### Attachment **VII –**  **Sustainable Futures P2 Assessment for {**  **PPG }** **02 3** 

This chemical is the subject of a P2 Assessment for participation in the Sustainable Futurestm Initiative. The P2 assessment of { Poly(oxy
- 1,4- butanediyl), alpha
- hydro
-gamma - hydroxy
-, polymer with 1,6- diisocyanato hexane and 1,1’
- methylenebis[4
- isocyanatocyclohexane] }, referred to as { PPG }02 3 in the assessment, directly follows this cover letter. This summary includes the collection of results, assessment methods, and conclusions from the Sustainable Futurestm P2 Framework evaluation of this substance. The original modeling outputs and additional detail can be provided upon request. Incomplete data were available for { PPG }02 3 and predictive methods were employed in the assessment of the chemi cal. Evaluation of this isocyanate
-containing polymeric substance was based on review of the polymer properties, as well as evaluation of residual monomer . { PPG }02 3 is predicted to have a high overall concern for persistence, with an environmental half
- l ife of > 180 days. { PPG }02 3 is predicted to have a low concern for bioaccumulation. { PPG }02 3 is predicted to have a low hazard concern for aquatic toxicity . { PPG }02 3 is predicted to have low hazard concerns for acute and cancer human health effects. However, the substance has been predicted to pose a moderate hazard concern for chronic human health hazards, as well as to have the potential for skin and respiratory tract sensitization. The conclusion of the { PPG }02 3 aquatic risk assessment is that, b ased on low hazard, there is a low potential for risk. The conclusion of the { PPG }02 3 general population human health risk assessments is that, based on the predicted hazards and modeled exposure for the substance, there is a low potential for risk. The conclusion of the { PPG }023 occupation al risk assessment is that, based on the hazards identified for the substance, there is the potential for occupation al dermal risk associated with the manufacture and use of the substance. It should be noted that thi s risk assessment does not take PPE and other exposure controls into account when determining exposure and risk . The { PPG } MSDS, which is included with the PMN , indicates that workers should wear gloves and use other personal protective measures when hand ling { PPG }02 3 or when exposure may occur. Further, both { PPG Industries, Inc . } and the customer which will use { PPG }023 have significant experience in the safe handling and use of isocyanate materials and participate in health and safety plans to reduce exposure to potentially hazardous substances. It is our opinion that based on this assessment of the chemical and information included in the PMN submission and manufacturer’s MSDS, including use of gloves and appropriate exposure controls, { PPG }02 3 will not pose an unreasonable risk to human health or the environment.

# Sustainable Futures

**Summary Assessment Using**  **P2 Framework Models**

**Chemical Assessed:** { PPG }023 **CAS Registry Number:** N/A **Participant Name:** { PPG Industries, Inc . } **Date of Assess ment:**  12/09/2011 This document was developed to help compile estimation results from U.S. EPA OPPT’s P2 Fram ework Models and is used by O PPT during Susta inable Futures (SF) training described on the US EPS Sustainable Futures hom epage at: http://www.epa.gov/oppt/sf/
. Participants in the voluntary SF Pilot Project are asked to submit the information contained in this assessment along with their SF PMNs in their choice of format. **Use of this specific format is not mandatory.**3 **Record ID: {**  PPG }023 **Submitter: {**  PPG Industries, In c . **} Chemical Structure** 

**Is this a representative structure?** Yes **Mn :**  4,124 Dalton s **% <1,000:** 5.1%; **% <500:** 2.4% **Physical Form:** Solid (neat) **CAS RN:** N/A **Trade Nam e:**  PMN 5079 **Use: {**  Component in Golf Ball Resins } **Production Volume:** 730,000 kg/yr **SMILES:** SMILES not used **Name: {**  Poly(oxy
- 1,4- butanediyl), alpha
- hydro
-gamma - hydroxy
-, polymer with 1,6-diisocyanato hexane and 1,1’
- methylenebis[4
- isocyanatocyclohexane ] } **Synonyms:** PMN 5079 **SUSTAINABLE FUTURES SUMMARY:**

**Concern Level HIGH**  **MODERATE LOW**  **Persistence X**  **Bioconcentration X**  **Non -** **Cancer Health Hazard X**  **Cancer Health Hazard X**  **Aquatic Toxicity Hazard X**  **Is the chemical predicted to be a PBT by PB T Profiler?**  Not Run in PBT Profiler

