Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 2 of 85 

Table of Contents 

1.0 Executive Summary.......................................................................................................... 4 

Regulatory Recommendation .................................................................................................. 6 

2.0 Background ....................................................................................................................... 6 

3.0 Ingredient Profile.............................................................................................................. 7 

3.1 Summary of Proposed Uses.......................................................................................... 7 

3.2 Structural Information................................................................................................. 7 

3.3 Physical and Chemical Properties............................................................................... 8 

4.0 Hazard Characterization/Assessment............................................................................. 9 

4.1 Database Summary....................................................................................................... 9 

4.2 Toxicological Effects and Metabolism ........................................................................ 9 

4.3 Dermal Absorption ..................................................................................................... 13 

4.4 Mutagenicity................................................................................................................ 13 

4.5 Carcinogenic Potential................................................................................................ 15 

4.6 FQPA Considerations................................................................................................. 16 

4.7 Toxicity Endpoint Selection and Levels of Concern................................................ 18 

4.8 Endocrine Disruption ................................................................................................. 20 

5.0 Dietary Exposure/Risk Characterization ..................................................................... 21 

5.1 Residues of Concern ................................................................................................... 21 

5.2 Drinking Water Residue Profile................................................................................ 22 

5.3 Food Residue Profile................................................................................................... 22 

5.4 Analytical Methodology.............................................................................................. 24 

5.5 Dietary (Food and Water) Exposure and Risk......................................................... 24 

5.5.1 Acute Dietary Exposure and Risk ..................................................................... 24 

5.5.2 Chronic Dietary Exposure and Risk ................................................................. 24 

5.5.3 Cancer Dietary Exposure and Risk................................................................... 25 

5.5.4 Summary of Dietary Exposure and Risk Assessment Results........................ 25 

6.0 Residential (Non-Occupational) Exposure/Risk Characterization ............................ 25 

6.1 Residential Handler Exposure................................................................................... 26 

6.2 Residential Postapplication Exposure....................................................................... 31 

7.0 Aggregate Risk Assessments and Risk Characterization............................................ 36 

7.1 Acute Aggregate Risk ................................................................................................. 36 

7.2 Short-Term/Intermediate-Term Aggregate Risk..................................................... 36 

7.3 Long-Term Aggregate Risk ....................................................................................... 38 

7.4 Cancer Risk ................................................................................................................. 38 

8.0 Occupational Exposure/Risk Pathway.......................................................................... 38 

8.1 Handler Risk................................................................................................................ 38 

8.2 Occupational Postapplication Risk ........................................................................... 45 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 3 of 85 

9.0 Environmental Justice.................................................................................................... 46 

10.0 Human Studies................................................................................................................ 46 

APPENDIX A. Toxicity Data.................................................................................................... 48 

APPENDIX B. Structure-Activity Relationship (SAR) Discussion....................................... 62 

APPENDIX C. Drinking Water Surrogate Analysis.............................................................. 63 

APPENDIX D. Detailed Dietary Exposure and Risk Information........................................ 66 

D.1. Input File for Acute and Chronic Dietary Exposure Assessment ............................. 66 

D.2. Results File for Acute Dietary Assessment .................................................................. 84 

D.3. Results File for Chronic Dietary Assessment .............................................................. 85 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 4 of 85 

1.0 Executive Summary 

The Joint Inert Task Force (JITF) Cluster Support Team Number 5 (CST 5) has submitted a 

petition proposing to establish an exemption from the requirement of a tolerance under 40 CFR 

§180.910 for the alkylphenol ethoxylates (APEs). Approval of the request would permit use of 

these inert ingredients in pesticide products applied pre- and post-harvest. 

The toxicology database is adequate to assess risk for the APEs when used as inert ingredients in 

pesticide formulations. The available toxicity data indicate that the APE inerts have low to 

moderate acute oral and dermal toxicity, are a mild to moderate skin irritant, and an eye irritant. 

In the OECD Test Guideline 422 study with the APE parent compound, there was no evidence of 

increased susceptibility. Additionally, there was no evidence of neurotoxicity, developmental 

toxicity or reproductive toxicity in the OECD 422 study. The Agency has identified octylphenol 

as a potential metabolite/degradate of concern. The Agency considered available toxicity data on 

octylphenol as well as toxicity data on the structurally related nonylphenol when assessing the 

hazard for this potential degradate. The major effects seen in the metabolite/degradate databases 

are consistent with potential disturbances in estrogenic activity, but a complete mode of action 

analysis has not been conducted. These effects are the most sensitive endpoints for both 

metabolites and were considered the key findings for regulatory purposes. The Agency has used 

available data on the nonylphenol and octylphenol metabolites, which specifically look at these 

effects, to establish dietary endpoints for both the parent compound and the degradates of 

concern. The Agency considers the toxicity database to be sufficient to address potential 

hazards, and the Agency is regulating on the most sensitive endpoints seen in the database; 

effects which are well characterized with clear NOAELs. Further, the Agency has conducted a 

highly conservative exposure assessment that is not likely to underestimate risk; therefore, it is 

appropriate to reduce the FQPA safety factor to 1X for the dietary risk assessments. Endpoints 

for residential risk assessments were selected from the OECD 422 Test Guideline study 

conducted on the parent compound. However, since the study was not designed to detect 

specific perturbations to estrogenic activity that are the most sensitive effects seen for the 

metabolites, the Agency has retained the FQPA 10X safety factor for the residential risk 

assessments. Endpoints for worker risk assessments were also selected from the OECD 422 Test 

Guideline study conducted on the parent compound. 

An acute dietary endpoint for risk assessment was selected for the parent compound and 

octylphenol from a study conducted with octylphenol and is based on increased postimplantation loss. A chronic dietary endpoint for risk assessment was selected for octylphenol 

from two literature studies on nonylphenol, which were considered co-critical, a 2-generation 

reproduction study in rats and a 3-generation reproduction study in rats. The effects observed 

included significant increases in pituitary weight in parental males and decreases in ovary weight 

in parental females, significant acceleration of vaginal opening in the pups and decreases in the 

number of implants and live pups. Endpoints for residential and occupational risk assessments 

for the parent compound for all exposure durations and incidental oral and inhalation routes of 

exposure were selected from the OECD 422 Test Guideline study on the parent compound. The 

effects observed included clinical signs, decreased body weight gain in both sexes, decreased 

thymus weight in females, and increased liver weight and liver hypertrophy in males, and 

decreased pup body weight in both sexes. Since there was no assessment of specific estrogenic 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 5 of 85 

effects determined to be most sensitive for metabolites in the OECD 422 study on the parent 

compound, the FQPA safety factor was retained to protect infants and children (residential 

exposures to the parent compound). Quantitative dermal risk assessments were not performed 

for occupational or residential exposures. When potential endpoints are considered in light of an 

estimated conservative dermal absorption value of 1%, effect levels would be at or above the 

limit dose. Therefore the Agency concludes that a quantitative dermal risk assessment is not 

required for the APEs. The Agency has concluded, based on weight of the evidence, that there is 

not sufficient evidence to warrant a quantitative cancer assessment. 

Uncertainty in the mutagenicity database must be addressed. Assuming activation and/or in vivo

metabolism will take into account potential metabolites, the Agency is recommending a tiered 

approach to required data for the parent compound. The following confirmatory data for the 

parent compound are required, a new Ames assay and a mouse lymphoma assay (Tier 1), a bone 

marrow assay (Tier 2), and a two-year cancer bioassay in rats and mice (Tier 3). At any point 

should a tier yield negative findings, no additional data from the next tier will be required. 

Sufficient data were provided on the chemical identity of the APEs; however, limited data are 

available on the metabolism and environmental degradation of this compound. The Agency 

relied collectively on the submitted physicochemical data, structure-activity relationship 

information, as well as information on other surfactants and chemicals of similar size and 

functionality to determine the residues of concern for this inert ingredient. The Agency has 

concluded that the residues of concern in food and drinking water are the parent APE 

compounds, their partially de-ethoxylated degradation products, as well as the degradation 

product p-t-octylphenol. 

No residue data were provided for the APE inerts. In the absence of data, the Agency has 

developed an approach that uses surrogate information to derive upper bound exposure estimates 

for the subject inert ingredient. Provided that the concentration of the APE inerts is limited to no 

more than 7% by weight in the end-use product, acute and chronic dietary (food and water) risks 

are not of concern. 

A screening level residential exposure and risk assessment was completed for products 

containing the APEs as inert ingredients. Provided the APEs are limited to no more than 7% by 

weight in the final formulation for outdoor products, and 3% for indoor products, residential 

risks are not of concern for the U.S. population and all subpopulations, including children 1 – 2 

years of age, the most highly exposed subgroup. Further, provided the limits noted above are 

imposed, there are no aggregate risks of concern. 

 

HED has completed an occupational exposure and risk assessment for the APE inerts. 

Occupational handler risks are not of concern for all scenarios. Occupational postapplication 

exposures were not assessed for the APEs because no dermal hazard was identified. 

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

human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions 

to Address Environmental Justice in Minority Populations and Low-Income Populations," 

http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf). 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 6 of 85 

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

intentionally exposed to a pesticide. These studies have received the appropriate ethical review 

for use in risk assessment. 

 

Regulatory Recommendation 

Provided the amount of the APE inert is limited to no more than 7% by weight in final pesticide 

formulations for agricultural and outdoor residential products, and 3% for indoor residential 

products, there are no human health risk considerations that would preclude the establishment of 

one-year time limited exemptions from the requirement of a tolerance as follows: 

Under 40CFR 180.910: 

α-[p-(1,1 ,3,3-tetramethylbutyl)phenyl]-ω-hydroxypoly (oxyethylene) produced by the 

condensation of 1 mole of p-(l,1,3,3- tetramethylbutyl)phenol with a range of 1-14 or 30-

70 moles of ethylene oxide: if a blend of products is used, the average range number of 

moles of ethylene oxide reacted to produce any product that is a component of the blend 

shall be in the range of 1-14 

 

Given concerns raised in the literature for potential mutagenicity, confirmatory toxicity testing is 

required prior to establishing permanent exemptions from the requirement of a tolerance for 

these inert ingredients. A tiered approach to the confirmatory data is proposed. The testing 

scheme is as follows: 

Tier 1: A new Ames and a mouse lymphoma assay 

Tier 2: A bone marrow assay 

Tier 3: Two-year cancer bioassays in the mouse and the rat 

Note: The petitioner has requested an exemption under 180.910 only (pre- and post-harvest 

uses). HED has determined that the conclusions in this memorandum also support an exemption 

with the limitations noted above under 180.920 for direct application to livestock. 

2.0 Background 

Inert ingredients are those ingredients that are added to end use products that are not active 

ingredients. The terms "active ingredient" and "inert ingredient" are defined under the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA). An active ingredient is one that prevents, 

destroys, repels or mitigates a pest, or is a plant regulator, defoliant, desiccant or nitrogen 

stabilizer. The statute defines the term "inert ingredient" as an ingredient that is not active. 

As mandated by the Food Quality Protection Act (FQPA) of 1996, EPA conducted a 

reassessment of tolerances and exemptions from the requirement of tolerances for inert 

ingredients used in pesticide products to determine if they met FFDCA’s revised standard of 

safety. As a result of that reassessment, the Agency published a final rule in the Federal Register 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 7 of 85 

(FR Notice Volume 71, No. 153, p. 45422, Aug 9, 2006) proposing revocation of specific 

exemptions from the requirement of a tolerance due to insufficient data. 

In response to the proposed revocation, the Joint Inerts Task Force (JITF) Cluster Support Team 

(CST) 5 submitted a petition dated October 31, 2008 and supplement dated April 15, 2009 

proposing to establish an exemption from the requirement of a tolerance to support pre- and postharvest uses of a group of inerts known collectively as the “alkylphenol ethoxylates” or APEs as 

follows under 40CFR 180.910: 

α-[p-(1,1 ,3,3-tetramethylbutyl)phenyl]-ω-hydroxypoly (oxyethylene) produced by the 

condensation of 1 mole of p-(l,1,3,3- tetramethylbutyl)phenol with a range of 1-14 or 30-

70 moles of ethylene oxide: if a blend of products is used, the average range number of 

moles of ethylene oxide reacted to produce any product that is a component of the blend 

shall be in the range of 1-14 with the percent in pesticide formulation not to exceed 5.0% 

 

The Agency reviewed the submitted information and concluded that a safety finding could not be 

made to support the requested exemptions from the requirement of tolerance (D366012, D. 

Davis, 7/9/09). Subsequent to the issuance of the July memorandum, the petitioner submitted 

additional citations and data to address concerns raised by the Agency in the supplemental 

submission from Exponent dated August 21, 2009. This risk assessment considers all data and 

literature citations submitted to the Agency as of the issuance date of this memorandum. 

3.0 Ingredient Profile 

3.1 Summary of Proposed Uses 

The alkyphenol ethoxylates are used as surfactants in pesticide formulations. In addition to uses 

in formulations applied in agricultural settings, the APEs are used in household products such as 

floor cleaners, detergent sanitizers and waterless hand cleaners, as well as in industrial settings. 

EPA’s search of products which contain the APEs has indicated that these inerts may be present 

in pesticide products applied to companion animals. 

3.2 Structural Information 

The akylphenol ethoxylates as described in the submitted exemption request are t-octylphenols 

with one or more ethylene oxide molecules attached at the phenol. The number of ethylene 

oxide groups can range from 1-14 or 30-70. The structure, descriptor, and CAS numbers for 

these groups are provided in Table 3.2, below. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 8 of 85 

Table 3.2. Alkyl Phenol Ethoxylates (APE) Chemical Information

Chemical Structure 1 

Common name Alkyl Phenol Ethoxylates (APE) 

CAS Numbers CAS RN 9036-19-5: Poly (oxy-l, 2-ethanediyl), alpha- [4-(1,1,3,3-

tetramethylbutyl)phenyl]- omega-hydroxyCAS RN 9002-93-1: Poly (oxy-l, 2-ethanediyl), alpha- [4-(1,1,3,3-

tetramethylbutyl)phenyl]- omega-hydroxyDescriptor [alpha]-[p-(1,1 ,3,3-Tetramethylbutyl)phenyl]-[ omega]-hydroxypoly (oxyethylene) 

produced by the condensation of 1 mole of p-(l,1,3,3- tetramethylbutyl)phenol with 

a range of 1-14 or 30-70 moles of ethylene oxide: if a blend of products is used, the 

average range number of moles of ethylene oxide reacted to produce any product 

that is a component of the blend shall be in the range of 1-14 or 30-70 

1 Figure excerpted from petition, “Petition Proposing An Exemption From The Requirement Of A Tolerance For Residues Of 

Joint Inerts Task Force Cluster 5: "Alkyl Phenol Ethoxylates" In Or On Raw Agricultural Products And Food Products”; page 6 

dated October 31, 2008. 

3.3 Physical and Chemical Properties

Physicochemical data were estimated for the APE cluster using publicly available Estimation 

Program Interface suite (EPI SuiteTM) modeling 

(http://www.epa.gov/opptintr/exposure/pubs/episuite.htm and are provided in Table 3.3. The 

basis for the estimated Estimation Program Interface suite (EPI SuiteTM) modeling 

physicochemical calculations and model capabilities are described in the EPA document titled 

The Use of Structure-Activity Relationships (SAR) in the High Production Volume Chemicals 

Challenge Program (EPA 1999). The EPA EPI SuiteTM 3.2 model calculations for water 

solubility are based on KOW (WSKOWWIN model) and molecular fragments (WATERNT 

model). EPA has cautioned in the publication OPPTS Pollution Prevention P2 Network (EPA, 

2005), that EPI SuiteTM 3.2 water solubility calculations are not reliable for dispersible 

compounds such as surfactants. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 9 of 85 

Table 3.3. Physicochemical Properties of Representative Alkyl Phenol Ethoxylates (APE)1

CAS No. Descriptor MW Log 

KOW 

Melting 

Point (°C) 

Boiling 

Point (°C) 

Vapor 

Pressure 

(mm Hg) 

Water 

Solubility2

(mg/L) 

9002-93-1 Moles POE 

n = 1 250.38 4.86 95.66 334.45 6.99 2.54 10.9 

9002-93-1 Moles POE 

n = 9 602.81 2.67 267.22 616.94 9.4 x 10-17 2.63 1040 

9036-19-5 Moles POE 

n = 5 426.6 3.77 191.94 475.9 1.79 x 10-11 4.12 117 

9036-19-5 Moles POE 

n = 14 823.08 1.3 349.58 793.25 1.65 x 10-23 1.33 14,400 

9036-19-5 Moles POE 

n = 30 

1527.9

4 -3.09 349.84 1357.44 5.55 x 10-43 0.102 1,000,000 

1 Table values taken from petition submission. 

2 The EPI SuiteTM model calculates water solubility based on the octanol-water partition coefficient (Kow) 

(WSKOWWIN) and molecular fragments (WATERNT). The first value reflects the WSKOWWIN calculation and 

the second value reflects the WATERNT calculation. 

4.0 Hazard Characterization/Assessment 

4.1 Database Summary 

The existing toxicology database for the APE inerts consists of one OECD Test Guideline 422 

combined repeated dose toxicity study with the reproduction/ developmental toxicity screening 

test in rats on octylphenoxy poly(ethyleneoxy)ethanol, branched (CAS 9002-93-1). 

Additionally, toxicity data are available for the potential metabolite, octylphenol. These data 

include acute data and several studies from the scientific literature [a two-generation 

reproduction study in rats, a female pubertal assay, mutagenicity studies, and several short-term 

studies]. Further, to supplement the octylphenol database, additional data from the open 

scientific literature on nonylphenol (a chemical that differs by only one carbon from octylphenol) 

was also considered. 

The OECD Test Guideline 422 study conducted on the parent compound provides information 

on the possible health hazards likely to arise from repeated exposure. The method comprises the 

basic repeated dose toxicity study as well as a reproduction/developmental toxicity-screening test 

and also places emphasis on neurological effects as a specific endpoint. Therefore, the study can 

provide information on general toxicity as well as possible developmental, reproductive, and 

neurological effects. It can also provide basic indications of immunological effects. 

4.2 Toxicological Effects and Metabolism 

Toxicological Effects 

Octylphenol Ethoxylates (Parent Compounds)

The available toxicity data indicate that APE inerts have low to moderate acute oral and dermal 

toxicity, are a mild to moderate skin irritant, and an eye irritant. Based on the analysis of the 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 10 of 85 

studies in the open literature, there is both positive and negative evidence that ethoxylated 

octylphenol (CAS 9036-19-5) is mutagenic in bacteria (Salmonella typhimurium) and 

mammalian (CHO, mouse lymphoma) cells. 

In the OECD 422 study on a representative parent compound (CAS 9002-93-1), parental toxicity 

manifested as clinical signs (pushing head through bedding after dosing), decreased body-weight 

gain in both sexes during the premating period, decreased thymus weight in females, increased 

liver weight in males, and increased incidence of centrilobular hepatocyte hypertrophy in males 

at the same dose levels where the offspring showed decreased pup body weight in both sexes. 

There was no evidence of increased susceptibility. There was no evidence of reproductive 

toxicity or neurotoxicity in the parental animals. 

In a study referenced in the petition (Hazelden and Wilson, 1986), skeletal abnormalities 

(supernumerary ribs) were observed following dietary exposure of dams to the surfactant Triton 

X-100 (CAS # 9036-19-5) during gestation days 6-17 at both dose levels tested. The OECD 422 

study did not include an examination for skeletal anomalies of the offspring. 

 

The Agency has concern with respect to impacts on estrogenic activity seen in studies conducted 

on a potential degradate, octylphenol. The OECD 422 study on the parent compound does not 

assess certain endpoints related to the estrogenic activity that were the most sensitive effects 

observed in studies on the degradate. 

In a screening literature search, several studies were found that suggest mutagenic potential. 

Ethoxylated octylphenol was shown to be mutagenic in bacteria (Salmonella typhimurium) and 

mammalian (CHO, mouse lymphoma) cells with and without metabolic activation. In other 

Ames Salmonella/ microsome plate tests (tester strains TA98, TA100, TA1535, TA1537, 

TA1538), the parent compound did not exhibit mutagenic activity with or without metabolic 

activation. 

Octylphenol (Metabolite/Degradate)

The major effects seen in the metabolite/degradate octylphenol database appear to be related to 

potential disturbances in estrogenic activity. Given the limited database for octylphenol, the 

Agency is also considering data on nonylphenol, a chemical that differs by only one carbon from 

octylphenol. The estrogenic activity effects appear to be the most sensitive endpoints for 

nonylphenol and were considered the key findings for regulatory purposes. In a screening 

literature search, several studies were found describing similar effects following octylphenol 

exposure that are consistent with estrogenic activity, including acceleration of the vaginal 

opening. These studies on octylphenol are described below. 

In the published two-generation reproduction study by Tyl et al. (1999) on octylphenol, no 

effects were reported on reproductive function, testes, prostate, or ovary weights or morphology, 

on sperm counts, motility, morphology, production, or on estrous cyclicity; however, a 

significant reduction (↓18-20%) in uterine weight was observed in the F0 females at the high 

dose. Decreased pup body weight was observed during the latter part of lactation (LD 14 and 21; 

F1 ↓13-16%**; ↓F2 6-8%). There was a slight delay in acquisition of vaginal patency and 

preputial separation at the high dose in both generations, which was accompanied by minimal 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 11 of 85 

decreases in body weight (↓6%). The delays in sexual maturation are statistically significant, 

although not very large. The delays in male sexual maturation would be consistent with impacts 

on estrogenic activity; however, one would expect the vaginal opening to be advanced, not 

delayed (as observed in Laws, et al. 2000). The NOAEL from this study is 10 mg/kg/day and 

the LOAEL, based on decreased body weights in adults and during the latter portion of lactation 

in offspring and minor delays in acquisition preputial separation, is 111 mg/kg/day. 

In the open literature, 4-tert-octylphenol (OP) is shown to have estrogen-like action in in vitro 

and in vivo assays. This is based on changes in uterine weight, estrus cyclicity and the afternoon 

surge of FSH, LH, and prolactin, as well as interference with sexual receptive behavior. 

Neonatal exposures to OP and exposures of female rats during infancy cause premature vaginal 

opening, induction of persistent estrus, abnormal development of uteri, and disruption of the 

cyclic release of LH, FSH, and prolactin. Decline in serum FSH and LH levels has also been 

reported in 14-day old female rats neonatally exposed to 4-tert-octylphenol. Although in many of 

the studies, the route of exposure is by subcutaneous administration, in studies comparing the 

subcutaneous and oral (gavage) routes of exposure to OP, effects on uterine weight were 

reported after both routes of exposure, with the magnitude of the effects being greater following 

subcutaneous injection. Vaginal opening was significantly accelerated following gavage dosing 

in a female rat pubertal assay. 

In a screening literature search, several studies were found that suggest mutagenic potential.

Octylphenol induced a high incidence of sister chromosome exchange (SCE) and caused DNA 

migration in one comet assay and tail length and tail moment were significantly different in an in 

vivo (comet) assay. In the His+ revertant assay in bacteria (Salmonella typhimurium), 

octylphenol was mutagenic in TA98 and TA100 strains without metabolic activation. 

Octylphenol did not exhibit mutagenic activity in three Ames Salmonella/microsome plate tests 

and was negative in chromosomal aberration/Chinese hamster lung (CHL) cells with and without 

S9. Structural chromosomal aberration and polyploidy cells were not induced in Chinese 

hamster lung (CHL/IU) cells. 

Nonylphenol (Structurally Related Compound)

There are several multigeneration reproductive toxicity studies in rats on nonylphenol that 

demonstrate no adverse effects on reproductive function. Two of the multigeneration 

reproduction studies in the open literature on nonylphenol demonstrate an acceleration of vaginal 

opening (VO). Additionally, there are several pubertal onset assays on nonylphenol in which 

acceleration of vaginal opening, delay of preputial separation, and estrous cycle changes have 

been demonstrated in the rat. These are described below: 

In a published three-generation reproduction study in rats (Tyl et al., 1999) on branched pnonylphenol, no effects were reported on reproductive parameters, testes and epididymides 

weight or morphology, on sperm counts, motility, morphology, production; however, a 

significant reduction in ovarian weight was observed in the F0 (↓32%) and F1 (↓20%) females at 

the high dose. Decreased pup body weights and body-weight gains were observed in both sexes 

during the latter part of lactation (LD 21; F1 ↓16%; ↓F2 11%; ↓F3 8%). Kidney toxicity was 

reported in males at 650 and 2000 ppm, as evidenced by increased kidney weights and kidney 

histopathology (medullary cysts, mineralization of corticomedullary junction, and tubular 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 12 of 85 

nephropathy). A NOAEL of 200 ppm (≈15 mg/kg/day) for kidney effects was reported. 

Anogenital distance was not measured, and acquisition of vaginal patency and preputial 

separation were not assessed in this study following nonylphenol exposure. 

In another published 2-generation reproduction study in rats (Nagao, et al., 2001) on nonylphenol 

(2, 10, 50 mg/kg/day), parental effects included increased liver, kidney, and pituitary weights in 

males, decreased thymus weight (↓24%) in males, decreased ovary weight (↓18%) in F0 and F1 

females, increase in TSH levels (males), and centrilobular hepatocyte hypertrophy in both sexes 

at the high dose. There was a significant decrease in the number of implantation sites (F2). 

Developmental effects included decreased number of live pups, decreased pup viability (PND 0-

4), increase in serum FSH level and decrease in T3 level for males, decreases in LH and TSH 

levels, and an increase in T3 levels for females at 50 mg/kg/day. The timing of vaginal opening 

was accelerated (F1) at 50 mg/kg/day, but no effect was observed on the timing of preputial 

separation. No adverse changes in behavior or learning in offspring were reported. The NOAEL 

is 10 mg/kg/day. 

In a multigeneration reproduction study in rats with the branched nonylphenol (Chapin, et al., 

1999), small increases in estrus length (F1 14%; F2 18%) were observed at 2000 ppm (100 

mg/kg/day), and vaginal opening was accelerated by ≈2 days at 650 ppm (30 mg/kg/day) and ≈6 

days at 2000 ppm (100 mg/kg/day) in F1, F2, F3 generations. Uterine weights at PND 21 were 

increased in 650 ppm (14%) and 2000 ppm (50%) F1 females. The NOAEL was 200 ppm (9 

mg/kg/day). 

