TSCA NEW CHEMICALS REVIEW PROGRAM

STANDARD REVIEW RISK ASSESSMENT ON

MEDIUM-CHAIN CHLORINATED PARAFFINS 

(PMN P-14-0683, P-14-0684)

This assessment was conducted under EPA’s TSCA Section 5 New Chemicals 

Review Program. EPA is assessing Medium-Chain Chlorinated Paraffin (MCCP) 

and Long-Chain Chlorinated Paraffin (LCCP) chemicals as part of its New 

Chemicals Program. As with all Premanufacture Notice (PMN) submissions, EPA 

followed the approaches, methods and statutory provisions of TSCA section 5 for 

the chlorinated paraffin PMNs assessments. 

United States

Environmental Protection Agency

Premanufacture Notification 

Number: P-14-0683-0684

Office of Chemical Safety and 

Pollution Prevention
2

CONCLUSIONS

Based on its assessment of the available hazard and exposure information on P-14-0683/0684, 

EPA/OPPT concludes the following pertaining to the potential manufacturing, processing and 

use of these PMN substances

1. Occupational Exposures: given the assumptions, data and scenarios evaluated in this 

assessment, there were no risks found for workers from either dermal or inhalation 

exposures.

2. General Population Exposures (from environmental releases): given the assumptions, data 

and scenarios evaluated in this assessment, there were no risks found to humans from 

environmental releases via exposure to drinking water or fish ingestion.

3. Environmental Assessment:

a. Using estimated environmental concentrations, the PMN substances may present an 

unreasonable risk following acute and chronic exposures to aquatic organisms.

b. Using available measured concentrations of MCCP congener groups in the environment as 

supporting information, the PMN substances:

i. Are expected to partition to sediment and may partition to soil through land 

application of biosolids and,

ii. May be released to the environment at levels at or above estimated concentrations of 

MCCP congener groups that may present an unreasonable risk following acute 

and chronic exposures to aquatic organisms.

4. PBT Assessment: The PMN substances may be very persistent and very bioaccumulative.
3

TABLE OF CONTENTS

TABLE OF CONTENTS ............................................................................................................. 3

1 INTRODUCTION................................................................................................................. 5

1.1 PMNS RECEIVED ......................................................................................................................................5

1.2 CHEMISTRY...............................................................................................................................................5

1.3 USES............................................................................................................................................................7

2 ENVIRONMENTAL FATE................................................................................................. 8

2.1 ENVIRONMENTAL PERSISTENCE.........................................................................................................8

2.2 BIOCONCENTRATION AND BIOACCUMULATION............................................................................9

3 ECOLOGICAL HAZARD OVERVIEW.......................................................................... 10

4 HUMAN HEALTH HAZARD OVERVIEW ................................................................... 13

4.1 MCCP HEALTH DATA REVIEW............................................................................................................13

5 EXPOSURE INFORMATION........................................................................................... 15

5.1 ENVIRONMENTAL MONITORING.......................................................................................................15

5.2 MODELED ENVIRONMENTAL RELEASES ........................................................................................17

5.3 EXPOSURE ESTIMATES ........................................................................................................................19

5.3.1 Occupational Exposure Estimates..........................................................................................................19

5.3.2 Consumer Exposure Estimates...............................................................................................................20

6 RISK ASSESSMENT.......................................................................................................... 20

6.1 ENVIRONMENTAL ASSESSMENT..................................................................................................................20

6.1.1 Risk Estimates Using Environmental Monitoring Data .........................................................................21

6.1.2 Risk Estimates Using Modeled Exposures..............................................................................................22

6.2 HUMAN HEALTH.........................................................................................................................................23

6.2.1 Workers ..................................................................................................................................................24

6.2.2 General Population (from Environmental Releases) .............................................................................25

7 CONCLUSIONS.................................................................................................................. 27

8 REFERENCES .................................................................................................................... 28

9 APPENDICES...................................................................................................................... 42

Appendix A ENVIRONMENTAL FATE AND BIOACCUMULATION STUDY 

SUMMARIES.............................................................................................................................. 43

A-1 ENVIRONMENTAL PERSISTENCE.....................................................................................................43

A-1-1 Abiotic Degradation ..............................................................................................................................43

A-1-1-1 Fate in Air........................................................................................................................................................ 43

A-1-2 Biodegradation ......................................................................................................................................44

A-1-2-1 Fate in Wastewater Treatment......................................................................................................................... 44

A-1-2-2 Fate in Surface and Groundwater .................................................................................................................... 45

A-1-2-3 Fate in Soil ...................................................................................................................................................... 45

A-2 BIOCONCENTRATION AND BIOACCUMULATION ........................................................................50

Appendix B ECOTOXICITY STUDY SUMMARIES........................................................... 56

B-1 MCCP ECOTOXICITY DATA................................................................................................................56
4

B-1-1 Acute Fish Toxicity ................................................................................................................................56

B-1-2 Acute Aquatic Invertebrate Toxicity ......................................................................................................56

B-1-3 Algae Toxicity ........................................................................................................................................59

B-1-4 Chronic Fish Toxicity ............................................................................................................................60

B-1-5 Chronic Aquatic Invertebrate Toxicity ..................................................................................................62

B-1-6 Chronic Aquatic Sediment Invertebrate Toxicity ...................................................................................65

B-1-7 Avian Toxicity ........................................................................................................................................67

B-1-8 Terrestrial Invertebrate Toxicity............................................................................................................68

B-1-9 Soil Microorganism Toxicity..................................................................................................................69

B-1-10 Terrestrial Plant Toxicity.....................................................................................................................69

B-1-11 Conclusions..........................................................................................................................................70

Appendix C HUMAN HEALTH HAZARD STUDY SUMMARIES.................................... 71

C-1 MCCP HEALTH DATA REVIEW ..........................................................................................................71

C-1-1 Metabolism ............................................................................................................................................71

C-1-2 Acute Toxicity ........................................................................................................................................71

C-1-3 Irritation and Sensitization ....................................................................................................................71

C-1-4 Repeated-dose Toxicity ..........................................................................................................................72

C-1-5 Genotoxicity...........................................................................................................................................73

C-1-6 Carcinogenicity......................................................................................................................................73

C-1-7 Developmental Reproductive Toxicity ...................................................................................................77

Appendix D ENVIRONMENTAL MONITORING DATA .................................................. 84

D-1 MCCP MONITORING DATA.................................................................................................................84

D-1-1 Surface Water........................................................................................................................................84

D-1-2 Sediment ................................................................................................................................................86

D-1-3 Biosolids and Soil..................................................................................................................................95

D-1-4 Biota ......................................................................................................................................................95

Appendix E ENGINEERING (ChemSTEER) REPORTS ON P-14-0683 AND P-14-0684 98

Appendix F EXPOSURE SCENARIO ESTIMATES.......................................................... 111
5

1 INTRODUCTION

1.1 PMNS RECEIVED

Qualice submitted two Premanufacture Notices (PMNs) identified by EPA/OPPT as mediumchain chlorinated paraffins (MCCPs: P-14-0683 and P-14-0684) of varying chain lengths with 

the formula CxH(2x-y+2)Cly and x equaling 14 to 17 and y equaling 6 to > 24. Table 1 lists basic 

information Qualice supplied on these two PMNs.

Table 1: Identification, Production Volume and Use of P-14-0683 and P-14-0684

PMN Chemical Name First Year/Third Year 

Production Volume (kg)

Uses Log 

Kow

Water

Solubility

P-14-0683 Tetradecane, 

chloro 2,500,000/15,000,000

50% flame retardant in 

rubber products and 50% 

additive in lubricants

4.70 

(E)

< 0.03 

mg/L (E)

P-14-0684 Alkanes, C14-16,

chloro 2,500,000/15,000,000

50% flame retardant in 

rubber products and 50% 

additive in lubricants

4.70 

(E)

< 0.03 

mg/L (E)

E = Estimated

Although the specific PMNs in this application are MCCPs, this standard review presents data 

and information on short-chain chlorinated paraffins (SCCPs) and long-chain chlorinated 

paraffins analogs. The continuum of carbon chain length and degree/percent of chlorination in all 

of the CPs and the relationship among them needs to be kept in mind.

1.2 CHEMISTRY

Shown below are the structures and chlorine content of P-14-0683 and P-14-0684. Note that P14-0683 is 98% C14 and P-14-0684 is approximately 58% C14, the remainder of the latter being 

higher chain lengths:

Cl Cl Cl Cl Cl Cl Cl

Cl

Cl Cl Cl Cl Cl

Cl

P-14-0683 C14 98%; alpha olefin 94%; 

Cl level 92% 6 - 8 Cl atoms (52% - 60%)

P-14-0684 C14 58%; C15+ ~ 40%; 

Cl level 92% 6 - 8 Cl atoms (52% - 60%)
6

CPs have an unknown or variable composition (classified as UVCB1compounds for TSCA 

Inventory purposes) of polychlorinated n-alkanes. The carbon chain length usually varies 

between 10 and 30 carbon atoms and the degree of chlorination can vary between 30 and 75

wt%. EPA/OPPT subdivides CPs according to their carbon chain length into the following 

categories:

1. Short chain CPs (SCCPs, C10-13) 

2. Medium chain CPs (MCCPs, C14-17) 

3. Long chain CPs (LCCPs, C 18-20) 

4. Very long chain CPs (vLCCP, C>20)

SCCPs and MCCPs exist as liquids at standard temperature and pressure. CPs with a carbon 

chain length ≥ 18 are subdivided based on their physical state, which is a function of chain length 

and chlorine content. The LCCPs and vLCCPs up to 70 wt% Cl are typically liquids (40 – 55 

wt% Cl) while above 70 wt% Cl they are waxy solids. 

CP products contain a variety of carbon chain lengths that have been chlorinated to different 

degrees (i.e., variation in the number and position of the chlorine atoms on the carbon chain). 

The individual isomer content of commercial CPs is rarely identified because the number of 

possible individual congener groups is extremely large. Consequently, the physicochemical 

properties of CPs vary by carbon chain length and chlorine content. Increased molecular weight 

correlates to higher melting and boiling points, lower vapor pressures and water solubilities, and 

greater Log Kow (logarithm of octanol:water partition coefficient). The MCCP products 

considered for this analysis are liquids with chlorination levels between 40 to 60 percent. The 

physicochemical properties of interest in this risk assessment include: physical form, water 

solubility, vapor pressure, and log KOW (see Table 2).

Table 2: Physiochemical Informationa,b

wt% Cl Melting 

Point Boiling Point Vapor Pressure Water Solubility Log KOW

MCCPs > 40 < 25°C

(pour point) > 200°C (dec) < 0.036 Paat 20°C

27 μg/L

at 20°C

> 5.5 

(measured)

8.30 

(estimated)c,d

aSource: EURAR of MCCP (ECB, 2008)

bBecause most CP products are liquids and the CPs begin decomposing at 200°C (via loss of HCl), melting point 

and boiling points are considered less important in characterizing hazard and risk.

cValue calculated using the KOWWIN Program (v1.68) available in EPA/OPPT’s Estimation Programs Interface 

(EPI) Suite TM. This estimate was generated using a representative MCCP (i.e., C14H24Cl6, 52 wt% Cl) with the 

following SMILES notation: CCC(Cl)CC(Cl)CCCl)CC(Cl)CC(Cl)CC(Cl)C. 

dThe EURAR (ECB, 2008) cited Renberg’s liquid chromatography to measure a log KOW between 5.5 and 8.2 and 

then chose to use log KOW = 7 as a representative log KOW for MCCP 45 – 52 wt% Cl.

 

1 UVCB are chemical substances whose composition is Unknown or Variable compositions, Complex reaction 

products and Biological materials.
7

Analytical challenges exist with evaluating CPs due to the sheer number of congener groups2that 

may be present in CP products. The existence of multiple chain lengths in the UVCBs such as P14-0683 and P-14-0684 requires the use of analytical methods that separate congener groups 

based on retention time in a column and mass spectrum of the respective peaks. Several lines of

evidence support the use of a representative SCCP or MCCP product as a surrogate for congener 

groups present in MCCP or LCCP commercial products, respectively.

Hüttig (2006) and Hüttig and Oehme (2006) reported that most commercial MCCP products 

were > 60 wt% of the C14 chain-length congener groups and the C15 chain-length congener 

groups comprised the majority of the remaining  40 wt%. The authors found < 15 wt% C16

chain-length congener groups present in most commercial MCCP samples and little to no C17

chain-length congener groups. Additional studies have reported that the C14 and C15 chain-length 

congener groups are the predominant MCCPs present in environmental media and in human 

breast milk (Bayen et al., 2006; Chen et al., 2011; Reth et al., 2006; Wang et al., 2013). Some 

variation is possible in commercial products where the C14 and C15 chain-length congener groups 

may not be the predominant congener groups in a specific MCCP product; however, even in 

these products, the C14 and C15 chain-length congener groups may serve as reasonable worse 

case surrogates for the C16-17 chain-length congener groups, due to their greater bioavailability 

and mobility in environmental media (ECB, 2005).

These analyses, in conjunction with measured or estimated physicochemical and environmental 

fate properties, allow for the reasonable use of associating commercial products with CP levels 

found in environmental media and biota. For example, the experimental observation that MCCP 

(C14 – C17) are abundant in sediment has been explained using known water solubility and vapor 

pressure values in conjunction with predicted degradation pathways (de Boer, 2010). EPA/OPPT

determined that the toxic endpoints of interest were measured for only one CP (Cereclor S52®)

commercial product. Therefore, this approach of relating one commercial product with other 

commercial products is critical for attributing the hazard characterization to CPs of different 

sources. Thus, available information (hazard and environmental monitoring data) on one 

commercial product (Cereclor S52®) is used as a representative CP for this assessment.

Experimental data on SCCPs shows that these products are more toxic than the longer chain CPs

(e.g., MCCPs). Therefore, when endpoint specific data were lacking for the PMN, EPA/OPPT 

used measured data from SCCPs as surrogates for potential hazards and risks for the PMNs. 

1.3 USES

Qualace reported that 50% of both P-14-0683 and P-14-0684 would be used in metal working 

fluid (MWF) lubricants as a heat and pressure stabilizer. The remaining 50% will be used as a 

flame retardant for rubber compounding. Chlorination rates for these MCCP are more constant

for the rubber formulating applications (only using 52 – 53% Cl CP), while the amount of 

chlorine by weight is required for MWF varies based on the extreme conditions of the different 

metal working processes. 

Table 3 provides the trade names, range of chlorination and percent PMN substance in the final 

use products.

 

2 For this report, congener groups is used to recognize the existence of different chain lengths and degrees of 

chlorination that could be present in any given CP product.
8

Table 3: Trade Names, Percent Chlorination and PMN Concentration in Final Use 

Products

PMN Trade Names Percent 

Chlorination

Percent PMN in final 

Product

P-14-0683 CPAR MCCO 40-60 15% in lubricating oils and 

P-14-0684 CPAR MCCP 10% in final rubber product

2 ENVIRONMENTAL FATE

EPA/OPPT reviewed available information on the environmental fate of MCCPs and LCCPs in 

different environmental compartments and the properties that control transport (summarized in 

Appendix A). In addition, EPA/OPPT reviewed assessments performed by Canada (EC, 2008a)

and the EU (EA, 2009; ECB, 2005) to inform its assessment.

2.1 ENVIRONMENTAL PERSISTENCE

Abiotic studies have shown that MCCPs are stable to hydrolysis and to direct photolysis in water 

and air. In laboratory studies using hydrocarbon solvents, CPs were shown to poorly absorb UV 

light and no direct photodegradation was observed. The atmospheric half-life has been estimated 

at 1 - 2 days (EA, 2009; ECB, 2005), based on estimated values for the second order rate 

constant with atmospheric hydroxyl radicals for MCCPs (40 and 56 wt% Cl). The persistence of 

MCCPs increases with carbon chain length and higher chlorine content (EA, 2009; ECB, 2005).

Existing biotic degradation data suggest there are a number of microbial species capable of 

degrading shorter chain, lower chlorinated MCCP congener groups. Longer and higher 

chlorinated chemicals also may be degraded, but at much slower rates (Allpress and Gowland, 

1999; Muir, 2010; Omori et al., 1987). The results from laboratory studies of microbial 

metabolism, using both isolated species and mixed cultures of acclimated microbes, show that 

MCCPs and LCCPs may be degraded by direct metabolism or co-metabolism by some microbes 

and microbial consortia in soil, wastewater treatment systems, sediment, and other environmental 

media. Overall, the existing studies suggest that with microbial degradation, dechlorination and 

carbon chain cleavage may be possible in some media (see Table A-1); however the degree of 

degradation is generally low (Allpress and Gowland, 1999; Muir, 2010; Omori et al., 1987). 

In general, MCCP and LCCP congener groups with longer chain lengths and higher degrees of 

chlorination are expected to be highly persistent in some environmental compartments. In 

contrast, shorter and less chlorinated congener groups are likely to degrade rapidly, especially in 

aerobic environments. Because persistence appears to increase with chain length, LCCPs are 

generally expected to be more persistent than MCCPs (EA, 2009; ECB, 2005).

Based on the review of available literature and studies submitted by various manufacturers, 

including confidential business information (CBI) not publically available, EPA/OPPT’s 

conclusions regarding environmental persistence of MCCPs is consistent with those provided by 

Canada and the EU. 

Canada’s assessment (EC, 2008a),states:
9

“Information on physical properties of MCCPs, and especially LCCPs, is limited. Values 

used in this assessment are based on extrapolations mainly from SCCPs or QSARs. The 

analysis of SCCPs and MCCPs in sediment cores and associated calculations provide 

strong evidence for the persistence of these substances in the environment. Even though 

there are no data for persistence of LCCPs in sediment, based on biodegradation data 

which indicate increasing stability with increasing carbon chain length, it is reasonable 

to conclude that LCCPs are persistent in sediment.”

The EU assessment on MCCPs states (ECB, 2005):

3

“No standard ready or inherent biodegradation tests results are available for mediumchain chlorinated paraffins. From the available information, medium-chain chlorinated 

paraffins can be considered to be not biodegradable in such test systems and so a 

biodegradation rate MCCPs of 0 day-1 is used in the risk assessment. 

There is evidence that some microorganisms may be capable of degrading MCCPs in the 

environment in acclimated or co-metabolic systems. The potential for biodegradation 

appears to increase with decreasing chlorine content. However, it is not possible from 

the available data to derive rate constants for biodegradation in soil, surface water and 

sediment systems. As a worst case approach, no biodegradation will be assumed in these 

media in the PEC calculations.

Hydrolysis is not expected to be a significant degradation process for medium-chain 

chlorinated paraffins in the environment. An atmospheric half-life of 1-2 days is 

estimated for reaction with hydroxyl radicals. A value for the rate constant for the 

reaction (kOH) of 8 x 10-12 cm3 molecule-1s

-1

is used for the environmental modelling in 

the risk assessment.”

EPA/OPPT generally concurs with these characterizations. In the absence of information on 

specific congener groups and data for MCCP products, EPA/OPPT concludes that at least some 

congener groups present in MCCP products are persistent to very persistent; with estimated halflives in air exceeding 2 days and estimated half-lives in water or sediments exceeding 2 months 

(60 days) (ECB, 2005; EA, 2009)

2.2 BIOCONCENTRATION AND BIOACCUMULATION

Recent reviews of the potential for MCCPs to bioaccumulate have shown that, while data are 

limited, some congener groups are bioaccumulative or very bioaccumulative (EC, 2008a; ECB, 

2005; Houde et al., 2008; Thompson and Vaughan, 2014). A summary of studies reviewed by 

EPA/OPPT is provided in Appendix A. 

Based on EPA/OPPT’s review of existing studies (Bengtsson et al., 1979; CPC, 1980, 1983a, 

1983b; Fisk et al., 1999; Fisk et al., 1998; Houde et al., 2008; Madeley and Maddock, 1983a, 

 

3

 Note, since the EU issued its assessment in 2005, standard inherent biodegradation studies were performed and are 

summarized in Appendix A.
10

1983b; Madeley and Thompson, 1983; Renberg et al., 1986; Thompson et al., 2000), 

EPA/OPPT concludes that bioconcentration varies with the chain lengths and degree of 

chlorination within the CP mixture and species evaluated. Shorter and less chlorinated chemicals 

are readily taken up by organisms but also may be excreted or degraded after absorption (Arnot, 

2013). Longer and more highly chlorinated chemicals are typically not absorbed across cellular 

membranes and are not accumulated in tissues. Some MCCP chemicals with intermediate chain 

length and chlorination may be absorbed and retained. The available evidence for MCCP 

congener groups with intermediate chain lengths and chlorination suggests that some may have 

BCFs or BAFs greater than 1000 or 5000 (EC, 2008a; ECB, 2005, 2008). This suggests that 

some congener groups in MCCP products may be bioaccumulative or very bioaccumulative.

The Canadian assessment on MCCPs states (EC, 2008a):

“On the basis of the available information, and in particular the field BAF estimates, it is 

concluded that MCCPs are bioaccumulative substances...” 

EPA/OPPT generally concurs with these characterizations. In the absence of information on 

specific congener groups and data for MCCP products, EPA/OPPT concludes that at least some 

congener groups present in MCCP products are bioaccumulative to very bioaccumulative based 

on multiple lines of evidence, including: Log Kow values, modeled BCFs, laboratory-measured 

BCFs, field-measured BAFs, field-measured BMFs, laboratory-measured biota-sediment 

bioaccumulation factors (BSAFs) and the presence of MCCPs in human and wildlife biota.

3 ECOLOGICAL HAZARD OVERVIEW

The available ecotoxicity data on MCCPs are summarized in Appendix B, along with the criteria 

EPA/OPPT used for identifying the highest quality studies. Ecotoxicity studies for MCCPs have 

been conducted in fish, aquatic invertebrates and plants, sediment and soil invertebrates, and 

terrestrial plants and invertebrates. Though no avian reproduction studies were available on 

MCCPs, a high quality study was available on a SCCP product (C10-12, 58 wt% Cl) with similar 

physicochemical properties to MCCPs and was used for informing EPA/OPPT’s hazard 

evaluation (ECB, 2000). EPA/OPPT concludes that the studies summarized in Table 4 were the 

highest quality for assessing potential hazards in the aquatic, sediment and terrestrial 

compartments.
11

Table 4: Summary of Aquatic, Sediment and Terrestrial Ecotoxicity Data for MCCPs

Test Substance

Test 

Organism

(Species)

Test Guideline; Study 

type

Endpoint Value1 Reference

Aquatic Invertebrates

Cereclor S-52 (52% 

wt. Cl, C14-17)

Water flea

(Daphnia 

magna)

OECD 202, 1984; Acute 

immobilization test

EC50 0.0059 CPA (1996)

Cereclor S-52 (52% 

wt. Cl, C14-17)

Water flea

(Daphnia 

magna)

OECD 202- Part II, 1984; 

Reproduction test

NOEC

LOEC

MATC

0.01

0.018

0.013

(Thompson, 

et al., 1997)

Sediment-Dwelling Invertebrates

Cereclor S-52 (52% 

wt. Cl, C14-17)

Amphipod

(Hyalella 

azteca)

OECD 218- Draft, 2001; 

28-day prolonged sediment 

toxicity study

NOEC

LOEC

MATC

130

270

187

Thompson et 

al. (2002)

Terrestrial Invertebrates

Cereclor S-52 (52%

wt. Cl, C14-17)

Earthworm

(Eisenia 

fetida)

OECD Guideline-Draft, 

2000; 28-day reproductive 

toxicity test

NOEC

LOEC 

MATC

79 

280 

149 

Thompson et 

al. (2001d)

Terrestrial Vertebrates

Commercial CP 

(58% wt. Cl, C10-12 )

Mallard 

duck (Anas 

platyrhync

hos)

EPA 560/6-82-002; 22-

week reproduction test

NOEC

LOEC

168

1000

ECB (2000)

1 Units are mg/L for aquatic invertebrates, mg/kg dry weight sediment for sediment-dwelling

invertebrates; mg/kg dry weight soil for earthworm study; and mg/kg diet for the duck study.

Using the concentrations in the “value” column in Table 4 to represent hazard, the Agency 

derived concentrations of concern (COCs) by applying assessment factors of five or ten for acute 

or chronic exposures, respectively, which account for laboratory variability and represents

species sensitivity distributions (following USEPA, 2012). The COCs derived for aquatic-, 

sediment-, and terrestrial-dwelling organisms are summarized in Table 5. 

The most reliable and acceptable studies indicate that for MCCPs, the toxicity to aquatic 

organisms are from the CPA (1996) study for acute toxicity and the Thompson et al. (1997) 

study for chronic toxicity:

 Acute COC: The 48-hour EC50 value 0.0059 mg/L is divided by an assessment factor of 

5 to yield an acute concentration of concern (CoC) of 0.00118 mg/L, or 0.001 mg/L, or 1 

μg/L (1 ppb). 

Aquatic Acute COC = 1 ppb.

 Chronic COC: The chronic value 0.013 mg/L is divided by an assessment factor of 10 to 

yield 0.0013 mg/L or 1.3 μg/L or 1.3 ppb.

Aquatic COC = 1 ppb.

The most reliable and acceptable value for the acute toxicity to aquatic sediment invertebrate 

organisms is based on the MCCP material from the Thompson et al. (2002) 28-d study. The 28-d 

sediment invertebrate GMATC value of 187 mg/kg dry wt sediment is used to assess hazard. 

Using methods in USEPA (2012): 
12

 Acute COC: The chronic value 187 mg/kg dry wt. is multiplied by an acute to chronic 

ratio for invertebrates (10) to yield 1,870 mg/kg dry wt. This value is then divided by an 

assessment factor of 5 to yield 374 mg/kg dry wt. 

Aquatic Sediment Acute COC = 374 mg/kg dry wt sediment.

 Chronic COC: The 28-d sediment invertebrate GMATC of 187 mg/kg dry wt sediment is 

divided by an assessment factor of 10 to yield 18.7 mg/kg dry wt sediment. 

Aquatic Sediment COC = 18.7 mg/kg dry wt sediment.

The most reliable and acceptable value for acute toxicity to terrestrial invertebrates is based on 

the MCCP material from the Thompson et al. (2001a) study. The 28-d terrestrial invertebrate 

GMATC value of 149 mg/kg dry wt soil from this study will be used. Using methods in USEPA 

(2012): 

 Acute COC: To calculate an acute concern concentration from the chronic value the 

value 149 mg/kg dry wt, is multiplied by an acute to chronic ratio for invertebrates (10) 

to yield 1,490 mg/kg dry wt. This value is then divided by an assessment factor of 5 to 

yield 298 mg/kg dry wt.

Terrestrial Invertebrate Acute COC = 298 mg/kg dry wt.

 Chronic COC: The 28-d terrestrial invertebrate GMATC of 149 mg/kg dry wt is divided 

by an assessment factor of 10 to yield 14.9 mg/kg dry wt.

 Terrestrial Invertebrate Chronic COC = 14.9 mg/kg dry wt.

The most reliable and acceptable value for acute toxicity to terrestrial vertebrates is based on the 

MCCP material from the ECB (2001) study. The 22-week terrestrial vertebrate NOEC value of 

168 mg/kg dry wt soil from this study will be used. Using methods in USEPA (2012): 

 Acute COC: To calculate an acute concern concentration from the chronic value the 

value 168 mg/kg diet is multiplied by an acute to chronic ratio for invertebrates (10) to 

yield 1,680 mg/kg diet. This value is then divided by an assessment factor of 5 to yield 

336 mg/kg diet.

Terrestrial Vertebrate Acute COC = 336 mg/kg diet.

 Chronic COC: The 22-week terrestrial vertebrate NOEC of 168 mg/kg diet is divided by 

an assessment factor of 10 to yield 16.8 mg/kg diet.

Terrestrial Vertebrate Chronic COC = 16.8 mg/kg diet.
13

Table 5: COCs for Environmental Toxicity of MCCPs

Compartment Test organism Endpoint Value Assessment 

factor COC

Surface water Water flea

EC50 0.0059 mg/L 5 0.001 mg/L

21-day MATC 0.013 mg/L 10 0.001 mg/L

Sediment Amphipod MATC 187 mg/kg dw 10 18.7 mg/kg dry 

wt. sediment

Terrestrial

Earthworm 28-day MATC 149 mg/kg dw 10 14.9 mg/kg dry 

wt. soil

Mallard duck 22-week NOEC 168 mg/kg diet 10 16.8 mg/kg diet

4 HUMAN HEALTH HAZARD OVERVIEW

A summary of EPA/OPPT’s evaluations on MCCPs is provided in section 4.1; individual study 

reviews are provided in Appendix C.

4.1 MCCP HEALTH DATA REVIEW

There is no information on inhalation absorption of MCCPs in humans or in animals. Based on 

their low vapor pressure and low water solubility, absorption following inhalation or dermal 

exposure is expected to be limited. Previous evaluations concluded that absorption by the 

inhalation and dermal routes of exposure will not exceed 50 or 1%, respectively (ECB 2005; EA 

2009). Some MCCPs demonstrated moderate absorption and metabolism following oral 

exposure in animals. In general, absorption and metabolism are related to their carbon chain 

length and degree of chlorination; the longer the carbon chain length and the higher the degree of 

chlorination, the less absorption and metabolism. 

No information is available on the toxicity of MCCPs in humans; however, the toxicology of 

these compounds has been evaluated in experimental animals. Studies in rats and rabbits have 

shown that MCCPs caused slight skin irritation and have low eye irritation potential. No 

evidence of skin sensitization was found when tested in guinea pigs. The liver, kidney and 

thyroid are the target organs of MCCPs in oral repeated dose studies in experimental animals

(see Table C-1 in Appendix C). MCCPs induced increased liver weight, enzyme activity, and 

histopathological changes at high dose levels. Some of these hepatic effects are likely related to 

an increase in metabolic demand as an adaptive response, as well as to peroxisome proliferation, 

which are considered of limited toxicological significant to humans. However, liver necrosis was 

observed in a 90-day study in rats at 360 mg/kg-bw/day; this effect is considered relevant to 

humans. The reported effects in the kidney may have been produced by the parent compound or 

from metabolites. Mechanistic data cannot totally rule out that some kidney effects are relevant 

to humans. From the data available, a LOAEL of 625 mg/kg-bw/day based on histopathological 

changes in the kidneys of female rats is identified in a 90-day toxicity study, and a NOAEL of 23 

mg/kg-bw/day based on increased kidney weight at 222 mg/kg-bw/day is identified from another 

90-day study in rats (CXR, 2005). Repeated dose studies in rats reported some changes in 

histopathology and hormone levels of the thyroid. However, it may be concluded based on an 
14

evaluation of the mechanistic data that the thyroid effects observed in rats is of little relevance to 

chronic toxicity in humans.

There is no information on the carcinogenicity of MCCPs; however, carcinogenicity studies on a 

SCCP and a vLCCP are available. These studies, along with the genotoxicity data on MCCPs, 

may be used to inform the carcinogenic potential of MCCPs. When administered by gavage, a 

SCCP (C12, 60 wt% Cl) caused increased incidences of liver tumors in male and female rats, 

kidney tumors in male rats, and thyroid tumors in female rats. However, based on mechanistic 

considerations, these tumors are considered to be of little or no relevance to humans (details in 

ECB, 2008 and in Appendix C). An increased incidence of malignant lymphoma in male mice 

was reported at the highest dose of 5,000 mg/kg-bw/day in carcinogenicity studies of a vLCCP 

(C23, 43 wt% Cl) in male and female rats and mice. However, malignant lymphoma is one of the 

more variable tumors in mice and has a viral origin in many cases. No increased incidence of 

malignant lymphoma was observed in the carcinogenicity study on an SCCP. Further, MCCPs 

are non-genotoxic. Therefore, it may be concluded that MCCPs are unlikely to pose a 

carcinogenic hazard to humans.

A series of range-finding and definitive prenatal developmental and reproductive toxicity studies 

were conducted in rats and rabbits with medium-chain chlorinated paraffins (MCCPs). These 

studies were conducted between 1981 and 1986. They appear to be valid toxicity studies, 

conducted according to the standard methodologies available at the time. 

In several prenatal developmental toxicity studies with MCCPs conducted via gavage, no signs 

of maternal toxicity were seen at doses as high as 500 mg/kg-bw/day in rats and 100 mg/kgbw/day in rabbits. Likewise, no signs of developmental toxicity were observed at doses as high 

as 5000 mg/kg-bw/day in rats and 100 mg/kg-bw/day in rabbits. 

Two reproductive toxicity studies with MCCPs in rats have been conducted. A one-generation 

reproductive toxicity range-finding study showed that administration of approximately 100 and 

400 mg/kg-bw/day MCCPs via the diet had no effect on fertility or other reproductive 

parameters; however, internal hemorrhaging and deaths in pups were observed at doses from 74 

mg/kg-bw/day (1000 ppm) up to approximately 400 mg/kg-bw/day (6250 ppm). These effects in 

the pups were not seen in a more recent definitive one-generation reproductive toxicity study 

with exposure to MCCPs for 11-12 weeks to doses as high as 100 mg/kg-bw/day (1200 ppm).

Internal hemorrhaging was not seen in the adult animals in either of these studies at doses as high 

as 400 mg/kg-bw/day (6250 ppm), or in another study in non-pregnant female rats repeatedly

exposed to doses as high as 1000 mg/kg-bw/day. However, when dams were exposed to 

approximately 500 mg/kg-bw/day (6250 ppm) MCCPs during cohabitation, gestation, and 

lactation, signs of hemorrhaging were observed in dams that died at the time of parturition. 

Taken together, the results of these studies suggest that newborns during lactation and pregnant 

females at the time of parturition are a potentially sensitive subpopulation; with a possible 

LOAEL for internal hemorrhaging and deaths in pups at an oral dose of 74 mg/kg-bw/day. 

Additional studies with MCCPs have been conducted in an effort to clarify the possible causes of

the hemorrhaging in the pups. One (single-dose; 6250 ppm or 538 mg/kg-bw/day) study showed 

maternal death during parturition due to low levels of vitamin K and related hemorrhaging, 
15

suggesting that the act of parturition places dams at higher risk. It was concluded from this study 

and a cross-fostering study that the fetus relies on clotting factors via mother’s milk and severe 

deficiencies in vitamin K levels and related clotting factors in the pups results in hemorrhaging.

No guideline developmental neurotoxicity studies on MCCPs were located. It is not clear if any 

developmental neurotoxicity endpoints were measured in the available prenatal 

developmental/reproductive toxicity studies; none were explicitly stated. The only information 

available regarding behavior during development is from cage-side observations in pups through 

lactation day 21. In these cases, no dose-related differences were reported in F1 post-weaning 

appearance or cage-side behaviors. While thyroid hormone induced effects were observed in 

adults, no data exist for developmental studies. Current studies do not evaluate developmental 

neurotoxicity following perinatal exposures.

In this assessment, the lowest NOAEL (90-day value of 23 mg/kg/d from the rat study described 

above; CXR, 2005) will be used to assess occupational and non-occupational (i.e., general 

population) risks of MCCPs.

5 EXPOSURE INFORMATION

EPA/OPPT used the information in this section and our standard PMN approaches to estimate 

potential worker exposures from activities associated with manufacturing, processing and use of 

P-14-0683 and P-14-0684. Environmental releases from these activities were also estimated for 

use in assessing risk to both human health (general population) and the environment (aquatic 

organisms). In addition, EPA/OPPT reviewed the available information on measured 

environmental concentrations of MCCPs and LCCPs, which are not normally available for 

PMNs.

5.1 ENVIRONMENTAL MONITORING

For this assessment, environmental monitoring data consisting of measured levels of MCCPs in 

surface water, sediment and soil were used to characterize potential environmental exposure to 

MCCPs. These data are not amenable to determining the ultimate release source (i.e., 

manufacturing, processing, or use) into the environment; however, they provide some insight on 

the geographical and temporal distribution of MCCPs. Appendix D contains information and 

data used in this risk assessment.

Studies published between 1980 and 2013 that reported environmental concentrations of MCCPs 

and were reviewed for this assessment. Monitoring studies from the early 1980s could not 

distinguish between the different chain lengths of CPs. The introduction of modern techniques, 

such as electron capture negative ion mass spectrometry (ECNI-MS) allowed for the detection of 

specific congeners, although difficulties with these methods have persisted (e.g., detection of low 

chlorination congeners in samples). Tomy (2010) performed a round robin laboratory study of 

SCCPs that highlighted the inability of the ECNI-MS method to consistently measure a reference 

sample, with concentrations varying up to a factor of six. Subsequent work showed that 

significant errors (up to a factor of ten) could be introduced by the improper selection of the 

calibration standards (Coelhan et al., 2000). A more recent inter-laboratory study of SCCPs 
16

found good agreement amongst the laboratories that used ECNI-MS (Pellizzato et al., 2009), but 

similar inter-laboratory studies for MCCPs or LCCPs have not been completed (Tomy, 2010). 

