Office of Water 

Office Science and 

Technology 

EPA 820-D-14-036 

May 2014 

Draft Update of Human Health
 

Ambient Water Quality Criteria:
 

 

Di-n-Butyl Phthalate
 

84-74-2
 

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EPA 820-D-14-036 

May 2014 

Update of Human Health
 

Ambient Water Quality Criteria:
 

Di-n-Butyl Phthalate
 

84-74-2
 

Draft 

Office of Science and Technology
 

Office of Water
 

U.S. Environmental Protection Agency
 

Washington, DC 20460
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Di-n-Butyl Phthalate 84-74-2 

Table of Contents 

Introduction: Plan and Scope of Update 

Problem Formulation 

Criteria Formulas- Analysis Plan 

Exposure Factors 

Body Weight 

Drinking Water Intake 

Fish Consumption Rate 

Bioaccumulation Factor 

Hazard Identification and Dose Response 

Reference Dose 

Relative Source Contribution 

Criteria Derivation- Analysis 

Criteria Characterization 

Chemical Name / Synonyms 

References 

Introduction: Plan and Scope of Update 

Human health ambient water quality criteria (AWQC) are numeric values for pollutant 

concentrations in ambient waters that the U.S. Environmental Protection Agency (EPA) 

considers to be protective of human health. EPA periodically revises water quality criteria to 

ensure that they reflect the latest scientific knowledge. The current revisions of the criteria for 

di-n-butyl phthalate, contained in this document, incorporate updated information regarding 

relative source contribution, body weight, drinking water intake, fish consumption rate, and 

bioaccumulation. Relative source contribution recommendations are identified in EPA’s 

‘Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health 

(2000)’ (USEPA, 2000). Updated body weight and drinking water intake data are identified in 

EPA’s ‘Exposure Factors Handbook: 2011 Edition’ (USEPA, 2011). The bioaccumulation factor 

data is updated using EPA’s Estimation Program Interface (EPI) Suite modeling program (USEPA, 

2012a). The overall fish consumption rate and trophic level breakdowns are updated using 

EPA’s ‘Estimated Fish Consumption Rates for the U.S. Population and Selected Subpopulations 

(NHANES 2003-2010)’ (USEPA, 2014). Unless otherwise specified, all sources of information 

used in this update are from peer reviewed sources. 

Note that the term "water quality criteria" can carry one of two possible meanings, 

depending on the section of the Clean Water Act (CWA) associated with the particular criteria 

at issue. “Water quality criteria” may refer to national water quality criteria recommendations 

issued under CWA § 304. “Water quality criteria” may also refer to water quality criteria 

components of water quality standards adopted by states, territories, or authorized tribes 

under CWA § 303. 

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Di-n-Butyl Phthalate 84-74-2 

National ambient water quality criteria recommendations for human health are issued 

by the EPA under CWA §304. They are based on the latest scientific information on the 

relationship between the effects of a constituent concentration and human health. Protective 

assumptions are made regarding the potential human exposure intakes. These criteria do not 

reflect consideration of non-human health endpoints or economic impacts. Nor do they reflect 

the technological feasibility of meeting the chemical concentrations in ambient water. National 

ambient water quality criteria recommendations for human health are not automatically 

incorporated into water quality standards adopted by states, territories, or authorized tribes. 

Rather, they provide scientific information to states, territories and authorized tribes to assist 

them in adopting ambient water quality criteria for human health in water quality standards 

that meet CWA requirements. National ambient water quality criteria recommendations for 

human health are not regulations themselves and they do not impose legally binding 

requirements on EPA, states, territories, authorized tribes, or the public. States, territories, and 

authorized tribes have the discretion to adopt, where appropriate, other scientifically 

defensible water quality criteria that differ from EPA’s national ambient recommended criteria 

for human health. 

Ambient water quality criteria components of water quality standards are generally 

adopted by the states, territories, and authorized tribes themselves, under §303(c)(2). (In 

certain circumstances EPA also may promulgate this type of criterion itself, pursuant to 

§303(c)(4)). State ambient water quality criteria for human health represent a quality of water 

that sufficiently protects human health to support a designated use of the state, territory, or 

authorized tribe. Such criteria may be expressed in terms of constituent concentrations, levels, 

or narrative statements. Once ambient water quality criteria for human health are adopted by a 

state, territory, or authorized tribe into their water quality standards, they provide a basis for 

controlling discharges or releases of pollutants, for developing permit limits, assessing waters, 

and developing total maximum daily loads (TMDLs) for waters that do not meet the water 

quality standard. Ambient water quality criteria for human health have a regulatory impact 

once they have been adopted into water quality standards by the state, territory, or authorized 

tribe under § 303(c)(2) (or alternatively issued by EPA pursuant to § 303(c)(4)). 