The age of vaginal opening was advanced following oral exposure to branched p-nonylphenol 

(50 and 100 mg/kg/day; 5.3 and 6.8 days) from postnatal days 21-35 (Laws, et al., 2000). The 

NOAEL was demonstrated at 25 mg/kg/day. Estrous cycle changes and accelerated vaginal 

opening were observed following 20-day postnatal exposure (100 mg/kg/day; 6.7 days) to 

branched p-nonylphenol (Kim, et al., 2002). The NOAEL was 10 mg/kg/day. The age of 

preputial separation was delayed following oral exposure to nonylphenol (100 mg/kg/day). 

Metabolism

The registrant has not provided metabolism studies for the parent, but did cite a study for the 

potential degradate octylphenol, CAS 140-66-9 (p- (1,1,3,3-tetramethylbutyl)phenol). 

There are a few literature studies available for the nonylphenol ethoxylates (NPEs), which are 

structurally similar to the octylphenol ethoxylates. One study where the NPEs were labeled in 

the ethoxylate chain indicated that excretion of the NPEs in urine was nearly complete in 2 days, 

and excretion of radiolabeled carbon via the urinary and pulmonary pathways decreased and 

fecal excretion increased as the ethoxylate chain length increased, indicating decreased 

gastrointestinal absorption as polyethoxylation increases. A study where the NPEs were labeled 

in the phenyl ring showed no 14CO2 in the expired air. These studies also showed that the 

ethoxylate chain moiety was absorbed from the digestive tract following oral exposure and 

metabolized less completely as the chain length increased. The principle urinary metabolites 

were identified as the carboxylic acids of polyethylene glycols and glucuronic acid conjugates of 

nonylphenol. 

Based on this information, the Agency concludes that the registrant has proposed a reasonable 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 13 of 85 

description of the metabolic pathway in mammals. By extrapolation from the NPE studies, it is 

likely that the octylphenol alkoxylate (POE) chain is cleaved to octylphenol and the carboxylic 

acids of the polyethylene glycols. Octylphenol is subjected to glucuronic acid conjugation and 

can be excreted. The carboxylic acids can be further conjugated or excreted directly. 

Octylphenol Metabolism

The registrant cited a literature study, Certa, et al., (1996), which showed that in the rat, tOP was 

rapidly excreted (single i. v. dose of 5 mg/kg; half-life 5 hours in males; >36 hours in females) 

by first-pass hepatic metabolism via glucuronide conjugation. Following an oral dose (50 or 200 

mg/kg), enterohepatic circulation was suggested, with detectable levels of tOP in the blood at 48 

hours. Following repeated exposure, a dose of 200 mg/kg/day saturates metabolic capacity of 

the rat for clearance. Studies with the nonylphenol degradate indicated that it is readily 

conjugated, particularly to the glucuronide conjugate, facilitating excretion. 

4.3 Dermal Absorption

There are no dermal absorption data on the APE inerts or on the octylphenol metabolite/ 

degradate. The JITF CST 5 submitted dermal absorption information on the closely related 

compounds nonylphenol and nonylphenol etthoxylates, which indicate that dermal absorption of 

1% would be a reasonable conservative assumption for the range of compounds in CST 5. The 

Agency has reviewed the submitted information and concurs that a dermal absorption value of 

1% is a conservative estimate. Quantitative dermal risk assessments will not be performed for 

occupational or residential exposures. 

4.4 Mutagenicity 

Oxtylphenol Ethoxylates (Parent Compound)

The Agency conducted a literature search to look for mutagenicity data in the open literature. 

There is both positive and negative evidence that ethoxylated octylphenol is mutagenic in 

bacteria (Salmonella typhimurium) and mammalian (CHO, mouse lymphoma) cells. Positive 

findings: (1) caused reproducible positive increases in the mean number of TA1535 revertants 

per plate in both presence (3.7 and 4.4-fold) and absence (5.0 and 2.9-fold) of S-9 

(Lawlor/Haworth, 1989); (2) exhibited genetic activity in strains TA-1535 and TA-100 with and 

without S9 and was considered mutagenic (DeGraff/Brusick, 1981). (3) an in vitro cytogenicity 

assay measuring chromosome aberration frequencies in Chinese hamster ovary (CHO) cells 

(with and without S9), CAS 9036-19-5 was considered clearly positive, causing significant 

increases in chromosome aberrations both with and without metabolic activation. (4) in a mouse 

lymphoma forward mutation assay (L5178Y TK+/-), CAS 9036-19-5 induced significant 

increases in the mutant frequency at the TK locus in L5178Y mouse lymphoma cells with and 

without metabolic activation. (5) was positive in in vitro HeLa cell assay (CST 5 reference). 

Negative findings: (1) did not cause a positive increase in the number of histidine revertants per 

plate of any of the tester strains with or without S9 (Lawlor, et al., 1989); (2) did not exhibit 

mutagenic activity in Ames Salmonella/microsome reverse mutation assay (tester strains TA98, 

TA100, TA1535, TA1537, TA1538) with and without ±S9 (Jagannath/Myhr; 1986); (3) did not 

exhibit mutagenic activity in Ames assay in any tester strains with and without ±S9 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 14 of 85 

(Jagannath/Brusick; 1981); (4) did not exhibit mutagenic activity in Ames microsome spot test 

(DeGraff/Brusick; 1983). 

Octylphenol (Metabolite/Degradate)

Based on the analysis of the studies in the open literature, there is both positive and negative 

evidence that octylphenol is mutagenic. Positive findings: (1) mutagenicity was observed in 

TA98 and TA100 strains without metabolic activation in the His+ revertant assay in bacteria 

(Salmonella typhimurium), Boyacioglu, et al., 2007; (2) tail length and tail moment significantly 

different in an in vivo (comet) assay (Ulutas, et al., 2009); (3) caused DNA migration in comet 

assay and induced high incidence of sister chromosome exchange (SCE); Tayama, et al., 2008. 

Negative findings: (1) three studies (OECD SIDS) in bacteria (Salmonella typhimurium) were 

negative in all tester strain (±S9); (2) in chromosomal aberration/Chinese hamster lung (CHL) 

cells were not induced with and without S9 (OECD SIDS); (3) structural chromosomal 

aberration and polyploidy cells were not induced in Chinese hamster lung (CHL/IU) cells 

(Kusakabe, et al., 2002); (4) did not result in chromosome aberration (Tayama, et al., 2008). 

Additionally, based on the analysis of studies in the open literature, there is both positive and 

negative evidence that nonylphenol is mutagenic. Positive findings: (1) caused DNA migration 

in comet assay and induced high incidence of sister chromosome exchange (SCE); Tayama, et 

al., 2008; (2) in vitro cytogenicity assay for sister chromatid exchange in Chinese hamster ovary 

(CHO) cells, nonylphenol was positive for inducing sister chromatid exchange without S9 and 

negative with S9 (Murli, et al., 1986); (3) in mouse lymphoma forward mutation assay (L5178Y 

TK+/-), nonylphenol was mutagenic with activation and non-mutagenic without S9 

(Cifone/Myhr, 1985); (4) nonylphenol induced micronuclei in peripheral blood and bone marrow 

reticulocytes (Kim, et al., 2006; in Polish). Additionally, nonylphenol induced apoptosis of 

Jurkat cells by caspase-8 dependent mechanisms (inhibited the proliferation and induced loss of 

mitochondrial membrane potential, caspase-8 activation, internucleosomal DNA fragmentation), 

Yao, et al., 2007. Negative findings: (1) in an Ames Salmonella microsome reverse mutation 

assay (strains TA98, TA100, TA1535, TA1537, TA1538), Jagannath/Myhr, 1985; (2) in an in 

vitro transformation of BALB/C-3T3 cells assay, nonylphenol did not induce a significant 

increase in the frequency of transformed foci; (3) did not result in chromosome aberration 

(Tayama, et al., 2008); (4) in vitro cytogenicity assay in Chinese hamster ovary (CHO) cells, 

nonylphenol was negative for inducing sister chromatid exchange with S9 (Murli, et al., 1986); 

(5) in mouse lymphoma forward mutation assay (L5178Y TK+/-), nonylphenol was nonmutagenic without S9 (Cifone/Myhr, 1985). 

Though equivocal, the findings in the literature need to be addressed; therefore, HED is 

requesting confirmatory data to speak to the concern raised by the positive mutagenicity 

findings. A proposed tiered approach to addressing this concern is described as follows. 

 

The following studies are required for the parent compound, assuming activation and/or in vivo

metabolism will take into account potential metabolites. The Agency recommends a tiered 

approach to the confirmatory toxicity testing. 

Tier 1: A new Ames assay (870.5100 – Bacterial reverse mutation test) and a mouse lymphoma 

assay (870.5300 – In vitro mammalian cell gene mutation test) 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 15 of 85 

Tier 2: A bone marrow assay (870.5395 – Mammalian erythrocyte micronucleus test) 

Tier 3: Two-year cancer bioassays in the mouse and rat (870.4200 – Carcinogenicity (mouse) 

and 870.4300 – combined Chronic Toxicity/Carcinogenicity (rat)) 

If the Tier 1 tests are negative, then the Tier 2 and Tier 3 tests would not be required. Further, if 

there are positive findings in Tier 1, but the Tier 2 test is negative, the Tier 3 study will not be 

required. The Agency notes, that if the petitioner wishes to assume that the Tier 1 assays will be 

positive based on literature study data, they may move directly to the Tier 2 testing. 

4.5 Carcinogenic Potential 

There are no chronic toxicity studies available for the APE inerts. The Agency used a qualitative 

structure activity relationship (SAR) database, DEREK Version 11, to determine if there were 

structural alerts suggestive of carcinogenicity. No structural alerts were identified for the parent 

APE compounds. 

No chronic toxicity studies are available for the tert-octylphenol metabolite/degradate. The 

Agency used a qualitative structure activity relationship (SAR) database, DEREK Version 11, to 

determine if there were structural alerts suggestive of carcinogenicity. While there were alerts 

for the degradate, including the estrogenic effects noted in the literature, as well as concern for 

chromosome damage, no structural alerts specific to carcinogenicity were noted. 

The structurally related nonylphenol has been shown to act as a tumor promotor. Several studies 

demonstrate effects on tumor development following nonylphenol exposure. These include (1) in 

a two-stage transformation of BALB/C-3T3 cells, nonylphenol markedly enhanced 

transformation of cells pretreated with sub-threshold dose of carcinogen (MCA) in promotion 

phase (nonylphenol acts as a pure promoter); may cause enhancement of carcinogenesis in vivo 

(Sakai, 2001); (2) in a multi-organ carcinogenesis model in rats, nonylphenol significantly 

increased the total incidence of adenomas and carcinomas in lungs; possible role for oxidative 

damage in nonylphenol-induced lung tumors was suggested (Seike, et al., 2003); (3) significant 

promotion of mammary tumor development in DMBA-induced female transgenic rats and 

acceleration of induction in non-transgenic females (enhancing effects on tumorigenesis in vivo); 

nonylphenol caused proliferation of MCF-7 cells at high dose levels (10-6 – 10-5 M) 

(Fukamachi, et al., (2004); (4) nonylphenol increased mammary cancer formation in MMTVneu 

mice; (5) nonylphenol transactivated the endogenous estrogen receptor (ER) alpha in a direct 

fashion; using steroid-receptor-negative HeLa cells engineered to express ERalpha and ERbeta 

and the hormone-binding domains of both ERalpha and ERbeta, nonylphenol confirmed the 

direct transcriptional activity; significantly stimulated the proliferation of MCF-7 and T47D 

breast cancer cell lines Vivacqua, et al., 2004; (6) FVB/NTgN (MMTVneu) 202Mul mice, 

susceptible to mammary cancer were fed nonylphenol for 32 weeks; nonylphenol increased both 

tumor incidence and latency at 45 mg/kg/day. 

The Agency has carefully considered the weight of the evidence with respect to carcinogenicity 

for both the parent compound and for the octyl phenol degradate. There were no structural alerts 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 16 of 85 

specifically for carcinogenicity and there were equivocal mutagenicity findings in the literature 

studies. HED does not believe at this time that there is sufficient evidence to warrant a 

quantitative cancer risk assessment. 

4.6 FQPA Considerations

In the case of the parent compounds, there was no increased susceptibility to the offspring of rats 

following pre- and post-natal exposure in the OECD 422 combined repeated dose toxicity study 

with the reproduction/developmental toxicity screening test. The offspring effects (decreased 

body weight in male and female offspring) occurred at 300 mg/kg/day in the presence of 

maternal toxicity, which was manifested as clinical signs, decreased body-weight gain, increased 

liver weight and liver hypertrophy in males, and decreased thymus weight in females at 300 

mg/kg/day. However, a study referenced in the petition (Hazelden and Wilson, 1986) suggests 

more severe developmental effects (supernumerary rib) following gestational exposure via the 

diet during gestation days 6-17. The OECD study did not include a skeletal examination of the 

offspring. Since the OECD study with APE did not assess its impact on the estrogen system, it

cannot be used alone to properly assess the most sensitive endpoint. However, selecting the point 

of departure from the OECD 422 study, which is based on a NOAEL of 150 mg/kg/day and 

decreased body-weight gain in both sexes during the premating period, decreased thymus weight 

in females, and increased liver weight and liver hypertrophy in males at the LOAEL of 300 

mg/kg/day, and retaining the FQPA safety factor of 10X is comparable to using the point of 

departure from the reproduction studies on the most toxicologically potent compound 

(nonylphenol) that assessed estrogenic activity (endpoint: accelerated vaginal opening; point of 

departure: 10 mg/kg/day). The endpoint (accelerated vaginal opening) and point of departure (10 

mg/kg/day) are considered health protective of effects not assessed in the OECD 422 studies on 

the parent compounds. 

For the octyl phenol metabolite, the two-generation reproduction study in rats showed a delay in 

the acquisition of preputial separation in both the F1 and F2 pups, and the timing of vaginal 

opening was accelerated in a study in prepubertal female rats. For the nonylphenol metabolite, 

two of the multigeneration reproduction studies in rats and two studies in prepubertal female rats 

showed acceleration in the acquisition of vaginal patency. A delay in preputial separation was 

observed in male rats in a pubertal onset assay. The combined toxicology databases currently 

available on octylphenol and nonylphenol identify accelerated vaginal opening as the most 

consistent and sensitive endpoint, and a clear NOAEL of 10 mg/kg/day has been demonstrated. 

In a developmental toxicity study with the parent compound, developmental toxicity was 

demonstrated, as evidenced by the increased incidence of supernumerary ribs following exposure 

to the dams during gestation days 6-17. However, the low pregnancy rate among all groups 

(56%-70%) in this study makes interpretation of the results difficult. Additionally, the OECD 

422 study did not include a skeletal examination of the offspring. A developmental toxicity study 

was identified in the octylphenol database, and a clear NOAEL of 15.6 mg/kg/day (postimplantation loss) was established. The point of departure for octylphenol was selected from this 

study for the acute dietary (females 13+) exposure. This study is considered appropriate and 

health protective of effects observed in the developmental toxicity study with the parent 

compound. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 17 of 85 

Since the rat reproduction studies on the most toxicologically potent compound (nonylphenol) 

identified a clear NOAEL of 10 mg/kg/day for the most sensitive endpoint (accelerated vaginal 

opening), and the selected point of departure of 10 mg/kg/day (NOAEL for accelerated vaginal 

opening) for the dietary risk assessment is protective of offspring effects, there are no residual 

concerns. 

The FQPA safety factor can be reduced to 1X for the metabolite upon which the dietary 

assessment is based for the following reasons: 

• The most sensitive endpoint from the most toxicologically potent compound 

(nonylphenol) was selected for risk assessment and is considered health protective. The 

database for nonylphenol is protective of octylphenol, which has a limited database. 

There are several studies on nonylphenol (2 multigeneration reproduction studies, 

pubertal onset assays, uterotrophic assays), which demonstrate acceleration of vaginal 

opening (VO) in the rat. Accelerated VO is the most consistent and sensitive endpoint 

identified. Clear NOAELs for this endpoint have been identified following exposure to 

nonylphenol. 

• While endpoints were not selected from the OECD 422 screening test in rats following 

pre- and post-natal exposure to the parent compound based on concerns that the study did 

not look for impacts on the estrogen system, the Agency does note that no increased 

susceptibility was demonstrated in the offspring in the OECD 422 screening test in rats 

following pre- and post-natal exposure to the parent compound. 

• Although a developmental toxicity study was identified in the open literature for the 

parent compound, a study on octylphenol demonstrated an increase in post-implantation 

loss following exposure to the dams from gestation day 0-8. A clear NOAEL of 15.6 

mg/kg/day was established for the offspring effects. Since the point of departure selected 

from that study for acute dietary exposure to the octylphenol metabolite is 15.6 

mg/kg/day, this value is considered health protective of offspring effects that might be 

found following octylphenol exposure. 

• There is a two-generation reproduction study in rats on octylphenol that demonstrates no 

adverse effects on reproductive function. 

• Although the available mammalian toxicity database does not include any chronic 

toxicity data, there is one 2-generation reproduction study on octylphenol and several 

multigeneration reproduction studies on the most toxicologically potent compound in the 

risk assessment, nonylphenol, in which test animals were dosed for extended periods of 

time and across generations. 

• The exposure assessments used in this risk assessment are considered to be highly 

conservative. In the absence of substantial information on environmental degradation, 

the Agency has conducted an assessment which assumes that 100% of the parent 

compound is degradated to the more toxic degradate, octylphenol. Further, the 

assessment assumed residues of octylphenol will be present in all foods consumed at 

levels consistent with the highest established pesticide tolerance, and in drinking water at 

a high-end estimated level of 100 ppb. The Agency anticipates that this assessment will 

overestimate risk. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 18 of 85 

The FQPA safety factor is retained (10X) for the parent compound upon which the residential 

assessment is based for the following reasons: 

• Although endpoints from the OECD 422 screening tests in rats following pre- and postnatal exposure to the parent compound were selected for the residential and occupational 

exposure risk assessments, there are concerns that the study did not look for the most 

sensitive endpoints for the estrogen system. 

• The Agency does note that no increased susceptibility was demonstrated in the offspring 

in the OECD 422 screening test in rats following pre- and post-natal exposure to the 

parent compound. 

4.7 Toxicity Endpoint Selection and Levels of Concern 

A summary of the points of departure (PoD) for risk assessment may be found in Tables 4.6.1 

and 4.6.2, below. 

Endpoints selected are those to be used for the parent compound and the octylphenol metabolite 

risk assessments. The acute and chronic dietary assessment endpoints were selected from the 

available octylphenol and nonylphenol metabolite databases. The residential and occupational 

assessment endpoints were selected from the OECD 422 study on the parent compound. Since 

the study with the parent compound did not look for certain potential effects on the estrogenic 

system, which were observed to be most sensitive for the metabolites, the FQPA safety factor of 

10X is retained for the residential risk assessments for the parent compound. 

For the general population, no toxic effects were identified resulting from a single day’s 

exposure. Therefore, an acute dietary risk assessment for the general population is not required. 

For females 13+, increased post-implantation loss was observed following exposure of dams to 

octylphenol during gestation days 0 to 8. This endpoint is considered appropriate as an effect that 

could result from a single day’s exposure. Therefore, an acute dietary risk assessment for females 

13+ is required. 

 

Endpoints for the chronic dietary assessment were selected from two literature studies on 

nonylphenol, which were considered co-critical. In a 2-generation reproduction study in rats 

(Nagao, 2001) effects observed at the LOAEL of 50 mg/kg/day were significant increases in 

pituitary weight in parental males and decreases in ovary weight in parental females. Effects 

found in the pups were significant acceleration of vaginal opening and decreases in the number 

of implants and live pups. The NOAEL for the parental and pup effects was 10 mg/kg/day. In a 

3-generation reproduction study in rats (Chapin, 1999), vaginal opening was also accelerated at a 

LOAEL of 30 mg/kg/day; the NOAEL was approximately 9 mg/kg/day. A 100X uncertainty 

factor was applied to account for the 10X interspecies and 10X intraspecies uncertainty factors, 

resulting in a chronic reference dose (cRfD) of 0.10 mg/kg/day. Since the 10X FQPA safety 

factor was removed, the chronic population adjusted dose (cPAD) is the same as the cRfD (0.10 

mg/kg/day). 

Endpoints for the residential (short- and intermediate-term incidental oral and inhalation) and 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 19 of 85 

occupational (short- and intermediate-term inhalation) exposures were selected from the OECD 

422 study in the rat on the parent compound with a NOAEL of 150 mg/kg/day. Effects observed 

at the LOAEL of 300 mg/kg/day were clinical signs, decreased body-weight gain in both sexes 

during the premating period, decreased thymus weight in females, increased liver weight in 

males, and increased incidence of centrilobular hepatocyte hypertrophy in males. Since studies

with the parent compound did not look for certain potential effects on the estrogenic system, 

which were observed to be most sensitive for the metabolites, the FQPA safety factor of 10X 

was retained. 

Quantitative dermal risk assessments will not be performed for occupational or residential 

exposures. When potential endpoints are considered in light of an estimated conservative dermal 

absorption value of 1%, effect levels would be at or above the limit dose. Therefore the Agency 

concludes that a quanitative dermal risk assessment is not required for the APEs. 

Although the available mammalian toxicity database does not include any chronic toxicity data, 

there are several multigeneration reproduction studies on the most toxicologically potent 

compound in this risk assessment, as well as a 2-generation reproduction study in rats on 

octylphenol. Based on the very conservative exposure assessment, the 10X interspecies and 10X 

intraspecies uncertainty factors would be adequately protective, and no additional uncertainty 

factor is needed for extrapolating from subchronic to chronic exposure. 

The level of concern (LOC) is for margins of exposures (MOEs) that are less than 1000 and is 

based on 10x for interspecies extrapolation animals to humans and 10x for variation in sensitivity 

among humans. The FQPA safety factor was retained (10X). 

These LOCs are applicable to all non-occupational populations, including individuals exposed in 

a residential setting. Risks from oral and inhalation routes of exposure should be combined since 

common endpoints (same study) were selected for these routes. The LOC for occupationally 

exposed workers is 100. 

Table 4.6.2 Summary of Toxicological Doses and Endpoints for Alkylphenol Ethoxylates (APE) and 

their Metabolites (including octylphenol) for Use in Human Health Risk Assessments 

Exposure/ 

Scenario 

Point of 

Departure 

Uncertainty 

Factors 

RfD, PAD, Level of 

Concern for Risk 

Assessment Study and Toxicological Effects 

Acute Dietary 

(general population) 

An endpoint attributable to a single exposure was not seen in the database; therefore a point of departure was not 

selected. 

Acute Dietary 

(females 13+) 

NOAEL = 

15.6 

mg/kg/day 

UFA= 10x 

UFH=10x 

FQPA SF = 1X 

aRfD = 0.156 

mg/kg/day 

aPAD= 0.156 

mg/kg/day 

initiation and maintenance of pregnancy in rats 

(Harazone and Ema, 2001) 

LOAEL = 31.3 mg/kg/day, based on increased % 

post-implantation loss following exposure of dams 

during gestation days 0-8.
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 20 of 85 

Table 4.6.2 Summary of Toxicological Doses and Endpoints for Alkylphenol Ethoxylates (APE) and 

their Metabolites (including octylphenol) for Use in Human Health Risk Assessments 

Exposure/ 

Scenario 

Point of 

Departure 

Uncertainty 

Factors 

RfD, PAD, Level of 

Concern for Risk 

Assessment Study and Toxicological Effects 

Chronic Dietary (All 

Populations) 

NOAEL = 10 

mg/kg/day 

UFA= 10x 

UFH=10x 

FQPA SF = 1X

cRfD = 0.1 mg/kg/day 

cPAD= 0.1 mg/kg/day

2-generation reproduction study in rats 

(Nagao, et al., 2001), 

LOAEL = 50 mg/kg/day, based on significant 

increases in pituitary weight (↑12%, males), 

decreases in ovary weight (↓18%) in F0 animals; 

timing of vaginal opening significantly accelerated 

in F1 females; decreases in the numbers of 

implants and live F2 pups born were observed 

(NOAEL 10 mg/kg/day). 

3-generation reproduction study in rats 

(Chapin, et al., 1999). 

LOAEL = 30 mg/kg/day, based on vaginal opening 

was accelerated by ≈2 days and ≈6 days in F1, F2, 

and F3 generations following dietary exposure at 

30 and 100 mg/kg/day respectively (NOAEL ≈9 

mg/kg/day) 

Incidental Oral and 

Inhalation 

(Short- and IntermediateTerm) 

 NOAEL = 

150 

mg/kg/day 

Inhalation 

toxicity is 

assumed to be 

equivalent to 

oral toxicity 

Dermal 

absorption of 

1% 

Dermal 

equivalent 

dose = 10000 

mg/kg/day 

UFA= 10x 

UFH=10x 

FQPA SF = 10x 

Residential LOC for 

MOE = 1000 

Occupational LOC for 

MOE= 100 

OECD Test Guideline 422 study (MRID 

47585801) (octylphenoxy 

poly(ethyleneoxy)ethanol, branched) 

Parental systemic LOAEL = 300 mg/kg/day, 

based on clinical signs (pushing head through 

bedding after dosing), decreased body-weight 

gain in both sexes during the premating period, 

decreased thymus weight in females, increased 

liver weight in males, and increased incidence of 

centrilobular hepatocyte hypertrophy in males 

Cancer (oral, dermal, 

inhalation) 

Classification: not classified; no alerts identified in SAR with respect to carcinogenicity; potential mutagenicity 

concern identified in open literature for parent compound and metabolite. Weight of the evidence determination 

that there is no sufficient evidence to warrant a quantitative cancer risk assessment. 

Point of Departure (PoD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning 

of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. 

LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable. 

4.8 Endocrine Disruption 

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor 

Screening Program (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 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 21 of 85 

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. 

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. 

This list of chemicals was selected based on the potential for human exposure through pathways 

such as food and water, residential activity, and certain post-application agricultural scenarios. 

This list should not be construed as a list of known or likely endocrine disruptors. 

APE and its octylphenol metabolite are not among the group of 9 inert ingredients on the initial 

list to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all 

pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP test orders/data call-ins 

for all pesticide active ingredients and inerts. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/. 

5.0 Dietary Exposure/Risk Characterization 

5.1 Residues of Concern 

The Agency considered whether the selected representative chemicals for toxicity testing from 

the APE cluster were representative of the entire cluster. Based on the representative chemical 

structures, the generic cluster structures, the submitted physicochemical EPI SuiteTM information 

as well as the structure-activity relationship analysis detailed in Appendix D of this review, the 

Agency concurs that the cluster grouping is appropriate. 