The majority of the monitoring data were collected in Europe, and some more recent monitoring

data were collected in China. Over time and across countries, industrial practices and effluent 

pre-treatment have varied. Some of the monitoring studies only published their final measured 

concentrations, and did not include the details of the analytical techniques and sampling 

locations. Generally, EPA/OPPT used studies sponsored by the environmental agencies, but full 

documentation is lacking for even these studies. The industrial sectors studied by other countries 

also are present in the US, suggesting that conditions in the US may be similar. 

The level of detail provided in the studies varied. Some studies provided detailed information 

regarding sampling locations (e.g., impacted sites), analytical methodology, and final sample 

results including detection limits, quantitation limits, and estimated values. In contrast, other 

studies provided only a summary of the results combined from a number of studies. These 

summaries also did not provide details of the data analysis to obtain sample results. In addition, 

certain studies reported concentrations within a given country but did not provide additional 

details about the exact sampling location. Given the disparate conditions (i.e., number of sites 

sampled, temporal period over which samples collected, differing analytical methods, etc.) 

across the data sets, EPA/OPPT was unable to determine a central tendency or distribution for 

the data sets, and a range was used instead. Studies using older analytical techniques that did not 

distinguish CP congeners were not used in this assessment. Other nations’ assessments that used 

newer, more reliable, analytical techniques were considered.

EPA/OPPT used the following selection criteria to identify the studies included in this 

assessment:

 Specific mention of MCCP/LCCP chain length;

 Use of modern analytical techniques to distinguish categories of CPs;

 At a minimum, general information on sampling location.

EPA/OPPT used the monitoring data summarized in Tables 6 for this assessment. When a limit 

of detection (LOD) value was reported for non-detectable results4, EPA/OPPT used one half of 

the LOD value, as described in greater detail below. 

Even though the existing monitoring data were limited in quality and quantity, and it remains 

unclear how well the measured data describe the potential range of US MCCP use scenarios, 

EPA/OPPT concluded that the data in Tables 6 represented the best available monitoring 

information for MCCPs. These data provide some evidence that MCCPs are released into the 

environment; however, these data reflect discrete locations and times, and the extent to which 

they are representative of the overall distribution of MCCPs is unknown.

 

4 Examples would be “not detected” (ND), negligible, or with a “less than” qualifier.
17

Table 6: Summary of Measured Concentrations of MCCPs in Environmental Media and Biota

Media n Minimum Unit Maximum Unit References

Surface 

water

(non-marine)

15 <2.50×10-10 mg/L 1.49×10-3 mg/L

Coelhan (2010); EC (2008); 

Houde et al. (2008); IPCS (1996); 

Muir et al. (2003); USEPA 

(1988) Petersen et al., 2006a

Sediment 

(non-marine) 78 2.00×10-3 mg/kgb 6.51×101 mg/kg dw

Borgen et al. (2003); Chen 

(2011); EC (2008); Iozza et al. 

(2008); IPCS (1996); Nicholls et 

al. (2001);

Petersen et al. (2006); Pribylova 

et al. (2006); Tomy et al. (1998, 

1999a,b); USEPA (1988)

Sediment 

(marine) 54 5.00×10-3 mg/kg dw 1.64×101 mg/kg dw

Huttig et al. (2004); Huttig and 

Oehme (2005, 2006); Kemmlein 

et al. (2002); Muir et al. (2000)

Sludge 9 5.00×10-5 mg/kgb 9.70×103 mg/kg dw Stevens et al. (2003); Pribylova et 

al. (2006)

Soil 12 2.1 × 10-6 mg/kg 

dw 8.5 × 10-2 mg/kg dw Iozza (2010); Wang et al. (2013)

Biota 

(aquatic) 120 < 2.00×10-7 mg/kg 2.63 mg/kg ww

Bennie et al. (2000); EC (1993); 

EC (2008); Houde et al. (2008); 

IVL(2009); Kemmlein et al. 

(2002);

Muir (2010); Muir et al. (2000); 

Muir et al. (2003); Reth et al. 

(2005, 2006); Tomy et al. 

(1999a); USEPA (1998)

Biota 

(terrestrial) 8 5.00×10-3 mg/kg ww

3.70×10-1 mg/kg ww Reth et al. (2006)

aPetersen et al. (2006) reported results for two water samples; EPA/OPPT assumed these were non-marine surface 

water samples.

bThe weight type was not reported (i.e., wet, dry, or lipid weight).

Notes:

1. All values provided in the table above represent total MCCPs and not individual MCCP isomers.

2. The “n” value represents the number of media-specific MCCP monitoring data values that were compiled from 

various articles in the raw data table (provided in Appendix D). 

3. In some cases, the minimum values in the table are preceded by “<”. This indicates that the value reported in 

article was reported as a non-detect. In such cases, one half of the lowest reported detection limit was compiled as the 

‘minimum’ reported monitoring data.

4. dw – dry weight and ww – wet weight

5.2 MODELED ENVIRONMENTAL RELEASES 

EPA/OPPT used screening-level models to generate environmental release estimates for P-14-

0683 and P-14-0684, which were used to calculate exposure concentrations for estimating risks 

to humans and aquatic organisms. EPA/OPPT used the Chemical Screening Tool for Exposures 

and Environmental Releases (ChemSTEER ver.2) to estimate environmental releases from 

industrial processes; the results are provided in Appendix E. Inputs to the ChemSTEER ver. 2 

release modeling were based on multiple sources, including information provided by Dover, 

published OECD Emission Scenario Documents, EPA/OPPT Generic Scenarios, and EPA/OPPT
18

models for estimating environmental releases. Table 7 provides a general summary of the release 

assessment.

Table 7: Summary of Estimated Release to Water

PMN Chemical Name Manufacturing Processing Use

P-14-0683 Tetradecane, chloro Yes

(one day/year)

Yes, from two 

processes

Yes, from two use 

types P-14-0684 Alkanes, C14-16, chloro

Exposure pathways of interest for human health include drinking water, fish ingestion, and air 

stack emissions. For aquatic organisms, the exposure pathway of concern is from direct releases 

to water. EPA/OPPT assessed each of these pathways by using the ChemSTEER ver. 2 release 

estimates as inputs to the Exposure and Fate Assessment Screening Tool (E-FAST V2.0) for 

estimating industrial releases and concentrations in the foregoing exposure pathways. 

EPA/OPPT assumed that potential releases to water occurred from indirect discharges to publicly 

owned treatment works (POTW). The E-FAST V2.0 modeling applied an assumption of 90%

removal of MCCPs at the POTW. Water concentrations were estimated using E-FAST V2.0’s 

probabilistic dilution model (PDM), which predicts downstream chemical concentrations from 

industrial discharges. These values were reported as the central tendency for a median flow site, 

a low flow site, and the lowest seven-day average flow that occurs on average once every ten 

years (i.e., 7Q10). These estimated water concentrations were compared to the COC of 1 μg/L 

for chronic aquatic invertebrates (see Table 5). Air stack emissions were estimated using generic 

scenarios, which assumed inhalation exposures occurring 100 meters downwind of a facility. 

EPA/OPPT used these estimated values for calculating human health and environmental risks of 

P-14-0683 and 0684.

The results of the E-FAST V2.0 modeling are provided in Appendix F. Table 8 presents the 

values used in the risk assessment. As explained in the footnotes to Table 8, the values represent 

reasonable worst-case scenarios based on the processing and use scenarios presented in Table 7. 

However, these estimates require consideration of two important caveats: (1) limited 

environmental monitoring data are available, and (2) MCCPs are expected to partition to 

particulates and sediment; however, the E-FAST V2.0 models do not account for this 

partitioning.
19

Table 8: E-FAST Modeling Values used1

Scenario2 Water Release - Human Air Release -

Human

Water Release –

Aquatic 

Organisms3

Drinking Water

(mg/kg/d)

Fish Ingestion

(mg/kg/d)

Stack Air LADD 

(mg/kg/d)

Range of 

Concentrations 

(g/L)

Manufacturing 1.19 x 10-56.22 x 10-51.69 x 10-3one day/year

Proc1 –

Formulation of 

MWFs3

1.48 x 10-47.70 x 10-43.23 x 10-35.6 – 40 (206)

Proc2 –

Compounding of 

rubber products

9.70 x 10-45.07 x 10-37.20 x 10-335 – 257 (1310)

Use1 – Use of 

MWFs

1.39 x 10-47.26 x 10-45.55 x 10-43 – 37 (333)

Use2 – Converting 

rubber products

4.81 x 10-52.51 x 10-47.50 x 10-31 – 13 (110)

1 Taken from Appendix F. Values represent the highest concentrations/estimated doses for chronic (i.e., repeated 

exposure scenarios) for human health. 

2 MWF = metal working fluids.

3 For PMNs, environmental risk was evaluated by performing a PDM as described above and in the E-FAST 

Manual (2007). The ranges encompass concentrations from the central tendency for a median flow site (e.g., 5.6 

μg/L) up to the central tendency for a low flow site (e.g., 40 μg/L) – this example taken from the second row. The 

central tendency was calculated using the harmonic mean flow. The value in parentheses represents the 7Q10 (e.g., 

206 μg/L) value normally used to determine acute risk.

5.3 EXPOSURE ESTIMATES

5.3.1 Occupational Exposure Estimates

EPA/OPPT calculated screening-level workplace exposure estimates with ChemSTEER ver. 

2.Table 9 provides a summary of the exposure estimates used in this risk assessment for 

evaluating worker exposures to P-14-0683 and P-14-0684; detailed information is provided in 

Appendix E. 
20

Table 9: Summary of Occupational Exposure Estimates Used1,2

Route of 

Exposure

Mfg Proc1

(MWF)

Proc 2

(Rubber)

Use 1

(MWF)

Use 2

(Rubber)

Inhalation

(mg/day)

Negligible (due to low 

vapor pressure) 0.03 – 4.4 1.5 - 5.3 0.7 - 15

Dermal

(mg/day)

1100 –

1200 340 – 2200 2200 260 - 370 Nonquantifiable3

1 All values apply to P-14-0683 and P-14-0684

2 The following represent the estimated number of sites and workers per scenario:

 Manufacturing (one site, three workers – 250 days/year)

 Proc 1 = Metalworking Fluid Processing (20 sites, 80 workers – 240 days/year)

 Proc 2 = Compounding of rubber products (six sites, 144 workers – 250 days per year)

 Use 1 = Metalworking fluid (3101 sites, 148,848 workers – 247 days/year)

 Use 2 = Converting of rubber products (16 sites, 768 workers – 250 days/year)

3 PMN will be encapsulated in rubber sheets/blocks during handling of rubber raw material. While some 

surface contact may occur, dermal exposure to solids in this form is non-quantifiable.

5.3.2 Consumer Exposure Estimates

Qualace did not identify consumer uses in its PMN applications for P-14-0683 and P-14-0684; 

therefore, the Agency did not perform an assessment for these types of exposures.

6 RISK ASSESSMENT

6.1 Environmental Assessment

PMN risk assessments typically use modeled exposure values because new chemical substances 

are not in the stream of US commerce; however, for MCCPs, measured environmental data are 

available for some locations in the US and abroad. Though these data are not specific to P-14-

0683 and 0684, the data contain MCCP congener groups that may be present in the PMN 

substances. However, EPA/OPPT used modeled exposure values as the principal source for its 

decision making because the modeled exposure values were generated using exposure scenarios 

that are representative of the types of uses and releases that may occur with P-14-0683 and 0684. 

In contrast, the measured environmental data are generally not amenable for identifying the types 

of uses or releases from which the measured congeners originated. Therefore, EPA/OPPT used 

these measured data as supporting information, along with modeled exposure values, to calculate 

potential environmental risks using the risk quotient (RQ) method. 

The RQ method integrates the results of exposure and ecotoxicity data (USEPA, 1998). 

An RQ is defined as:

RQ = Environmental Concentration ÷ Effect Level

where, the environmental concentration represents measured (see Table 6) or estimated (see 

Table 8) values for each compartment (i.e., water, sediment, and soil), and the effect level 

represents the COC for aquatic, benthic, or terrestrial species (see Table 5). 
21

An RQ greater than one serves as a benchmark for identifying whether aquatic concentrations of 

P-14-0683 and P-14-0684 may present an unreasonable risk to aquatic- and sediment-dwelling 

organisms. 

6.1.1 Risk Estimates Using Environmental Monitoring Data 

The RQs shown in Table 10 suggest that measured concentrations of MCCPs in water and 

sediment may present an unreasonable risk of acute and chronic injury to aquatic organisms and 

may present an unreasonable risk of chronic injury to sediment-dwelling organisms. However, 

several limitations must be noted about the monitoring studies and the level of uncertainty that 

they contribute to the basis of these findings. First, the reported concentrations represent 

minimum and maximum values that span, at a minimum, several orders of magnitude and 

translate to RQs of less than one (i.e., no risk finding) or greater than one (i.e., risk finding), 

respectively. Second, the temporal and geographical distributions of these data, along with the 

different types of uses and releases that may have served as the originating sources, make it 

impossible to describe the central tendency of these data. Finally, the frequency and magnitude 

of locations with relevant use and release scenarios to the PMN substances, which may result in 

environmental releases of MCCPs that exceed the relevant COCs, is unknown. In addition to 

these general limitations, there are specific limitations and uncertainties that preclude using these 

values as the sole source from which to inform potential environmental concentrations and risks 

that may result from the specific uses and releases associated with P-14-0683 and P-14-0684. 

Table 10: Risk Quotients Calculated from Environmental Monitoring Data for Surface Water, 

Sediment and the Terrestrial Environment

Environmental 

Concentration

Effect Level 

(i.e., COC) RQs1

Acute Risk

Aquatic Species

< 2.50×10-10 to 

1.49×10-3 mg/L 0.001 mg/L < 2.50×10-7

to 1.49

Chronic Risk

Aquatic Species

< 2.50×10-10 to 

1.49×10-3 mg/L 0.001 mg/L < 2.50×10-7

to 1.49

Chronic Risk

Sediment-dwelling Species

Non-marine Environment

0.002 to 65 mg/kg 

dw 18.7 mg/kg dw 1.07×10-4

to 3.5

Chronic Risk

Terrestrial Species Insufficient Data 14.9 mg/kg dw2 Not calculated

1Bolded values represent those that may present an unreasonable risk of injury.

2The COCs for terrestrial invertebrates and vertebrates were 14.9 mg/kg dw and 16.8 mg/kg diet, 

respectively. Since these values were comparable, EPA/OPPT used the lowest value for calculating RQs 

for this compartment.

For surface water, EPA/OPPT based the aquatic risk findings for MCCPs on the highest 

concentration reported by Petersen et al. (2006). These authors collected two surface water 

samples from an undisclosed location(s) in Norway and measured the concentration of MCCP 

congener groups (i.e., C14-17). The authors reported a concentration of 1.49 × 10-3 mg/L for 

MCCP congener groups in one sample; however, a numerical value was not provided for the 

second sample, rather the distribution of congener groups was displayed in a bar graph. Based on 

the ordinate scale, the concentration of MCCP congener groups in the second sample was greater 

than zero, but less than 5.0 × 10-4 mg/L. Of the monitoring studies reviewed by EPA/OPPT (see 
22

Appendix D), the Petersen et al. (2006) value of 1.49 × 10-3is the only surface water 

concentration that resulted in an RQ greater than one. All other surface water concentrations are 

at least one order of magnitude below 1.49 × 10-3 mg/L (i.e., RQs < 1). 

For sediment concentrations, EPA/OPPT reviewed multiple studies, some of which reported 

values that exceeded the COC. Nicholls et al. (2001) reported the most relevant data for P-14-

0683 and 0684. These authors measured concentrations of MCCPs at locations in the United 

Kingdom where specific industries were known to employ MCCPs in the use categories 

identified for the PMN substances (e.g., lubricant in MWFs). Eight locations were sampled at 

three distances downstream (i.e., 100 meters, 300 meters, and 1-2 kilometers) from the respective 

sewage treatment works. At four of the locations, at least one of the sampled downstream values 

exceeded the COC (i.e., RQs > 1, risk finding). Though it is not possible to parse out the 

contribution of specific uses to the measured values, these data support that releases occur at 

locations with relevant uses to the PMN substances, which contribute to the environmental load 

of MCCP congener groups and in some cases result in RQs greater than one. 

For soil concentrations, EPA/OPPT was unable to calculate RQs for terrestrial organisms due to 

the absence of relevant measured data from biosolid-amended soils. Though Iozza (2010) and 

Wang et al. (2013) reported measured levels of MCCPs in soil, the samples were collected from 

sites in remote alpine locations or industrialized areas, respectively. These data are relevant for 

assessing airborne deposition of MCCPs/LCCPs; however, the reported concentrations are of 

questionable relevance with informing concentrations of MCCPs/LCCPs that may occur in 

biosolid-amended agricultural soils.

Due to the foregoing limitations and resulting uncertainties with the measured environmental 

data, EPA/OPPT used these data in a limited capacity for estimating potential risks associated 

with the use categories identified for P-14-0683 and 0684. Specifically, these data were used as 

supporting information to inform the relevant pathways for estimating potential releases from 

relevant use categories for the PMN substances. A summary of the estimated release values and 

associated RQs that EPA/OPPT used as the primary basis for evaluating the potential risks of P14-0683 and 0684 is presented in the following section. 

6.1.2 Risk Estimates Using Modeled Exposures 

The RQs shown in Table 11 suggest that the intended processes and uses for P-14-0683 and 0684 

are expected to result in releases to surface water at concentrations that may present an 

unreasonable risk of injury to aquatic organisms. 

It is noteworthy that these estimated concentrations are within the range of measured surface 

water concentrations reported for MCCP congener groups (Table 6). Though there is uncertainty 

whether the form (i.e., dissolved or particle bound) of MCCP impacts the aquatic toxicity, the 

estimated values suggest that either form may exist. The median stream flow estimates are all 

below the reported water solubility for both PMN substances (Table 1). Since the available 

aquatic toxicity data support that dissolved MCCP congener groups cause toxicity, the median 

stream flow values suggest that the risk finding for this scenario is plausible. The low stream 

flow and 7Q10 flow scenarios estimate water concentrations that far exceed the estimated water 

solubility of P-14-0683 and P-14-0684. Under these scenarios, the MCCP congener groups 

would likely be bound to particulates and would eventually settle out in sediment. Nicholls et al. 
23

(2001) provided support for this pathway and showed that sediment concentrations of MCCP 

congener groups generally increased with distance downstream from the source outfall. Based on 

the foregoing information, EPA/OPPT concludes the following: 1) the median stream flow 

values were adequate for determining that environmental releases of P-14-0683 and P-14-0684 

may present an unreasonable risk of injury to aquatic organisms; and 2) it was unnecessary to 

estimate sediment concentrations of MCCP congener groups because any potential risks to 

sediment-dwelling organisms would be managed by addressing the risks identified for aquatic 

organisms. 

Table 11: Risk Assessment of Aquatic Organisms Using Modeled Exposures1

Scenario Estimated Water Concentrations (μg/L)2 RQs

Median Stream 

Flow Scenario

Low Stream 

Flow Scenario

7Q10

Flow Scenario

Proc1 –

Formulation of 

MWFs1

5.6 40 206 5.6 – 206

Proc2 –

Compounding of 

rubber products

35 257 1310 3.5 – 1310

Use1 – Use of 

MWFs

3 37 333 3 – 333

Use2 – Converting 

rubber products

1.1 12.8 110 1.1 - 110

1Taken from full model run of summary data presented in Appendix E (only summary table presented in Appendix). 

Full model runs are available on request.

2For PMNs, EPA/OPPT evaluated potential environmental risks by performing a PDM as described above and in 

the Exposure and Fate Assessment Screening Tool (E-FAST) Version 2.0 Documentation Manual (2007)”, 

available at: http://www.epa.gov/opptintr/exposure/pubs/efast2man.pdf

6.2 Human Health

EPA/OPPT assessed potential risks to workers and the general population by calculating margins 

of exposure (MOE). This approach is performed according to the following equation:

MOE = Point of Departure (POD) ÷ Estimated human exposure

For the PODs, EPA/OPPT identified effect levels from an oral repeated dose toxicity study, 

which served as the basis for calculating human equivalent doses (HEDs). CXR (2005) reported 

a NOAEL of 23 mg/kg-bw/day based on increased kidney weight at 222 mg/kg-bw/day in male 

rats exposed through diet for 90 days to an MCCP congener group (C14-17, 52 wt% Cl). 

Using the effect levels of 23 mg/kg-bw/day, EPA/OPPT performed route-to-route extrapolations 

to develop HEDs for inhalation and dermal exposures in workers and for inhalation and oral 

exposures in the general population. EPA/OPPT did not assess oral exposures for workers, due to 

the unlikely nature of exposures occurring by this route. The respective HEDs served as the 

PODs for calculating MOEs, along with the previously reported estimated human exposure 

values for workers (Table 9) and the general population (Table 8). 
24

EPA/OPPT compared the MOEs to a benchmark value that consisted of a multiplicative 

composite of three possible uncertainty factors (UFs): intraspecies variability (UFH; default value 

= 10), interspecies variability (UFA; default value = 10), and LOAEL-to-NOAEL extrapolation 

uncertainty (UFL; default value =10). The UFH and UFA may each be subdivided to account for

toxicokinetics (TK; default value = 3.16) and toxicodynamics (TD; default value = 3.16). When 

effect levels from experimental animal studies are converted to HEDs, the Agency’s default 

approach is to reduce the TK subfactor of UFA to 1 (i.e., UFA = TK × TD = 1 × 3.16 ≈ 3). 

EPA/OPPT interpreted MOEs that were equal to or below a benchmark value (e.g., MOE < 1000 

[UFH × UFA × UFL = 1000]) as an indication that the scenario(s) may present an unreasonable 

risk of injury to human health, whereas the MOEs that were above the benchmark value as a low

risk finding. In the following sections, more detailed descriptions are provided on: 1) converting 

effect levels to route- and exposure-specific HEDs; 2) determining the appropriate UFs for the 

benchmark value, and 3) evaluating risk estimates for workers and the general population. 

6.2.1 Workers

EPA/OPPT performed route-to-route extrapolations to convert the oral NOAEL of 23 mg/kgbw/day (i.e., MCCP congener groups to an HED value for inhalation exposures to workers (i.e., 

HEDINHAL-WORKER) using the following equation:

HEDINHAL-WORKER = NOAELORAL × (1 ÷ sRVRAT) × (ABSORAL-RAT ÷ ABSINHAL- HUMAN) × (sRVHUMAN ÷ wRV)

where, 

NOAELORAL = 23 mg/kg-bw/day

sRVRAT = rat standard respiratory volume for 8-hours = 0.38 m3/kg bw

ABSORAL-RAT = percent absorption by the oral route in rats = 50%

ABSINHAL-HUMAN = percent absorption by inhalation in humans = 50%

sRVHUMAN = human standard respiratory volume for 8-hours = 6.7 m3

wRV = worker respiratory volume for 8-hours = 10 m3

Using this algorithm, the oral NOAEL of 23 mg/kg-bw was calculated to be an HEDINHALWORKER values of 41 mg/m3

. 

EPA/OPPT calculated the HED values for dermal exposures to workers (i.e., HEDDERM-WORKER) 

based on the following equation:

HEDDERM-WORKER = NOAELORAL × (ABSORAL-RAT ÷ ABSDERMAL- HUMAN) × (BWRAT ÷ BWHUMAN)

1/4

where,

NOAELORAL = 23 mg/kg-bw/day

ABSORAL-RAT = percent absorption by the oral route in rats = 50%

ABSDERM-HUMAN = percent absorption by the dermal route in humans = 1%

BWRAT = rat bodyweight = 0.250 kg
25

BWHUMAN = human bodyweight = 71.8 kg

The resulting HEDDERM-WORKER values equal 4600 mg/kg-bw/day for MCCP congener groups. 

EPA/OPPT used the foregoing HED values to inform the appropriate application of UFs to 

derive benchmark values. For MCCP congener groups, a benchmark value of 30 was applied. 

This value consisted of the following individual UFs. A default UFH of 10 was applied due to the 

absence of experimental data to inform the TK and TD subfactors of this UF. A reduced UFA of 

3 was applied to account for a TK subfactor of 1 after converting the effect levels to HEDs (i.e., 

the use of allometric scaling). The UFA of 3 accounted for the remaining uncertainty associated 

with TD variability. Thus, the acceptable MOE would be 30 (10 times 3). 

EPA/OPPT used the HEDINHAL-WORKER and HEDDERM-WORKER values for calculating the 

respective MOEs using the estimated exposure values presented in Table 9. As shown in Table 

12, the MOEs for P-14-0683 and P-14-0684 all exceeded the respective benchmark value of 30, 

which indicate a finding of no risk to workers for the processes and uses evaluated in this 

assessment.

Table 12: Occupational MOEs for P-14-0683 and P-14-0684

6.2.2 General Population (from Environmental Releases)

EPA/OPPT converted the oral NOAEL of 23 mg/kg-bw/day to an HED value for oral exposures 

to the general population (i.e., HEDORAL-GENPOP) using the following equation:

HEDORAL-GENPOP = NOAELORAL × (ABSORAL-RAT ÷ ABSORAL- HUMAN) × (BWRAT ÷ BWHUMAN)

1/4 × (5 days ÷ 7 days)a

where, 

NOAELORAL = 23 mg/kg-bw/day

ABSORAL-RAT = percent absorption by the oral route in rats = 50%

Exposure 

Route Exposure Scenario1

Margins of Exposure

(Benchmark MOE = 

30)

Inhalation Manufacturing No exposure

Proc 1 – MWF Processing No exposure

Proc 2 – Compounding rubber 186 – 27,333

Use 1 – MWF 155 – 547

Use 2 Converting rubber 55 - 1171

Dermal Manufacturing 27,523 – 30,025

Proc 1 – MWF Processing 15,013 – 97,141

Proc 2 – Compounding rubber 15,013

Use 1 – MWF 89,265 – 127,031

Use 2 Converting rubber Non-quantifiable

1Processing 1= Formulation of metal working fluids, Processing 2 = compounding of 

rubber products, Use 1 = use of metal working fluids, Use 2 = converting rubber 

products
26

ABSORAL-HUMAN = percent absorption by the oral route in humans = 50%

BWRAT = rat bodyweight = 0.250 kg

BWHUMAN = human bodyweight = 71.8 kg

aA duration-specific adjustment was only applied to the oral LOAEL of 100 mg/kgbw/day because the animals were gavaged five days per week. 

For assessing inhalation exposures to the general population, EPA/OPPT performed route-toroute extrapolations to convert the oral NOAEL of 23 mg/kg-bw/day to an HED value for 

inhalation exposures to the general population (i.e., HEDINHAL-GENPOP) using the following 

equation:

HEDINHAL-HUMAN = NOAELORAL × (1 ÷ sRVRAT) × (ABSORAL-RAT ÷ ABSINHAL- HUMAN) × (5 days ÷ 7 days)a

where, 

NOAELORAL = 23 mg/kg-bw/day

sRVRAT = rat standard respiratory volume for 8-hours = 1.15 m3/kg bw

ABSORAL-RAT = percent absorption by the oral route in rats = 50%

ABSINHAL-HUMAN = percent absorption by inhalation in humans = 50%

aA duration-specific adjustment was only applied to the oral LOAEL of 100 mg/kgbw/day because the animals were gavaged five days per week.

For the oral NOAEL of 23 mg/kg-bw/day, the HEDINHAL-GENPOP value is equal 20 mg/m3. 

The same benchmark value of 30 was used for evaluating the general population MOEs. These 

benchmark values consisted of the same individual UFs and rationale discussed previously for 

workers. 

EPA/OPPT used the HEDORAL-GENPOP and HEDINHAL-GENPOP values for calculating the respective 

MOEs using the estimated exposure values presented in Table 8. As shown in Table 13, the 

MOEs for P-14-0683 and P-14-0684 all exceeded the respective benchmark values, which 

indicate a finding of no risk to the general population for environmental exposures that may 

occur due to the processes and uses evaluated in this assessment.
27

Table 13: General Population MOEs for P-14-0683 and P-14-0684 1

Scenario

Water Release Air Release

Drinking Water MOE2

(Benchmark MOE = 30)

Fish Ingestion MOE 

(Benchmark MOE = 30) 

Stack Air MOE 

(Benchmark MOE = 30)

Manufacturing 7.7 × 106 1.5 × 106 1.2 × 104

PROC1:Formulation 

of MWFs 6.2 × 105 1.2 × 105 6.2 × 103

PROC2: Compounding 

Rubbers 9.5 × 104 1.6 × 104 2.8 × 103

USE1: Use of MWF 6.6 × 105 1.3 × 105 3.6 × 104

USE2: Converting 

Rubber 1.9 × 106 3.7 × 105 2.7 × 103

1Taken from Appendix E. Values represent the highest concentrations/estimated doses (reported as the 

lifetime average daily dose, or LADD) for chronic (i.e., repeated exposure scenarios) for human health.

2 MOE = margin of exposure. In this risk assessment, MOEs of greater than 30 is acceptable.

7 CONCLUSIONS

Based on its assessment of the available hazard and exposure information on P-14-0683/0684, 

EPA/OPPT concludes the following pertaining to the potential manufacturing, processing and 

use of these PMN substances 

5. Occupational Exposures: given the assumptions, data and scenarios evaluated in this 

assessment, there were no risks found for workers from either dermal or inhalation 

exposures. 

6. General Population Exposures (from environmental releases): given the assumptions, data 

and scenarios evaluated in this assessment, there were no risks found to humans from

environmental releases via exposure to drinking water or fish ingestion. 

7. Environmental Assessment:

a. Using estimated environmental concentrations, the PMN substances may present an 

unreasonable risk following acute and chronic exposures to aquatic organisms.

b. Using available measured concentrations of MCCP congener groups in the environment as 

supporting information, the PMN substances:

iii. Are expected to partition to sediment and may partition to soil through land 

application of biosolids and,

iv. May be released to the environment at levels at or above estimated concentrations of 

MCCP congener groups that may present an unreasonable risk following acute 

and chronic exposures to aquatic organisms.

8. PBT Assessment: The PMN substances may be very persistent and very bioaccumulative.
28

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42

9 APPENDICES
43

Appendix A ENVIRONMENTAL FATE AND 

BIOACCUMULATION STUDY SUMMARIES

A-1 ENVIRONMENTAL PERSISTENCE

A-1-1 Abiotic Degradation

Generally, CPs are stable to hydrolysis and to direct photolysis in air and water, though very 

limited data exist on hydrolysis and direct and indirect photolysis in soil, water, or air. In studies 

using aliphatic hydrocarbon solvents, CPs were shown to be poor absorbers of UV light and no 

direct photodegradation was observed (Friedman and Lombardo, 1975; Lombardo et al., 1975).

Koh and Thiemann (2001) studied photolysis of aqueous solutions for CPs products with chain 

lengths ranging from C10 to C24 including an MCCP product, Hoechst CP52, with chain lengths 

from C12 to C18 and an average of 52 wt% Cl. A mercury vapor lamp with main radiation 

wavelengths of 254, 302, 313, 366,405/408, and 436 was used in batch experiments. Following a 

5 hour radiation time, estimated atmospheric degradation rates showed photolysis half-lives of 

less than 20 hours based on measurement of free chloride and analysis of degradation products. 

The MCCP product had a T1/2 of 12.8 hour in aqueous solution. The addition of peroxide or 

acetone increased the photolysis rate suggesting that indirect photolysis may be significant. The 

authors also reported that longer chain CPs were formed during this study and speculated that 

recombination of smaller alkyl radicals could occur under some conditions. 

Thermal degradation data for MCCPs and LCCPs are limited, but studies of SCCPs and 

Polyvinyl chlorides suggest MCCPs are degraded rapidly at 250 - 350 °C (Bergman et al., 1984). 

Dehydrohalogenation may lead to the formation of a large number of aliphatic and aromatic 

compounds. Chlorine radical formation can lead to production of highly chlorinated aromatics 

including polychlorinated biphenyls. Higher Cl content results in production of greater numbers 

and amounts of chlorinated aromatics (Bergman et al., 1984).

A-1-1-1 Fate in Air

As noted above, CPs lack structural components that absorb light in the UV or visible spectrum, 

so direct photolysis is not expected to occur. The atmospheric half-life has been estimated at 1 -

2 days (EA, 2009; ECB, 2005), based on estimated values for the second order rate constant for 

reaction with atmospheric hydroxyl radicals for MCCPs with lower chlorine contents between 40 

and 56 wt%. EPA/OPPT also estimated atmospheric half-lives for MCCPs (40 and 70 Cl wt%) 

calculated using EPI SuiteTM/AOPWINTM (v. 1.92a) that range from about 1 to > 4 days (see 

Table_Apx A-1). MCCPs with the shorter chain lengths and higher chlorine contents were 

calculated to be more persistent. 

MCCPs have low estimated vapor pressures (4.5 × 10-8to 2.27 × 10-3 Pa at 20 - 25°C) and a 

Henry’s law constant (HLC) (0.014 - 51.3 Pa × m3/mol for C14-17 congener groups) and are not 

expected to partition to air. They may be transported associated with particulate matter, and have 

been reported in indoor and outdoor air and house dust (Barber et al., 2005; Fridén et al., 2011; 

Hilger et al., 2013). Wide spread soil contamination and occurrence in artic samples suggest that 
44

MCCPs behave similarly to other chlorinated persistent organic pollutants (POPs) with high 

production volumes and releases, and are subject to long range transport (Dick et al., 2010; 

Medeiros et al., 2011; Tomy et al., 2000). 

Table_Apx A-1: Estimated Atmospheric Half 

Lives Using EPI SuiteTM/AOPWINTM (v. 1.92a) for 

Varying MCCP Chain Length and Chlorination 

Percents Based on Wt. 

Chain Length 40 Cl Wt% 70 Cl Wt%

C14 1.0 4.4

C15 0.8 3.0

C16 0.8 3.0

C17 0.8 2.9

A-1-2 Biodegradation

EPA/OPPT reviewed studies from the open literature and submitted to the Agency including 

those described in the Canada and EU assessments and referenced in Table_Apx A-2 (EC, 

2008a; ECB, 2005) to determine biodegradation under a variety of environmental conditions.

Some of these studies used modified test conditions to enhance or maximize biodegradation. 

EPA/OPPT concurs with the EU’s conclusions that under these modified test conditions, C14

41.3% by wt. Cl and a C14 45.5% by wt. Cl substances are readily biodegradable. C 15 51% by 

wt. Cl were found to be inherently degradable and possibly readily degradable in modified 

OECD 301 and 301D tests. This suggests that CPs with these chain lengths and shorter, and this 

degree of chlorination and lower, are inherently degradable. More highly chlorinated and longer 

carbon chain CPs (C14-17 51.7% by wt. Cl, C14 55% by wt. Cl, C14 60.2% by wt. Cl, and C14 -17

63.2% by wt. Cl) biodegraded over a range of 2-54% in 28 days to 4-57% at up to 60 days. The 

most highly chlorinated, (C14-17, 63.2 wt% Cl) biodegraded 5% in 28 days and 10% at 60 days 

in the enhanced biodegradation studies, suggesting that longer chain and higher chlorination can 

contribute to greater persistence under most environmental conditions. (Van Ginkel, 2014 a and 

b; Van Ginkel 2010 a-d; Van Ginkel and Louwerse 2010 a and b).

A-1-2-1 Fate in Wastewater Treatment

In its review of the available measured data on MCCPs in wastewater treatment from data in 

from other countries, EPA/OPPT determined that CPs are present in the majority of municipal 

waste water treatment plant (WWTP) influent (Coelhan, 2010; Nicholls et al., 2001; Stevens et 

al., 2003; Zeng et al., 2013). Low water solubility and relatively high partitioning coefficients 

suggest that most of the MCCPs and LCCPs entering WWTP systems will associate with solids. 

Some biodegradation of shorter chain, lower chlorinated MCCP congener groups may occur, 

while longer chain length, more chlorinated congener groups will be resistant to aerobic and 

anaerobic degradation. Shorter and lower chlorinated congener groups have higher vapor 

pressure and may be lost to the vapor phase during aeration. WWTP effluent also contains some 

particulate-associated MCCPs. Because of their low water solubility, little MCCP or LCCP will 

be in the dissolved phase, and the majority will be removed along with settled sludge. Once 

associated with the sludge, the CPs will generally be stable in sludge treatment and remain in the 

residual biosolids. Land application of biosolids will transfer the MCCPs and LCCPs to 
45

agricultural and other soils (Nicholls et al., 2001; Stevens et al., 2003). Because 50 - 60% of 

biosolids in the US are land applied, the majority of MCCPs and LCCPs entering WWTPs may 

be released to the environment via application to soil, and may be transported from contaminated 

soil to other locations and media by soil erosion, runoff, and wind borne particulates, and 

volatilization.

A-1-2-2 Fate in Surface and Groundwater

Because they generally have low water solubility, high sorption coefficients, and tend to partition 

to solids, MCCPs and LCCPs released to surface water will partition to surficial sediment where 

they may be buried and removed from potential degradation processes. This explains what is 

found in the limited monitoring data that exist - MCCP concentrations in surface water are 

generally in the low pg/L range, while sediment concentrations are several orders of magnitude 

higher (EC, 2008a). 

