# TSCA N EW 

# C HEMICALS 

# R EVIEW 

# P ROGRAM



# S TANDARD 

# R EVIEW 

# R ISK 

# A SSESSMENT ON



# M EDIUM



# - C HAIN 

# C HLORINATED 

# P ARAFFINS 

# (PMN P

- 1 4

- 0 683 , P

- 1 4

- 0 684 )

This assessment was conducted under EPA’s TSCA Se ction 5 New Chemicals
Review Program. EPA is assessing Me dium

- C hain Chlorinated Paraffin (MCCP) and Long

- Chain Chlorinated Paraffin (LCCP) chemicals as pa rt of its New Chemicals P rogram. As with all Premanufacture Notice (PMN) submissions, EPA followed the approaches, methods and statutory provisions of TSCA sec tion 5 for the chlorinated paraffin PMNs assessments. United States Environmental Protection Agency Premanufacture Notifica tion
Number: P

- 1 4

- 0 683

- 0 684 Office of Chemical Safety and Pollution Prevention2 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 environmenta l concentrations, the PMN substances ma y 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 subs tances: i. A re expected to partition to sediment and may partition to soil through land application of biosolids and

, ii. M ay be released to the environment at levels at or above estimated concentrations of MCCP congener groups that may present an unreasonable ri sk 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 OV ERVIEW

................................ ................................ .......... 10

4 HUMAN HEAL TH 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 R ISK ASSESSMENT

................................ ................................ ................................ .......... 20

6.1 E NVIRONMENTAL A SSESSMENT

................................ ................................ ................................ .................. 20 6.1.1 Risk Estimates Using Environmental Monitoring Data

................................ ................................ ......... 21 6.1.2 Risk Estimates Using Modeled Exposures

................................ ................................ .............................. 22 6.2 H UMAN H EALTH

................................ ................................ ................................ ................................ ......... 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

................................ ................................ ................................ ................ 564

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 Aqua tic 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 Conclu sions

................................ ................................ ................................ ................................ .......... 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

................................ .......................... 1115



## 1 INTRODUCTION

1.1 PMN S RECEIVED
Qualice submitted two Premanufacture Notices (PMNs) identified by EPA/OP PT as medium

chain chlorinated paraffins (MCCPs : P

- 14

- 0683 and P

- 14

- 0684 ) of varying chain lengths with the formula C x H (2x

- y+2) Cl y and x equaling 14 to 17 and y equaling 6 to > 24. Table 1 lists basic inform ation Qualice supplied on the se 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
K ow Water

S olubility

P

- 14

- 0683 Tetradecane,

chloro 2,500,000/15,000,000 50% flame retardant in rubber product s and 50% additive in lubricant s 4.70 (E) < 0.03 mg/L (E)

P

- 14

- 0684 Alkanes, C 14

- 16 ,

chloro 2,500,000/15,000,000 50% flame retardant in rubber products and 50% additive in lubricant s 4.70 (E) < 0.03 mg/L (E)

E = Estimated

Although the specific PMNs in this application are MC CPs, 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 t he CPs and the relationship among the m needs to be kept in mind.



### 1.2 CHEMISTRY

Shown below are the structu res and chlorine content of P

- 14

- 0683 and P

- 14

- 0684. Note that P

14

- 0683 is 98% C 14 and P

- 14

- 0684 is approximately 58% C 14 , the remainder of the latter b eing 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 UVCB 1 compounds for TSCA Inventory purposes) of polychlorinated n

- alkanes . The carbon chain length usually varies between 10 and 30 carbon atoms and the degree of chlor ination can vary between 3 0 and 7 5

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

1. Short chain CPs (SCCPs, C 10

- 13 )

2. Medium chain CPs (MCCPs, C 14

- 17 ) 3. Long chain CPs (LCCPs, C 1 8

- 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 w t % 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 at oms on the carbon chain). The individual isomer content of commercial CPs is rarely identified because the number of possible individual congener group s is extremely large. Consequently , the physicochemical properties of CPs vary by carbon chain length and chlorine content. I ncreased molecular weight correlates to higher melting and boiling points, lower vapor pressures and water solubilit ies

, and greater Log K ow (l ogarithm of o ctanol: w ater p artition coefficient ). The MCCP products considered for this analy sis are liquids with chlorination levels between 40 to 60 percent. T he physicochemical properties of interest in this risk assessment include: physical form, water solubility, vapor pressure, and log K OW ( see Table 2 ).

Table 2: Physiochemical Infor mation a ,b

wt% Cl Melting

Point Boiling Point Vapor Pressure Water Solubility Log K OW

MCCPs > 40 < 25 °C

(pour point) > 200 °C (dec) < 0.036 Pa at 20 °C 27 μg/L

at 20 °C > 5.5

(measured) 8.30 (estimated) c , d

a Source: EURAR of MCCP (ECB, 2008)

b Because most CP produ cts 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.

c Value calculated using the KOWWIN Program (v1.68) available in EPA/OPPT ’s Estimatio n Programs Interface (EPI) Suite TM . This estimate was generated using a representative MCCP ( i.e. , C 14 H 24 Cl 6 , 52 wt % Cl) with the following SMILES notation: CCC(Cl)CC(Cl)CCCl)CC(Cl)CC(Cl)CC(Cl)C.

d The EURAR (ECB, 2008) cited Renberg’s liquid chromatogra phy to measure a log K OW between 5.5 and 8.2 and then chose to use log K OW = 7 as a representative log K OW 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 groups 2 that may be present in CP pro ducts. The existence of multiple chain lengths in the UVCBs such as P

1 4

- 0 68 3 and P

- 1 4

- 0 684 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 C 14 chain

- length congener groups and the C 15 chain

- length congener groups comprised the majority of the remaining

 40 wt%. The authors found < 15 wt% C 16 chain

- l ength congener groups present in most commercial MCCP samples and little to no C 17 chain

- length congener groups. Additional studies have reported that the C 14 and C 15 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 C 14 and C 15 chain

- length congener groups may not be t he predominant congener groups in a specific MCCP product; however, even in these products, the C 14 and C 15 chain

- length congener groups may serve as reasonable worse case surrogates for the C 1 6

- 17 chain

- length congener groups, due to their greater bioavai lability 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 (C 14

– C 17 ) 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 end points 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 haz ard 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 the se 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 t hat 50% of both P

- 14

- 0683 and P

- 14

- 0684 would be used in metal working fluid (MW F ) lubricants as a heat and pressure s tabilizer. The remaining 50% will be used as a flame re tardant for rubber compounding. Chlorination rates for these MCCP are more constant for the r ubber formulating applications ( only using 52

– 53% Cl CP ) , while the amount of chlorine by w eight 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 pro ducts

.

2 For this report, congener groups is used to recognize the existence of different chain lengths and d egrees of chlorination that could be present in any given CP product.8

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

PMN Trade Names Percent Chlorination Percent PMN in final
Product
P

- 14

- 0683 CPAR MCCO 40

- 60 15 % in lu bricating oils and 10% in final rubber product P

- 14

- 0684 CPAR MCCP



## 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 tra nsport (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 sh own 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 o rder rate

constant with atmospheric hydroxyl radicals for MCCPs ( 40 and 56 wt % Cl)

. The p ersistence of MCCPs increase s 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 group s. Longer and higher chlorinated chemicals also may be degra ded, 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 wi th 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 group s 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 group s are l ikely 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 s tudies 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 a ssessment (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 associa ted 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 medium

chain chlorinated paraffins. From the available information, medium

- chain chlorinated paraffins can be considered to be not biodegradable in such test systems and so a bio degradation 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 wit h hydroxyl radicals. A value for the rate co nstant for the reaction (k OH

) of 8 x 10

- 12 cm 3 molecule

- 1 s - 1 is used for the environmental mod elling in the risk assessment.”

EPA/OPPT generally concurs with these characterizations . In the absence of information on specific co ngener groups and data for MCCP products

, EPA/OPPT concludes that at least some
congener group s present in MCCP products are persistent to very persistent; with estimated half

lives 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 group s are bioaccumulative or very bioaccumulative (EC, 2008a; ECB, 2005; Houde et al., 20 08; 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 wi th 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 highl y 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 grou p s 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 group s in MCCP product s may be b ioaccumulative 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 gener ally concurs with these characterizations . I n the absence of information on specific congener group s and data for MCCP product s, EPA/OPPT concludes that at least some

congener group s present in MCCP product s are bioaccumulative to very bioaccumulative base d on multiple lin es of evidence, including: Log K ow values , modeled BCF s , laboratory

- mea sured BCFs, field

- measured BAFs, field

- measured BMFs, laboratory

- measured biota

- sediment bioaccumulation factor s ( BSAFs ) and the presence of MCCPs in human and wildlife biota.



## 3 ECO LOGICAL 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. E cotoxicity studies for MCCP s 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 (C 10

- 12 , 58 wt % Cl) with similar physic ochemical properties to MCCPs and was used for informing EPA/OPPT ’s hazard evaluation (E CB

, 2000). EPA/OPPT concludes that the studies summarized in Table 4 were the highest quality for assessing potential h azards in the aquatic, sediment and terrestrial

c ompartments.11

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

Test Substance Test

Organism (Species) Test Guideline; Study type End

point Value 1 Reference

Aquatic Invertebrates
Cereclor S

- 52 (52%

wt

. Cl, C 14

- 17 ) Water flea

( Daphnia

magna ) OECD 202, 1984; Acute

immobilization test EC 50 0.0059 CPA (1996)

Cereclor S

- 52 (52%

wt. Cl, C 14

- 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, C 14

- 17 ) Amphipod

( Hyalella

azteca ) OECD 218

- Draft, 2001;

28

- day prolonged sediment toxicity study NOEC
L OEC MATC 130

270 187 Thompson et

al. (2002)

Terrestrial Invertebrates
Cereclor S

- 52 (52 %

wt

. Cl, C 14

- 17 ) Earthworm

( Eis enia fetida ) OECD Guideline

- Draft,

2000; 28

- day reproductive toxicity test NOEC LOEC MATC 79

280 149 Thompson et

al. (2001d)

Terrestr ial Vertebrates
Commercial CP ( 58 % wt. Cl, C 10

- 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 factor s of five or ten for acute or chronic exposures, respectively, which account for laboratory variability and represent s species sensitivity distributions (fol lowing US EPA, 2012). The COCs derived for aquatic

- , sediment

- , and terrestrial

- dwelling organisms a re 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 C O C: The 48

- hour EC 50 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 C OC = 1 ppb

.

 Chronic C O C: T he chronic value 0.013 mg/L is divided by a n assessment factor of 10 to yield 0.0013 mg/L or 1.3 μg/L or 1.3 ppb. Aquatic CO C = 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. ( 2 00 2 ) 28

- d study. T he 28

- d sediment invertebrate GMATC value of 187 m g/kg dry wt sediment is used to assess hazard

. U sing methods in US EPA (2012):12

 Acute C O C: T he ch ronic 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 : T he 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 sedim ent. Aquatic Sediment COC = 18.7 mg/kg dry wt sediment.

The most reliable and acceptable valu e for acute toxicity to terrestrial invertebrates is based on the MCCP material from the Th ompson et al. ( 2001 a ) study . The 28

- d terrestrial invertebrate GMATC va lue of 149 mg/kg dry wt soil from this study will be used. U sing m ethods in US EPA (2012):

 Acute COC : To c alculat e an acute concern concentration from the ch ronic value the value 149 m g/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 C OC : T he 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 = 1 4.9 mg/kg dry wt

.

The most reliable and acceptable valu e for acute toxicity to te rrestrial vertebrates is based on the MCCP material from the ECB ( 2001 ) study . The 2 2

- week terrestrial vertebrate NOEC va lue of 168 mg/kg dry wt soil from this study will be used. Using methods in US EPA (2012):

 Acute COC : To calculate an acute concern co ncentration from the ch ronic value the value 1 68 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 ass essment factor of 5 to yield 336 mg/kg diet

. Terrestrial V ertebrat e Acute COC = 336 mg/kg die t.

 Chronic COC : T he 22

- week terrestrial vertebrate NOEC of 168 mg/kg die t is divided by an assessment factor of 10 to yield 16.8 mg/kg d ie t

. Terrestrial V ertebrate Chronic COC = 1 6.8 mg/kg die t.13

Table 5 : COC s for E nvi ronme ntal T oxicity of MCCPs

Compartment Test organism Endpoint Value Assessment factor COC

Surface water Water flea EC 50 0.0059 mg/L 5 0.001 mg/L

21

- day MATC 0. 0 13 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 OVERVIE W
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 R EVIEW 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

expos ure i s 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 follo wing oral

e xposure 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 informatio n 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 rab bits have shown that MCCPs caused slight skin irritation and hav e low eye irritation potential. No evidence of skin sensitization was fou nd 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 histopathologica l 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 toxico logical 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 paren t compound or from metab olites. 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. Howe ver, it may be concluded based on an14

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 studi es on a SCCP and a v LCCP are available. These studies, along with the genotoxicity data on MCCPs, may be used to inform the ca rcinogenic potential of MCCPs. When administered by gavage, a SCCP (C 12 , 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 v LCCP (C 23 , 43 wt% Cl) in male and female rats and mice. However, malignant lymphoma is one of the more variable tumors in mice and ha s a viral origin in many cases. No increased incidence of malignant lymphoma was observed in the ca rcinogenicity study on an SCCP. Fu rther, MCCPs

are non

- genotoxic. Therefore, it may be concluded that MCCPs are unlikely to pose a carcinogenic ha zard 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 co nducted 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 a nd 100 mg/kg

bw/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 MCCP s 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 approximatel y 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 stud ies 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) MCCP s during cohabitation, gestation, and lactation, signs of hemorrhaging were observed in dams that died at the time of parturiti on

. T aken 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 ora l 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 t o low levels of vitamin K and related hemorrhaging,15

suggesting that the act of parturiti on 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
defic iencies in vitamin K levels and related clotting factors in the p ups results in hemorrhaging.

No guideline developmental neurotoxicity studies on MCCPs were located. It is not clear if any developmental neurot oxicity endpoints were measured in the availab le prenatal developmental/reproductive toxicity studie s; 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 diff erences were reported in F 1 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 perina tal 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) risk s of MCCPs

.