Very limited information is available for the Alkyl Phenol Ethoxylates (APE) with respect to 

plant and livestock metabolism. There is extensive information in the literature on 

environmental degradation1

, and some information on bacterial and mammalian metabolism, all 

of which indicate similar degradation of the APE compounds. The ethoxylate moiety is 

degraded by sequential removal of the ethoxylate groups, eventually degrading to p-toctylphenol. The structure and other identifiers for p-t-octylphenol are presented in Table 5.1.1. 

There are studies in the literature cited in Klecka (2005) that suggests plants have the ability to 

take up the APE residues from treated soil. Therefore, the Agency has concluded that the 

residues of concern in food and drinking water are the parent APE compounds, their partially deethoxylated degradation products, as well as the degradation product p-t-octylphenol. 

 

1

 Klecka, G.M., Staples, C.A., Losey, B.S. and Woodburn, K.B., “Assessment Of The 

Persistence And Bioaccumulation Potential For Nonylphenol, Octylphenol, And Their 

Ethoxylates For Categorization And Screening of The Canadian Domestic Substance List”. 

Prepared for the Alkylphenols and ethoxylates Research Council 2005. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 22 of 85 

Table 5.1.1. p-t-Octylphenol Chemical Information

Chemical Structure 1 

O

Common name p-tert-octyl phenol 

CAS Numbers 140-66-9 

CAS Name 4-(1,1,3,3-tetramethylbutyl)-phenol 

5.2 Drinking Water Residue Profile 

Selected alkylphenol ethoxylates and p-t-octylphenol have been found in many different water 

monitoring studies. In a review article, Ying et al 2

 state that the APEs and their metabolites are 

ubiquitous in the environment because of their wide use patterns ̧ and have been detected in air, 

water, sediment, soil and biota. The APEs and metabolites have been found in ground and 

surface waters. Furthermore, they are not completely degraded by wastewater treatment plants, 

and have been found in plant effluents. The APEs and their metabolites have been found in 

surface water in monitoring studies by the United States Geological Survey (USGS). In addition, 

a screening literature search revealed numerous monitoring studies by the states and other 

entities where selected APEs and p-t-octylphenol were found in ground and surface water. Many 

of these studies cannot distinguish the source of these compounds, which could have been from 

consumer, industrial, and/or agricultural uses of the APEs. A study of groundwater in Spain in 

an agricultural area3

 found the highest levels of p-t-octylphenol in an agricultural area, as 

compared to the urban and industrial areas sampled. 

In a supplement to the CST5 petition, the registrants reported the results of the National Health 

and Nutrition Examination Surveys (NHANES) for 2003-20044

, which indicated measureable 

quantities of the p-t-octyl phenol (tOP) metabolite, in the urine of the general US population for 

all ages 6-60 years. The octylphenol was detected in 57.4% of samples at total concentrations of 

0.2 μg/L–20.6 μg/L. Currently, there is no way to determine the source of the tOP found in 

urine, as it may have been result of exposure to personal care products ̧ contamination of water 

from manufacturing or agricultural sources, detergents, and/or residues in food from use as an 

inert ingredient. 

5.3 Food Residue Profile 

 

2

 Ying et al. / (2002) Environment International 28 (2002) 215– 226 

3

 LaTorre et al., “Presence of nonylphenol, octyphenol and bisphenol a in two aquifers close to agricultural, 

industrial and urban areas”. Chromatographia 2003, 57, January (No. 1/2) pp. 111-116 4

 Calafat AM, Ye X, Wong L-Y, Reidy JA, Needham LL. Exposure of the U.S. population to bisphenol A and 4-

tertiary-octylphenol: 2003–2004. Environ Health Perspect. 2008b;116:39–44. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 23 of 85 

No residue data were submitted for the APE inert ingredients or for the octylphenol 

metabolite/degradate. Nonylphenols (NPs), compounds very similar to the octylphenol 

degradate have been found in food 5

 in Germany. The highest level found was 19 ppb in apples. 

Again, there could be multiple sources of the NPs, but the authors do mention nonylphenol 

ethoxylate surfactants as a potential source for the nonylphenols found. 

In the absence of extensive data, the Agency has developed an approach which uses surrogate 

information to derive upper bound exposure estimates for inert ingredients and their 

metabolites/degradates, as appropriate. The upper bound exposure estimates are based on the 

highest tolerance for a given commodity from a list of 57 high use insecticides (22), herbicides 

(20), and fungicides (17). The 57 pesticides were selected based on an overall ranking scheme 

that included consideration of the 1999 data for active ingredients use. All herbicides at greater 

than 5 million lbs/yr and all fungicides and insecticides at greater than 1 million lbs/yr were 

included as candidate surrogate chemicals. 

OPP assumed that the residue level of the inert ingredient would be no higher than the highest 

tolerance for a given commodity. Implicit in this assumption is that there would be similar rates 

of degradation between the active and inert ingredient (if any) and that the concentration of inert 

ingredient in the scenarios leading to these highest of tolerances would be no higher than the 

concentration of the active ingredient. 

To summarize, the Agency believes the assumptions used to estimate dietary exposures lead to a 

very conservative assessment of dietary risk for the following reasons: 

• the highest tolerance level from the surrogate pesticides for every food is used; 

• 100% crop treated (%CT) is assumed for all crops (every food eaten by a person each day 

has tolerance-level residues); 

• many of these high tolerances are based on very short pre-harvest intervals where there is 

little time for degradation, whereas actual pesticide applications occur throughout the 

growing season; 

• no consideration was given to potential degradation between harvest and consumption 

(use of tolerance level residues which are typically one to two orders of magnitude higher 

than actual residues found in monitoring data); 

• residue values were assigned to every commodity in DEEMTM with no consideration 

given to potential reduction in residues from washing or cooking. 

Although sufficient information to quantify actual residue levels in food is not available, the 

compounding of these conservative assumptions will lead to a significant exaggeration of actual 

exposures. OPP does not believe that this approach underestimates exposure in the absence of 

residue data. 

 

5

 Guenther et al, “Endocrine Disrupting Nonylphenols Are Ubiquitous in Food”. Environmental Science & 

Technology 2002 36 (8), 1676-1680 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 24 of 85 

5.4 Analytical Methodology 

Since this request is for an exemption from the requirement of a tolerance, an analytical method 

for enforcement purposes is not required to support this action. 

5.5 Dietary (Food and Water) Exposure and Risk 

The model and inputs used for the alkylphenol ethoxylate inert ingredients dietary risk 

assessments are described briefly in Section 5.3 and below. A complete description of the 

dietary exposure and risk assessment is provided in the memorandum for a different inert 

ingredient cluster entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic 

Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.” 

(D361707, S. Piper, 2/25/09). 

Chronic aggregate dietary (food and drinking water) exposure and risk assessments were 

conducted using the Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 2.03 which 

uses food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of 

Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. 

5.5.1. Acute Dietary Exposure and Risk 

A hazard endpoint for acute exposure to the sulfate and phosphate derivatives of the APE inert 

ingredients was identified only for females ages 13-49; no hazard endpoints for acute exposure 

were identified for any other population group. A conservative screening level assessment was 

conducted for acute (one-day) dietary (food and drinking water) exposure using the highest 

tolerance level residue for all food forms, including meat, milk, poultry and eggs, default 

processing factors for dried commodities and 100% CT. In addition, a default concentration of 

100 ppb was assumed for inert ingredient residues in drinking water. 

Provided the maximum concentration of the inert ingredient in the final pesticide formulation is 

limited to no more than 7% by weight, the chronic dietary exposure estimates for food and 

drinking water are below HED’s level of concern (<100% cPAD). When limited to no more 

than 7% of the end-use product, the phosphate and sulfate derivatives of APE inert dietary 

exposure for food and drinking water is 37% of the cPAD for the females ages 13-49. See Table 

5.5.4 below for a summary of results. 

5.5.2 Chronic Dietary Exposure and Risk 

A conservative screening level assessment was conducted for chronic dietary (food and drinking 

water) exposure using the highest tolerance level residue for all food forms, including meat, 

milk, poultry and eggs, default processing factors for dried commodities and 100% CT. In 

addition, a default concentration of 100 ppb was assumed for inert ingredient residues in 

drinking water. 

Provided the maximum concentration of the inert ingredient in the final pesticide formulation is 

limited to no more than 7% by weight, the chronic dietary exposure estimates for food and 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 25 of 85 

drinking water are below HED’s level of concern (<100% cPAD) for the U.S. population and all 

population subgroups. When limited to no more than 7% of the end-use product, the sulfate and 

phosphate derivatives of the APE inert dietary exposure for food and drinking water is 29% of 

the cPAD for the U.S. population and 90% of the cPAD for children 1-2 yrs old, the most highly 

exposed population subgroup. See Table 5.4.4, below for a summary of results. 

5.5.3 Cancer Dietary Exposure and Risk 

HED has determined that a quantitative cancer risk assessment is not warranted for the APEs; 

therefore, a cancer dietary exposure assessment was not performed. 

5.5.4. Summary of Dietary Exposure and Risk Assessment Results 

The results of the chronic dietary risk assessment are shown in the summary table, below. The 

residue input files and the dietary exposure detailed results are contained in Appendix D of this 

memorandum. 

Table 5.5.4. Summary of Dietary (Food and Drinking Water) Exposure and Risk for the Alkylphenol 

Ethoxylates (APE) 

Acute Dietary 

(95th Percentile) 

Chronic Dietary 

Population Subgroup 

Dietary Exposure 

(mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % cPAD 

General U.S. Population 0.02862 29 

All Infants (< 1 year old) 0.06153 62 

Children 1-2 years old 0.09005 90 

Children 3-5 years old 0.06719 67 

Children 6-12 years old 0.03748 38 

Youth 13-19 years old 0.02149 22 

Adults 20-49 years old 0.02191 22 

Adults 50+ years old 

No acute endpoint selected 

0.02307 23 

Females 13-49 years old 0.05791 37 0.02204 22 

The most highly exposed subgroup is bolded.

6.0 Residential (Non-Occupational) Exposure/Risk Characterization 

A screening level residential exposure and risk assessment was completed for products 

containing APE inert ingredients. Details of the assumptions informing the residential exposure 

and risk assessment can be found in “JITF Inert Ingredients. Residential and Occupational 

Exposure Assessment Algorithms and Assumptions Appendix for the Human Health Risk 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 26 of 85 

Assessments to Support Proposed Exemption from the Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide Formulations”, D364751, 5/7/09. A summary of the residential 

exposure and risk assessment is presented below. 

The level of concern (LOC) for these risk assessments is an MOE of 1000 based on the standard 

10X inter-species and 10X intra-species extrapolation safety factors, as well as the database 

uncertainty factor of 10X. 

6.1 Residential Handler Exposure 

Exposure Scenarios

The Agency selected representative scenarios, based on end-use product application methods and 

labeled application rates. The APE inerts are used in pesticide formulation that may be used in 

and around the home. These residential pesticide products are typically formulated as liquids in 

concentrates or as wettable powders. In addition, these inerts may be used in pesticide products 

applied to pets and companion animals as a dust formulation. Lastly, these inerts may be present 

in consumer-type cleaning products used in and around the home. HED conducted an 

assessment to represent worst-case residential exposure by assessing: 

• APE in pesticide formulations (fungicides/insecticides/herbicides); (Outdoor Scenarios) 

• APE in disinfectant-type uses; (Indoor Scenarios) 

• APE in dust pet products; (Pet Product Scenarios) 

Based on information provided by the Registration Divison (RD), the APE inerts can be present 

in cosmetics, personal care products, and consumer cleaning products. Therefore, HED assessed 

the disinfectant-type products containing the APE inerts using exposure scenarios used by OPP’s 

Antimicrobials Division to represent worst-case residential handler exposure. 

Mixer/Loader/Applicator High Exposure Outdoor Scenarios: 

The mixer/loader/applicator high exposure outdoor scenarios use data from the Outdoor 

Residential Exposure Task Force to represent high exposure outdoor residential scenarios: 

• Liquid products: Low Pressure Handwand (ORETF data) 

• Liquid products: Hose End Sprayer (ORETF data) 

• Ready to Use (RTU): Trigger Pump Sprayer Applications (ORETF data) 

Exposure Data and Assumptions: 

A series of assumptions and exposure factors served as the basis for completing the residential 

handler risk assessments for the APE inerts. Each assumption and factor is detailed below. In 

addition to these factors, unit exposures were used to calculate risk estimates. 

The Agency used assumptions based on the Residential Exposure Assessment Standard 

Operating Procedures (Residential SOPs). Key assumptions used in this assessment are 

summarized below. 

• The maximum application rate for the inert based on its use in a class of pesticide 

(herbicide/insecticide/fungicide) has been assessed for the short-term exposure duration. 

• Residential risk assessments are based on high-end estimates of what residential handlers 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 27 of 85 

5 gallons formulated pesticide solution*(9 lbs/gallon)*(7% APE)*(1 part product concentrate/10 parts water) = 0.315 lbs 

APE in formulated pesticide solutions per day 

(i.e., homeowners) would typically treat. Per HED’s Residential SOPs (1997 & 2001 

revision), residential pesticide handlers are assumed to mix and apply a volume of 5 

gallons of product per day. 

• For outdoor pesticide applications, residential handlers are assumed to use a total of 

0.315 lbs APE per day. This estimate is based on the following assumptions: 

o Five (5) gallons of formulated pesticide solution are assumed to be used per day 

by a residential handler (Revised Residential SOPs Area Treated, February, 

2001). Consistent with HED’s residential SOPs, the density of the formulated 

pesticide solution is assumed to be 9 lbs/gallon. The upper bound to the amount 

of APE iner in the pesticide products is 7%. Therefore, residential exposure 

assessment assumes 7% APE in any pesticide product formulation. Product 

concentrates are assumed to be diluted at a 1 to 10 ratio with water. 

• Residential exposure is assessed assuming clothing consisting of a short-sleeved shirt, 

short pants and no gloves or respiratory protection. This is considered to be typical 

clothing for a residential pesticide applicator. 

• No dermal endpoint was selected from the hazard database for APE; therefore 

quantitative dermal exposure assessment was not assessed. 

HED believes the duration of exposure for most homeowner applications of home garden and 

lawn care products is best represented by the short-term duration (1 to 30 days). These exposure 

scenarios include the application of herbicides to lawns and insecticides/fungicides to gardens, 

ornamental plants, or lawns. While these types of applications may be applied on consecutive 

days, they are not likely to exceed 30 consecutive application days. 

Mixer/Loader/Applicator High Exposure Indoor Scenarios:

The mixer/loader/applicator high exposure outdoor scenarios use data from the proprietary 

Chemical Manufacturers Association (CMA) antimicrobial exposure study, and the Pesticide 

Handlers Exposure Database to represent high exposure indoor residential scenarios: 

• Liquid Products: Mopping Use (CMA data) 

• Liquids Products: Wiping Use (CMA data) 

• Aerosol Spray/Trigger pump/Air Deodorization Use (PHED data) 

The Agency used assumptions based on methodology developed by the Anti-Microbial Division 

(AD) of the Office of Pesticide Programs and the Residential SOPs to assess exposure and risk 

from indoor use of household cleaning products containing the APE inerts. Based on 

information from OPP’s Registration Division (RD), the Agency assumed that the maximum 

percentage by weight in indoor products would be 3% APE. 

Unit Exposure Values: Unit exposure values were taken from the proprietary Chemical 

Manufacturers Association (CMA) antimicrobial exposure study (USEPA, 1999: DP Barcode 

D247642) or from the PHED data presented in HED’s Residential SOPs (USEPA, 1997). 

“JITF Inert Ingredients. Residential and Occupational Exposure Assessment Algorithms and 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 28 of 85 

1 gallon formulated pesticide solution*(8.34 lbs/gallon)*(3% APE)*(2 oz/ 128 oz dilution factor) = 0.004 lbs APE in 

formulated pesticide solutions per day 

0.13 gallon formulated pesticide solution*(8.34 lbs/gallon)*(3% APE) = 0.033 lbs APE in formulated pesticide solutions 

per day 

Assumptions Appendix for the Human Health Risk Assessments to Support Proposed Exemption 

from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations”, 

D364751, 5/7/09 contains additional information about the disinfectant-type exposure scenarios 

assessed in this document. 

The following key assumptions were used in this assessment: 

• For the mopping scenario, the CMA dermal and inhalation unit exposure values for 

ungloved mopping were used (71.6 mg/lb inert. and 2.38 mg/lb inert, respectively). 

These values are based on data collected from six replicates mopping floors and receiving 

exposure via contact mopping activites. 

• For the wiping scenario, the CMA dermal and inhalation unit exposure values for 

ungloved wiping were used (2,870 mg/lb inert and 67.3 mg/lb inert, respectively). These 

values are based on data collected from six replicates (dental technicians) who used a 

finger pump sprayer to apply the product and then wiped surfaces (e.g., fixtures, etc.) 

with a cloth. 

• For aerosol spray, trigger pump and air deodorization scenarios, the PHED dermal and 

inhalation unit exposure values are 220 mg/lb inert and 2.4 mg/lb inert, respectively. The 

values are based on homeowners applying an aerosol insecticide to baseboards in 

kitchens and are representative of a handler wearing short pants and a short sleeve shirt, 

with no gloves. 

The quantities handled/treated were estimated based on information from various sources and 

assumptions. 

• For the mopping scenarios, it was assumed that 1 gallon of diluted solution is used by 

residential handlers. HED assumes that indoor products are assumed to have the same 

density as water (8.34 lbs/gallon). While typical product concentrate directions indicate 

that 1 oz concentrated product per 1 gallon of water should be used, HED followed 

OPP’s Antimicrobial Division’s (AD’s) SOP and assumed a dilution factor of 2 oz 

concentrated product/128 oz (1 gallon) of water for the residential handler risk 

assessment to represent heavy-duty cleaning formulations. Based on information from 

RD, HED assumed that the maximum percentage by weight of APE in indoor products is 

3%. 

• For the wiping and trigger pump spray scenarios, it was assumed that 0.5 liter (0.13 gal) 

of ready-to-use (RTU) solution is used. For consumer-type products, HED assumed that 

the maximum percentage by weight of APE in indoor products is 3%. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 29 of 85 

• For the aerosol foam spray and air deodorization scenarios, HED assumed that one can of 

product is used. For the aerosol spray/trigger pump/air deodorization scenario, HED 

assumed that a 12 oz net weight product is used (0.094 gallons). HED assumed that the 

maximum percentage by weight of APE in indoor products is 3%. 

Quantitative dermal risk assessments will not be performed for the APE inerts. When potential 

dermal endpoints are considered in light of an estimated conservative dermal absorption value of 

1%, effect levels would be at or above the limit dose. Therefore the Agency concludes that a 

quantitative dermal risk assessment is not required for the APE inerts. 

HED believes the duration of exposure for most homeowner applications of indoor cleaning 

products is believed to be best represented by the short-term duration (1 to 30 days) because the 

different scenarios (i.e. methods of application) are assumed to be episodic, not daily. In 

addition, residential handlers are assumed to use different cleaning products with varying active 

and inert ingredients. 

Mixer/Loader/Applicator High Exposure Pet Product Scenarios:

• Pet Dust scenario (Dust application to pets) 

 

According to information provided by RD, products intended for use on pets contain less than 

1% APE in the formulation. The relevant products for direct application to pets and companion 

animals are dust-based. For the residential handler exposure assessment, HED assumed that 

products associated with the pet use scenarios contained 1% APE in products applied directly to 

pets. 

The following key assumptions were used in this assessment: 

• For the pet dust scenario, ten percent (0.1) of the inert applied to the pet is available for 

residential dermal and inhalation exposure during the application process. This 

assumption is based on the professional judgment of the OPP/HED staff and assumed to 

be an upper-percentile value. 

The quantities handled/treated were estimated based on information from various sources and 

assumptions. 

• For the pet dust scenario, it is assumed that the product application rate is 1/3 ounce per 

10 pounds of pet treated. The residential SOPs specify a 30 pound dog is treated; 

therefore 1 oz of dust product is assumed to be applied to the treated pet. 

• HED assumed that the upper bound percentage of APE inert in dust-based pet product is 

1%. 

No dermal endpoint was selected from the hazard database for APE; therefore quantitative 

dermal exposure assessment was not assessed. 

The duration of exposure for most homeowner applications of pet products is believed to be best 

represented by the short-term duration (1 to 30 days) because typical direct pet treatment 

products indicate episodic, not daily use. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 30 of 85 

Risk Summary

For all residential handler scenarios, risk estimates are not of concern (i.e., MOEs are all greater 

than 100) for the inhalation route-specific assessment. A summary of the results are provided 

below in Tables 6.1.1, below. 

The Agency believes that the handler scenarios assessed represent worse-case exposures and 

risks resulting from use of indoor and outdoor pesticide products, cleaning products, and pet 

products containing the APE inerts in residential environments. 

Table 6.1.1. Short-term Exposure and Risks for APE Residential Handlers 

Exposure 

Scenario 

(Formulation/ 

Application)

Application 

Rate1 (lb 

inert/ 

gallon) 

Quantity 

Handled/ 

Treated 

per day2

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(mg/ lb 

inert)3

Dermal 

Dose 

(mg/kg 

/day)4

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total 

MOE8

Outdoor Products 

Liquids/ Low 

Pressure 

Handwand (ST) 

(ORETF data) 

0.063 

lb/gal 

5 

gallons 38 0.003 NA 0.000014 NA 11,000,000 NA 

Liquids/ Hose End 

Sprayer, Lawn 

(ST) 

(ORETF data) 

0.063 

lb/gal 

5 

gallons 11 0.017 NA 0.000077 NA 2,000,000 NA 

Liquids/ Trigger 

Sprayer/ Home 

Garden (ST) 

(ORETF data) 

0.063 

lb/gal 

5 

gallons 54 0.0019 NA 0.0000086 NA 18,000,000 NA 

Indoor Products 

Indoor hard 

surface, Mopping 

(ST) 

(CMA data) 

0.004 

lb/gal 1 gallon 71.6 2.38 NA 0.00013 NA 1,100,000 NA 

Indoor hard 

surface, Wiping 

(ST) 

(CMA data) 

0.25 lb/gal 0.13 

gallons 2870 67.3 NA 0.0313 NA 4,800 NA 

Indoor hard 

surface, Aerosol 

spray (ST) 

(PHED data) 

0.25 lb/gal 

0.094 

gallons 

(12 oz) 

220 2.4 NA 0.00081 NA 190,000 NA 

1

Application rates are based on maximum application rates of products containing APE inerts multiplied by 7% for outdoor 

products and 3% for indoor products to convert from product application rate to inert application rate. 2

Quantity treated daily values are back-calculated from 5 gallons of product used per day (Revised Residential SOPs 2001) for 

outdoor products. Indoor products are assumed to be used at 1 gallon of solution for the mopping scenario, 0.5 L of solution for 

the wiping scenario, and a 12 oz can of spray for the aerosol spray/air deodorization scenario. 3

Unit Exposure data sources are identified in the exposure scenario column. All exposure scenarios assess exposure reflecting 

applicators wearing short-sleeved shirts and shorts and no respiratory protection. 4

Daily Dermal Dose = NA 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (mg inert / lb inert) * Application Rate (lb /gal) * Quantity handled 

(gallons/day)) / Body Weight (70 kg) 

6 Dermal MOE = NA 

7 Inhalation MOE = PoD (NOAEL of 150 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

 Total MOE = NA; no quantitative dermal exposure assessment. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 31 of 85 

Table 6.1.2. Short-term Exposure and Risks for APE Residential Handlers for Pet Dust 

Products

Exposure 

Scenario 

(Formulation) 

Application 

Rate1 

(mg/day) 

Fraction (F) 

product available 

for exposure 

Dermal 

Dose 

(mg/kg 

/day)2

Daily 

Inhalation 

Dose 

(mg/kg/day)3

Baseline 

Dermal MOE4

Baseline 

Inhalation 

MOE5

Total MOE6

Pet Products 

Pet Dust Product 

(ST) 

(HED Residential 

Pet SOP) 

284 mg/day 0.1 NA 0.00405 NA 37,000 NA 

1

Application rate based on 1 oz applied, 1% inert in dust formulation. 2

Daily Dermal Dose = NA 

3

Daily Inhalation Dose = (Application Rate (mg /day) * F))/ Body Weight (70 kg) 4 Dermal MOE = NA 

5

 Inhalation MOE = PoD (NOAEL of 150 mg/kg/day) / Daily inhalation dose (mg/kg/day) 6

 Total MOE = NA; no quantitative dermal exposure assessment. 

6.2 Residential Postapplication Exposure

Exposure Scenarios

Residential postapplication exposures result when bystanders, such as children come in contact 

with the APE inerts in areas where end-use products have recently been applied (e.g., treated 

lawns, gardens or recently cleaned surfaces). The Agency selected representative scenarios, 

based on end-use product application methods and labeled application rates. HED conducted an 

assessment to represent worst-case residential exposure by assessing post application exposures 

and risks from: 

• APE in pesticide formulations (fungicides/ insecticides/ herbicides); (Outdoor Scenarios) 

• APE in disinfectant-type uses; (Indoor Scenarios) 

• APE in dust pet treatments; (Pet Product Scenarios) 

The Agency considers incidental oral (children only) the primary exposure routes for the APE 

inerts. The Agency typically also assesses dermal exposure (adults and children) but no 

quantitative dermal exposure assessment is required for APEs since no dermal endpoint was 

selected from the hazard database. Inhalation exposures are not typically calculated for 

postapplication scenarios because inhalation exposures generally account for a negligible 

percentage of the overall body burden for most pesticide chemicals. Any inhalation exposure 

through the postapplication route will be less than the inhalation exposures assessed by 

residential handlers above in section 6.1 which are not of concern. 

For all postapplication exposure scenarios, exposures are assessed at short- and intermediateterm exposure durations because residues may be present on treated lawns, indoor treated 

surfaces, or on treated pets for lengths of time consistent with short- and intermediate-term 

exposure. Additionally, residential postapplication exposure can occur in commercially treated 

environments (e.g., schools, child care facilities, hospitals). If the products are used on a routine 

basis (i.e., daily), exposures may occur over an intermediate-term time duration (30 days – 6 

months). 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 32 of 85 

Postapplication High End Outdoor Exposure Scenarios

• Hand-to-Mouth activity for toddlers on treated lawns (children)

• Object-to-Mouth activity for toddlers on treated lawns (children)

• Soil ingestion from treated soil (children)

 

The exposures from these routes and scenarios were considered individually and were also added 

together, where appropriate, to determine a total dose for children exposure to treated lawns. 