MCCPs may leach from soil and be transported to groundwater, but low solubility and high 

sorption will act to keep dissolved concentrations very low. Facilitated transport with colloids 

and particulates may occur so that MCCPs can be transported in groundwater, but in general, 

concentrations in this compartment are expected to be very low. MCCPs that are introduced to 

groundwater will tend to partition to the solid phase and not be mobile.

A-1-2-3 Fate in Soil 

Existing monitoring data suggest that MCCPs are present in soil, probably as a result of 

atmospheric transport and deposition. Areas near sources, such as land receiving wastewater 

biosolids, manufacturing and processing facilities, and electronic waste processing and recycling 

facilities are shown to have higher levels (Wang et al., 2013). MCCPs are expected to be stable 

in soil, and once deposited, could remain/persist in the soil for years or decades. Burial and 

advective transport away from the site of deposition are the major dissipation processes. No data 

are available on soil photolysis, although aqueous photolysis data suggest that indirect photolysis 

may result in degradation to shorter and less chlorinated CP congener groups. No soil 

biodegradation data exists, but some strains of bacteria that can co-metabolize MCCPs have been 

identified (Allpress and Gowland, 1999). If degradation does occur, it is expected to be slow 

with T1/2 of at least months to years.
46

Table_Apx A-2: Review of MCCP and LCCP Biodegradation Studies

Biodegradation Studies on MCCPs (C14-17) and LCCPs (C>18) 

Study 

Authors

Publication 

Date

MCCP/LCCP 

Chemicals 

Evaluated (i.e., 

C-length, wt% 

Cl)

Method Study 

Duration

Noteworthy Results and 

Implications

MCCPs

Van Ginkel 2010d C14 45 wt% Cl Closed 

bottle 28 days

Approximately 64% degraded in 

28 days

Based on oxygen demand

Van Ginkel 2010b C14-17 45.6 wt% Cl Closed 

bottle 28 days

Approximately 51% in 28 days 

and 63% in 42 days degradation

Based on oxygen demand

Van Ginkel 2010c C14-17 51.7 wt% Cl Closed 

bottle 28 days

Approximately 27% degradation 

in 28 days and 57% after 60 days 

Based on oxygen demand

Van Ginkel 2010a C14-17 63.2 wt% Cl Closed 

bottle 28 days

Approximately 5% degradation 

after 28 days and 10% after 60 

days.

Van Ginkel 

and 

Louwerse

2010a

C14 41.3-60.2 wt% 

Cl%

Closed 

bottle with 

river water 

and sludge 

inoculum

28 days

Approximately 66% (41.3 wt% 

Cl) to 11 (60.2 wt% Cl) 

degradation in 28 days 

respectively

Van Ginkel 

and 

Louwerse

2010b

C14 41.3-50 wt% 

Cl

Batch 

reactor

21 and 

105 days

41.3 wt% Cl: 79% degradation in 

21 days and 94% at 105 days

50 wt% Cl: 14% degradation by 

21 days 5 wt% Cl in 80 days 

based on quantitation of released 

chloride 

Conclusions: Quantification of degradation was by oxygen uptake or chloride release. No information 

on the chemical distribution in the test material or degradates was provided.

These studies used modified test conditions to enhance or maximize biodegradation. Under these 

modified test conditions, C14 41.3 wt% Cl and a C14 45.5 wt% Cl substances are readily biodegradable. 

More highly chlorinated and longer carbon chain CPs (C14-17 51.7 wt% Cl, C14 55 wt% Cl, C14 60.2 wt% 

Cl, and C14-17 63.2 wt% Cl) biodegraded over a range of 2 – 54% in 28 days to 4 – 57% at up to 60 days. 

The most highly chlorinated, (C14-17 63.2 wt% Cl) biodegraded 5% in 28 days and 10% at 60 days in the 

enhanced biodegradation studies, suggesting that longer chain and higher chlorination can contribute to 

greater persistence under most environmental conditions. 

Van Ginkel 2014b C15 51 wt% Cl 

Closed 

bottle 

(301D)

60 day

43% and 63% degradation at 28 

and 60 days
47

Biodegradation Studies on MCCPs (C14-17) and LCCPs (C>18) 

Study 

Authors

Publication 

Date

MCCP/LCCP 

Chemicals 

Evaluated (i.e., 

C-length, wt% 

Cl)

Method Study 

Duration

Noteworthy Results and 

Implications

Van Ginkel 2014a C15 51wt% Cl Closed 

bottle (301) 60 day 37% and 57% degradation at 28 and 60 days

Conclusions: Unlike the 2010 series of studies, these most recent biodegradation studies did not have 

significant protocol modifications and the C15 51 wt% Cl were found to be inherently degradable and 

possibly readily degradable in OECD 301 and 301D tests.

Madeley and 

Birtley 1980

C14-17 mixed 

product, 40 wt% 

Cl

BOD test 25 days

Approximately 15.5% 

degradation as measured by 

theoretical BOD in nonacclimated samples and 22.5% 

degradation in acclimated 

samples.1

Madeley and 

Birtley 1980

C14-17 mixed 

product, 45 wt% 

Cl

BOD test 25 days

Approximately 10% degradation 

as measured by theoretical BOD 

in non-acclimated samples and 

30% degradation with acclimated 

soil microbes added.1

Madeley and 

Birtley 1980

C14-17 mixed 

product, 52 wt% 

Cl

BOD test 25 days

Approximately 4% degradation 

as measured by theoretical BOD 

in non-acclimated samples and 

6% degradation with acclimated 

soil microbes added.1

Madeley and 

Birtley 1980

C14-17 mixed 

product, 58 wt% 

Cl

BOD test 25 days

No significant degradation

Conclusions: The data from Madeley and Birtley suggests the potential for biodegradation but has 

significant limitations. The BOD studies were done on mixed products. No attempt was made to 

determine which specific congeners were degraded or the reaction products. No identification of the 

congeners present was provided. The degradation was estimated from the BOD but other compounds 

may have contributed to the ThBOD in the bottles. BOD measurements are highly variable as evidenced 

by the decrease in the C20-30 42% of > 50% between day 20 and 25.

1The ThOD (theoretical oxygen demand) was estimated (ThOD (g O2/g substance) = 16[2×c+0.5×(hcl)]/mw; where c=number of carbon atoms, h=number of hydrogen atoms, cl=number of chlorine atoms 

and MW = molecular weight). This is questionable for a product containing mixture of congeners as was 

used in all studies. 

LCCPs

Madeley and 

Birtley 1980

C20-30 mixed 

product, 42 wt% 

Cl

BOD test 25 days

Approximately 7.5% degradation 

as measured by theoretical BOD 

in non-acclimated samples and 

23% degradation with acclimated 

soil microbes added.1
48

Biodegradation Studies on MCCPs (C14-17) and LCCPs (C>18) 

Study 

Authors

Publication 

Date

MCCP/LCCP 

Chemicals 

Evaluated (i.e., 

C-length, wt% 

Cl)

Method Study 

Duration

Noteworthy Results and 

Implications

Madeley and 

Birtley 1980 C25 “chlorinated pentacosane”

14C on 

central 

carbon

8 weeks 

(mean)

11% of 14C- released as CO2.

Non-acclimated microbes.

Conclusions: The data from Madeley and Birtley suggests the potential for biodegradation but has 

significant limitations. The BOD studies were done on mixed products. No attempt was made to 

determine which specific congeners were degraded or the reaction products. No identification of the 

congeners present was provided. The degradation was estimated from the BOD but other compounds 

may have contributed to the ThBOD in the bottles. BOD measurements are highly variable as evidenced 

by the decrease in the C20-30 42% of > 50% between day 20 and 25.

1The ThOD (theoretical oxygen demand) was estimated (ThOD (g O2/g substance) = 16[2×c+0.5×(hcl)]/mw; where c=number of carbon atoms, h=number of hydrogen atoms, cl=number of chlorine atoms 

and MW = molecular weight). This is questionable for a product containing mixture of congeners as was 

used in all studies. 

Hildebrecht 1972

C20-30 mixed 

product, 42 wt% 

Cl

BOD test 5 days

25% degradation. Degradation 

was estimated by the authors as 

the% of the theoretical BOD 

based on the total carbon content 

of the test solution. Substances 

other than the chlorinated 

paraffin contributed to this total 

carbon content.

Hildebrecht 1972

> C20-30 mixed 

product, 70 wt% 

Cl

BOD test 5 days

2% degradation. Degradation was 

estimated by the authors as the%

of the theoretical BOD based on 

the total carbon content of the 

test solution. Substances other 

than the chlorinated paraffin 

contributed to this total carbon 

content.

Hildebrecht 1972

> C20-30 mixed 

product, 70 wt% 

Cl

BOD test 5 days

65% degradation. Degradation 

was estimated by the authors as 

the% of the theoretical BOD 

based on the total carbon content 

of the test solution. Substances 

other than the chlorinated 

paraffin contributed to this total 

carbon content.

Conclusions: As described by the (EA, 2009), Hildebrecht’s results are questionable (Hildebrecht, 

1972). This report is not available so it cannot be reviewed directly, but others have reported that it 

provided limited details. A surfactant, other carbon sources, and nutrients were added that may have 

contributed BOD. The extent of degradation was determined by the comparing the oxygen consumption 
49

Biodegradation Studies on MCCPs (C14-17) and LCCPs (C>18) 

Study 

Authors

Publication 

Date

MCCP/LCCP 

Chemicals 

Evaluated (i.e., 

C-length, wt% 

Cl)

Method Study 

Duration

Noteworthy Results and 

Implications

in the test with the theoretical oxygen demand (ThOD) based on oxidation to CO2 of the total organic 

carbon present in the solution from all sources. This estimation of ThOD does not take into account 

oxygen consumption by other compounds or the unknown composition. Of the CPs in the mixture, as the 

UK report concludes, “It is not possible to draw definite conclusions as to the degradability of the 

chlorinated paraffins in these tests” (EA, 2009).

Hoechst AG 1976 and 

1977 C18-20, 35 wt% Cl BOD test 5 days 0.7% degradation

Hoechst AG 1976 and 

1977 C18-20, 44 wt% Cl BOD test 5 days < 1.2% degradation

Hoechst AG 1976 and 

1977 C18-20, 49 wt% Cl BOD test 5 days < 2.3% degradation

Hoechst AG 1976 and 

1977 C18-20, 52 wt% Cl BOD test 5 days < 0.6% degradation

Conclusions: The Hoechst reports from early industry studies are not available so it is not possible to 

directly review the data (Hoechst, 1976, 1977). Others (EA, 2009) have reported the limitations of the 

studies. Limited details of the studies were apparently reported by Hoechst. These tests were done on 

mixtures of congeners with unknown composition. They reported that the majority of the CPs were 

removed by sorption on to the solids so no degradation may have occurred that would have been detected 

as BOD. The tests were run for 5 days using non-acclimated sludge microbes so degradation may have 

been possible but had not yet occurred.

Omori et al. 1987 C24.5H44.5Cl6.5, 40.5 

wt% Cl

Chloride 

release 48 hours

9.9% degradation using bacterial 

strain HK-3;

13% H15-4;

2.2% HK-6;

3.5% HK-8; 

33% using mixed bacterial 

culture (HK-3, HK-6, HK-8 and 

HK-10)

Omori et al. 1987 C24.5H41Cl10, 50 

wt% Cl

Chloride 

release 48 hours

3% degradation using bacterial 

strain HK-3;

9% H15-4;

1.8% HK-6;

2.6% HK-8

Omori et al. 1987 C24.5H30Cl21, 70 

wt% Cl

Chloride 

release 48 hours

2.6% degradation using bacterial 

strain HK-3;

12% H15-4;

1.4% HK-6;

1.7% HK-8; 

15% using mixed bacterial 

culture (HK-3, HK-6, HK-8 and 

HK-10)
50

Biodegradation Studies on MCCPs (C14-17) and LCCPs (C>18) 

Study 

Authors

Publication 

Date

MCCP/LCCP 

Chemicals 

Evaluated (i.e., 

C-length, wt% 

Cl)

Method Study 

Duration

Noteworthy Results and 

Implications

Conclusions: Omori et al. (1987) showed the potential for biodegradation using pure and mixed cultures 

in short (48 hour) incubations. No information on the starting mixtures were provided except average 

compositions. No data on the products were reported. Loss of Cl suggests dechlorination can occur and 

that lower Cl content or shorter chain lengths may be produced.

Allpress and 

Gowland 1999 C18-20, 48 wt% Cl Chloride release 71 days 11% degradation using Rhodococcus sp. bacteria

Allpress and 

Gowland 1999 C> 20, 42 wt% Cl Chloride release 71 days 14% degradation using Rhodococcus sp. bacteria

Conclusions: Allpress and Gowland (1999) also showed that CPs have the potential to biodegrade using 

pure culture. They used mixed congener products and did not provide any information on the 

composition of the starting material or the degradation products. They found that the Rhodococcus sp. 

was able to use CPs as carbon source as well as an energy source.

1The ThOD (theoretical oxygen demand) was estimated (ThOD (g O2/g substance) = 16[2×c+0.5×(h-cl)]/mw; where 

c=number of carbon atoms, h=number of hydrogen atoms, cl=number of chlorine atoms and MW = molecular 

weight). This is questionable for a product containing mixture of congeners as was used in all studies.

A-2 BIOCONCENTRATION AND BIOACCUMULATION

EPA/OPPT’s review of measured data on bioaccumulation of MCCPs are somewhat limited and 

conclusions vary with type of CP product and species evaluated (Bengtsson et al., 1979; CPC, 

1980, 1983a, 1983b; Fisk et al., 1999; Fisk et al., 1998; Houde et al., 2008; Madeley and 

Maddock, 1983a, 1983b; Madeley and Thompson, 1983; Renberg et al., 1986; Thompson et al., 

2000).

The limited measured data on MCCPs and LCCPs, informed by data on SCCPs, suggests that 

bioaccumulation is a function of chain length and degree of chlorination (see Table_Apx A-3). 

Some MCCP chemicals with intermediate chain length and chlorination may be absorbed and 

retained. The available evidence for MCCP congener groups with intermediate chain lengths and 

chlorination suggests that some may have BCFs or BAFs greater than 1000 or 5000 (EC, 2008b; 

ECB, 2008). This suggests that some congener groups in MCCP products may be 

bioaccumulative or very bioaccumulative. In conclusion, some MCCP congener groups present 

in the products are both very persistent and very bioaccumulative.

Additional evidence for bioaccumulation of MCCPs is provided by Houde et al. (2008). Fieldderived log BAFs for MCCPs (C14-15), ranging from 6.5 to 7.3, were reported for several Lake 

Ontario aquatic species from multiple trophic levels. Canada’s assessment of MCCPs also 

indicates that modeled BAFs for a number of MCCPs (using the Modified Gobas BAF Model 

with assumption of no metabolism), were all above 5000, suggesting high to very high 

bioaccumulation (EC, 2008a). Evidence of bioaccumulation in sediment-dwelling organisms is 

also provided in a study by Fisk et al. (1998). Biota-sediment accumulation factors (BASFs) 
51

ranging from 0.6 to 4.4 were reported for oligochaetes, which indicate bioaccumulation of 

MCCPs from sediment to biota (USEPA, 2009).

The Houde et al. (2008) study also provides evidence of biomagnification of MCCPs. BMFs 

derived for food chains in Lake Ontario and Lake Michigan ranged from 1 to 15. More 

specifically, large BMFs were observed for all MCCP chain lengths in Lake Ontario, and for C14

MCCPs in Lake Michigan, indicating biomagnification. BMFs (2.4 – 7.7) were also above 1 for 

smelt and lake trout in Lake Michigan. 

In laboratory studies with rainbow trout and oligochaetes, lipid-normalized equilibrium BMFs 

estimated from a first-order bioaccumulation model for constant dietary exposure ranged from 

0.4 - 5.0 (Fisk et al., 1996; Fisk et al., 2000; Fisk et al., 1998).

Most of the laboratory-based BCF studies (Bengtsson et al., 1979; CPC, 1980, 1983a, 1983b; 

Fisk et al., 1999; Fisk et al., 1998; Houde et al., 2008; Madeley and Maddock, 1983a, 1983b; 

Madeley and Thompson, 1983; Renberg et al., 1986; Thompson et al., 2000), were reported to 

have been conducted at MCCPs concentrations above the water solubility limit and hence likely 

underestimate the true BCF (summarized in Appendix C). Furthermore, acetone as a solvent in 

these tests, so they do not adhere to OECD guidelines. Nonetheless, some BCF values estimated 

from these studies indicate MCCPs are bioaccumulative (e.g., bleak and rainbow trout (32-2856) 

and BCF of 6920 for common mussel).
52

Table_Apx A-3: Review of MCCP and LCCP Bioaccumulation Studies

Bioaccumulation studies on MCCPs (C14-17) and LCCPs (> C18) 

MCCPs

Study 

Authors

Publication 

Date

MCCP/LCCP 

Chemicals 

Evaluated (i.e., 

C-length,% Cl)

Method Study 

Duration Noteworthy Results and Implications

Houde et al. 2008 C14-15 Only BAF = 

([predator]/[water 

(filtered)]);

BMF) = 

[predator]/[prey]) 

where the 

concentrations in 

predator and prey 

are on a lipid basis

Three sampling 

periods:

October 2000, 

June 2002, and

July 2004.

Issues related to the temporal variability of water 

concentrations over the period of biota sampling 

(1999 – 2004) in this study have been raised 

(ECB, 2005; EC, 2008) contributing to 

uncertainties associated with the reported BAF 

values.

Log BAF = 

Plankton: C14=6.2; C15=6.6; ∑=6.5

Alewife: C14=7.0; C15=6.8; ∑=6.9

Sculpin: C14=7.4; C15=7.2; ∑=7.3

Rainbow smelt: C14=7.4; C15=7.1; ∑=7.2

Lake trout: C14=6.8; C15=6.5; ∑=6.6

BMF (Lake Ontario) =

0.25 (lake trout – alewife);

0.14 (lake trout – smelt);

8.7 (sculpin –Diporeia)

BMF (Lake Michigan) = 

0.22 (lake trout – alewife); 

0.94 (lake trout – sculpin);

0.88 (sculpin – Diporeia)
53

Thompson et 

al.; as 

summarized 

in ECB, 

2005

2000 n-pentadecane-8-

14C, 51% Cl 

mixed with a 

non-radiolabelled C14-17, 

51% Cl 

chlorinated 

paraffin

Freshwater; flowthrough; acetone 

solvent used;

35 days Steady-state may not have been achieved, so 

kinetic BCF data considered more reliable. 

BCF = 860 L/kg at 35 days when exposed at 0.9 

ug/L

BCF = 265 L/kg at 35 days when exposed at 4.9 

ug/L

kinetic BCF = 1,087 L/kg at 35 days when 

exposed at 0.9 ug/L

kinetic BCF = 349 L/kg at 35 days when exposed 

at 4.9 ug/L

CPC 

(Madeley et 

al.); as 

summarized 

in ECB, 

2005

1983 commercial 

product mixed 

with a npentadecane-8-

14C chlorinated to 

a similar degree

freshwater; flowthrough; rainbow 

trout; acetone 

solvent used

60 days Concentrations above water solubility; hence, 

water concentrations may be overestimated and 

BCF underestimated. 

Uncertainty as to whether steady-state was 

reached.

BCF = 32-45 l/kg on a wet weight basis when 

exposed at 1.05 mg/l; 

BCF = 42-67 l/kg on a wet weight basis when 

exposed at the 4.5 mg/l

CPC 

(Madeley 

and 

Pearson); as 

summarized 

in ECB, 

2005

1980 C14-17, 45% Cl freshwater; flowthrough; rainbow 

trout; 

28 days Measured water concentrations questionable; 

water concentrations may be overestimated and 

BCF underestimated. 

BCF = 50-60 l/kg based on nominal exposure 

concentrations

BCF = 280-600 l/kg based on measured water 

concentrations

Madeley and 

Maddock; as 

summarized 

1983 Total MCCPs Bioconcentration 

factors. MCCPs 

concentrations were 

above the water 

No Information BCF = 32 – 2856 for common mussel, bleak and 

rainbow trout. May not have reached steady-state.
54

in ECB, 

2005

solubility limit, 

using acetone as the 

co-solvent in the 

test solutions, and 

hence are not in 

compliance with 

OECD guideline 

requirements

Fisk et al. 1999 Average formula: 

C14H23.3Cl6.7, 

55% Cl

freshwater; medaka 

eggs

20-days Uncertainty as to whether steady-state was 

reached; hence BCFs probably represent lower 

limit of true value

BCF = 32- 680 L/kg 

Fisk et al. 1998 14C16 35% Cl and 

14C16 69% Cl

Lake sediments 

were spiked and 

worms added after 

18 and 32

No Information Kinetic BAF probably represents the

upper limit of the true bioaccumulation factor

14C16 35% Cl

14-day BSAFss = 0.7

Kinetic BSAF = 4.4

14C16 69% Cl 

14-day BSAFss = 0.2

Kinetic BSAF = 0.6

Bengtsson et 

al.

1979 C14-17, 50% Cl seawater; semistatic; bleak;

acetone solvent 

used

14 days Measured water concentrations questionable; 

water concentrations may be overestimated and 

BCF underestimated. 

BCF  40 L/kg

Madeley and 

Thompson; 

as 

summarized 

1983 commercial C14-

17, 52% Cl

seawater; flowthrough; mussel

acetone solvent 

used

60 days BCFs = 2,182 L/kg (parent compound analysis) 

or 2,856 L/kg (14C-measurements) when exposed 

to 0.22 mg/l
55

in ECB, 

2005

BCF = 339 L/kg (parent compound analysis) or 

429 l/kg (14C measurements)

when exposed to 3.8 mg/l.

Renberg et 

al.

1985 C16H30.7Cl3.3

(34% Cl) and 

C12H16Cl9.8

(68.5% Cl) 

mixture 

synthesized with 

14C radiolabel

Flow through 

exposure to mussel 

(Mytilus edulis)

C16 - 0.13 and 5.0 

μg/L

C16 - 28 day 

uptake

C12 - 21 day 

uptake followed 

by 28 day 

depuration

Steady state BCF about 7000 for C16 and 

140,000 for C12 based on 14C quantification.

No chemical specific analysis for CPs. 

Metabolism and accumulation of degradation 

products may have accounted for high values.

LCCPs

Bengtsson et 

al.; as 

summarized 

in ECB, 

2005

1979 C18–26 concentrations were 

above the water 

solubility limit and 

hence are not in 

compliance with 

OECD guideline 

requirements

No Information Concentrations above water solubility; hence, 

water concentrations may be overestimated and 

BCF underestimated. Uncertainty as to whether 

steady-state was reached.

BCF reported = 8 – 16 L/kg
56

Appendix B ECOTOXICITY STUDY SUMMARIES

B-1 MCCP ECOTOXICITY DATA

B-1-1 Acute Fish Toxicity

(1) Mayer and Ellersieck (1986)

A series of 96-hour acute fish toxicity studies were conducted by the United States Geological 

Survey’s Columbia National Fisheries Research Laboratory with Paroil 1048 by Mayer and 

Ellersieck (1986). Although the chemical composition of Paroil 1048 is not defined in Mayer 

and Ellersieck (1986), the Chlorinated Paraffins Environmental Hazard Criteria developed by the 

United Nations Environment Programme (IPCS, 1996); identified Paroil 1048 as a product of 

Dover Chemical Company with the average molecular formula of C15H26Cl6 and a chlorine 

content of 50 – 52% Cl. The studies followed a test guideline that was similar to ASTM 

guidelines. Bluegill sunfish (Lepomis macrochirus) and yellow perch (Perca flavescens) were 

exposed to the test substance (100% commercial formulation) in a flow-through test system. 

Channel catfish (Ictalurus punctatus) and rainbow trout (Oncorhynchus mykiss) were exposed to 

the test substance in a static test system. A solvent was not used for this exposure. The average 

pH level was between 7.4 and 7.5 for all tests. Test temperature was 12°C for bluegill sunfish, 

rainbow trout, and yellow perch and was 20°C for channel catfish. Dilution water hardness was 

44 mg CaCO3/L in the rainbow trout and channel catfish test system and 314 mg CaCO3/L for 

the bluegill sunfish and yellow perch test system. Reported effect levels are considered to be 

nominal with LC50 values of > 10 mg/L for bluegill sunfish, channel catfish, and yellow perch 

and > 0.011 mg/L for rainbow trout; all values are greatly above the limit of solubility. Using a 

weight-of-evidence approach, these studies were considered acceptable to characterize the acute 

fish toxicity endpoint.

96-hr LC50 = No effects at saturation (NES)

(2) Linden et al. (1979)

A 96-hour acute fish toxicity study was published by Linden et al. (1979). Groups of 10 bleak 

(Alburnus alburnus) were exposed to six nominal unspecified concentrations of Cereclor S52 

(C14-17, 52% Cl), Chloroparaffin huls 40G (C15.5, 40% Cl), and Witaclor 50 (C14-17, 50% Cl) 

under static test conditions. Salinity was 7 ppt, pH was 7.8, temperature was 10°C, and dissolved 

oxygen was considered by study authors to be satisfactory. EPA/OPPT requires reporting of 

dissolved oxygen concentrations to determine study adequacy. EPA/OPPT also does not 

consider the test species, the bleak, a standard test species. The 96-hour fish LC50 values were > 

10,000 mg/L, > 5,000, and > 5,000 for Cereclor S52, Chlorapraffin huls 40G, and Witaclor 50. 

Given effect levels observed in Mayer and Ellersieck (1986) and the reported water solubility of 

medium chain paraffins, these studies were considered acceptable to characterize the acute 

saltwater fish toxicity endpoint as ‘no effects at saturation’.

96-hr LC50 = NES

B-1-2 Acute Aquatic Invertebrate Toxicity

(1) CPA (1996)
57

A 48-hour acute Daphnia magna toxicity study was conducted by CPA (1996) according to 

OECD TG 202 with GLP compliance using a static test system. The test substance was identified 

as Cereclor S52, a C14-17 chlorinated paraffin with 52% chlorination that contained 0.3% epoxy 

soya bean oil stabilizer as well as a small amount of radio labeled n-pentadecane-8-14C (51% 

chlorinated). Four replicates of 5 D. magna Straus (< 24 hours old) were exposed to nominal 

concentrations of 0 (dilution water control), 0 (solvent control), 0.0032, 0.0056, 0.01, 0.018, 

0.032, 0.056, and 0.1 mg/L test substance in acetone (0.1 mL/L). Test solutions were prepared by 

adding the appropriate stock solution to dilution water while continuously and vigorously 

stirring with a magnetic follower. Appearance of test solutions was not provided. Corresponding 

mean measured concentrations determined by radiochemical methods were 0.0025, 0.0041, 

0.0094, 0.015, 0.024, 0.047, and 0.095 mg/L. Daphnid loading was 25 daphnids/L. Over the 

course of the study dissolved oxygen concentrations remained between 9 and 9.2 mg/L, pH 

remained within 8 and 8.1, and temperatures were 20 ± 1°C. Dilution water had a total water 

hardness of 248 mg CaCO3/L. At 48 hours, 0%, 45%, 90%, 75%, 85%, 100%, and 100% 

immobilization was observed at the mean measured concentrations of 0.0025, 0.0041, 0.0094, 

0.015, 0.024, 0.047, and 0.095 mg/L, respectively. Red coloration on parts of the exoskeleton 

was observed in animals exposed to each of the test substance treatments, which the laboratory 

notes as being of an uncertain significance. The mean measured 48-hour EC50 was determined to 

be 0.0059 mg/L. The study was acceptable.

48-hr EC50 = 0.0059 mg/L

(2) Koh and Thiemann (2001)

A 48-hour acute Daphnia magna toxicity study was conducted at the University of Bremen, 

Department of Physical and Environmental Chemistry with CP 52 (C12-18, 52% chlorination) 

according to DIN 38412 by Koh and Thiemann (2001). Study methods were not fully 

characterized. Additional communications with the study author Wolfram Thiemann clarified 

that a static test system was used with nominal test concentrations. Based on communications 

with the study author, local (Bremen, Germany) tap water was used without adjustments. 

Presumed pH was between 5 and 6 and water hardness was between 35.7 and 53.5 mg CaCO3/L. 

Ambient laboratory air temperature was around 21°C. The solvent acetone was used to maintain 

test substance in solution. Floating effects at the surface of the water were observed in individual 

cases due to undissolved oil slicks, but communications with the study author noted that there

was no significant loss of daphnids due to mechanical trapping since most daphnid swam away 

from these occasional slicks observed at the higher test concentrations. The 48-hour EC50 was 

0.052 mg/L. Given the consistently high toxic effect levels observed in other daphnid studies, 

this study was considered acceptable to support the characterization of the acute daphnid toxicity 

endpoint.

48-hr EC50 = 0.052 mg/L

(3) CPA (1994)

A 48-hour acute Daphnia magna toxicity study was conducted by CPA (1994) according to 

OECD TG 202 with GLP compliance using a static test system. The test substance was identified 

as Cereclor S52, a C14-17 chlorinated paraffin with 52% chlorination that was mixed with an 

equal weight of radio labeled n-pentadecane-8-14C (51% chlorinated). Four replicates of 5 D. 

magna (< 24 hours old) were exposed to 0% (dilution water control), 6.3%, 12.5%, 25%, 50%, 

and 100% of stock solution containing test substance. The test substance was prepared in 

solution by: 1.) combining 0.75 g test substance and 25 mL acetone to a borosilicate glass 

conical flask, 2.) evaporation of the acetone using a stream of nitrogen, 3.) addition of 1.5 L 

dilution water, 4.) stirring for three days, and 5.) filtration of the aqueous phase. Radiochemical 

methods were used to determine the concentration of test substance in solution. Nominal 
58

concentrations of 0 (dilution water control), 0.14, 0.28, 0.55, 1.1, and 2.2 mg/L were within 86 –

100% of measured concentrations. Concerns regarding test solution preparation methods and 

analytical technique were identified by the submitter that included increasing the level of more 

soluble impurities (i.e., short chain chlorinated paraffins), questionable analytical monitoring 

results due to the presence of radio-labeled impurities, and abnormally low recovery of the 

chlorinated paraffin into hexane. Over the course of the study dissolved oxygen concentrations 

remained between 8 and 9 mg/L, pH remained within 8 and 8.1, and temperatures were 20 ± 1 

°C. Dilution water had a total water hardness of 237 mg CaCO3/L. Observed immobilization was 

limited to the highest test concentration (100% solution) with 55% immobilization. 

The study is unacceptable since EPA/OPPT agrees that methods used to prepare the test 

solution and analyze the test concentrations were questionable.

(4) Frank (1993); Frank and Steinhauser (1994)

The following study summary (Frank, 1993; Frank and Steinhauser, 1994), provided in the ECB 

(2005) MCCP risk assessment, was considered supportive of the aquatic invertebrate hazard 

determination. The chlorinated paraffin used in these studies was a commercial C14-17 product 

with a 52% by weight chlorine content. Daphnia magna were exposed to nominal concentrations 

of either 100 mg/L or 10,000 mg/L. The 100 mg/L solution was sonicated for 1 hour and then 

left to stand in the dark for 48 hours before use. The 10,000 mg/L solution also stood for 48 

hours in the dark before use, but this time without sonication. After this period, both solutions 

were filtered firstly with glass filters and then with membrane filters to remove undissolved test 

substance. The concentrations of medium-chain chlorinated paraffin in the water soluble 

fractions were then determined by AOX (adsorbable organic halogen) analysis (detection limit of 

10 μg/L Cl was equivalent to around 20 μg/L of the chlorinated paraffin). This analysis showed 

that the concentration of chlorinated paraffin present in the water soluble fraction was around 

0.404 - 0.500 mg/L for the 10,000 mg/L nominal solution and 0.071 - 0.142 mg/L for the 100 

mg/L stock solution. The acute (48-hour) toxicity tests were carried out using dilutions of the 

two prepared water soluble fractions. The method used was DIN 38 412, Teil 11, which is 

equivalent to OECD 202. 

In the tests using the water soluble fraction from the 100 mg/L nominal solutions no toxicity was 

seen at concentrations up to the undiluted stock solution (i.e., no effects up to around 0.071-

0.142 mg/L). In experiments using the water soluble fraction from the 10,000 mg/L stock 

solution, an EC0 of 0.140 mg/L (also reported as 0.100 - 0.110 mg/L in the paper) and an EC25 

of 0.423 mg/L (also reported as 0.420-0.470 mg/L in the paper) was determined (maximum 

mortality seen was 25%) (Frank, 1993). The latter results for the 10,000 mg/L stock solution 

were reported by Frank and Steinhauser (1994) as EC0 = 0.140 mg/L and EC25 = 0.339 mg/L, 

and it was noted that some of the Daphnia were floating on the surface of the test solution. In the 

later study (Frank and Steinhauser, 1994), the results of further acute toxicity studies were 

reported using the same test method. An EC50 of 0.037 mg/L and an EC0 of 0.009 mg/L were 

determined using the water soluble fraction from the 100 mg/L stock solution and no toxic 

effects were seen in tests with the water soluble fraction from the 10,000 mg/L stock solution 

(approximately EC0 ≥ 0.525 mg/L). The authors noted that the effects seen in the acute tests 

showed poor reproducibility, probably because effects were seen only around the water 

solubility limit of the substance. However, the authors thought that the possibility of undissolved 

droplets affecting the results could be ruled out, as floating Daphnia were only sporadically 

observed in the test.

The results of these studies should be treated with caution, as the effects were mainly seen 

in the saturated solutions only. 48-hour EC50 = 0.037 mg/L; 100 mg/L stock 
59

(5) Thompson and Gore (1999)

The following study summary (Thompson and Gore, 1999), provided in the ECB (2005) MCCP 

risk assessment, was considered supportive of the aquatic invertebrates hazard determination. 

The acute toxicity of C14-17, 52% wt. Cl substance was tested using the freshwater crustacean 

Gammarus pulex and the freshwater daphnid, Daphnia magna. The medium-chain chlorinated 

paraffin used was dissolved in acetone and then added to beakers in two separate studies 

containing either G. pulex or D. magna to give nominal concentrations of 0.1, 0.32, and 1.0 

mg/L. A control and solvent control (containing 0.1 mL/L acetone) were also run. The tests were 

carried out for 96 hours at 15 oC, with the solutions being renewed after 48 hours. The water 

used in the study had a hardness of 220 mg/L as CaCO3 and had a pH of 8.0 - 9.2. No mortalities 

of the G. pulex were seen in any of the test substance solutions or control. One animal died in the 

solvent control. Therefore, no significant toxic effects were seen with the medium-chain 

chlorinated paraffin over the concentration range tested. This contrasted markedly to the 

situation when D. magna were exposed using the same test system at 20°C over 48 hours, where 

complete immobilization was seen at the lowest test concentration (0.1 mg/L). The high 

immobilization rate observed in D. magna in this study appears consistent with the other studies 

and G. pulex appear to be a less sensitive to medium chained chlorinated paraffins then D.

magna.

(6) Tarkpea et al. (1981)

The Tarkpea et al. (1981); as quoted in IPCS (1996) summary, provided in the ECB (2005)

MCCP risk assessment, was considered supportive of the aquatic invertebrates hazard 

determination. The results of tests with the brackish water harpacticoid Nitocra spinipes have 

been reported (Tarkpea et al., 1981). No other details of the test were reported but the test 

method was probably the same as reported by Tarkpea et al. (1981), where a static method was 

employed using water of salinity 7‰ at a temperature of 20 - 22°C without aeration, probably 

using acetone as co-solvent. 

The results are considered supportive to address aquatic invertebrate acute toxicity. 

96-hour LC50 = 9 mg/L (C14-17, 45% wt Cl)

96-hour LC50 >10,000 mg/L (C14-17, 52% wt. Cl)

B-1-3 Algae Toxicity

(1) Thompson, Smyth, et al. (1997)

A 96-hour algae toxicity study was conducted by Thompson, Smyth, et al. (1997) according to 

OECD TG 201 with GLP compliance using a static test system. The test substance was a 

commercial product of a C14-17 chlorinated paraffin with 52% chlorination that contained 0.3% 

epoxy soya bean oil stabilizer as well as a small amount of radio labeled n-pentadecane-8-14C 

(51% chlorinated). Selenastrum capricornutum were exposed to nominal concentrations of 0 

(dilution water control), 0 (solvent control), 0.1, 0.18, 0.32, 0.56, 1, 1.8, and 3.2 mg/L test 

substance in the solvent acetone. Six replicates were tested for the solvent control and three 

replicates were tested for each treatment and the dilution water control. A mean measured 

concentration of 0.49, 0.77, and 1.2 mg/L was determined using radiochemical analysis for the 

nominal concentrations of 1, 1.8, and 3.2 mg/L, respectively, but effects were reported based on 

nominal test concentrations. At the start of the test, the pH was 7.4 - 7.5, but had reached 10.0 -

10.3 by the end of the test. The shift in pH was thought to be a function of the high control 

growth rates observed in the test according to the study summary and may have affected the 

outcome of the study; however, the section-by-section coefficient of variation for the solvent 

control remained below 35% indicating acceptable control growth rates throughout the duration 
60

of the study. The maximum inhibition in the growth rate and biomass seen was 3% and 18%, 

respectively, but a dose response relationship was not seen. Both the 72-hour and 96-hour EC50

values based on growth rate and biomass calculations were > 3.2 mg/L (nominal) or > 1.2 mg/L 

(mean measured). The nominal NOEC was 0.1 mg/L and the nominal LOEC based on 18%

biomass inhibition was 0.18 mg/L. A MATC of 0.134 mg/L was calculated by EPA/OPPT as the 

geometric mean of the NOEC and LOEC. The study was considered acceptable.