## 5 EXPOSURE INFORMATION

EPA/OPP T 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

- 0 6 83 and P

- 14

- 0 6 84. Environmental releases from these activities were al so 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 no rmally 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 dat a 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 dat a used in this risk assessment.

Studies published between 1980 and 2013 that reported environmental concentrations of MCCP s and were reviewed for this assessment. Monitoring studies from the early 1980s could not distinguish between the different chain le ngths 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 chlorina tion 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 stand ards (Coelhan et al., 2000) . A more recent inter

- laboratory study of SCCPs16

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 concentration s, 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 ot her 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 studie s 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 o f 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 sample d, 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 t echniques 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 incl uded 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 asses sment . W hen a limit of detection (LOD) value was reported for non

- detectable results 4

, 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 rang e of US MCCP use scenarios, EPA/OPPT conc luded that the data in Tables 6 represented the best available monitoring information for MCCPs . These data provide some evidence that M CCPs 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 un known.

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

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

Media n Minimum Unit Maximum Unit References

Surface

water (non

- marine) 15 <2.50×10

- 10 mg/L 1. 4 9×10

- 3 mg/L Coelhan (2010); EC (2008); Houde et al. (2008); IPCS (1996); Muir et al. (2003); USEPA (1988) Petersen et al., 2006 a

Sediment (non

- marine) 78 2.00×10

- 3 mg/kg b 6.51×10 1 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 1.64×10 1 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/kg b 9.70×10 3 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); Kemmle in 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)

a Petersen et al. (2006) reported results for two water samples; EPA/OPPT assumed these were non

- marine surface water samples.

b The 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 ind icates 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 R ELEASES

EPA/OPPT used screening

- level models to generate environmental release estimates for P

- 14

- 0683 and P

- 14

- 0684, which were use d to calculate exposure concentrations for estimating risks to humans and aquatic organisms. EPA/OPPT used the Chemical Sc reening 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, in cluding information provided by Dover

, published OECD Emission Scenario Documents, EPA/OPPT Generic Scenarios, and EPA/OPPT18

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

assessment.

Table 7: Summary of Es timated 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, C 14

- 16 , chloro

Exposure pathways of interest for human hea lth 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

owne d 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 probabilis tic dilution model (PDM), which predicts downstream chemical concentrations fro m 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 c ompared to the COC of 1 μg /L f or chronic aquatic in vertebrates (see Table 5)

. Air stack emissions were estimate d using generic scenarios, which assumed inhalation exposures occurring 100 meters downwind of a facility. EPA/OPPT used these est imated values f or calculating human health and environmental risk s 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 re present 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 expe cted to partition to particulates and sediment; however, the E

- FAST V2.0 models do not account for this partitioning.19

T able 8 : E

- FAST Modeling Value s used 1
Scenario 2 Water Release

- Human Air Release

- Human Water Release

–

Aquatic Organisms 3 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

- 5 6.22 x 10

- 5 1.69 x 10

- 3 one day/year
Proc 1

– Formulation of
MWFs 3 1.48 x 10

- 4 7.70 x 10

- 4 3.23 x 10

- 3 5.6

– 40 (206)

Proc2

– Compounding of rubber products 9.70 x 10

- 4 5.07 x 10

- 3 7.20 x 10

- 3 35

– 257 (1310)

Use1

– Use o f
MWFs 1.39 x 10

- 4 7.26 x 10

- 4 5.55 x 10

- 4 3

– 37 (333)

Use2

– Converting rubber products 4.81 x 10

- 5 2.51 x 10

- 4 7.50 x 10

- 3 1

– 13 (110)

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

ex posure 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). T he range s encompass concentrations from the central tendency for a medi an 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 thi s risk assessment for evaluating worker exposures to P

- 14

- 0683 and P

- 14

- 0684 ; d etailed information is provided in Appendix E

.20

Table 9: Summary of Occupational Exposure Estim ates Used 1 ,2

Rout e 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 Non

quantifiable 3

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:

 Manufac turing (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 mater ial. While some surface contact may occur, dermal exposure to solids in this form is non

- quantifiable.

5.3.2 C onsumer 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 p erform 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 enviro nmental 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 environmen tal 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 potenti al e nvironmental 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 co ncentration 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 1 0 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 magn itude 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 releas es 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 concentration s and risks that may result from the specific uses and releases associated with P

- 14

- 0683 and P

- 14

- 0684.

Table 1 0 : Risk Quotients Calculated from Environmental Monitoring D ata for Surface Water, Sediment and the Terrestrial Environment
Environmental Co ncentration Effect Level

( i.e. , COC) RQs 1

Acute Risk Aquatic Species < 2.50×10

- 10 to 1. 4 9×10

- 3 mg/L 0.001 mg/L < 2.50×10

- 7 to 1.49

Chronic Risk Aquatic Species < 2.50×10

- 10 to 1. 4 9×10

- 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 dw 2 Not calculated

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

. 2 The COC s 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 compa rtment

.

For surface water, EPA/OPPT based the aquat ic 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. , C 14

- 17 ). T he 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 ordinat e 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 (see22

Appendix D), the Petersen et al. (2006) value of 1.49 × 10

- 3 is the only surfa ce 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 wh ich 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 loc ations, 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 a bsence 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 locat ions 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 associate d RQs that EPA/OPPT used as the primary basis for evaluating the potential risks of P

14

- 0683 and 0684 is presented in the following section.

6.1.2 Risk Estimates Using Model ed Exposures The RQs shown in Table 11 suggest that the intended processes and uses f or 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 surfac e 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 s tream 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 fi nding 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. Bas ed 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.

T able 1 1 : Risk Assessment of Aquatic Org anisms Using Modeled Exposures 1
Scenario Estimated Water Concentrations ( μ g/L) 2 RQs

Median Stream Flow Scenario Low Stream

Flow Scenario 7Q10

Flow Scenario
Proc1

– Formulation of
MWFs 1 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

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

. Full model runs are available on request.

2 For 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 stud y , 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 (C 14

- 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 an d 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 c alculating 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 (UF H ; default value = 10), interspecies variability (UF A ; default value = 10), and LOAEL

- to

- NOAEL extrapolation uncertainty (UF L ; default value =10). The UF H and UF A 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 UF A to 1 ( i.e. , UF A = TK × T D = 1 × 3.16 ≈ 3).

EPA/OPPT interpreted MOEs that were equal to or below a benchmark value ( e.g. , MOE < 1000 [UF H × UF A × UF L = 1000]) as an indication that the scenario(s) may present an unreasonable risk of injury to human health, whereas the MOEs that were a bove 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/kg

bw/day ( i.e. , MCCP congener groups to an HED value for inhalation exposures to workers ( i .e. , HED INHAL

- WORKER ) using the following equation:

HED INHAL

- WORKER = NOAEL ORAL × (1 ÷ sRV RAT ) × (ABS ORAL

- RAT ÷ ABS INHAL

- HUMAN ) × (sRV HUMAN ÷ wRV)

where,

NOAEL ORAL = 23 mg/kg

- bw/day
sRV RAT = rat standard respiratory volume for 8

- hours = 0.38 m 3 /kg b w ABS ORAL

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

- HUMAN = percent absorpti on by inhalation in humans = 50 %
sRV HUMAN = human standard respiratory volume for 8

- hours = 6.7 m 3 wRV = worker respiratory volume for 8

- hours = 10 m 3

Usin g this algorithm, the oral NOAEL of 23 mg/kg

- bw was calculated to be an H ED INHAL

WORKER values of 41 mg/m 3

.

EPA/OPPT calculated the HED values for dermal exposures to workers ( i.e. , HED DERM

- WORKER ) based on the following equation:

HED DERM

- WORKER = NOAEL ORAL × (ABS ORAL

- RAT ÷ ABS DERMAL

- HUMAN ) × (BW RAT ÷ BW HUMAN ) 1/4

where,

NOAEL ORAL = 23 mg/kg

- bw/day ABS ORAL

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

- HUMAN = percent absorption by the dermal route in humans = 1%
BW RAT = rat bodyweigh t = 0.250 kg25

BW HUMAN = human bodyweight = 71.8 kg

The resulting HED DERM

- 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 M CCP congener groups, a benchmark value of 30 was applied. This value consisted of the following individual UFs. A default UF H of 10 was applied due to the absence of experimental data to inform the TK and TD subfactors of this UF. A reduced UF A of 3 was ap plied to account for a TK subfactor of 1 after converting the effect levels to HEDs (i.e., the use of allometric scaling) . The UF A 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 HED INHAL

- WORKER and HED DERM

- WORKER values for calculating the respective MOEs using the estimated exposure values presented in Table 9. As shown in Table
1 2, the MOEs for P

- 14

- 068 3 an d P

- 14

- 0 684 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. , HED ORAL

- GENPOP ) using the following equat ion:

HED ORAL

- GENPOP = NOAEL ORAL × (ABS ORAL

- RAT ÷ ABS ORAL

- HUMAN ) × (BW RAT ÷ BW HUMAN ) 1/4 × (5 days ÷ 7 days) a

where,

NOAEL ORAL = 23 mg/kg

- bw/day ABS ORAL

- RAT = percent absorption by the oral route in rats = 50 % Exposure Route Exposure Scenario 1 Margins of Exposure (Benchmark MOE = 30 )
Inh alation M anufacturing 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 M anufacturing 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

1 Processing 1= Formulation of metal working fluids, Processing 2 = compounding of rubber products, Use 1 = use of metal working fluids, Use 2 = converting rubber products26

ABS ORAL

- HUMAN = percent absorption b y the oral route in humans = 50 %
BW RAT = rat bodyweight = 0.250 kg
BW HUMAN = human bodyweight = 71.8 kg

a A duration

- specific adjustment was only applied to the oral LOAEL of 100 mg/kg

bw/day because the animals were gavaged five days per week.

For assessing in halation exposures to the general population, EPA/OPPT performed route

- to

route 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. , HED INHAL

- GENPOP ) using the following equat ion:

HED INHAL

- HUMAN = NOAEL ORAL × (1 ÷ sRV RAT ) × (ABS ORAL

- RAT ÷ ABS INHAL

- HUMAN ) × (5 days ÷ 7 days) a

where,

NOAEL ORAL = 23 mg/kg

- bw/day
sRV RAT = rat standard respiratory volume for 8

- hours = 1.15 m 3 /kg bw ABS ORAL

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

- HUMAN = percent absorpti on by inhalation in humans = 50 %

a A duration

- specific adjustment was only applied to the oral LOAEL of 100 mg/kg

bw/day because the animals were gavaged five days per week.

For the oral NOAEL of 23 mg/ kg

- bw/day, the HED INHAL

- GENPOP value is equal 20 mg/m 3

.

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 HED ORAL

- GENPOP and HED INHAL

- GENPOP values for calculating the respective MOEs using the estimated exposure values presented in Table 8. As shown in Table 1 3, the MOEs for P

- 14

- 0683 and P

- 1 4

- 0 684 all exceeded the respective benchmark values, w hich 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 Wate r Release Air Release

Drinking Water MOE 2 (Benchmark MOE = 30) Fish Ingestion MOE (Benchmark MOE = 30) Stack Air MOE (Benchmark MOE = 30)
Manufacturing 7.7 × 10 6 1.5 × 10 6 1.2 × 10 4
PROC1:Formulation of MWFs 6.2 × 10 5 1.2 × 10 5 6.2 × 10 3

PROC2: Compo unding Rubbers 9.5 × 10 4 1.6 × 10 4 2.8 × 10 3

USE1: Use of MWF 6.6 × 10 5 1.3 × 10 5 3.6 × 10 4 USE2: Converting Rubber 1.9 × 10 6 3.7 × 10 5 2.7 × 10 3

1 Taken from Appendix E. Values represent the highest concentrations/estimated doses (reported as the lifeti me 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 e xposure 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 ma y present an unreasonable risk following acute and chronic exposures to aquatic orga nisms

.

b. Using available measured concentrations of MCCP congener groups in the environment as supporting information, the PMN substances: iii. A re expected to partition to sediment and may partition to soil through land application of biosolids and

, iv. M ay be r eleased 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 a nd very bioaccumulative

.28



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## 9 APPENDICES43



## Appendix A ENVIRONMENTAL FATE AND
BIOACCUMULATION STUDY SUMMARIES

A

- 1 ENVIRONMENTAL PERSISTENCE

A

- 1

- 1 Abiotic D egradation Generally, CPs are stable to hydrolysis and to direct pho tolysis 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 photodegradatio n 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 C 10 to C 24 including an MCCP product , Hoechst CP52, with chain length s from C 12 to C 18 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 pho tolysis half

- lives of less than 20 hours based on measurement of free chloride and analysis of degradation products. The MCCP product had a T 1/2 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 an d 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 wit h atmospheric hydroxyl radicals for MCCPs with lower chlorin e contents between 40 and 56 wt %. EPA/OPPT also estimated atmospheric half

- l ives for MCCPs (40 and 70 Cl wt %) calculated using EPI SuiteTM/AOPWINTM (v. 1.92a) that range from about 1 to > 4 days (se e 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

- 8 to 2.27 × 10

- 3 Pa at 20

- 25°C) and a Henry’s law co nstant (HLC) (0.014

- 51.3 Pa × m 3 /mol for C 14

- 17 congener group s) 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 that44

MCCPs behave similarly to other chlorinated persistent organic pollutants (POPs) with high produ ction 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 Atmos pheric 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 %
C 14 1.0 4.4
C 15 0.8 3.0
C 16 0.8 3.0
C 17 0.8 2.9



### A

- 1

- 2 Biodegradation

E PA/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 enh ance or maximize biodegradation

. EPA/OPPT concurs with the EU’s conclusions that under these modified test conditions, C 14 4 1.3 % by wt. C l and a C 14 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 lo nger carbon chain CPs (C 14

- 17 51.7 % by wt. Cl, C 14 55 % by wt. Cl, C 14 60.2% by wt. Cl, and C 14
- 17 63.2 % by wt. Cl) biodegraded over a range of 2

- 54% in 2 8 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 persist ence 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)

. L ow 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 group s may occur, while longe r chain length, more chlorinated congener group s will be resistant to aerobic and anaerobic degradation. Shorter and lower chlorinated congener group s have higher vapor pressure and may be lost to the vapor phase during aeration. WWTP effluent also contain s 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 associat ed 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 to45

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 wi nd 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 concentrati ons 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 particul ates 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 So il 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 wast e 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 si te 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 biodegra dation 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 T 1/2 of at least months to years.46

Table_Apx A

- 2 : Review of MCCP and LCCP Biodegradation Studies

Biodegradation Studies on MCCPs (C 14 - 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 2010 d C 14 45 wt% Cl Close d bottle 28 days Approximately 64% degraded in

28 days Based on oxygen demand

Van Ginkel 2010 b C 14

- 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 2010 c C 14

- 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 2010 a C 14

- 17 63.2 wt% Cl Closed bottle 28 days Approximately 5% degradation

after 28 days and 10% after 60 days.

