg/kg/day (actual daily 

intake) 

LOAEL = 1034 mg/kg/day based on 

decreased body weight and kidney 

effects (increased relative kidney 

weights and increased incidence of 

protein droplet nephropathy in males). 

The kidney effects observed are 

attributable to alpha 2-u globulin 

accumulation which is species specific 

(rat) and not appropriate for human risk 

assessment. 

870.3100 14-Week Feeding - 

Rat 

 45387902 

0, 100, 150, 300, 1000 mg/kg/day 

NOAEL = 301 mg/kg/day 

LOAEL =1033 mg/kg/day based on 

decreased body weight and kidney 

effects (increased relative kidney 

weights and increased incidence of 

protein droplet nephropathy in males). 

The kidney effects observed are 

attributable to alpha 2-u globulin 

accumulation which is species specific 

(rat) and not appropriate for human risk 

assessment 

870.3250 Dermal Subchronic - 

Rat 

 MRID 44408716 

0, 80, 200, and 500 mg/kg/day NOAEL (systemic) = 200 mg/kg/day 

LOAEL (systemic) = 500 mg/kg/day 

based on kidney effects (hyaline 

degeneration in the kidneys, increased 

incidence of foci of tubular 

regeneration, and chronic kidney 

inflammation). The kidney effects 

observed are attributable to alpha 2-u 

globulin accumulation which is species 
Page 16 of 23

Table A.2. KBR 3023 (Picaridin) Subchronic, Chronic, and Other Toxicity. 

GUIDELINE 

NO. 

STUDY TYPE MRID NO. (YEAR)/ 

CLASSIFICATION /DOSES 

RESULTS 

specific (rat) and not appropriate for 

human risk assessment. 

NOAEL (dermal irritation)=not 

determined 

LOAEL (dermal irritation) = 80 

mg/kg/day (scabs, red foci, and 

exfoliation at the dosing site). 

870.3700 Dermal 

Developmental 

Toxicity - Rat 

 MRID 44408725 

0, 50, 200, and 400 mg/kg/day 

Maternal and Developmental 

NOAEL=400 mg/kg/day 

LOAEL= not determined 

870.3700 Dermal 

Developmental 

Toxicity - Rabbit 

MRID 44408721 

0, 50, 100, and 200 mg/kg/day 

Maternal and Developmental 

NOAEL=200 mg/kg/day 

LOAEL= not determined 

870.3800 Dermal Reproductive 

Toxicity - Rat 

MRID 44408727 

0, 50, 100, and 200 mg/kg/day 

Systemic, reproductive, and Offspring 

NOAEL=200 mg/kg/day 

LOAEL= not determined 

870.4100 Dermal Chronic 

Toxicity - Dog 

MRID 44408718 NOAEL=200 mg/kg/day 

LOAEL= not determined 

870.4200 Dermal 

Carcinogenicity - 

Mouse (18 months) 

 MRID 44408719 

0, 50, 100, and 200 mg/kg/day 

NOAEL=200 mg/kg/day 

LOAEL= not determined 

There is no evidence of 

carcinogenicity. 

870.4300 Dermal Chronic 

Toxicity/Carcinogeni

city-Rat 

 MRID 44408728 

0, 50, 100, and 200 mg/kg/day 

NOAEL=200 mg/kg/day 

LOAEL= not determined 

There is no evidence of 

carcinogenicity. 

870.5265 Salmonella 

typhimurium

Mammalian 

Activation Gene 

Mutation Assay 

MRID 44408729 Negative 

870.5300 In Vitro Gene 

Mutation Assay in 

Chinese Hamster 

V79 Cells 

MRID 45231801 Negative 

870.5375 In Vitro Mammalian 

Chromosome 

MRID 44408732 Clastogenic in CHO cells in the 

absence of metabolic activation. 
Page 17 of 23

Table A.2. KBR 3023 (Picaridin) Subchronic, Chronic, and Other Toxicity. 