72-hr ErC50 = NES 

72-hr EbC50 = NES 

72-hr NOECb = 0.1 mg/L 

72-hr LOECb = 0.18 mg/L 

72-hr MATC = 0.134 mg/L 

(2) Koh and Thiemann (2001)

A 72-hour algae toxicity study was conducted by the University of Bremen, Department of 

Physical and Environmental Chemistry with CP 52 (C12-18, 52% chlorination) according to DIN 

38412 by Koh and Thiemann (2001). Study methods were not fully characterized. Additional 

communications with the study author Wolfram Thiemann clarified that a static test system was 

used with nominal test concentrations. Scenedesmus subspicatus were exposed to the test 

substance and cell density was determined using a particle counter. Based on communications 

with the study author, local (Bremen, Germany) tap water was used without adjustments. 

Presumed pH was between 5 and 6 and water hardness was between 35.7 and 53.5 mg CaCO3/L. 

Ambient laboratory air temperature was around 21°C. The solvent acetone was used to maintain 

test substance in solution. Effects were calculated based on growth rate. No effects were 

observed up to 0.1 mg/L. 

Due to deficiencies/missing details in the study methods, the study alone was not acceptable 

to characterize aquatic toxicity to plants.

72-hr NOEC = 0.1 mg/L (Highest Test Concentration)

B-1-4 Chronic Fish Toxicity

(1) CPC (1983b)

A 60-day fish toxicity study was conducted by Brixham Laboratories in 1983 with radio-labeled 

chlorinated (52%) n-pentadecane (Trade Name: Cereclor S52) under flow through testing 

conditions (CPC, 1983b). A full non-confidential study report was submitted under TSCA in 

1983 as DCN 40-8332184 (OTS Fiche 0507258) (CPC, 1983b). Two replicates of 3 immature 

rainbow trout (Oncorhynchus mykiss, formerly Salmo gairdneri) per concentration were exposed 

to nominal concentrations of 0 (dilution water control), 0 (acetone control, 500 ppm), 1, or 5.6 

mg/L in 500 ppm acetone. Corresponding mean measured concentrations were 0, 0, 1.05, and 4.5 

mg/L. Test concentrations were determined by radio activity measurements. Flow rate of the test 

system was 0.25 mL/minute for exposure concentrations. No mortality or adverse sub-lethal 

behavioral effects were observed for the duration of the 60-day exposure period. Effects 

observed were limited to the highest test concentration and involved sluggish movements. The 

measured NOEC was identified as 4.5 mg/L. In addition to the hazard assessment, the submitter 

provided an assessment of bioconcentration which indicated that analytically determined 

exposure concentrations of 1.05 and 4.5 mg/L resulted in fish tissue concentrations of 34 and 

190 μg/g wet weight, respectively. This study appears to have been previously reviewed by 

EPA/OPPT in 1985. The previous conclusion that “a fish full life cycle toxicity test or 

modification thereof is needed to address the effects of CPs present in fish eggs during 

embryonic development” is still relevant for MCCPs. 
61

This study is considered unacceptable to characterize chronic population-level effects in 

fish. 

(2) CPC, 1980

A 28-day fish toxicity study was conducted by Brixham Laboratories in 1978 with a C14-17 

chlorinated paraffin having 45% chlorination under unspecified testing conditions (CPC, 1980). 

The study report was submitted under TSCA in 1992 as DCN 88920006972 (OTS Fiche 

0545375). Rainbow trout (Oncorhynchus mykiss) per concentration were exposed to nominal 

concentrations of 0 (dilution water control), 0.1, or 1 mg/L in acetone. The age and size of the 

rainbow trout used in the study were not specified in the study. The specific environmental 

conditions of the test, such as pH, temperature and water quality were not specified in the report. 

Concentrations of the chlorinated paraffin in the test water were measured using thin layer 

chromatography (TLC) analytical procedures resulting in mean measured concentrations of 0.01 

and 0.18 mg/L. Mortality and behavior (response to food, general behavior, swimming behavior 

and pigmentation) were assessed during the 28-day study. Survival was 96.6 and 100% for the 

mean measured exposures of 0.01 and 0.18. No behavioral effects were seen over the course of 

the study. 

The study was considered unacceptable to characterize the chronic fish toxicity endpoint 

since insufficient study details were provided including the age and/or the life-stages of the 

exposed organisms.

(3) Fisk et al. (1999)

A 20-day Japanese medaka (Oryzias latipes) embryo toxicity study was conducted with the 

formulation C14H24.9Cl5.1, 48% Cl (composition: 10.5% 1, 2, 13, 14-tetrachlorotetradecane 

(42.3% Cl); 74.3% x, 1, 2, 13, 14-pentachlorotetradecane (47.7% Cl); 14.2% x, y, 1, 2, 13, 13-

hexachlorotetradecane (52.6% Cl); 1.0% x, y, z, 1, 2, 13, 14-heptachlorotetradecane (56.4% Cl) 

by Fisk et al. (1999) under static testing conditions. Five sets of 10 vials containing 1 egg each 

were exposed to nominal concentrations of 0.001, 0.010, 0.100, 1, or 10 mg/L test substance 

starting after fertilization and terminating approximately 3 days post-hatch. No adverse effects 

were reported in exposed embryos. 

The study was considered unacceptable primarily due to insufficient exposure duration 

and insufficient number of eggs per exposure concentration.

(4) Fisk et al. (1999)

A 20-day Japanese medaka (Oryzias latipes) embryo toxicity study was conducted with the 

formulation 14C-C14H23.3Cl6.7, 55% Cl (composition: 0.2% C14H26Cl4 (42.3% Cl), 4.4% 

C14H25Cl5 (47.7% Cl), 34% C14H24Cl6 (52.6% Cl), 45% C14H23Cl7 (56.4% Cl), 14% C14H22Cl8

(59.9% Cl), and 1.9% C14H21Cl9 (62.8% Cl)) by Fisk et al. (1999) under static testing conditions. 

Five sets of 10 vials containing 1 egg each were exposed to measured concentrations of 0.0014, 

0.012, 0.120, 0.420, or 1.6 mg/L test substance starting after fertilization and terminating 

approximately 3 days post-hatch. No adverse effects were reported in exposed embryos. 

Concentrations of the test substance were found in larvae and eggs in a dose-dependent manner 

(with exception of the highest concentration) suggesting that the substance can diffuse through 

the egg shell. Corresponding measured concentrations in eggs were 0.04, 8.4, 63, 110, and 72 

mg/kg and corresponding measured concentrations in larvae were 0.24, 8.2, 45, 84, and 51 mg/L. 

The study was considered unacceptable primarily due to insufficient exposure duration 

and insufficient number of eggs per exposure concentration.

(5) Cooley et al. (2001) as summarized in ECB (2005)
62

The following summary provided in the 2005 European Chemical Bureau Risk Assessment of 

MCCP was considered supportive, but did not characterize all fish life-cycle stages (ECB, 2008). 

Cooley et al. (2001) studied the toxicity of C14H24.9Cl5.1, 48% Cl [as described in (Fisk et al., 

1999)] to juvenile rainbow trout (Oncorhynchus mykiss) through dietary exposure. Treatment 

groups of 10 fish were exposed to 0.78 and 2.9 mg/kg for 21 days and 0.082 mg/kg for 85 days. 

Three control groups were also run. Histological examination and analysis of the chlorinated 

paraffin concentration was performed in five fish per treatment after 21 days in the two higher 

test concentrations and in three fish per treatment after 85 days in the lowest test concentration. 

Three fish were also sacrificed from each low exposure group and the remaining control group 

(but were not analyzed) after 21 days of exposure. Quantitative histomorphological 

measurements were also carried out on livers and thyroid of the exposed fish in the middle 

exposure group after 21 days, and also the low exposure group after 85 days. The parameters 

investigated included hepatocyte nuclear diameter, hepatocyte volume index, nucleus:cytoplasm 

area ratio and thyroid epithelium cell height. Livers displaying mild hepatocyte necrosis and 

moderate to severe depletion of glycogen/lipids were reported for the 0.78 mg/kg exposure. At 

2.9 mg/L abnormal behavior was observed from day 3 onwards. Quantitative effects following 

21 days of exposure were limited to a significantly (p = 0.05) reduced mean hepatocyte volume 

in 2.9 mg/L exposure group. 

This study is considered unacceptable to characterize chronic population-level effects in 

fish. 

(6) Cooley et al. (2001)

Cooley et al. (2001) studied the toxicity of 14C-C14H23.3Cl6.7, 55% Cl [as described in (Fisk et 

al., 1999)] to juvenile rainbow trout (Oncorhynchus mykiss) through dietary exposure. 

Treatment groups of 10 fish were exposed to 29 and 78 mg/kg for 21 days and 5.7 mg/kg for 85 

days. Three control groups were also run. Histological examination and analysis of the 

chlorinated paraffin concentration was performed in five fish per treatment after 21 days in the 

two higher test concentrations and in three fish per treatment after 85 days in the lowest test 

concentration. Three fish were also sacrificed from each low exposure group and the remaining 

control group (but were not analyzed) after 21 days of exposure. Quantitative 

histomorphological measurements were also carried out on livers and thyroid of the exposed fish 

in the middle exposure group after 21 days, and also the low exposure group after 85 days. The 

parameters investigated included hepatocyte nuclear diameter, hepatocyte volume index, 

nucleus:cytoplasm area ratio and thyroid epithelium cell height. At 29 mg/kg abnormal behavior 

was observed from day 2 onwards and livers exhibited mild to moderate hepatocyte necrosis and 

moderate to severe depletion of glycogen lipids. Abnormal behavior from day 3 onward was also 

observed at 78 mg/kg. 

This study is considered unacceptable to characterize chronic population-level effects in 

fish. 

B-1-5 Chronic Aquatic Invertebrate Toxicity

(1) Thompson, Williams, et al. (1997)

A 21-day chronic Daphnia magna reproduction toxicity study was conducted by Thompson, 

Williams, et al. (1997) according to OECD 202, Part II using a static-renewal test system with 

renewal on Monday, Wednesday, and Friday of each week. The test substance was identified as 

Cereclor S52, a C14-17 chlorinated paraffin with 52% chlorination that contained 0.3% epoxy soya 

bean oil stabilizer as well as a small amount of radiolabelled n-pentadecane-8-14C (51% 

chlorinated). Ten replicates of 1 Daphnia magna Straus (< 24 hours old) were tested per 
63

exposure concentration, which did not comply with OECD 202, Part II requirements that at least 

40 daphnid be tested per concentration. These small population sizes may have had an effect on 

significance testing to determine NOEC and LOEC values. Nominal concentrations were 0 

(dilution water control), 0 (solvent control), 0.0056, 0.01, 0.018, 0.032, 0.056, and 0.1 mg/L test 

substance in acetone (0.025 mL/L). Results from the acute daphnid study by the same author do 

not appear to have been considered when selecting concentrations for this study. Test solutions 

were prepared by adding the appropriate stock solution to dilution water while continuously and 

vigorously stirring with a magnetic follower. Based on analysis of 4 renewal intervals (two 48-

hour intervals and two 72-hour intervals, corresponding mean measured concentrations 

determined by radiochemical methods were 0.0037, 0.005, 0.01, 0.018, 0.032, and 0.065 mg/L 

and were 78 - 94% of nominal concentrations at the start of the renewal period and 7.3 - 61% of 

nominal concentrations at the end of the renewal period indicating a notable loss of test 

substance.. In the dilution water control, 20% mortality was observed. Overall, dilution water 

control and solvent control results were significantly different for reproductive parameters. The 

test was carried out at temperatures of 19.5 - 20.3°C, at pH levels of 7.41 - 8.13, and at dissolved 

oxygen concentrations of 6.2 - 9.2 mg/L. A measured 21-day parental LC50 value of 0.025 mg/L 

was reported, which shows less toxicity then what was reported in the corresponding acute 

toxicity study by the same author using the same test substance. A significant decrease in the 

number of live offspring was reported at the mean measured concentration of 0.018 mg/L and 

delayed release of first offspring (statistical significance not determined) was observed at higher 

concentrations. Percentage dead offspring reported was 0%, 0%, 5.9%, 20.4%, and 18.5% for the 

0.0037, 0.005, 0.01, 0.018, 0.032, and 0.065 mg/L mean measured exposures. A mean measured 

NOEC and LOEC were determined to be 0.01 and 0.018 mg/L, respectively, resulting in a ChV 

(geometric mean of NOEC and LOEC) of 0.013 mg/L. The inability to maintain test 

concentrations during renewal periods, the intermittent analysis of test concentrations, and a 

smaller population size may have contributed to inconsistencies with the survivability results 

compared to the acute studies and may have affected subsequent reproductive results. Given the 

uncertainties of the test, reported effect levels may not represent a worst case scenario but do 

exhibit a clear dose response relationship with a clearly defined statistically significant effect 

level. Thus, the study is considered acceptable to characterize the chronic invertebrate endpoint 

given that secondary source studies including TNO (1993) (21-d NOEC = 0.004 - 0.008 mg/L), 

Frank (1993), and Frank and Steinhauser (1994) (21-d MATC = 0.006 mg/L) provided in the 

2005 European Chemical Bureau Risk Assessment of MCCP (ECB, 2005) indicate even higher 

toxicity.

21-d NOEC = 0.01 mg/L

21-d LOEC = 0.018 mg/L 

21-d MATC = 0.013 mg/L 

(2) CPC (1983a)

A 60-day mussel toxicity study was conducted by Brixham Laboratories in 1983 with radiolabeled chlorinated (52%) n-pentadecane (Trade Name: Cereclor S52) under flow through 

testing conditions (CPC, 1983a). A full non-CBI study report was submitted under TSCA in 

1983 as DCN 40-8332184 (OTS Fiche 0507258). Mussels (Mytilus edulis) were exposed to 

nominal concentrations of 0 (dilution sea water control), 0 (acetone control, 500 ppm), 0.56, or 

5.6 mg/L in 500 ppm acetone. Two replicates of 50 mussels were tested for the dilution water 

and solvent controls and a single replicate of 50 mussels was exposed for each treatment 

concentration. Corresponding mean measured concentrations were 0, 0, 0.22, and 3.8 mg/L. Test 

solutions were cloudy at the higher test concentration. Test concentrations were determined by 

radio activity measurements. Flow rate of the test system was 0.25 mL/minute for exposure 

concentrations. Over the course of the study, water temperature ranged from 14.6 – 15.6°C, pH 
64

ranged from 8.0 – 8.3, and the dissolved oxygen concentrations ranged from 6.1 – 8.25 mg/L. 

Dilution water salinity was 34 – 35.5 ppb, which is high by OPPTS standards. One mussel 

exposed to 0.56 mg/L dies, and two mussels exposed to controls died; this was not considered to 

be a test substance related effect. Decreases in filter feeding were observed at 5.6 mg/L. In 

addition, the submitter provided an assessment of bioconcentration, but this assessment does not 

appear to include a depuration phase. Overall, the 60 day NOEC and LOEC were 0.22 and 3.8 

mg/L, respectively, based on reduced filtration. The study was acceptable to characterize mussel 

toxicity, but mussels are not considered a standard species to fulfill the chronic aquatic 

invertebrate toxicity endpoint.

60-d NOEC = 0.22 mg/L

60-d LOEC = 3.8 mg/L (reduced filtration)

(3) Frank (1993); Frank and Steinhauser (1994)

The following study summary for (Frank, 1993; Frank and Steinhauser, 1994), provided in the 

ECB (2005) MCCP risk assessment, was considered supportive of the aquatic invertebrates 

hazard determination. A 21-day chronic Daphnia magna reproduction toxicity study was 

conducted using a static-renewal test system (renewal 3 times/week). The test substance was 

identified as C14-17 chlorinated paraffin with 52% chlorination, which was tested as a water 

soluble fraction of two stock solutions (dilutions used 1:2 to 1:32). Nominal test concentrations 

prepared from the 100 mg/L stock solution were 3.125, 6.25, 12.5, 25, and 50 mg/L. Nominal 

test concentrations prepared from the 10,000 mg/L stock solution were 312.5, 625, 1250, 2500, 

and 5000 mg/L. Analytical monitoring of test concentrations was conducted, but only the final 

effect levels were presented as measured concentrations. Methods for test solution preparation 

were not provided in the summary. The tests were carried out at 20°C and at pH 7.79 - 8.44. 

In the experiments using the 100 mg/L stock solution the mortality seen in the exposed 

populations was 0% at 3.125 mg/L, 0% at 6.25 mg/L, 20% at 12.5 mg/L, 90% at 25 mg/L, and 

100% at 50 mg/L. In the experiments using the 10,000 mg/L stock solution the mortality seen in 

the exposed populations was 0% at 312.5 mg/L, 30% at 625 mg/L, 70% at 1250 mg/L, and 100% 

at lower dilutions (>1250 mg/L). In the experiments using the 100 mg/L stock solution the 

average number of young/adult was 82 at 3.125 mg/L, 89 at 6.25 mg/L, 80 at 12.5 mg/L, 15 at 

25 mg/L and 0 at 50 mg/L (all parents died). Similarly in the experiments using the 10,000 mg/L 

stock solution the average number of young/adult was 74 at 312.5 mg/L, 64 at 625 mg/L, 43 at 

1250 mg/L, and 0 at 2,500 and 5,000 mg/L (all parents died). Based on these effects, 

survivability/mortality appears to be the more sensitive endpoint. Based on the known measured 

concentrations in the stock solutions and the dilution rates used the NOEC for mortality was 

around 0.0044-0.0089 mg/L for the 100 mg/L nominal stock solution experiments and 0.0126-

0.0156 mg/L for the 10000 mg/L nominal stock solution experiments. The corresponding 

LOECs were 0.0089- 0.0178 mg/L (100 mg/L nominal stock) and 0.0253-0.0313 μg/L (10 g/L 

nominal stock). The MATC of 0.006 mg/L was calculated using the geometric mean from the 

most conservative NOEC (0.0044 mg/L) and LOEC (0.0089 mg/).

These data are considered supportive of the aquatic invertebrate hazard determination.

(4) TNO (1993)

The following study summary for TNO (1993) provided in the ECB (2005) MCCP risk 

assessment, was considered supportive of the aquatic invertebrates hazard determination. A 21-

day chronic Daphnia magna reproduction toxicity study was conducted using a static-renewal 

test system (renewal 3 times/week). The test substance was identified as C14-17 chlorinated 

paraffin with 52% chlorination. The test solutions were prepared by stirring 20 g of the test 

substance in 2 litres of heated water (60°C) with stirring and then filtration through a 0.8 μm and 
65

0.2 μm filter. This resulting stock solution was referred to as a water soluble fraction, but given 

that each concentration was not independently prepared, the test solutions is considered by 

EPA/OPPT to be merely a mixed and filtered solution that was subsequently diluted. Following 

dilution of the stock solution, exposure concentrations were analytically determined using the 

extractable organic halogen method, but not provided in the study summary. The test was carried 

out at 20 ± 1°C and solutions were gently aerated from day 9 onwards. The pH of the test water 

varied between 7.7 and 8.3, the dissolved oxygen concentration was > 7 mg/L, and the hardness 

was 214 mg CaCO3/L. Test solutions were clear. Although analytical results obtained were 

considered to be too erratic to allow precise determination of concentrations (according to the 

study summary in ECB (2005)), the NOEC was reported based on survivability and/or 

reproductive effects. A LOEC in mg/L was not reported in the summary, nor could EPA/OPPT

extrapolate one. However, it is still unclear as to the levels of saturation of each solution the 

organisms were exposed to based on the extraction technique and nominal loading rates. 

This study is not considered acceptable for determining hazard, thus the results were not 

used in this assessment.

B-1-6 Chronic Aquatic Sediment Invertebrate Toxicity

(1) Thompson et al. (2001a)

A 28-day prolonged sediment invertebrate toxicity study with spiked sediment was conducted by 

Thompson et al. (2001a) according to OECD 218 draft guideline (February 2000 version) using 

a static test system. The substance used in the test was commercial C14-17, 52% wt. Cl substance 

containing no stabilizers (the substance was reported to have a C14-17 content of 99.06% with 

0.67% of C10-13 chain length substances) that was mixed with a small amount of a radio labeled 

n-pentadecane-8-14C, 51% wt. Cl substance (radiochemical purity > 96.6%). Three replicates of 

15 midge (Chironomus riparius) larvae (< 48 hours post hatch) were exposed to nominal 

concentrations of 0 (sediment control), 0 (solvent sediment control), 44, 140, 440, 1400, 4400, or 

14,000 mg/kg dry wt. sediment. Corresponding mean measured concentrations of 0 (sediment 

control), 0 (solvent sediment control), 36, 110, 370, 1200, 3800, and 13,000 mg/kg dry wt. 

sediment were determined using radiochemical analysis. The sediment used in the test was an 

artificial sediment that did not fully adhere to the final OECD TG recommendations, but the 

composition of 10% sphagnum moss peat, 70% quartz sand, 20% kaolinite clay, and < 0.1% 

calcium carbonate are not considerably different. The sediment had a mean organic carbon 

content of 4.9% and a pH of 6.0. The sediment was spiked with the test substance by mixing a 

solution of the test substance in acetone with the dry sand component of the sediment and 

allowing the acetone to evaporate overnight under an air stream. Over the course of the study, 

temperature was maintained at 20 ± 1°C, pH levels were 6.2 - 7.6, and dissolved oxygen in 

overlying water was maintained at 7.3 - 8.6 mg/L. Time to first emergence, mean emergence 

time, mean number emerged per replicate, and sex ratio was assessed for each exposure group. 

Statistically significant effects (Dunnett’s procedure, p = 0.05) were limited to a decrease in 

mean number emerged per replicate in the 13,000 mg/kg dry wt. sediment exposed midges. The 

overall mean measured NOEC of 3,800 mg/kg dry wt. sediment corresponded to 1,460 mg/kg on 

a wet weight basis. Based on the mean measured NOEC and LOEC of 3,800 and 13,000 mg/kg 

dry wt. sediment, respectively, the MATC was 7,029 mg/kg dry wt. sediment. The study was 

acceptable.

28-d NOEC = 3,800 mg/kg dry wt sediment

28-d LOEC = 13,000 mg/kg dry wt sediment

28-d MATC = 7,029 mg/kg dry wt sediment

(2) Thompson et al. (2001b)
66

A 28-day prolonged sediment invertebrate toxicity study with spiked sediment was conducted by 

Thompson et al. (2001b) according to methods described in Phipps et al. (1993) using a static 

test system. The substance used in the test was commercial Cereclor S52 (C14-17, 52% wt. Cl 

with no stabilizers). The substance was reported to have a C14-17 content of 99.06% with 0.67% 

of C10-13 chain length substances and was mixed with a small amount of a radio labeled npentadecane-8-14C, 51% wt. Cl substance (radiochemical purity > 96.6%). Six replicates of 10 

oligochaete (Lumbriculus variegatus) adults were exposed to nominal concentrations of 0 

(sediment control), 0 (solvent sediment control), 44, 140, 440, 1,400, 4,400, and 14,000 mg/kg 

dry wt. sediment. Corresponding mean measured concentrations of 0 (sediment control), 0 

(solvent sediment control), 39, 130, 410, 1,300, 4,000, and 13,000 mg/kg dry wt. sediment were 

determined using radiochemical analysis. The sediment used in the test was an artificial sediment 

consisting of 10% sphagnum moss peat, 70% quartz sand, 20% kaolinite clay, and < 0.1% 

calcium carbonate. The sediment had a mean organic carbon content of 4.9% and a pH of 6.0. 

The test sediments were made up by adding the test substance to the sand phase as a solution in 

acetone, evaporating the acetone overnight and mixing the spiked sand with the rest of the

sediment for 16 hours. Throughout the duration of the study, water temperature was maintained 

at 20 ± 1°C, pH remained between 6.3 and 7.9. Mortality and reproductive success were 

determined by total number of worms at study termination since differentiation of adult and 

young worms is difficult. Mean number of worms per replicate and mean total dry weight of 

worms per replicate was significantly different from controls (Dunnett’s procedure, P = 0.05) at 

mean measured concentrations of 410 mg/kg dry weight sediment and greater. Thus, the NOEC 

and LOEC were 130 and 410 mg/kg dry wt. sediment and the ChV (geometric mean of the 

NOEC and LOEC) were 230.9 mg/kg dry wt. sediment. The study was acceptable.

28-d NOEC = 130 mg/kg dry wt sediment

28-d LOEC = 410 mg/kg dry wt sediment

28-d ChV = 230.9 mg/kg dry wt sediment

(3) Thompson et al. (2002)

A 28-day prolonged sediment toxicity study with amphipod Hyalella azteca in spiked sediment 

was conducted by Thompson et al. (2002) using a static-renewal test system with weekly 

renewals. The substance used in the test was a mixture of a commercial medium-chain 

chlorinated paraffin product (C14-17, 52.5% wt. Cl) mixed with a small amount of a radio labeled 

chlorinated n-pentadecane-8-14C (51% wt. Cl). Six replicates per concentration of ten juvenile 

Hyalella azteca (7-day-old) were exposed to 0 (sediment control), 0 (acetone sediment control), 

38, 75, 150, 300, or 600 mg/kg dry weight sediment in acetone. The concentration of the test 

substance was measured in the sediment phase by radiochemical analysis with concentrations at 

the start of the exposure period of 85 - 97% of the nominal values and concentrations at the end 

of the 29-day exposure period of 78 - 90% of nominal. Results of the test were expressed as the 

arithmetic mean concentrations. The sediment used in the test was an artificial sediment 

consisting of 10% sphagnum moss peat, 70% quartz sand, 20% kaolinite clay, and < 0.1% 

calcium carbonate. The sediment had a mean organic carbon content of 4.9% and a pH of 6.0. 

The test sediments were made up by adding the test substance to the sand phase as a solution in 

acetone, evaporating the acetone overnight and mixing the spiked sand with the rest of the 

sediment and water. Over the course of the study, dissolved oxygen ranged from 7.7 to 8.4 mg/l, 

pH ranged from 7.0 to 7.6, water hardness ranged from 41 to 42 mg CaCO3/l, and temperature 

ranged from 22.4 - 23.2°C. The endpoints investigated in the study included survival, growth 

(dry weight) and sexual development of females (proportion of gravid females). Controls 

responded adequately. For the survival endpoint, a statistically significant (p = 0.05) reduction in 

survival was seen at 470 mg/kg dry weight. A statistically significant (p = 0.05) reduction in 

mean weight was seen at 270 mg/kg dry weight. For the sexual development endpoint, there was 
67

a statistically significant (p = 0.05) reduction in the proportion of gravid females in the 470 

mg/kg dry weight treatment. The mean measured NOEC and LOEC for survival and 

reproductive toxicity was 270 and 470 mg/kg dry weight sediment, respectively. The mean 

measured NOEC and LOEC for growth was 130 and 270 mg/kg dry weight sediment, 

respectively, resulting in a MATC of 187 mg/kg dry weight sediment. The study is acceptable.

28-d NOEC = 130 mg/kg dry wt sediment

28-d LOEC = 270 mg/kg dry wt sediment

28-d MATC = 187 mg/kg dry wt sediment

B-1-7 Avian Toxicity

(1) Madeley and Birtley (1980)

An acute avian toxicity study conducted according to methods described in US EPA’s Pesticide 

Program Guidelines for Registering Pesticides (FR 40, 123, 26913, 26915) was published by 

Madeley and Birtley (1980). Following a range-finding study, groups of 5 male and 5 female 

ring-necked pheasants (Phasianus colchicus) were exposed by gavage to 0 (control) or 24,606 

mg/kg Cereclor S52 (C14-17, 52% Cl) and then observed for 14 days. Based on reported tissue 

concentrations, the test substance is believed to have been absorbed by the ring-necked pheasant. 

Doses up to 24,606 mg/kg failed to produce any abnormal clinical signs or mortality. Thus, the 

LD50 was > 24,606 mg/kg Cereclor S52. 

The study was acceptable. Acute LD50 > 24,606 ppm

(2) Madeley and Birtley (1980)

An acute avian toxicity study conducted according to methods described in US EPA’s Pesticide 

Program Guidelines for Registering Pesticides (FR 40, 123, 26913, 26915) was published by 

Madeley and Birtley (1980). Following a range-finding study, groups of 5 male and 5 female 

mallard ducks (Anas platyrynchos) were exposed by gavage to 0 (control) or 10,280 mg/kg 

Cereclor S52 (C14-17, 52% Cl) and then observed for 14 days. Based on reported tissue 

concentrations, the test substance is believed to have been absorbed by the mallard ducks. Doses 

up to 10,280 mg/kg failed to produce any abnormal clinical signs or mortality. Thus, the LD50

was > 10,280 mg/kg. 

The study was acceptable. Acute LD50 > 10,280 ppm

(3) Madeley and Birtley (1980)

A sub-acute dietary avian toxicity study conducted according to methods described in US EPA’s 

Pesticide Program Guidelines for Registering Pesticides (FR 40, 123, 26913, 26915) was 

published by Madeley and Birtley (1980). Following a range-finding study, groups of 5 male and 

5 female ring-necked pheasants (Phasianus colchicus) were exposed to diets containing 0 

(control), 1,000, or 24,063 ppm Cereclor S52 (C14-17, 52% Cl) for 5 days. Three groups were 

exposed to the negative control and two groups were exposed to each of the treatment 

concentrations. Based on reported tissue concentrations, the test substance is believed to have 

been absorbed by the ring-necked pheasant. Good health was noted in all control and treatment 

groups. No abnormal effects were noted at necropsy. Thus, the LD50 was > 24,063 ppm. 

The study was acceptable. 5-day LD50 > 24,063 ppm

(4) Madeley and Birtley (1980)

A sub-acute dietary avian toxicity study conducted according to methods described in US EPA’s 

Pesticide Program Guidelines for Registering Pesticides (FR 40, 123, 26913, 26915) was 

published by Madeley and Birtley (1980). Following a range-finding study, groups of 5 male and 

5 female mallard ducks (Anas platyrynchos) were exposed to diets containing 0 (control), 1,000, 
68

or 24,063 ppm Cereclor S52 (C14-17, 52% Cl) for 5 days. Three groups were exposed to the 

negative control and two groups were exposed to each of the treatment concentrations. Inferior 

food intake was noted for ducks, but weight gain was comparable to controls. Based on reported 

tissue concentrations, the test substance is believed to have been absorbed by the mallard ducks. 

Good health was noted in all control and treatment groups. No abnormal effects were noted at 

necropsy. Thus, the LD50 was > 24,063 ppm.

The study was acceptable. 5-day LD50 > 24,063 ppm

(5) Unpublished study reviewed in the ECB (2000)

The effects of C10-12, 58% Cl chlorinated paraffin (mean-measured 29, 168, and 954 mg/kg-diet) 

on the reproduction of mallard ducks (Anas platyrhynchos) were evaluated over 22 weeks 

including a 9-week pre-egg-laying period without photostimulation, a 3-week pre-egg-laying 

period with photostimulation, and 10-week egg-laying period with photostimulation. There were 

no significant effects on adult body weight, food consumption, eggs laid, number of cracked 

eggs, mean egg weight, live 21-day embryos, hatchlings, 14-day old survivors, or day 0 and day 

14 hatchling weights. A statistically-significant decrease in mean eggshell thickness of 5% was 

observed in the mean-measured 954 mg/kg-diet treatment group compared to the control even 

though mean eggshell thickness in the 954 mg/kg-diet treatment group was within the range of 

normal values. In addition, a decrease in 14-day embryo viability of 10% was observed in the 

mean-measured 954 mg/kg-diet treatment group compared to the control. This decrease was not 

statistically significant over the entire 10-week egg-laying period but was statistically significant 

on weeks 3 and 6. The mean-measured NOEC and LOEC values were 168 and 954 mg/kg-diet, 

respectively, based on reproductive endpoints.

The study was acceptable. NOEC of 168 mg/kg-diet; LOEC of 954 mg/kg-diet.

B-1-8 Terrestrial Invertebrate Toxicity

(1) Thompson et al. (2001d) 

A 28-day earthworm reproductive toxicity test was conducted by Thompson et al. (2001d)

according to OECD guidelines. The substance tested was commercial C14-17, 52% wt. Cl 

substance containing no stabilizers (the substance was reported to have a C14-17 content of 

99.06% with 0.67% of C10-13 chain length substances) and a small amount of 14C-labelled npentadecane, 51% wt. Cl substance. Four replicates per concentration of 10 adult earthworm 

(Eisenia fetida) were exposed to nominal concentrations of 0 (soil control), 0 (solvent soil 

control), 100, 320, 1000, 3200, or 10,000 mg/kg dry wt. soil. Corresponding mean measured 

concentrations of 0 (soil control), 0 (solvent soil control), 79, 280, 900, 2,800, or 9,300 mg/kg 

dry wt. was determined using radiochemical analysis; concentrations identified as approximate 

() were approximated using the mean% of nominal (87%) determined in other treatments. 

Measured tissue concentrations in adults on day 28 were 169, 802, and 732 mg/kg wet weight for 

the 79, 900, and 9,300 mg/kg dry weight exposure groups. Measured tissue concentrations in 

juveniles on day 56 were 140 and 1,011 mg/kg wet weight for the 79 and 900 mg/kg dry weight 

exposure groups. The soil used in the test was an artificial soil consisting of 10% sphagnum 

moss peat, 70% quartz sand, 20% kaolinite clay, and 0.25% calcium carbonate. The soil had an 

organic carbon content of 4.7% and a pH of 6.66 - 7.09. Nominal test temperatures remained at 

20 ± 1°C. The soils were prepared up by firstly adding the test substance in solution with acetone 

to a small portion of soil, evaporating out the acetone overnight under a stream of compressed 

air, and then mixing with the remainder of the soil. Before use, distilled water was added to the 

dry soil to provide a soil wet:dry ratio of 1.35. Following the 28-day parental exposure period, 

adult earthworms were removed, and vessels were incubated for an additional 28 days to allow 

hatching of any egg cocoons produced by parent. Effects assessed were parental survival, growth 
69

as determined by change in weight of parents, and reproduction as determined by number of live 

offspring. A statistically significant (p = 0.05) reduction in parental survival (85%) was observed 

at 9,300 mg/kg dry wt. soil. A statistically significant (recalculated with Dunnett’s Procedure, p 

= 0.05) reduction in parental weight was reported at 2800 mg/kg dry wt. soil. A statistically 

significant (recalculated with Dunnett’s Procedure, p = 0.05) reduction in number of live 

offspring was reported at 280 mg/kg dry wt. soil. The MATC (geometric mean of the NOEC and 

LOEC) based on these values is 149 mg/kg dry wt. soil. In addition, the submitter assesses 

corresponding tissue concentrations in earthworms and determines that at nominal 

concentrations of 100 mg/kg dry wt. soil the concentration in parental earthworm tissue after 28 

days is 850 mg/kg dry wt. and in juvenile worms after 56 days was 703 mg/kg dry wt. The study 

was acceptable.

28-d NOEC = 79 mg/kg dry wt soil

28-d LOEC = 280 mg/kg dry wt soil

28-d MATC = 149 mg/kg dry wt soil

B-1-9 Soil Microorganism Toxicity

(1) Thompson (2002)

A 28-day soil microorganisms toxicity test was conducted by Thompson (2002) according to 

OECD 216 (Soil Microorganisms: Nitrogen Transformation Test) with GLP compliance using a 

static test system. The substance tested was commercial C14-17, 52% wt. Cl substance containing 

no stabilizers (the substance was reported to have a C14-17 content of 97.35% with 0.66% of C10-

13 chain length substances). Three replicates of nitrogen producing bacteria per concentration 

were exposed to natural soil (sieved 0.2 mm) with an organic carbon content of 1.6% that was 

spiked with nominal concentrations of 25, 50, 100, 200, or 400 mg/kg dry wt. soil MCCP. Soil 

was amended by the addition of an organic nitrogen source referred to as lucerne meal and an 

amended and unamended control was tested concurrently with the test. Although a 13% decrease 

in nitrate production was observed in bacteria exposed to the highest test concentration (400 

mg/kg dry wt. soil), there was no significant (p = 0.05) inhibition of nitrogen producing bacteria 

resulting in a 28-day EC50, NOEC, and LOEC of > 400, 400, and > 400 mg/kg dry wt. soil. The 

study was acceptable.

28-d NOEC = 400 mg/kg dry wt soil 

28-d LOEC > 400 mg/kg dry wt soil

B-1-10 Terrestrial Plant Toxicity

(1) Thompson et al. (2001c)

A 28-day seed germination and vegetative vigor study was conducted by Thompson et al. 