Van Ginkel and
Louwe rse 2010 a C 14 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 2010 b C 14 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 releas e

. 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, C 14 41.3 wt% Cl and a C 14 45.5 wt% Cl substances are readily biodegradable

. More highly chlorinated and longer carbon chain CPs (C 14

- 17 51.7 wt% Cl, C 14 55 wt% Cl, C 14 60.2 wt% Cl, and C 14

- 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, ( C 14

- 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 b C 15 51 wt% Cl Closed bottle (301D) 60 day 43% and 63 % degradation at 28

and 60 days47

Biodegradation Studies on MCCPs (C 14 - 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 2014 a C 15 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 C 15 51 wt% Cl were found to be inherently degradable and possibly readily degradable in OECD 301 and 301D tests.

Madeley and Birtley 1980 C 14

- 17 mixed produ ct, 40 wt% Cl BOD test 25 days Approximately 15.5 % degradation as measured by theoretical BOD in non

acclimated samples and 22.5 % degradation in acclimated samples. 1

Madeley and Birtley 1980 C 14

- 17 mixed product, 45 wt% Cl BOD test 25 days Approximately 1 0% degradation as measured by theoretical BOD in non

- acclimated samples and 30% degradation with acclimated soil microbes added. 1

Madeley and Birtley 1980 C 14

- 17 mixed product, 52 wt% Cl BOD test 25 days Approximately 4% degradation as measured by theoret ical BOD in non

- acclimated samples and 6% degradation with acclimated soil microbes added. 1

Madeley and Birtley 1980 C 14

- 17 mixed product, 58 wt% Cl BOD test 25 days No significant degradation

Conclusions: The data from Madeley and Birtley suggests the p otential 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 provi ded. 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 C 20

- 30 42% of > 50 % between day 20 and 25.

1 The ThOD (theoretica l oxygen demand) was estimated (ThOD (g O 2 /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 co ngeners as was used in all studies

. LCCPs

Madeley and Birtley 1980 C 20

- 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 microb es added. 148

Biodegradation Studies on MCCPs (C 14 - 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 C 25 “chlorinated pentacosane” 14 C on

central carbon 8 weeks

(mean) 11% of 14 C

- released as CO 2. 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 f rom 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 C 20

- 30 42 % of > 50 % between day 20 and 25.

1 The ThOD (theoretical oxygen demand) was estimated (Th OD (g O 2 /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

.

Hildebrecht 1972 C 20

- 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

p araffin contributed to this total carbon content.

Hildebrecht 1972 > C 20

- 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 sol ution. Substances other than the chlorinated paraffin contributed to this total carbon

content.

Hildebrecht 1972 > C 20

- 30 mixed product, 70 wt% Cl BOD test 5 days 65% degradation. Degradation was estimated by the authors as the % of the theoretical BOD ba sed 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 consumption49

Biodegradation Studies on MCCPs (C 14 - 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 CO 2 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 te sts” (EA, 2009)

.

Hoechst AG 1976 and

1977 C 18

- 20 , 35 wt% Cl BOD test 5 days 0.7% degradation

Hoechst AG 1976 and

1977 C 18

- 20 , 44 wt% Cl BOD test 5 days < 1.2% degradation

Hoechst AG 1976 and

1977 C 18

- 20 , 49 wt% Cl BOD test 5 days < 2.3% degradation

Hoechst AG 1976 and

1977 C 18

- 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. L imited 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 occu rred 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 C 24.5 H 44.5 Cl 6.5 , 40.5 wt% Cl Chloride

release 48 hours 9.9% deg radation 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 C 24.5 H 41 Cl 10, 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 C 24.5 H 30 Cl 21, 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 (C 14 - 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. Allpres s and Gowland 1999 C 18

- 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 b iodegrade 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.

1 The ThOD (theoretical oxygen demand) was estimated (ThOD (g O 2 /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 questionab le 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 e t al., 2000)

.

T he limited measured data on MCCP s 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 intermed iate chain length and chlorination may be absorbed and retained . The available evidence for MCCP congener group s with intermediate chain lengths and chlorination suggests that some may have BCF s or BAF s greater than 1000 or 5000 (EC, 2008b; ECB, 2008) . This suggests that some congener group s in MCCP product s may be bioaccumulative or very bioaccumulative . In conclusion, some MCCP congener group s present in the product s are both very per sistent and very bioaccumulative.

Additional evidence for bioaccumulation of MCCPs is provided by Houde et al. (2008) . Field

derived log BAFs for MCCPs (C 14

- 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

ran ging 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 o f 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 C 14 MCCPs in Lake Michigan, indicating biomagni fication. 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 ar e 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 (C 14

- 17 ) an d LCCPs (> C 18 )
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 C 14

- 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

- 14 C, 51% Cl mixed with a

non

- radio

labelled C 14

- 17 , 51% Cl chlorinated paraffin Freshwater; flow

through; 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 n

pentadecane

- 8

- 14 C chlorinated to

a similar degree freshwater; flow

through; 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 C 14

- 17 , 45% Cl freshwater; flow

through; 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

su mmarized 1983 Total MCCPs Bioconcentration factors

. MCCPs concentrations were above the water No Inform ation 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 A verage formula: C 14 H 23.3 Cl 6.7 , 55% Cl freshwater; medaka

eggs 20

- days Uncertainty as to whether steady

- state was reached; hence BCFs p robably represent lower limit of true value

BCF = 32

- 680 L/kg
Fisk et al. 1998 14 C 16 35% Cl and

14 C 16 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 bioaccumu lation factor

14 C 16 35 % Cl
14

- day BSAFss = 0.7 Kinetic BSAF = 4.4

14 C 16 69 % Cl
14

- day BSAFss = 0.2 Kinetic BSAF = 0.6

Beng tsson et al. 1979 C 14

- 17 , 50% Cl seawater; semi

static; bleak; acetone solvent used 14 days Measured water concentrations questi onable; water concentrations may be overestimated and BCF underestimated.

BCF

 40 L

/kg
Madel e y and Thom p son ;

as summarized 1983 commercial C 14

-
17 , 52% Cl seawater; flow

through; mussel acetone solvent used 60 days BCFs = 2,182 L/kg (parent compound analysis) or 2,856 L/kg ( 14 C

- measurements) when exposed to 0.22 mg/l55 in ECB, 2005 BCF = 339 L/kg (parent compound analysis) or 429 l/kg ( 14 C measurements) when exposed to 3.8 mg/l. Renberg et al. 1985 C 16 H 30.7 Cl 3.3 (34% Cl) and C 12 H 16 Cl 9.8 (68.5% Cl) mixtur e synthesized with

14 C radiolabel Flow through

exposure to mussel ( Mytilus edulis )

C 16
- 0.13 and 5.0

μ g/L C 16
- 28 day

uptake C 12
- 21 day uptake followed by 28 day depuration Steady state BCF about 7000 for C16 and

140,000 for C12 based on 14C quantifica tion.

No chemical specific analysis for CPs. Metabolism and accumulation of degradation products may have accounted for high values.

LCCPs Beng tsson et al. ; as summarized in ECB, 2005 1979 C 18

– 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/kg56



## Appendix B ECO TOXICITY 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 de fined in Mayer and Ellersieck (1986) , the Chlorinated Paraffin s 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 C 15 H 26 Cl 6 and a chlor ine 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

- th rough 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 test s. 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 CaCO 3 /L in the rainbow trout and channel catfish test system and 314 mg CaCO 3 /L for the bluegill sunfish and yellow perch test system. Reported effect levels are considered to be nominal with LC 50 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 LC 50 = 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 (C 14

- 17 , 52 % Cl), Chloroparaffin huls 40G (C 15.5 , 40 % Cl), and Witaclor 50 (C 14

- 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 ble ak, a standard test species. The 96

- hour fish LC 50 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 acceptabl e to characterize the acute saltwater fish toxicity endpoint as ‘no effects at saturation’.
96

- hr LC 50 = NES



### B

- 1

- 2 Acute Aquatic Invertebrate Toxicity
(1) CPA (1996)57

A 48

- hour acute Daphnia magna toxicity study was condu cted 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 C 14

- 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. App earance 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 dis solved 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 CaCO 3 /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 labora tory notes as being of an uncertain significance. The mean measured 48

- hour EC 50 was determined to be 0.0059 mg/L. The study was acceptable. 48

- hr EC 50 = 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 (C 12

- 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 nomin al 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 CaCO 3 /L. Ambient laboratory air temperatu re 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 EC 50 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 EC 50 = 0.052 mg/L

(3) CPA (1994) A 48

- hour acute Daphnia magna toxic ity 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 C 14

- 17 chlorinated paraffin with 52% chlorinat ion 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 su bstance. 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.) stirr ing for three days, and 5.) filtration of the aqueous phase. Radiochemical methods were used to determine the concentration of test substance in solution. Nominal58

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), q uestionable 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 r emained within 8 and 8.1, and temperatures were 20 ± 1 °C. Dilution water had a total water hardness of 237 mg CaCO 3 /L. Observed immobilization was limited to the highest test concentration (100 % solution) with 55 % immobilization. The study is unaccepta ble 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 Steinha user, 1994) , provided in the ECB (2005) MCCP risk assessment, was considered supportive of the aquatic invertebrate haz ard determination. The chlorinated paraffin used in these studies was a commercial C 14

- 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 sonic ated 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 filter s 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 w as 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 sol uble 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 solutio n, an EC 0 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 stoc k solution were reported by Frank and Steinhauser (1994) as EC 0 = 0.140 mg/L and EC 25 = 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 EC 50 of 0.037 mg/L and an EC 0 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 EC 0 ≥ 0.525 mg/L). The authors noted that the eff ects 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 r uled 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 EC 50 = 0.037 mg/L; 100 mg/L stock59

(5) Thompson and Gore (1999) The following study summary (Thom pson and Gore, 1999)

, provided in the ECB (2005) MCCP risk assessment, was considered supportive of the aquatic inver tebrates hazard determination. The acute toxicity of C 14

- 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 t hen 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 hour s 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 CaCO 3 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 d ied 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 usin g 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 w ater harpacticoid Nitocra spinipes have been reported (Tarkpea et al., 1981) . No other details of the test were reported but the tes t 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 LC 50 = 9 mg/L (C14

- 17, 45% wt Cl) 96

- hour LC 50 >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 C 14

- 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 te st 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 radio chemical 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 r emained below 35% indicating acceptable control growth rates throughout the duration60

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 EC 50 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 calculate d by EPA/OPPT as the geometric mean of the NOEC and LOEC. The study was considered acceptable.
72

- hr E r C 50 = NES 72

- hr E b C 50 = NES 72

- hr NOEC b = 0.1 mg/L 72

- hr LOEC b = 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 Univer sity of Bremen, Department of Physical and Environmental Chemistry with CP 52 (C 12

- 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 CaCO 3 /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 Ch ronic 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 co ncentration 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

exp osure 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 toxi city 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 C 14

- 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 stu dy. 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 ) embry o toxicity study was conducted with the formulation C 14 H 24.9 Cl 5.1 , 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 fertiliz ation 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 14 C

- C 14 H 23.3 Cl 6.7 , 55% Cl (composition: 0.2% C 14 H 26 Cl 4 (42.3% Cl), 4.4% C 14 H 25 Cl 5 (47.7% Cl), 34% C 14 H 24 Cl 6 (52.6% Cl), 45% C 14 H 23 Cl 7 (56.4% Cl), 14% C 14 H 22 C l 8 (59.9% Cl), and 1.9% C 14 H 21 Cl 9 (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 ter minating 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 s ubstance 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 p rimarily 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 su pportive, but did not characterize all fish life

- cycle stages (ECB, 2008)

. Cooley et al. (2001) studied the toxicity of C 14 H 24.9 Cl 5.1 , 48% Cl [as descri bed in (Fisk et al., 1999) ] to juvenil e 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 chlorin ated 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 l ow 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 d epletion 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 volu me in 2.9 mg/L exposure group. This study is considered unacceptable to characterize chronic population

- level effects in fish.