Residential postapplication exposure is assessed on the day of application, typically referred to as 

Day 0. 

Exposure Data and Assumptions

A series of assumptions and exposure factors served as the basis for completing the residential 

postapplication risk assessments. The assumptions and factors used in the risk calculations are 

consistent with current HED policy for completing residential exposure assessments (i.e., SOPs 

for Residential Exposure Assessment [1997 and 2001 revision]). 

Exposures to adults/children after contact with treated lawns have been addressed using the latest 

approaches for this scenario including: 

• For child exposure, the mean of median values for male and female 3 year olds was used 

to estimate exposure (15 kg). 

• Based on HED’s Residential SOPs, it was assumed that the surface area used for each 

hand-to-mouth event is 20 cm2 (based on the surface area of three fingers of a toddler’s 

hand). For short-term exposures, it is assumed that there were 20 events per hour (90th

percentile, according to the SOP) and for intermediate-term exposures, it was assumed 

that there were 9.5 event/hour (mean value). 

• The exposure time used is 4 hours a day (USEPA, 2000 and 2001). 

• The saliva extraction efficiency used is 50% (USEPA, 2000 and 2001). 

• Pesticidal products are assumed to contain a maximum of 7% APE by weight in the end 

use products. 

• The relevant application rates for APE containing products are derived above in Section 

6.1 

Postapplication High End Indoor Exposure Scenarios

Standard methodologies based on HED’s Residential SOPs were used to assess residential 

postapplication exposure to consumer-type products (e.g., hard surface cleaners). 

Based on information provided by RD, HED assumed that the maximum percentage by weight in 

indoor products would be 3% APE. Based on an overall query of products that contain APE, this 

reflects a high-end concentration. 

HED believes the duration of exposure for most homeowner applications of indoor cleaning 

products is believed to be best represented by the short-term duration (1 to 30 days) because the 

different scenarios (i.e. methods of application) are assumed to be episodic, not daily. In 

addition, homeowners are assumed to use different cleaning products with varying active and 

inert ingredients. However, intermediate-term exposure is assessed for children because 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 33 of 85 

disinfectant products are used frequently in schools and day care centers where children can 

spend significant amounts of time. In those environments, cleaning products can be used on a 

daily basis. Also, residues may persist on surfaces to which children can be exposed. 

The Agency used assumptions based on the Residential SOPs. The following key assumptions 

were used in this assessment: 

• Toddlers (3 years old) were used to represent the 1 to 6 year old age group and are 

assumed to weigh 15 kg, the mean of median values for male and female toddlers 

(USEPA, 2000 and 2001). 

• Based on HED’s Residential SOPs, it was assumed that the surface area used for each 

hand-to-mouth event is 20 cm2

 (based on the surface area of three fingers of a toddler’s 

hand). For short-term exposures, it is assumed that there were 20 events per hour (90th

percentile, according to the SOP) and for intermediate-term exposures, it was assumed 

that there were 9.5 event/hour (mean value). 

• The exposure time was 4 hours a day (USEPA, 2000 and 2001). 

• The saliva extraction efficiency was 50% (USEPA, 2000 and 2001). 

• No label information was available to represent the volume of disinfectant to be used for 

cleaning surfaces such as floors. It was assumed that the diluted treatment solution was 

applied at a rate of 1 gallon per 1,000 sq. ft. 

• The maximum application rate on the product labels for application to hard surfaces is 

8.34 lbs product/gal, based on the density of water. The amount of product used is 

assumed to be 0.5 gallons per day at a rate of 1 gallon/1000 ft2

, (i.e., 0.5 gallons for 500 

ft2). Therefore, the application rate used for the hard surface cleaner scenario in the post 

application scenario was 3.9x10-6 lbs inert/ft2

 [(1 gallon of product used * 8.34 

lbs/gallon)/1000 ft2 cleaned = 0.008 lb product/ft2); (0.008 lb product/ ft2 * 3% inert in a 

given disinfectant formulation * 2 oz/128 oz dilution factor= 3.9x10-6 lb/ft2

 /per day)] 

(See Table 6.2: Indoor Cleaning Products). 

• No data is available regarding the quantity of solution residue left on the floor after 

treatment. As a conservative measure, it was assumed that 25% of the cleaner remains 

after the final mopping. This assumption has been used by the AD for other Office of 

Pesticide Program risk assessments. 

• No transferable residue data were available that could be used to estimate the transfer 

factor from the floor to skin. Therefore, it is assumed that 10% of the deposition rate is 

available for dermal transfer (USEPA, 2000 and 2001). 

No dermal endpoint was selected from the hazard database for APE inerts; therefore quantitative 

dermal exposure assessment was not assessed. 

Postapplication High End Pet Product Exposure Scenarios

Standard methodologies based on HED’s Residential SOPs were used to assess residential 

postapplication exposure to pesticidal products used on pets. 

Based on information from RD, HED assumed that the upper bound percentage of APE inert in 

dust-based pet product is 1%. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 34 of 85 

Our assessment assumes 28,400 mg of product applied in each application (1 ounce of dust). For 

the pet dust scenario, it is assumed that the application rate is 1/3 ounce per 10 pounds of pet 

treated. The residential SOPs specify a 30 pound dog is treated; therefore 1 oz of dust product is 

assumed to be used. 

The residue of pesticidal dust treatments on pets is expected to remain available for transfer and 

exposures are expected to occur over a short- and intermediate-term time duration (1- 30 days, 

30 days – 6 months, respectively). 

The Agency used assumptions based on the Residential SOPs. The following key assumptions 

were used in this assessment: 

• Toddlers (3 years old) were used to represent the 1 to 6 year old age group and are 

assumed to weigh 15 kg, the median for male and female toddlers (USEPA, 2000 and 

2001). 

• For the pet dust scenario, it is assumed that the application rate is 1/3 ounce per 10 

pounds of pet treated. The residential SOPs specify a 30 pound dog is treated; therefore 1 

oz of dust product is assumed to be used. 

• It is assumed that one pet is contacted per day. 

• On the day of application, it may be assumed that 20% (0.2) of the maximum application 

rate is available on the pet’s body and transferred to the adult/toddler as a dislodgeable 

residue. This value is believed to be an upper-percentile assumption (US EPA, 1999 

SAP). 

• Postapplication activities are assed on the same day that the pesticide is applied because it 

is assumed that individuals could come in contact with the pet immediately after 

application. 

• The surface animal of a dog is determined using a representative (average) animal, or a 

medium-sized (30 lb) dog. Estimated risks are based on an even loading of residues 

across the entire surface of a 30 lb dog, where Surface area (cm2

) = ((12.3 * (BW 

(lb)*454)^0.65)) = 2490 cm2

 from HED’s 1993 Wildlife Exposure Factors Handbook. 

Pet Product Postapplication HTM Exposure Assumptions: 

• Based on HED’s Residential SOPs, it was assumed that the surface area used for each 

hand-to-mouth event is 20 cm2, representing the surface area of the child’s hands entering 

the mouth (assumed to be 3 fingers). 

• Saliva extraction efficiency is assumed to be 50% (i.e. every time the hand goes in the 

mouth approximately half of the residues on the hand are removed). 

• The approach used to address the hand-to-mouth exposure pathway has been modified 

since 1999 Draft Policy 13, “Postapplication Exposure Assessment for Children from 

Treated Pets.” In the revised approach, the frequency term has been modified to an 

equilibrium approach analogous to the dermal exposure component (i.e., the frequency = 

1 event/day). This approach was revised since the data from which the transferable 

residues concentrations were determined rely on a continuous contact (grooming) 

technique that would lead to concentrations on the hands which are anticipated to be 

significantly higher than would result from petting/hugging. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 35 of 85 

Risks were calculated using the Margin of Exposure (MOE) approach, which compares a 

toxicological PoD to an exposure estimate. Exposure algorithms and additional information on 

calculating the risk estimates for residential postapplication exposure (except for the residential 

postapplication hand-to-mouth exposures from pet dusts described above) can be found in “JITF 

Inert Ingredients. Residential and Occupational Exposure Assessment Algorithms and 

Assumptions Appendix for the Human Health Risk Assessments to Support Proposed Exemption 

from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations”, 

D364751,” 5/7/09. 

Risk Summary

A summary of the residential postapplication exposure and risk estimates are presented in Table 

6.2, below. Short- and intermediate-term post application risks for children are not of concern 

(i.e., the MOEs for the assessed scenarios are greater than 100) for both the short- and 

intermediate-term exposure durations. 

Risk Characterization

At this time, residue dissipation data or reliable use pattern data are not available, including the 

frequency and duration of use of antimicrobial products in the residential setting. The Agency 

does not believe that the use patterns of many residential products result in intermediate-term 

exposure. However, the Agency notes that intermediate-term exposure to children may occur in 

areas where disinfecting products are used more frequently (i.e., schools and day care centers). 

Table 6.2. Residential Postapplication Short- and Intermediate-term Exposures and Risks 

for APE

Exposure Scenario Application Rate1 Exposed 

Population & 

Exposure 

Duration2

Daily Dose 

(mg/kg/day)3

MOE4

Outdoor Lawn Products 

Adult ST NA NA 

Adult IT NA NA 

Child ST NA NA 

Dermal Exposure to 

Treated Lawns 

Child IT NA NA 

Hand-to-Mouth from Child ST 0.00471 32,000 

Treated Lawn Child IT 0.00224 67,000 

Object-to-Mouth Child ST 

from Treated Lawn Child IT 0.00118 130,000 

Child ST Soil Ingestion Child IT 1.58E-5 9,500,000 

Total Lawn Child ST NA NA 

Combined 

Exposures* 

0.315 lb/day 

Child IT NA NA 

Indoor Cleaning Product 

Dermal Exposure to Child ST 

Treated Indoor 

Surface 

Child IT NA NA 

Hand-to-Mouth from Child ST 0.00255 59,000 

Treated Indoor 

Surface 

3.9E-6 lb/ft2

Child IT 0.0012 120,000 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 36 of 85 

Table 6.2. Residential Postapplication Short- and Intermediate-term Exposures and Risks 

for APE

Exposure Scenario Application Rate1 Exposed 

Population & 

Exposure 

Duration2

Daily Dose 

(mg/kg/day)3

MOE4

Total Surface Child ST NA NA 

Combined 

Exposures*

Child IT NA NA 

Pet Product 

Adult ST 

Adult IT NA NA 

Child ST 

Dermal Exposure to 

Treated Pet 

Child IT NA NA 

Hand-to-Mouth from Child ST 

Treated Pet Child IT 0.00632 24,000 

Total Pet Child ST 

Combined 

Exposures*

284 mg/day 

Child IT NA NA 

1 Application rates for outdoor products are derived in Section 6.1 Application rates for indoor and pet products are derived in 

Section 6.2. 

2 ST and IT indicate short- or intermediate-term exposure durations 3 Daily Dose = Daily Dose algorithms for various residential postapplication scenarios outlined in “JITF Inert Ingredients. 

Residential and Occupational Exposure Assessment Algorithms and Assumptions Appendix for the Human Health Risk 

Assessments to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide 

Formulations”, D364751, 5/7/09. 

4

 MOE = PoD (NOAEL of 150 mg/kg/day)/ Daily dose (mg/kg/day) 

5

 Total Combined Exposures = NA; no quantitative dermal exposure assessment. 

7.0 Aggregate Risk Assessments and Risk Characterization 

7.1 Acute Aggregate Risk 

Acute aggregate risk includes risks from food and water only. As shown in Section 5.5.1, acute 

aggregate risks are not of concern. 

7.2 Short-Term/Intermediate-Term Aggregate Risk 

Short-term and intermediate-term aggregate risk assessments for the APE inert ingredients 

combine high end residential short- or intermediate-term exposures with average food and 

drinking water exposures, and compare this total to a short- or intermediate term PoD. 

The point of departure for the dietary risk assessment is 10 mg/kg/day and the LOC is 100 for the 

APEs. The point of departure for the residential risk assessment is 150 mg/kg/day and the LOC 

is 1000 for the APEs. For the purpose of aggregating risks from dietary and residential 

exposure, the Agency is using the ARI (Aggregate Risk Index) approach for aggregate risk 

assessment. This approach allows for combining exposures which must be compared to different 

NOAELs and different LOCs. Potential risks of concerns are identified by an ARI of less than 1. 

Short- and intermediate term residential exposures are summarized in Table 7.2.1. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 37 of 85 

Table 7.2.1. Short- and Intermediate-Term Residential Exposures for the APE Aggregate 

Risk Calculations 

Population Handler MOE 1

Postapplication 

MOE2

Residential Total 

MOE 

Short-Term 

Adult Male 

4,800

Source: Table 6.1 

Indoor hard surface, Wiping (ST) 

N/A 4,800 

Adult Female 4,800

Source: Table 6.1 

 Indoor hard surface, Wiping 

(ST)

N/A

4,800 

Child N/A 24,000

Source: Table 6.2 

 Pet Product HTM Exposure (IT) 

24,000 

Intermediate-Term 

Adult Male N/A N/A N/A 

Adult Female N/A N/A N/A 

Child N/A 24,000

Source: Table 6.2 

Pet Product HTM Exposure (IT)

24,000 

1 – Handler MOE represents high end inhalation handler exposure, where the exposure duration is appropriate to assess 

2 – Postapplication MOE represents high end incidental oral exposure to outdoor lawn products or indoor cleaning products for 

the relevant exposure duration 

Short- and intermediate-term aggregate risks are summarized in Table 7.2.2. Short- and 

intermediate-term aggregate risks are not of concern for adults or children. 

Table 7.2.2 Short-Term and/or Intermediate-Term Aggregate Risk Calculations for APE 1

Short- or Intermediate-Term Scenario 

Population Food & 

Water 

MOE 

Dietary 

LOC 

ARI 

food & 

water 

Residential 

MOE 

Residential 

LOC 

ARI 

Residential 

Aggregate 

ARI2

Short-Term 

Adult Male 430 100 4.3 4,800 1,000 4.8 2.3 

Adult Female 430 100 4.3 4,800 1,000 4.8 2.3 

Child 110 100 1.1 24,000 1,000 24 1.0 

Intermediate-Term 

Adult Male 430 100 4.3 NA 1,000 N/A 4.3 

Adult Female 430 100 4.3 NA 1,000 N/A 4.3 

Child 110 100 1.1 24,000 1,000 24 1.0 1

ARI = [MOECALCULATED/LOC] Aggregate risks of concern are identifiefy by an ARI less than 1. Residential MOEs used in 

aggregate assessment found in Table 7.2.1. Dietary MOEs = NOAEL/ exposure values in Table 5.5.4. 2

 Aggregate ARI = 1/[ [(1/ARI food & water) + (1/ARI residential)]] 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 38 of 85 

7.3 Long-Term Aggregate Risk 

Long-term aggregate risk includes risks from food and water only. As shown in Section 5.5.2, 

long-term aggregate risks are not of concern. 

7.4 Cancer Risk 

The Agency has determined that a quantitative cancer assessment is not required for the APE 

inert ingredients; therefore, a cancer dietary aggregate exposure assessment was not performed. 

8.0 Occupational Exposure/Risk Pathway 

Based on examination of product labels which may contain the APE as inert ingredients, HED 

has determined that exposure to handlers can occur in a variety of occupational environments. 

Details of the occupational exposure assessment for the APE inerts can be found in the document 

“JITF Inert Ingredients. Residential and Occupational Exposure Assessment Algorithms and 

Assumptions Appendix for the Human Health Risk Assessments to Support Proposed Exemption 

from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations”, 

D364751,” 5/7/09. 

The representative occupational scenarios selected by the Agency for assessment were evaluated 

based on likely maximum application rates for products which may contain the APE inerts for 

the short-term exposure assessment, and average application rates for products likely to contain 

APE as inerts for the intermediate- and long-term exposure durations. Active ingredient 

application rates were corrected for the maximum amount of APE likely to be in the final 

formulations to determine exposure and risk from exposure to APE grouped by 

fungicide/insecticide or herbicide. A summary of the occupational assessment is presented 

below. 

The level of concern (LOC) for these risk assessments is an MOE of 100 based on the standard 

10X inter and 10X intra species uncertainty safety factors. 

8.1 Handler Risk 

Exposure Scenarios

Exposure to pesticide handlers is likely during the occupational use of pesticides containing the 

APE inert ingredients. Inhalation exposure was estimated using PHED and ORETF data. The 

quantitative exposure/risk assessment developed for occupational handlers to support the 

requested exemption from the requirement of a tolerance for the APE is based on the following 

scenarios. HED notes that these scenarios were selected to represent the scenarios with the 

highest potential exposure. 

Mixer/Loader/Applicators: 

1) Mixer/Loader for aerial application- high acreage field crops (liquids) 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 39 of 85 

2) Mixer/Loader for airblast application- tree nuts crops (both liquid and wettable 

powder) 

3) Mixer/Loader for groundboom application- high acreage field crops and turf (liquids 

and wettable powder) 

4) Applicators for aerial application- high acreage field crops (liquid) 

5) Applicators for airblast- tree nut crops 

6) Applicators for groundboom- high acreage field crops and turf 

7) Mixer/Loader/Applicator- low pressure handwand (liquids and wettable powders)* 

8) High pressure handwand- greenhouse (wettable powders) 

9) Flagging- high acreage field crops (liquids) 

* Uses ORETF unit exposure data. All others use PHED data. 

Risk estimates were calculated using the Margin of Exposure (MOE) which is a ratio of the 

toxicological PoD to the daily dose. Daily dose values are calculated by first calculating 

exposures by considering application parameters (i.e., rate and area treated) along with unit 

exposures. Exposures are then normalized by body weight to calculate dose levels. Inhalation 

short- and intermediate-term exposure is compared to the inhalation PoD of 100 mg/kg/day 

(same PoD for short- and intermediate-term exposure durations). No dermal endpoint was 

selected from the hazard database for APE; therefore quantitative dermal exposure assessment 

was not assessed. To assess handler risks, the Agency used surrogate unit exposure data from 

the Pesticide Handlers Exposure Database (PHED), and ORETF data. 

The following assumptions and factors were used in order to complete the exposure and risk 

assessment for occupational handlers/applicators: 

• All worker scenarios were assumed to be short- and intermediate-term in exposure 

durations (i.e., 1-30 days and 1-6 months) except the greenhouse/hothouse scenario. 

• For scenarios where greenhouse/hothouse applications are possible, long-term exposure 

(6+ months) was assessed. The greenhouse/hothouse scenarios are the non-turf 

"ornamental" scenarios in Tables 8.1.1, 8.1.2, and 8.1.3 

• The exposure assessment assumes an 8 hour work day. 

• The maximum application rate per pesticide group (herbicide/insecticide/fungicide) has 

been assessed for the short-term exposure duration. 

• The average application rate per pesticide group (herbicide/insecticide/fungicide) has 

been assessed for the intermediate-term exposure duration. 

• A body weight of 70 kg was assumed because the relevant toxicological PoDs were not 

gender specific. 

• The baseline clothing level for occupational exposure scenarios is considered to be an 

individual wearing long pants, a long-sleeved shirt, shoes, socks, no chemical-resistant 

gloves, and no respiratory protection. 

• The upper bound to the amount of APE inert in the pesticide products is 7%. Therefore, 

the occupational exposure assessment assumes 7% APE in any pesticidal product 

formulation 

Risk Characterization:

HED initially assessed handler exposure and risks for the APE inerts in fungicides, herbicides 

and insecticides at baseline PPE (long pants, a long-sleeved shirt, shoes, socks, no chemical-
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 40 of 85 

resistant gloves, and no respiratory protection) which HED considers to be standard agricultural 

worker clothing. 

When handlers are wearing standard worker clothing (i.e., baseline PPE and no respiratory 

protection) no occupational handler scenario indicates a risk of concern. 

For the mixer/loader/applicator scenarios described in the occupational handler tables (below), 

the ORETF handler studies have no data for baseline dermal exposure because the handlers in 

the study wore gloves and no respiratory protection. HED believes baseline exposure is relevant 

to assess for these exposure scenarios (i.e., baseline dermal PPE and no respiratory protection). 

Therefore, both ORETF and PHED scenarios are shown in the mixer/loader/applicator section of 

the occupational handler tables. Baseline inhalation MOEs are reported “as is” because ORETF 

study participants did not wear respiratory protection. Additional explanation of the ORETF 

studies is available in “JITF Inert Ingredients. Residential and Occupational Exposure 

Assessment Algorithms and Assumptions Appendix for the Human Health Risk Assessments to 

Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert 

Ingredients in Pesticide Formulations”, D364751,” 5/7/09.

Table 8.1.1. Exposure and Risks for Occupational Handlers of APE in Herbicide Products (All 

Exposure Durations) at Baseline Dermal PPE

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total 

MOE8

Mixer/Loader Scenarios 

Liquids/ Aerial 

Application/ High Acreage 

Crops (ST) 

0.728 NA 0.015 NA 10,000 NA 

Liquids/ Aerial 

Application/ High Acreage 

Crops (IT) 

0.14 

1200 

NA 0.0029 NA 52,000 NA 

Liquids/ Airblast/ Nut Tree 

(ST) 0.504 NA 0.00035 NA 430,000 NA 

Liquids/ Airblast/ Nut Tree 

(IT) 0.224 

40 

NA 0.00015 NA 980,000 NA 

Liquids/ Groundboom/ 

High Acreage Crops (ST) 0.728 NA 0.0025 NA 60,000 NA 

Liquids/ Groundboom/ 

High Acreage Crops (IT) 0.14 

200 

NA 0.00048 NA 310,000 NA 

Liquids/ Groundboom/ 

Turf (ST) 0.728 NA 0.0005 NA 300,000 NA 

Liquids/ Groundboom/ 

Turf (IT) 0.14 

40 

NA 0.0001 NA 1,600,000 NA 

Liquids/ Low Pressure 

Handwand/ Turf (ST) 0.504 NA 0.00004 NA 3,500,000 NA 

Liquids/ Low Pressure 

Handwand/ Turf (IT) 0.504 

5 

2.9 1.2 

NA 0.00004 NA 3,500,000 NA 

Wettable Powder/ Airblast/ 

Nut Tree (ST) 0.112 NA 0.00275 NA 55,000 NA 

Wettable Powder/ Airblast/ 

Nut Tree (IT) 0.112 

40 

NA 0.00275 NA 55,000 NA 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (ST) 

0.112 NA 0.01376 NA 11,000 NA 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (IT) 

0.07 

200 

NA 0.0086 NA 17,000 NA 

Wettable Powder/ 

Groundboom/ Turf (ST) 0.112 NA 0.00275 NA 55,000 NA 

Wettable Powder/ 

Groundboom/ Turf (IT) 0.07 

40 

3.7 43 

NA 0.00172 NA 87,000 NA 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 41 of 85 

Table 8.1.1. Exposure and Risks for Occupational Handlers of APE in Herbicide Products (All 

Exposure Durations) at Baseline Dermal PPE

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total 

MOE8

Wettable powder/ Low 

Pressure Handwand/ Turf 

(ST) 

0.504 NA 0.00155 NA 97,000 NA 

Wettable powder/ Low 

Pressure Handwand/ Turf 

(IT) 

0.504 

5 

NA 0.00155 NA 97,000 NA 

Applicator Scenarios 

Liquid/ Aerial Application/ 

High Acreage Crops (ST)9 0.728 NA 0.0008 NA 180,000 NA 

Liquid/ Aerial Application/ 

High Acreage Crops (IT)9 0.14 

1200 

Eng 

control 

only: 

0.0055 

Eng 

control 

only: 

0.068 NA 0.0002 NA 920,000 NA 

Airblast/ Nut Tree (ST) 0.112 NA 0.00029 NA 520,000 NA 

Airblast/ Nut Tree (IT) 0.112 40 0.36 4.5 NA 0.00029 NA 520,000 NA 

Groundboom/ High 

Acreage Crops (ST) 0.728 NA 0.0015 NA 97,000 NA 

Groundboom/ High 

Acreage Crops (IT) 0.14 

200 

NA 0.0003 NA 510,000 NA 

Groundboom/ Turf (ST) 0.728 NA 0.00031 NA 490,000 NA 

Groundboom/ Turf (IT) 0.14 40 

0.014 0.74 

NA 0.00006 NA 2,500,000 NA 

Mixer/Loader/Applicator Scenarios 

Low Pressure Handwand/ 

Turf (ORETF data) (ST)10 0.504 NA 0.00024 NA 630,000 NA 

Low Pressure Handwand/ 

Turf (ORETF data) (IT)10 0.504 

5 No 

Data 6.6 

NA 0.00024 NA 630,000 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (ST)10 0.504 NA 0.0396 NA 3,800 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (IT)10 0.504 NA 0.0396 NA 3,800 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (LT)10 0.504 

5 No 

Data 1100 

NA 0.0396 NA 3,800 NA 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(ST) 

0.504 NA 0.0011 NA 140,000 NA 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(IT) 

0.504 NA 0.0011 NA 140,000 NA 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(LT) 

0.504 

5 100 30 

NA 0.0011 NA 140,000 NA 

Flagger Scenarios 

Liquid/ Flagger/ High 

Acreage Crops (ST) 0.728 NA 0.0044 NA 180,000 NA 

Liquid/ Flagger/ High 

Acreage Crops (IT) 0.14 

1200 0.011 0.35 

NA 0.00084 NA 34,000 NA 1

Application rates are based on maximum application rates of products containing inerts in APE multiplied by 7% to convert to 

application rate of just inert in a product (Pesticide products assumed to contain a maximum of 7% inert APE). Application rates 

for Short-term (ST) exposure risk estimates are based on maximum application rates. Application rates for Intermediate-term 

(IT) and long-term (LT) exposures are based on average application rates. Baseline Dermal PPE is single layer clothing, no 

gloves. 

2

Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of 

concern. 