(2001c) to assess toxicity to wheat (Triticum aestivum; monocotyledon), oilseed rape (Brassica 

napus; ditcotyledon), and mung bean (Phaseolus aureus; dicotyledonous legume) using OECD 

guideline 208 (July, 2000 Revision). The substance tested was commercial C14-17, 52% wt. Cl 

substance containing no stabilizers (the substance was reported to have a C14-17 content of 

99.06% with 0.67% of C10-13 chain length substances) and a small amount of 14C-labelled npentadecane, 51% wt. Cl substance. For each species, four replicate pots per exposure 

concentration each containing 9 seeds were exposed for 28 days to nominal exposure 

concentrations of 0 (soil control), 0 (solvent soil control), 50, 158, 500, 1,580, or 5,000 mg/kg 

dry wt. Mean measured concentrations of 49, 520, and 5,800 mg/kg dry wt. soil were 

determined for the nominal test concentrations of 50, 500, and, 5,000 mg/kg dry weight soil; 

based on this observed stability, the submitter uses nominal test concentrations for effect level 

determination. The soils were prepared by firstly adding the test substance in solution with 
70

acetone to dry silver sand, evaporating the acetone overnight, and mixing the spiked sand with 

the soil. Over the course of the study, temperatures were maintained between 16 and 31°C. 

Effects assessed were seed germination, emergence (% emerged plants on Day 14), vegetative 

growth (mean shoot dry weight per plant), and visual appearance of seedling. No statistically 

significant differences (p = 0.05) were observed in wheat, oilseed rape; however, control 

emergence for oilseed rape was below OECD recommendations of 70% suggesting issues with 

the test system and invalidating the oilseed rape test. A statistically significant reduction in 

growth was seen at 1,580 and 5,000 mg/kg dry wt. for mungbean when compared to soil control 

results, but not solvent control results. Since soil control and solvent control means were equal 

(two tailed T-Test) indicating no solvent interference, comparison of treatments was made to the 

soil control. Thus, the NOEC and LOEC for terrestrial plants was 500 and 1,580 mg/kg dry wt. 

soil and the MATC (geometric mean of the NOEC and LOEC) was 888.8 mg/kg dry wt. soil. 

The study was acceptable to characterize both monocot (wheat) and dicot (mung bean) seed 

germination and vegetative vigor; reproductive effects remain uncharacterized.

28-d NOEC = 500 mg/kg dry wt soil

28-d LOEC = 1,580 mg/kg dry wt soil

28-d MATC = 888.8 mg/kg dry wt soil

B-1-11 Conclusions

Sufficient data were available to characterize the acute fish, the acute aquatic invertebrate, the 

chronic aquatic invertebrate, the chronic aquatic sediment invertebrate, avian, and terrestrial 

plant toxicity endpoints for MCCPs. Data for other toxicity endpoints (i.e., chronic fish, aquatic 

plant, etc.) were inconclusive due to lack of study details, uncertainties in analytical methods, or 

test material preparation methods; thus, these data are included in order to characterize risk in a 

qualitative manner, but are used as supportive for the categories under which they are provided. 

Supporting data were included in order to provide a weight-of-evidence approach used to 

characterize some endpoints. 

Most of the data provided in this review indicated several difficulties were encountered when 

testing in an aquatic environment. These included: (1) getting the material into solution, (2) 

measuring the material in solution, and (3) characterizing the effects for each study listed. Often 

there were many details of a given study omitted, prohibiting a full and robust review of the data. 

The (estimated) physical-chemical properties of MCCPs (water solubility values of 

approximately 30 μg/L and Log Kow values between 4-8) suggest these materials may not 

partition to the aquatic media or elicit toxicity to aquatic organisms within the water column. 
71

Appendix C HUMAN HEALTH HAZARD STUDY SUMMARIES

C-1 MCCP HEALTH DATA REVIEW

When evaluating the risks of workers from exposure to MCCPs based on the available repeateddose toxicology studies, the EU’s draft Risk Assessment Report (RAR) on MCCPs concluded 

that except metal working fluids (MWF) use, “There is at present no need for further 

information and/or testing or for risk reduction measures beyond those which are being applied 

already” ( ECB, 2008).

Using the NOAEL (23 mg/kg-bw/day) of kidney toxicity identified in the 90-day oral study in 

rats (CXR, 2005), a MOS of 70,000 was estimated for dermal exposure of consumers resulting 

from wearing leather clothes treated with MCCP. For inhalation exposure of consumers using 

metal fluids containing MCCP, a MOS of 2,875 was obtained. Therefore, it was also concluded 

that: “There is present no need for further information and/or testing or for risk reduction 

measures beyond those which are being applied already” (ECB, 2008).

C-1-1 Metabolism 

There is no information on inhalation absorption of MCCPs in humans or in animals. Based on 

their low vapor pressure and low water solubility, absorption following inhalation or dermal 

exposure is expected to be limited. An in vitro study using human skin showed that after 24 

hours, approximately 0.7% of a C15 chlorinated paraffin was absorbed (Scott, 1984; cited in:

ECB, 2008). Oral studies (IRDC, 1984, CXR, 2005; cited in: ECB, 2008) showed that 

approximately 50% of a single dose of [8-

14C]-labeled C15 chlorinated paraffin (52 wt% Cl) was 

absorbed from the GI tract in rats. Excretion via feces was the major route of elimination of 

radiolabeled material. Elimination of radioactivity from body tissues occurred with an 

elimination half-life of approximately 2-5 days (liver and kidney) or approximately 2 weeks 

(adipose tissue). 

C-1-2 Acute Toxicity

There is no information on the effects of a single exposure to MCCPs in humans. No deaths and 

only limited, non-specific clinical signs of toxicity resulting from exposure of rats to very high 

doses were observed in an acute oral toxicity study of MCCPs (C14-17, 51-60 wt% Cl); the LD50

was reported to be > 4,000 mg/kg bw (Birtley et al., 1980; cited in: IPCS, 1996). Though no 

acute toxicity data are available for MCCP by the inhalation or dermal route of exposure, the low 

acute toxicity data for SCCPs by these routes suggest that MCCPs are likely to have low acute 

inhalation and dermal toxicity.

C-1-3 Irritation and Sensitization

No signs of skin irritation were seen with MCCPs (C14-17, 45 wt% Cl), and only slight erythema 

on the shaved skin was reported in one rabbit at 24 hours exposed to MCCPs (C14-17, 40 wt% Cl) 

(Chater, 1978; cited in: ECB, 2008). A mild skin irritancy response was reported in one of nine 

unpublished skin irritation studies of MCCPs (C14-17, 51-60% Cl) in rats (Birtley et al., 1980; 

cited in: ECB, 2008). The material caused slight, transient eye irritation in rabbits (Birtley et al., 

1980; Kuhnert et al., 1986; cited in: ECB, 2008).
72

No skin sensitization reactions were produced in guinea pig maximization tests conducted on 

MCCPs (C14-17, 40-45 wt% Cl) (Murmann, 1988; Chater, 1978; cited in: ECB, 2008). 

C-1-4 Repeated-dose Toxicity

There are a number of repeated dose toxicity studies (up to 90-days duration) of MCCPs (C14-17

40 wt% Cl or 52 wt% Cl) in rats by oral exposure (CXR, 2005; Poon et al., 1995; IRDC, 1984; 

Birtley et al., 1980; and Wyatt et al., 1997; cited in: ECB, 2008). Though the quality and 

reliability of these studies differs, the liver, kidney, and thyroid were consistently established as 

the target organs. A summary of the results from these studies is provided in Table 1. 

MCCPs caused an increase in liver weight in male rats at exposure levels of > 100 mg/kgbw/day) and in female rats at exposure levels of > 32 mg/kg-bw/day. Liver enzyme induction 

was reported in male and female rats starting from 222 and 100 mg/kg-bw/day, respectively. 

Liver hypertrophy of trace to minimal severity was reported in male rats at dose levels of > 100 

mg/kg-bw/day and higher. Collectively, these changes are likely to be related to an increase in 

metabolic demand as an adaptive response and to peroxisome proliferation, both of which are 

considered of no or limited toxicological significance to humans. Though Poon et al. (1995) 

reported various histopathological effects in the liver of male and female rats at dose levels > 36 

mg/kg-bw/day, there are a number of deficiencies with this study, including the scoring and 

classification of histopathological findings and limited reporting of data, which preclude its 

utility in hazard evaluation. This conclusion is consistent with previous evaluations of this study 

(ECB, 2008). Further, despite the consistency of findings reported in the review article by 

Birtley et al. (1980) with other 90-day studies, these findings should be viewed cautiously 

because the original full study report is not available. Based on the available data, the studies by 

IRDC (1984) and CXR (2005) provide the most reliable data for identifying effect levels of 

MCCPs on the liver. For the purposes of this assessment, a NOAEL of 100 mg/kg-bw/day was 

chosen based on increases in absolute liver weight (i.e., 22-26%), liver hypertrophy of trace 

severity, and enzyme induction (i.e., 30% increase). 

Kidney effects have been reported in a number of studies, with effect levels typically being 

observed at the limit doses. MCCPs (C14-17 52 wt% Cl) caused significant increases (9-13%) in 

kidney weight at 222 mg/kg-bw/day (CXR, 2005; cited in: ECB, 2008), as well as “chronic 

nephritis” and tubular pigmentation in the kidney of female rats at 625 mg/kg-bw/day (IRDC, 

1984, cited in: ECB, 2008). One study reported a dose-related increase in congestion starting at 

32 mg/kg-bw/day; however, no information was provided on the incidence or severity of this 

effect (Birtley et al., 1980; cited in: ECB, 2008). An additional study reported minimal to mild 

hyaline-droplet like cytoplasmic inclusions, starting at > 0.4 mg/kg-bw/day in male rats. This 

effect is considered of limited relevance to humans. The authors also reported minimal doserelated increases with inner medullary tubular dilation at an incidence of 1/10, 4/10, and 8/10 

female rats at 4, 42, and 420 mg/kg-bw/day, respectively (Poon et al., 1995; cited in: ECB, 

2008). Though this effect is considered relevant to humans, the study suffers from a number of 

limitations, which preclude utilizing it for hazard evaluation. However, based on the incidence 

reported by the authors, the NOAEL of 42 mg/kg-bw/day for kidney effects is consistent with 

the NOAEL of 23 mg/kg-bw/day reported in the CXR (2005) study. Therefore, a NOAEL of 23 

mg/kg-bw/day was chosen for the kidney, based on increases in organ weight at the next highest 

dose level. 

MCCPs (C14-17 52 wt% Cl) have been reported to cause minimal to mild adaptive 

histopathological changes in the thyroid (i.e., follicular cell hypertrophy and hyperplasia) in two 
73

studies in rats starting at 50 ppm (4 mg/kg-bw/day) and above (Poon et al., 1995; IRDC, 1985). 

Decreased T4 levels and increased TSH levels in the plasma were also seen at similar dose 

levels. As noted previously, these results have been drawn into question based on the scoring and 

classification for histopathology, the limited reporting of data, and the inconsistent findings from 

other more robust studies (ECB, 2008). Therefore, these studies will not be considered further 

for hazard identification. IRDC (1985) reported mild to moderate hypertrophy and hyperplasia in 

male rats at dose levels of > 10 mg/kg-bw/day and higher, whereas changes in absolute organ 

weights of male and female rats were not observed except at the limit dose of 625 mg/kg-bw/day 

(IRDC, 1985; cited in: ECB, 2008). The remaining studies that evaluated thyroid hormone 

levels identified a decrease in plasma free T3 in male rats, but not total T3 or free/total T4, and an 

increase in TSH in female rats at dose levels of 24.6 or 242 mg/kg-bw/day, respectively (CXR, 

2005; cited in: ECB, 2008), or fluctuations in thyroid hormones in male or female rats at doses 

of > 312 mg/kg-bw/day or higher (Wyatt et al., 1997; cited in: ECB, 2008). There is evidence 

that the thyroid effects observed are attributable to stimulation of this organ arising from a 

negative feedback effect arising from plasma T4 depletion following increased excretion of this 

hormone. This depletion of plasma T4 results from the induction of hepatic UDPG-transferase, 

increased glucuronidation, and ultimately excretion of T4 following exposure to MCCPs. The 

pituitary responds to the decreased levels of T4 by releasing more TSH, which in turn leads to 

increased production of T4 by the thyroid. The continuous stimulation of the thyroid in response 

to the increased excretion of plasma T4 is predicted to ultimately give rise to hypertrophy and 

hyperplasia in this organ. Humans, unlike rodents, possess T4-globulin binding protein and are 

therefore less susceptible to plasma T4 depletion and hence any resultant thyroid stimulation. The 

thyroid effects observed in rats are not considered to be of relevance to chronic human health at 

relevant levels of exposure, although these changes may be relevant for assessing potential 

adverse outcomes during reproduction and development, as discussed under section. 

C-1-5 Genotoxicity

MCCPs (C14-17 40-52 wt% Cl) are not mutagenic to bacteria. Three in vivo bone marrow studies 

also show that MCCPs are not clastogenic (cited in: ECB, 2008). Therefore, it may be concluded 

that MCCPs possess a low potential to cause genotoxic effects.

C-1-6 Carcinogenicity

There is no information on the carcinogenicity of MCCPs. When administered by gavage, a 

SCCP (C12, 60 wt% Cl) caused increased incidences liver tumors in male and female rats, kidney 

tumors in male rats, and thyroid tumors in female rats (NTP, 1986). However, on mechanistic 

considerations, these tumors are considered to be of little or no relevance to humans. This 

conclusion is consistent with previous carcinogenicity evaluations (ECB, 2008). An increased 

incidence of malignant lymphoma in male mice was reported at the highest dose of 5,000 mg/kgbw/day in carcinogenicity studies of a LCCP (C23, 43 wt% Cl) in male and female rats and mice. 

However, malignant lymphoma is one of the more variable tumors in mice and has a viral origin 

in many cases. No increased incidence of malignant lymphoma was observed in the 

carcinogenicity study on a SCCP (C12, 60 wt% Cl). Based on structure-activity relationships and 

the absence of positive genotoxicity data on MCCPs, the available carcinogenicity studies on a 

SCCP and a LCCP suggest that MCCPs are not expected to pose a carcinogenic hazard to 

humans. 
74

Table_Apx C-1: Summary of Results from 90-Day Studies in Rats Administered MCCPs

Strain (sample size) Test substance and 

dose levels

Target 

organ

Effect levels

F-344 

(10 rats/sex/group)1

C14-17, 52 wt% Cl

Dietary intake for ♂: 0, 

2.38, 9.34, 23.0, or 222 

mg/kg-bw/day.

Dietary intake for ♀: 0, 

2.51, 9.70, 24.6, or 242 

mg/kg-bw/day.

Liver

♂ at 222 and ♀ at 242 mg/kg-bw/day, 13-31% ↑ in organ weight

♂ at 222 mg/kg-bw/day, minimal centrilobular hypertrophy in 9/10 animals

♂ at 222 mg/kg-bw/day, 82% ↑ in microsomal T4-UDPGA-glucuronyl transferase activity

♀ at 100, 300, and 300 mg/kg-bw/day, 30, 30, and 252% ↑ in microsomal T4-UDPGA-glucuronyl transferase activity, 

respectively

Kidney

♂ at 222 and ♀ at 242 mg/kg-bw/day, 9-13% ↓ in organ weight

♂ at > 222 and ♀ at 242 mg/kg-bw/day, no treatment-related histopathology

Thyroid

♂ at 222 mg/kg-bw/day, 17% ↑ in plasma TSH

♂ at 23.0 and 222 mg/kg-bw/day, 26% or 22% ↓ in plasma free T3, respectively, but no effects on total T3 or on free/total 

T4 at any dose

♀ at > 242 mg/kg-bw/day, no effects on free/total T3 or T4

♀at 24.6 and 242 mg/kg-bw/day, 20 and 39% ↑ in plasma TSH

♂at > 222 and ♀ at 242 mg/kg-bw/day, no treatment-related histopathology

Sprague-Dawley 

(10 rats/sex/group)2

C14-17, 52 wt% Cl

Dietary intake for ♂: 0, 

0.4, 4, 36, or 360 

mg/kg-bw/day.

Dietary intake for ♀: 0, 

0.4, 4, 42, or 420 

mg/kg-bw/day.

Liver

♂ at 360 and ♀ at 420 mg/kg-bw/day, 28 and 48% ↑ in absolute and relative weights, respectively

♂ and ♀ at < 4 mg/kg-bw/day, no treatment-related histopathology

♂at 36 and ♀ at 42 mg/kg-bw/day, minimal increase in anisokaryosis and vesiculation of the nuclei

♂ at 360 and ♀ at 420 mg/kg-bw/day, mild increase in anisokaryosis and vesiculation of the nuclei (7-10 animals)

♂ at 360 mg/kg-bw/day, ↑ in perivenous homogeneity

♀ at 42 and 420 mg/kg-bw/day, ↑ in perivenous homogeneity

♂ at 360 and ♀ at 420 mg/kg-bw/day, ↑ in single cell necrosis (incidence not reported)

Kidney

♂ at 360 and ♀ at 420 mg/kg-bw/day, 11% ↑ in absolute and relative weights

♂ at > 0.4 mg/kg-bw/day, minimal to mild hyaline-droplet like cytoplasmic inclusions, with significant accumulation at 
75

Table_Apx C-1: Summary of Results from 90-Day Studies in Rats Administered MCCPs

Strain (sample size) Test substance and 

dose levels

Target 

organ

Effect levels

the limit dose

♀ at > 4 mg/kg-bw/day, minimal dose-related inner medullary tubular dilation seen in 0/10, 0/10, 1/10, 4/10, and 8/10 

animals

Thyroid

♂ at 36 and 360 mg/kg-bw/day, minimal to mild morphological changes affecting the architecture (i.e., reduced follicle 

sizes and collapsed angularity) and the epithelium (i.e., increased height, cytoplasmic vacuolation, and nuclear 

vesiculation)

♀ at > 4 mg/kg-bw/day, minimal to mild morphological changes affecting the architecture (i.e., reduced follicle sizes and 

collapsed angularity) and the epithelium (i.e., increased height, cytoplasmic vacuolation, and nuclear vesiculation)

F-344 

(15 rats/sex/group)3

C14-17, 52 wt% Cl

Dietary intake for ♂ 

and ♀: 0, 10, 100, or 

625 mg/kg-bw/day.

Liver

♂ and ♀ at 100 and 625 mg/kg-bw/day, 22-26% and 64-92% ↑ in absolute weight values, respectively

♂ at 100 and 625 mg/kg-bw/day, hypertrophy of trace severity seen in 1/15 and 13/15 animals, respectively

♀ at 625 mg/kg-bw/day, hypertrophy of trace severity seen in 13/15 animals

Kidney

♂ and ♀ at 625 mg/kg-bw/day, 18% ↑ in absolute weight values

♂ at > 10 mg/kg-bw/day, trace to mild nephritis seen in 1/15, 3/15, 4/15, and 10/15 animals

♀ at 625 mg/kg-bw/day, tubular pigmentation (9/14 animals)

Thyroid

♂ at 625 mg/kg-bw/day, 50% ↑ in absolute weight values

♂ at > 10 mg/kg-bw/day, mild to moderate hypertrophy observed in controls with a dose-dependent trend towards ↑ 

severity in treated animals

♂ at > 10 mg/kg-bw/day, trace to mild hyperplasia with a dose-dependent trend towards ↑ severity 

Adrenal ♂ and ♀ at 625 mg/kg-bw/day, 25% ↑ in absolute weight values

Wistar-derived

(24 rats/sex/group)4

C14-17, 52 wt% Cl, 

containing epoxidized 

vegetable oil as a 

stabilizer

Dietary intake for ♂: 0, 

33, 167, or 333 mg/kgbw/day.

Liver

♂ at 167 and 333 mg/kg-bw/day, 15 and 22% ↑ in relative weight values, respectively

♀ at 32, 160, and 320 mg/kg-bw/day, 11, 21, and 48% ↑ in relative weight values, respectively

♂ at 333 and ♀ at 320 mg/kg-bw/day, no histopathological abnormalities

♂ at > 33 and ♀ at > 32 mg/kg-bw/day, dose-related ↑ in proliferation of smooth endoplasmic reticulum (electron 

microscopy)
76

Table_Apx C-1: Summary of Results from 90-Day Studies in Rats Administered MCCPs

Strain (sample size) Test substance and 

dose levels

Target 

organ

Effect levels

Dietary intake for ♀: 0, 

32, 160, or 320 mg/kgbw/day. Kidney

♂ and ♀ at limit dose, 15% ↑ in relative weight

♂ and ♀, dose-related ↑ in congestion (incidence and severity not reported) 

♂ and ♀ at > limit dose, no histopathological abnormalities

F-344 

(10 rats/sex/group)5

C14-17, 40 wt% Cl

Oral gavage for ♂ and 

♀: 0, 312, or 625 

mg/kg-bw/day

Liver

♂ and ♀ at 312 and 625 mg/kg-bw/day, 37 and 72% ↑ in relative weight, respectively, (absolute weight and bodyweight 

not presented)

♂ and ♀, dose-related ↑ in centrilobular hypertrophy (incidence and severity not reported) 

♂ and ♀ at 312 and 625 mg/kg-bw/day, dose-related ↑ in β-oxidation from day 29 onwards (~2.7- and 3.3-fold ↑, 

respectively, at study termination)

♂ and ♀ at 312 and 625 mg/kg-bw/day, dose-related ↑ in UDPG-transferase activity from day 15 onwards (up to 100% ↑, 

respectively)

Thyroid

♂ and ♀ at 312 and 625 mg/kg-bw/day, ↓ in levels of free and plasma T3, which reached statistical significance on days 

15 and 57

♂ at 312 and 625 mg/kg-bw/day, ↑ TSH up to 2-fold on day 8 only

♀ at 312 and 625 mg/kg-bw/day, T3 significantly ↑ by day 91

♀ at 312 and 625 mg/kg-bw/day, total plasma T4 significantly ↓ by up to 25% on day 57

♂ and ♀ at 312 and 625 mg/kg-bw/day, ↑ follicular cell hypertrophy throughout the study, and accompanied by follicular 

cell hyperplasia on days 55 and 91 (incidence and severity not reported)

♂ and ♀ at 312 and 625 mg/kg-bw/day, significantly ↑ replicative DNA synthesis on day 29, but not on day 91

1 CXR (2005), cited in: ECB (2008).

2 Poon et al. (1995), cited in: ECB (2008).

3

IRDC (1984), cited in: ECB (2008).

4 Birtley et al. (1980), cited in: ECB (2008); note, this study was only summarized in the review by Birtley et al. (1980). The underlying original study report was not available.

5 Wyatt et al. (1997), cited in: ECB (2008).
77

C-1-7 Developmental Reproductive Toxicity

A series of range-finding and definitive prenatal developmental and reproductive toxicity studies 

were conducted in rats and rabbits with medium-chain chlorinated paraffins (MCCPs). These 

studies were conducted between 1981 and 1986. They appear to be valid toxicity studies, 

conducted according to the standard methodologies available at the time. More recently, 

additional studies with MCCPs have been conducted in an attempt to determine the cause of 

hemorrhaging in the pups observed in a one-generation reproductive toxicity range-finding 

study. 

In several prenatal developmental toxicity studies with MCCPs conducted via gavage, no signs 

of maternal toxicity were seen at doses as high as 500 mg/kg-bw/day in rats and 100 mg/kgbw/day in rabbits. Likewise, no signs of developmental toxicity were observed at doses as high 

as 5000 mg/kg-bw/day in rats and 100 mg/kg-bw/day in rabbits. 

Two reproductive toxicity studies with MCCPs in rats have been conducted. A one-generation 

reproductive toxicity range-finding study showed that administration of approximately 100 and 

400 mg/kg-bw/day MCCPs via the diet had no effect on fertility or other reproductive 

parameters; however, internal hemorrhaging and deaths in pups were observed beginning from 

74 mg/kg-bw/day (1000 ppm) up to approximately 400 mg/kg-bw/day (6250 ppm). These effects 

in the pups were not seen in a more recent definitive one-generation reproductive toxicity study 

with exposure to MCCPs for 11-12 weeks to doses as high as 100 mg/kg-bw/day (1200 ppm). 

Internal hemorrhaging was not seen in the adult animals in either of these studies at doses as 

high as 400 mg/kg-bw/day (6250 ppm), or in another study in non-pregnant female rats 

repeatedly exposed to doses as high as 1000 mg/kg-bw/day. However, when dams were exposed 

to approximately 500 mg/kg-bw/day (6250 ppm) MCCPs during cohabitation, gestation, and 

lactation, signs of hemorrhaging were observed in dams that died at the time of parturition. 

Taken together, the results of these studies suggest that newborns during lactation and pregnant 

females at the time of parturition are a potentially sensitive subpopulation. 

The UK Risk Assessment (February, 2008) did not use the LOAEL of 74 mg/kg-bw/day (1000 

ppm) from the one-generation reproductive toxicity range-finder study as a point of departure

because the pup deaths at that dose were not statistically significant. The study itself used a 

limited number of animals and was intended for dose range-finding purposes only and, more 

importantly, the pup deaths were not repeated in a more recently conducted definitive study. 

With respect to developmental/reproductive toxicity, the UK Risk Assessment identified two 

subpopulations at risk: offspring during lactation and pregnant dams at parturition. The 

NOAELs from the definitive one-generation reproductive toxicity study (a maternal NOAEL ~ 

47 mg/kg-bw/day (600 ppm) for effects on the offspring mediated via lactation; and a maternal 

NOAEL ~ 100 mg/kg-bw/day (1200 ppm) for effects on the dam during the time of parturition) 

were used to calculate risk. Assuming a conservative value of 50% oral absorption, the margin of 

safety (MOS) for effects on the offspring mediated via lactation and effects on the dam during 

the time of parturition were calculated for workers, consumers, and other scenarios. In all but 

one scenario (oil-based metal working fluids), the margins of safety were above 100 and in many 

cases, several fold above. In addition, margins of exposure were calculated for infants exposed 

via breast milk and via cow’s milk, and in both instances, large MOEs (i.e., > 100) were 

calculated. 
78

Additional studies with MCCPs have been conducted in an effort to clarify the possible causes of 

the hemorrhaging in the pups. One (single-dose; 6250 ppm or 538 mg/kg-bw/day) study showed 

maternal death during parturition due to low levels of vitamin K and related hemorrhaging, 

suggesting that the act of parturition places dams at higher risk. It was concluded in data from 

this study and a cross-fostering study that the fetus relies on clotting factors via mother’s milk 

and severe deficiencies in vitamin K levels and related clotting factors in the pups results in 

hemorrhaging. 

No definitive developmental neurotoxicity studies on MCCPs were located. It is not clear if any 

developmental neurotoxicity endpoints were actually measured in the available prenatal 

developmental/reproductive toxicity studies; none were explicitly stated. The only information 

available regarding behavior during development is from cage-side observations in pups through 

LD 21. In these cases, no dose-related differences were reported in F1 post-weaning appearance 

or cage-side behaviors. 

In the prenatal developmental toxicity study in rats, the LOAEL for maternal toxicity was 

2000 mg/kg-bw/day based on clinical signs. The NOAEL for maternal toxicity was 500 

mg/kg/day. The NOAEL for developmental toxicity was 5000 mg/kg-bw/day, the highest 

dose tested. 

In the prenatal developmental toxicity study in rabbits, no adverse, treatment-related effects were 

reported in the dams or the offspring. The NOAEL for both maternal and developmental 

toxicity was 100 mg/kg-bw/day, the highest dose tested. 

In the reproduction range-finding study in rats, the LOAEL for maternal toxicity was 6250 

ppm (463 mg/kg-bw/day) based on reductions in body weight gains. The NOAEL for 

maternal toxicity was 1000 ppm (74 mg/kg-bw/day). The LOAEL for developmental 

toxicity was 1000 ppm (62/74 mg/kg/day) based on pup mortality associated with internal 

hemorrhages. The NOAEL for developmental toxicity was 100 ppm (6/8 mg/kg-bw/day). 

No effects on any reproductive parameters were reported. The NOAEL for reproductive 

toxicity was 6250 ppm (384/463 mg/kg-bw/day). 

In the one-generation reproduction toxicity study in rats, the LOAEL for maternal toxicity was 

1200 ppm (~100 mg/kg-bw/day) based on increases in liver weight; the NOAEL for 

maternal toxicity was 600 ppm (~ 47 mg/kg-bw/day). The NOAEL for developmental and 

reproductive toxicity was 1200 ppm (~ 84/99 mg/kg-bw/day), the highest dose tested. 

Basis for Conclusions

In a range-finding prenatal developmental toxicity study in pregnant Charles River COBS CD 

rats administered MCCPs (C14-17, 52 wt% Cl) via gavage at dose levels of 0, 1000, 1500, and 

2500 mg/kg-bw/day on gestation days (GD) 6-20, no effects were observed in the dams at doses 

up to 2500 mg/kg-bw/day (IRDC, 1983, 1984; cited in: ECB, 2008). As a result, doses greater 

than 2500 mg/kg-bw/day were selected for the definitive study. 

In the definitive study, four groups of 25 pregnant Charles River COBS CD rats were 

administered MCCPs (C14-17, 52 wt% Cl) via gavage at doses of 0, 500, 2000, and 5000 mg/kgbw/day on GD 6-19 (IRDC, 1984; cited in: ECB, 2008). Unmated males and females were 

individually housed and acclimated for 21-days in an environmentally controlled room. At the 

end of the acclimation period, all animals were weighed and subjected to a detailed physical 
79

examination. One female and one male rat were placed together for mating. Confirmation of 

mating was based on evidence of a copulatory plug or by vaginal smear for sperm. The day 

mating was confirmed was designated as day 0 of gestation. Test article was administered to 

pregnant females orally by gavage as a single daily dose on GD 6-19. During treatment, pregnant 

females were observed daily for mortality and clinical signs of toxicity. Any females not 

surviving to scheduled sacrifice were necropsied. Body weights were recorded on GD 0, 6, 9, 12, 

16, and 20. All females were sacrificed on GD 20 and the uterus and ovaries excised for 

examination. The number and location of viable and nonviable fetuses, early and late 

resorptions, and the number of total implantations and corpora lutea were recorded. The uterus 

was weighed. The abdominal and thoracic cavities underwent gross examination. Maternal 

tissues were preserved for future histopathological analysis. Fetuses were weighed, sexed, 

tagged, and examined for external malformations and variations, including the palate and the 

eyes. The fetuses underwent visceral and skeletal examinations for malformations and 

developmental variations. 

The only effects reported in dams consisted of an increased incidence in wet matted and yellow 

stained haircoat in the anogenital area at 5000 mg/kg-bw/day, and soft stool at > 2000 mg/kgbw/day. No treatment-related adverse effects were reported in offspring at doses up to 5000 

mg/kg-bw/day. The LOAEL for maternal toxicity was 2000 mg/kg-bw/day based on clinical 

signs; the NOAEL for maternal toxicity was 500 mg/kg-bw/day. The NOAEL for developmental 

toxicity was 5000 mg/kg-bw/day, the highest dose tested. 

In a range-finding prenatal developmental toxicity study in pregnant Dutch Belted rabbits 

administered MCCPs (C14-17, 52 wt% Cl) via gavage at dose levels of 0, 100, 300, 1000, 2000, 

and 3000 mg/kg/day on GD 6-27, an increase in the number of abortions was observed at > 1000 

mg/kg/day (IRDC, 1982a; cited in: ECB, 2008). Body weight reductions in the dams were 

reported at 100 and 300 mg/kg/day. As a result, another range-finding prenatal developmental 

toxicity study in rabbits was initiated. This second range-finding study showed decreases in 

maternal weight gain at 80 and 160 mg/kg-bw/day (IRDC, 1982b; cited in: ECB, 2008). 

Based on the results of these range-finding studies, dose levels of 10, 30, and 100 mg/kg-bw/day 

were selected for the definitive prenatal oral gavage developmental toxicity study (IRDC, 1983; 

cited in: ECB, 2008). In the definitive study, four groups of 16 pregnant Dutch Belted rabbits 

were administered 0, 10, 30, and 100 mg/kg-bw/day MCCPs (C14-17, 52 wt% Cl) via gavage on 

GD 6-27. Unmated males and females were individually housed and acclimated for 50-days in 

an environmentally controlled room. As a result of a positive finding for parasites in stool 

samples collected during acclimation, all rabbits received sodium sulfamethazine in their 

drinking water for 16 days during the acclimation period. This treatment was terminated 4 weeks 

prior to study initiation and only rabbits testing negative for parasites were placed on study. At 

the end of the acclimation period, all animals were weighed and subjected to a detailed 

examination. Females were impregnated via artificial insemination. Three weeks prior to 

artificial insemination, females were given chorionic gonadotropin via an injection in a marginal 

ear vein in order to induce superovulation. Semen was collected from males of proven fertility 

and evaluated for motility. The day of artificial insemination was designated as day 0 of 

gestation. During treatment, pregnant females were observed for mortality and clinical signs of 

toxicity. Body weights were recorded on GD 0, 6, 12, 18, 24, and 28. Any females not surviving 

to scheduled sacrifice were necropsied. On GD 28, all surviving females were sacrificed and the 

uterus and ovaries excised for examination. The location and number of viable and nonviable 

fetuses, early and late resorptions, and the number of total implantations and corpora lutea were 

recorded. The uterus was weighed. The thoracic and abdominal cavities underwent gross 
80

examination. Pooled samples of abdominal adipose tissue from 3 dams were frozen for future 

analysis. Each fetus was sexed, weighed, and examined for external malformations and 

variations, including the palate and the eyes, as well as visceral and skeletal examinations for 

malformations and developmental variations, including examination of the brain and the heart.

No adverse, treatment-related effects were reported in the dams or the offspring at doses up to 

100 mg/kg-bw/day. The NOAEL for both maternal and developmental toxicity was 100 mg/kgbw/day, the highest dose tested. 

In a one-generation reproductive toxicity range-finding study, four groups of 5 male and 10 

female Charles River COBS SC rats were administered MCCP (C14-17, 52 wt% Cl) via the diet at 

0, 100, 1000, and 6250 ppm (~ 0, 6, 62, and 384 mg/kg-bw/day, respectively, in males; and 0, 8, 

74, or 463 mg/kg-bw/day, respectively, in females) (IRDC, 1985; cited in: ECB, 2008). F0

animals were exposed to test substance from 28 days prior to mating until sacrifice; F1 animals 

were treated from weaning until sacrifice, with additional potential exposures occurring in utero

and during lactation. All F0 males were sacrificed after the mating period. Following the 

premating period, each male was cohabited with two females for 10 days. Females were 

examined for evidence of copulation by means of vaginal smears and/or the appearance of a 

vaginal plug. The day evidence of copulation was determined was designated as day 0 of 

gestation. Direct dosing began at 83 days of age for the F0 parents and at 21 days of age for the 

F1 weanlings. The F0 and F1 animals were observed for clinical signs of toxicity, changes in 

general appearance and behavior, and mortality. In the F0 adults, body weights and food 

consumption were measured weekly; in addition, body weights were measured in F0 females on 

GD 0, 7, 14, and 20; and on lactation days (LD) 0, 7, 14, and 21. Estrous cyclicity was 

determined in F0 females prior to mating, during mating, and prior to dosing. All F0 females 

were allowed to deliver. The day the entire litter was found and delivery was judged to be 

complete was designated as LD 0. Gestation duration was calculated. Following delivery, all 

pups were examined for external malformations and the numbers of live births and stillbirths 

(litter size) was recorded for each dam. Pups were weighed, sexed, and examined externally on 

LD 0, 7, 14, and 21. Litter size was determined on LD 0, 4, 10, and 21. The number of male and 

female pups was recorded on LD 4. Litters were examined daily for survival. F0 females were 

examined for behaviors in nesting and nursing. On LD 21, all dams were sacrificed and a gross 

necropsy performed, including examination of the uterine contents for implantation sites; and ten 

F1 weanlings/sex/dose were sacrificed and necropsied. Five F1 males and ten F1 females/dose 

group were retained after LD 21 and sacrificed at 70 days (10 weeks) of age and necropsied. Due 

to high mortality in high-dose F1 pups, the surviving F1 pups in the high-dose group and an equal 

number of control pups were sacrificed on LD 6 and 7 and necropsied. Blood was collected via

heart puncture and complete blood counts performed. Bone marrow smears were collected from 

the femur, and the abdominal contents of the pups with milk in the stomach were collected and 

frozen for future analyses. 

Effects in the adults consisted of isolated reductions food consumption and body weight in the 

dams at 6250 ppm. Effects in the offspring consisted of significant reductions in pup survival at 

the high dose (none of the F1 pups in the high-dose group survived until lactation day 21); and 

slight (11%, not statistically significant) decreases in pup survival, and labored breathing,

subcutaneous hematoma, pale discoloration, blood around the orifices, pale liver, kidney, and 

spleen, and blood in the cranial cavity and brain beginning at the mid-dose. No dose-response, 

treatment-related adverse effects were reported in the offspring in the low dose group. 