(6) Cooley et al. (200 1) Cooley et al. (2001) studied the toxicity of 14C

- C 14 H 23.3 Cl 6.7 , 55% Cl [as described in (Fisk et al., 1999) ] to juvenile rainbow trout (Oncorhynchus mykiss) through dietary exposure.
Tr eatment 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 af ter 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 h epatocyte 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 se vere 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) ac cording 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 C 14

- 17 chlorinated paraffin with 52% chlorination that contained 0.3% epoxy soy a 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 per63

exposure concentration, which did not comply with OECD 202, Part II requiremen ts 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, 0.0 1, 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 dete rmined 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 nota ble 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 LC 50 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 observe d 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, re spectively, 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 in consistencies 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 dos e 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 radio

labeled 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 con centrations 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 eac h 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 syst em was 0.25 mL/minute for exposure concentrations. Over the course of the study, water temperature ranged from 14.6

– 15.6°C, pH64

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 chara cterize 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) M CCP 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 ide ntified as C 14

- 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 conc entrations. 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 3.1 25 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 lowe r 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 t he 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 endpoi nt. 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 sto ck 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 support ive o f 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 sta tic

- renewal test system (renewal 3 times/week). The test substance was identified as C 14

- 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 and65

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 ca rried 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 CaCO 3 /L. Test solutions were clear. Although analy tical 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 e ach 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 Invertebra te 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 C 14

- 17 , 52% wt. Cl substance containing no stabilizers (the substance was reported to have a C 14

- 17 content of 99.06% with 0.67% of C 10

- 13 chain length substances) that was mixed with a small amount of a radio labeled

n

- pentadecane

- 8

- 14C, 51% wt. Cl substance (r adiochemical 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 artif icial 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. O ver 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 s ex 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 (C 14

- 17 , 52% wt. Cl with no stabilizers). The substance was reported to have a C 14

- 17 content of 99. 06% with 0.67% of C 10

- 13 chain length substances and was mixed with a small amount of a radio labeled n

pentadecane

- 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. Th e 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 differentiat ion 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/k g 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 te st system with weekly renewals. The substance used in the test was a mixture of a commercial medium

- chain chlorinated paraffin product (C 14

- 17 , 52.5% wt. Cl) mixed with a small amount of a radio labeled chlorinated n

- pentadecane

- 8

- 14C (51% wt. Cl). Six rep licates 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 i n 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, di ssolved 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 CaCO 3 /l, and temperature ranged from 22.4

- 23.2 ° C. The endpoints investigated in the study included survival, growth (dry weight) and sexual deve lopment 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 was67

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 sur vival 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 pu blished 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 (C 14

- 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
LD 50 was > 24,606 mg/kg Cereclor S52. The study was acceptable. Acute LD 50 > 24,606 ppm

(2) Madeley and Birtley (1980) An acute avian toxicity study conducted according to methods described in US EPA’s Pestici de 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 (C 14

- 17 , 52% Cl) and then observed for 14 days. Based on rep orted 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 LD 50 was > 10,280 mg/kg. The study was acceptable. Acute LD 50 > 10,280 ppm

(3) Madeley and Birtley (1980) A sub

- acute dietary avian toxicity stu dy 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, o r 24,063 ppm Cereclor S52 (C 14

- 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 be en 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 LD 50 was > 24,063 ppm. The study was acceptable

. 5

- day LD 50 > 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 (C 14

- 17 , 52% Cl) for 5 days. T hree 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 su bstance 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 LD 50 was > 24,063 ppm. The study was acceptable

. 5

- day LD 50 > 24,063 ppm

(5) Unpublished study reviewed in the ECB (2000) The effects of C 10

- 12 , 58% Cl chlorinated paraffin (mean

- measured 29, 168, and 954 mg/kg

- diet ) on the reproduction of mallard ducks ( Anas platyrhyncho s ) 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 consump tion, 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

- meas ured 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 9 54 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 C 14

- 17 , 52% wt. Cl substance containing no stabilizers (the substance was reported to have a C 14

- 17 content of 99.06% with 0.67% of C 10

- 13 chain length substances) and a small a mount of 14C

- labelled n

pentadecane, 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 approximate d 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 ju veniles 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 carbona te. 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 ear thworms 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, growth69

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 w as 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 thes e 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 i s 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 toxi city test was conducted by Thomps on (2002) according to OECD 216 (Soil Microorganisms: Nitrogen Transformation Test) with GLP compliance using a static test system. The substance tested was commercial C 14

- 17 , 52% wt. Cl substance containing no stabilizers (the substance was reported to h ave a C 14

- 17 content of 97.35% with 0.66% of C 10

-
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% decre ase 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 EC 50 , NOEC, and LOEC of > 400, 400, a nd > 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 C 14

- 17 , 52% wt. Cl substance containing no stabilizers (the substance was reported to have a C 14

- 17 content of 99.06% with 0.67% of C 10

- 13 chain length substances) and a small amount of 14C

- labelled n

pentadecane, 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 with70

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 is sues 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 cont rol 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 (geomet ric 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 w t soil 28

- d LOEC = 1,580 mg/kg dry wt soil 28

- d MATC = 888.8 mg/kg dry wt soil



### B

- 1

- 11 Conclusion s
Sufficient data were available to char acterize the acute fish, the acute aquatic invertebrate

, the chronic aquatic invertebrate

, the chronic aquatic sediment inver tebrate, avian, and terrestrial plant toxicity endpoints for MCCPs

. D ata 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 preparatio n 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 use d 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 solu tion, 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

appr oximately 30 μg/L and Log K ow 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 repeated

dose 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 infor mation 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 fo r 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 ” (E CB , 2008).



### C

- 1

- 1 Metabolism

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

. Based on their low vapor pre ssure 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 C 15 chlorinated paraffin was absorbed (Scott, 1984; cited in : E CB , 2008)

. Oral studies (IRDC, 1984, CXR, 2005; cited in : E CB , 2008) showed that approximately 50 % of a single dose of [8

- 14 C]

- labeled C 15 chlorinated paraffin (52 wt % Cl ) was absorbed from the GI tract in rats

. Excretion via feces was the major r oute 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 inform ation 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 (C 14

- 17, 51

- 60 wt% Cl); the LD 50 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 sugge st 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 (C 14

- 17 , 45 wt% Cl), and only slight erythema on the shaved skin was reported in one rabbit at 24 hour s exposed to MCCPs (C 14

- 17 , 40 wt% Cl) (Chater, 1978; cited in: E CB , 2008)

. A mild skin irritancy response was reported in one of nine unpublished skin irritation studies of MCCPs (C 14

- 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 (C 14

- 17 , 40

- 45 wt% Cl) (Mu rmann, 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 (C 14

- 17 40 wt% Cl or 52 wt% Cl) in rats by oral exposure (CXR, 2005; Poon et al ., 1995; IRDC, 1 984; 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/kg

bw/day) and in female rats at exposure levels of > 32 mg/kg

- bw/day

. Liver enzyme induction was reported in male and female rats s tarting 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 metaboli c 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 i s 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 origin al 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 (C 14

- 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 dose

related incre ases 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 f rom 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 (2 005) 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 (C 14

- 17 52 wt% Cl) have been reported to cause minimal to mild adaptive histopathological changes in t he thyroid ( i.e. , follicular cell hypertrophy and hyperplasia) in two73

studies in rats starting at 50 ppm (4 mg/kg

- bw/day) and above (Poon et al ., 1995; IRDC, 1985)

. Decreased T 4 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 T 3 in male rats, but not total T 3 or free/total T 4 , an d 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 i n: 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 T 4 depletion following increased excretion of this hormone

. This depletion of pl asma T 4 results from the induction of hepatic UDPG

- transferase, increased glucuronidation, and ultimately excretion of T 4 following exposure to MCCPs

. The pituitary responds to the decreased levels of T 4 by releasing more TSH, which in turn leads to incre ased production of T 4 by the thyroid

. The continuous stimulation of the thyroid in response to the increased excretion of plasma T 4 is predicted to ultimately give rise to hypertrophy and hyperplasia in this organ

. Humans, unlike rodents, possess T 4
- glob ulin binding protein and are therefore less susceptible to plasma T 4 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 , a lthough these changes may be relevant for assessing potential adverse outcomes during reproduction and development, as discussed under section

.



### C

- 1

- 5 Genotoxicity
MCCPs (C 14

- 17 40

- 52 wt% Cl) are not mutagenic to bacteria. Three in vivo bone marrow studies als o 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 (C 12 , 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 n o 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/kg

bw/day in carcinogenicity studies of a L CCP (C 23 , 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 (C 12 , 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 human s.74 Table _Apx C

- 1 : Summary of Results from 90

- Day Studies in Rats A dministered MCCPs

Strain (sample size) Test substance and dose levels Target

organ Effect levels

F

- 344 (10 rats/sex/group) 1 C 14

- 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 T 4 - UDPGA

- glucuronyl transferase activity

♀ at 100, 300, and 300 mg/kg

- bw/day, 30, 30, and 252 % ↑ in microsomal T 4 - UDPGA

- glucuronyl transferase activity, respectively

Kidney ♂ at 222 and ♀ at 242 mg/kg

- bw/day, 9

- 13 % ↓ in organ we ight

♂ at > 222 and ♀ at 242 mg/kg

- bw/day, no treatment

- related histopathology

Thyroid ♂ at 222 mg/kg

- bw/day, 17 % ↑ in plasma TSH

♂ a t 23.0 and 222 mg/kg

- bw/day, 26% or 22 % ↓ in plasma free T 3 , respectively, but no effects on total T 3 or on free/tota l
T 4 at any dose

♀ at > 242 mg/kg

- bw/day, no effects on free/total T 3 or T 4

♀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 C 14

- 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 at75 Table _Apx C

- 1 : Summary of Results from 90

- Day Studies in Rats A dministered 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, an d nuclear vesiculation)

F

- 344 (15 rats/sex/group) 3 C 14

- 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 6 25 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 hypertroph y 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 va lues

Wistar

- derived (24 rats/sex/group) 4 C 14

- 17 , 52 wt% Cl,

containing epoxidized vegetable oil as a stabilizer

Dietary intake for ♂: 0, 33, 167, or 333 mg/kg

bw/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 A dministered MCCPs

Strain (sample size) Test substance and dose levels Target

organ Effect levels

Dietary intake for ♀: 0, 32, 160, or 320 mg/kg

bw/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 C 14

- 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 ter mination)

♂ 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 T 3 , which reached statistical signi ficance 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, T 3 significantly ↑ by day 91

♀ at 312 and 625 mg/kg

- bw/day, total plasma T 4 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 Bir tley et al . (1980)

. The underlying original study report was not available.

5 Wyatt et al . (1997), cited in: ECB (2008).77



### C

- 1

- 7 Developmen tal Reproductive Toxicity A series of range

- finding and definitive prenatal developmental and reproductive toxicity st udies 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 tim e

. 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 stud ies 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/kg

bw/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 no t 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 stud ies at dos es 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) MCCP s during cohabitation, ge station, and lactation, signs of hemorrhaging were observed in dams that died at the time of parturition

. T aken 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 st atistically 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 develo pmental/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 abso rption , 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 flui ds), 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 v itamin 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 differ ences were reported in F 1 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 bot h 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 b ody weight gains

. The NOAE L 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 /da y) 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

.

B asis for C onclusions

In a range

- finding prenatal developmental toxicity study in pregnant Charles River COBS CD rats administered MCCPs (C 14

- 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 th e 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 w ere administered MCCPs ( C 14

- 17 , 52 wt% Cl) via gavage at doses of 0, 500, 2000, and 5000 mg/kg

bw/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 contro lled room

. At the end of the acclimation period, all animals were weighed and subjected to a detailed physical79

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 examina tion

. 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

. M aternal 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/kg

bw/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 developmenta l 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 ( C 14

- 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 deve lopmental 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, a nd 100 mg/kg

- bw/day MCCPs ( C 14

- 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 col lected 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 p laced 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 gona dotropin 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 an d 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 abdomi nal cavities underwent gross80

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 a t doses up to 100 mg/kg

- bw/day

. The NOAEL for both maternal and developmental toxicity was 100 mg/kg

bw /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 M CCP (C 14

- 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)

. F 0 animals were exposed to test substance from 28 days prior to mating until sacrifice; F 1 animals were treated from weaning until sacrifice, with additional potential exposures occurring in utero and during lactation. All F 0 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 da y 0 of gestation

. Direct dosing began at 83 days of age for the F 0 parents and at 21 days of age for the
F 1 weanlings

. The F 0 and F 1 animals were observed for clinical signs of toxicity, changes in general appearance and behavior, and mortality

. In the F 0 adults, body weights and food consumption were measured weekly; in addition, body weights were measured in F 0 females on GD 0, 7, 14, and 20; and on lactation days (LD) 0, 7, 14, and 21

. Estrous cyclicity was determined in F 0 females prior to mating, d uring mating, and prior to dosing

. All F 0 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

. F 0 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
F 1 weanlings/sex/dose were sacrificed and necropsied

. Five F 1 males and ten F 1 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 F 1 pups, the surviving F 1 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 fr om 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 F 1 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 F 1 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 in81

the low

- and mid

- dose groups but not the high

- dose group

. There were no dose

- related differences in F 1 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 le vels 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/kg

bw/day)

. The LOA EL 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 (C 14

- 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

- depen dent 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 t he 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 fo rmation 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 (C 14

- 1 7 , 52 wt% 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 f ed 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 b y 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 d ose 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 (C 14

- 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 from82

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 treat ment

- 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 we ight 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 b y 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 i ncreased significantly after LD 4

. The majority of these pups showed internal hemorrhages at necropsy

. It was concluded that data from this study and the cross

fostering study performed by Hart et al . (1985) suggest that the fetus receives sufficient vit amin
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 mi lk) 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 highe r 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 repo rtedly 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 (C 14

- 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 fema les 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 cli nical 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 r atio, 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 gr oup 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 animal s 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 an d 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 weigh ts

. No adverse effects were reported on pre

- and post

- natal survival and growth up to sacrifice83

(weaning)

. Though no histopathology was performed, the body cavity and cranial cavity were opened and examined for any signs of hemorrhaging

. None was report ed

. 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 tox icity was 1200 ppm (~ 84/99 mg/kg

bw/ d ay), 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 wil l partition to suspended particulates, sediment, sludge, or soil. Reported MCCP concentrations in surface water range from < 2.5 0 × 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

man y 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, 20 08b). 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 collect ed 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 asses sment 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

concentrat ions 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 cons idered acceptable, EPA/OPPT used the lowest and highest reported concentrations (< 2.5 0 × 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)

< 1.00×1 0

- 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 9.00×1 0

- 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.

-- : Sin gle 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 ele ctron 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 va lue 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 lagoon s and drainage ditch es fr om 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 i ncluded as the y are not considered as surface water concentrations86



### D

- 1

- 2 Sediment

MCCP sediment concentrations from marine and non

- marine environments ranged from 5 .00 × 10

- 3 to 1.64 × 10 1 mg/kg dw and from 2.00 × 10

- 3 to 6.51 × 10 1 mg/kg dw, respectively.