The water quality criteria at issue in this document are national ambient water quality 

criteria recommendations for human health issued under CWA § 304. Unless expressly 

indicated otherwise, all references to “criteria,” “water quality criteria,” “ambient water quality 

criteria (AWQC) recommendations,” or similar variants thereof, are references to national 

ambient water quality criteria recommendations for human health. 

Problem Formulation 

Problem formulation provides a strategic framework for water quality criteria 

development by focusing on the most relevant endpoints and increasing the transparency of 

the effects assessment process. The structure of this criteria document is consistent with U.S. 

EPA’s ‘Framework for Human Health Risk Assessment to Inform Decision Making’ (USEPA, 

2012b). 

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Di-n-Butyl Phthalate 84-74-2 

In the development of AWQC, EPA currently follows the deterministic assessment 

methodology outlined in EPA’s ‘Methodology for Deriving Ambient Water Quality Criteria for 

the Protection of Human Health (2000)’ (USEPA, 2000), hereafter known as the 2000 

Methodology. For pollutants that exhibit a threshold of exposure before deleterious effects 

occur, such as is the case for non-carcinogens, the 2000 Methodology applies a relative source 

contribution (RSC) to determine the amount of the reference dose (RfD) apportioned to fish 

consumption (freshwater and estuarine species) and drinking water intake. The RSC value is 

applied to chemicals with an RfD to ensure that exposure to these chemicals from drinking 

water and fish ingestion, when combined with all other sources, will not exceed the reference 

dose. Other exposures routes, including but not limited to, dermal exposure, inhalation 

exposure, marine fish and shellfish consumption (when not included in the fish consumption 

rate), and non-fish dietary exposures (fruits, vegetables, grains, meats or poultry) are 

accounted for in the percentage of the RfD that remains, after accounting for the RSC. 

Criteria Formulas- Analysis Plan 

The following formulas are used to develop the human health ambient water quality 

criteria. EPA develops criteria for ambient waters typically considering two routes of exposure. 

The first formula is for a criterion that assumes exposure through both the consumption of 

water and the consumption of aquatic organisms. The second formula is for a criterion that 

assumes exposure through the consumption of aquatic organisms, but not water. The use of 

one criterion over the other depends on the designated use of the water bodies in question (i.e. 

drinking water source and/or fishable waters). 

EPA recommends inclusion of the drinking water exposure pathway for ambient surface 

waters where drinking water is a designated use for the following reasons: (1) Drinking water is 

a designated use for surface waters under the CWA and, therefore, criteria are needed to 

assure that this designated use can be protected and maintained. (2) Although rare, there are 

some public water supplies that provide drinking water from surface water sources without 

treatment. (3) Even among the majority of water supplies that do treat surface waters, existing 

treatments may not necessarily be effective for reducing levels of particular contaminants. (4) 

In consideration of the Agency’s goals of pollution prevention, ambient waters should not be 

contaminated to a level where the burden of achieving health objectives is shifted away from 

those responsible for pollutant discharges and placed on downstream users to bear the costs of 

upgraded or supplemental water treatment (USEPA, 2000). 

EPA recommends the organism only criterion in those cases where the designated uses 

of a water body include only supporting fishable uses under Section 101(a) of the CWA and, 

thus, fish or shellfish for human consumption, but not as a drinking water supply source (e.g., 

non-potable estuarine waters) (USEPA, 2000). 

