.. 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: February 20, 2013 

SUBJECT: Soap Salts: Updated Tier I Review ofHwnan Incidents 

PCCode:079021,079009,031801 

Decision No.: 469863 

Petition No.: NA 

DP Barcode: D405417 

Registration No.: NA 

Regulatory Action: NA 

Risk Assessment Type: NA Case No.: NA 

TXRNo.:NA 

MRIDNo.:NA 

CAS No.: 10124-65-9, 68952-95-4, 84776-33-0 

40CFR:NA 

Ver.Apr.08 

Shanna Recore, Industrial Hygienist ~ n A " I\ . d FROM: 

Toxicology 

Health Effects 

and 

Division 

Epidemiology 

(7509P) 

Branch l1 ~~ 

THROUGH: David Miller, Acting Branch Chief ,5 . J /IL Ao/eP-ZIJ/3 

Toxicology and Epidemiology Branc 'i 

Health Effects Division (7509P) 

TO: Matt Lloyd, Risk Assessor 

Risk Assessment Branch VII 

Health Effects Division (7509P) 

and 

Monica Wait, Chemical Review Manager 

Risk Management & Implementation Branch III 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Soap salts incidents were previously analyzed in 2008 (M. Hawkins and J. Cordova, 

10/30/2008, Updated Review of Soap Incident Reports). In this review, no incidents were 

identified in IDS from 2000 to 2008. Updated incident analyses are included from the Main 

and Aggregate Incident Data System (IDS) from January 1, 2007, to September 4, 2012. 

Additionally, 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) 1998-2008 dataset was analyzed. The results are 

consistent with the previous analyses. The results are as follows: 

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 For the Main IDS, from January 1, 2007 to September 4, 2012, there were 7 incidents 

reported for single chemical only in the database and 1 additional incident reported 

involving more than one chemical. These incidents were classified as moderate 

severity. These incidents are described in table 1. 

 In Aggregate IDS, from January 1, 2007 to September 4, 2012, there were 104 

reported incidents involving soap salts. These incidents were classified as minor 

severity. 

 A query of the SENSOR-Pesticides dataset from 1998 to 2008 identified a total of 30 

cases involving soap salts. Thirteen of these cases occurred at the individual’s place 

of work. Twenty nine of the cases were low severity (all SENSOR cases are 

symptomatic). 

 The Agricultural Health Study (AHS) is also a potential source of information 

associated with the human health effect associated with certain pesticides. Soap salts 

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

this report. 

In summary, based on the continued low frequency and severity of incident cases reported for 

soap salts, 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 

Soap salts 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 

Eligibility 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. This review is intended to 

provide an update to the previously prepared incident report (M. Hawkins and J. Cordova, 

10/30/2008, Updated Review of Soap Incident Reports). 

II. BACKGROUND 

 

The soap and soap salts registration review case is comprised of three active ingredients which 

are currently associated with active product registrations. These chemicals are (1) ammonium 

salts of C8 - C18 saturated and C18 unsaturated fatty acids; (2) potassium salts of C12—C18

saturated fatty acids; and (3) sodium salts of mixed fatty acid esters. Potassium salts are 

produced by adding potassium hydroxide to fatty acids found in animal fats and in plant oils, 
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such as palm, coconut, olive, castor, and cottonseed oils. A similar process is used for producing 

the ammonium and sodium soap salts. 

The potassium salts are used as insecticides, herbicides, fungicides and algaecides in a variety of 

settings, including food crops and residences. The ammonium salts are used as herbicides and 

deer and rabbit repellents, also in a wide variety of settings including agricultural settings. The 

sodium salts are used as a deer repellent in residential settings only. 

For this evaluation, both the OPP IDS and NIOSH SENSOR databases were consulted for 

pesticide incident data on the active ingredients Soap Salts (PC Codes 079021, 079009, 031801). 

The purpose of the database search is to identify potential patterns in the frequency and severity 

of the health effects attributed to soap salt exposure. 

III. RESULTS/DISCUSSION 

a. IDS 

OPP’s IDS includes reports of alleged human health incidents from various sources, including 

mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports 

from registrants, other federal and state health and environmental agencies, and individual 

consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from 

across the U.S. and most incidents have all relevant product information recorded. 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. 

 Main IDS contains incidents resulting in higher severity outcomes and provides more 

detail with regard to case specifics. 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 one active ingredient (as 

opposed to pesticide products with multiple active ingredients) are considered to 

provide more certain information about the potential effects of exposure from the 

pesticide. 

 Aggregate IDS contains incidents resulting in less severe human incidents (minor, 

unknown, or no effects outcomes). These are reported by registrants only as counts in 

what are aggregate summaries. 

For the Main IDS, from January 1, 2007 to September 4, 2012, there were 7 incidents reported 

for single chemical only in the database and 1 additional incident reported involving more than 

one chemical. These incidents were classified as moderate severity. These incidents are 

described in table 1. 