3

Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess baseline dermal PPE plus baseline inhalation exposure except for aerial applicator scenarios, which assess 

inhalation and dermal exposures with engineering controls. 4

Daily Dermal Dose = NA 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 42 of 85 

6 Dermal MOE = NA 

7

ST Inhalation MOE = PoD (NOAEL of 150 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

Total Combined MOE = NA; no quantitative dermal exposure assessment 9

Aerial applicators do not have baseline exposure: only engineering control exposure can be assessed. 10These scenarios have baseline inhalation unit exposures, but not baseline dermal unit exposures. The M/L/A scenario assessed 

has a higher unit exposure at baseline dermal exposure than either of the two scenarios shown at baseline PPE plus gloves dermal 

exposure. 

Table 8.1.2. Exposure and Risks for Occupational Handlers of APE in Insecticide Products (All 

Exposure Durations) at Baseline Dermal PPE

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total 

MOE8

Mixer/Loader Scenarios 

Liquids/ Aerial 

Application/ High 

Acreage Crops (ST) 

0.14 NA 0.00288 NA 52,000 NA 

Liquids/ Aerial 

Application/ High 

Acreage Crops (IT) 

0.049 

1200 

NA 0.001 NA 150,000 NA 

Liquids/ Airblast/ Nut 

Tree (ST) 0.63 NA 0.00043 NA 350,000 NA 

Liquids/ Airblast/ Nut 

Tree (IT) 0.175 

40 

NA 0.00012 NA 1,300,000 NA 

Liquids/ Groundboom/ 

High Acreage Crops (ST) 0.14 NA 0.00048 NA 310,000 NA 

Liquids/ Groundboom/ 

High Acreage Crops (IT) 0.049 

200 

NA 0.00017 NA 890,000 NA 

Liquids/ Groundboom/ 

Turf (ST) 0.14 NA 0.0001 NA 1,600,000 NA 

Liquids/ Groundboom/ 

Turf (IT) 0.049 

40 

NA 0.00003 NA 4,500,000 NA 

Liquids/ Low Pressure 

Handwand/ Turf (ST) 0.504 NA 0.00004 NA 3,500,000 NA 

Liquids/ Low Pressure 

Handwand/ Turf (IT) 0.504 

5 

2.9 1.2 

NA 0.00004 NA 3,500,000 NA 

Wettable Powder/ 

Airblast/ Nut Tree (ST) 0.42 NA 0.0103 NA 15,000 NA 

Wettable Powder/ 

Airblast/ Nut Tree (IT) 0.21 

40 

NA 0.0052 NA 29,000 NA 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (ST) 

0.112 NA 0.0138 NA 11,000 NA 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (IT) 

0.049 

200 

NA 0.006 NA 25,000 NA 

Wettable Powder/ 

Groundboom/ Turf (ST) 0.112 NA 0.0023 NA 55,000 NA 

Wettable Powder/ 

Groundboom/ Turf (IT) 0.049 

40 

NA 0.0012 NA 120,000 NA 

Wettable powder/ Low 

Pressure Handwand/ Turf 

(ST) 

0.504 NA 0.0016 NA 97,000 NA 

Wettable powder/ Low 

Pressure Handwand/ Turf 

(IT) 

0.504 

5 

3.7 43 

NA 0.0016 NA 97,000 NA 

Applicator Scenarios 

Liquid/ Aerial 

Application/ High 

Acreage Crops (ST)9 0.14 NA 0.0002 NA 920,000 NA 

Liquid/ Aerial 

Application/ High 

Acreage Crops (IT)9 0.049 

1200 

Eng 

control 

only: 

0.0055 

Eng 

control 

only: 

0.068 NA 0.0001 NA 2,600,000 NA 

Airblast/ Nut Tree (ST) 0.63 NA 0.0016 NA 93,000 NA 

Airblast/ Nut Tree (IT) 0.175 40 0.36 4.5 NA 0.00045 NA 330,000 NA 

Groundboom/ High 

Acreage Crops (ST) 0.14 200 0.014 0.74 NA 0.0003 NA 510,000 NA 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 43 of 85 

Table 8.1.2. Exposure and Risks for Occupational Handlers of APE in Insecticide Products (All 

Exposure Durations) at Baseline Dermal PPE

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total 

MOE8

Groundboom/ High 

Acreage Crops (IT) 0.049 NA 0.0001 NA 1,400,000 NA 

Groundboom/ Turf (ST) 0.14 NA 0.00006 NA 2,500,000 NA 

Groundboom/ Turf (IT) 0.049 40 NA 0.00002 NA 7,200,000 NA 

Mixer/Loader/Applicator Scenarios 

Low Pressure Handwand/ 

Turf (ORETF data) (ST)10 0.504 NA 0.00024 NA 630,000 NA 

Low Pressure Handwand/ 

Turf (ORETF data) (IT)10 0.504 

5 NA 6.6 

NA 0.00024 NA 630,000 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (ST)10 0.504 NA 0.0396 NA 3,800 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (IT)10 0.504 NA 0.0396 NA 3,800 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (LT)10 0.504 

5 NA 1100 

NA 0.0396 NA 3,800 NA 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(ST) 

0.504 NA 0.0011 NA 140,000 NA 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(IT) 

0.504 NA 0.0011 NA 140,000 NA 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(LT) 

0.504 

5 100 30 

NA 0.0011 NA 140,000 NA 

Flagger Scenarios 

Liquid/ Flagger/ High 

Acreage Crops (ST) 0.14 NA 0.00084 NA 180,000 NA 

Liquid/ Flagger/ High 

Acreage Crops (IT) 0.049 

1200 0.011 0.35 

NA 0.00029 NA 510,000 NA 1

Application rates are based on maximum application rates of products containing inerts in APE multiplied by 7% to convert to 

application rate of just inert in a product (Pesticide products assumed to contain a maximum of 7% inert APE). Application rates 

for Short-term (ST) exposure risk estimates are based on maximum application rates. Application rates for Intermediate-term 

(IT) and long-term (LT) exposures are based on average application rates. Baseline Dermal PPE is single layer clothing, no 

gloves. 

2

Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of 

concern. 

3

Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess baseline dermal PPE plus baseline inhalation exposure except for aerial applicator scenarios, which assess 

inhalation and dermal exposures with engineering controls. 4

Daily Dermal Dose = NA 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 

6 Dermal MOE = NA 

7

ST Inhalation MOE = PoD (NOAEL of 150 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

Total Combined MOE = NA; no quantitative dermal exposure assessment 

9

Aerial applicators do not have baseline exposure: only engineering control exposure can be assessed. 10These scenarios have baseline inhalation unit exposures, but not baseline dermal unit exposures. The M/L/A scenario assessed 

has a higher unit exposure at baseline dermal exposure than either of the two scenarios shown at baseline PPE plus gloves dermal 

exposure. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 44 of 85 

Table 8.1.3. Exposure and Risks for Occupational Handlers of APE in Fungicide Products (All 

Exposure Durations) at Baseline Dermal PPE

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total MOE8

Mixer/Loader Scenarios 

Liquids/ Aerial 

Application/ High 

Acreage Crops (ST) 

0.35 NA 0.0072 NA 21,000 NA 

Liquids/ Aerial 

Application/ High 

Acreage Crops (IT) 

0.049 

1200 

NA 0.001 NA 150,000 NA 

Liquids/ Airblast/ Nut 

Tree (ST) 0.77 NA 0.00053 NA 280,000 NA 

Liquids/ Airblast/ Nut 

Tree (IT) 0.21 

40 

NA 0.00014 NA 1,000,000 NA 

Liquids/ Groundboom/ 

High Acreage Crops (ST) 0.35 NA 0.0012 NA 130,000 NA 

Liquids/ Groundboom/ 

High Acreage Crops (IT) 0.049 

200 

NA 0.00017 NA 890,000 NA 

Liquids/ Groundboom/ 

Turf (ST) 0.35 NA 0.00024 NA 630,000 NA 

Liquids/ Groundboom/ 

Turf (IT) 0.049 

40 

NA 0.00003 NA 4,500,000 NA 

Liquids/ Low Pressure 

Handwand/ Turf (ST) 0.504 NA 0.00004 NA 3,500,000 NA 

Liquids/ Low Pressure 

Handwand/ Turf (IT) 0.504 

5 

2.9 1.2 

NA 0.00004 NA 3,500,000 NA 

Wettable Powder/ 

Airblast/ Nut Tree (ST) 0.49 NA 0.012 NA 12,000 NA 

Wettable Powder/ 

Airblast/ Nut Tree (IT) 0.14 

40 

NA 0.0034 NA 44,000 NA 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (ST) 

0.07 NA 0.0086 NA 1,7000 NA 

Wettable Powder/ 

Groundboom/ High 

Acreage Crops (IT) 

0.042 

200 

NA 0.0052 NA 29,000 NA 

Wettable Powder/ 

Groundboom/ Turf (ST) 0.07 NA 0.0017 NA 87,000 NA 

Wettable Powder/ 

Groundboom/ Turf (IT) 0.042 

40 

NA 0.00103 NA 150,000 NA 

Wettable powder/ Low 

Pressure Handwand/ Turf 

(ST) 

0.504 NA 0.0016 NA 97,000 NA 

Wettable powder/ Low 

Pressure Handwand/ Turf 

(IT) 

0.504 

5 

3.7 43 

NA 0.0016 NA 97,000 NA 

Applicator Scenarios 

Liquid/ Aerial 

Application/ High 

Acreage Crops (ST)9 0.35 NA 0.0004 NA 370,000 NA 

Liquid/ Aerial 

Application/ High 

Acreage Crops (IT)9 0.049 

1200 

Eng 

control 

only: 

0.0055 

Eng 

control 

only: 

0.068 NA 0.0001 NA 2,600,000 NA 

Airblast/ Nut Tree (ST) 0.49 NA 0.0013 NA 120,000 NA 

Airblast/ Nut Tree (IT) 0.21 40 0.36 4.5 NA 0.00054 NA 280,000 NA 

Groundboom/ High 

Acreage Crops (ST) 0.35 NA 0.00074 NA 200,000 NA 

Groundboom/ High 

Acreage Crops (IT) 0.049 

200 

NA 0.0001 NA 1,400,000 NA 

Groundboom/ Turf (ST) 0.35 NA 0.00015 NA 1,000,000 NA 

Groundboom/ Turf (IT) 0.049 40 

0.014 0.74 

NA 0.00002 NA 7,200,000 NA 

Mixer/Loader/Applicator Scenarios 

Low Pressure Handwand/ 

Turf (ORETF data) (ST)10 0.504 NA 0.00024 NA 630,000 NA 

Low Pressure Handwand/ 0.504 

5 No 

Data 6.6 

NA 0.00024 NA 630,000 NA 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 45 of 85 

Table 8.1.3. Exposure and Risks for Occupational Handlers of APE in Fungicide Products (All 

Exposure Durations) at Baseline Dermal PPE

Exposure Scenario 

(Formulation/ 

Application/ Crop) 

Application 

Rate1 (lb 

inert/ A) 

Area 

Treated 

Daily2 

(acres) 

Dermal 

Unit 

Exposure 

(mg/lb 

inert)3

Inhalation 

Unit 

Exposure 

(ug/ lb 

inert)3

Baseline 

Dermal 

Dose 

(mg/kg 

/day)4

Baseline 

Inhalation 

Dose 

(mg/kg/ 

day)5

Baseline 

Dermal 

MOE6

Baseline 

Inhalation 

MOE7

Total MOE8

Turf (ORETF data) (IT)10

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (ST)10 0.504 NA 0.0396 NA 3,800 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (IT)10 0.504 NA 0.0396 NA 3,800 NA 

Wettable Powder/ Low 

Pressure Handwand/ 

Ornamentals (LT)10 0.504 

5 No 

Data 1100 

NA 0.0396 NA 3,800 NA 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(ST) 

0.504 NA 0.001 NA 140,000 NA 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(IT) 

0.504 NA 0.001 NA 140,000 NA 

Liquid/ Low Pressure 

Handwand/ Ornamentals 

(LT) 

0.504 

5 100 30 

NA 0.001 NA 140,000 NA 

Flagger Scenarios 

Liquid/ Flagger/ High 

Acreage Crops (ST) 0.35 NA 0.0021 NA 71,000 NA 

Liquid/ Flagger/ High 

Acreage Crops (IT) 0.049 

1200 0.011 0.35 

NA 0.00029 NA 510,000 NA 1

Application rates are based on maximum application rates of products containing inerts in APE multiplied by 7% to convert to 

application rate of just inert in a product (Pesticide products assumed to contain a maximum of 7% inert APE). Application rates 

for Short-term (ST) exposure risk estimates are based on maximum application rates. Application rates for Intermediate-term 

(IT) and long-term (LT) exposures are based on average application rates. Baseline Dermal PPE is single layer clothing, no 

gloves. 

2

Area treated daily values are from the EPA HED estimates of acreage treated in a single day for each exposure scenario of 

concern. 

3

Unit Exposure values are reported in PHED Surrogate Exposure Guide dated August 1998 or from ORETF data. All exposure 

scenarios assess baseline dermal PPE plus baseline inhalation exposure except for aerial applicator scenarios, which assess 

inhalation and dermal exposures with engineering controls. 4

Daily Dermal Dose = NA 

5

 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate

(lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg) 

6 Dermal MOE = NA 

7

ST Inhalation MOE = PoD (NOAEL of 150 mg/kg/day) / Daily inhalation dose (mg/kg/day) 8

Total Combined MOE = NA; no quantitative dermal exposure assessment 9

Aerial applicators do not have baseline exposure: only engineering control exposure can be assessed. 10These scenarios have baseline inhalation unit exposures, but not baseline dermal unit exposures. The M/L/A scenario assessed 

has a higher unit exposure at baseline dermal exposure than either of the two scenarios shown at baseline PPE plus gloves dermal 

exposure. 

8.2 Occupational Postapplication Risk 

HED uses the term postapplication to describe exposures that occur when individuals are present 

in an occupational environment that has been previously treated with a pesticide (also referred to 

as re-entry exposure). Such exposures may occur when workers enter previously treated areas to 

perform job functions, including activities related to crop production, such as scouting for pests 

or harvesting. Postapplication exposure levels vary over time and depend on such things as the 

type of activity, the nature of the crop or target that was treated, the type of pesticide application, 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 46 of 85 

and the chemical’s degradation properties. In addition, the timing of pesticide applications, 

relative to harvest activities, can greatly reduce the potential for postapplication exposure. 

Inhalation exposures are not typically calculated for postapplication scenarios because inhalation 

exposures generally account for a negligible percentage of the overall body burden for most 

pesticide chemicals. This is particularly true for chemicals with a low vapor pressure such as the 

APEs (1.79E-011 to 5.55E-43 mmHg at 25°C). The exposures typically considered for 

occupational post-application workers result from dermal contact with treated plants which 

occurs as workers engage in various job tasks such as harvesting. Occupational postapplication 

exposures were not assessed for the APEs because no dermal hazard was identified. 

9.0 Environmental Justice 

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

human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions 

to Address Environmental Justice in Minority Populations and Low-Income Populations," 

http://www.eh.doe.gov/oepa/guidance/justice/eo12898.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 

postapplication 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. 

10.0 Human Studies 

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

intentionally exposed to a pesticide. These studies, listed below, have received the appropriate 

ethical review for use in risk assessment. 

 The PHED Task Force, 1998. The Pesticide Handler Exposure Database (PHED), 

Version 1.1. Task Force members: Health Canada, U.S. Environmental Protection 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 47 of 85 

Agency, the California Department of Pesticide regulation, and the American Crop 

Protection Association; released August 1998. 

 ORETF Handler Studies (MRID 44972201): Outdoor Residential Exposure Task 

Chemical Manufacturers Association (CMA) antimicrobial exposure study (USEPA, 

1999: DP Barcode D247642) 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 48 of 85 

APPENDIX A. Toxicity Data 

Table A.1. Acute Toxicity Profile of Alkylphenol Ethoxylates (APE) 

Guideline 

No. Study Type MRIDs # Results 

Toxicity 

Category 

81-1 Acute Oral – 

rat 

JITF Cluster 

Support Team 5, 

10/31/08 

CAS 9002-93-1 

LD50 = 500 mg/kg (males) 

II 

81-1 Acute Oral – 

rat 

JITF Cluster 

Support Team 5, 

10/31/08 

CAS 9036-19-5 

LD50 = 16000 mg/kg 

IV 

81-2 Acute 

Dermal 

JITF Cluster 

Support Team 5, 

10/31/08 

CAS 9002-93-1 

LD50 = 8000 mg/kg 

LD50 = 12,300 mg/kg 

IV 

81-2 Acute 

Dermal 

JITF Cluster 

Support Team 5, 

10/31/08 

CAS 9036-19-5 

LD50 = 4490 mg/kg 

III 

81-5 Dermal 

Irritation 

JITF Cluster 

Support Team 5, 

10/31/08 

Mild to moderate skin irritation III 

Table A.2 Acute Toxicity Profile of Octyl Phenol (OP) 

Guideline 

No. Study Type MRIDs # Results 

Toxicity 

Category 

81-1 

(OECD 

401) 

Acute Oral 

rat 

JITF Cluster 

Support Team 5, 

April 15, 2009 

CAS 140-66-9 

LD50 >2000 mg/kg 

III 

81-1 Acute 

Dermal 

rabbit 

JITF Cluster 

Support Team 5, 

April 15, 2009 

CAS 140-66-9 

LD50 = 1880 mg/kg 

II 

81-3 Acute 

Inhalation rat 

JITF Cluster 

Support Team 5, 

April 15, 2009 

CAS 140-66-9 

LC100 (24 hrs) ≤ 116 mg/L 

IV 

81-4 Eye Irritation JITF Cluster 

Support Team 5, 

April 15, 2009 

Severe eye irritation I 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 49 of 85 

Table A.2 Acute Toxicity Profile of Octyl Phenol (OP) 

Guideline 

No. Study Type MRIDs # Results 

Toxicity 

Category 

81-5 Dermal 

Irritation 

JITF Cluster 

Support Team 5, 

April 15, 2009 

Mild skin irritation IV 

Table A.3. Toxicology Profile of the Alkylphenol Ethoxylates (APE) 

Guideline No./ Study 

Type

MRID No. (year)/ 

Classification /Doses Results

OECD 422 

ReproductionDevelopmental 

Screen in rats (MRID 

47585801) 

Octylphenoxy 

poly(ethyleneoxy)ethanol, 

branched 

CAS 9002-93-1

MRID 47585801 (2008) 

0, 50, 150, 300 mg/kg/day 

(Purity 99.5%) 

Acceptable/guideline 

Parental NOAEL= 150 mg/kg/day 

Parental LOAEL = 300 mg/kg/day, based on clinical signs 

(pushing head through bedding after dosing), decreased 

body-weight gain in both sexes during the premating 

period, decreased thymus weight in females, increased liver 

weight in males, and increased incidence of centrilobular 

hepatocyte hypertrophy in males 

Developmental toxicity NOAEL = 150 mg/kg/day 

Developmental toxicity LOAEL = 300 mg/kg/day based on 

decreased pup weight in both sexes. 

Reproductive toxicity NOAEL = 300 mg/kg/day 

Rat Developmental Study 

(GD 6-17) 

Octylphenoxy 

poly(ethyleneoxy)ethanol, 

branched 

CAS 9002-93-1

Hazelden, KP and Wilson, JA 

(1986). 

0.06 or 0.3% in diet 

(70 and 340 mg/kg/day) 

 

NOAEL= 70 mg/kg/day 

LOAEL- 340 mg/kg/day, based on skeletal abnormalities in 

pups (supernumerary ribs and enhanced ossification) 

Table A.4. Toxicology Profile for the Octylphenol (OP)

Guideline No./ Study 

Type

MRID No. (year)/ Classification 

/Doses Results
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 50 of 85 

Table A.4. Toxicology Profile for the Octylphenol (OP)

Guideline No./ Study 

Type

MRID No. (year)/ Classification 

/Doses Results

870.3800 2-generation 

reproduction study – 

rat 

Octylphenol 

CAS 140-66-9

Tyl, et al. (1999) 

Regul. Toxicol. Pharmacol. 30, 81-

95. 

Purity: 90.2% 

0, 0.2, 20, 200, or 2000 ppm 

ranges: OP intake, depending on 

age and sex 

0.2 ppm = 0.011-0.034 mg/kg/day 

20 ppm = 1.05-3.3 mg/kg/day 

200 ppm = 10.9-32.6 mg/kg/day 

2000 ppm = 111-369 mg/kg/day 

Systemic/postnatal toxicity NOAEL = 10 

mg/kg/day 

Systemic/postnatal toxicity LOAEL = 111 

mg/kg/day, based on decreased body weights in 

adults and during the latter portion of lactation in 

offspring and minor delays in acquisition of vaginal 

opening and preputial separation. 

Reproductive toxicity NOAEL = 111 mg/kg/day 

No effects on reproductive parameters, testes, 

prostate, or ovary weights or morphology, on 

sperm counts, motility, morphology, production, or 

on estrous cyclicity; 

Non-guideline 

4-tert-octylphenol 

maintenance of 

pregnancy rats. 

Harazono, A and Ema, M (2001). 

Toxicology Letters 119: 79-84. 

Dams dosed on GD 0-8 (sacrificed 

on GD 20) 

0, 15.6, 31.3, 62.5, 125 mg/kg/day 

gavage (olive oil) 

NOAEL = 15.6 mg/kg/day 

LOAEL = 31.3 mg/kg/day, based on increased 

incidence of post-implantation loss, decreased 

BWG and FC 

pregnancy rate not affected 

Non-guideline 

p-octylphenol 

Nagao, T; Yishimura, S; Saito, Y; 

et al. (2001). Reproductive 

Toxicology 15: 683-692. 

 (96%) 

12.5, 25, 50, 100 mg/kg/day PND 

1-5 gavage (corn oil) 

NOAEL = 25 mg/kg/day, based on 

LOAEL = 50 mg/kg/day, based on slight delays in 

acquisition of puberty in males and females, slight 

↓ BW; ↓ viability; deaths during PND 1-6: 2 ♀ 50 

mg/kg/day; 5 ♀/6 ♂ 100 mg/kg/day; no deaths in 

control , 12.5 and 25 mg/kg/day 

 no dysfunction of reproductive performance 

(mating, fertility) in male or female; no disruption 

of development or reproductive tract @ 100 

mg/kg/day 

Non-guideline 

4-tert-octylphenol 

female prepubertal 

rats dosed on days 21-

35 and monitored daily 

for vaginal opening, 

evaluation of estrous 

cyclicity 

3-day uterotrophic 

assay 

Laws, et al. (2000). Toxicological 

Sciences 54, 154-167. 

(97%) 

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

gavage (corn oil) 

0, 50, 100, 200, 400 mg/kg/day 

once/day for 3 days (oral gavage or 

sc) 

↑ uterine wt @ 100-400 mg/kg/day (both groups) 

vaginal opening accelerated by about 3.2 days @ 

200 mg/kg/day 

decreased # of 4- and 5-day cycles @ 200 

mg/kg/day 

increased # days in diestrus @ 200 mg/kg/day 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 51 of 85 

Table A.5. Octylphenol Mutagenicity Studies 

Study Type Citation/Year/Doses Results 

Ames test/Salmonella 

typhimurium TA98, TA100, 

TA1535, TA1537, TA1538/ 

no data (±S9) 

Directive 84/449/EEC (GLP) 

Huels Report # AM-91/11, 

1991 

0-5000 μg/plate 

p-octylphenol (95%) 

DMSO 

Genotoxic effect: negative

Ames test/Salmonella 

typhimurium TA98, TA100, 

TA1535, TA1537, 

±S9 

Ames, et al. Mutat Research 31: 

347-364, 1982 

 (not GLP) 

Bayer report # 11209, 1982 

EPA/OPTS Public File 

878213505; microfiche # 

0205841 

0-12500 μg/plate 

95% isooctylphenol, 

(containing 93.1% poctylphenol) 

ethanol 

Genotoxic effect: negative

Bacterial gene mutation 

study/Salmonella typhimurium 

TA98, TA100, TA1535, 

TA1537 and E.coli WP2 uvrA 

±S9 

Guidelines for Screening 

Mutagenicity Testing of 

Chemicals (Japan, 1994) 

 (GLP) 

Chemical Investigation 

Promoting Committee 

Toxicity Testing Reports of 

Environmental Chemicals, 

Volume 1, 1994. 

S. typhimurium 0, 1.56, 

3.13, 6.25, 12.5, 25, 100, 

200 μg/plate 

E. coli 0, 125, 250, 500, 

1000, 2000 μg/plate 

p-tert-octylphenol (>97%) 

vehicle: no data

Cytotoxicity: +S9: 200 μg/plate; -S9: 25 μg/plate 

Genotoxic effects: E. coli and S. typhimurium: negative ±S9

Chromosomal Aberration/ Chinese 

hamster CHL cells 

±S9 

Guidelines for Screening 

Mutagenicity Testing of Chemicals 

(Japan, 1994) 

 (GLP) 

-S9: 0, 0.004, 0.008, 0.016 

mg/mL 

+S9: 0, 0.010, 0.020, 0.040 

mg/mL 

p-tert-octylphenol (>97%) 

vehicle: no data 

Cytotoxicity: +S9: >0.04 mg/mL; -S9: >0.16 mg/mL 

Genotoxic effects: negative ±S9

His+ revertant assay with use of 

Salmonella thyphimurim TA98 

and TA100 

Standard plate incorporation: 

Maron & Ames, 1983 

Boyacioglu, M. et al., 2007. 

EU L. Fisheries & Aquatic 

Sciences 24, 299-302

10, 20, 40, 80, 160 μg/L 

octylphenol 

DMSO 

Mutagenicity observed at 40 μg/L in TA 98 strains; 20 μg/L with TA 

100 strain without metabolic activation 

in vivo genotoxic effects (rat) using 

single-cell gel electrophoresis 

(comet assay) 

Ulutas, et al., 2009 abstract – 

Toxicology Letters 1895: 557-

S273 

125, 250 mg/kg/ day (30 days) 

4-tert-octylphenol 

Tail length and tail moment found significantly different at 250 

mg/kg/day; not at 125 mg/kg/day 

study for genotoxicity in CHO-K1 

cells using sister-chromatid 

exchange (SCE), chromosome 

aberration (CA), and DNA strand 

break (comet) assays 

Tayama, S. et al., 2008. 