Reductions in body weight in F1 male and female pups occurred during LD 7, 14, and 21, but 

these reductions were not statistically significantly different from controls, and were seen only in 
81

the low- and mid-dose groups but not the high-dose group. There were no dose-related 

differences in F1 post-weaning appearance, behavior, food consumption, or clinical or 

anatomical pathology in the low- and mid-dose groups. Based on the results of this study, it was 

recommended that dosage levels in a two-generation reproduction toxicity study not exceed 1000 

ppm. The LOAEL for maternal toxicity was 6250 ppm (~463 mg/kg-bw/day) based on 

reductions in body weight gains. The NOAEL for maternal toxicity was 1000 ppm (~74 mg/kgbw/day). The LOAEL for developmental toxicity was 1000 ppm (~62/74 mg/kg-bw/day) based 

on pup mortality due to hemorrhaging. The NOAEL for developmental toxicity was 100 ppm 

(~6/8 mg/kg-bw/day). No effects on any of the reproductive parameters were reported. The 

NOAEL for reproductive toxicity was 6250 ppm (~384/463 mg/kg-bw/day). 

In an effort to determine the cause of hemorrhaging in the pups at the high dose from the 

reproductive toxicity range-finding study, a screening level cross-fostering developmental 

toxicity study was conducted in Charles River COBS Wistar rats fed diets containing either 0 or 

6250 ppm (~ 3125 mg/kg-bw/day) MCCPs (C14-17, 52 wt% Cl) for 4 weeks prior to mating and 

throughout pregnancy in a series of groups (Hart et al., 1985; cited in: ECB, 2008). Offspring 

from two of these groups (pups from control females reared from treated females, and pups 

reared from their treated mothers) showed high-pup mortality associated with internal 

hemorrhages. Hematological assays in the pups from these two groups showed decreases in 

factor X, resulting in a disruption of a vitamin K-dependent clotting system (lower plasma 

vitamin K levels). It was concluded that the pup mortalities were due to internal hemorrhages 

caused by a decrease in the vitamin K-dependent hemostatic mechanism (not examined in this 

study), induced during lactational exposures via the milk from mothers receiving MCCPs. 

Additional studies have been conducted to investigate two hypotheses in an effort to clarify the 

possible causes of the hemorrhaging in the pups. 

The first hypothesis proposes that MCCPs induce a catabolism of vitamin K in lactating rats 

leading to decreased plasma concentrations and ultimately low levels of vitamin K in the milk 

pups receive (vitamin K controls the formation of several clotting factors in the liver). In order to 

test this hypothesis, a preliminary study (CXR Biosciences Ltd., 2003; cited in: ECB, 2008) was 

conducted in which three groups of 6 female adult Sprague-Dawley were administered MCCPs 

(C14-17, 52wt% Cl) via gavage at doses of 0, 500, or 1000 mg/kg-bw/day for 21 days while being 

fed a normal diet or a vitamin K-deficient diet. Following exposures to MCCPs, significant 

decreases in plasma concentrations of a clotting factor were seen in rats fed a normal diet; 

however, these decreases did not affect prothrombin clotting times. Reductions of a clotting 

factor in both treated and control groups were also seen in animals fed a vitamin-K deficient diet. 

Plasma vitamin K levels were not affected by treatment in the normal diets, but they were lower 

in high-dose animals fed vitamin K-deficient diets. The results from this study suggested that 

MCCPs did not adversely affect the blood clotting system in adult female rats treated for 3 

weeks up to a dose of 1000 mg/kg-bw/day; and the hemorrhaging effects in pups are unlikely to 

be mediated by reduced vitamin K levels in breast milk. 

The second hypothesis proposes that MCCPs transferred to the pups through breast milk causes 

disruption of the pup clotting system. In order to test this hypothesis, a study (CXR Biosciences 

Ltd., 2004; cited in: ECB, 2008) was conducted in two groups of 16 male and 32 female 

Sprague-Dawley rats administered 0 or 6250 ppm (~ 0 and 513 and 538 mg/kg-bw/day in males 

and females, respectively) MCCPs (C14-17, 52 wt% Cl) for 4 weeks prior to mating, during 

cohabitation, gestation, and lactation until study termination (at about 2 weeks after the first 

litters were born, due to high rate of pup mortality). Milk, blood, and liver samples from 
82

lactating dams, and blood and liver samples from lactating pups were assessed for plasma 

vitamin K levels. Five dams died or were killed at the time of parturition (16% mortality). These 

deaths were considered to be treatment-related as there was no indication of obstruction or 

hindrance to delivery. The clinical necropsy of these dams showed effects suggestive of 

hemorrhaging in 3 out of the 5 dams and one male who died. Slight reductions in food 

consumption and body weight gains were observed during gestation and lactation. There were no 

effects on mating performance or duration of gestation. Concentrations of plasma vitamin K 

levels in adult females having gone through lactation and pregnancy was markedly decreased by 

treatment with MCCPs, which in turn produced a decrease in activity of the plasma clotting 

factors in treated dams. Prothrombin clotting times were not affected in the dams, suggesting that 

the functional reserve in these adult animals was sufficient. Pup plasma volumes were reportedly 

insufficient to measure vitamin K directly, but clotting factor activities were possible to analyze. 

No effects on litter size at birth or on pup mortality from birth to LD 4 were reported; however, 

after pup mortality increased significantly after LD 4. The majority of these pups showed 

internal hemorrhages at necropsy. It was concluded that data from this study and the crossfostering study performed by Hart et al. (1985) suggest that the fetus receives sufficient vitamin 

K via the placenta, but after birth becomes severely deficient in vitamin K and related clotting 

factors and relies on these factors via mother’s milk. In addition, the pups also receive 

considerable levels of MCCPs via lactation (through mother’s milk) which may also contribute 

to further reducing the vitamin K levels. These severe deficiencies in vitamin K levels and 

related clotting factors in the pups results in hemorrhaging. It was also concluded that the act of 

parturition places dams at higher risk. 

More recently, a definitive one-generation reproductive toxicity study was conducted to refine 

the NOAEL for effects in the offspring and to further explore the mechanisms of hemorrhaging 

(CXR, 2006; cited in: ECB, 2008). This study was reportedly conducted in compliance with 

OECD TG 421 and Good Laboratory Practice standards. Four groups of 12-17 male and female 

Sprague-Dawley rats were administered 0, 300, 600, and 1200 ppm (~ 0 and 21, 44, and 84 

mg/kg-bw/day in males; and 0, 23, 47, and 99 mg/kg-bw/day in females) MCCPs (C14-17, 52 

wt% Cl) for 4 weeks prior to mating, during cohabitation, gestation, and lactation until study 

termination (for a total treatment of 11-12 weeks). Males were terminated on LD 4 (9 weeks of 

treatment) and females were allowed to litter and rear their offspring until PND 21. Females 

were sacrificed on LD 21. Adult males were assessed for signs of clinical toxicity, body weight, 

food consumption, and macropathology. Adult females were assessed for signs of clinical 

toxicity, body weight, food consumption, gestation length, parturition, liver weights, and 

macropathology. Mating performance and fertility were also evaluated. Offspring evaluations 

included clinical signs of toxicity, litter size, survival, sex ratio, body weight, and pathological 

examinations at necropsy. Milk, blood, and liver samples were obtained from selected offspring 

at specific time points between birth of litters and PND 21. In addition, blood, liver, and milk 

samples from a satellite group of five females and their litters from the control and high-dose 

group (1200 ppm) were collected for future analysis. Analysis of these samples was still pending 

at the time of the UK assessment. 

No adverse effects were reported in the adult animals for clinical condition, body weight, body 

weight gain, food consumption, estrous cycling, mating performance, pre-coital interval, fertility, 

number of implantations, gestation lengths, or parturition. The only effect reported was for 

higher absolute and relative liver weights in high-dose females (1200 ppm; 99 mg/kg-bw/day). 

Likewise, no adverse effects were in the offspring at any dose level for litter size, sex ratio, 

offspring survival, body weights, body weight gains, macropathology and liver weights. No 

adverse effects were reported on pre- and post-natal survival and growth up to sacrifice 
83

(weaning). Though no histopathology was performed, the body cavity and cranial cavity were 

opened and examined for any signs of hemorrhaging. None was reported. Based on the results of 

this study, the LOAEL for maternal toxicity was 1200 ppm (~100 mg/kg-bw/day) based on 

increases in liver weight; the NOAEL for maternal toxicity was 600 ppm (~ 47 mg/kg-bw/day). 

The NOAEL for developmental and reproductive toxicity was 1200 ppm (~ 84/99 mg/kgbw/day), the highest dose tested. 
84

Appendix D ENVIRONMENTAL MONITORING DATA

D-1 MCCP MONITORING DATA 

D-1-1 Surface Water

It is known that over time, based on their molecular weight and physicochemical properties, 

MCCPs in surface water will partition to suspended particulates, sediment, sludge, or soil. 

Reported MCCP concentrations in surface water range from < 2.50 × 10-10 mg/L to 1.49 x 10-3

(Table_Apx D-1-1). Very little information is available on the specific sampling locations for 

many of the surface water measurements reported in Table_Apx D-1-1. Limited documentation 

is available on two of the studies (Petersen et al., 2006 and Muir, 2003). Two sources provide a 

review of the literature with very little details (IPCS, 1996 and EC, 2008b). Two studies do 

provide detailed information on the sampling approach, including location (Houde et al., 2008 

and USEPA, 1988). The Petersen et al. (2006) study, which had the highest published 

concentration, reported results for water samples collected from different Norwegian locations. 

EPA/OPPT assumes that these samples were collected in non-marine waters. Three studies found 

were not used in this assessment (BUA, 1992; Hoechst, 1987; and Willis, 1994). However, all of 

the studies used in the assessment use modern analytical techniques, reference the specific CPs 

of interest, and provide, at a minimum, general information on the sampling location. Given the 

paucity of surface water data available, EPA/OPPT used measurements from the selected studies

and used the minimum and maximum values in this assessment.

Measurements of dissolved (filtered) concentrations were generally ND with few exceptions. 

Concentrations measured in surface water were largely from studies that measured total water 

concentrations which included MCCPs sorbed to particulates. More recent monitoring studies 

(Error! Reference source not found.e_Apx D-1-1) have focused on measuring MCCPs in 

suspended solids, sediment pore water, and sediment. 

Early analytical methods using thin layer chromatography (TLC) were used to measure CPs in 

surface water. However, this method has poor sensitivity and reproducibility, and provide false 

negative results. Current methods of quantification using gas or liquid chromatography coupled 

with a range of detectors (i.e., mass spectrometry; MS) are more reliable. Nearly all of the water 

concentrations were measurements taken at a single point in time (i.e., the samples were not time 

series samples). Absent more extensive monitoring data, the Agency assumed that the available 

data could be extrapolated to longer time periods for determination of a chronic exposure 

concentration. 

MCCP concentrations in surface water, reported in Error! Reference source not found.e_Apx

D-1-1, rely on test methods that filtered or pre-filtered samples before they were analyzed, which 

can underestimate environmental concentrations. Where appropriate, reported values were 

converted to a common unit, as presented in the table. For the purposes of this assessment, in the 

studies considered acceptable, EPA/OPPT used the lowest and highest reported concentrations (< 

2.50 × 10-10 mg/L to 1.49 x 10-3) to evaluate risks of potential concern to aquatic organisms.
85

Table_Apx D-1-1: Surface Water Concentrations of MCCPs, sorted by country

Media Country

Location

City, State or 

Province

Comments Converted 

Concentration Common Units Analytical Method References

Surface water

Canada Lake Ontario

Maximum 2.60×10-9 mg/L NR EC (2008b)

< 2.50×10-10 mg/L GC-HRMS-MAB Houde et al. (2008)

< 1.00×10

-8 mg/L GC-ECNI-MS Muir et al. (2003)

Maximum 4.70×10-8 mg/L GC-HRMS-MAB Houde et al. (2008)

Mean 9.00×10

-10 mg/L GC-HRMS-MAB Houde et al. (2008)

Germany

River Lech at 

Langsweid --- 1.90×10-4 mg/L NR IPCS (1996)

River Lech at Rain --- 1.70×10-4 mg/L NR IPCS (1996)

River Lech at 

Gersthofen --- 9.00×10-5 mg/L NR IPCS (1996)

River Lech at 

Augsburg < 2.50×10-5 mg/L NR IPCS (1996)

River Danube at 

Marxheim

--- 7.00×10-5 mg/L NR IPCS (1996)

< 3.00×10-5 mg/L NR IPCS (1996)

Norway NR --- 1.49×10-3 mg/L GC-ECNI-MS Petersen et al. (2006)

United Kingdom Multiple locations < 1×10-4 mg/L GC-ECNI-MS Nicholls et al. (2001)

United States Sugar Creek, Ohio < 7.50×10-5 mg/L GC-ECNI-MS USEPA (1988)

Central European 

Country NR < 5.00×10-5 mg/L GC-ECNI-MS Coelhan (2010)

NR: Not recorded. Location description was not provided in the study.

--: Single sample value reported above the detection limit; therefore, no data qualifier required.

GC-HRMS-MAB: Gas chromatography-high resolution mass spectrometry with metastable atom bombardment ionization

GC-ECNI-MS: Gas chromatography in combination with electron capture negative ion mass spectrometry

Notes:

1. All values provided in the table above represent total MCCP and not individual MCCP isomers

2. In some cases, the minimum values in the table are preceded by “<”. This indicates that the value reported in article was reported as a non-detect. In such cases, one half of 

the lowest reported detection limit was compiled as the ‘minimum’ reported monitoring data

3. All concentrations measured from impoundment lagoons and drainage ditches from the USEPA (1988) study have not been included as they are not considered as surface 

water concentrations

4. All concentrations measured from suspended solid matter fraction from influents from the Coelhan (2010) study have not been included as they are not considered as surface 

water concentrations
86

D-1-2 Sediment

MCCP sediment concentrations from marine and non-marine environments ranged from 5.00 ×

10-3to 1.64 × 101mg/kg dw and from 2.00 × 10-3to 6.51 × 101 mg/kg dw, respectively. 

For the purposes of this assessment, in the studies considered acceptable, EPA used the lowest 

and highest reported marine and non-marine sediment concentrations (5.00 × 10-3to 1.64 × 101

mg/kg dw and 2.00 × 10-3to 6.51 × 101, respectively) to evaluate risks of potential concern to 

sediment organisms (Table_Apx D-1-2). Where appropriate, reported values were converted to a 

common unit, as presented in the table.
87

Table_Apx D-1-2: Sediment Concentrations of MCCPs, Sorted by Country

Media Country

Location

Comments Converted 

Concentration

Common 

Units References

City, State or Province

Sediment

(Marine)

Australia NR

--- 1.11 mg/kg dw Kemmlein et al. 

(2002)

--- 1.17 mg/kg dw Kemmlein et al. 

(2002)

--- 3.11 mg/kg dw Kemmlein et al. 

(2002)

--- 1.64×101 mg/kg dw Kemmlein et al. 

(2002)

Canada Hamilton Harbour 

(Windemere basin) --- 2.90×10-1 mg/kg* Muir et al. (2000)

Germany

German Bight, North Sea

--- 5.00×10-3 mg/kg dw Hüttig et al. 

(2004)

--- 9.00×10-3 mg/kg dw Hüttig et al. 

(2004)

--- 9.00×10-3 mg/kg dw Hüttig et al. 

(2004)

--- 1.30×10-2 mg/kg dw Hüttig et al. 

(2004)

--- 2.80×10-2 mg/kg dw Hüttig et al. 

(2004)

--- 1.46×10-1 mg/kg dw Hüttig et al. 

(2004)

Baltic Sea

--- 9.30×10-2 mg/kg dw Hüttig et al. 

(2004)

--- 1.15×10-1 mg/kg dw Hüttig et al. 

(2004)

--- 1.22×10-1 mg/kg dw Hüttig et al. 

(2004)

--- 2.11×10-1 mg/kg dw Hüttig et al. 

(2004)

--- 4.99×10-1 mg/kg dw Hüttig et al. 

(2004)
88

Media Country

Location

Comments Converted 

Concentration

Common 

Units References

City, State or Province

North and Baltic Sea

--- 2.20×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 2.30×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 3.30×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 3.40×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 3.70×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 3.90×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 4.30×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 4.30×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 4.80×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 5.40×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 5.80×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 6.10×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 7.20×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 7.60×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 7.70×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 8.10×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 8.50×10

-2 mg/kg dw Hüttig and Oehme 

(2006)

--- 8.70×10

-2 mg/kg dw Hüttig and Oehme 

(2006)
89

Media Country

Location

Comments Converted 

Concentration

Common 

Units References

City, State or Province

--- 1.49×10

-1 mg/kg dw Hüttig and Oehme 

(2006)

--- 1.49×10

-1 mg/kg dw Hüttig and Oehme 

(2006)

--- 1.49×10

-1 mg/kg dw Hüttig and Oehme 

(2006)

--- 2.75×10

-1 mg/kg dw Hüttig and Oehme 

(2006)

--- 9.10×10

-2 mg/kg dw Hüttig and Oehme 

(2005)

--- 4.80×10

-2 mg/kg dw Hüttig and Oehme 

(2005)

--- 1.98×10

-1 mg/kg dw Hüttig and Oehme 

(2005)

--- 1.31×10

-1 mg/kg dw Hüttig and Oehme 

(2005)

--- 1.32×10

-1 mg/kg dw Hüttig and Oehme 

(2005)

--- 3.03×10

-1 mg/kg dw Hüttig and Oehme 

(2005)

--- 1.53×10

-1 mg/kg dw Hüttig and Oehme 

(2005)

--- 1.14×10

-1 mg/kg dw Hüttig and Oehme 

(2005)

--- 4.00×10

-2 mg/kg dw Hüttig and Oehme 

(2005)

--- 2.70×10

-2 mg/kg dw Hüttig and Oehme 

(2005)

--- 1.80×10

-2 mg/kg dw Hüttig and Oehme 

(2005)

--- 1.90×10

-2 mg/kg dw Hüttig and Oehme 

(2005)

--- 3.00×10

-2 mg/kg dw Hüttig and Oehme 

(2005)

--- 3.20×10

-2 mg/kg dw Hüttig and Oehme 

(2005)
90

Media Country

Location

Comments Converted 

Concentration

Common 

Units References

City, State or Province

--- 1.80×10

-2 mg/kg dw Hüttig and Oehme 

(2005)

--- 2.40×10

-2 mg/kg dw Hüttig and Oehme

(2005)

Sediment

(Non-

marine)

Canada

Lake Erie --- 6.80×10

-2 mg/kg dw Tomy and Stern 

(1999)

Lake St Francis

Minimum 7.50×10

-1 mg/kg dw EC (2008b)

Maximum 1.2 mg/kg dw EC (2008b)

Czech 

Republic

NR Minimum 2.00×10

-3 mg/kg* Pribylova et al. 

(2006)

Labe

Sum 1.80×10

-2 mg/kg dw Pribylova et al. 

(2006)

Sum 7.30×10

-2 mg/kg dw Pribylova et al. 

(2006)

Libis-Labe Sum 1.6 mg/kg dw Pribylova et al. 

(2006)

Bilina Sum 3.10×10

-2 mg/kg dw Pribylova et al. 

(2006)

Mala Becva Sum 1.13×10

-1 mg/kg dw Pribylova et al. 

(2006)

Becva Sum 1.20×10

-1 mg/kg dw Pribylova et al. 

(2006)

Morava Sum 1.93×10

-1 mg/kg dw Pribylova et al. 

(2006)

Ohre

Sum 3.08×10

-1 mg/kg dw Pribylova et al. 

(2006)

Sum 6.00×10

-1 mg/kg dw Pribylova et al. 

(2006)

Sum 5.58 mg/kg dw Pribylova et al. 

(2006)

Morava Sum 4.16×10

-1 mg/kg dw Pribylova et al. 

(2006)

Dyje Sum 7.57×10

-1 mg/kg dw Pribylova et al. 

(2006)
91

Media Country

Location

Comments Converted 

Concentration

Common 

Units References

City, State or Province

Drevnice Sum 8.93×10

-1 mg/kg dw Pribylova et al. 

(2006)

Germany

Bodensee (middle)

< 5.00×10

-3

mg/kg dw IPCS (1996)

--- 7.00×10

-2 mg/kg dw IPCS (1996)

River Lech

< 5.00×10

-3 mg/kg dw IPCS (1996)

--- 3.25×10

-1 mg/kg dw IPCS (1996)

Maximum 7.00×10

-1 mg/kg*

Tomy et al. (1998)

River Rhine

--- 6.00×10

-2 mg/kg dw IPCS (1996)

--- 8.50×10

-2 mg/kg dw IPCS (1996)

--- 1.40×10

-1 mg/kg dw IPCS (1996)

Minimum 1.45×10

-1 mg/kg dw IPCS (1996)

Maximum 2.05×10

-1 mg/kg dw IPCS (1996)

River Elbe at Hamburg

Minimum1.30×10

-1 mg/kg dw IPCS (1996)

Maximum 2.30×10

-1 mg/kg dw IPCS (1996)

River Main

Minimum 1.60×10

-1 mg/kg dw IPCS (1996)

Maximum 2.60×10

-1 mg/kg dw IPCS (1996)

Outer Alster, Hamburg --- 3.70×10

-1 mg/kg dw IPCS (1996)

Norway NR

minimum 5.00×10

-2 mg/kg dw Petersen et al. 

(2006)

maximum 3.24 mg/kg dw Petersen et al. 

(2006)

--- 2.7 mg/kg ww Borgen et al. 

(2003)

--- 1.14×10

1 mg/kg ww

Borgen et al. 

(2003)

South China Pearl River Delta

Minimum 8.80×10

-1 mg/kg dw Chen et al. (2011)

Minimum 1.1 mg/kg dw Chen et al. (2011)

Minimum 1.4 mg/kg dw Chen et al. (2011)

Maximum 1.4 mg/kg dw Chen et al. (2011)

Maximum 3.8 mg/kg dw Chen et al. (2011)
92

Media Country

Location

Comments Converted 

Concentration

Common 

Units References

City, State or Province

Mean 3.9 mg/kg dw Chen et al. (2011)

Mean 2.10×10

1 mg/kg dw Chen et al. (2011)

Maximum 3.80×10

1 mg/kg dw Chen et al. (2011)

Switzerland

Lake Thun

Minimum 5.00×10

-3 mg/kg dw Iozza et al. (2008)

Maximum 2.60×10

-2 mg/kg dw Iozza et al. (2008)

Lake Zurich Maximum 5.00×10

-3 mg/kg* Tomy et al. (1998)

United 

Kingdom

NR< 1.00×10

-1 mg/kg dw Nicholls et al. 

(2001)

South West Region: Grand 

Union Canal

--- 3.00×10

-1 mg/kg dw Nicholls et al. 

(2001)

--- 2.7 mg/kg dw Nicholls et al. 

(2001)

--- 2.8 mg/kg dw Nicholls et al. 

(2001)

South West Region; Bristol 

Avon River

--- 5.00×10

-1 mg/kg dw Nicholls et al. 

(2001)

--- 6.00×10

-1 mg/kg dw Nicholls et al. 

(2001)

--- 8.00×10

-1 mg/kg dw Nicholls et al. 

(2001)

North East Region: Hull 

River

--- 1.0 mg/kg dw Nicholls et al. 

(2001)

--- 1.35×10

1 mg/kg dw Nicholls et al. 

(2001)

--- 1.1 mg/kg dw Nicholls et al. 

(2001)

South West Region: Colne 

River

--- 1.4 mg/kg dw Nicholls et al. 

(2001)

--- 2.0 mg/kg dw Nicholls et al. 

(2001)

West Midlands Region: 

Trent River

--- 3.8 mg/kg dw Nicholls et al. 

(2001)

--- 6.02×10

1 mg/kg dw Nicholls et al. 

(2001)
93

Media Country

Location

Comments Converted 

Concentration

Common 

Units References

City, State or Province

--- 6.51×101 mg/kg dw Nicholls et al. 

(2001)

North West Region: 

Hornsmill brook

--- 5.6 mg/kg dw Nicholls et al. 

(2001)

--- 1.25×101 mg/kg dw Nicholls et al. 

(2001)

--- 1.83×101 mg/kg dw Nicholls et al. 

(2001)

North East Region: Hull 

River

--- 1.0 mg/kg dw Nicholls et al. 

(2001)

--- 1.1 mg/kg dw Nicholls et al. 

(2001)

--- 1.35×101 mg/kg dw Nicholls et al. 

(2001)

East Midlands Region: Idle 

River

--- 1.62×101 mg/kg dw Nicholls et al. 

(2001)

--- 4.39×101 mg/kg dw Nicholls et al. 

(2001)

Northumberland Region: 

Skerne River

--- 1.80×101 mg/kg dw Nicholls et al. 

(2001)

--- 2.56×101 mg/kg dw Nicholls et al. 

(2001)

--- 5.84×101 mg/kg dw Nicholls et al.

(2001)

East Anglia Region: Lark 

River

--- 3.22×101 mg/kg dw Nicholls et al. 

(2001)

--- 4.50×101 mg/kg dw Nicholls et al. 

(2001)

--- 6.04×101 mg/kg dw Nicholls et al. 

(2001)

United States

Detroit River --- 6.80×10-2 mg/kg dw Tomy et al. (1999)

Sugar Creek, Ohio Reported as trace with range of 

1.5-5; used the average 3.25×10-3 mg/kg dw USEPA (1988)
94

Media Country

Location

Comments Converted 

Concentration

Common 

Units References

City, State or Province

Reported as trace with range of 

1.5-5; used the average 3.25×10-3 mg/kg dw

USEPA (1988)

--- 6.80×10-3 mg/kg dw USEPA (1988)

--- 8.20×10-3 mg/kg dw USEPA (1988)

--- 7.60×10-1 mg/kg dw USEPA (1988)

--- 2.10×101 mg/kg dw USEPA (1988)

--- 3.40×101 mg/kg dw USEPA (1988)

--- 5.00×101 mg/kg dw USEPA (1988)

Note:

NR: Not recorded. Location description was not provided in the study.

--: Single sample value reported above the detection limit; therefore, no data qualifier required.

1. All values provided in the table above represent total MCCP and not individual MCCP isomers

2. In some cases, the minimum values in the table are preceded by “<”. This indicates that the value reported in article was reported as a non-detect. In such cases, one half of 

the lowest reported detection limit was compiled as the ‘minimum’ reported monitoring data 

3. dw. – dry weight and ww. – wet weight
95

D-1-3 Biosolids and Soil

CPs are detected more frequently and at higher concentrations in treated sewage sludge (i.e., 

biosolids) than in soil. MCCP concentrations ranged from 5.00 × 10-5to 9.70 × 103 mg/kg dw in 

sludge and from 1.5 × 10-2to 8.5 × 10-2 mg/kg dw in soil. It is unclear if the difference in MCCP 

concentrations in sludge and soil is related to the smaller sample sizes for these media compared 

to the typically larger data sets available for water and sediment. To determine the most reliable 

studies for its consideration, EPA/OPPT used the following criteria: designation of specific 

MCCP chain length and the appropriate analytical methodology. Thus, EPA/OPPT did not use 

information from other published studies reporting measured CPs in sludge and soil because they 

did not distinguish the CPs measured (e.g., Nicholls et al., 2001); although they reported total CP 

concentrations at much lower levels ranging from 3.00 × 10-5to 2.3 mg/kg dw. .

Stevens et al. (2003) measured MCCP concentrations in sludge samples obtained from 14 

WWTPs in the UK. MCCP concentrations ranged from 3.00 × 101to 9.70 × 103 mg/kg dw. The 

authors concluded that these very high concentrations were likely the result of releases from 

numerous and ongoing diffuse sources.

Although risk to terrestrial species was not calculated, EPA/OPPT notes that the lowest and 

highest reported biosolid and soil concentrations (5.00 × 10-5to 9.70 × 103 mg/kg dw and 1.5 ×

10-2to 8.5 × 10-2 mg/kg dw, respectively) represents a very large range (up to eight orders of 

magnitude (Table_Apx D-1-3).

Table_Apx D-1-3: Biosolid and Soil Concentrations of MCCPs

Location Media

Concentration

Units References Minimum Maximum

Switzerland Soil 1.5 × 10-2 8.5 × 10-2 mg/kg dw Iozza (2010)

China Soil 2.1 × 10-61.53 × 10-3 mg/kg dw Wang et al. (2013)

Czech Republic Sewage Sludge 7.36 × 10-12.30 mg/kg dw Pribylova et al. (2006)

United 

Kingdom Sewage Sludge 3.00 × 101

9.70 × 103 mg/kg dw Stevens et al. (2003)

United States Sewage Sludge 5.00 × 10-55.00 × 10-5 mg/kg dw Pribylova et al. (2006)

D-1-4 Biota

EPA/OPPT reviewed available published literature and summarized MCCP concentrations in 

tissues of aquatic and terrestrial biota (Table D-4). Measured tissue concentrations for aquatic 

biota ranged from ND to 2.63 mg/kg ww (i.e., beluga whales, seals, rainbow trout, carp, 

mackerel, arctic char, mussels, crustaceans, and plankton) and ranged from 5.00 × 10-3to 3.70 ×

10-1 mg/kg ww in terrestrial biota. The concentrations measured in the terrestrial studies did not 

designate the specific CP congener groups measured. 
96

As a result of the Agency’s evaluation, MCCPs were found in organisms across many different 

trophic levels indicating widespread environmental contamination (Table_Apx D-1-4). The data 

were insufficient for EPA/OPPT to draw conclusions about trends based on region, species, time, 

or other factors.

While EPA/OPPT determined the concentrations of MCCPs in aquatic and terrestrial biota range 

from ND to 2.63 mg/kg ww and from 5.00 × 10-3to 3.70 × 10-1 mg/kg ww, respectively, in this 

assessment, the Agency did not use tissue concentrations to determine risks of potential concern 

for biota. Rather, it used the risk quotient (RQ) method and the conventional PMN approach as 

described in Section 6.
97

Table_Apx D-1-4: Biota Concentrations of MCCPs

Location Media 

Description Minimum Units Min Reference Maximum Units Max Reference

Aquatic Biota

Australia Invertebrates 2.32x10-5 mg/kg lw Kemmlein et al. (2002) 3.05x10-5 mg/kg lw Kemmlein et al. (2002)

Canada

Mammals 5.45x10-7 mg/kg ww Bennie et al. (2000) 8.00x10-5 mg/kg ww Bennie et al. (2000)

Fish 2.57x10-7 mg/kg ww Bennie et al. (2000) 2.63 mg/kg ww Muir et al. (2000)

Invertebrates ND1 mg/kg ww EC (1993) ND1 mg/kg ww EC (1993)

Total ND1 mg/kg ww EC (1993) 2.63 mg/kg ww Muir et al. (2000)

Europe Fish 7.00x10-3 mg/kg ww Reth et al. (2006) 4.70x10-2 mg/kg ww Reth et al. (2006)

North Sea/Baltic Sea 

Region2 Fish ND3 mg/kg ww IVL (2009) 2.6x10-1 mg/kg ww Reth et al. (2005)

United States

Fish 2.90x10-3 mg/kg ww Tomy and Stern (1999) 9.04x10-1 mg/kg ww Tomy and Stern (1999)

Invertebrates 3.50x10-3 mg/kg ww USEPA (1988) 1.70x10-1 mg/kg ww USEPA (1988)

Total 2.90x10-3 mg/kg ww Tomy and Stern (1999) 9.04x10-1 mg/kg ww Tomy and Stern (1999)

United States / Canada 

- Great Lakes 

Fish 1.80x10-3 mg/kg ww Muir et al. (2003) 1.10x10-1 mg/kg ww Muir et al. (2003)

Invertebrates 2.40x10-3 mg/kg ww EC (2008a) 1.60x10-2 mg/kg ww Muir et al. (2003)

Total 1.80x10-3 mg/kg ww Muir et al. (2003) 1.10x10-1 mg/kg ww. Muir et al. (2003)

Terrestrial Biota

Europe Birds 5.00x10-3 mg/kg ww Reth et al. (2006) 3.70x10-1 mg/kg ww Reth et al. (2006)

Notes:

Summary values represent total MCCP and not individual MCCP isomers.

1 MCCPs were not detected in Invertebrates from Canada. Detection limit = 4.0 × 10-7 mg/kg; 1⁄2 DL = 2.0 × 10-7

(EC, 1993).

2 North Sea/Baltic Sea Region includes the following countries: Estonia, Latvia, Lithuania, Norway, Poland, and Sweden.

3 The minimum MCCP concentration value for fish from the North Sea/Baltic Sea Region was non-detect. The detection limit = 2.5 × 10-4 mg/kg; 1⁄2 DL = 1.25 × 10-4

(IVL 2009)
98

Appendix E ENGINEERING (ChemSTEER) REPORTS ON P-14-

0683 AND P-14-0684

INITIAL REVIEW ENGINEERING REPORT

P-14-0684 C

P-14-0683, P-14-0684

CEB Staff Draft 8/26/2014 11:00:00 PM

ENGINEER:

PV (kg/yr): 15000000

Revision Notes/Assessment Overview: 

SUBMITTER: Qualice, LLC (submitter)

USE: The uses are equally split between flame retardant/plasticizer in the rubber (50%) and lubricant in metal 

working fluids (MWFs) (50%). These uses are consistent with all the lit and previous cases submitted. Other 

potential uses are listed elsewhere. Lubricants can have more variety of chlorine content based on application 

needs, while rubber formulations have chlorine content more steady around the 52% levels. Related Cases 

Submitted Together: P-14-0683, P-14-0684.

OTHER USES: Generic uses MCCP: 1) Substances are used as a flame retardant/plasticizer in polymers; 2) used 

as lubricants in automotives 3) as components of solvent based paints, adhesives and sealants. The paints are 

specialty paints for applications where weather resistant coatings are needed, such as steel construction, industrial 

flooring, road marking, window sealants and pools; and 4) flame retardants / waterproofers to textiles.

MSDS: Yes LABEL: Yes

Gen Eqpt: Eng Controls: Under normal conditions of use, natural ventilation should effectively remove and 

prevent buildup of any vapor/mist/fume/dust generated from the handling of this product. // Eye/Face: If splashes 

are likely to occur, wear safety glasses with side-shields or a face shield with safety glasses. // Skin: Normal work 

clothing (long sleeved shirts and long pants) is recommended. If splashes are likely to occur, use apron or 

impervious suit, such as a Tyvek coverall. If liquid contact is likely to occur, manufacturer recommends nitrile 

gloves (ex: N-DEX Nitrile).

Respirator: No personal respiratory protective equipment normally required. If mist is generated (heating, 

spraying) and engineering controls are not sufficient, wear NIOSH certified organic vapor respirator with 

particulate filter.

Health Effects: Eye: Contact with eyes may cause irritation // Skin: Prolonged and/or repeated skin contact may 

result in mild irritation or redness // Inhalation: Avoid breathing vapors or mists of this product. May cause irritation 

of respiratory tract. // Ingestion: Small amounts (a tablespoonful) swallowed during normal handling operations are 

not likely to cause injury; swallowing amounts larger than that may cause injury.

TLV/PEL: - none established

CRSS: (7/17/2014 1:00:00 AM):

Chemical Name: Tetradecane, chloro derivs.

S-H2O: 0.000005 g/L @

VP: 2.0E-6 torr @

MW: 440 0.0%<500 0.0%<1000

Physical State and Misc CRSS Info: 

Neat: liquid Mfg: liquid

Proc/Form: liquid End Use: 10 - 15% in final product. The stoicheometer of the process diagram would 

produce PMN products that are average molecular formula containing 6 - 8 chlorine atoms. The starting olefin is

98% C14 and 93% alpha oleffin. The typical MW is near 440 daltons for a Cl7 congener based on total PV of > 40 

to < 70 wt% chlorine content.
99

Consumer Use: No

SAT (concerns): (7/17/2014 11:00:00 PM):

Related Cases and Misc SAT Info:

Same as P-12-0283. Analogs: P-12-0282, P-12-0357, P-12-0453 all MCCPs

Migration to groundwater: Slow

PBT rating: P3 B3 T2

Health: 1, No exposures needed

Eco: 3, Water (All releases to water with a CC = 1 ppb), XB Testing (Testing desired)

OCCUPATIONAL EXPOSURE RATING: 2-3D

NOTES & KEY ASSUMPTIONS:

Generated by the 06/07/2005 version of ChemSTEER. This is a consolidated set: P14-0683 & 0684. The two PMNs 

have identical volume, use rate, concentration and uses. PB ratings are P2B3; therefore, a full assessment is 

performed. This is an exposure-based case; all exposure criteria met; XB testing desired for Eco. //// Note

P14-0684 was previously submitted as P12-0357 by Trinity, but the case was later withdrawn. //// The PMN is a 

MCCP product that is manufactured domestically and used in the following applications: 1) 50% as a flame retardant 

in rubber products; and 2) 50% as a lubricant in metal working fluids (MWFs). // The technical contact was called, 

see contact report for details. // Note, this IRER is consistent with past assessment of P12-0357 (same chemical as 

P14-0684, same uses), except that this IRER assesses a separate converting operation based on latest information 

provided by technical contact. Further, this IRER was prepared using the same methdology as the following past 

MCCP cases: P12-0277 through P12-0284, and P12-0453. //// For MFG: Submitter estimates were used for 

assessing submitter specified waste streams and standard models were used to assess equipment cleaning. Dermal 

exposure was assessed using standard models and inhalation exposure is expected to be negl. // For downstream 

processing and use operations: The release and exposure estimates were based on a combination of submitter 

provided data and data available in various literature sources. The literature sources include 1) previous EPA/OPPT

assessments on chlorinated paraffins; 2) foreign risk assessments on MCCPs and LCCPs (e.g. EU risk assessments); 

3) EPA/OPPT Generic Scenarios; and 4) OECD Emission Scenario Documents. Due to the uncertainty at multiple 

downstream use sites, the most conservative data were chosen when evaluating releases for downstream operations.