For the purpose s of this assessment, in the studies considered acceptable, EPA used the lowest and highest reported marine and non

- marine sediment concentrations ( 5 .00 × 10

- 3 to 1.64 × 10 1 mg/kg dw and 2.00 × 10

- 3 to 6.51 × 10 1 , respectively) to evaluate risks of potenti al 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 C oncentrations of MCCPs, Sorted by C ountry

Media Country Location
Comments Convert ed 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)

--- 1.64×10 1 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 a l. (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 m g/kg dw Hüttig et al. (2004)

--- 4.99×10

- 1 mg/kg dw Hüttig et al. (2004)88

Media Country Location
Comments Convert ed 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 O ehme (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 a nd Oehme (2006)

--- 8.50×10

- 2 mg/kg dw Hüttig and Oehme (2006)

--- 8.7 0×10

- 2 mg/kg dw Hüttig and Oehme (2006)89

Media Country Location
Comments Convert ed 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 a nd 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 Convert ed 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 Convert ed 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 m g/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* T omy 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 Minimum 1 .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 Convert ed 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/k g 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 Convert ed Concentration Common

Units References City, State or Province

--- 6.51×10 1 mg/kg dw Nicholls et al. (2001)

North West Region: Hornsmill brook --- 5.6 mg /kg dw Nicholls et al. (2001)

--- 1.25×10 1 mg/kg dw Nicholl s et al. (2001)

--- 1.83×10 1 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)

--- 1.35×10 1 mg/kg dw Nicholls et al. (2001)

East Midlands Region: Idle

River --- 1.62×10 1 mg/kg dw Nicholls et al. (2001)

--- 4.39×10 1 mg/kg dw Nicholls et al. (2001)

Northumberland Region: Skerne River --- 1.80×10 1 mg/kg dw Nicholls et al. (2001)

--- 2.56×10 1 mg/kg dw Nicholls et al. (2001)

--- 5 .84×10 1 mg/kg dw Nicholls et al. (2001)

East Anglia Region: Lark

River --- 3.22×10 1 mg/kg dw Nicholls et al. (2001)

--- 4.50×10 1 mg/kg dw Nicholls et al. (2001)

--- 6.04×10 1 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 Convert ed Concentration Common

Units References City, State or Province

Reported as trac e 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)

--- 2.10×10 1 mg/kg dw USEPA (1988)

--- 3.40×10 1 mg/kg dw USEPA (1988)

--- 5.00×10 1 mg/kg d w 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 qualif ier 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 rep orted a s 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 weight95



### D

- 1

- 3 Biosolids and Soil CPs are detected more frequently and at higher concen trations in treated sewage sludge ( i.e., biosolids) than in soil. MCCP concentrations ranged from 5.00 × 10

- 5 to 9.70 × 10 3 m g/kg dw in sludge and from 1

. 5 × 10

- 2 to 8.5 × 10

- 2 m g/kg dw in soil. It is unclear if the difference in MCCP concentrations in slu dge 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

con centrations at much lower levels ranging from 3.00 × 10

- 5 to 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 × 10 1 to 9.70 × 10 3 m g/kg dw. The authors concluded that these very high concentrations were likely the result of releases from

numerou s 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

- 5 to 9.70 × 10 3 m g/kg dw and 1

. 5 × 10

- 2 to 8.5 × 10

- 2 m g/kg dw, respec tively) represents a very large range (up to eight orders of magnitude (Table _Apx D

- 1

- 3).

Table _Apx D

- 1

- 3 : Biosolid and S o il C oncentrations 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

- 6 1.53 × 10

- 3 mg/kg dw Wang et al. (2013) Czech Republic Sewage Sludge 7.36 × 10

- 1 2.30 mg /kg dw Pribylova et al. (2006)
United Kingdom Sewage Sludge 3.00 × 10 1 9.70 × 10 3 mg /kg dw Stevens et al. (2003)

United States Sewage Sludge 5.00 × 10

- 5 5.00 × 10

- 5 mg /kg dw Pribylova et al. (2006)



### D

- 1

- 4 Biota

EPA/OPPT reviewed available published literature and summarize d 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, a nd plankton) and ranged from 5.00 × 10

- 3 to 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 f ound 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 EP A/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

- 3 to 3.70 × 10

- 1 m g/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 C oncentrations 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 ND 1 mg/kg ww EC (1993) ND 1 mg/kg ww EC (1993)

Total ND 1 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 Region 2 Fish ND 3 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 an d 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

Eur ope 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 Can ada. 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 m g/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

- 1 4

- 0684 C
P

- 1 4

- 068 3

, P

- 1 4

- 0684 CEB Staff Draft 8/2 6 /2014 1 1 :0 0 :00 PM

ENGINEER:
PV (kg/yr): 15000000

Revision Note s /Assessment Overview:

SUBMITTER: Qualice, LLC (submitte r )

USE: The uses are equally split between flame retardant/plasticizer in the rub ber (5 0 %) and lubricant in metal working fluids (MWF s ) ( 5 0 %)

. 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

ne eds, while rubber formulations have chlorine content more steady around the 5 2 % levels. Related Cases Submitted Together: P

- 1 4

- 068 3 , P

- 1 4

- 068 4

.

OTHER USES: Generic uses MCCP: 1) Substances are used as a flame retardan t /plasticizer in polymer s ; 2) used

a s lubricants in automotives 3) as components of solvent based paint s , adhesives and sealant s

. The paints are specialty paints for applications where weather resistant coatings are neede d , such as steel constructio n , industrial
floorin g , road markin g , wi ndow sealants and pool s ; and 4) flame retardants / waterproofers to textile s

.

MSD S : Yes LABE L : Yes

Gen Eqpt: Eng Control s : Under normal conditions of us e , natural ventilation should effectively remove and prevent buildup of any vapo r /mis t /fum e /dust gener ated from the handling of this produc t . // Eye/Face: If splashes are likely to occur, wear safety glasses with side

- shields or a face shield with safety glasse s . // Skin: Normal work clothing (long sleeved shirts and long pant s ) is recommende d

. If splashe s are likely to occu r , use apron or impervious suit, such as a Tyvek coveral l

. If liquid contact is likely to occu r , manufacturer recommends nitrile gloves (ex: N

- DEX Nitrile). Respirato r : No personal respiratory protective equipment normally require d

. I f mist is generated (heating, sprayin g ) and engineering controls are not sufficien t , wear NIOSH certified organic vapor respirator with particulate filte r

. Health Effect s : Eye: Contact with eyes may cause irritation // Skin: Prolonged an d /or repeated skin contact may result in mild irritation or redness // Inhalatio n : Avoid breathing vapors or mists of this produc t . May cause irritation of respiratory trac t . // Ingestio n : Small amounts (a tablespoonfu l ) swallowed during normal handling operations are not li kely to cause injur y ; swallowing amounts larger than that may cause injur y

. TLV/PE L :

- none established

CRS S : (7/1 7 /2014 1 :0 0 :00 AM): Chemical Name: Tetradecane, chloro deriv s

. S

- H2O: 0.000005 g/L @
VP: 2.0E

- 6 torr @
MW: 440 0.0%<500 0.0%<1000 Physical S tate and Misc CRSS Inf o : Nea t : liquid Mf

g : liquid Proc/Form: liquid End Use: 10

- 15 % in final produc t . The stoicheometer of the process diagram would produce PMN products that are average molecular formula containing 6

- 8 chlorine atoms

. The starting o lefin is
9 8 % C14 and 9 3 % alpha oleffi n

. The typical MW is near 440 daltons for a C l 7 congener based on total PV of > 40
to < 70 wt % chlorine conten t

.99

Consumer Us e : No

SAT (concerns): (7/1 7 /2014 1 1 :0 0 :00 PM):

Related Cases and Misc SAT Inf o : Same as P

- 1 2

- 028 3

. Analog s : P

- 1 2

- 028 2 , P

- 1 2

- 035 7 , P

- 1 2

- 0453 all MCCPs Migration to groundwate r : Slow
PBT rating: P 3 B 3 T 2
Health: 1, No exposures needed
Eco: 3, Water (All releases to water with a CC = 1 pp b ), XB Testing (Testing desire d )

OCCUPATIONAL EXPOSURE RAT IN G : 2

- 3D

NOTES & KEY ASSUMPTION S : Generated by the 0 6 /0 7 /2005 version of ChemSTEER. This is a consolidated se t : P1 4

- 0683 & 068 4

. The two PMNs have identical volume, use rate, concentration and use s . PB ratings are P2 B3; therefor e , a full assessment is

p erformed

. This is an exposur e

- based case; all exposure criteria me t ; XB testing desired for Ec o

. //// Note
P1 4

- 0684 was previously submitted as P1 2

- 0357 by Trinity, but the case was later withdraw n . //// The PMN is a MCCP product that is manufactured dom estically and used in the following application s : 1) 5 0 % as a flame retardant in rubber product s ; and 2) 5 0 % as a lubricant in metal working fluids (MWF s ). // The technical contact was called, see contact report for detail s . // Note, this IRER is consisten t with past assessment of P1 2

- 0357 (same chemical as
P 1 4

- 068 4 , same use s ), except that this IRER assesses a separate converting operation based on latest information provided by technical contac t

. Furthe r , this IRER was prepared using the same methdology as the following past
MCCP cases: P1 2

- 0277 through P 1 2

- 028 4 , and P 1 2

- 045 3 . //// For MF G : Submitter estimates were used for assessing submitter specified waste streams and standard models were used to assess equipment cleanin g . Dermal exposure was assessed using standard models and inhalation exposure is expected to be neg l . // For downstream processing and use operation s : The release and exposure estimates were based on a combination of submitter provided data and data available in various literature source s

. The literature sources include 1) previous EPA/OPPT assessments on chlorinated paraffin s ; 2) foreign risk assessments on MCCPs and LCCPs (e.g. EU risk assessment s ); 3) EPA/OPPT Generic Scenario s ; and 4) OECD Emission Scenario Documents. Due to the unce rtainty at multiple downstream use site s , the most conservative data were chosen when evaluating releases for downstream operation s

.

POLLUTION PREVENTION CONSIDERATION S : P2 claims were made for the MCCP being an alternative to the SCC P

. P2 claims were al so made for MCCP as an alternative for phthalate s

. While true neither merits recognitio n

.

P2 REC: P2 claims were made for the MCCP being an alternative to the SCC P

. P2 claims were also made for MCCP as an alternative for phthalate s

. While true neithe r merits recognitio n

.

EXPOSUR E

- BASED REVIEW: Yes (3 criteria met)

1) # of workers expose d : 14 9 ,846 >100 0 ? Yes 2) >100 workers with > 10 mg/day inhalation exposur e : Yes 3) (a ) >100 workers w/1

- 10 mg/day in h . exp. & >100 day s /yr: Yes (b) Routine Dermal Con t : > 250 workers & > 100 day s /yr: YesMFG: Batch Manufacturing of PMN

Number of Site s /Locatio n : 1 submitter sit e (s)

100 Qualic e , LLC Hamlet NC 28345 Basis: Per submission, 1 submitter sit e , 375 bt/y r , 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/y r

. Ass umed 3 processing lines per sit e

. Process Description: Feedstock charged to a reactor

--- > chlorine gas in fed to reactor

--- > byproduct gas is recovered and treated and produces waste PMN strea m , bleach and HCl product

--- > reaction forms PMN (liqui d , 10 0%)

-- > QC sampling

--- > stabilizer added

--- > transfer to storage

--- > loading PMN product (liqui d , 100%) into tank trucks (90% of PV) or totes (10% of PV) (submissio n )



### 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 mediu m

.

Water or Incineration or Landfill Conservativ e : 4.0E+2 k g /sit e

- day over 1 day/yr from 1 sites or 4.0E+2 k g / y r t o : uncertain from: Equipment Cleaning Losses of Liquid s 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 neede d ). As conservativ e , CEB assesses cleaning of equipment for 1 day/yr to address the possibility of equipment cleaning due to unforseen circumstances with
releases to uncertain medi a

.

Incineration Output 2: 2.2E+1 k g /sit e

- day over 250 day/yr from 1 sites or 5.4E+3 k g / y r t o : of f

- site incineration (submission) from: Waste from Byproduct Gas Recovery basis: User

- Defined Loss Rate Mode l . The submission estimates 7.2 k g /bt of PMN is released to of f

- site incineration from waste PMN produced during byproduct gas recover y . CS calculates 3 bt/day resulting in a release of (7 .2 x 3) = 2 1 .6 k g /sit e

- day.

Landfill Output 2: 9.0E+0 k g /sit e

- day over 250 day/yr from 1 sites or 2.2E+3 k g / y r t o : RCRA Subtitle D landfill (submission) from: Carbon Waste from HCl Carbon Treatment basis: User

- Defined Loss Rate Mode l . The submission esti mates 3 k g /bt of PMN is released to a RCRA subtitle D landfill from waste carbon produced HCl carbon treatmen t . CS calculates 3 bt/day resulting in a release of (3 x 3) = 9 k g /sit e

- day.



### RELEASE TOTAL

8.0E+3 kg/yr

- all sites



### OCCUPATIONAL EXPOSURES ESTIM ATE SUMMARY Tot. # of workers exposed via assessed route s : 6 Basis: The submission estimates up to 3 worker s /site exposed to PMN at during various activitie s . As conservativ e , CEB assesses dermal exposure for all workers to liquid PMN at 10 0 % during sampli ng (1

- han d ) and loading (2

- han d ) activitie s

.101

Dermal:
Exposure to Liquid High End: 1.1E+3 m g /day over 250 days/yr Number of workers (all sites) with Dermal exposur e : 3 Basis: Sampling Liquid Produc t ; EPA/OPPT 1

- Hand Dermal Contact with Liquids Mode l

.

Dermal:

Exposure to Liquid High End: 2.2E+3 m g /day over 250 days/yr Number of workers (all sites) with Dermal exposur e : 3 Basis: Loading Liquid Product into Transport Container s ; EPA/OPPT 2

- Hand Dermal Contact with Liquids Mode l

.P

- 1 4

- 0684 C

P

- 1 4

- 068 3

, P

- 1 4

- 0684

PRO C 2: Compounding of Rubber Products (5 0 % of P V )

Nu mber of Site s /Locatio n : 6 submitter sit e (s)

102 unknown site Mebane NC unknown site Youngsville NC unknown site Marysville OH unknown site Hannibal MO unknown site Calhoun GA unknown site S t . Mar y ' s OH Basis: Per submission, the PMN is used at 100% in rubber compounding at 6 customer site s . The technical contacts indicate s the PMN may be present in rubber products from 10

- 15%. CEB assumes 15% to conservati vely assess exposures and 250 day s /yr based on 2004 ESD for Plastic Convertin g . CS calculates a use rate of 5,000 kg/site

- da y

. Process Description: PMN (liqui d , 100%) unl oaded from tank trucks

--- > piped into mixe r , mix with raw rubber and other additives at high temperature

--- > molten rubber extruded into sheet s , blocks an d /or molds (PM N , 10

- 15% entrained in solid ) and shipped to downstream sites (submissio n , CRS S , tec hnical contact for P 14

- 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 mediu m . The submission does not provide inf ormation on releases during the manufacture of rubber product s . The methology used t o assess the standard reviews for P 1 2

- 0277 through P 1 2

- 0284 (LCCP and MCCP product s ) was used to assess releases during this operatio n . The only exception being container c leaning releases which are estimated using information from the submitter and technical contac t

.