Mutation Research 649: 114-

125

OP: 0, 0.025, 0.05, 0.075, 

0.1, 0.125, 0.15 mM 

4-octylphenol (>97%) 

DMSO 

Octylphenol caused DNA migration in comet assay and induced high 

incidence of SCE; results suggest octylphenol causes repairable DNA 

damage, including SCEs; does not result in chromosome aberration 

(CA). 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 52 of 85 

Table A.5. Octylphenol Mutagenicity Studies 

Study Type Citation/Year/Doses Results 

Chinese hamster lung (CHL/IU) 

cells 

OECD HPV testing program 

±S9

5 mg/mL or 10 mM 

p-tert-octylphenol 

(CAS 140-66-9) 

DMSO 

Structural chromosomal aberration and polyploidy cells were not 

induced at doses manifesting 50% or less than 50% cytotoxicity (or at 

5 mg/mL or 10 mM) 

Ethoxylated Octylphenol 

Ames Salmonella Microsome 

Reverse Mutation Assay 

Tester strains TA98, TA100, 

TA1535, TA1537, TA1538 

±S9 (Aroclor-induced rat liver) 

Ames, et al., 1975 

±S9 

GLP 

Lawlor,TE, Haworth, L (1989). 

Mutagenicity Test on C-1358 

in the Ames 

Salmonella/Microsome 

Reverse Mutation Assay. 

Hazleton Laboratories 

America, Inc. Study No. 

10882-0-4-1. 

(EPA/OTS Doc# 

86960000404S)

0, 5, 10, 25, 50, 100, 150 

μL/plate 

C-1358 (mixture of 3 

components, A, B, C) 

 (deionized water) 

CAS 9036-19-5 

Caused reproducible positive increases in mean number of TA1535 

revertants per plate in both presence (3.7 and 4.4-fold) and absence 

(5.0 and 2.9-fold) of S-9 

In Vitro Cytogenicity Assay 

Measuring Chromosome 

Aberration Frequencies in 

Chinese Hamster Ovary (CHO) 

Cells. 

±S9 

GLP

Galloway, SM and Brusick, 

DJ. (1981). Mutagenicity 

Evaluation of C-213 in an In 

Vitro Cytogenicity Assay 

Measuring Chromosome 

Aberration Frequencies in 

Chinese Hamster Ovary (CHO) 

Cells. Litton Bionetics, Inc. 

Project No. 20990. 

(EPA/OTS Doc# 

86960000410S)

-S9: 0, 0.456, 0.683, 0.911, 

1.139, 1.367 μL/mL 

+S9: 0, 0.24, 0.49, 0.98, 1.46*, 

1.95* μL/mL 

(*cytotoxic) 

repeat +S: 

0.91, 1.14, 1.37, 1.60, 1.82 

μL/mL 

C-213 CAS 9036-19-5 

Caused significant increase in chromosome aberrations both with 

and without metabolic activation; considered clearly positive 

Ames Salmonella Microsome 

Reverse Mutation Assay 

Tester strains TA98, TA100, 

TA1535, TA1537, TA1538 

±S9 (Aroclor-induced rat liver) 

Ames, et al., 1975 

±S9 

GLP 

DeGraff WG and Brusick, DJ 

(1983). Mutagenicity 

Evaluation of C-445 

(Ingredients A, G, J, K, L) in 

the Ames Salmonella/ 

Microsome Plate Test. Litton 

Bionetics, Inc. Project No. 

20988. 

(EPA/OTS Doc# 

86960000419S)

0, 1, 5, 10, 25, 50, 100, 150 

μL/plate 

C-445 (ingredients A, G, J. K. 

And L); CAS 9036-19-5

Exhibited genetic activity in strains TA-1535 and TA-100 with and 

without S9 and was considered mutagenic 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 53 of 85 

Table A.5. Octylphenol Mutagenicity Studies 

Study Type Citation/Year/Doses Results 

Mouse lymphoma forward mutation 

assay (L5178Y TK+/-) 

±S9 

GLP

Cifone, MA and Myhr, BC. 

(1983). Mutagenicity 

Evaluation of C-445 in the 

Mouse Lymphoma Forward 

Mutation Assay. Litton 

Bionetics, Inc. Project No. 

20989. 

(EPA/OTS Doc# 

86960000422S) 

-S9: 0, 3.91, 7.81, 15.6, 31.3, 

62.5 nL/mL 

+S9: 0, 15.6, 31.3, 62.5, 125, 

250, 600 nL/mL 

C-445; CAS 9036-19-5 

Induced significant increases in the mutant frequency at the TK 

locus in L5178Y mouse lymphoma cells; considered active in the 

mouse lymphoma forward mutation assay with and without 

metabolic activation 

Ames Salmonella Microsome 

Reverse Mutation Assay 

Tester strains TA98, TA100, 

TA1535, TA1537, TA1538 

±S9 (Aroclor-induced rat liver) 

Ames, et al., 1975 

±S9 

GLP 

Lawlor,TE, Valentine, DC. 

(1989). Mutagenicity Test on 

C-1358 in the Ames 

Salmonella/Microsome 

Reverse Mutation Assay. 

Hazleton Laboratories 

America, Inc. Study No. 

10985-0-401. 

(EPA/OTS Doc# 

86960000420S) 

0, 1, 5, 10, 25, 50, 100, 150 

μL/plate 

C-1008; CAS 9036-19-5 

Did not cause a positive increase in the number of histidine 

revertants per plate of any of the tester strains with or without S9 

Ames Salmonella Microsome 

Reverse Mutation Assay 

Tester strains TA98, TA100, 

TA1535, TA1537, TA1538 

±S9 (Aroclor-induced rat liver) 

Ames, et al., 1975 

±S9 

GLP

Jagannath, DR and Myhr, BC 

(1986). Mutagenicity 

Evaluation of C-1008 Batch 

No. 26050 in the Ames 

Salmonella/Microsome 

Reverse Mutation Assay. 

Hazleton Laboratories 

America, Inc. Project No. 

20988. 

(EPA/OTS Doc# 

86960000415S) 

0, 1, 5, 10, 25, 50, 100, 150 

μL/plate 

C-233; CAS 9036-19-5 

Did not exhibit mutagenic activity in these assays (±S9) 

Ames Salmonella Microsome 

Reverse Mutation Assay 

Tester strains TA98, TA100, 

TA1535, TA1537, TA1538 

±S9 (Aroclor-induced rat liver) 

Ames, et al., 1975 

±S9 

Jagannath, DR and Brusick, DJ 

(1981). Mutagenicity 

Evaluation of C-233 in the 

Ames Salmonella/ 

Microsome Reverse Mutation 

Assay. Litton Bionetics, Inc. 

Project No. 20988. 

(EPA/OTS Doc# 

86960000414S) 

0, 1, 5, 10, 25, 50, 100, 150 

μL/plate 

C-233; CAS 9036-19-5 

Did not exhibit mutagenic activity in these assays (±S9) 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 54 of 85 

Table A.5. Octylphenol Mutagenicity Studies 

Study Type Citation/Year/Doses Results 

Ames Salmonella Microsome 

Reverse Mutation Assay 

Tester strains TA98, TA100, 

TA1535, TA1537, TA1538 

±S9 (Aroclor-induced rat liver) 

Ames, et al., 1975 

±S9 

DeGraff WG and Brusick, DJ 

(1983). Mutagenicity 

Evaluation of C-449 in the 

Ames Salmonella/ Microsome 

Spot Test. Litton Bionetics, 

Inc. Project No. 20988. 

(EPA/OTS Doc# 

86960000421S) 

One 5 cm strand of test 

material /plate 

C-449 (glossy white fibers) 

CAS 9036-19-5 

Did not exhibit mutagenic activity in these assays (±S9) 

in vitro HeLa cell assay MSDS/JITF CST 5 

21mg/L CAS 9002-93-1 

Positive in an in vitro HeLa cell assay at 20 mg/L; 

 

Table A.6 Acute Toxicity Profile of Nonylphenol Ethoxylate (NPE) Phosphate and Sulfate Derivatives - CST 9

Guideline No. Study Type MRIDs # Results

Toxicity 

Category

81-1 Acute Oral – rat No MRID NPE phosphates 

CAS 68412-53-3 (ester, branched) 

LD50 = 4450 mg/kg 

CAS 68954-84-7 (Na salt, 

branched) 

LD50 = 5.7 mL/kg (5700 mg/kg) 

CAS 68584-47-4 (K salt, 

branched) 

LD50 > 4000 mg/kg 

CAS 51811-79-1 (linear NPE 

phosphate) 

LD50 >500-5000 mg/kg 

III 

IV 

III 

III 

81-1 Acute Oral – rat No MRID NPE sulfates 

CAS 9014-90-8 (linear Na salt) 

LD50 = 10000 mg/kg 

CAS 68649-55-8 (branched 

ammonium salt) 

LD50 = 29328 mg/kg 

IV 

IV 

81-2 Acute Dermal -rabbit No MRID CAS 68649-55-8 (branched 

ammonium salt) 

LD50 = 4400 mg/kg III 

81-3 Acute Inhalation - rat No data 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 55 of 85 

Table A.6 Acute Toxicity Profile of Nonylphenol Ethoxylate (NPE) Phosphate and Sulfate Derivatives - CST 9

Guideline No. Study Type MRIDs # Results

Toxicity 

Category

81-4 Primary Eye Irritation 

Rabbit 

No MRID CAS 68412-53-3 (ester, branched) 

Severely irritating 

CAS 68954-84-7 (Na salt, 

branched) 

Severely irritating 

CAS 68584-47-4 (K salt, 

branched) 

Severe eye irritant 

CAS 51811-79-1 (linear NPE 

phosphate) 

Severely irritating 

CAS 68649-55-8 (branched 

ammonium salt) 

Severely irritating 

I 

I 

I 

I 

I 

81-5 Primary Skin 

Irritation – rabbit 

No MRID CAS 68412-53-3 (ester, branched) 

corrosive 

CAS 68954-84-7 (Na salt, 

branched) 

Severely irritating 

CAS 68584-47-4 (K salt, 

branched) 

Skin irritant 

CAS 68649-55-8 (branched 

ammonium salt) 

Severely irritating 

I 

I 

I 

I 

81-6 Dermal Sensitization No data 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 56 of 85 

Table A.7: Toxicology Profile of Nonylphenol Ethoxylate (NPE) Phosphate and Sulfate Derivatives - CST 9

Guideline No./ Study Type MRID No. (year)/ 

Classification /Doses

Results

OECD 422 (870.3650) 

Combined repeated dose 

toxicity study w/ a 

reproduction/developmental 

toxicity screening test - rats 

[HanRcc:WIST (SPF)] 

MRID 47603701 (2008) 

0, 100, 300 or 1000 mg/kg 

bw/day (actual doses: 0, 132, 

396 and 1321 mg/kg/day due 

to the misapplication of a 

correction factor of 1.39) 

(gavage) 

95% inert 

males dosed for 28 days (14 

days premating/14 days post 

mating); females dosed for 14 

days prior to mating, through 

gestation until offspring 

reached PND 4 

CAS 68412-53-3 

(polyoxyethylene 

nonylphenyl ether, 

branched, phosphate 

Acceptable/guideline 

Parental systemic NOAEL = 100 mg/kg/day. 

Parental systemic LOAEL = 300 mg/kg/day, based on clinical 

signs [pushing head through bedding (both sexes; throughout 

study), soft feces (females; mating and gestation periods)], 

decreased food consumption and decreased body weight gain in 

males and females during the pre-mating period. 

 

Developmental toxicity NOAEL = 300 mg/kg bw/day in males 

and females. 

Developmental toxicity LOAEL = 1000 mg/kg bw/day, based on 

decreased body weight and body-weight gain in the offspring 

(both sexes). 

At 1000 mg/kg/day, the viability index was decreased (93% of 

control) slightly, but the number of litters affected at 1000 

mg/kg/day was not significantly increased compared to the 

control (2 vs 1). 

Reproductive toxicity NOAEL = 1000 mg/kg/day 

OECD 422 (870.3650) 

Combined repeated dose 

toxicity study w/ a 

reproduction/developmental 

toxicity screening test - rats 

[HanRcc:WIST (SPF)] 

MRID 47693702 (2008) 

0, 100, 300, or 1000 

mg/kg/day (gavage) 

males dosed for 28 days (14 

days premating/14 days post 

mating); females dosed for 14 

days prior to mating, through 

gestation until offspring 

reached PND 4 

CAS 9014-90-8 

(sodium nonylphenol 

ethoxylate sulfate 

 (30.76% purity) 

acceptable/nonguideline 

Parental systemic NOAEL = 300 mg/kg/day. 

Parental systemic LOAEL = 1000 mg/kg/day, based on 

mortality, clinical signs (soft feces, signs of discomfort), 

decreased body weight gain, liver toxicity, and lesions in the 

nonglandular stomach in both sexes and decreased body

temperature and locomotor activity, hematologic effects, and 

kidney lesions in females. 

Developmental toxicity NOAEL = 300 mg/kg/day. 

Developmental toxicity LOAEL = 1000 mg/kg/day, based on 

a reduction in the birth index, increased post-implantation 

loss, decreased number of live pups/litter at birth, increased 

number of dead pups and litters with dead pups, decreased 

viability index, and decreased pup body weight and bodyweight gain. 

Reproductive toxicity NOAEL = 1000 mg/kg/day 

Reproductive toxicity LOAEL = not attained. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 57 of 85 

Table A.7: Toxicology Profile of Nonylphenol Ethoxylate (NPE) Phosphate and Sulfate Derivatives - CST 9

Guideline No./ Study Type MRID No. (year)/ 

Classification /Doses

Results

870.5100 

Bacterial reverse mutation 

test 

870.5100 

No MRID 

strains TA1535, TA1537, 

TA98 and TA100 of 

Salmonella typhimurium 0, 40, 

200, 1000, 5000, or 25000 

μg/plate with and without S9 

activation 

Negative without S9 all strains; negative with S9 in TA1535, TA 

1537, and TA 100; TA98, 30% revertants @ two highest doses 

with marked toxicity at highest dose 

cited in JITF Cluster 9 Support Team petition 

 

Table A.8: Toxicology Profile of Nonylphenol (CAS 25154-52-3 and 84852-15-3)

Study Type Citation (year)/Doses Results

870.3800 2-generation 

reproduction study – rat 

branched 4-nonylphenol 

CAS# 84852-15-3 

Chapin, et al. (1999). 

Toxicological Sciences 52, 80-

91. 

200, 650, 2000 ppm in diet 

(NIH-07 feed) 

F0 pairs consumed NP for 6 

weeks prior to mating 

calculated doses: 9-35; 30-

100; 100-350 mg/kg/day 

NOAEL (offspring/developmental) = 9 mg/kg/day 

LOAEL (offspring/developmental) = 30 mg/kg/day, based on 

early onset of puberty in female offspring 

NOAEL (reproductive toxicity) = 100 mg/kg/day (HDT) 

NOAEL (systemic) = not attained 

LOAEL (systemic) = 9 mg/kg/day, based on increased incidence 

of kidney lesions (tubular mineralization and dilatation, 

medullary cysts, hydronephrosis) in male rats. 

870.3800 2-generation 

reproduction study – rat 

nonylphenol 

CAS 25154-52-3 

Nagao, et al. (2001). 

Reproductive Toxicology 15, 

293-315. 

99% pure 

0, 2, 10, or 50 mg/kg/day 

gavage; corn oil 

F0 males dosed for 12 

weeks/F0 females dosed for 2 

weeks prior to mating 

Parental systemic NOAEL = 10 mg/kg/day. 

Parental systemic LOAEL = 50 mg/kg/day, based on 

increased liver, kidney, and pituitary weights in males, 

decreased thymus weight (↓24%) in males, decreased ovary

weight (↓18%) in females, increase in TSH levels (males), 

centrilobular hepatocyte hypertrophy in both sexes 

Developmental toxicity NOAEL = 10 mg/kg/day. 

Developmental toxicity LOAEL = 50 mg/kg/day, based on 

significant decreases in the # implantation sites in F1 females 

and live F2 pups/litter, vaginal opening was accelerated (F1). 

No effect on the timing of preputial separation. No adverse 

changes in behavior or learning in offspring 

@ 250 mg/kg/day, ↓testosterone, ↑ FSH, TSH, T3 (males) 

Reproductive toxicity NOAEL = 50 mg/kg/day (HDT) 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 58 of 85 

Table A.8: Toxicology Profile of Nonylphenol (CAS 25154-52-3 and 84852-15-3)

Study Type Citation (year)/Doses Results

870.3800 2-generation 

reproduction study – rat 

para-nonylphenyl 

CAS 84852-15-3 

Tyl, et al. (2006). 

Toxicological Sciences 92(1), 

295-310 

94.25% purity 

0, 20 200, 650, or 2000 ppm in 

Purina 5002 diet 

0 or 650 ppm in NIH-07 diet 

≈0, 1.5, 15, 50, 150, 

mg/kg/day 

Developmental toxicity NOAEL = 650 ppm (50 mg/kg/day). 

Developmental toxicity LOAEL = 2000 ppm (150 mg/kg/day), 

based on decreased pup body weight on PND 21 (↓16, 11, 8% in 

F1, F2, F3, respectively) and decreased absolute and relative 

ovary weight (all generations). Offspring: pup survival not 

affected (PND 4 and weaning); # live pups, sex ratio, pup BW 

PND 4 comparable among groups; PND 21 BW (litter basis) @ 

2000 ppm ↓ 16%, 11%, 8% (F1, F2, F3); male pup BW @ 

sacrifice on PND 21 18%, 12%, 9% (F1, F2, F3) 

(acquisition of VO and PPS not assessed; AGD and estrous 

cyclicity not assessed) 

Parental systemic NOAEL = 200 ppm (15 mg/kg/day). 

Parental systemic LOAEL = 650 ppm (50 mg/kg/day), based on 

increased kidney weights and kidney histopathology (medullary 

cysts, mineralization of corticomedullary junction, and tubular 

nephropathy) in males. At 2000 ppm (150 mg/kg/day), decreased 

ovarian weight (absolute and relative). 

Reproductive toxicity NOAEL = 150 mg/kg/day 

Enhanced OECD Test 

Guideline 407 (rat) 

p-nonylphenol (branched) 

CAS 84852-15-3 

Woo, et al. (2007). 

Arch. Toxicol 81: 77-88. 

oral (gavage) 10, 50, 250 

mg/kg/day for 28 days 

(olive oil) 

NOAEL = 10 mg/kg/day 

LOAEL = 50 mg/kg/day, based on increased thyroid weight 

(males), ↑LH in females 

At 250 mg/kg/day; there was an increase in days in estrus and 

irregular estrous cycling in 8/10 females; increased thyroid 

weight (females), ↑ TSH (females; atrophy of spleen and thymus 

(females) 

Non-guideline 

4-nonylphenol (mixture of 

branched side chains 

containing 85% p-isomers) 

female prepubertal rats dosed 

on days 21-35 and monitored 

daily for vaginal opening, 

evaluation of estrous cyclicity 

3-day uterotrophic assay 

Laws, et al. (2000). 

Toxicological Sciences 54, 

154-167. 

0, 25, 50, 100 mg/kg/day 

(PND 21-35) 

gavage (corn oil) 

0, 25, 50, 100, 200 mg/kg/day 

once/day for 3 days (oral 

gavage or sc) 

Accelerated timing of vaginal opening opening [1.5 days at 25 

mg/kg/day; 5.3 days at 50 mg/kg/day; 6.8 days at 100 

mg/kg/day]; decrease in # 4-5 day cycles; increased uterine 

weight at ≥50 mg/kg/day 

Non-guideline

male pubertal assay (rat) 

Tan, et al. (2003). Toxicology 

Letters 143: 261-270. 

PND 23-52/53 

corn oil gavage 

100 mg/kg/day 

body weight not affected but preputial separation age was 

delayed; 33% reached preputial separation before PND 53 

compared to 100% of controls; seminal vesicle + coagulation 

gland weight and testicular tubule diameter were significantly 

decreased; 

all control rats showed normal pattern of spermatogenic cycle, 

but 5 of 12 NP rats did not show any form of spermatogenic 

cycle; there were presence of multinucleated giant cells and 

sloughing of seminiferous epithelium and spermatogenic cells 

into the lumen of seminiferous tubule 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 59 of 85 

Table A.8: Toxicology Profile of Nonylphenol (CAS 25154-52-3 and 84852-15-3)

Study Type Citation (year)/Doses Results

Non-guideline 

3-day uterotrophic assay 

female pubertal onset assay 

p-nonyl- phenol, (mixture of 

branched side-chains 

containing a minimum of 

92% p-isomers) 

CAS# 104-40-5 

Kim, et al. (2002). 

Reproductive Toxicology 16: 

259-268. 

uterotrophic assay (sc) 

3 consecutive days (PND 20, 

21, 22) 10, 25, 50, 100, 200 

mg/kg/day 

Pubertal onset assay gavage 

10, 50, 100 mg/kg/day from 

PND 21 for 20 days 

ethanol/corn oil 

3-day uterotrophic assay: ↑ uterine weight @ 100 and 200 

mg/kg/day (dose-related); @ 200 mg/kg/day, 3.19-fold ↑ in 

uterine weight; 1.77-fold ↑ vaginal weight; ↓ovarian weight @ 

100 mg/kg/day (30%) and 200 mg/kg/day (33%) 

female pubertal onset assay: ↓ovarian and uterine weights at 100 

mg/kg/day (no effect on BW); thyroid weight ns ↑; 

VO significantly accelerated @ 50 (1.5 days) and 100 (6.7 days) 

mg/kg/day (mean BW at age of VO significantly decreased @ 

100 mg/kg/day); decreased serum T4 levels @ 100 mg/kg/day 

(↓19%), serum TSH increased (>30%); estrous cycle 

significantly affected @ 100 mg/kg/day (# days in diestrus was ↑

from VO to day 32, which was ≈the mean VO day of control 

animals) 

Non-guideline 

4-tert-octylphenol 

maintenance of pregnancy 

rats. 

Harazono, A and Ema, M 

(2001). 

Toxicology Letters 119: 79-

84. 

Dams dosed on GD 0-8 

(sacrificed on GD 20) 

0, 15.6, 31.3, 62.5, 125 

mg/kg/day 

gavage (olive oil) 

NOAEL = 15.6 mg/kg/day 

LOAEL = 31.3 mg/kg/day, based on increased 

incidence of post-implantation loss, decreased BWG and FC 

pregnancy rate not affected 

870.5900 

In Vitro Cytogenicity Assay 

for Sister Chromatid 

Exchange in Chinese 

Hamster Ovary (CHO) Cells. 

±S9 

Murli, H. and Ivett, JL. 

(1986). Mutagenic Evaluation 

of C-818 Lot #92748 in an In 

Vitro Cytogenic Assay 

Measuring Sister Chromatid 

Exchange in Chinese Hamster 

Ovary (CHO) Cells. Hazleton 

Biotechnologies. HB Project 

No. 20990. 

(EPA/OTS Doc# 

889200002872) 

0, 1, 3.33, 10, 33.3, 100 

μg/mL 

Repeat ; 0, 20, 30, 40, 50, 75 

μg/mL 

C-818 (CAS 25154-52-3) 

vehicle acetone 

Positive for inducing sister chromatid exchange in CHO cells 

without S9; negative with S9 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 60 of 85 

Table A.8: Toxicology Profile of Nonylphenol (CAS 25154-52-3 and 84852-15-3)

Study Type Citation (year)/Doses Results

870.5300 

Mouse lymphoma forward 

mutation assay (L5178Y 

TK+/-) 

±S9 

Cifone, MA and Myhr, BC. 

(1985). Mutagenicity of C-818 

in a Mouse Lymphoma 

Mutation Assay. Litton 

Bionetics, Inc. Project No. 

20989. 

(EPA/OTS Doc# 

889200002872)

+S9: 0, 12.9, 25.8, 38.6, 51.5, 

77.3, 103, 129 μg/mL 

-S9: 0, 10.3, 20.6, 41.2, 51.5, 

61.8, 82.4 μg /mL 

C-818 (CAS 25154-52-3) 

Acetone 

Mutagenic with activation (2.2-fold to 4-fold); 

Non-mutagenic without S9. 

study for genotoxicity in 

CHO-K1 cells using sisterchromatid exchange (SCE), 

chromosome aberration (CA), 

and DNA strand break 

(comet) assays

Tayama, S. et al., 2008. 

Mutation Research 649: 114-

125 

NP: 0, 0.025, 0.05, 0.075, 0.1 

mM 

4-nonylphenol (>97%) 

DMSO 

Nonylphenol caused DNA migration in comet assay and induced 

SCE; results suggest nonylphenol causes repairable DNA 

damage, including SCEs; does not result in chromosome 

aberration (CA). 

870.5100 

Ames Salmonella Microsome 

Reverse Mutation Assay 

Tester strains TA98, TA100, 

TA1535, TA1537, TA1538 

±S9 (Aroclor-induced rat 

liver) 

Ames, et al., 1975 

±S9 

Jagannath, DR and Myhr, BC 

(1985). Mutagenicity 

Evaluation of C-818 Batch 

No. 92748 in the Ames 

Salmonella/Microsome Plate 

Test. Litton Bionetics, Inc. 

Project No. 20989. 

(EPA/OTS Doc# 

86960000408S) 

0, 1, 10, 100, 500, 1000, 2500, 

5000 μg/plate 

C-818 (CAS 25154-52-3) 

Did not exhibit mutagenic activity in these assays (±S9) 

870. 

In vitro transformation of 

BALB/C-3T3 cells assay 

Matthews, EJ and Myhr, BC 

(1985). Evaluation of C-818 in 

the In Vitro Transformation of 

BALB/C-3T3 Cells Assay. 

Litton Bionetics, Inc. Project 

No. 20992 

(EPA/OTS Doc# 

86960000409S) 

0, 3.67, 14.7, 29.3, 44, 55 μg 

/mL 

C-818 (CAS 25154-52-3) 

Did not induce a significant increase in the frequency of 

transformed foci 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 61 of 85 

Table A.9. Other Nonylphenol Studies 

Study Type Citation/Year/Doses Results 

Two-stage transformation of 

BALB/C-3T3 cells (a model of 

two-stage carcinogenesis 

Sakai, A. (2001). PNonylphenol Acts as a 

Promoter in the BALB/3T3 

Cell Transformation 

5, 10, 20, 40 μM 

NP 

CAS 25154-52-3 

Treatment at 5-40 μM NP in promotion phase markedly enhanced 

transformation of cells pretreated with sub-threshold dose of 

carcinogen (MCA) but not of cells not pretreated with MCA. 