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The formulas for deriving the criteria values are as follows (USEPA, 2000): 

For consumption of water and organisms: 

 

 

AWQC (μg/L) = RfD (mg/kg·d) × RSC × BW (kg) × 1000 μg/mg* 

4 DI (L/d) + ∑ (F·Ί (Ιͽ/ ͇) ∓ !FΊ (ͫ Ιͽ)) Ί 2 

 

For consumption of organisms only: 

 

 

AWQC (μg/L) = RfD (mg/kg·d) × RSC × BW (kg) × 1000 (μg/mg)* 

∑4 (F·Ί (Ιͽ/ ͇) ∓ !FΊ (ͫ Ιͽ)) Ί 2 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4 

Where: 

AWQC = ambient water quality criteria 

RfD = reference dose 

RSC = relative source contribution 

BW = body weight 

DI = drinking water intake 

∑ i=2 = summation of ϭ̯ΜϢ͋ν ͕Ϊι ̯θϢ̯χΊ̽ χιΪζ·Ί̽ Μ͋ϭ͋Μν (Αͫ) Ϯ·͋ι͋ χ·͋ Μ͋χχ͋ι ͞Ί͟ νχ̯Σ͇ν ͕Ϊι χ·͋ 

trophic levels to be considered, starting with TL 2 and proceeding to TL 4 

FCRi = fish consumption rate for aquatic trophic levels 2, 3, and 4 

BAFi = bioaccumulation factor for aquatic trophic levels 2, 3, and 4 

 

 

Di-n-Butyl Phthalate 84-74-2 

(Eq. 1) 

(Eq. 2) 

The following sections identify each of the components of the formulas for the human 

health ambient water quality criteria and provide reference sources, previously used values 

when available, and the values to be used in the updated criteria. 

Exposure Factors: 

Body Weight 

 The updated recommended body weight (BW) is 80 kg which represents the mean 

weight for adults 21 years of age and older. This recommendation is found in EPA’s ‘Exposure 

Factors Handbook: 2011 Edition’ in Chapter 8. It was based on data derived from the National 

Health and Nutrition Examination Survey (NHANES) 1999−2006 (USEPA, 2011). This body 

weight replaces the recommended standard weight for adults of 70 kg that was described in 

the 2000 Methodology which was approximated from the mean body weight of adults from the 

National Health and Nutrition Examination Survey (NHANES) III database (1988-1994) and a 

1989 study by the National Cancer Institute (USEPA, 2000). 

* 1000 μg/mg is used to convert the units of mass into micrograms from milligrams. 

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Di-n-Butyl Phthalate 84-74-2 

Drinking Water Intake 

The updated drinking water intake (DI) is 3 L/day, rounded from 3.091 L/day for 

consumer-only estimates of direct and indirect water ingestion based on NHANES 2003-2006 

data for all sources of water at the 90th percentile for adults (≥21 years of age) (USEPA, 2011). 

Direct water is defined as water ingested directly as a beverage (from all sources); indirect 

water is defined as water added in the preparation of food or beverages, not including indirect 

consumption of bottled water. This recommended value is found in EPA’s ‘Exposure Factors 

Handbook: 2011 Edition’ in Table 3-36. It replaces the drinking water intake standard of 2 L/day 

described in the 2000 Methodology which represented the 86th percentile for adults 20 years 

and older in the US Department of Agriculture’s 1994-96 Continuing Survey of Food Intake by 

Individuals (CSFII) analysis or the 88th percentile of adults in the National Cancer Institute study 

of the 1977-78 Nationwide Food Consumption Survey (USEPA, 2000). 

Fish Consumption Rate 

The updated fish consumption rate (FCR) for the general adult population is 22 

grams/day (0.022 kg/day) (USEPA, 2014: see Table 9a). It represents the 90th percentile per 

capita consumption rate of freshwater and estuarine fish for the U.S. adult population 21 years 

of age and older based on the Centers for Disease Control and Prevention (CDC) National 

Health and Nutrition Examination Surveys (NHANES) conducted from 2003-2010. It replaces the 

FCR default of 17.5 grams/day, which represented an estimate of the 90th percentile per capita 

consumption rate of freshwater and estuarine fish for the U.S. adult population based on the 

U.S. Department of Agriculture’s (USDA’s) Continuing Survey of Food Intake by Individuals 

(CSFII) 1994-96 data (USEPA, 2002a). 

As recommended in the 2000 Methodology, this update to the criteria distinguishes a 

trophic level (TL) breakdown of the fish consumption rate to provide a better representation of 

͇Ί͋χ̯ιΘ ͋ϳζΪνϢι͋ χΪ ͕Ίν· ̯χ ΢ϢΜχΊζΜ͋ χιΪζ·Ί̽ Μ͋ϭ͋Μν ̈́ !Σ Ϊιͽ̯ΣΊν΢͛ν χιΪζ·Ί̽ ζΪνΊχion in the aquatic 

food web can have an important effect on the magnitude of bioaccumulation of certain 

chemicals. The trophic levels are numbered 2, 3, and 4 and account for different categories of 

fish and shellfish species based on their position in the aquatic food web. TL2 accounts for 

benthic filter feeders, TL3 accounts for forage fish, and TL4 accounts for predatory fish. 