In Aggregate IDS, from January 1, 2007 to September 4, 2012, there were 104 reported incidents 

involving soap salts. These incidents were classified as minor severity. 

b. NIOSH SENSOR 
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The NIOSH SENSOR database covers 11 states from 1998-2008, 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 physicians, reports from State Departments of 

Agriculture, and physician reports to state 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 

protocol 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 data system 

is accessible to participating states and EPA. 

A query of the SENSOR-Pesticides dataset from 1998 to 2008 identified a total of 30 cases 

involving soap salts. Thirteen of these cases occurred at the individual’s place of work and were 

therefore coded as work-related. Twenty nine of the cases were low severity (all SENSOR cases 

are symptomatic). One case was moderate severity due to ocular symptoms; this case involves a 

woman who got Safer Insect Killing Soap in her eye. Her reported symptoms include: corneal 

abrasion, eye pain/irritation and or inflammation, and conjunctivitis. The database indicates both 

patient and physician reported these symptoms. In summary, 11 cases reported ocular 

symptoms, 7 cases reported dermal symptoms, 7 cases reported GI symptoms, 9 cases reported 

respiratory symptoms, 13 cases reported nervous/sensory symptoms, and 2 cases reported 

cardiovascular symptoms. 

c. AHS 

The AHS is a high quality, prospective epidemiology study evaluating the link between pesticide 

use and various health outcomes including cancer. The AHS includes private and commercial 

pesticide applicators and their spouses. If there are AHS findings relevant to a particular 

pesticide going through registration review, the Agency will ensure they are fully reviewed in the 

risk assessment phase of the process. The AHS includes information on use of 50 different 

pesticide active ingredients commonly used in agriculture. 

Soap salts are not included in the AHS, and therefore this study does not provide information for 

this report. 

IV. CONCLUSION 

Updated incident analyses of the Main and Aggregate Incident Data System (IDS) from 

January 1, 2007, to September 4, 2012 and are consistent with the previous analyses. 

Additionally, a query of NIOSH SENSOR was analyzed. The results are consistent with the 

previous analyses. 

Based on the continued low frequency and severity of incident cases reported for soap salts, there 

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

analysis will be conducted. 

 
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Table 1: Main IDS Incidents involving Soap Salts 

Human Incidents Chemical: Soap Salts PC Code: 079021, 079009, 031801 Incident Package Report

Incident Date Location

Registration Number Product Name

Exposure Severity* Incident Descrip

018675 - 00001 6/3/2007 DEER PARK, NY 

067702-00011-036909 

GARDEN SAFE BRAND INSECTICIDAL SOAP MULTI-PURPOSE INSECT KILLER CONCEN 

HC 

A 76 year old felettuce and vegon her hands anpants during the exposure, she einflammation anon her right leg psoriasis. She cand washed the 

019033 - 00019 9/28/2007 WHITE FISH, MT 

067702-00012-072155 

2-IN-1 MOSS & ALGAE KILLER READY-TOSPRAY 

HC 

A 57 year old mlater he was expwhich resolved inhaler. 12 hourlethargic. Three went to his MD. was feeling fine

020065 - 00003 6/25/2008 

PATCHOGUE, NY 

062719-00515 

M-PEDE INSECTICIDE/FUNGICIDE 

HC 

A 41 year old feneighbor was aexperienced a c

020877 - 00371 5/6/2009 CUTBANK, MT 

067702-00021-000239 

ECOSENSE BRAND INSECTICIDAL SOAP 

HC 

A 63 year old feeyes while usinand redness in 

021181 - 00015 8/19/2009 

MANHATTAN BEACH, CA 

067702-00013-039609 

GARDEN SAFE BRAND INSECTICIDAL SOAP MULT-PURPOSE INSECT KILLER 

HC An 83 year fem

experienced higand metallic tas

021191 - 00011 1/1/2009 WA 

067702-00021-000239 

ECOSENSE BRAND INSECTICIDAL SOAP 

HC 

A 48 year old mtreated with the on his thighs, chMD and was dia
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Incident Package Report

Incident Date Location

Registration Number Product Name

Exposure Severity* Incident Descrip

023011 - 00145 5/8/2011 BALTIMORE, MD

067702-00021-000239 

ECOSENSE INSECTICIDAL SOAP 

HC 

The case uses tfrom the emergunspecified reaallergy and the iodine in this pro

* Severity Categories H-A Human Fatality Death (if the person died) H-B Human Major Major (if the person alleged or exhibited symptoms which may have been lifethreatening, or resulted in adverse reproductive effects or in residual disability) H-C Human Moderate Moderate (if the person alleged or exhibited symptoms more pronounced, more prolonged 

or of a more systemic nature than minor symptoms; and involved some form of treatment, even though symptoms were not life threatening and the person returned to his/her preexposure state of health with no additional residual disability) 

H-D Human Minor Minor (if the person alleged or exhibited some symptoms, but they were minimally 

traumatic; the symptoms resolved rapidly and usually involve skin, eye or respiratory irritation) 

H-E Human Unspecified Unspecified (if symptoms are unknown, unspecified or are alleged to be of a delayed or 

chronic nature that may appear in the future) 

H Human Undetermined (an undetermined severity) from 40 CFR § 159.184