Treatment at 5-40 μM NP in initiation phase did not induce cell 

transformation with and without post-treatment by TPA (potent tumor 

promoter) 

Results indicate that NP acts as a pure promoter and may cause 

enhancement of carcinogenesis in vivo. Enhancement by NP of MCAinitiated transformation was suggested not to be mediated by estrogen 

receptors in BALB/3T3 cells 

Multi-organ carcinogenesis model 

in male F344 rats 

Seike, N.; Wanibuchi, H; 

Morimura, K; et al. (2003). 

Enhancement of Lung 

Carcinogenesis by 

Nonylphenol and Genistein in 

a F344 Rat Multiorgan 

Carcinogenesis Model. Cancer 

Letters 192: 25-36. 

25 or 250 ppm nonylphenol 

(NP) in diet for 28 weeks 

250 ppm NP after DHPN 

initiation 

Total incidence of adenomas and carcinomas in lungs significantly 

higher 

Formation of 8-hydroxy-2’-deoxyquanosine, a marker of oxygen 

radical-mediated DNA damage, was significantly increased 

Prostate carcinogenesis assessment Yoshino, H Nabae, K, Doi, Y, 

et al. (2005). Lack of effects of 

Gestational and Lactational 

Exposure to 4-Nonylphenol on 

PhIP-Induced Rat Prostate 

Carcinogenesis. J. Toxicol 

Pathol 18: 183-188. 

Gavage 0, 0.1, 10, 100 

mg/kg/day 4-nonylphenol 

during pregnancy and lactation 

period 

♂F344 rats PhIP 1/week from 

5 weeks of age for 19 weeks 

Prolonged gestation @ 100 mg/kg/day 

NP does not modify susceptibility of ♂ offspring to food-derived 

prostate carcinogen PhIP 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 62 of 85 

APPENDIX B. Structure-Activity Relationship (SAR) Discussion 

HED used DEREK for Windows (V. 11) to assess the potential toxicity of compounds in the 

inerts mixture as well as potential degradates. Two compounds were screened, the smallest APE 

compound in this cluster as well as the t-octylphenol degradate. The structures are shown in 

Figure 1 below. 

Figure B-1. Structures of Compounds Subjected to Structure-Activity Analysis 

O

O

O

O

Derek for Windows (LHASA Ltd.) is an expert system for the prediction of toxicity. It relies on 

a knowledge base of structural alerts and rules developed by scientists. When a test compound is 

inputted into the program, Derek for Windows scans the test compound for structural alerts 

contained within its database that are associated with specific toxicological endpoints and applies 

a series of reasoning rules to determine the likelihood of toxicity for the test compound. 

Information is provided on the rules used to make the prediction, along with descriptions of 

structural alerts identified, comments, available example compounds linked to the alerts and 

literature references. 

There were no structural alerts of significance for the parent APE. There were alerts for the 

degradate, including the estrogenic effects noted in the literature, as well as concern for 

chromosome damage. T-octyl phenol is in the data set for the DEREK alerts for chromosome 

damage 6

. 

 

6 Title: Relevance of chemical structure and cytotoxicity to the induction of chromosome aberrations based on the testing 

results of 98 high production volume industrial chemicals. 

Author: Kusakabe H, Yamakage K, Wakuri S, Sasaki K, Nakagawa Y, Watanabe M, Hayashi M, Sofuni T, Ono H and Tanaka 

N. 

Source: Mutation Research, 2002, 517, 187-198, available at "http://dx.doi.org/10.1016/S1383-5718(02)00062-1". 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 63 of 85 

APPENDIX C. Drinking Water Surrogate Analysis 

Summary of Drinking Water Estimates of Four Surrogate Inert Chemicals 

Notes:

1. Used a North Carolina cotton scenario with application date on July 1. This scenario should 

be a good representative of the numbers that you can expect from EFED. Also tried 

manipulation of application dates and weather files to ensure that there are no aberrations; 

these values look good in that regard. 

2. PCA factors were not applied, but the impact of applying such factors (i.e., 0.5 to 0.9) would 

be insignificant in comparison to the vast uncertainties surrounding generation of 

concentrations from surrogate chemicals as well as uncertainties regarding the actual timing 

of applications. 

3. All simulations were made at approximately 1 lb/A. Concentrations resulting from other 

application rates will be directly proportional to the application rate. 

4. Table 1 gives the normalized concentration estimates for the case where all mass is applied 

on a single day. This should be the most conservative case. 

5. Table 2 gives the normalized concentration estimates for the case where mass is distributed 

evenly over a 100-day period (April to June). 

6. A range of degradation rates were used because degradation information was not available. 3 

simulations were made 1) chemically stable in water and soil, 2) a 100 day half life in water 

and soil, and 3) a 10-day half life in water and soil. This should cover degradation. 

7. Table 3 gives the chemical inputs used in the simulations. 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 64 of 85 

Table 1. DW concentration for application lumped on a single day. (This maximizes the 

acute concentrations.) All concentrations are normalized to a yearly application of 1 kg/hA 

(1.12 lb/acre). 

 Chemical 

1 

Chemical 

2 

Chemical 

3 

Chemical 

4 

Estimates based on Stable Assumption 

Acute (ppb) 1.1 41 33 0.005 

Chronic 0.69 15 19 0.003 

Cancer 0.47 12 15 0.002 

 

Estimates based on assumption of a 100-

day half life in soil and water 

Acute (ppb) 0.74 36 22 0.003 

Chronic 0.33 8.8 7.7 0.002 

Cancer 0.25 6.4 6.4 0.001 

 

Estimates based on assumption of a 10-day 

half life in soil and water 

Acute (ppb) 0.48 25 15 0.002 

Chronic 0.04 1.1 0.96 0.0002 

Cancer 0.03 0.65 0.60 0.0002 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 65 of 85 

Table 2. DW concentration for applications spread out over a 100-day period. This 

simulates a more even distribution of pesticide over the growing season. All concentrations 

are normalized to a yearly application of 1 kg/hA (1.12 lb/acre). 

 Chemical 

1 

Chemical 

2 

Chemical 

3 

Chemical 

4 

Spread Out Values 

 

Estimates based on Stable Assumption 

Acute (ppb) 0.98 29 28 0.004 

Chronic 0.70 13 18 0.003 

Cancer 0.48 10 15 0.002 

 

Estimates based on assumption of a 100-day 

half life in soil and water 

0.57 21 17 0.003 

0.36 6.9 7.2 0.002 

0.27 5.3 6.4 0.001 

 

Estimates based on assumption of a 10-day 

half life in soil and water 

0.16 7.8 4.3 0.001 

0.04 0.79 0.77 0.0002 

0.03 0.61 0.63 0.0002 

Table 3 Chemical Inputs used in Simulations. 

 Chemical 1 Chemical 2 Chemical 3 Chemical 4

Chemical Inputs: 

MW 928 274 302 1185 

Solubility (mg/L) 382 299 19.5 6.69e-8 

V.P. (mmHg) 5.8e-27 1.76e-8 3.86e-8 3.77e-33 

Koc (ml/g) 9.44e6 152 1345 2.57e9 

 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 66 of 85 

APPENDIX D. Detailed Dietary Exposure and Risk Information 

D.1. Input File for Acute and Chronic Dietary Exposure Assessment 

Filename: C:\Documents and Settings\colinger\My 

Documents\Inerts\Cst5\Inerts_57active_Cluster5_100ppbH2Orev_7PCTform.R98 

Chemical: Octylphenols (Cluster 5) 

RfD(Chronic): .1 mg/kg bw/day NOEL(Chronic): 10 mg/kg bw/day 

RfD(Acute): .156 mg/kg bw/day NOEL(Acute): 15.6 mg/kg bw/day 

Date created/last modified: 12-03-2009/13:18:38/8 Program ver. 2.03 

Comment: Inert 57 active ingredients + drinking water (100ppb); 100x safety factor 

-------------------------------------------------------------------------------- 

 EPA Crop Def Res Adj.Factors Comment 

 Code Grp Commodity Name (ppm) #1 #2 

-------- ---- ------------------------------- ---------- ------ ------ ------- 

95000010 O Acerola 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

18000020 18 Alfalfa, seed 0.500000 1.000 0.140 glypho 

 Full comment: glyphosate 

14000030 14 Almond 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

14000031 14 Almond-babyfood 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

14000040 14 Almond, oil 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

14000041 14 Almond, oil-babyfood 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

04010050 4A Amaranth, leafy 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

95000060 O Amaranth, grain 5.000000 1.000 0.140 glypho 

 Full comment: glyphosate [wheat] 

11000070 11 Apple, fruit with peel 25.000000 1.000 0.140 captan 

11000080 11 Apple, peeled fruit 25.000000 1.000 0.140 captan 

11000081 11 Apple, peeled fruit-babyfood 25.000000 1.000 0.140 captan 

11000090 11 Apple, dried 25.000000 8.000 0.140 captan 

11000091 11 Apple, dried-babyfood 25.000000 8.000 0.140 captan 

11000100 11 Apple, juice 25.000000 1.000 0.140 captan 

11000101 11 Apple, juice-babyfood 25.000000 1.000 0.140 captan 

11000110 11 Apple, sauce 25.000000 1.000 0.140 captan 

11000111 11 Apple, sauce-babyfood 25.000000 1.000 0.140 captan 

12000120 12 Apricot 15.000000 1.000 0.140 TM 

12000121 12 Apricot-babyfood 15.000000 1.000 0.140 TM 

12000130 12 Apricot, dried 15.000000 6.000 0.140 TM 

12000140 12 Apricot, juice 15.000000 1.000 0.140 TM 

12000141 12 Apricot, juice-babyfood 15.000000 1.000 0.140 TM 

01030150 1CD Arrowroot, flour 1.000000 1.000 0.140 diuron 

 Full comment: diuron (potato transl] 

01030151 1CD Arrowroot, flour-babyfood 1.000000 1.000 0.140 diuron 

 Full comment: diuron (potato transl] 

95000160 O Artichoke, globe 5.000000 1.000 0.140 permet 

 Full comment: permethrin 

01030170 1CD Artichoke, Jerusalem 1.000000 1.000 0.140 diuron 

 Full comment: diuron (potato transl] 

04010180 4A Arugula 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

95000190 O Asparagus 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95000200 O Avocado 25.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al 

09020210 9B Balsam pear 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

95000220 O Bamboo, shoots 0.200000 1.000 0.140 glypho 

 Full comment: glyphosate 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 67 of 85 

95000230 O Banana 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95000231 O Banana-babyfood 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95000240 O Banana, dried 10.000000 3.900 0.140 carbar 

 Full comment: carbaryl 

95000241 O Banana, dried-babyfood 10.000000 3.900 0.140 carbar 

 Full comment: carbaryl 

15000250 15 Barley, pearled barley 20.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15000251 15 Barley, pearled barley-babyfood 20.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15000260 15 Barley, flour 20.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15000261 15 Barley, flour-babyfood 20.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15000270 15 Barley, bran 30.000000 1.000 0.140 glypho 

 Full comment: glyphosate for bran 

19010280 19A Basil, fresh leaves 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

19010281 19A Basil, fresh leaves-babyfood 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

19010290 19A Basil, dried leaves 260.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

19010291 19A Basil, dried leaves-babyfood 260.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

06030300 6C Bean, black, seed 7.000000 1.000 0.140 maneb 

06020310 6B Bean, broad, succulent 10.000000 1.000 0.140 maneb; 

 Full comment: maneb;carbaryl (CG 6) 

06030320 6C Bean, broad, seed 7.000000 1.000 0.140 maneb 

06020330 6B Bean, cowpea, succulent 10.000000 1.000 0.140 maneb; 

 Full comment: maneb;carbaryl (CG 6) 

06030340 6C Bean, cowpea, seed 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

06030350 6C Bean, great northern, seed 7.000000 1.000 0.140 maneb 

06030360 6C Bean, kidney, seed 7.000000 1.000 0.140 maneb 

06020370 6B Bean, lima, succulent 10.000000 1.000 0.140 maneb; 

 Full comment: maneb;carbaryl (CG 6) 

06030380 6C Bean, lima, seed 7.000000 1.000 0.140 maneb 

06030390 6C Bean, mung, seed 2.000000 1.000 0.140 triflu 

 Full comment: trifluralin 

06030400 6C Bean, navy, seed 7.000000 1.000 0.140 maneb 

06030410 6C Bean, pink, seed 7.000000 1.000 0.140 maneb 

06030420 6C Bean, pinto, seed 7.000000 1.000 0.140 maneb 

06010430 6A Bean, snap, succulent 5.000000 1.000 0.140 chloro 

 Full comment: chlorothalonil 

06010431 6A Bean, snap, succulent-babyfood 5.000000 1.000 0.140 chloro 

 Full comment: chlorothalonil 

21000440 M Beef, meat 2.000000 1.000 0.140 endosu 

 Full comment: endosulfuran 

21000441 M Beef, meat-babyfood 2.000000 1.000 0.140 endosu 

 Full comment: endosulfuran 

21000450 M Beef, meat, dried 2.000000 1.920 0.140 endosu 

 Full comment: endosulfuran 

21000460 M Beef, meat byproducts 1.000000 1.000 0.140 diuron 

21000461 M Beef, meat byproducts-babyfood 1.000000 1.000 0.140 diuron 

21000470 M Beef, fat 13.000000 1.000 0.140 endosu 

 Full comment: endosufuran 

21000471 M Beef,fat-babyfood 13.000000 1.000 0.140 endosu 

 Full comment: endosufuran 

21000480 M Beef, kidney 4.000000 1.000 0.140 glypho 

 Full comment: glyphosate; 2,4-D 

21000490 M Beef, liver 5.000000 1.000 0.140 endosu 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 68 of 85 

 Full comment: endosulfuran 

21000491 M Beef, liver-babyfood 5.000000 1.000 0.140 endosu 

 Full comment: endosulfuran 

01010500 1AB Beet, garden, roots 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

01010501 1AB Beet, garden, roots-babyfood 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

02000510 2 Beet, garden, tops 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin (CG 2) 

01010520 1A Beet, sugar 15.000000 1.000 0.140 chlorp 

 Full comment: chlorpyrifos 

01010521 1A Beet, sugar-babyfood 15.000000 1.000 0.140 chlorp 

 Full comment: chlorpyrifos 

01010530 1A Beet, sugar, molasses 15.000000 1.000 0.140 chlorp 

 Full comment: chlorpyrifos 

01010531 1A Beet, sugar, molasses-babyfood 15.000000 1.000 0.140 chlorp 

 Full comment: chlorpyrifos 

95000540 O Belgium endive 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

13010550 13A Blackberry 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

13010560 13A Blackberry, juice 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

13010561 13A Blackberry, juice-babyfood 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

13020570 13B Blueberry 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

13020571 13B Blueberry-babyfood 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

13010580 13A Boysenberry 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

14000590 14 Brazil nut 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

95000600 O Breadfruit 0.200000 1.000 0.140 glypho 

 Full comment: glyphosate 

05010610 5A Broccoli 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

05010611 5A Broccoli-babyfood 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

05010620 5A Broccoli, Chinese 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

05020630 5B Broccoli raab 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

05010640 5A Brussels sprouts 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

15000650 15 Buckwheat 0.100000 1.000 0.140 metola 

 Full comment: metolachlor 

15000660 15 Buckwheat, flour 0.100000 1.000 0.140 metola 

 Full comment: metolachlor 

01010670 1AB Burdock 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl (carrot) 

14000680 14 Butternut 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

05010690 5A Cabbage 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

05020700 5B Cabbage, Chinese, bok choy 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

05010710 5A Cabbage, Chinese, napa 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

05010720 5A Cabbage, Chinese, mustard 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

95000730 O Cactus 0.500000 1.000 0.140 glypho 

 Full comment: glyphosate 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 69 of 85 

95000740 O Canistel 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

09010750 9A Cantaloupe 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

04020760 4B Cardoon 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

95000770 O Carob 0.050000 1.000 0.140 chloro 

 Full comment: chlorothanil 

01010780 1AB Carrot 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

01010781 1AB Carrot-babyfood 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

01010790 1AB Carrot, juice 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

09010800 9A Casaba 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

14000810 14 Cashew 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

01030820 1CD Cassava 1.000000 1.000 0.140 diuron 

 Full comment: diuron [potato transl] 

01030821 1CD Cassava-babyfood 1.000000 1.000 0.140 diuron 

 Full comment: diuron [potato transl] 

05010830 5A Cauliflower 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

01010840 1AB Celeriac 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl (carrot) 

04020850 4B Celery 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

04020851 4B Celery-babyfood 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

04020860 4B Celery, juice 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

04020870 4B Celtuce 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

09020880 9B Chayote, fruit 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

95000890 O Cherimoya 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

12000900 12 Cherry 50.000000 1.000 0.140 captan 

12000901 12 Cherry-babyfood 50.000000 1.000 0.140 captan 

12000910 12 Cherry, juice 50.000000 1.000 0.140 captan 

12000911 12 Cherry, juice-babyfood 50.000000 1.000 0.140 captan 

14000920 14 Chestnut 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

40000930 P Chicken, meat 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

40000931 P Chicken, meat-babyfood 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

40000940 P Chicken, liver 5.000000 1.000 0.140 iprodi 

 Full comment: iprodione 

40000950 P Chicken, meat byproducts 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

40000951 P Chicken, meat byproducts-babyfoo 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

40000960 P Chicken, fat 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

40000961 P Chicken, fat-babyfood 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

40000970 P Chicken, skin 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

40000971 P Chicken, skin-babyfood 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

06030980 6C Chickpea, seed 7.000000 1.000 0.140 maneb 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 70 of 85 

06030981 6C Chickpea, seed-babyfood 7.000000 1.000 0.140 maneb 

06030990 6C Chickpea, flour 7.000000 1.000 0.140 maneb 

01011000 1AB Chicory, roots 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl [carrot] 

02001010 2 Chicory, tops 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin (CG 2) 

09021020 9B Chinese waxgourd 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

19011030 19A Chive 

 110-Uncooked; Fresh or N/S; Cook Meth N/S 

 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [herbs] 

 210-Cooked; Fresh or N/S; Cook Meth N/S 

 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [herbs] 

 211-Cooked; Fresh or N/S; Baked 

 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [herbs] 

 212-Cooked; Fresh or N/S; Boiled 

 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [herbs] 

 213-Cooked; Fresh or N/S; Fried 

 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [herbs] 

 221-Cooked; Frozen; Baked 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [herbs] 

 240-Cooked; Canned; Cook Meth N/S 

 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [herbs] 

 242-Cooked; Canned; Boiled 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [herbs] 

04011040 4A Chrysanthemum, garland 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

19021050 19B Cinnamon 38.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [spice] 

19021051 19B Cinnamon-babyfood 38.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [spice] 

10001060 10 Citrus citron 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

10001070 10 Citrus hybrids 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

10001080 10 Citrus, oil 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

95001090 O Cocoa bean, chocolate 0.050000 1.000 0.140 chloro 

 Full comment: chlorothalonil 

95001100 O Cocoa bean, powder 0.050000 1.000 0.140 chloro 

 Full comment: chlorothalonil 

95001110 O Coconut, meat 0.100000 1.000 0.140 glypho 

 Full comment: glyphosate 

95001111 O Coconut- meat-babyfood 0.100000 1.000 0.140 glypho 

 Full comment: glyphosate 

95001120 O Coconut, dried 0.100000 2.100 0.140 glypho 

 Full comment: glyphosate 

95001130 O Coconut, milk 0.100000 1.000 0.140 glypho 

 Full comment: glyphosate 

95001140 O Coconut, oil 0.100000 1.000 0.140 glypho 

 Full comment: glyphosate 

95001141 O Coconut, oil-babyfood 0.100000 1.000 0.140 glypho 

 Full comment: glyphosate 

95001150 O Coffee, roasted bean 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

95001160 O Coffee, instant 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 71 of 85 

05021170 5B Collards 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

19011180 19A Coriander, leaves 30.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

19011181 19A Coriander, leaves-babyfood 30.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

19021190 19B Coriander, seed 38.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [spice] 

19021191 19B Coriander, seed-babyfood 38.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [spice] 

15001200 15 Corn, field, flour 0.150000 1.000 0.140 lambda 

 Full comment: lambda-cyhalothrin 

15001201 15 Corn, field, flour-babyfood 0.150000 1.000 0.140 lambda 

 Full comment: lambda-cyhalothrin 

15001210 15 Corn, field, meal 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15001211 15 Corn, field, meal-babyfood 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15001220 15 Corn, field, bran 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15001230 15 Corn, field, starch 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15001231 15 Corn, field, starch-babyfood 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15001240 15 Corn, field, syrup 1.000000 1.500 0.140 glypho 

 Full comment: glyphosate 

15001241 15 Corn, field, syrup-babyfood 1.000000 1.500 0.140 glypho 

 Full comment: glyphosate 

15001250 15 Corn, field, oil 3.000000 1.000 0.140 chloro 

 Full comment: chloropyrifos 

15001251 15 Corn, field, oil-babyfood 3.000000 1.000 0.140 chloro 

 Full comment: chloropyrifos 

15001260 15 Corn, pop 0.500000 1.000 0.140 mancoz 

 Full comment: mancozeb 

15001270 15 Corn, sweet 5.000000 1.000 0.140 maneb; 

 Full comment: maneb;carbaryl 

15001271 15 Corn, sweet-babyfood 5.000000 1.000 0.140 maneb; 

 Full comment: maneb;carbaryl 

95001280 O Cottonseed, oil 35.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

95001281 O Cottonseed, oil-babyfood 35.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

11001290 11 Crabapple 20.000000 1.000 0.140 phosme 

 Full comment: phosmet 

95001300 O Cranberry 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95001301 O Cranberry-babyfood 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95001310 O Cranberry, dried 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95001320 O Cranberry, juice 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95001321 O Cranberry, juice-babyfood 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

04011330 4A Cress, garden 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

04011340 4A Cress, upland 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

09021350 9B Cucumber 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

13021360 13B Currant 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

13021370 13B Currant, dried 40.000000 1.000 0.140 fosety 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 72 of 85 

 Full comment: fosetyl-al (berries) 

04011380 4A Dandelion, leaves 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

01031390 1CD Dasheen, corm 1.000000 1.000 0.140 diuron 

 Full comment: diuron [potato transl] 

02001400 2 Dasheen, leaves 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin (CG 2) 

95001410 O Date 0.200000 1.000 0.140 glypho 

 Full comment: glyphosate 

13011420 13A Dewberry 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

19021430 19B Dill, seed 38.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [spice] 

19011440 19A Dillweed 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [herb] 

70001450 P Egg, whole 1.500000 1.000 0.140 iprodi 

 Full comment: iprodione 

70001451 P Egg, whole-babyfood 1.500000 1.000 0.140 iprodi 

 Full comment: iprodione 

70001460 P Egg, white 1.500000 1.000 0.140 iprodi 

 Full comment: iprodione 

70001461 P Egg, white (solids)-babyfood 1.500000 1.000 0.140 iprodi 

 Full comment: iprodione 

70001470 P Egg, yolk 1.500000 1.000 0.140 iprodi 

 Full comment: iprodione 

70001471 P Egg, yolk-babyfood 1.500000 1.000 0.140 iprodi 

 Full comment: iprodione 

08001480 8 Eggplant 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

13021490 13B Elderberry 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

04011500 4A Endive 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

95001510 O Feijoa 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

04021520 4B Fennel, Florence 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

95001530 O Fig 7.000000 1.000 0.140 maneb 

95001540 O Fig, dried 7.000000 1.000 0.140 maneb 

14001550 14 Filbert 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

14001560 14 Filbert, oil 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

80001570 F Fish-freshwater finfish 2.000000 1.000 0.140 diuron 

 Full comment: diuron [catfish] 

80001580 F Fish-freshwater finfish, farm ra 2.000000 1.000 0.140 diuron 

80001590 F Fish-saltwater finfish, tuna 2.000000 1.000 0.140 diuron 

 Full comment: diuron [catfish] 

80001600 F Fish-saltwater finfish, other 2.000000 1.000 0.140 diuron 

 Full comment: diuron [catfish] 

80001610 F Fish-shellfish, crustacean 3.000000 1.000 0.140 glypho 

 Full comment: glyphosate [shellfish] 

80001620 F Fish-shellfish, mollusc 3.000000 1.000 0.140 glypho 

 Full comment: glyphosate [shellfish] 

20001630 20 Flaxseed, oil 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

03001640 3 Garlic 0.200000 1.000 0.140 glypho 

 Full comment: glyphosate (CG 3) 

03001650 3 Garlic, dried 0.200000 1.000 0.140 glypho 

 Full comment: glyphosate (CG 3) 

03001651 3 Garlic, dried-babyfood 0.200000 1.000 0.140 glypho 

 Full comment: glyphosate (CG 3) 

01031660 1CD Ginger 0.200000 1.000 0.140 glypho 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 73 of 85 

 Full comment: glyphosate 

01031661 1CD Ginger-babyfood 0.200000 1.000 0.140 glypho 

 Full comment: glyphosate 

01031670 1CD Ginger, dried 0.200000 1.000 0.140 glypho 

 Full comment: glyphosate 

01011680 1AB Ginseng, dried 4.000000 1.000 0.140 iprodi 

 Full comment: iprodione 

23001690 M Goat, meat 2.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

23001700 M Goat, meat byproducts 1.000000 1.000 0.140 diuron 

 Full comment: diuron; propanil 

23001710 M Goat, fat 13.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

23001720 M Goat, kidney 4.000000 1.000 0.140 endosu 

 Full comment: endosulfan; 2,4-D 

23001730 M Goat, liver 5.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

13021740 13B Gooseberry 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

95001750 O Grape 25.000000 1.000 0.140 captan 

95001760 O Grape, juice 25.000000 1.000 0.140 captan 

95001761 O Grape, juice-babyfood 25.000000 1.000 0.140 captan 

95001770 O Grape, leaves 25.000000 1.000 0.140 captan 

95001780 O Grape, raisin 25.000000 1.000 0.140 captan 

95001790 O Grape, wine and sherry 25.000000 1.000 0.140 captan 

10001800 10 Grapefruit 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

10001810 10 Grapefruit, juice 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

06031820 6C Guar, seed 7.000000 1.000 0.140 maneb 

06031821 6C Guar, seed-babyfood 7.000000 1.000 0.140 maneb 

95001830 O Guava 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

95001831 O Guava-babyfood 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

19011840 19A Herbs, other 

 110-Uncooked; Fresh or N/S; Cook Meth N/S 

 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 150-Uncooked; Cured etc; Cook Meth N/S 