In order to derive the trophic level breakdown of the 22 grams/day freshwater and 

estuarine FCR, the trophic level specific freshwater and estuarine FCR data sets for adults 21 

years of age and older were identified (USEPA, 2014: see Tables 16a, 17a, and 18a). In each 

trophic level specific data set, the ratio of that trophic level’s 90th percentile FCR compared to 

the summation of all three trophic level specific 90th percentile FCRs was applied to the 22 

grams/day FCR used in this update. The trophic level ratios were calculated as follows: TL ratio 

= 90th percentile FCR for the TL divided by the sum of the 90th percentile FCRs for all TLs. TL2 = 

7.6/21.3 = 0.3568 (35.68%), TL3 = 8.6/21.3 = 0.4038 (40.38%), and TL4 = 5.1/21.3 = 0.2394 

(23.94%). Applying these ratios to the updated FCR of 22 grams/day result in trophic level 

breakdowns of TL2 = 8 grams/day (0.008 kg/day); TL3 = 9 grams/day (0.009 kg/day); and TL4 = 5 

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Di-n-Butyl Phthalate 84-74-2 

grams/day (0.005 kg/day). These resulting trophic level FCRs are well within the confidence 

intervals for each of the trophic level specific distributions’ 90th percentiles and add to the total 

of 22 grams/day (USEPA, 2014). 

Bioaccumulation Factor 

Several attributes of the bioaccumulation process are important to understand when 

deriving national BAFs for use in setting national 304(a) criteria. First, the term 

“bioaccumulation” refers to the uptake and retention of a chemical by an aquatic organism 

from all surrounding media (e.g., water, food, sediment). The term “bioconcentration” refers to 

the uptake and retention of a chemical by an aquatic organism from water only. For some 

chemicals (particularly those that are highly persistent and hydrophobic), the magnitude of 

bioaccumulation by aquatic organisms can be substantially greater than the magnitude of 

bioconcentration. Thus, an assessment of bioconcentration alone may underestimate the 

extent of accumulation in aquatic biota for these chemicals. Accordingly, EPA’s guidelines 

presented in the 2000 Methodology emphasize the measurement or estimation of chemical 

bioaccumulation by aquatic organisms (USEPA, 2000). 

The bioaccumulation factors ( AF) have been estimated using EPA’s Estimation Program 

Interface (EPI) Suite (USEPA, 2012a). The CF AFTM program within EPI Suite estimates fish 

bioaccumulation factors using octanol-water partition coefficients (KOW) and biotransformation 

data from a model designed by Arnot and Gobas (2003). The model includes mechanistic 

processes for bioaccumulation such as chemical uptake from the water at the gill surface and 

from the diet, chemical elimination at the gill surface, fecal egestion, growth dilution and 

metabolic biotransformation. Other processes included in the calculations are bioavailability in 

the water column (only the freely dissolved fraction can bioconcentrate) and absorption 

efficiencies at the gill and in the gastrointestinal tract. The model requires the octanol-water 

partition coefficient (KOW) of the chemical and the normalized whole-body metabolic 

biotransformation rate constant as input parameters to predict BAF values. Model predictions 

may be highly uncertain for chemicals that have estimated log KOW values > 9. The model is not 

recommended at this time for chemicals that appreciably ionize, for pigments and dyes, or for 

perfluorinated substances (USEPA, 2012a). 

For di-n-butyl phthalate, BAFs have been estimated using the EPI Suite model (USEPA, 

2012a) as described above for trophic levels 2, 3, and 4. The estimated lower (TL2), mid (TL3), 

and upper (TL4) trophic level BAFs for di-n-butyl phthalate (log KOW = 4.50) are 236.2 L/kg, 209.4 

L/kg, and 159.4 L/kg wet-weight, respectively. These estimated BAFs replace the 

bioconcentration factor (BCF) of 89 L/kg used in the 2002 criteria derivations, which was 

calculated from a log KOW and the weighted average bioconcentration values for diethyl and di2-ethylhexyl phthalates and represented all trophic levels (USEPA, 1980). 