Air High End: 1.2E+0 k g /sit e

- day over 250 day/yr from 6 sites or 1.9E+3 k g / y r t o : water or air (ESD, 2010 EU CSR) from: Fugitive Air Emission from Extrusion basis: User

- Defined Loss Rate Mode l . Per ES D , fugitive air emissions generated during rubber converting can be
0.0 5 % with engineering controls depending on the type of coversion process (e.g. extrusio n , injection molding,
calendarin g ). The 2004 GS for Plas tics Compounding estimates that 5 0 % of air emissions will settle and be ultimately released to water while the other 5 0 % remains in ai r . As conservativ e , CEB assesses fugitive air emissions at a loss rate of 0.0 5 % with 5 0 % to water and 5 0 % to air.

Water
H igh End: 1.2E+0 k g /sit e

- day over 250 day/yr from 6 sites or 1.9E+3 k g / y r t o : water or air (ESD, 2010 EU CSR) from: Fugitive Air Emission from Extrusion basis: User

- Defined Loss Rate Mode l . Per ES D , fugitive air emissions generated during rubber converting can be
0.0 5 % with engineering controls depending on the type of coversion process (e.g. extrusio n , injection molding, calendarin g ). The 2004 GS for Plastics Compounding estimates that 5 0 % of air emissions will settle and be ultimately released to water whi le the other 5 0 % remains in ai r . As conservativ e , CEB assesses fugitive air
emissions at a loss rate of 0.0 5 % with 5 0 % to water and 5 0 % to air.

Water or Incineration or Landfill High End: 5.0E

- 1 k g /sit e

- day over 250 day/yr from 6 sites or 7.5E+2 k g /yr

t o : water, incineration, or landfill (R M

- 2) from: Spillage During Raw Material Handling basis: User

- Defined Loss Rate Mode l

. A 2010 EU CSR assessment on MCCPs estimated these releases to be
0.0 1 % of PV with releases to water or solid wast e

. .

Water or Inc ineration or Landfill Conservativ e : 1.0E+2 k g /sit e

- day over 250 day/yr from 6 sites or 1.5E+5 k g /yr

t o : Uncertainfrom: 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 fro m equipment cleaning using the EPA/OPPT model loss rate of 2%

. Due to multiple unknow sites, release to uncertain media (water, incineration or landfil l ) is assume d

.

Water or Incineration or Landfill High End: 3.8E+1 k g /sit e

- day over 1 day/yr from 6 sit es or 2.3E+2 k g / y r t o : water, incineration or land (ESD) from: Cleaning Liquid Residuals from Tank Trucks Used to Transport the Raw Material basis: EPA/OPPT Bulk Transport Residual Mode l , CEB standard 0.2% residual. The submission states that tank trucks are reused and are not cleaned between use s . For P 1 2

- 035 7 , technical contact stated that in a scenario where the they will need to be taken out of servic e , tank trucks will be sent to a third party truck washing facilit y . To account for the possibility of containers being removed from servic e , 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 route s : 144 Basis: The submission estimates 1 worke r /sit e . The 2004 ESD for Plastic Compounding estimates up to 24 worker s /sit e . CEB uses the ESD estimate as conservativ e

.

Inhalatio n :

Exposure to Vapor High End of Rang e : 4.4E+0 m g /day over 250 days/yr Low End of Rang e : 3.0E

- 2 m g /day over 250 days/yr Number of workers (all sites) with Inhalation exposur e : 144 Basis: Fugitive Air Emission from Extrusio n ; User

- defined Inhalation Mode l

. The 2004 GS for Plastics Compounding suggests that inhalation exposure is negligible for no n

- volatile substances during compoundin g

. A 2010 EU Risk Assessment on MCCP contains monitorin g | data from plastic compounding operations is the E U . 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 conservativ e , exposures estimates are presented based on the low and high of the range for these data and assuming up to 8 hr exposure duratio n

. .



### INHALATION MONITORING DATA REVIEW 1) Uncertainty (estimate based on mode l , regulatory limi t , or data not specific to industr y ): Yes 2) (a ) Exposure level > 1 mg/da y ? Yes (b) Hazard Rating for health of 2 or greate r ? No Inhalation Monitoring Data Desire d ? Yes (both criteria me t )

Dermal:

Exposure to Liquid High End: 2.2E+3 m g /day over 250 days/yr Number of workers (all sites) with Dermal exposur e : 144 Basis: Unloading Liquid Raw Material from Tank Truck s ; EPA/OPPT 2

- Hand Dermal Contact with Liquids Mode l

.P

- 1 4

- 0684 C

P

- 1 4

- 068 3

, P

- 1 4

- 0684

PRO C 1: Formulation of Metalworking Fluids (5 0 % of P V )

Number of Site s /Locatio n : 10 submitter sit e (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 s ite Milwaukee WI unknown site Cincinnati OH unknown site Crystal Lake IL unknown site Linden NJ Basis: Per submission, 20 MWF formulation site s , 150 kg PMN/bt, 240 exposure day s /y r , PMN used as a liquid at 100%. For past case P 12

- 0357, technical contact es timates 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 exposure s . CS calculates a use rate of 1,562.5 kg/site

- day
based on 240 da y /yr operatio n

. Process Description: PMN ( liqui d , 100%) is unloaded from tanks trucks (90% of PV) and totes (10% of PV)

-- - > transfer to storage

--- > feed into blending tan k , mixed with base oils and other additives

--- > packaging of metal working fluids containi n g PMN (10

- 15%) (submissio n , tec hnical contact from P 12

- 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 mediu m . The submission states there are no releases during formulation of MWF s . The methology used
to assesses the standard reviews for P 1 2

- 0277 through P 1 2

- 0284 and P 1 2

- 0357 (LCCP and MCCP product s ) was used to assesses releases during this operatio n . The only exception being container cleaning releases which are estimated using information from the submitter and technical contac t

.

Water or Incineration or Landfill High End: 3.8E+1 k g /sit e

- day over 1 day/yr from 20 sites or 7.6E+2 k g / y r t o : uncertain from: Cleaning Liquid Residuals from Totes and Tank Trucks Use d to Transport the Raw Material basis: EPA/OPPT Bulk Transport Residual Mode l , CEB standard 0.2% residual. The submission states that totes and tank trucks are reused and are not cleaned between use s . From contact report for P 1 2

- 035 7 , the technical

contact stated that in a scenario where the they will need to be taken out of servic e , 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 servic e , CEB assesses releases from container cleaning
for 1 day/yr with releases to uncertain media.

Water or Incineration or Landfill Conservativ e : 1.6E+1 k g /sit e

- day over 240 day/yr from 20 sites or 7.5E+4 k g / y r t o : Uncer tain from: Equipment Cleaning Losses of Liquids from a Mixing Tank basis: EPA/OPPT Single Vessel Residual Mode l , CEB standard 1% residual

. The submission does not address equipment cleaning at downstream formulation site s

. Due to uncertainty at multiple downstream site s , CEB assesses releases to uncertain media using the standard model loss fraction assuming cleaning once per da y

.

Air Output 2: 7.8E

- 2 k g /sit e

- day over 240 day/yr from 20 sites or 3.8E+2 k g / y r t o : fugitive air (2002 EU RA, 2010 Japan R A ) from: Fugitive Air Emissions basis: User

- Defined Loss Rate Mode l

. A 2010 Japanese RA for SCCPs suggests 0.00 5 % release to air during MWF formulation. Due to uncertainty at multiple downstream use site s , CEB includes this release source using this estimat e

.Incineration or Landfill

105

Output 2: 3.1E+1 k g /sit e

- day over 240 day/yr from 20 sites or 1.5E+5 k g / y r t o : incineration or landfill (2002 EU RA) from: Of f

- Spec Material basis: User

- Defined Loss Rate Mode l . Data from a 2002 EU RA estimates a 1

- 2% loss rate from disposal of
of f

- spec batches released to solid wast e . Due to uncertainty at multiple downstream use site s , CEB includes this release source using the high end estimate with releases to incineration or landfil l

.



### RELEASE TOTAL

2.3E+5 kg/yr

- all sites



### OCCUPATIONAL EXPOSUR ES ESTIMATE SUMMARY Tot. # of workers exposed via assessed route s : 80 Basis: The submission estimates 80 workers for all sites (avg 4 worker s /sit e ). As conservativ e , CEB assesses all workers are exposed to PMN at 10 0 % (unloadin g ) and 1 5 % (loadin g ).

Derma l:

Exposure to Liquid High End: 2.2E+3 m g /day over 240 days/yr Number of workers (all sites) with Dermal exposur e : 80 Basis: Unloading Liquid Raw Material from Totes and Tank Truck s ; EPA/OPPT 2

- Hand Dermal Contact with Liquids
Model.

Dermal:

Exposure t o Liquid High End: 3.4E+2 m g /day over 240 days/yr Number of workers (all sites) with Dermal exposur e : 80 Basis: Loading Liquid Product into Drum s ; EPA/OPPT 2

- Hand Dermal Contact with Liquids Mode l

.106

P

- 1 4

- 0684 C
P

- 1 4

- 068 3

, P

- 1 4

- 0684

USE1: Use of Metalworkin g Fluids (5 0 % of P V )

Number of Site s /Locatio n : 1 submitter sit e (s) unknown sites Basis: The submission does not address the use of formulated MWFs containing the PM N . The lubricant products contain
10

- 15% PMN per contact report for P 12

- 0357. CEB assumes 15 % to conservatively assess exposure s . The 2011 ESD for MWF Operations estimates 247 day s /yr of operatio n . The ESD estimates the number of sites a s : ( 7,500,000 kg/y r ) / ( 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 PM N . As conservativ e , CEB assumes 247 day s /yr of operation and the ESD estimate of 3,101 sites to maximize k g /site

- day releas e . CEB also assumes 15% PMN in
raw material and assumes no dilution as conservativ e . CS calcu la tes a use ra te of 9.7918 kg/site

- da y

. Process Description: Bulk MWF containing PMN (liqui d , 10

- 15%,) is unloaded from transport containers

--- > transfer to mixing vessel

--- > possible dilution of if wate r

- based MWF

--- > transfer to metal shaping trough

--- > metal sh aping 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 sour ces to the same mediu m . The submission does not provide information on releases during the use of MWF s . The ESD
was used to assess releases during this operatio n

.

Water or Incineration or Landfill High End: 9.4E

- 1 k g /sit e

- day over 18 day/yr from 3101 sit es or 5.2E+4 k g / y r t o : 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 us e

. Due to uncer tainty at multiple downstream site s , these releases are assessed to uncertain media using a 3% loss rate per the ES D

.

Water Output 2: 1.0E+0 k g /sit e

- day over 247 day/yr from 3101 sites or 8.0E+5 k g / y r t o : o n

- site WWTP or POTW (ESD) from: Dragout Losses
b asis: User

- Defined Loss Rate Mode l . The 2011 ESD for MWF Operations estimates a loss rate of 1 1 % from dragout with releases to o n

- site WWTP or POT W . These data are based on U .S. industry data collected during the development of effluent guidelines for the metalworking industr y . Due to uncertainty at multiple downstream site s , CEB assesses dragout releases using the ESD estimate of 1 1 % and accounting for upstream losses from container cleaning: (1

- 0.0 3 ) x 0.11 = 0.106 7 . Releases are assessed to water via o n

- site WWTP or POTW per submission and
ESD.

Water or Incineration or Landfill Output 2: 3.4E+0 k g /sit e

- day over 247 day/yr from 3101 sites or 2.6E+6 k g / y r t o : water, incineration, or landfill (ESD) from: Filter Media and Other Recycling Waste basis: User

- Defined Loss Rate Mode l . The 2011 ESD for MWF Operations estimates these releases to account for a
3 6 % loss rate with releases to wate r , incineration, or landfill (water

- based fluid s ) or incineration or landfill (straight

- oil). Accounting for upstream cont ainer cleaning losse s : (1

- 0.0 3 ) x 0.36 = 0.349 2 . CEB assesses these releases to water, incineration, or landfill based on uncertain t y at multiple downstream use site s

.

Water or Incineration or Landfill Output 2: 4.4E+0 k g /sit e

- day over 247 day/yr from 31 01 sites or 3.3E+6 k g / y r t o : water, incineration, or landfill (ESD) from: Spent Metalworking Fluid basis: User

- Defined Loss Rate Mode l . The 2011 ESD for MWF Operations also assesses 10 0 % release with the spent MWF disposed to water (water

- based fluid s ) or incineration or landfill (straight oil fluid s ) with at least onebath changeout occurring per day at a facility with multiple baths in us e . Based on uncertainty at multiple107

downstream use sites, CEB assesses the spent MWF to wate r , incineration, or landfill . Account for upstream
losse s , the loss rate is calculated as: (1

- 0.0 3 ) x (1

- 0.0 5

- 0.1 1

- 0.3 8 ) = 0.446 2

.

Air Output 2: 4.7E

- 1 k g /sit e

- day over 247 day/yr from 3101 sites or 3.6E+5 k g / y r t o : air (2002 EU RA) from: Misting/Evaporation basis: User

- Defined Los s Rate Mode l . A 2002 EU RA for MCCP estimates mistin g /evaporation losses to range from 2 to 5% depending on the type of MWF begin use d . Based on uncertainty at multiple downstream site s , CEB uses the most conservative estimate of 5% loss to air from mistin g /evaporatio n . Account for upstream losses from
container cleanin g : (1

- 0.0 3 ) x 0.05 = 0.0485



### RELEASE TOTAL

7.2E+6 kg/yr

- all sites



### OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY
Tot. # of workers exposed via assessed route s : 148848 Basis: The 2011 ESD for MW F Use estimates 48 worker s /sit e . CEB assesses 48 worker s /site as conservative, due to uncertainty at downstream use sites.