 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 210-Cooked; Fresh or N/S; Cook Meth N/S 

 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 211-Cooked; Fresh or N/S; Baked 

 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 212-Cooked; Fresh or N/S; Boiled 

 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 213-Cooked; Fresh or N/S; Fried 

 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 215-Cooked; Fresh or N/S; Boiled/baked 

 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 221-Cooked; Frozen; Baked 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 230-Cooked; Dried; Cook Meth N/S 

 260.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 232-Cooked; Dried; Boiled 260.000000 1.000 0.140 azoxys 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 74 of 85 

 Full comment: azoxystrobin 

 233-Cooked; Dried; Fried 260.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 240-Cooked; Canned; Cook Meth N/S 

 260.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 242-Cooked; Canned; Boiled 260.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 250-Cooked; Cured etc; Cook Meth N/S 

 260.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 252-Cooked; Cured etc; Boiled 260.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

 253-Cooked; Cured etc; Fried 260.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

19011841 19A Herbs, other-babyfood 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

14001850 14 Hickory nut 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

95001860 O Honey 30.000000 1.000 0.140 glypho 

 Full comment: glyphosate[sugarcane mol trans] 

95001861 O Honey-babyfood 30.000000 1.000 0.140 glypho 

 Full comment: glyphosate[sugarcane mol trans] 

09011870 9A Honeydew melon 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

95001880 O Hop 1.000000 1.000 0.140 methyl 

 Full comment: methyl parathion 

24001890 M Horse, meat 2.000000 1.000 0.140 endosu 

 Full comment: endosulfuran 

01011900 1AB Horseradish 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

13021910 13B Huckleberry 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

95001920 O Jaboticaba 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

95001930 O Jackfruit 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

05021940 5B Kale 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

95001950 O Kiwifruit 25.000000 1.000 0.140 phosme 

 Full comment: phosmet 

05011960 5A Kohlrabi 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

10001970 10 Kumquat 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

03001980 3 Leek 3.000000 1.000 0.140 methom 

 Full comment: methomyl 

10001990 10 Lemon 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

10002000 10 Lemon, juice 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

10002001 10 Lemon, juice-babyfood 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

10002010 10 Lemon, peel 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

19012020 19A Lemongrass 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [herb] 

06032030 6C Lentil, seed 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

04012040 4A Lettuce, head 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

04012050 4A Lettuce, leaf 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 75 of 85 

10002060 10 Lime 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

10002070 10 Lime, juice 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

10002071 10 Lime, juice-babyfood 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

13012080 13A Loganberry 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

95002090 O Longan 3.000000 1.000 0.140 imidac 

 Full comment: imidacloprid 

11002100 11 Loquat 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

95002110 O Lychee 3.000000 1.000 0.140 imidac 

 Full comment: imidacloprid 

95002120 O Lychee, dried 3.000000 1.850 0.140 imidac 

 Full comment: imidacloprid 

14002130 14 Macadamia nut 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

95002140 O Mamey apple 0.200000 1.000 0.140 glypho 

 Full comment: glyphosate 

95002150 O Mango 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

95002151 O Mango-babyfood 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

95002160 O Mango, dried 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

95002170 O Mango, juice 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

95002171 O Mango, juice-babyfood 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

95002180 O Maple, sugar 15.000000 1.000 0.140 chlorp 

 Full comment: chlorpyrifos [sugarbeet] 

95002190 O Maple syrup 15.000000 1.000 0.140 chlorp 

 Full comment: chlorpyrifos [sugarbeet] 

19012200 19A Marjoram 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [herb] 

19012201 19A Marjoram-babyfood 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [herb] 

28002210 M Meat, game 2.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

27002220 D Milk, fat 2.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

27002221 D Milk, fat - baby food/infant for 2.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

27012230 D Milk, nonfat solids 0.500000 1.000 0.140 iprodi 

 Full comment: iprodione 

27012231 D Milk, nonfat solids-baby food/in 0.500000 1.000 0.140 iprodi 

 Full comment: iprodione 

27022240 D Milk, water 0.500000 1.000 0.140 iprodi 

 Full comment: iprodione 

27022241 D Milk, water-babyfood/infant form 0.500000 1.000 0.140 iprodi 

 Full comment: iprodione 

27032251 D Milk, sugar (lactose)-baby food/ 0.500000 1.000 0.140 iprodi 

 Full comment: iprodione 

15002260 15 Millet, grain 2.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95002270 O Mulberry 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al [blueberry] 

95002280 O Mushroom 5.000000 1.000 0.140 permet 

 Full comment: permethrin 

05022290 5B Mustard greens 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

12002300 12 Nectarine 25.000000 1.000 0.140 captan 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 76 of 85 

15002310 15 Oat, bran 20.000000 1.000 0.140 mancoz 

 Full comment: mancozeb 

15002320 15 Oat, flour 20.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15002321 15 Oat, flour-babyfood 20.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15002330 15 Oat, groats/rolled oats 20.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15002331 15 Oat, groats/rolled oats-babyfood 20.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

08002340 8 Okra 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95002350 O Olive 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95002360 O Olive, oil 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

03002370 3 Onion, dry bulb 7.000000 1.000 0.140 maneb; 

 Full comment: maneb; ziram 

03002371 3 Onion, dry bulb-babyfood 7.000000 1.000 0.140 maneb; 

 Full comment: maneb; ziram 

03002380 3 Onion, dry bulb, dried 7.000000 9.000 0.140 maneb; 

 Full comment: maneb; ziram 

03002381 3 Onion, dry bulb, dried-babyfood 7.000000 9.000 0.140 maneb; 

 Full comment: maneb; ziram 

03002390 3 Onion, green 10.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al 

10002400 10 Orange 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

10002410 10 Orange, juice 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

10002411 10 Orange, juice-babyfood 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

10002420 10 Orange, peel 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

95002430 O Palm heart, leaves 0.200000 1.000 0.140 glypho 

 Full comment: glyphosate 

95002440 O Palm, oil 0.100000 1.000 0.140 glypho 

 Full comment: glyphosate 

95002441 O Palm, oil-babyfood 0.100000 1.000 0.140 glypho 

 Full comment: glyphosate 

95002450 O Papaya 15.000000 1.000 0.140 chloro 

 Full comment: chlorothanil 

95002451 O Papaya-babyfood 15.000000 1.000 0.140 chloro 

 Full comment: chlorothanil 

95002460 O Papaya, dried 15.000000 1.800 0.140 chloro 

 Full comment: chlorothanil 

95002470 O Papaya, juice 15.000000 1.000 0.140 chloro 

 Full comment: chlorothanil 

04012480 4A Parsley, leaves 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

19012490 19A Parsley, dried leaves 12.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

19012491 19A Parsley, dried leaves-babyfood 12.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

01012500 1AB Parsley, turnip rooted 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

01012510 1AB Parsnip 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

01012511 1AB Parsnip-babyfood 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95002520 O Passionfruit 3.000000 1.000 0.140 chloro 

 Full comment: chlorothanil 

95002521 O Passionfruit-babyfood 3.000000 1.000 0.140 chloro 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 77 of 85 

 Full comment: chlorothanil 

95002530 O Passionfruit, juice 3.000000 1.000 0.140 chloro 

 Full comment: chlorothanil 

95002531 O Passionfruit, juice-babyfood 3.000000 1.000 0.140 chloro 

 Full comment: chlorothanil 

95002540 O Pawpaw 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

06022550 6B Pea, succulent 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

06022551 6B Pea, succulent-babyfood 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

06032560 6C Pea, dry 8.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

06032561 6C Pea, dry-babyfood 8.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

06012570 6A Pea, edible podded, succulent 3.000000 1.000 0.140 bentaz 

 Full comment: bentazon 

06032580 6C Pea, pigeon, seed 8.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

06022590 6B Pea, pigeon, succulent 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

12002600 12 Peach 15.000000 1.000 0.140 captan 

12002601 12 Peach-babyfood 15.000000 1.000 0.140 captan 

12002610 12 Peach, dried 15.000000 7.000 0.140 captan 

12002611 12 Peach, dried-babyfood 15.000000 7.000 0.140 captan 

12002620 12 Peach, juice 15.000000 1.000 0.140 captan 

12002621 12 Peach, juice-babyfood 15.000000 1.000 0.140 captan 

95002630 O Peanut 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95002640 O Peanut, butter 5.000000 1.890 0.140 carbar 

 Full comment: carbaryl 

95002650 O Peanut, oil 0.600000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

11002660 11 Pear 25.000000 1.000 0.140 captan 

11002661 11 Pear-babyfood 25.000000 1.000 0.140 captan 

11002670 11 Pear, dried 25.000000 6.250 0.140 captan 

11002680 11 Pear, juice 25.000000 1.000 0.140 captan 

11002681 11 Pear, juice-babyfood 25.000000 1.000 0.140 captan 

14002690 14 Pecan 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

08002700 8 Pepper, bell 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

08002701 8 Pepper, bell-babyfood 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

08002710 8 Pepper, bell, dried 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

08002711 8 Pepper, bell, dried-babyfood 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

08002720 8 Pepper, nonbell 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

08002721 8 Pepper, nonbell-babyfood 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

08002730 8 Pepper, nonbell, dried 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

19022740 19B Pepper, black and white 38.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [spice] 

19022741 19B Pepper, black and white-babyfood 38.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [spice] 

95002750 O Peppermint 200.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

95002760 O Peppermint, oil 200.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

95002770 O Persimmon 3.000000 1.000 0.140 imidac 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 78 of 85 

 Full comment: imidacloprid 

95002780 O Pine nut 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

95002790 O Pineapple 2.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95002791 O Pineapple-babyfood 2.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95002800 O Pineapple, dried 2.000000 5.000 0.140 carbar 

 Full comment: carbaryl 

95002810 O Pineapple, juice 2.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95002811 O Pineapple, juice-babyfood 2.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

14002820 14 Pistachio 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

95002830 O Plantain 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl [banana] 

95002840 O Plantain, dried 10.000000 3.900 0.140 carbar 

 Full comment: carbaryl [banana] 

12002850 12 Plum 10.000000 1.000 0.140 captan 

 Full comment: captan;carbaryl 

12002851 12 Plum-babyfood 10.000000 1.000 0.140 captan 

 Full comment: captan;carbaryl 

12002860 12 Plum, prune, fresh 10.000000 1.000 0.140 captan 

 Full comment: captan;carbaryl 

12002861 12 Plum, prune, fresh-babyfood 10.000000 1.000 0.140 captan 

 Full comment: captan;carbaryl 

12002870 12 Plum, prune, dried 10.000000 1.000 0.140 captan 

 Full comment: captan;carbaryl 

12002871 12 Plum, prune, dried-babyfood 10.000000 1.000 0.140 captan 

 Full comment: captan;carbaryl 

12002880 12 Plum, prune, juice 10.000000 1.000 0.140 captan 

 Full comment: captan;carbaryl 

12002881 12 Plum, prune, juice-babyfood 10.000000 1.000 0.140 captan 

 Full comment: captan;carbaryl 

95002890 O Pomegranate 0.900000 1.000 0.140 imidac 

 Full comment: imidacloprid 

25002900 M Pork, meat 2.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

25002901 M Pork, meat-babyfood 2.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

25002910 M Pork, skin 13.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

25002920 M Pork, meat byproducts 1.000000 1.000 0.140 diuron 

25002921 M Pork, meat byproducts-babyfood 1.000000 1.000 0.140 diuron 

25002930 M Pork, fat 13.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

25002931 M Pork, fat-babyfood 13.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

25002940 M Pork, kidney 4.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

25002950 M Pork, liver 5.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

01032960 1C Potato, chips 1.000000 1.000 0.140 imidac 

 Full comment: imidacloprid 

01032970 1C Potato, dry (granules/ flakes) 1.000000 6.500 0.140 diuron 

01032971 1C Potato, dry (granules/ flakes)-b 1.000000 6.500 0.140 diuron 

01032980 1C Potato, flour 1.000000 1.000 0.140 diuron 

01032981 1C Potato, flour-babyfood 1.000000 1.000 0.140 diuron 

01032990 1C Potato, tuber, w/peel 1.000000 1.000 0.140 diuron 

01032991 1C Potato, tuber, w/peel-babyfood 1.000000 1.000 0.140 diuron 

01033000 1C Potato, tuber, w/o peel 1.000000 1.000 0.140 diuron 

01033001 1C Potato, tuber, w/o peel-babyfood 1.000000 1.000 0.140 diuron 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 79 of 85 

60003010 P Poultry, other, meat 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

60003020 P Poultry, other, liver 5.000000 1.000 0.140 iprodi 

 Full comment: iprodione 

60003030 P Poultry, other, meat byproducts 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

60003040 P Poultry, other, fat 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

60003050 P Poultry, other, skin 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95003060 O Psyllium, seed 10.000000 1.000 0.140 propan 

 Full comment: propanil [rice] 

10003070 10 Pummelo 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

09023080 9B Pumpkin 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

09023090 9B Pumpkin, seed 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

11003100 11 Quince 10.000000 1.000 0.140 mancoz 

 Full comment: mancozeb 

95003110 O Quinoa, grain 5.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

29003120 M Rabbit, meat 2.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

04013130 4A Radicchio 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

01013140 1AB Radish, roots 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

02003150 2 Radish, tops 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin (CG 2) 

01013160 1AB Radish, Oriental, roots 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

02003170 2 Radish, Oriental, tops 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin (CG 2) 

05023180 5B Rape greens 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

20003190 20 Rapeseed, oil 10.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

20003191 20 Rapeseed, oil-babyfood 10.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

13013200 13A Raspberry 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

13013201 13A Raspberry-babyfood 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

13013210 13A Raspberry, juice 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

13013211 13A Raspberry, juice-babyfood 40.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al (berries) 

04023220 4B Rhubarb 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

15003230 15 Rice, white 10.000000 1.000 0.140 propan 

 Full comment: propanil 

15003231 15 Rice, white-babyfood 10.000000 1.000 0.140 propan 

 Full comment: propanil 

15003240 15 Rice, brown 10.000000 1.000 0.140 propan 

 Full comment: propanil 

15003241 15 Rice, brown-babyfood 10.000000 1.000 0.140 propan 

 Full comment: propanil 

15003250 15 Rice, flour 10.000000 1.000 0.140 propan 

 Full comment: propanil 

15003251 15 Rice, flour-babyfood 10.000000 1.000 0.140 propan 

 Full comment: propanil 

15003260 15 Rice, bran 40.000000 1.000 0.140 propan 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 80 of 85 

 Full comment: propanil 

15003261 15 Rice, bran-babyfood 40.000000 1.000 0.140 propan 

 Full comment: propanil 

01013270 1AB Rutabaga 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

15003280 15 Rye, grain 5.000000 1.000 0.140 mancoz 

 Full comment: mancozeb 

15003290 15 Rye, flour 5.000000 1.000 0.140 mancoz 

 Full comment: mancozeb 

20003300 20 Safflower, oil 85.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

20003301 20 Safflower, oil-babyfood 85.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

01013310 1AB Salsify, roots 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

02003320 2 Salsify, tops 50.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin (CG 2) 

95003330 O Sapote, Mamey 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

19013340 19A Savory 38.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [spice] 

95003350 O Seaweed 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

95003351 O Seaweed-babyfood 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

95003360 O Sesame, seed 0.100000 1.000 0.140 glypho 

 Full comment: glyphosate 

95003361 O Sesame, seed-babyfood 0.100000 1.000 0.140 glypho 

 Full comment: glyphosate 

95003370 O Sesame, oil 0.100000 1.000 0.140 glypho 

 Full comment: glyphosate 

95003371 O Sesame, oil-babyfood 0.100000 1.000 0.140 glypho 

 Full comment: glyphosate 

03003380 3 Shallot 0.200000 1.000 0.140 pendim 

 Full comment: pendimethalin 

26003390 M Sheep, meat 2.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

26003391 M Sheep, meat-babyfood 2.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

26003400 M Sheep, meat byproducts 5.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

26003410 M Sheep, fat 13.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

26003411 M Sheep, fat-babyfood 13.000000 1.000 0.140 endosu 

 Full comment: endosulfan 

26003420 M Sheep, kidney 4.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

26003430 M Sheep, liver 5.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15003440 15 Sorghum, grain 15.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15003450 15 Sorghum, syrup 15.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

95003460 O Soursop 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

06003470 6 Soybean, seed 20.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

06003480 6 Soybean, flour 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

06003481 6 Soybean, flour-babyfood 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

06003490 6 Soybean, soy milk 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 81 of 85 

06003491 6 Soybean, soy milk-babyfood or in 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

06003500 6 Soybean, oil 0.300000 1.000 0.140 bifent 

 Full comment: bifenthrin 

06003501 6 Soybean, oil-babyfood 0.300000 1.000 0.140 bifent 

 Full comment: bifenthrin 

95003510 O Spanish lime 3.000000 1.000 0.140 imidac 

 Full comment: imidacloprid 

95003520 O Spearmint 200.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

95003530 O Spearmint, oil 200.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

19023540 19B Spices, other 38.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [spice] 

19023541 19B Spices, other-babyfood 38.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin [spice] 

04013550 4A Spinach 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

04013551 4A Spinach-babyfood 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

09023560 9B Squash, summer 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

09023561 9B Squash, summer-babyfood 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

09023570 9B Squash, winter 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

09023571 9B Squash, winter-babyfood 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

95003580 O Starfruit 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

95003590 O Strawberry 75.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al 

95003591 O Strawberry-babyfood 75.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al 

95003600 O Strawberry, juice 75.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al 

95003601 O Strawberry, juice-babyfood 75.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al 

95003610 O Sugar apple 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

95003620 O Sugarcane, sugar 2.000000 1.000 0.140 glypho 

 Full comment: glyphosate;2,4-D 

95003621 O Sugarcane, sugar-babyfood 2.000000 1.000 0.140 glypho 

 Full comment: glyphosate;2,4-D 

95003630 O Sugarcane, molasses 30.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

95003631 O Sugarcane, molasses-babyfood 30.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

20003640 20 Sunflower, seed 2.500000 1.000 0.140 alachl 

 Full comment: alachlor 

20003650 20 Sunflower, oil 0.300000 1.000 0.140 lambda 

 Full comment: lambda-cyhalothrin 

20003651 20 Sunflower, oil-babyfood 0.300000 1.000 0.140 lambda 

 Full comment: lambda-cyhalothrin 

01033660 1CD Sweet potato 10.000000 1.000 0.140 phosme 

 Full comment: phosmet 

01033661 1CD Sweet potato-babyfood 10.000000 1.000 0.140 phosme 

 Full comment: phosmet 

04023670 4B Swiss chard 100.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 4) 

95003680 O Tamarind 2.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

10003690 10 Tangerine 10.000000 1.000 0.140 azoxys 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 82 of 85 

 Full comment: azoxystrobin ( citrus CG) 

10003700 10 Tangerine, juice 10.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin ( citrus CG) 

01033710 1CD Tanier, corm 1.000000 1.000 0.140 diuron 

 Full comment: diuron [potato transl] 

95003720 O Tea, dried 10.000000 1.000 0.140 propar 

 Full comment: propargite 

95003730 O Tea, instant 7.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

08003740 8 Tomatillo 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

08003750 8 Tomato 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

08003751 8 Tomato-babyfood 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

08003760 8 Tomato, paste 6.000000 1.000 0.140 imidac 

 Full comment: imidacloprid 

08003761 8 Tomato, paste-babyfood 6.000000 1.000 0.140 imidac 

 Full comment: imidacloprid 

08003770 8 Tomato, puree 3.000000 1.000 0.140 imidac 

 Full comment: imidacloprid 

08003771 8 Tomato, puree-babyfood 3.000000 1.000 0.140 imidac 

 Full comment: imidacloprid 

08003780 8 Tomato, dried 10.000000 14.300 0.140 carbar 

 Full comment: carbaryl 

08003781 8 Tomato, dried-babyfood 10.000000 14.300 0.140 carbar 

 Full comment: carbaryl 

08003790 8 Tomato, juice 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

95003800 O Tomato, Tree 10.000000 1.000 0.140 carbar 

 Full comment: carbaryl [tomato] 

15003810 15 Triticale, flour 5.000000 1.000 0.140 glypho 

 Full comment: glyphosate [wheat transl] 

15003811 15 Triticale, flour-babyfood 5.000000 1.000 0.140 glypho 

 Full comment: glyphosate [wheat transl] 

50003820 P Turkey, meat 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

50003821 P Turkey, meat-babyfood 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

50003830 P Turkey, liver 5.000000 1.000 0.140 iprodi 

 Full comment: iprodione 

50003831 P Turkey, liver-babyfood 5.000000 1.000 0.140 iprodi 

 Full comment: iprodione 

50003840 P Turkey, meat byproducts 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

50003841 P Turkey, meat byproducts-babyfood 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

50003850 P Turkey, fat 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

50003851 P Turkey, fat-babyfood 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

50003860 P Turkey, skin 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

50003861 P Turkey, skin-babyfood 5.000000 1.000 0.140 carbar 

 Full comment: carbaryl 

01033870 1CD Turmeric 1.000000 1.000 0.140 diuron 

 Full comment: diuron [potato transl] 

05023890 5B Turnip, greens 60.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (CG 5) 

01013880 1AB Turnip, roots 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-al 

95003900 O Vinegar 25.000000 1.000 0.140 captan 

 Full comment: captan [apple] 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 83 of 85 

14003910 14 Walnut 1.000000 1.000 0.140 glypho 

 Full comment: glyphosate (tree nut) 

86010000 O Water, direct, all sources 0.100000 1.000 1.000 defaul 

 Full comment: default 100 ppb 

86020000 O Water, indirect, all sources 0.100000 1.000 1.000 defaul 

 Full comment: default 100 ppb 

95003970 O Water chestnut 1.000000 1.000 0.140 carbar 

 Full comment: carbaryl [pecan] 

95003980 O Watercress 6.000000 1.000 0.140 methom 

 Full comment: methomyl 

09013990 9A Watermelon 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

09014000 9A Watermelon, juice 15.000000 1.000 0.140 fosety 

 Full comment: fosetyl-Al (curcurbits) 

15004010 15 Wheat, grain 5.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15004011 15 Wheat, grain-babyfood 5.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15004020 15 Wheat, flour 5.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15004021 15 Wheat, flour-babyfood 5.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15004030 15 Wheat, germ 5.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15004040 15 Wheat, bran 20.000000 1.000 0.140 glypho 

 Full comment: glyphosate 

15004050 15 Wild rice 5.000000 1.000 0.140 azoxys 

 Full comment: azoxystrobin 

01034060 1CD Yam, true 10.000000 1.000 0.140 phosme 

 Full comment: phosmet 

01034070 1CD Yam bean 10.000000 1.000 0.140 phosme 

 Full comment: phosmet 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 84 of 85 

D.2. Results File for Acute Dietary Assessment 

U.S. Environmental Protection Agency Ver. 2.02 

DEEM-FCID ACUTE Analysis for OCTYLPHENOLS (CLUSTER 5) (1994-98 data) 

Residue file: Inerts_57active_Cluster5_100ppbH2Orev_7PCTform.R98 

 Adjustment factor #2 used. 

Analysis Date: 12-03-2009/13:20:11 Residue file dated: 12-03-2009/13:18:38/8 

NOEL (Acute) = 15.600000 mg/kg body-wt/day 

Daily totals for food and foodform consumption used. 

Run Comment: "Inert 57 active ingredients + drinking water (100ppb); 100x safe 

ty factor" 

=============================================================================== 

Summary calculations (per capita): 

 95th Percentile 99th Percentile 99.9th Percentile 

 Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE 

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- 

Females 13-49 yrs: 

 0.057907 37.12 269 0.088782 56.91 175 0.133126 85.34 117 
Alkylphenol Ethoxylates Human Health Risk Assessment 

Page 85 of 85 

D.3. Results File for Chronic Dietary Assessment 

U.S. Environmental Protection Agency Ver. 2.00 

DEEM-FCID Chronic analysis for OCTYLPHENOLS (CLUSTER 5) (1994-98 data) 

Residue file name: C:\Documents and Settings\colinger\My 

Documents\Inerts\Cst5\Inerts_57active_Cluster5_100ppbH2Orev_7PCTform.R98 

 Adjustment factor #2 used. 

Analysis Date 12-03-2009/13:23:24 Residue file dated: 12-03-2009/13:18:38/8 

Reference dose (RfD, Chronic) = .1 mg/kg bw/day 

COMMENT 1: Inert 57 active ingredients + drinking water (100ppb); 100x safety factor 

=============================================================================== 

 Total exposure by population subgroup 

------------------------------------------------------------------------------- 

 Total Exposure 

 ----------------------------------- 

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

-------------------------------------- ------------- --------------- 

U.S. Population (total) 0.028624 28.6% 

U.S. Population (spring season) 0.029168 29.2% 

U.S. Population (summer season) 0.029070 29.1% 

U.S. Population (autumn season) 0.028092 28.1% 

U.S. Population (winter season) 0.028176 28.2% 

Northeast region 0.030808 30.8% 

Midwest region 0.028497 28.5% 

Southern region 0.025730 25.7% 

Western region 0.031395 31.4% 

Hispanics 0.030295 30.3% 

Non-hispanic whites 0.028050 28.0% 

Non-hispanic blacks 0.027661 27.7% 

Non-hisp/non-white/non-black 0.036798 36.8% 

All infants (< 1 year) 0.061534 61.5% 

Nursing infants 0.031984 32.0% 

Non-nursing infants 0.072752 72.8% 

Children 1-6 yrs 0.071949 71.9% 

Children 7-12 yrs 0.035224 35.2% 

Females 13-19 (not preg or nursing) 0.020727 20.7% 

Females 20+ (not preg or nursing) 0.022710 22.7% 

Females 13-50 yrs 0.023387 23.4% 

Females 13+ (preg/not nursing) 0.024700 24.7% 

Females 13+ (nursing) 0.029474 29.5% 

Males 13-19 yrs 0.022081 22.1% 

Males 20+ yrs 0.021804 21.8% 

Seniors 55+ 0.023120 23.1% 

Children 1-2 yrs 0.090052 90.1% 

Children 3-5 yrs 0.067194 67.2% 

Children 6-12 yrs 0.037482 37.5% 

Youth 13-19 yrs 0.021487 21.5% 

Adults 20-49 yrs 0.021909 21.9% 

Adults 50+ yrs 0.023071 23.1% 

Females 13-49 yrs 0.022040 22.0% 

----------------------------------------------------------------------------