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Di-n-Butyl Phthalate 84-74-2 

Hazard Identification and Dose Response: 

Reference Dose 

The reference dose (RfD) is an estimate (with uncertainty spanning approximately an 

order of magnitude) of a daily oral exposure for a chronic duration (up to a lifetime) to the 

human population (including sensitive subgroups) that is likely to be without an appreciable risk 

of deleterious effects during a lifetime. It can be derived from laboratory animal dosing studies 

in which a no observed adverse effect level (NOAEL), lowest observed adverse effect level 

(LOAEL), or benchmark dose (with uncertainty factors generally applied to reflect limitations of 

the data used) can be obtained. The RfD for di-n-butyl phthalate is 1 × 10 –1 mg/kg·day (0.1 

mg/kg·day) (USEPA, 1990). 

The principle study by Smith (1953) chosen to calculate the reference dose for di-n-butyl 

phthalate was based on increased mortality in rats orally exposed to di-n-butyl phthalate. The 

study was a subchronic to chronic study with a NOAEL of 1.25 × 102 mg/kg·day. An uncertainty 

factor of 1000× was applied to account for interspecies extrapolation (10×), intraspecies 

variation (10×), and subchronic to chronic study variation (10×) (USEPA, 1990). 

Relative Source Contribution 

 The relative source contribution (RSC) component of the human health ambient water 

quality criteria (AWQC) calculation for threshold non-carcinogens and non-linear carcinogens 

allows a percentage of the reference dose’s exposure to be attributed to ambient water and 

freshwater and estuarine fish consumption (including estuarine species harvested in near 

coastal waters) when there are other potential exposure sources. The RSC describes the portion 

of the RfD available for AWQC-related sources (often a 20% default is utilized) (USEPA, 2000). 

The remainder of the RfD is allocated for other sources of the pollutant. The rationale for this 

approach is that for pollutants exhibiting threshold effects, the objective of the AWQC is to 

ensure that an individual’s total exposure from all sources does not exceed that threshold level. 

Exposures outside of the RSC include, but are not limited to, exposure to a particular pollutant 

from marine fish consumption (not included in the fish consumption rate), non-fish food 

consumption (fruits, vegetables, and grains), dermal exposure, and respiratory exposure. The 

percentage of exposure of the reference dose that these other exposures account for is equal 

to 100 percent minus the RSC. 

In the absence of scientific data, the application of the EPA’s default value of 20 percent 

RSC in calculating 304(a) criteria or establishing State or Tribal water quality standards under 

Section 303(c) will ensure that the designated use for a water body is protected. This 20 

percent default for RSC can only be replaced where sufficient data are available to develop a 

scientifically defensible alternative value. If appropriate, scientific data demonstrating that 

other sources and routes of exposure besides water and freshwater/estuarine fish are not 

anticipated for the pollutant in question, then the RSC may be raised to the appropriate level, 

based on the data (USEPA, 2000). 

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Di-n-Butyl Phthalate 84-74-2 

Previously, the AWQC for di-n-butyl phthalate were calculated using a default RSC of 

100 percent that does not comply with the 2000 Methodology. EPA recommends a RSC of 20 

percent (0.20) for di-n-butyl phthalate as the default value. 

Criteria Derivation- Analysis 

Table 1 summarizes model inputs used to derive the 2014 updated human health 

ambient water quality criteria for di-n-butyl phthalate. Criteria calculations are presented 

below. These updated di-n-butyl phthalate criteria recommendations are based on the 2000 

Methodology and updated exposure assumptions as described above (Exposure Factors). 

Table 1. Summary of input parameters for 2014 human health ambient water quality criteria 

for di-n-butyl phthalate 

Component Value Source Input Characterization 

RfD 0.1 mg/kg·day USEPA, 

1990 

uncertainty factor = 100 (10 for interspecies 

extrapolation; 10 for intraspecies variation; 10 for 

subchronic to chronic study variation) 

RSC 0.20 USEPA, 

2000 default value 

BW 80 kg USEPA, 

2011 mean weight for adults (≥21 Θ̯͋ιν of age) 

DI 3 L/day USEPA, 

2011 90th ζ͋ι̽͋ΣχΊΜ͋ ͕Ϊι ̯͇ϢΜχν (≥21 Θ̯͋ιν of age) 