Dermal:

Exposure to Liquid High End: 2.6E+2 m g /day over 247 days/yr Number of workers (all sites) with Dermal exposur e : 148848
Bas is: Unloading Liquid Raw Material from Drum s ; EPA/OPPT 2

- Hand Dermal Contact with Liquids Mode l

.

Dermal:

Exposure to Mist

: m g /day over days/ y r

: 3.7E+2 m g /day over 247 days/yr Number of workers (all sites) with Dermal exposur e : 148848 Basis: Exposure During Metalworking Operatio n ; User

- defined Dermal Mode l . The 2011 ESD for MWF Operations estimates an average dermal surface loading rate for MWFs of 2.9 mg/cm2

- hr during metalworking operation s . These data are more conservative than the EP A /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 %.

Inhalatio n :

Exposure to Mist High End of Rang e : 5.3E+0 m g /day over 247 days/yr Typical: 1.5E+0 m g /day over 247 days/yr Number of workers (all sites) with Inhalation exposur e : 148848 Basis: Exposure During Metalworking Operatio n ; User

- defined Inhalati on Mode l . The 2011 ESD for MWF Operations estimates typical mist concentrations ranging from 0.19 to 0.39 mg/ m 3 and high end concentrations ranging from 0.87 to 1.42 mg/m3 depending on the type of MWF use d . These estimates are based on the geometric mean ( typica l ) and 90th percentile data (high en d ) 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 percentile s

. CEB assumes the PMN is 37.5% of the mis t

. ( GS assumes that water con c . is 60% and the PMN is then estimated to be 15/40 = 37.5% of the mis t

. 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 mode l , regulatory limi t , or data not specific to industr y ): Yes 2) (a ) Exposure level > 1 mg/da y ? Yes (b) Hazard Rating for health of 2 or greate r ? No Inhalation Monitoring Data Desire d ? Yes (both criteria me t )Deliberative D raf t

- Do not cite or Quote

109 P

- 1 4

- 0684 C
P

- 1 4

- 068 3

, P

- 1 4

- 0684

U SE2: Converting of Rubber Products (5 0 % of P V )

Number of Site s /Locatio n : 1 submitter sit e (s) unknown sit e (s) Basis: Submission does not provide the number of rubber converting site s

. Per 2004 ESD on Plastics Convertin g , 250 da y /yr operation and a default plastic use rate of (38,738 MM kg/y r ) / ( 12,191 sites) / ( 250 da y /y r ) = 12,710.36 kg/site

- day (general plastic s )

. CS calculates 16 sites. Process Description: Rubber block s , sheets or molds containing PMN (solid, 10

- 15%) are unloaded

--- > forming (heati n g )

--- > molding and shaping using various processes (injection moldin g , extrusion, castin g , calendarin g , et c .)

-- - > trimming

--- > finishing

--- > finish ed 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 mediu m . The 2004 Plastics Converting ESD is referenced for this operatio n

.

Incineration or Landfill Output 2: 4.8E+1 k g /sit e

- day over 250 day/yr from 16 sites or 1.9E+5 k g / y r t o : landfill or incineration from: Scrap Material basis: User

- Defined Loss Rate Mode l

. 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 consi dered most likel y

.

Incineration or Landfill Output 2: 1.9E+1 k g /sit e

- day over 250 day/yr from 16 sites or 7.5E+4 k g / y r t o : incineration or landfill from: Cleaning Solid/ Powder Residuals from Containers Used to Transport the Raw Material basis: EPA/OPPT Solid Residuals in Transport Containers Mode l , CEB standard 1% residual

. Solid compounded plastic residuals considered most likely to be handled as solid waste with disposal to landfill or incineratio n

.

Incineration or Landfill Conservativ e : 3.8E+1 k g /s it e

- day over 250 day/yr from 16 sites or 1.5E+5 k g / y r t o : 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 residua l material in equipment is considered most likely to be handled as solid waste and disposed by landfill or incineratio n

.

Water or Incineration or Landfill Output 2: 1.9E

- 1 k g /sit e

- day over 250 day/yr from 16 sites or 7.6E+2 k g / y r t o : water, incineration or landfill from: Dust Generation from Converting basis: User

- Defined Loss Rate Mode l

. Per ES D , 0.0 1 % loss of daily use rat e

. Particles are originally released to air but are expected to eventually settle to the groun d . Dust particles are expected to be cleaned from equipment and floor with water or disposed directly to landfil l

.

Air Output 2: 2.4E+0 k g /sit e

- day over 250 day/yr from 16 sites or 9.5E+3 k g / y r t o : Water (5 0 %) or Air (5 0 %) ( ESD) from: Fugitive Air Emission from Converting basis: User

- Define d Loss Rate Mode l

. Based on Plastics Converting GS (200 4 ), Most plastic additives areDeliberative D raf t

- Do not cite or Quote

110 no n

- volatile; howeve r , converting operations may be performed at elevated temperature s ; thus slight volatilization

may occu r . A release of 0.2 5 % of the daily use rate is estimate d

. Particles are originally released to air but subsequent condensation may result in losses to wate r . As a conservative estimat e , 5 0 % is assumed to be released to water and 5 0 % is assumed to be released to the atmosphere

. NOTE: The CSR estimat es 0.0 5 % loss for this activit y

.

Water Output 2: 2.4E+0 k g /sit e

- day over 250 day/yr from 16 sites or 9.5E+3 k g / y r t o : Water (5 0 %) or Air (5 0 %) ( ESD) from: Fugitive Air Emission from Converting basis: User

- Defined Loss Rate Mode l

. Based on Plastics Conve rting GS (200 4 ), Most plastic additives are

no n

- volatile; howeve r , converting operations may be performed at elevated temperature s ; thus slight volatilization

may occu r . A release of 0.2 5 % of the daily use rate is estimate d

. Particles are originally relea sed to air but subsequent condensation may result in losses to wate r . As a conservative estimat e , 5 0 % is assumed to be released to
water and 5 0 % is assumed to be released to the atmosphere

. NOTE: The CSR estimates 0.0 5 % loss for this activit y

.

Water or Incineration or Landfill Output 2: 1.9E

- 1 k g /sit e

- day over 250 day/yr from 16 sites or 7.6E+2 k g / y r t o : water, incineration or landfill (R M

- 2_ from: Raw Material Spillage basis: User

- Defined Loss Rate Mode l

. A 2010 EU CSR assessment on MCCPs estimated th ese releases to be
0.0 1 % of PV with releases to water or solid wast e . 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 exp osed via assessed route s : 768 Basis: Per 2004 ESD for Plastics Convertin g , 48 worker s /sit e

.

Inhalatio n :

Exposure to Mist High End of Rang e : 1.5E+1 m g /day over 250 days/yr Low End of Rang e : 7.0E

- 1 m g /day over 250 days/yr Number of workers (all sites) wi th Inhalation exposur e : 768 Basis: Inhalation Exposure during Convertin g ; User

- defined Inhalation Mode l

. 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 dat a . Based on uncertainty in multiple downstream use sites and the fact that these dat a 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 mode l , regulatory limi t , or data n ot specific to industr y ): Yes 2) (a ) Exposure level > 1 mg/da y ? Yes (b) Hazard Rating for health of 2 or greate r ? No Inhalation Monitoring Data Desire d ? Yes (both c111 

## Appendix F EXPOSURE SCENARIO ESTIMATES

(E

- FAST Model Run)

INITIAL REVIEW EXPOSURE REPORT (IRExR)

C hemical ID: P

- 14

- 0683 C (P

- 14

- 0683 and P

- 14

- 0684)

Results Table: Dose, Concentration, and Days Exceeded Results Summary

Exposure Scenario 1 Water Landfill Stack Air Fugitive Air

Release activity(ies) 2 ;
exposure c alculation(s) 3 Drinking Water Fish Ingestion 7Q10 4
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 a ctivity 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 r eleases 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.112113 Results Table: Exposure Ba sed (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? No114 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

W WT
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 EST IMATES

Exposure Units Drinking Water Results Drinking

Water Units Fish Ingestion Results Fish Ingestion Units

50% 10% 50% 10%

Cancer

LADD pot 2.13E

- 07 1.19E

- 05 mg/kg/day 1.11E

- 06 6.22E

- 05 mg/kg/day

LADC pot 1.64E

- 05 9.17E

- 04 mg/L 1.19E

- 02 0.66 mg /kg

Acute

ADR pot 1.62E

- 03 0.16 mg/kg/day 3.57E

- 02 2.00 mg/kg/day116 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 CALCU LATION: 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 Ai r Concentration (Fugitive): 0.00 μ g/m 3

Max 24 Hour Average Air Concentration(Fugitive): 0.00 μ g/m 3

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 μ g/m 3

Max 24 Hour Average Air Concentration (Stack): 2840.00 μ g/m 3117

Exposure Units Results

(Stack) Results

(Fugitive) ASSUMPTIONS

ED (years) AT

(years) BW

(kg) Inh. Rate

(m 3 /hr)

Cancer

LADD pot (mg/kg/day) 1.21E

- 04 N/A 33.00 78.00 80.00 0.61

LADC pot (mg/m 3 ) 6.60E

- 04 N/A 33.00 78.00 NA NA

Acute

ADR pot (mg/kg/day) 0.52 N/A NA 1 day 80.00 0.61

Stack Parameter Data Fugi tive 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 Te rrain 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 m118 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 LAND FILL

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

LADD pot 2 .13E

- 07 1.19E

- 05 mg/kg/day 1.11E

- 06 6.22E

- 05 mg/kg/day

LADC pot 1.64E

- 05 9.17E

- 04 mg/L 1.19E

- 02 0.66 mg/kg

Acute

ADR pot N/A N/A mg/kg/day N/A N/A mg/kg/day120 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

SLUDGE 1

AND DAYS OF RELEASE (kg/site/day ) /(da

y s) 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 5.95E

5 Rapid <2.5 7.55E

- 5

Exposure Units Results ASSUMPTIONS

ED (years) AT

(years) BW

(kg) IR

(L/day)

Cancer

LADD pot (mg/kg/day) 3.89E

- 04 33.00 78.00 80.00 1.04

LADC pot (mg/L) 2.99E

- 02 33.00 78.00 NA NA121 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

Num ber 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 μ g/m 3

Max 24 H our Average Air Concentration(Fugitive): N/A μ g/m 3

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 μ g/m 3

Max 24 Hour Average Air Concentration (Stack): N/A μ g/m 3122

Exposure Units Results

(Stack) Results

(Fugitive) ASSUMPTIONS

ED (years) AT

(years) BW

(kg) Inh. Rate

(m 3 /hr)

Cancer

LADD pot (mg/kg/day) 1.69E

- 03 N/A 33.00 78.00 80.00 0.61

LADC pot (mg/m 3 ) 9.22E

- 03 N/A 33.00 78.00 NA NA

Acute

ADR pot (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 He ight: 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

Te rrain 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 m123 INITIAL REVIEW EXP OSURE 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 Re leases: 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 DESCRIPTIO N: 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 ESTIMATE S

Exposure Units Drinking Water Results Drinking

Water Units Fish Ingestion Results Fish Ingestion Units

50% 10% 50% 10%

Cancer

LADD pot 2.83E

- 07 2.05E

- 06 mg/kg/day 1.48E

- 06 1.07E

- 05 mg/kg/day

LADC pot 2.17E

- 05 1.58E

- 04 mg/L 1.57E

- 02 0.11 mg/kg

Acute

ADR pot 1.65E

- 03 1.54E

- 02 mg/kg/day 4.73E

- 02 0.34 mg/kg/day125 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 CAL CULATION: 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 A nnual Average Air Concentration (Fugitive): 0.56 μ g/m 3

Max 24 Hour Average Air Concentration(Fugitive): 10.70 μ g/m 3

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 Releas e: 1700.00 kg/yr

Max Annual Average Air Concentration (Stack): 0.31 μ g/m 3

Max 24 Hour Average Air Concentration (Stack): 570.00 μ g/m 3126

Exposure Units Results

(Stack) Results

(Fugitive) ASSUMPTIONS

ED (years) AT

(years) BW

(kg) Inh. Rate

( m 3 /hr)

Cancer

LADD pot (mg/kg/day) 2.43E

- 05 4.34E

- 05 33.00 78.00 80.00 0.61

LADC pot (mg/m 3 ) 1.33E

- 04 2.37E

- 04 33.00 78.00 NA NA

Acute

ADR pot (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

Do wnwash Information: Facility Length: NA m
Facility Width: NA m
Facility Height: NA m127 INITIAL REVIEW EXPOSURE REPORT

Chemical ID : P

- 14

- 0683 Assessor:

ENVIRONMENTAL RELEASES

Scenario#: 4 Number of Release Sites: 20

.
Releas e 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 0.0 0 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

R ELEASE (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 Result s Drinking

Water Units Fish Ingestion Results Fish Ingestion Units

50% 10% 50% 10%

Cancer

LADD pot 2.01E

- 05 1.46E

- 04 mg/kg/day 1.05E

- 04 7.63E

- 04 mg/kg/day

LADC pot 1.55E

- 03 1.12E

- 02 mg/L 1.12 8.14 mg/kg

Acute

ADR pot 4.89E

- 04 4.56E

- 03 mg/kg/day 1 .40E

- 02 0.10 mg/kg/day129130 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 High131 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 INITIA L 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

LADD pot 2.03E

- 05 1.48E

- 04 mg/kg/day 1.06E

- 04 7.70E

- 04 mg/kg/day

LADC pot 1.56E

- 03 1.14E

- 02 mg/L 1.13 8.22 mg/kg

Acute

ADR pot N/A N/A mg/kg/day N/A N/A mg/kg/day133 INITIAL REVIEW EXPOSURE REPORT Chemical ID: P

- 14

- 0683

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 5 ACTIVI TY: 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

SLUDGE 1

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 releas e.