POLLUTION PREVENTION CONSIDERATIONS:

P2 claims were made for the MCCP being an alternative to the SCCP. P2 claims were also made for MCCP as an 

alternative for phthalates. While true neither merits recognition.

P2 REC: P2 claims were made for the MCCP being an alternative to the SCCP. P2 claims were also made for

MCCP as an alternative for phthalates. While true neither merits recognition.

EXPOSURE-BASED REVIEW: Yes (3 criteria met)

1) # of workers exposed: 149,846 >1000? Yes

2) >100 workers with > 10 mg/day inhalation exposure: Yes

3) (a) >100 workers w/1-10 mg/day inh. exp. & >100 days/yr: Yes

(b) Routine Dermal Cont: > 250 workers & > 100 days/yr: Yes
MFG: Batch Manufacturing of PMN

Number of Sites/Location: 1 submitter site(s)

100

Qualice, LLC Hamlet NC 28345

Basis: Per submission, 1 submitter site, 375 bt/yr, 12 hr/bt, 20,000 kg/bt, PMN produced as a liquid at 100%. CS calculates 750 

bt/yr based on submitted PV of 15,000,000 kg/yr. Assumed 3 processing lines per site.

Process Description: Feedstock charged to a reactor ---> chlorine gas in fed to reactor ---> byproduct gas is recovered and 

treated and produces waste PMN stream, bleach and HCl product ---> reaction forms PMN (liquid, 100%) --> QC sampling ---> 

stabilizer added ---> transfer to storage ---> loading PMN product (liquid, 100%) into tank trucks (90% of PV) or totes (10% of 

PV) (submission)

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below may coincide with daily releases from the other sources 

to the same medium.

Water or Incineration or Landfill

Conservative: 4.0E+2 kg/site-day over 1 day/yr from 1 sites or 4.0E+2 kg/yr

to: uncertain

from: Equipment Cleaning Losses of Liquids from Multiple Vessels

basis: EPA/OPPT Multiple Process Vessel Residual Model, CEB standard 2% residual. The submission states that 

equipment cleaning is not performed between batches (not needed). As conservative, CEB assesses cleaning of 

equipment for 1 day/yr to address the possibility of equipment cleaning due to unforseen circumstances with 

releases to uncertain media.

Incineration

Output 2: 2.2E+1 kg/site-day over 250 day/yr from 1 sites or 5.4E+3 kg/yr

to: off-site incineration (submission)

from: Waste from Byproduct Gas Recovery

basis: User-Defined Loss Rate Model. The submission estimates 7.2 kg/bt of PMN is released to off-site incineration 

from waste PMN produced during byproduct gas recovery. CS calculates 3 bt/day resulting in a release of (7.2 x 3) =

21.6 kg/site-day.

Landfill

Output 2: 9.0E+0 kg/site-day over 250 day/yr from 1 sites or 2.2E+3 kg/yr

to: RCRA Subtitle D landfill (submission)

from: Carbon Waste from HCl Carbon Treatment

basis: User-Defined Loss Rate Model. The submission estimates 3 kg/bt of PMN is released to a RCRA subtitle D

landfill from waste carbon produced HCl carbon treatment. CS calculates 3 bt/day resulting in a release of (3 x 3) =

9 kg/site-day.

RELEASE TOTAL

8.0E+3 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 6

Basis: The submission estimates up to 3 workers/site exposed to PMN at during various activities. As conservative, 

CEB assesses dermal exposure for all workers to liquid PMN at 100% during sampling (1-hand) and loading

(2-hand) activities.
101

Dermal:

Exposure to Liquid

High End: 1.1E+3 mg/day over 250 days/yr

Number of workers (all sites) with Dermal exposure: 3

Basis: Sampling Liquid Product; EPA/OPPT 1-Hand Dermal Contact with Liquids Model.

Dermal:

Exposure to Liquid

High End: 2.2E+3 mg/day over 250 days/yr

Number of workers (all sites) with Dermal exposure: 3

Basis: Loading Liquid Product into Transport Containers; EPA/OPPT 2-Hand Dermal Contact with Liquids Model.
P-14-0684 C

P-14-0683, P-14-0684

PROC2: Compounding of Rubber Products (50% of PV)

Number of Sites/Location: 6 submitter site(s)

102

unknown site Mebane NC 

unknown site Youngsville NC 

unknown site Marysville OH 

unknown site Hannibal MO 

unknown site Calhoun GA 

unknown site St. Mary's OH

Basis: Per submission, the PMN is used at 100% in rubber compounding at 6 customer sites. The technical contacts indicates 

the PMN may be present in rubber products from 10-15%. CEB assumes 15% to conservatively assess exposures and 250 

days/yr based on 2004 ESD for Plastic Converting. CS calculates a use rate of 5,000 kg/site-day.

Process Description: PMN (liquid, 100%) unloaded from tank trucks ---> piped into mixer, mix with raw rubber and other 

additives at high temperature ---> molten rubber extruded into sheets, blocks and/or molds (PMN, 10-15% entrained in solid ) 

and shipped to downstream sites (submission, CRSS, technical contact for P14-0683/684 and P12-0282)

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below may coincide with daily releases from the other sources to 

the same medium. The submission does not provide information on releases during the manufacture of rubber 

products. The methology used to assess the standard reviews for P12-0277 through P12-0284 (LCCP and MCCP 

products) was used to assess releases during this operation. The only exception being container cleaning releases 

which are estimated using information from the submitter and technical contact.

Air

High End: 1.2E+0 kg/site-day over 250 day/yr from 6 sites or 1.9E+3 kg/yr

to: water or air (ESD, 2010 EU CSR)

from: Fugitive Air Emission from Extrusion

basis: User-Defined Loss Rate Model. Per ESD, fugitive air emissions generated during rubber converting can be

0.05% with engineering controls depending on the type of coversion process (e.g. extrusion, injection molding, 

calendaring). The 2004 GS for Plastics Compounding estimates that 50% of air emissions will settle and be 

ultimately released to water while the other 50% remains in air. As conservative, CEB assesses fugitive air 

emissions at a loss rate of 0.05% with 50% to water and 50% to air.

Water

High End: 1.2E+0 kg/site-day over 250 day/yr from 6 sites or 1.9E+3 kg/yr

to: water or air (ESD, 2010 EU CSR)

from: Fugitive Air Emission from Extrusion

basis: User-Defined Loss Rate Model. Per ESD, fugitive air emissions generated during rubber converting can be

0.05% with engineering controls depending on the type of coversion process (e.g. extrusion, injection molding, 

calendaring). The 2004 GS for Plastics Compounding estimates that 50% of air emissions will settle and be 

ultimately released to water while the other 50% remains in air. As conservative, CEB assesses fugitive air 

emissions at a loss rate of 0.05% with 50% to water and 50% to air.

Water or Incineration or Landfill

High End: 5.0E-1 kg/site-day over 250 day/yr from 6 sites or 7.5E+2 kg/yr

to: water, incineration, or landfill (RM-2)

from: Spillage During Raw Material Handling

basis: User-Defined Loss Rate Model. A 2010 EU CSR assessment on MCCPs estimated these releases to be

0.01% of PV with releases to water or solid waste. .

Water or Incineration or Landfill

Conservative: 1.0E+2 kg/site-day over 250 day/yr from 6 sites or 1.5E+5 kg/yr

to: Uncertain
from: Equipment Cleaning Losses of from Multiple Vessels

103

basis: EPA/OPPT Multiple Process Vessel Residual Model, CEB standard 2% residual. The 2004 GS for Plastics

Compounding estimates releases from equipment cleaning using the EPA/OPPT model loss rate of 2%. Due to 

multiple unknow sites, release to uncertain media (water, incineration or landfill) is assumed.

Water or Incineration or Landfill

High End: 3.8E+1 kg/site-day over 1 day/yr from 6 sites or 2.3E+2 kg/yr

to: water, incineration or land (ESD)

from: Cleaning Liquid Residuals from Tank Trucks Used to Transport the Raw Material

basis: EPA/OPPT Bulk Transport Residual Model, CEB standard 0.2% residual. The submission states that tank 

trucks are reused and are not cleaned between uses. For P12-0357, technical contact stated that in a scenario where 

the they will need to be taken out of service, tank trucks will be sent to a third party truck washing facility. To 

account for the possibility of containers being removed from service, CEB assesses releases from container cleaning 

for 1 day/yr with releases to uncertain media.

RELEASE TOTAL

1.5E+5 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 144

Basis: The submission estimates 1 worker/site. The 2004 ESD for Plastic Compounding estimates up to 24 

workers/site. CEB uses the ESD estimate as conservative.

Inhalation:

Exposure to Vapor

High End of Range: 4.4E+0 mg/day over 250 days/yr

Low End of Range: 3.0E-2 mg/day over 250 days/yr

Number of workers (all sites) with Inhalation exposure: 144

Basis: Fugitive Air Emission from Extrusion; User-defined Inhalation Model. The 2004 GS for Plastics Compounding 

suggests that inhalation exposure is negligible for non-volatile substances during compounding. A 2010 EU Risk Assessment on 

MCCP contains monitoring| data from plastic compounding operations is the EU. The monitoring data is based on 32 air samples 

from 4 sites. Results showed MCCP air concentrations ranging from <0. 003 to 0.44 mg/m3 with a median of 0.03 mg/m3 and a

90th percentile of 0.15 mg/m3. It is unknown whether these data represent area or personal monitoring data . As conservative, 

exposures estimates are presented based on the low and high of the range for these data and assuming up to 8 hr exposure 

duration. .

INHALATION MONITORING DATA REVIEW

1) Uncertainty (estimate based on model, regulatory limit, or data not specific to industry): Yes

2) (a) Exposure level > 1 mg/day? Yes

(b) Hazard Rating for health of 2 or greater? No

Inhalation Monitoring Data Desired? Yes (both criteria met)

Dermal:

Exposure to Liquid

High End: 2.2E+3 mg/day over 250 days/yr

Number of workers (all sites) with Dermal exposure: 144

Basis: Unloading Liquid Raw Material from Tank Trucks; EPA/OPPT 2-Hand Dermal Contact with Liquids Model.
P-14-0684 C

P-14-0683, P-14-0684

PROC1: Formulation of Metalworking Fluids (50% of PV)

Number of Sites/Location: 10 submitter site(s)

104

unknown site Goshen NY 

unknown site Harvey IL 

unknown sites Cleveland OH 

unknown sites Detroit MI 

unknown sites Philadelphia PA 

unknown site Mantua NJ 

unknown site Milwaukee WI 

unknown site Cincinnati OH 

unknown site Crystal Lake IL 

unknown site Linden NJ

Basis: Per submission, 20 MWF formulation sites, 150 kg PMN/bt, 240 exposure days/yr, PMN used as a liquid at 100%. For 

past case P12-0357, technical contact estimates the PMN will be in products at 10-15%. CEB assumes 100% PMN in raw 

material and 15% PMN in plastic product to conservatively assess exposures. CS calculates a use rate of 1,562.5 kg/site-day 

based on 240 day/yr operation.

Process Description: PMN (liquid, 100%) is unloaded from tanks trucks (90% of PV) and totes (10% of PV) ---> transfer to 

storage ---> feed into blending tank, mixed with base oils and other additives ---> packaging of metal working fluids containing 

PMN (10 - 15%) (submission, technical contact from P12-0357)

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below may coincide with daily releases from the other sources 

to the same medium. The submission states there are no releases during formulation of MWFs. The methology used 

to assesses the standard reviews for P12-0277 through P12-0284 and P12-0357 (LCCP and MCCP products) was 

used to assesses releases during this operation. The only exception being container cleaning releases which are

estimated using information from the submitter and technical contact.

Water or Incineration or Landfill

High End: 3.8E+1 kg/site-day over 1 day/yr from 20 sites or 7.6E+2 kg/yr

to: uncertain

from: Cleaning Liquid Residuals from Totes and Tank Trucks Used to Transport the Raw Material

basis: EPA/OPPT Bulk Transport Residual Model, CEB standard 0.2% residual. The submission states that totes 

and tank trucks are reused and are not cleaned between uses. From contact report for P12-0357, the technical 

contact stated that in a scenario where the they will need to be taken out of service, totes would be sent to a third 

party handler for cleaning and disposal and tank trucks will be sent to a third party truck washing facility. To

account for the possibility of containers being removed from service, CEB assesses releases from container cleaning 

for 1 day/yr with releases to uncertain media.

Water or Incineration or Landfill

Conservative: 1.6E+1 kg/site-day over 240 day/yr from 20 sites or 7.5E+4 kg/yr

to: Uncertain

from: Equipment Cleaning Losses of Liquids from a Mixing Tank

basis: EPA/OPPT Single Vessel Residual Model, CEB standard 1% residual. The submission does not address 

equipment cleaning at downstream formulation sites. Due to uncertainty at multiple downstream sites, CEB 

assesses releases to uncertain media using the standard model loss fraction assuming cleaning once per day.

Air

Output 2: 7.8E-2 kg/site-day over 240 day/yr from 20 sites or 3.8E+2 kg/yr

to: fugitive air (2002 EU RA, 2010 Japan RA)

from: Fugitive Air Emissions

basis: User-Defined Loss Rate Model. A 2010 Japanese RA for SCCPs suggests 0.005% release to air during MWF 

formulation. Due to uncertainty at multiple downstream use sites, CEB includes this release source using this 

estimate.
Incineration or Landfill

105

Output 2: 3.1E+1 kg/site-day over 240 day/yr from 20 sites or 1.5E+5 kg/yr

to: incineration or landfill (2002 EU RA)

from: Off-Spec Material

basis: User-Defined Loss Rate Model. Data from a 2002 EU RA estimates a 1-2% loss rate from disposal of

off-spec batches released to solid waste. Due to uncertainty at multiple downstream use sites, CEB includes this 

release source using the high end estimate with releases to incineration or landfill.

RELEASE TOTAL

2.3E+5 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 80

Basis: The submission estimates 80 workers for all sites (avg 4 workers/site). As conservative, CEB assesses all 

workers are exposed to PMN at 100% (unloading) and 15% (loading).

Dermal:

Exposure to Liquid

High End: 2.2E+3 mg/day over 240 days/yr

Number of workers (all sites) with Dermal exposure: 80

Basis: Unloading Liquid Raw Material from Totes and Tank Trucks; EPA/OPPT 2-Hand Dermal Contact with Liquids

Model.

Dermal:

Exposure to Liquid

High End: 3.4E+2 mg/day over 240 days/yr

Number of workers (all sites) with Dermal exposure: 80

Basis: Loading Liquid Product into Drums; EPA/OPPT 2-Hand Dermal Contact with Liquids Model.
106

P-14-0684 C

P-14-0683, P-14-0684

USE1: Use of Metalworking Fluids (50% of PV) 

Number of Sites/Location: 1 submitter site(s)

unknown sites

Basis: The submission does not address the use of formulated MWFs containing the PMN. The lubricant products contain

10-15% PMN per contact report for P12-0357. CEB assumes 15% to conservatively assess exposures. The 2011 ESD for MWF 

Operations estimates 247 days/yr of operation. The ESD estimates the number of sites as: (7,500,000 kg/yr) / (4,260 gal/site-yr x

1 kg/L x 3.785 L/gal x 0.15) = 3,101 sites. Environmental releases are of concern for this PMN. As conservative, CEB assumes

247 days/yr of operation and the ESD estimate of 3,101 sites to maximize kg/site-day release. CEB also assumes 15% PMN in 

raw material and assumes no dilution as conservative. CS calculates a use rate of 9.7918 kg/site-day.

Process Description: Bulk MWF containing PMN (liquid, 10 - 15%,) is unloaded from transport containers ---> transfer to 

mixing vessel ---> possible dilution of if water-based MWF ---> transfer to metal shaping trough ---> metal shaping operation

---> shaped metal part is rinsed and dried ---> spent MWF is drained and discarded (ESD)

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below may coincide with daily releases from the other sources 

to the same medium. The submission does not provide information on releases during the use of MWFs. The ESD 

was used to assess releases during this operation.

Water or Incineration or Landfill

High End: 9.4E-1 kg/site-day over 18 day/yr from 3101 sites or 5.2E+4 kg/yr

to: water, incineration, or landfill (ESD)

from: Cleaning Liquid Residuals from Drums Used to Transport the Raw Material

basis: EPA/OPPT Drum Residual Model, CEB standard 3% residual. The submission does not address end use. 

Due to uncertainty at multiple downstream sites, these releases are assessed to uncertain media using a 3% loss rate 

per the ESD.

Water

Output 2: 1.0E+0 kg/site-day over 247 day/yr from 3101 sites or 8.0E+5 kg/yr

to: on-site WWTP or POTW (ESD)

from: Dragout Losses

basis: User-Defined Loss Rate Model. The 2011 ESD for MWF Operations estimates a loss rate of 11% from 

dragout with releases to on-site WWTP or POTW. These data are based on U.S. industry data collected during the 

development of effluent guidelines for the metalworking industry. Due to uncertainty at multiple downstream sites, 

CEB assesses dragout releases using the ESD estimate of 11% and accounting for upstream losses from container 

cleaning: (1-0.03) x 0.11 = 0.1067. Releases are assessed to water via on-site WWTP or POTW per submission and 

ESD.

Water or Incineration or Landfill

Output 2: 3.4E+0 kg/site-day over 247 day/yr from 3101 sites or 2.6E+6 kg/yr

to: water, incineration, or landfill (ESD)

from: Filter Media and Other Recycling Waste

basis: User-Defined Loss Rate Model. The 2011 ESD for MWF Operations estimates these releases to account for a

36% loss rate with releases to water, incineration, or landfill (water-based fluids) or incineration or landfill 

(straight-oil). Accounting for upstream container cleaning losses: (1-0.03) x 0.36 = 0.3492. CEB assesses these 

releases to water, incineration, or landfill based on uncertainty at multiple downstream use sites.

Water or Incineration or Landfill

Output 2: 4.4E+0 kg/site-day over 247 day/yr from 3101 sites or 3.3E+6 kg/yr

to: water, incineration, or landfill (ESD)

from: Spent Metalworking Fluid

basis: User-Defined Loss Rate Model. The 2011 ESD for MWF Operations also assesses 100% release with the 

spent MWF disposed to water (water-based fluids) or incineration or landfill (straight oil fluids) with at least 

onebath changeout occurring per day at a facility with multiple baths in use. Based on uncertainty at multiple 
107

downstream use sites, CEB assesses the spent MWF to water, incineration, or landfill. Account for upstream 

losses, the loss rate is calculated as: (1-0.03) x (1-0.05-0.11-0.38) = 0.4462.

Air

Output 2: 4.7E-1 kg/site-day over 247 day/yr from 3101 sites or 3.6E+5 kg/yr

to: air (2002 EU RA)

from: Misting/Evaporation

basis: User-Defined Loss Rate Model. A 2002 EU RA for MCCP estimates misting/evaporation losses to range 

from 2 to 5% depending on the type of MWF begin used. Based on uncertainty at multiple downstream sites, CEB 

uses the most conservative estimate of 5% loss to air from misting/evaporation. Account for upstream losses from 

container cleaning: (1-0.03) x 0.05 = 0.0485

RELEASE TOTAL

7.2E+6 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 148848

Basis: The 2011 ESD for MWF Use estimates 48 workers/site. CEB assesses 48 workers/site as conservative, due 

to uncertainty at downstream use sites.

Dermal:

Exposure to Liquid

High End: 2.6E+2 mg/day over 247 days/yr

Number of workers (all sites) with Dermal exposure: 148848

Basis: Unloading Liquid Raw Material from Drums; EPA/OPPT 2-Hand Dermal Contact with Liquids Model.

Dermal:

Exposure to Mist

: mg/day over days/yr

: 3.7E+2 mg/day over 247 days/yr

Number of workers (all sites) with Dermal exposure: 148848

Basis: Exposure During Metalworking Operation; User-defined Dermal Model. The 2011 ESD for MWF Operations 

estimates an average dermal surface loading rate for MWFs of 2.9 mg/cm2-hr during metalworking operations. These data are 

more conservative than the EPA/OPPT 2-Hand Dermal Contact Model and are used to provide a conservative estimate of dermal 

exposure during MWF use due to uncertainty at downstream opeations. Per ESD, exposure is to fluid that has undergone a

10-fold dilution so PMN concentration is 15% x 10% = 1.5%.

Inhalation:

Exposure to Mist

High End of Range: 5.3E+0 mg/day over 247 days/yr

Typical: 1.5E+0 mg/day over 247 days/yr

Number of workers (all sites) with Inhalation exposure: 148848

Basis: Exposure During Metalworking Operation; User-defined Inhalation Model. The 2011 ESD for MWF Operations 

estimates typical mist concentrations ranging from 0.19 to 0.39 mg/m3 and high end concentrations ranging from 0.87 to 1.42 

mg/m3 depending on the type of MWF used. These estimates are based on the geometric mean (typical) and 90th percentile data 

(high end) of data collected by NIOSH from 942 machinists at 79 shops across the U.S. A range of inhalation exposure estimates 

are based the high end for the range of geometric means and 90th percentiles. CEB assumes the PMN is 37.5% of the mist. (GS 

assumes that water conc. is 60% and the PMN is then estimated to be 15/40 = 37.5% of the mist. 0.39 mg/m3 x 37.5% = 0.146 

mg/m3. 1.42 mg/m3 x 37.5% = 0.532 mg/m3.
108

INHALATION MONITORING DATA REVIEW

1) Uncertainty (estimate based on model, regulatory limit, or data not specific to industry): Yes

2) (a) Exposure level > 1 mg/day? Yes

(b) Hazard Rating for health of 2 or greater? No

Inhalation Monitoring Data Desired? Yes (both criteria met)
Deliberative Draft-Do not cite or Quote

109

P-14-0684 C

P-14-0683, P-14-0684

USE2: Converting of Rubber Products (50% of PV) 

Number of Sites/Location: 1 submitter site(s)

unknown site(s)

Basis: Submission does not provide the number of rubber converting sites. Per 2004 ESD on Plastics Converting, 250 day/yr 

operation and a default plastic use rate of (38,738 MM kg/yr) / (12,191 sites) / (250 day/yr) = 12,710.36 kg/site-day (general 

plastics). CS calculates 16 sites.

Process Description: Rubber blocks, sheets or molds containing PMN (solid, 10 - 15%) are unloaded ---> forming (heating)

---> molding and shaping using various processes (injection molding, extrusion, casting, calendaring, etc.) ---> trimming --->

finishing ---> finished rubber article

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below may coincide with daily releases from the other sources 

to the same medium. The 2004 Plastics Converting ESD is referenced for this operation.

Incineration or Landfill

Output 2: 4.8E+1 kg/site-day over 250 day/yr from 16 sites or 1.9E+5 kg/yr

to: landfill or incineration

from: Scrap Material

basis: User-Defined Loss Rate Model. The 2004 GS for Plastics Converting estimated these releases to be 2.5% of

PV. Expected to be handled as solid waste with disposal to landfill or incineration considered most likely.

Incineration or Landfill

Output 2: 1.9E+1 kg/site-day over 250 day/yr from 16 sites or 7.5E+4 kg/yr

to: incineration or landfill

from: Cleaning Solid/ Powder Residuals from Containers Used to Transport the Raw Material

basis: EPA/OPPT Solid Residuals in Transport Containers Model, CEB standard 1% residual. Solid compounded 

plastic residuals considered most likely to be handled as solid waste with disposal to landfill or incineration.

Incineration or Landfill

Conservative: 3.8E+1 kg/site-day over 250 day/yr from 16 sites or 1.5E+5 kg/yr

to: incineration or landfill

from: Equipment Cleaning Losses of Liquids from Multiple Vessels

basis: EPA/OPPT Multiple Process Vessel Residual Model, CEB standard 2% residual. Converted plastic residual 

material in equipment is considered most likely to be handled as solid waste and disposed by landfill or incineration.

Water or Incineration or Landfill

Output 2: 1.9E-1 kg/site-day over 250 day/yr from 16 sites or 7.6E+2 kg/yr

to: water, incineration or landfill

from: Dust Generation from Converting

basis: User-Defined Loss Rate Model. Per ESD, 0.01% loss of daily use rate. Particles are originally released to

air but are expected to eventually settle to the ground. Dust particles are expected to be cleaned from equipment and 

floor with water or disposed directly to landfill.

Air

Output 2: 2.4E+0 kg/site-day over 250 day/yr from 16 sites or 9.5E+3 kg/yr

to: Water (50%) or Air (50%) (ESD)

from: Fugitive Air Emission from Converting

basis: User-Defined Loss Rate Model. Based on Plastics Converting GS (2004), Most plastic additives are
Deliberative Draft-Do not cite or Quote

110

non-volatile; however, converting operations may be performed at elevated temperatures; thus slight volatilization 

may occur. A release of 0.25% of the daily use rate is estimated. Particles are originally released to air but 

subsequent condensation may result in losses to water. As a conservative estimate, 50% is assumed to be released to 

water and 50% is assumed to be released to the atmosphere. NOTE: The CSR estimates 0.05% loss for this activity.

Water

Output 2: 2.4E+0 kg/site-day over 250 day/yr from 16 sites or 9.5E+3 kg/yr

to: Water (50%) or Air (50%) (ESD)

from: Fugitive Air Emission from Converting

basis: User-Defined Loss Rate Model. Based on Plastics Converting GS (2004), Most plastic additives are

non-volatile; however, converting operations may be performed at elevated temperatures; thus slight volatilization 

may occur. A release of 0.25% of the daily use rate is estimated. Particles are originally released to air but 

subsequent condensation may result in losses to water. As a conservative estimate, 50% is assumed to be released to 

water and 50% is assumed to be released to the atmosphere. NOTE: The CSR estimates 0.05% loss for this

activity.

Water or Incineration or Landfill

Output 2: 1.9E-1 kg/site-day over 250 day/yr from 16 sites or 7.6E+2 kg/yr

to: water, incineration or landfill (RM-2_

from: Raw Material Spillage

basis: User-Defined Loss Rate Model. A 2010 EU CSR assessment on MCCPs estimated these releases to be

0.01% of PV with releases to water or solid waste. The 2010 EU CSR estimate is used as a basis to estimate releases 

from spillage.

RELEASE TOTAL

4.4E+5 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 768

Basis: Per 2004 ESD for Plastics Converting, 48 workers/site.

Inhalation:

Exposure to Mist

High End of Range: 1.5E+1 mg/day over 250 days/yr

Low End of Range: 7.0E-1 mg/day over 250 days/yr

Number of workers (all sites) with Inhalation exposure: 768

Basis: Inhalation Exposure during Converting; User-defined Inhalation Model. A 2008 EU RA on MCCPs and a 2010 EU 

CSR on MCCPs contains monitoring data from rubber manufacturing operations in the EU. The monitoring data suggest MCCP 

air concentrations ranging from 0.01 to 0.07 mg/m3 based on monitoring conducted at 1 site. It is unknown whether these data 

represent area or personal monitoring data. Based on uncertainty in multiple downstream use sites and the fact that these data are 

only basd on 1 site, CEB assesses exposures based on the high end of the EU data range (0.07 mg/m3) and the OSHA PEL (15 

mg/m3 x 0.1 = 1.5 mg/m3).

INHALATION MONITORING DATA REVIEW

1) Uncertainty (estimate based on model, regulatory limit, or data not specific to industry): Yes

2) (a) Exposure level > 1 mg/day? Yes

(b) Hazard Rating for health of 2 or greater? No

Inhalation Monitoring Data Desired? Yes (both c
111

Appendix F EXPOSURE SCENARIO ESTIMATES

(E-FAST Model Run)

INITIAL REVIEW EXPOSURE REPORT (IRExR)

Chemical ID: P-14-0683C 

(P-14-0683 and P-14-0684)

 

Results Table: Dose, Concentration, and Days Exceeded Results Summary

Exposure Scenario1 Water Landfill Stack Air Fugitive Air

Release activity(ies)2; 

exposure calculation(s)3

Drinking Water Fish Ingestion 7Q104

CC = 1

PDM 

Days 

Exceeded

LADD ADR LADD ADR LADD

ADR LADD ADR LADD

mg/kg/day mg/kg/day mg/kg/day mg/kg/day μg/l # Days mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

MFG: Max ADR: max 

acute eco

1.60E-01 --- 2.00E+00 --- 7.39E+03 --- --- 5.20E-01 --- --- ---

MFG: Max LADD --- 1.19E-05 --- 6.22E-05 --- --- 3.89E-04 --- 1.69E-03 --- ---

PROC 1: Max ADR: 

max acute eco

1.54E-02 --- 3.40E-01 --- 6.96E+02 --- --- 1.00E-01 --- 1.96E-03 ---

PROC 1: PDM1 --- --- --- --- 2.06E+02 240 --- --- --- --- ---

PROC 1: Max LADD --- 1.48E-04 --- 7.70E-04 --- --- 1.66E-03 --- 3.23E-03 --- 4.34E-05

PROC 2: Max ADR: 

max acute eco

3.98E-02 --- 8.90E-01 --- 1.80E+03 --- --- 1.70E-01 --- 2.93E-02 ---

PROC 2: PDM1 --- --- --- --- 1.31E+03 250 --- --- --- --- ---

PROC 2: Max LADD --- 9.70E-04 --- 5.07E-03 --- --- 3.70E-03 --- 7.20E-03 --- 6.95E-04

USE 1: Max ADR: max 

acute eco

7.87E-03 --- 1.00E-01 --- 3.69E+02 --- --- 1.08E-02 --- 1.17E-02 ---

USE 1: PDM1 --- --- --- --- 3.33E+02 245 --- --- --- --- ---

USE 1: Max LADD --- 1.39E-04 --- 7.26E-04 --- --- 2.85E-04 --- 5.55E-04 --- 2.69E-04

USE 2: Max ADR: max 

acute eco

2.35E-03 --- 3.22E-02 --- 1.10E+02 --- --- 1.30E-01 --- 6.04E-02 ---

USE 2: PDM1 --- --- --- --- 1.10E+02 238 --- --- --- --- ---

USE 2: Max LADD --- 4.81E-05 --- 2.51E-04 --- --- 3.86E-03 --- 7.51E-03 --- 1.39E-03

1 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation.

2 Release activities are from engineering report's Manufacturing (Mfg), Processing (Proc) and Use release activity labels.

 Multiple release activities are combined in one exposure scenario if their releases occur at same location.

3 Exposure calculations are Acute Dose Rate (ADR), Lifetime Average Daily Dose (LADD), and Probabilistic Dilution 

 Model (PDM). There may be one, two, or all three exposure calculations per exposure scenario.

 CC is the aquatic concentration of concern.

4 This column displays concentration values for the 7Q10 streamflow, which is defined as the average daily streamflow 

 of the seven consecutive days of lowest flow within a ten year period.
112
113

Results Table: Exposure Based (XB)/Persistent (P2B2) Criteria

Parameter Exp Based Persistent Exceedance Value

Drinking (Surface) Water Dose (mg/kg/day) No No

Fish Ingestion Dose (mg/kg/day) Yes Yes 5.07E-03

Inhalation Dose (mg/kg/day) Yes Yes 7.51E-03

Groundwater Dose (mg/kg/day) Yes Yes 3.86E-03

Surface Water Release After Treatment (kg/yr) Yes Yes 7.03E+05

Total Release After Treatment (kg/yr) Yes Yes 7.28E+06

Consumer Use? No
114

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites: 1. 

Release Activity: MFG: Max ADR

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 400.00 0.00 422.00 0.00

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 1.00 0.00/0.00 1.00 0.00

Per Site Release: 400.00 0.00/0.00 422.00 0.00

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 
115

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 1 Number of Sites: 1 RELEASE 

ACTIVITY:MFG: Max 

ADR

SIC-CODE DESCRIPTION: Organic Chemicals Manufacture

SIC-CODE (S): 2865,2869 EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 1. 400. 40.00 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 2825.61 935.49 634.16 514.20 14.16 42.76 63.08 77.79

ALL 10 50.57 9.38 5.41 4.53 790.98 4264.39 7393.72 8830.02

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 2.13E-07 1.19E-05 mg/kg/day 1.11E-06 6.22E-05 mg/kg/day

LADCpot 1.64E-05 9.17E-04 mg/L 1.19E-02 0.66 mg/kg

Acute

ADRpot 1.62E-03 0.16 mg/kg/day 3.57E-02 2.00 mg/kg/day
116

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 1 RELEASE ACTIVITY:MFG: Max ADR

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites: 1. 

Per Site Fugitive Release: NA kg/site/day

Fugitive Release Days per Year: NA days

% Removal via Fugitive Release: 0.00 %

Total Fugitive Release: NA kg/yr

Max Annual Average Air Concentration 

(Fugitive):

0.00 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive):

0.00 μg/m3

Per Site Stack Release: 422.00 kg/site/day

Stack Release Days per Year: 1.00 days

% Removal via Stack Release: 0.00 %

Total Stack Release: 422.00 kg/yr

Max Annual Average Air Concentration 

(Stack):

1.56 μg/m3

Max 24 Hour Average Air 

Concentration (Stack):

2840.00 μg/m3
117

Exposure Units

Results

(Stack)

Results

(Fugitive)

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

Inh. Rate 

(m3/hr)

Cancer

LADDpot (mg/kg/day) 1.21E-04 N/A 33.00 78.00 80.00 0.61

LADCpot (mg/m3) 6.60E-04 N/A 33.00 78.00 NA NA

Acute

ADRpot (mg/kg/day) 0.52 N/A NA 1 day 80.00 0.61

 Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: N/A

Inside Stack 

Diameter:

0.10 m Length of Release 

Opening:

N/A

Stack Gas Exit 

Velocity:

0.10 m/sec Width of Release 

Opening:

N/A

Stack Gas 

Temperature:

293.00 K

Meteorological and Terrain Information:

Surrounding Land Use: Rural

Terrain Height: 0.00 m

Distance to Residence of 

Interest: 100.00 m

Meteorological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m

Facility Width: NA m

Facility Height: NA m
118

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:2 Number of Release Sites: 1. 

Release Activity: MFG: Max LADD

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 400.00 2650.00 5900.00 0.00

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 1.00 1.00/0.00 1.00 0.00

Per Site Release: 400.00 2650.00/0.00 5900.00 0.00

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)
119

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 2 Number of Sites: 1 RELEASE 

ACTIVITY:MFG: Max 

LADD

SIC-CODE DESCRIPTION: Organic Chemicals Manufacture

SIC-CODE (S): 2865,2869 EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 1. 400. 40.00 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 2825.61 935.49 634.16 514.20 N/A N/A N/A N/A

ALL 10 50.57 9.38 5.41 4.53 N/A N/A N/A N/A

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 2.13E-07 1.19E-05 mg/kg/day 1.11E-06 6.22E-05 mg/kg/day

LADCpot 1.64E-05 9.17E-04 mg/L 1.19E-02 0.66 mg/kg

Acute

ADRpot N/A N/A mg/kg/day N/A N/A mg/kg/day
120

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 2 ACTIVITY: MFG: Max LADD

RELEASE DESCRIPTION: 

EXPOSED POPULATION: Adult

NUMBE

R OF

SITES

NON-SLUDGE 

LANDFILL 

RELEASE AND 

DAYS OF 

RELEASE

(kg/site/day)/(da

ys)

LANDFILLED 

SLUDGE1

AND DAYS OF 

RELEASE

(kg/site/day)/(da

ys)

MIGRATION 

DESCRIPTO

R

2

ADSORPTIO

N TO 

WASTEWATE

R SLUDGE

(%)

DRINKING 

WATER 

TREATMEN

T

(%)

1. 2650.00/1.00 0.00/0.00 Slow 0.00 0.00

 1 Landfilled sludge equals the fraction adsorbed to wastewater treatment sludge times the

surface water pre-treatment release.

 2 Migration Descriptor Log Koc

Groundwater Concentration (GWC)

(mg/L per kg release)

Negligible no migration None

Negligible to slow > 4.5 

3.21E-6 

Slow <4.5 to 

3.5 2.67E-5 

Moderate <3.5 to 2.5 5.95E5 

Rapid <2.5 

7.55E-5 

 Exposure Units Results

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

IR

(L/day)

Cancer

LADDpot (mg/kg/day) 3.89E-04 33.00 78.00 80.00 1.04

LADCpot (mg/L) 2.99E-02 33.00 78.00 NA NA
121

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 2 RELEASE ACTIVITY:MFG: Max LADD

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites: 1. 