FCR 

TL2 0.008 kg/day USEPA, 

2014 

90th percentile consumption rate for the U.S. adult 

population (≥21 Θ̯͋ιν of age) TL3 0.009 kg/day 

TL4 0.005 kg/day 

BAF 

TL2 236.2 L/kg 

USEPA, 

2012a 

EPI Suite KOW model estimated steady-state BAF values 

for non-ionic organic chemicals in 3 general trophic 

levels of fish in temperate environments (10°C) 

TL3 209.4 L/kg 

TL4 159.4 L/kg 

For consumption of water and organisms:
 

 

 

 

 

 

AWQC (μg/L) = RfD (mg/kg·d) × RSC × BW (kg) × 1000 μg/mg
 4 DI (L/d) + ∑ (F·Ί (Ιͽ ͇) ∓ !FΊ (ͫ Ιͽ)) ΊсϮ

= 0.1 mg/kg·d × 0.20 × 80 kg × 1000 μg/mg 

3 L/d + ((0.008 kg/d × 236.2 L/kg) + (0.009 kg/d × 209.4 L/kg) + (0.005 kg/d × 159.4 L/kg)) 

= 211.327 μg/L (rounded to 200 μg/L because of significant figures) 

For consumption of organisms only:
 

8
 

 

 

AWQC (μg/L) = RfD (mg/kg·d) × RSC × BW (kg) × 1000 (μg/mg)
 

∑4 (F·Ί (Ιͽ/ ͇) ∓ !FΊ (ͫ/ Ιͽ)) ΊсϮ
 

 

 

 

= 0.1 mg/kg·d × 0.20 × 80 kg × 1000 μg/mg 

(0.008 kg/d × 236.2 L/kg) + (0.009 kg/d × 209.4 L/kg) + (0.005 kg/d × 159.4 L/kg) 

= 350.018 μg/L (rounded to 400 μg/L because of significant figures) 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Di-n-Butyl Phthalate 84-74-2 

The updated human health ambient water quality criteria for di-n-butyl phthalate are 

200 μg/L (water and organism) and 400 μg/L (organism only) (Table 2). These updated criteria 

replace the previously published values (USEPA, 2002b). 

Table 2. Summary of EPA’s preciously recommended (2002) and updated (2014) human health 

ambient water quality criteria for di-n-butyl phthalate 

2002 Human Health AWQC 2014 Human Health AWQC 

Water and Organism 2,000 μg/L 200 μg/L 

Organism Only 4,500 μg/L 400 μg/L 

These AWQC are meant to be protective of human health for the general adult 

population for a set percentage (RSC) of the total allowed daily oral exposure for a chronic 

duration (up to a lifetime) of di-n-butyl phthalate. 

Criteria Characterization 

The updated 2014 human health AWQC for di-n-butyl phthalate take into account 

current data on health effects and exposure input parameters, consistent with the 2000 

Methodology. The updated 2014 human health AWQC for di-n-butyl phthalate are about an 

order of magnitude lower than EPA’s previously recommended 2002 criteria; i.e. the waterand-organism criterion decreased from 2,000 to 200 μg/L and the organism-only criterion 

decreased from 4,500 to 400 μg/L (Table 2). The following paragraphs describe the individual 

influence of each of the revised model inputs and exposure assumptions on the overall change 

in value. 

Body Weight 

EPA’s updated AWQC assume a higher body weight compared to the previously 

recommended 2002 criteria, reflecting a recent rise in average adult body weight among the 

U.S. population. The updated body weight assumption of 80 kg based on recent survey data 

from the 1999−2006 NHANES data is 10 kg greater than the previous recommendation of 70 kg. 

Assuming all other input parameters remain constant, a higher average body weight in the 

AWQC calculations (Eq. 1 and 2 above) results in higher AWQC. That is, as body weight 

increases, the level of a contaminant in water at or below which negative health effects are not 

anticipated from a lifetime of exposure also increases. 

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Di-n-Butyl Phthalate 84-74-2 

Drinking Water Intake 

The updated drinking water intake assumption is 3 L/day, which is higher than the 

previously recommended rate of 2 L/day. Assuming all other input parameters remain constant, 

a higher drinking water intake assumption in the AWQC calculations (Eq. 1 and 2 above) results 

in lower AWQC. That is, as drinking water intake increases, and thus overall exposure increases, 

the level of a contaminant in water at or below which negative health effects are not 

anticipated from a lifetime of exposure decreases. 