GUIDELINE 

NO. 

STUDY TYPE MRID NO. (YEAR)/ 

CLASSIFICATION /DOSES 

RESULTS 

Aberrations in CHO 

Cells 

870.5375 In Vitro Mammalian 

Chromosome 

Aberrations in CHO 

Cells 

MRID 44408733 

Clastogenic with metabolic activation 

for CHO cells; equivocal in the absence 

of metabolic activation. 

870.5395 In Vivo Mammalian 

Cytogenetics - 

Micronucleus Assay 

in Mice 

MRID 44408734 Negative 

870.5550 Unscheduled DNA 

Synthesis in Rat 

Hepatocytes 

MRID 44408730 Negative 

870.6200 Acute Dermal 

Neurotoxicity - Rats 

MRID 44408715 

0, 200, 600, and 2000 mg/kg/day 

NOAEL=2000 mg/kg/day 

LOAEL= not determined 

870.6200 Subchronic Dermal 

Neurotoxicity - Rats 

MRID 44408717 

0, 50, 100, and 200 mg/kg/day 

NOAEL=200 mg/kg/day 

LOAEL= not determined 

870.6300 Dermal 

Developmental 

Neurotoxicity - Rat 

Not required 

870.7485 Dermal and I.V. 

Metabolism - Rat 

MRID 44408735 Dermal: Animals dosed dermally 

absorbed 60-66% of the low-dose (20 

mg/kg, 0.5 mg/cm2

) and 40-55% of the 

high-dose (200 mg/kg, 5 mg/cm2) which 

suggests saturation. Elimination was 

mostly in the urine. Approximately 19-

33% of the dose was not recovered, 

most likely due to evaporation. 

Radioactivity remaining in the carcass 

after 7 days was 0.4-0.5% in males and 

0.2-0.4% in females. Absorption was 

rapid with half-lives of 0.8-3.4 hr. 

Plasma peak concentrations were 

reached within 6-8 hours of dosing and 

were higher in females than males. 

Elimination of radioactivity from 

plasma of dermally dosed animals was 

dose- and sex-dependent. 

I.V.: Within 48 hours of I.V. dosing, 

urinary elimination was 74-82% in 

males and 87-90% in females; fecal 

elimination was 12-17% in males and 5-

6% in females; and 0.4-0.5% remained 

in the body for both sexes. 
Page 18 of 23

Table A.2. KBR 3023 (Picaridin) Subchronic, Chronic, and Other Toxicity. 

GUIDELINE 

NO. 

STUDY TYPE MRID NO. (YEAR)/ 

CLASSIFICATION /DOSES 

RESULTS 

Metabolism: Nineteen metabolites 

were identified in urine and feces of 

both I.V. and dermally dosed rats. The 

metabolite profile and relative 

distribution of metabolites is similar in 

urine and feces, and between dose 

groups and sexes. The metabolism of 

KBR 3023 in rats primarily involves 

oxidation of the 2-hydroxyethyl group 

to an acid to form metabolite M16, 

coupled with hydroxylation of the 1-

methylpropyl group to form metabolites 

M8, M9, and M10. The other minor 

phase I metabolites result from 

hydroxylation of the piperidine ring 

(M1-M4 and M7). Minor phase II 

metabolites result from conjugation of 

glucuronic acid with parent (M14 and 

M15) or phase I metabolites (M5, M6, 

and M11-M13). 

870.7600 Dermal Absorption - 

Rat 

MRID 44408737 Rats were dermally dosed at nominal 

levels of 8, 40, or 200 mg/kg (0.133, 

0.67, or 3.33 mg/cm2

) for 8 hours. After 

8 hours, absorption of the applied dose 

was 14.4, 9.8, and 6.9% in males, and 

27.4, 12.6, and 8.9% in females, 

respectively; and skin retention of the 

applied dose was 5.5, 7.6, and 9.2% in 

males, and 4.8, 8.8, and 13.7% in 

females, respectively. 