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

- 5134

Exposure Units Results ASSUMPTIONS

ED (years) AT

(years) BW

(kg) IR

(L/day)

Cancer

LADD pot (mg/kg/day) 1.66E

- 03 33.00 78.00 80.00 1.04

LADC pot (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 μ g/m 3

Max 24 Hour Ave rage Air Concentration(Fugitive): N/A μ g/m 3

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/yr135

Max Annual Average Air Concentration (Stack): 41.70 μ g/m 3

Max 24 Hour Average Air Concentration (Stack): N/A μ g/m 3

Exposure Units Results

(Stack) Results

(Fugitive) ASSUMPTIONS

ED (years) AT

(years) BW

(kg) Inh. Rate

(m 3 /hr)

Cancer

LADD pot (mg/kg/day) 3.23E

- 03 4.34E

- 05 33.00 78.00 80.00 0.61

LADC pot (mg/m 3 ) 1.76E

- 02 2.37E

- 04 33.00 78.00 NA NA

Acute

ADR pot (mg/kg/day) N/A N/A NA 1 day 80.00 0.61

Inhalation Comments:136

Stack Parameter Data Fugitive Parameter Data Stack Heig ht 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:

S urrounding 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 He ight: NA m137 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 ES TIMATES

Exposure Units Drinking Water Results Drinking

Water Units Fish Ingestion Results Fish Ingestion Units

50% 10% 50% 10%

Cancer

LADD pot 7.31E

- 07 5.32E

- 06 mg/kg/day 3.82E

- 06 2.78E

- 05 mg/kg/day

LADC pot 5.62E

- 05 4.09E

- 04 mg/L 4.07E

- 02 0.30 m g/kg

Acute

ADR pot 4.27E

- 03 3.98E

- 02 mg/kg/day 0.12 0.89 mg/kg/day139 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 C ALCULATION: 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 An nual Average Air Concentration (Fugitive): 8.98 μ g/m 3

Max 24 Hour Average Air Concentration(Fugitive): 160.00 μ g/m 3

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 Relea se: 831.00 kg/yr

Max Annual Average Air Concentration (Stack): 0.51 μ g/m 3

Max 24 Hour Average Air Concentration (Stack): 930.00 μ g/m 3140

Exposure Units Results

(Stack) Results

(Fugitive) ASSUMPTIONS

ED (years) AT

(years) BW

(kg) Inh. Rate

( m 3 /hr)

Cancer

LADD pot (mg/kg/day) 3.96E

- 05 6.95E

- 04 33.00 78.00 80.00 0.61

LADC pot (mg/m 3 ) 2.16E

- 04 3.80E

- 03 33.00 78.00 NA NA

Acute

ADR pot (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

S tack 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

Downwa sh Information:

Facility Length: NA m
Facility Width: NA m
Facility Height: NA m141 INITIAL REVIEW EXPOSURE REPORT

Chemical ID : P

- 14

- 0683 Assessor:

ENVIRONMENTAL RELEASES

Scenario#: 7 Number of Release Sites: 6

.
Release A ctivity: 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
RE LEASES

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

REL EASE (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 3 0Q5 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
R esults Drinking

Water Units Fish Ingestion Results Fish Ingestion Units

50% 10% 50% 10%

Cancer

LADD pot 1.33E

- 04 9.67E

- 04 mg/kg/day 6.95E

- 04 5.05E

- 03 mg/kg/day

LADC pot 1.02E

- 02 7.44E

- 02 mg/L 7.41 53.88 mg/kg

Acute

ADR pot 3.11E

- 03 2.90E

- 02 mg/kg /day 8.92E

- 02 0.65 mg/kg/day143 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 rec eive 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 High144 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 IN ITIAL 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 PO TWs 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

LADD pot 1.33E

- 04 9.70E

- 04 mg/kg/day 6.97 E

- 04 5.07E

- 03 mg/kg/day

LADC pot 1.03E

- 02 7.46E

- 02 mg/L 7.43 54.04 mg/kg

Acute

ADR pot N/A N/A mg/kg/day N/A N/A mg/kg/day146 INITIAL REVIEW EXPOSURE REPORT Chemical ID: P

- 14

- 0683

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 8 A CTIVITY: 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

SLUDGE 1

AND DAYS OF RELEASE (kg/site/day ) /(day s) MIGRATION

DESCRIPTO
R 2 ADSORP TIO

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 5.95E

5 Rapid <2.5 7.55E

- 5

Exposure Units Results ASSUMPTIONS

ED (years) AT

(years) BW

(kg) IR

(L/day)

Cancer

LADD pot (mg/kg/day) 3.70E

- 03 33.00 78.00 80.00 1.04

LADC pot (mg/L) 0.28 33.00 78. 00 NA NA147 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 μ g/m 3

Max 24 Hour Average Air Concentration(Fugitive): N/A μ g/m 3

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 (St ack): 93.00 μ g/m 3

Max 24 Hour Average Air Concentration (Stack): N/A μ g/m 3148

Exposure Units Results

(Stack) Results

(Fugitive) ASSUMPTIONS

ED (years) AT

(years) BW

(kg) Inh. Rate

(m 3 /hr)

Cancer

LADD pot (mg/kg/day) 7.20E

- 03 6.95E

- 04 33.00 78.00 80.00 0.61

LADC pot (mg/m 3 ) 3.93E

- 02 3.80E

- 03 33.00 78.00 NA NA

Acute

ADR pot (mg/kg/day) N/A N/A NA 1 day 80.00 0.61

Inhalation Comments: Stack Parameter Data Fugitive Paramete r 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

Faci lity Height: NA m149 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 ACTI VITY: 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

LADD pot 8.79E

- 07 1.11E

- 05 mg/kg/day 4.59E

- 06 5.81E

- 05 mg/kg/day

LADC pot 6.76E

- 05 8.56E

- 04 mg/L 4.90E

- 02 0.62 mg/kg

Acut e

ADR pot 3.43E

- 04 7.87E

- 03 mg/kg/day 8.19E

- 03 0.10 mg/kg/day151152 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 CALCULA TION: 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 μ g/m 3

Max 24 Hour Average Air Concentration(Fugitive): 64.20 μ g/m 3

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: 4.8 8E+05 kg/yr

Max Annual Average Air Concentration (Stack): 0.58 μ g/m 3

Max 24 Hour Average Air Concentration (Stack): 58.90 μ g/m 3153

Exposure Units Results

(Stack) Results

(Fugitive) ASSUMPTIONS

ED (years) AT

(years) BW

(kg) Inh. Rate

(m 3 /hr)

Cancer

LADD pot (mg/kg/day) 4.50E

- 05 2.69E

- 04 33.00 78.00 80.00 0.61

LADC pot (mg/m 3 ) 2.46E

- 04 1.47E

- 03 33.00 78.00 NA NA

Acute

ADR pot (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

Sta ck 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

Downw ash Information:

Facility Length: NA m
Facility Width: NA m
Facility Height: NA m154 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
REL EASES

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 (k g/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 1 Q10

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

LADD pot 1.09E

- 05 1.38E

- 04 mg/kg/day 5.69E

- 05 7.20E

- 04 mg/kg/day

LADC pot 8.39E

- 04 1.06E

- 02 mg/L 0.61 7.68 mg/kg

Acute

ADR pot 3.10E

- 04 7.11E

- 03 mg/kg/day 7.40E

- 03 9.36E

- 02 mg/kg/day156 INITIAL REVIEW EX POSURE 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) Perce nt 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 High157 INITIAL REVIEW EXPOSURE REPORT

Chemical ID : P

- 14

- 0683 Assessor:

ENVI RONMENTAL 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 EXPOSUR E 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
TY PE % 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 Dr inking Water Results Drinking

Water Units Fish Ingestion Results Fish Ingestion Units

50% 10% 50% 10%

Cancer

LADD pot 1.10E

- 05 1.39E

- 04 mg/kg/day 5.74E

- 05 7.26E

- 04 mg/kg/day

LADC pot 8.45E

- 04 1.07E

- 02 mg/L 0.61 7.74 mg/kg

Acute

ADR pot N/A N/A mg /kg/day N/A N/A mg/kg/day159160 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

SLUDGE 1

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 S low 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 Concent ration (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

LADD pot (mg/kg/day) 2.85E

- 04 33.00 78.00 80.00 1.04

LADC pot (mg/L) 2.20E

- 02 33.00 78.00 NA NA161 INITIAL REVIEW EXPOSURE REPORT Chemical ID : P

- 14

- 0683

INHALATION EXPOSURE ESTIMATES (POST

- TREATMENT)

SCE NARIO #: 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

% Rem oval via Fugitive Release: 0.00 %

Total Fugitive Release: 3.60E+05 kg/yr

Max Annual Average Air Concentration (Fugitive): 3.48 μ g/m 3

Max 24 Hour Average Air Concentration(Fugitive): N/A μ g/m 3

Per Site Stack Release: 1943.52 kg/site/day

Stack Release D ays 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 μ g/m 3

Max 24 Hour Average Air Concentration (Stack): N/A μ g/m 3162

Exposure Units Results

(Stack ) Results

(Fugitive) ASSUMPTIONS

ED (years) AT

(years) BW

(kg) Inh. Rate

(m 3 /hr)

Cancer

LADD pot (mg/kg/day) 5.55E

- 04 2.69E

- 04 33.00 78.00 80.00 0.61

LADC pot (mg/m 3 ) 3.03E

- 03 1.47E

- 03 33.00 78.00 NA NA

Acute

ADR pot (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

Mete orological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m
Facility Width: NA m
Facility Height: NA m163 INITIAL REVIEW EXPOSURE REPORT

Chemical ID : P

- 14

- 0683 Assessor:

ENVIRONMENTAL RE LEASES

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 EXPO SED 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 % I LE 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

Exp osure Units Drinking Water Results Drinking

Water Units Fish Ingestion Results Fish Ingestion Units

50% 10% 50% 10%

Cancer

LADD pot 4.10E

- 06 4.81E

- 05 mg/kg/day 2.14E

- 05 2.51E

- 04 mg/kg/day

LADC pot 3.15E

- 04 3.70E

- 03 mg/L 0.23 2.68 mg/kg

Acute

ADR p ot 7.92E

- 05 2.35E

- 03 mg/kg/day 2.75E

- 03 3.22E

- 02 mg/kg/day165166 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 CALCULATI ON: 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 Ave rage Air Concentration (Fugitive): 18.00 μ g/m 3

Max 24 Hour Average Air Concentration(Fugitive): 330.00 μ g/m 3

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 μ g/m 3

Max 24 Hour Average Air Concentration (Stack): 710.00 μ g/m 3167

Exposure Units Results

(Stack) Results

(Fugitive) ASSUMPTIONS

ED (years) AT

(years) BW

(kg) Inh. Rate

(m 3 /hr)

Cancer

LADD pot (mg/kg/day) 7.53E

- 03 1.39E

- 03 33.00 78.00 80.00 0.61

LADC pot (mg/m 3 ) 4.11E

- 02 7.62E

- 03 33.00 78.00 NA NA

Acute

ADR pot (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

Sta ck 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 m168 INITIAL REVIEW EXPOSURE REPORT

Chemical ID : P

- 14

- 0683 Assessor:

ENVIRONMENTAL RELEASES

Scenario#: 13 Number of Release Sites: 16

.
Release Ac tivity: 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 0.0 0

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 RELEAS ES

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) POSTTREAT MENT

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 Inges tion Results Fish Ingestion Units

50% 10% 50% 10%

Cancer

LADD pot 4.10E

- 06 4.81E

- 05 mg/kg/day 2.14E

- 05 2.51E

- 04 mg/kg/day

LADC pot 3.15E

- 04 3.70E

- 03 mg/L 0.23 2.68 mg/kg

Acute

ADR pot 7.92E

- 05 2.35E

- 03 mg/kg/day 2.75E

- 03 3.22E

- 02 mg/kg/day170 INITI AL 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 High171 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 INITIA L 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 ES TIMATES

- 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

DRI NKING 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

LADD pot 4.10E

- 06 4.81E

- 05 mg/kg/day 2.14E

- 05 2.51E

- 04 mg/kg/day

LADC p ot 3.15E

- 04 3.70E

- 03 mg/L 0.23 2.68 mg/kg

Acute

ADR pot N/A N/A mg/kg/day N/A N/A mg/kg/day173174 INITIAL REVIEW EXPOSURE REPORT Chemical ID: P

- 14

- 0683

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 14 ACTIVITY: USE 2: Max LADD

REL EASE DESCRIPTION:

EXPOSED POPULATION: Adult

NUMBE R OF SITES NON

- SLUDGE

LANDFILL RELEASE AND DAYS OF RELEASE (kg/site/day ) /(day s) LANDFILLED

SLUDGE 1

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 releas e.

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

LADD pot (mg/kg/day) 3.86E

- 03 33.00 78.00 80.00 1.04

LADC pot (mg/L) 0.30 33.00 78.00 NA NA175 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 μ g/m 3

Max 24 Hour Average Air
Conce ntration(Fugitive): N/A μ g/m 3

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 μ g/m 3

Max 24 Hour Average Air Concentration (Stack): N/A μ g/m 3176

Exposure Units Results

(Stack) Results

(Fugitive) ASSUMPTIONS

ED (years) AT

(years) BW

(kg) Inh. Rate

(m 3 /hr)

Cancer

LADD pot (mg/kg/day) 7.51E

- 03 1.39E

- 03 33.00 78.00 80.00 0.61

LADC pot (mg/m 3 ) 4.10E

- 02 7.62E

- 03 33.00 78.00 NA NA

Acute

ADR pot (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:

Surroundi ng 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 m177 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: 1 6

. 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 μ g/m 3

Max 24 Hour Average Air Concentration(Fugitive): N/A μ g/m 3

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): 9 7.00 μ g/m 3

Max 24 Hour Average Air Concentration (Stack): N/A μ g/m 3

ASSUMPTIONS178

Exposure Units Results

(Stack) Results

(Fugitive) ED

(years) AT

(years) BW

(kg) Inh. Rate

(m 3 /hr)

Cancer

LADD pot (mg/kg/day) 7.51E

- 03 1.39E

- 03 33.00 78.00 80.00 0.61

LADC pot (mg/m 3 ) 4.10E

- 02 7.62E

- 03 33.00 78.00 NA NA

Acute

ADR pot (mg/kg/day) N/A N/A NA 1 day 80.00 0.61

Inhalation Comments:

Stack Parameter Data Fugitive Parameter Da ta 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 Infor mation:

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