Fish Consumption Rate 

The updated fish consumption rate is 22 g/day, divided into trophic level rates of 8 

g/day, 9 g/day, and 5 g/day for trophic levels 2, 3, and 4, respectively, which is higher than the 

previously recommended rate of 17.5 g/day. Assuming all other input parameters remain 

constant, a higher fish consumption rate assumption in the AWQC calculations (Eq. 1 and 2 

above) results in lower AWQC. That is, as fish consumption increase, and thus overall exposure 

increases, the level of a contaminant in water at or below which negative health effects are not 

anticipated from a lifetime of exposure decreases. 

Bioaccumulation Factor 

The updated AWQC rely on EPI Suite model-estimated BAFs rather than the previously 

recommended BCF of 89 L/kg. The lower (TL2), mid (TL3), and upper (TL4) trophic level BAFs 

assumed in the updated criteria equations (Eq. 1 and 2 above) are 236.2, 209.4, and 159.4 L/kg 

wet-weight, respectively. Assuming all other input parameters remain constant, the higher 

ratios of fish tissue concentrations to water concentrations of di-n-butyl phthalate by aquatic 

organisms result in lower AWQC. That is, as bioaccumulation or bioconcentration of a 

contaminant in fish and shellfish increases, and thus overall exposure increases, the level of a 

contaminant in water at or below which negative health effects are not anticipated from a 

lifetime of exposure decreases. The utilization of a bioaccumulation factor rather than a 

bioconcentration factor better represents the amount of a contaminant accumulating in an 

Ϊιͽ̯ΣΊν΢ ̼̯͋̽Ϣν͋ Ίχ ̯̽̽ΪϢΣχν ΣΪχ ΪΣΜΘ ͕Ϊι χ·͋ Ϊιͽ̯ΣΊν΢͛ν ͋ϳζΪνϢι͋ χΪ χ·͋ ζΪΜΜϢχ̯Σχ ΊΣ χ·͋ Ϯ̯χ͋ι 

column, but also from the food chain and surrounding environment as well as 

biotransformation of the pollutant in the organism due to metabolic processes. The utilization 

of the three trophic levels of fish and shellfish consumed, as opposed to representing all trophic 

levels of fish and shellfish consumed by a single value, allows for better exposure 

representation, especially when pollutants bioaccumulate in significantly different amounts for 

organisms in different trophic levels at different positions in the food chain. 

Relative Source Contribution 

The adoption of the recommended default RSC of 20 percent will be replacing the 

previous default of 100 percent. Assuming all other input parameters remain constant, a 

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Di-n-Butyl Phthalate 84-74-2 

smaller relative source contribution assumption in the AWQC calculations (Eq. 1 and 2 above) 

results in lower AWQC. That is, as the relative source contribution decreases, the level of a 

contaminant in water at or below which negative health effects are not anticipated from a 

lifetime of exposure decreases. 

Additional routes of exposure to a particular pollutant besides exposure from water 

intake and fish consumption are possible and may be considered when setting criteria for a 

state or tribe. Possible additional routes include, but are not limited to, dermal exposure, 

inhalation exposure, marine fish and shellfish consumption (when not included in the fish 

consumption rate), and non-fish dietary exposures (fruits, vegetables, grains, meats or poultry). 

If scientific evidence exists which indicate that one or more of these routes pose a significant 

risk of exposure, states and authorized tribes are encouraged to ensure that subpopulations are 

adequately protected. 

States, territories, and authorized tribes have the flexibility to develop criteria, on a sitespecific basis, that provide additional protection appropriate for highly exposed populations. 

EPA is aware that exposure patterns in general, and fish consumption in particular, vary 

substantially. EPA understands that highly exposed populations may be widely distributed 

geographically throughout a given state, territory, or authorized tribal area. EPA recommends 

that priority be given to identifying and adequately protecting the most highly exposed 

populations. Thus, if a state, territory, or authorized tribe determines that a highly exposed 

population is at greater risk and would not be adequately protected by criteria based on the 

general population, and by the national 304(a) criteria in particular, the state, territory, or 

authorized tribe may adopt more stringent criteria using alternative exposure assumptions 

(USEPA, 2000). Subpopulations that may be considered include, but are not limited to, 

recreational fishers, subsistence fishers, women of childbearing age, and children. When 

scientific data exist showing one of these subpopulations is at risk of greater exposure to the 

pollutant or are biologically more sensitive, then the relevant inputs should be considered in 

setting criteria. This could entail raising the fish consumption rate to a level more reflective of 

the subpopulation based on collected data or adjusting the body weight and drinking water 

intake. 