After 168 hours (7 days) absorption of 

the applied dose was 18.5, 18.1, and 

12.9% in males, and 24.9, 16.5, and 

21.1% in females, respectively; and skin 

retention of the applied dose was 1.9, 

1.0, and 0.8% in males, and 2.2, 1.0, and 

1.0% in females, respectively. 

After 168 hours (7 days) total absorption 

and skin-retained of the applied dose 

was 20.4, 19.1, and 13.7% in males, and 

27.1, 17.5, and 22.1% in females, 

respectively. 

Note: A dermal absorption factor of 

19.1% from the mid dose (40 

mg/kg/day) after 168 hours (due to 

continued absorption) was used with the 

in vitro dermal absorption data to 

determine a refined dermal dose for risk 

assessment. 
Page 19 of 23

Table A.2. KBR 3023 (Picaridin) Subchronic, Chronic, and Other Toxicity. 

GUIDELINE 

NO. 

STUDY TYPE MRID NO. (YEAR)/ 

CLASSIFICATION /DOSES 

RESULTS 

870.7600 Comparative In Vitro

Dermal Penetration 

Study Using Rat and 

Human Skin 

MRID 47342201 Mean total recoveries ranged from 

100.1-115.1% of the applied dose. For 

the technical formulation, 7.3% of the 

applied dose was directly absorbed 

through human skin, while 21.8% of the 

applied dose was directly absorbed 

through rat skin (2.97-fold difference). 

For the 15% (w/v) ethanol formulation, 

5.6% of the applied dose was directly 

absorbed through human skin, while 

16.8% of the applied dose was directly 

absorbed through rat skin (3.01-fold 

difference). For the technical 

formulation, 10.7% of the applied dose 

was potentially absorbable through 

human skin, while 25.2% of the applied 

dose was potentially absorbable through 

rat skin (2.4-fold difference). For the 

15% (w/v) ethanol formulation, 9.8% of 

the applied dose was potentially 

absorbable through human skin, while 

22.3% of the applied dose was 

potentially absorbable through rat skin 

(2.3-fold difference). 

870.7600 In Vitro Dermal 

Penetration Study 

Using Human Skin 

MRID 47340901 Higher mean dermal penetration in all 

skin layers was observed in Formula A 

compared to the SS formulation. The 

mean percentage of [14C]-KBR 3023 

that was directly absorbed was 2.1 fold 

higher in the Cutter Insect Repellent 

Formula A without sunscreen (12.44% 

dose) compared to the SS Formula with 

sunscreen (5.92% dose). Similarly, the 

mean percentage of [14C]-KBR 3023 

that was potentially absorbable was 1.6 

fold higher in Formula A (6.47% dose) 

compared to the SS Formula (3.93% 

dose). Thus, the sum of the mean 

percentage of [14C]-KBR 3023 that was 

directly absorbed and that which 

remained in the skin for potential 

absorption was 1.9 fold higher in 

Formula A (18.91% dose) compared to 

the SS Formula (9.85% dose). 
Page 20 of 23

Appendix B. Review of Human Research

A dermal absorption study with human volunteers [MRID 44408736 (1996) and 44408738 

(1994)] involving intentional exposure to picaridin was used in earlier assessments to determine 

a dermal absorption factor. However, the study was not used in the current assessment and the 

dermal absorption factor was determined using in vivo dermal absorption data in the rat, along 

with in vitro dermal absorption data in rat and human skin. If EPA decides to use any studies 

with human volunteers, EPA will ensure that all applicable regulatory requirements are met, 

including, but not limited to, the requirements for EPA ethics review and Human Studies Review 

Board review of certain research involving intentional exposure of human subjects. 

Appendix C. Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of registration review for picaridin, EPA reviewed these data and 

selected the most sensitive endpoints for relevant risk assessment scenarios from the existing 

hazard database. However, as required by FFDCA section 408(p), picaridin is subject to the 

endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list 

of chemicals identified for EDSP screening was published on June 14, 20131 and includes some 

 

1 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals. 
Page 21 of 23

pesticides scheduled for registration review and chemicals found in water. Neither of these lists 

should be construed as a list of known or likely endocrine disruptors. 