Per Site Fugitive Release: NA kg/site/day

Fugitive Release Days per Year: NA days

% Removal via Fugitive Release: 0.00 %

Total Fugitive Release: NA kg/yr

Max Annual Average Air Concentration 

(Fugitive):

0.00 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive):

N/A μg/m3

Per Site Stack Release: 5900.00 kg/site/day

Stack Release Days per Year: 1.00 days

% Removal via Stack Release: 0.00 %

Total Stack Release: 5900.00 kg/yr

Max Annual Average Air Concentration 

(Stack):

21.80 μg/m3

Max 24 Hour Average Air 

Concentration (Stack):

N/A μg/m3
122

Exposure Units

Results

(Stack)

Results

(Fugitive)

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

Inh. Rate 

(m3/hr)

Cancer

LADDpot (mg/kg/day) 1.69E-03 N/A 33.00 78.00 80.00 0.61

LADCpot (mg/m3) 9.22E-03 N/A 33.00 78.00 NA NA

Acute

ADRpot (mg/kg/day) N/A N/A NA 1 day 80.00 0.61

 Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: N/A

Inside Stack 

Diameter:

0.10 m Length of Release 

Opening:

N/A

Stack Gas Exit 

Velocity:

0.10 m/sec Width of Release 

Opening:

N/A

Stack Gas 

Temperature:

293.00 K

Meteorological and Terrain Information:

Surrounding Land Use: Rural

Terrain Height: 0.00 m

Distance to Residence of 

Interest: 100.00 m

Meteorological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m

Facility Width: NA m

Facility Height: NA m
123

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:3 Number of Release Sites: 20. 

Release Activity: PROC 1: Max ADR

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 1080.00 0.00 1700.00 374.40

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 1.00 0.00/0.00 1.00 240.00

Per Site Release: 54.00 0.00/0.00 85.00 7.80E-02

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 
124

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 3 Number of Sites: 20 RELEASE 

ACTIVITY:PROC 1: Max 

ADR

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

SIC-CODE (S): Subset of 4952 EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 1. 54. 5.40 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 288.00 123.84 78.18 66.05 18.75 43.60 69.07 81.76

ALL 10 39.60 13.29 7.76 7.57 136.36 406.32 695.88 713.34

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 2.83E-07 2.05E-06 mg/kg/day 1.48E-06 1.07E-05 mg/kg/day

LADCpot 2.17E-05 1.58E-04 mg/L 1.57E-02 0.11 mg/kg

Acute

ADRpot 1.65E-03 1.54E-02 mg/kg/day 4.73E-02 0.34 mg/kg/day
125

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 3 RELEASE ACTIVITY:PROC 1: Max ADR

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites: 20. 

Per Site Fugitive Release: 7.80E-02 kg/site/day

Fugitive Release Days per Year: 240.00 days

% Removal via Fugitive Release: 0.00 %

Total Fugitive Release: 374.40 kg/yr

Max Annual Average Air Concentration 

(Fugitive):

0.56 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive):

10.70 μg/m3

Per Site Stack Release: 85.00 kg/site/day

Stack Release Days per Year: 1.00 days

% Removal via Stack Release: 0.00 %

Total Stack Release: 1700.00 kg/yr

Max Annual Average Air Concentration 

(Stack):

0.31 μg/m3

Max 24 Hour Average Air 

Concentration (Stack):

570.00 μg/m3
126

Exposure Units

Results

(Stack)

Results

(Fugitive)

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

Inh. Rate 

(m3/hr)

Cancer

LADDpot (mg/kg/day) 2.43E-05 4.34E-05 33.00 78.00 80.00 0.61

LADCpot (mg/m3) 1.33E-04 2.37E-04 33.00 78.00 NA NA

Acute

ADRpot (mg/kg/day) 0.10 1.96E-03 NA 1 day 80.00 0.61

Inhalation Comments: 

 Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: 3.00 m

Inside Stack 

Diameter:

0.10 m Length of Release 

Opening:

10.00 m

Stack Gas Exit 

Velocity:

0.10 m/sec Width of Release 

Opening:

10.00 m

Stack Gas 

Temperature:

293.00 K

Meteorological and Terrain Information:

Surrounding Land Use: Rural

Terrain Height: 0.00 m

Distance to Residence of 

Interest: 100.00 m

Meteorological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m

Facility Width: NA m

Facility Height: NA m
127

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:4 Number of Release Sites: 20. 

Release Activity: PROC 1: PDM1

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 7.68E+04 0.00 0.00 0.00

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 240.00 0.00/0.00 0.00 0.00

Per Site Release: 16.00 0.00/0.00 0.00 0.00

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 
128

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 4 Number of Sites: 20 RELEASE 

ACTIVITY:PROC 1: 

PDM1

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

SIC-CODE (S): Subset of 4952 EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 240. 16. 1.60 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 288.00 123.84 78.18 66.05 5.56 12.92 20.47 24.22

ALL 10 39.60 13.29 7.76 7.57 40.40 120.39 206.19 211.36

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 2.01E-05 1.46E-04 mg/kg/day 1.05E-04 7.63E-04 mg/kg/day

LADCpot 1.55E-03 1.12E-02 mg/L 1.12 8.14 mg/kg

Acute

ADRpot 4.89E-04 4.56E-03 mg/kg/day 1.40E-02 0.10 mg/kg/day
129
130

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 4 RELEASE ACTIVITY: PROC 1: PDM1

SIC CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

ASSOCIATED SIC CODES: Subset of 4952

SIC CODE RESULTS

COC 

(μg/L)

Percent of 

Year COC 

Exceeded

Number of 

Days COC 

Exceeded

Release 

days/year

Loading 

(kg/site/day)

Waste 

Water

Treatment 

(%)

High/Avg

Analysis

1.00 66 240 240.00 16.00 90.00 High
131

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:5 Number of Release Sites: 20. 

Release Activity: PROC 1: Max LADD

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 7.76E+04 2.26E+05 2.26E+05 374.40

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 1.00 1.00/0.00 1.00 1.00

Per Site Release: 3878.00 1.13E+04/0.00 1.13E+04 18.72

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 
132

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 5 Number of Sites: 20 RELEASE 

ACTIVITY:PROC 1: Max 

LADD

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

SIC-CODE (S): Subset of 4952 EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 1. 3878. 387.80 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 288.00 123.84 78.18 66.05 N/A N/A N/A N/A

ALL 10 39.60 13.29 7.76 7.57 N/A N/A N/A N/A

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 2.03E-05 1.48E-04 mg/kg/day 1.06E-04 7.70E-04 mg/kg/day

LADCpot 1.56E-03 1.14E-02 mg/L 1.13 8.22 mg/kg

Acute

ADRpot N/A N/A mg/kg/day N/A N/A mg/kg/day
133

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 5 ACTIVITY: PROC 1: Max LADD

RELEASE DESCRIPTION: 

EXPOSED POPULATION: Adult

NUMBE

R OF

SITES

NON-SLUDGE 

LANDFILL 

RELEASE AND 

DAYS OF 

RELEASE

(kg/site/day)/(da

ys)

LANDFILLED 

SLUDGE1

AND DAYS OF 

RELEASE

(kg/site/day)/(da

ys)

MIGRATION 

DESCRIPTO

R

2

ADSORPTIO

N TO 

WASTEWATE

R SLUDGE

(%)

DRINKING 

WATER 

TREATMEN

T

(%)

20. 1.13E+04/1.00 0.00/0.00 Slow 0.00 0.00

 1 Landfilled sludge equals the fraction adsorbed to wastewater treatment sludge times the 

surface water pre-treatment release.

 2 Migration Descriptor Log Koc

Groundwater Concentration (GWC)

(mg/L per kg release)

Negligible no migration None

Negligible to slow > 4.5 

3.21E-6 

Slow <4.5 to 

3.5 2.67E-5 

Moderate <3.5 to 2.5 5.95E5 

Rapid <2.5 

7.55E-5 
134

 Exposure Units Results

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

IR

(L/day)

Cancer

LADDpot (mg/kg/day) 1.66E-03 33.00 78.00 80.00 1.04

LADCpot (mg/L) 0.13 33.00 78.00 NA NA

REMARKS:

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 5 RELEASE ACTIVITY:PROC 1: Max LADD

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites: 20. 

Per Site Fugitive Release: 18.72 kg/site/day

Fugitive Release Days per Year: 1.00 days

% Removal via Fugitive Release: 0.00 %

Total Fugitive Release: 374.40 kg/yr

Max Annual Average Air Concentration 

(Fugitive):

0.56 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive):

N/A μg/m3

Per Site Stack Release: 1.13E+04 kg/site/day

Stack Release Days per Year: 1.00 days

% Removal via Stack Release: 0.00 %

Total Stack Release: 2.26E+05 kg/yr
135

Max Annual Average Air Concentration 

(Stack):

41.70 μg/m3

Max 24 Hour Average Air 

Concentration (Stack):

N/A μg/m3

Exposure Units

Results

(Stack)

Results

(Fugitive)

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

Inh. Rate 

(m3/hr)

Cancer

LADDpot (mg/kg/day) 3.23E-03 4.34E-05 33.00 78.00 80.00 0.61

LADCpot (mg/m3) 1.76E-02 2.37E-04 33.00 78.00 NA NA

Acute

ADRpot (mg/kg/day) N/A N/A NA 1 day 80.00 0.61

Inhalation Comments: 
136

 Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: 3.00 m

Inside Stack 

Diameter:

0.10 m Length of Release 

Opening:

10.00 m

Stack Gas Exit 

Velocity:

0.10 m/sec Width of Release 

Opening:

10.00 m

Stack Gas 

Temperature:

293.00 K

Meteorological and Terrain Information:

Surrounding Land Use: Rural

Terrain Height: 0.00 m

Distance to Residence of 

Interest: 100.00 m

Meteorological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m

Facility Width: NA m

Facility Height: NA m
137

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:6 Number of Release Sites: 6. 

Release Activity: PROC 2: Max ADR

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 838.20 0.00 831.00 1800.00

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 1.00 0.00/0.00 1.00 250.00

Per Site Release: 139.70 0.00/0.00 138.50 1.20

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 
138

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 6 Number of Sites: 6 RELEASE 

ACTIVITY:PROC 2: Max 

ADR

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

SIC-CODE (S): Subset of 4952 EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 1. 139.7 13.97 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 288.00 123.84 78.18 66.05 48.51 112.81 178.69 211.51

ALL 10 39.60 13.29 7.76 7.57 352.78 1051.17 1800.26 1845.44

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 7.31E-07 5.32E-06 mg/kg/day 3.82E-06 2.78E-05 mg/kg/day

LADCpot 5.62E-05 4.09E-04 mg/L 4.07E-02 0.30 mg/kg

Acute

ADRpot 4.27E-03 3.98E-02 mg/kg/day 0.12 0.89 mg/kg/day
139

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 6 RELEASE ACTIVITY:PROC 2: Max ADR

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites: 6. 

Per Site Fugitive Release: 1.20 kg/site/day

Fugitive Release Days per Year: 250.00 days

% Removal via Fugitive Release: 0.00 %

Total Fugitive Release: 1800.00 kg/yr

Max Annual Average Air Concentration 

(Fugitive):

8.98 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive):

160.00 μg/m3

Per Site Stack Release: 138.50 kg/site/day

Stack Release Days per Year: 1.00 days

% Removal via Stack Release: 0.00 %

Total Stack Release: 831.00 kg/yr

Max Annual Average Air Concentration 

(Stack):

0.51 μg/m3

Max 24 Hour Average Air 

Concentration (Stack):

930.00 μg/m3
140

Exposure Units

Results

(Stack)

Results

(Fugitive)

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

Inh. Rate 

(m3/hr)

Cancer

LADDpot (mg/kg/day) 3.96E-05 6.95E-04 33.00 78.00 80.00 0.61

LADCpot (mg/m3) 2.16E-04 3.80E-03 33.00 78.00 NA NA

Acute

ADRpot (mg/kg/day) 0.17 2.93E-02 NA 1 day 80.00 0.61

Inhalation Comments: 

 Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: 3.00 m

Inside Stack 

Diameter:

0.10 m Length of Release 

Opening:

10.00 m

Stack Gas Exit 

Velocity:

0.10 m/sec Width of Release 

Opening:

10.00 m

Stack Gas 

Temperature:

293.00 K

Meteorological and Terrain Information:

Surrounding Land Use: Rural

Terrain Height: 0.00 m

Distance to Residence of 

Interest: 100.00 m

Meteorological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m

Facility Width: NA m

Facility Height: NA m
141

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:7 Number of Release Sites: 6. 

Release Activity: PROC 2: PDM1

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 1.53E+05 0.00 0.00 0.00

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 250.00 0.00/0.00 0.00 0.00

Per Site Release: 101.70 0.00/0.00 0.00 0.00

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 
142

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 7 Number of Sites: 6 RELEASE 

ACTIVITY:PROC 2: PDM1

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

SIC-CODE (S): Subset of 4952 EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 250. 101.7 10.17 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 288.00 123.84 78.18 66.05 35.31 82.12 130.08 153.97

ALL 10 39.60 13.29 7.76 7.57 256.82 765.24 1310.57 1343.46

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 1.33E-04 9.67E-04 mg/kg/day 6.95E-04 5.05E-03 mg/kg/day

LADCpot 1.02E-02 7.44E-02 mg/L 7.41 53.88 mg/kg

Acute

ADRpot 3.11E-03 2.90E-02 mg/kg/day 8.92E-02 0.65 mg/kg/day
143

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 7 RELEASE ACTIVITY: PROC 2: PDM1

SIC CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

ASSOCIATED SIC CODES: Subset of 4952

SIC CODE RESULTS

COC 

(μg/L)

Percent of 

Year COC 

Exceeded

Number of 

Days COC 

Exceeded

Release 

days/year

Loading 

(kg/site/day)

Waste 

Water

Treatment 

(%)

High/Avg

Analysis

1.00 68 250 250.00 101.70 90.00 High
144

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:8 Number of Release Sites: 6. 

Release Activity: PROC 2: Max LADD

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 1.53E+05 1.51E+05 1.51E+05 1800.00

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 1.00 1.00/0.00 1.00 1.00

Per Site Release: 2.55E+04 2.52E+04/0.00 2.52E+04 300.00

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 
145

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 8 Number of Sites: 6 RELEASE 

ACTIVITY:PROC 2: Max 

LADD

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

SIC-CODE (S): Subset of 4952 EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 1. 25500. 2550.00 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 288.00 123.84 78.18 66.05 N/A N/A N/A N/A

ALL 10 39.60 13.29 7.76 7.57 N/A N/A N/A N/A

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 1.33E-04 9.70E-04 mg/kg/day 6.97E-04 5.07E-03 mg/kg/day

LADCpot 1.03E-02 7.46E-02 mg/L 7.43 54.04 mg/kg

Acute

ADRpot N/A N/A mg/kg/day N/A N/A mg/kg/day
146

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 8 ACTIVITY: PROC 2: Max LADD

RELEASE DESCRIPTION: 

EXPOSED POPULATION: Adult

NUMBE

R OF

SITES

NON-SLUDGE 

LANDFILL 

RELEASE AND 

DAYS OF 

RELEASE

(kg/site/day)/(da

ys)

LANDFILLED 

SLUDGE1

AND DAYS OF 

RELEASE

(kg/site/day)/(day

s)

MIGRATION 

DESCRIPTO

R

2

ADSORPTIO

N TO 

WASTEWAT

ER SLUDGE

(%)

DRINKING 

WATER 

TREATMEN

T

(%)

6. 2.52E+04/1.00 0.00/0.00 Slow 0.00 0.00

 1 Landfilled sludge equals the fraction adsorbed to wastewater treatment sludge times the 

surface 

 water pre-treatment release.

 2 Migration Descriptor Log Koc

Groundwater Concentration (GWC)

(mg/L per kg release)

Negligible no migration None

Negligible to slow > 4.5 

3.21E-6 

Slow <4.5 to 

3.5 2.67E-5 

Moderate <3.5 to 2.5 5.95E5 

Rapid <2.5 

7.55E-5 

 Exposure Units Results

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

IR

(L/day)

Cancer

LADDpot (mg/kg/day) 3.70E-03 33.00 78.00 80.00 1.04

LADCpot (mg/L) 0.28 33.00 78.00 NA NA
147

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 8 RELEASE ACTIVITY:PROC 2: Max LADD

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites: 6. 

Per Site Fugitive Release: 300.00 kg/site/day

Fugitive Release Days per Year: 1.00 days

% Removal via Fugitive Release: 0.00 %

Total Fugitive Release: 1800.00 kg/yr

Max Annual Average Air Concentration 

(Fugitive):

8.98 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive):

N/A μg/m3

Per Site Stack Release: 2.52E+04 kg/site/day

Stack Release Days per Year: 1.00 days

% Removal via Stack Release: 0.00 %

Total Stack Release: 1.51E+05 kg/yr

Max Annual Average Air Concentration 

(Stack):

93.00 μg/m3

Max 24 Hour Average Air 

Concentration (Stack):

N/A μg/m3
148

Exposure Units

Results

(Stack)

Results

(Fugitive)

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

Inh. Rate 

(m3/hr)

Cancer

LADDpot (mg/kg/day) 7.20E-03 6.95E-04 33.00 78.00 80.00 0.61

LADCpot (mg/m3) 3.93E-02 3.80E-03 33.00 78.00 NA NA

Acute

ADRpot (mg/kg/day) N/A N/A NA 1 day 80.00 0.61

Inhalation Comments: 

 Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: 3.00 m

Inside Stack 

Diameter:

0.10 m Length of Release 

Opening:

10.00 m

Stack Gas Exit 

Velocity:

0.10 m/sec Width of Release 

Opening:

10.00 m

Stack Gas 

Temperature:

293.00 K

Meteorological and Terrain Information:

Surrounding Land Use: Rural

Terrain Height: 0.00 m

Distance to Residence of 

Interest: 100.00 m

Meteorological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m

Facility Width: NA m

Facility Height: NA m
149

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:9 Number of Release Sites: 3101. 

Release Activity: USE 1: Max ADR

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 5.44E+05 0.00 4.88E+05 3.60E+05

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 18.00 0.00/0.00 18.00 247.00

Per Site Release: 9.74 0.00/0.00 8.74 0.47

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 
150

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 9 Number of Sites: 3101 RELEASE 

ACTIVITY:USE 1: Max 

ADR

SIC-CODE DESCRIPTION: Metal Finishing

SIC-CODE (S): 34xx - 39xx EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 18. 9.74 0.97 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 300.46 107.45 67.50 55.59 3.24 9.06 14.43 17.52

ALL 10 23.74 4.69 2.64 2.27 41.03 207.68 368.94 429.07

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 8.79E-07 1.11E-05 mg/kg/day 4.59E-06 5.81E-05 mg/kg/day

LADCpot 6.76E-05 8.56E-04 mg/L 4.90E-02 0.62 mg/kg

Acute

ADRpot 3.43E-04 7.87E-03 mg/kg/day 8.19E-03 0.10 mg/kg/day
151
152

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 9 RELEASE ACTIVITY:USE 1: Max ADR

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites: 3101. 

Per Site Fugitive Release: 0.47 kg/site/day

Fugitive Release Days per Year: 247.00 days

% Removal via Fugitive Release: 0.00 %

Total Fugitive Release: 3.60E+05 kg/yr

Max Annual Average Air Concentration 

(Fugitive):

3.48 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive):

64.20 μg/m3

Per Site Stack Release: 8.74 kg/site/day

Stack Release Days per Year: 18.00 days

% Removal via Stack Release: 0.00 %

Total Stack Release: 4.88E+05 kg/yr

Max Annual Average Air Concentration 

(Stack):

0.58 μg/m3

Max 24 Hour Average Air 

Concentration (Stack):

58.90 μg/m3
153

Exposure Units

Results

(Stack)

Results

(Fugitive)

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

Inh. Rate 

(m3/hr)

Cancer

LADDpot (mg/kg/day) 4.50E-05 2.69E-04 33.00 78.00 80.00 0.61

LADCpot (mg/m3) 2.46E-04 1.47E-03 33.00 78.00 NA NA

Acute

ADRpot (mg/kg/day) 1.08E-02 1.17E-02 NA 1 day 80.00 0.61

Inhalation Comments: 

 Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: 3.00 m

Inside Stack 

Diameter:

0.10 m Length of Release 

Opening:

10.00 m

Stack Gas Exit 

Velocity:

0.10 m/sec Width of Release 

Opening:

10.00 m

Stack Gas 

Temperature:

293.00 K

Meteorological and Terrain Information:

Surrounding Land Use: Rural

Terrain Height: 0.00 m

Distance to Residence of 

Interest: 100.00 m

Meteorological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m

Facility Width: NA m

Facility Height: NA m
154

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:10 Number of Release Sites: 3101. 

Release Activity: USE 1: PDM1

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 6.74E+06 0.00 0.00 0.00

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 247.00 0.00/0.00 0.00 0.00

Per Site Release: 8.80 0.00/0.00 0.00 0.00

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 
155

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 10 Number of Sites: 3101 RELEASE 

ACTIVITY:USE 1: PDM1

SIC-CODE DESCRIPTION: Metal Finishing

SIC-CODE (S): 34xx - 39xx EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 247. 8.8 0.88 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 300.46 107.45 67.50 55.59 2.93 8.19 13.04 15.83

ALL 10 23.74 4.69 2.64 2.27 37.07 187.63 333.33 387.67

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 1.09E-05 1.38E-04 mg/kg/day 5.69E-05 7.20E-04 mg/kg/day

LADCpot 8.39E-04 1.06E-02 mg/L 0.61 7.68 mg/kg

Acute

ADRpot 3.10E-04 7.11E-03 mg/kg/day 7.40E-03 9.36E-02 mg/kg/day
156

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 10 RELEASE ACTIVITY: USE 1: PDM1

SIC CODE DESCRIPTION: Metal Finishing

ASSOCIATED SIC CODES: 34xx - 39xx

SIC CODE RESULTS

COC 

(μg/L)

Percent of 

Year COC 

Exceeded

Number of 

Days COC 

Exceeded

Release 

days/year

Loading 

(kg/site/day)

Waste 

Water

Treatment 

(%)

High/Avg

Analysis

1.00 67 245 247.00 8.80 90.00 High
157

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:11 Number of Release Sites: 3101. 

Release Activity: USE 1: Max LADD

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 6.79E+06 6.03E+06 6.03E+06 3.60E+05

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 1.00 1.00/0.00 1.00 1.00

Per Site Release: 2190.52 1943.52/0.00 1943.52 116.09

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 
158

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 11 Number of Sites: 3101 RELEASE 

ACTIVITY:USE 1: Max 

LADD

SIC-CODE DESCRIPTION: Metal Finishing

SIC-CODE (S): 34xx - 39xx EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 1. 2190.52 219.05 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 300.46 107.45 67.50 55.59 N/A N/A N/A N/A

ALL 10 23.74 4.69 2.64 2.27 N/A N/A N/A N/A

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 1.10E-05 1.39E-04 mg/kg/day 5.74E-05 7.26E-04 mg/kg/day

LADCpot 8.45E-04 1.07E-02 mg/L 0.61 7.74 mg/kg

Acute

ADRpot N/A N/A mg/kg/day N/A N/A mg/kg/day
159
160

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 11 ACTIVITY: USE 1: Max LADD

RELEASE DESCRIPTION: 

EXPOSED POPULATION: Adult

NUMBE

R OF

SITES

NON-SLUDGE 

LANDFILL 

RELEASE AND 

DAYS OF 

RELEASE

(kg/site/day)/(da

ys)

LANDFILLED 

SLUDGE1

AND DAYS OF 

RELEASE

(kg/site/day)/(day

s)

MIGRATION 

DESCRIPTO

R

2

ADSORPTIO

N TO 

WASTEWAT

ER SLUDGE

(%)

DRINKING 

WATER 

TREATMEN

T

(%)

3101. 1943.52/1.00 0.00/0.00 Slow 0.00 0.00

 1 Landfilled sludge equals the fraction adsorbed to wastewater treatment sludge times the 

surface water pre-treatment release.

 2 Migration Descriptor Log Koc

Groundwater Concentration (GWC)

(mg/L per kg release)

Negligible no migration None

Negligible to slow > 4.5 

3.21E-6 

Slow <4.5 to 

3.5 2.67E-5 

Moderate <3.5 to 2.5 5.95E5 

Rapid <2.5 

7.55E-5 

 Exposure Units Results

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

IR

(L/day)

Cancer

LADDpot (mg/kg/day) 2.85E-04 33.00 78.00 80.00 1.04

LADCpot (mg/L) 2.20E-02 33.00 78.00 NA NA
161

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 11 RELEASE ACTIVITY:USE 1: Max LADD

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites: 3101. 

Per Site Fugitive Release: 116.09 kg/site/day

Fugitive Release Days per Year: 1.00 days

% Removal via Fugitive Release: 0.00 %

Total Fugitive Release: 3.60E+05 kg/yr

Max Annual Average Air Concentration 

(Fugitive):

3.48 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive):

N/A μg/m3

Per Site Stack Release: 1943.52 kg/site/day

Stack Release Days per Year: 1.00 days

% Removal via Stack Release: 0.00 %

Total Stack Release: 6.03E+06 kg/yr

Max Annual Average Air Concentration 

(Stack):

7.17 μg/m3

Max 24 Hour Average Air 

Concentration (Stack):

N/A μg/m3
162

Exposure Units

Results

(Stack)

Results

(Fugitive)

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

Inh. Rate 

(m3/hr)

Cancer

LADDpot (mg/kg/day) 5.55E-04 2.69E-04 33.00 78.00 80.00 0.61

LADCpot (mg/m3) 3.03E-03 1.47E-03 33.00 78.00 NA NA

Acute

ADRpot (mg/kg/day) N/A N/A NA 1 day 80.00 0.61

Inhalation Comments: 

 Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: 3.00 m

Inside Stack 

Diameter:

0.10 m Length of Release 

Opening:

10.00 m

Stack Gas Exit 

Velocity:

0.10 m/sec Width of Release 

Opening:

10.00 m

Stack Gas 

Temperature:

293.00 K

Meteorological and Terrain Information:

Surrounding Land Use: Rural

Terrain Height: 0.00 m

Distance to Residence of 

Interest: 100.00 m

Meteorological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m

Facility Width: NA m

Facility Height: NA m
163

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:12 Number of Release Sites: 16. 

Release Activity: USE 2: Max ADR

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 1.11E+04 0.00 4.22E+05 9600.00

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 250.00 0.00/0.00 250.00 250.00

Per Site Release: 2.78 0.00/0.00 105.38 2.40

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 
164

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 12 Number of Sites: 16 RELEASE 

ACTIVITY:USE 2: Max 

ADR

SIC-CODE DESCRIPTION: Rubber Products Manufacture

SIC-CODE (S): 3011,3021,3031,3041 EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 250. 2.78 0.28 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 255.71 132.96 84.15 69.21 1.09 2.09 3.30 4.02

ALL 10 21.78 4.48 2.52 2.35 12.76 62.05 110.32 118.30

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 4.10E-06 4.81E-05 mg/kg/day 2.14E-05 2.51E-04 mg/kg/day

LADCpot 3.15E-04 3.70E-03 mg/L 0.23 2.68 mg/kg

Acute

ADRpot 7.92E-05 2.35E-03 mg/kg/day 2.75E-03 3.22E-02 mg/kg/day
165
166

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 12 RELEASE ACTIVITY:USE 2: Max ADR

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites: 16. 

Per Site Fugitive Release: 2.40 kg/site/day

Fugitive Release Days per Year: 250.00 days

% Removal via Fugitive Release: 0.00 %

Total Fugitive Release: 9600.00 kg/yr

Max Annual Average Air Concentration 

(Fugitive):

18.00 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive):

330.00 μg/m3

Per Site Stack Release: 105.38 kg/site/day

Stack Release Days per Year: 250.00 days

% Removal via Stack Release: 0.00 %

Total Stack Release: 4.22E+05 kg/yr

Max Annual Average Air Concentration 

(Stack):

97.20 μg/m3

Max 24 Hour Average Air 

Concentration (Stack):

710.00 μg/m3
167

Exposure Units

Results

(Stack)

Results

(Fugitive)

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

Inh. Rate 

(m3/hr)

Cancer

LADDpot (mg/kg/day) 7.53E-03 1.39E-03 33.00 78.00 80.00 0.61

LADCpot (mg/m3) 4.11E-02 7.62E-03 33.00 78.00 NA NA

Acute

ADRpot (mg/kg/day) 0.13 6.04E-02 NA 1 day 80.00 0.61

Inhalation Comments: 

 Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: 3.00 m

Inside Stack 

Diameter:

0.10 m Length of Release 

Opening:

10.00 m

Stack Gas Exit 

Velocity:

0.10 m/sec Width of Release 

Opening:

10.00 m

Stack Gas 

Temperature:

293.00 K

Meteorological and Terrain Information:

Surrounding Land Use: Rural

Terrain Height: 0.00 m

Distance to Residence of 

Interest: 100.00 m

Meteorological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m

Facility Width: NA m

Facility Height: NA m
168

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:13 Number of Release Sites: 16. 

Release Activity: USE 2: PDM1

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 1.11E+04 0.00 0.00 0.00

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 250.00 0.00/0.00 0.00 0.00

Per Site Release: 2.78 0.00/0.00 0.00 0.00

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 
169

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 13 Number of Sites: 16 RELEASE 

ACTIVITY:USE 2: PDM1

SIC-CODE DESCRIPTION: Rubber Products Manufacture

SIC-CODE (S): 3011,3021,3031,3041 EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 250. 2.78 0.28 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 255.71 132.96 84.15 69.21 1.09 2.09 3.30 4.02

ALL 10 21.78 4.48 2.52 2.35 12.76 62.05 110.32 118.30

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 4.10E-06 4.81E-05 mg/kg/day 2.14E-05 2.51E-04 mg/kg/day

LADCpot 3.15E-04 3.70E-03 mg/L 0.23 2.68 mg/kg

Acute

ADRpot 7.92E-05 2.35E-03 mg/kg/day 2.75E-03 3.22E-02 mg/kg/day
170

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 13 RELEASE ACTIVITY: USE 2: PDM1

SIC CODE DESCRIPTION: Rubber Products Manufacture

ASSOCIATED SIC CODES: 3011,3021,3031,3041

SIC CODE RESULTS

COC 

(μg/L)

Percent of 

Year COC 

Exceeded

Number of 

Days COC 

Exceeded

Release 

days/year

Loading 

(kg/site/day)

Waste 

Water

Treatment 

(%)

High/Avg

Analysis

1.00 65 238 250.00 2.78 90.00 High
171

 INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683 Assessor: 

ENVIRONMENTAL RELEASES

Scenario#:14 Number of Release Sites: 16. 

Release Activity: USE 2: Max LADD

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases: 1.11E+04 4.21E+05 4.21E+05 9600.00

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: 1.00 1.00/0.00 1.00 1.00

Per Site Release: 695.00 2.63E+04/0.00 2.63E+04 600.00

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 
172

INITIAL REVIEW EXPOSURE REPORT

 Chemical ID: P-14-0683

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER 

RELEASES

SCENARIO #: 14 Number of Sites: 16 RELEASE 

ACTIVITY:USE 2: Max 

LADD

SIC-CODE DESCRIPTION: Rubber Products Manufacture

SIC-CODE (S): 3011,3021,3031,3041 EXPOSED POPULATION: 

Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

90.00 1. 695. 69.50 0.00 724.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 255.71 132.96 84.15 69.21 N/A N/A N/A N/A

ALL 10 21.78 4.48 2.52 2.35 N/A N/A N/A N/A

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water 

Results

Drinking 

Water 

Units

Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 4.10E-06 4.81E-05 mg/kg/day 2.14E-05 2.51E-04 mg/kg/day

LADCpot 3.15E-04 3.70E-03 mg/L 0.23 2.68 mg/kg

Acute

ADRpot N/A N/A mg/kg/day N/A N/A mg/kg/day
173
174

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 14 ACTIVITY: USE 2: Max LADD

RELEASE DESCRIPTION: 

EXPOSED POPULATION: Adult

NUMBE

R OF

SITES

NON-SLUDGE 

LANDFILL 

RELEASE AND 

DAYS OF 

RELEASE

(kg/site/day)/(day

s)

LANDFILLED 

SLUDGE1

AND DAYS OF 

RELEASE

(kg/site/day)/(day

s)

MIGRATION 

DESCRIPTO

R

2

ADSORPTION 

TO 

WASTEWATE

R SLUDGE

(%)

DRINKING 

WATER 

TREATMEN

T

(%)

16. 2.63E+04/1.00 0.00/0.00 Slow 0.00 0.00

 1 Landfilled sludge equals the fraction adsorbed to wastewater treatment sludge times the 

surface 

 water pre-treatment release.

 2 Migration Descriptor Log Koc

Groundwater Concentration (GWC)

(mg/L per kg release)

Negligible no migration None

Negligible to slow > 4.5 

3.21E-6 

Slow <4.5 to 

3.5 2.67E-5 

Moderate <3.5 to 2.5 5.95E-5 

Rapid <2.5 

7.55E-5 

 Exposure Units Results

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

IR

(L/day)

Cancer

LADDpot (mg/kg/day) 3.86E-03 33.00 78.00 80.00 1.04

LADCpot (mg/L) 0.30 33.00 78.00 NA NA
175

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 14 RELEASE ACTIVITY:USE 2: Max LADD

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites: 16. 

Per Site Fugitive Release: 600.00 kg/site/day

Fugitive Release Days per Year: 1.00 days

% Removal via Fugitive Release: 0.00 %

Total Fugitive Release: 9600.00 kg/yr

Max Annual Average Air Concentration 

(Fugitive):

18.00 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive):

N/A μg/m3

Per Site Stack Release: 2.63E+04 kg/site/day

Stack Release Days per Year: 1.00 days

% Removal via Stack Release: 0.00 %

Total Stack Release: 4.21E+05 kg/yr

Max Annual Average Air Concentration 

(Stack):

97.00 μg/m3

Max 24 Hour Average Air Concentration 

(Stack):

N/A μg/m3
176

Exposure Units

Results

(Stack)

Results

(Fugitive)

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

Inh. Rate 

(m3/hr)

Cancer

LADDpot (mg/kg/day) 7.51E-03 1.39E-03 33.00 78.00 80.00 0.61

LADCpot (mg/m3) 4.10E-02 7.62E-03 33.00 78.00 NA NA

Acute

ADRpot (mg/kg/day) N/A N/A NA 1 day 80.00 0.61

Inhalation Comments: 

 Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: 3.00 m

Inside Stack 

Diameter:

0.10 m Length of Release 

Opening:

10.00 m

Stack Gas Exit 

Velocity:

0.10 m/sec Width of Release 

Opening:

10.00 m

Stack Gas 

Temperature:

293.00 K

Meteorological and Terrain Information:

Surrounding Land Use: Rural

Terrain Height: 0.00 m

Distance to Residence of 

Interest: 100.00 m

Meteorological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m

Facility Width: NA m

Facility Height: NA m
177

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-14-0683

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 14 RELEASE ACTIVITY:USE 2: Max LADD

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites: 16. 

Per Site Fugitive Release: 600.00 kg/site/day

Fugitive Release Days per Year: 1.00 days

% Removal via Fugitive Release: 0.00 %

Total Fugitive Release: 9600.00 kg/yr

Max Annual Average Air Concentration 

(Fugitive):

18.00 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive):

N/A μg/m3

Per Site Stack Release: 2.63E+04 kg/site/day

Stack Release Days per Year: 1.00 days

% Removal via Stack Release: 0.00 %

Total Stack Release: 4.21E+05 kg/yr

Max Annual Average Air Concentration 

(Stack):

97.00 μg/m3

Max 24 Hour Average Air Concentration 

(Stack):

N/A μg/m3

ASSUMPTIONS
178

Exposure Units

Results

(Stack)

Results

(Fugitive)

ED

(years)

AT

(years)

BW

(kg)

Inh. Rate 

(m3/hr)

Cancer

LADDpot (mg/kg/day) 7.51E-03 1.39E-03 33.00 78.00 80.00 0.61

LADCpot (mg/m3) 4.10E-02 7.62E-03 33.00 78.00 NA NA

Acute

ADRpot (mg/kg/day) N/A N/A NA 1 day 80.00 0.61

Inhalation Comments: 

 Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: 3.00 m

Inside Stack 

Diameter:

0.10 m Length of Release 

Opening:

10.00 m

Stack Gas Exit 

Velocity:

0.10 m/sec Width of Release 

Opening:

10.00 m

Stack Gas 

Temperature:

293.00 K

Meteorological and Terrain Information:

Surrounding Land Use: Rural

Terrain Height: 0.00 m

Distance to Residence of 

Interest: 100.00 m

Meteorological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m

Facility Width: NA m

Facility Height: NA m