Chemical Name / Synonyms 

 Di-n-butyl phthalate (CAS Number 84-74-2) 

 1,2-Benzenedicarboxylic Acid Dibutyl Ester 

 o-Benzenedicarboxylic Acid, Dibutyl Ester 

 Benzene-o-Dicarboxylic Acid Di-n-Butyl Ester 

 Butylphthalate 

 Celluflex DPB 

 Dibutyl 1,2-Benzene dicarboxylate 

 Dibutyl phthalate 

 Di-n-Butylphthalate 

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Di-n-Butyl Phthalate 84-74-2 

 Dibutyl-o-Phthalate 

 DPB 

 Elaol
 

 Ergoplast FDB
 

 Genoplast B
 

 Hexaplast M/B
 

 N-Butylphthalate 

 Palatinol C
 

 Phthalic Acid Dibutyl Ester
 

 Polycizer DBP 

 PX 104
 

 RC Plasticizer DBP
 

References 

Smith, C.C. 1953. Toxicity of butyl sterate, dibutyl sebacate, dibutyl phthalate and methoxyethyl 

oleate. Arch. Hyg. Occup. Med. 7: 310-318. 

USEPA (U.S. Environmental Protection Agency). 1980. Ambient Water Quality Criteria for 

Phthalate Esters. Office of Water. Washington, DC. EPA-440-5-80-067. 

http://water.epa.gov/scitech/swguidance/standards/criteria/upload/AWQC-forPhthalate-Esters_1980.pdf. 

USEPA (U.S. Environmental Protection Agency). 1990. Dibutyl phthalate (CASRN 84-74-2). 

Integrated Risk Information System. Retrieved 18 July 2013. 

http://www.epa.gov/iris/subst/0038.htm. 

USEPA (U.S. Environmental Protection Agency). 2000. Methodology for Deriving Ambient Water 

Quality Criteria for the Protection of Human Health. Office of Water. Washington, DC. 

EPA-822-B-00-004. 

http://water.epa.gov/scitech/swguidance/standards/upload/2005_05_06_criteria_hum 

anhealth_method_complete.pdf. 

USEPA (U.S. Environmental Protection Agency). 2002a. Estimated Per Capita Fish Consumption 

in the United States. Washington, DC. EPA-821-C-02-003. 

http://water.epa.gov/scitech/swguidance/standards/criteria/health/upload/consumpti 

on_report.pdf. 

USEPA (U.S. Environmental Protection Agency). 2002b. National Recommended Water Quality 

Criteria: 2002. Office of Water. Washington, DC. EPA-822-R-02-047. 

http://water.epa.gov/scitech/swguidance/standards/upload/2008_04_29_criteria_wqct 

able_nrwqc-2002.pdf. 

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Di-n-Butyl Phthalate 84-74-2 

USEPA (U.S. Environmental Protection Agency). 2011. Exposure Factors Handbook: 2011 

Edition. Office of Research and Development. Washington, DC. EPA-600-R-09-052F. 

http://www.epa.gov/ncea/efh/pdfs/efh-complete.pdf. 

USEPA (U.S. Environmental Protection Agency). 2012a. Estimation Programs Interface SuiteTM 

for Microsoft® Windows, v 4.10. United States Environmental Protection Agency, 

Washington, DC, USA. http://www.epa.gov/oppt/exposure/pubs/episuite.htm. 

USEPA (U.S. Environmental Protection Agency). 2012b. Framework for Human Health Risk 

Assessment to Inform Decision Making. Office of the Science Advisor. Washington, DC. 

EPA-601-D-12-001. http://www.epa.gov/raf/files/framework-document-7-13-12.pdf. 

USEPA (U.S. Environmental Protection Agency). 2014. Estimated Fish Consumption Rates for 

the U.S. Population and Selected Subpopulations (NHANES 2003-2010). Office of Water. 

Washington, DC. EPA-820-R-14-002. 

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