For further information on the status of the EDSP, the policies and procedures, the lists of 

chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website.2 

Appendix D. Picaridin Use Pattern 

Appendix D. Summary of Directions for Use of Picaridin. 

Formulation 

[EPA Reg. No.] 

Applic. 

Timing, 

Type, and 

Equip. 

Single 

Applic. 

Rate 

Max. No. 

Applic. per 

Day 

Specific Use Directions and 

Limitations 

KBR 3023 All-Family Insect 

Repellent Cream 

20% ai 

[39967-50]1 

RTU Cream 1 appl. 2 appl./day 

Apply evenly. Avoid applying excessive 

amounts of this product. Do not apply on 

children’s hands. 

KBR 3023 All-Family Insect 

Repellent Spray 

20% ai 

[39967-53]1 

RTU Spray 1 appl. 2 appl./day Do not apply in enclosed areas. 

Cutter Insect Repellent 7K 

7% ai 

[121-89] 

RTU Spray 1 appl. 3 appl./day Do not apply in enclosed areas. 

Cutter Insect Repellent 5KT 

5.75% ai 

[121-90] 

RTU 

Towelettes 

1 appl. 

(towelette) 3 appl./day Apply evenly. 

Cutter Insect Repellent 15KP 

15% ai 

[121-91] 

RTU Spray 

(6 oz 

container) 

1 appl. 3 appl./day Do not apply in enclosed areas. 

Cutter Insect Repellent 15KA 

15% ai 

[121-92] 

RTU Spray 

(6 oz 

container) 

1 appl. 3 appl./day Do not apply in enclosed areas. 

Cutter Insect Repellent 12KT 

12% ai 

[121-93] 

RTU 

Towelettes 

1 appl. 

(towelette) 3 appl./day Apply evenly. 

Cutter Insect Repellent 10KP 

10% ai 

[121-94] 

RTU Spray 1 appl. 3 appl./day Do not apply in enclosed areas. 

Cutter Insect Repellent 10KA 

10% ai 

[121-95] 

RTU Spray 

(6 oz 

container) 

1 appl. 3 appl./day Do not apply in enclosed areas. 

Cutter Insect Repellent SS 

SPF 30 

15% ai 

[121-97] 

RTU Spray 

(6 oz 

container) 

1 appl. 3 appl./day 

Reapply every 3-4 hours. For sunscreen 

protection apply as needed after towel 

drying, swimming or sweating. Do not 

apply on children < 6 months old of age. 

Cutter Insect Repellent 20KP 

20% ai 

[121-99] 

RTU Spray 1 appl. 2 appl./day Do not apply in enclosed areas. 

 

2

 http://www.epa.gov/endo/ 
Page 22 of 23

Appendix D. Summary of Directions for Use of Picaridin. 

Formulation 

[EPA Reg. No.] 

Applic. 

Timing, 

Type, and 

Equip. 

Single 

Applic. 

Rate 

Max. No. 

Applic. per 

Day 

Specific Use Directions and 

Limitations 

Cutter Insect Repellent 20KA 

20% ai 

[121-100] 

RTU Spray 

(6 oz 

container) 

1 appl. 1 appl./day Do not apply in enclosed areas. 

Ecopel All-Family Insect 

Repellent Spray 

20% ai 

[86374-1] 

RTU Spray 

(7 oz 

container) 

1 appl. 2 appl./day 

Hold 4-6 inches from skin while 

spraying, keeping nozzle pointed away 

from face. 

KBR 3023 All-Family Insect 

Repellent Cream II 

5% ai 

[3125-546 transferred to 4822-

535] 

RTU Cream 1 appl. 3 appl./day 

Apply evenly. Avoid applying excessive 

amounts of this product. Do not apply on 

children’s hands. 

KBR 3023 All-Family Insect 

Repellent Non-Aerosol Spray 

5% ai 

[4822-536] 

RTU Spray 1 appl. 3 appl./day Reapply every 3-4 hours. Do not apply in 

enclosed areas. 

KBR 3023 All-Family Insect 

Repellent Aerosol Spray 

10% ai 

[4822-537] 

RTU Aerosol 

Spray 

(12 oz bottle)

1 appl. 

3 appl./day 

(adult) 

2 appl./day 

(children) 

Reapply every 6 hours. Do not apply in 

enclosed areas. 

Geneva-T 

16% ai 

[4822-555] 

RTU 

Towelettes 

1 appl. 

(towelette) 2 appl./day Apply evenly. 

OFF! Deep Woods Sportsmen 

Insect Repellent V 

20% ai 

[4822-556] 

RTU Spray 1 appl. 2 appl./day Reapply every 8 hours. 

OFF! Deep Woods Sportsmen 

Insect Repellent VI 

20% ai 

[4822-564] 

RTU Spray 1 appl. 2 appl./day Reapply after 8 hours. 

AVON Skin-So-Soft SSS 

IR3535 Bug Guard Plus 

Picaridin Insect Repellent 

Aerosol Spray 

10% ai 

[806-29] 

RTU Aerosol 

Spray 1 appl. 2 appl./day 

Reapply every 7 hours for deer ticks, 

gnats, no-seeums, sand flies and biting 

midges; for mosquitos reapply after 6 

hours; for black flies reapply after 3 

hours. 

AVON Skin-So-Soft SSS 

IR3535 Bug Guard Plus 

Picaridin Insect Repellent 

Towelettes 

10% ai 

[806-30] 

RTU 

Towelettes 

1 appl. 

(towelette) 2 appl./day 

Apply evenly. Reapply every 8 hours for 

mosquitos; reapply after 6 hours for 

gnats, no-seeums, sand flies and biting 

midges. 

AVON Skin-So-Soft SSS 

IR3535 Bug Guard Plus 

Picaridin Insect Repellent 

Spray 

10% 

[806-31] 

RTU Spray 1 appl. 2 appl./day 

Reapply every 12 hours for deer ticks; for 

gnats, no-seeums, sand flies and biting 

midges reapply after 6 hours; for 

mosquitos reapply after 8 hours. 
Page 23 of 23

Appendix D. Summary of Directions for Use of Picaridin. 

Formulation 

[EPA Reg. No.] 

Applic. 

Timing, 

Type, and 

Equip. 

Single 

Applic. 

Rate 

Max. No. 

Applic. per 

Day 

Specific Use Directions and 

Limitations 

Natrapel 8-Hour Insect 

Repellent Wipes 

20% ai 

[56575-14] 

RTU 

Towelettes 

1 appl. 

(towelette) 2 appl./day Apply evenly. Reapply every 8 hours. 

Natrapel 8-Hour Insect 

Repellent Spray 

20% ai 

[56575-15] 

RTU Spray 1 appl. 2 appl./day 

Slightly moisten skin or clothing with a 

slow sweeping motion. Use of this 

product may cause skin reactions in rare 

cases. 

Insect Guard 3023 Insect 

Repellent 

20% ai 

[54287-22] 

RTU Spray 1 appl. 2 appl./day Reapply every 8 hours. 

Centaura Fly and Mosquito 

Spray Repellant 

20% ai 

[85972-1] 

RTU Spray 1 appl. 2 appl./day 

A “Ride Together” spray to protect the 

rider and horse. For use on horse (all 

breeds) and riders. Do not apply on 

horses intended for human consumption 

and under saddle. 

Insect Repellent Spray - Family 

& Active-Use Protection 

86459-1 

RTU Spray 1 appl. 2 appl./day Apply evenly. Protection for 8 hours. 

1 Major producer; product labels from companies with registered technical/manufacturing products.