**Overall Hazard Concern Human Health Hazard:**  Moderate **Aquatic Hazard:** Low **Overall Risk Human Health Risk:**  The Potential for Occupational Dermal Risk Exists **Aquatic Risk:** Low4 **Record ID: {**  PPG }023 **Submitter: {**  PPG Ind ustries, In c . **} PHYSICAL/CHEMICAL PROPERTIES:**  **Melting Point (deg C)** >20 °C (professional judgment) **Boiling Point (deg C)** Decomposes prior to boiling (professional judgment) **Boiling Point Pressure (mm Hg)** 760 **Vapor Pressure (mm Hg)** <10-8 (professional judgment) **Water Solubility** <1 mg/L (professional judgment) **Log K ow**  Not assessed **ENVIRONMENTAL TRANSPORT AND FATE:**

**Transport Henry’s Law Constant**  **– HLC (atm**  **- m**  **3 /mol)**  <10-8 (professional judgment) **Soil Adsorption Coefficient –**  **Log K oc**  Strong sorption to soil; negligible migration potential (professional judgment) **Bioconcentration Factor –**  **BCF** Low BCF Concern for polymer or unreacted monomer; 10 used for E
- FAST (professional judgment; EPI) **Persistence Experimental Biodeg Tests**  >180 day half
- life for b iodegradation, based on large size and hydrophobicity (professional judgment) **Probability of Rapid Biodegradation** Will not biodegrade fast (professional judgment) **Ultimate Biodeg Model Primary Biodeg Model**  **Ready Biodegradability** Not Ready Biodegradab le (professional judgment) **Atmospheric Half -**  **life** N/A due to lack of partitioning (professional judgment) **Hydrolysis Half -**  **life** Isocyanate hydrolysis rapid; amide hydrolysis slow (professional judgment) **Volatilization Half -**  **life for Model River** >1 year (professional judgment) **Volatilization Half -**  **life for Model Lake** >1 Year (professional judgment) **Removal in Sewage Treatment Plant** >90% ( PGD 2010) **Byproducts Degradation Products**  **Metabolites**5 **Record ID: {**  PPG0 }23 **Submitter: {**  PPG Industries, In c . **} E**  **COTOXICITY: ECOSAR Class**  Amides (monomer only) **Acute Toxicity Fish LC**  **5O** Low, based on NES for polymer or unreacted monomer* **Daphnid LC 5O**  Low, based on NES for polymer or unreacted monomer* **Green Algae EC 5O**  Low, based on NES for polymer or unreacted mo nomer* **Chronic Toxicity Fish ChV**  Low, based on NES for polymer or unreacted monomer* **Daphnid ChV** Low, based on NES for polymer or unreacted monomer* **Green Algae ChV** Low, based on NES for polymer or unreacted monomer* **Notes** * NES – No Effects at Saturation **Overall Aquatic Toxicity Hazard Concern** Low **NON -** **CANCER HEALTH EFFECTS: Acute Toxicity**  Low, based on 4,4 ́
- Methylenedicyclohexyl diisocyanate ( MDDI; CAS RN 5124- 30- 1 ), oral LD 50 of 1,065 mg/kg in rats (OECD 2005) **Irritation** Skin irritant, based on Primary Irritation Index of 5.5 of MDDI in rabbits; irritating to eyes (IUCLID 2004) **Skin Sensitizer** Positive, based on MDDI, skin and respiratory sensitizer in humans and animals, SD 50 of 0.20 mg/kg in mice ; occupational reports of contact dermatitis for isocyanate exposed workers (Stadler 1985) **Reproductive Effects** Moderate, based on MDDI, reproductive NOAEL of 3 mg/kg
-day in rat, aerosol, slightly reduced fertility (OECD 2005) **Developmental Effects** Moderate, based on MDDI, mild defects in offspring n ot greater than historical levels in controls (OECD 2005) **Immune System Effects** Moderate, based on MDDI, proliferation of lymphocytes in rats and i mmune system changes in exposed populations (IUCLID 2004) **Neurotoxicity** Inadequate information identifie d **Genotoxicity** Negative, based on MDDI , negative in Chinese Hamster Cell assay (OECD 2005) **Mutagenicity** Negative, based on MDDI, negative Ames test (OECD 2005) **Systemic Effects** Low, based on MDDI, subacute study indicated adverse effects were the result of local respiratory tract irritation (OECD 2005) **Overall Human Health Non -** **Cancer Hazard Concern** Moderate **CANCER HEALTH EFFECTS: Experimental data**  No specific evidence of carcinogenicity, but negative mutagenicity data suggest a low concern for MDDI **OncoLogic Results** Low, based on Polymers SAR **Overall Human Carcinogenicity Hazard Concern** Low6 **Record ID: {**  PPG }023 **Submitter: {**  PPG Industries, In c . **} INDUSTRIAL OPERATIONS INFORMATION**  **: Operation Name**  Manufacture **Number of S ites**  1 **Location** { PPG Ind ustries, Inc . , Oak Creek, WI Facility} **Operating Days Per Year** 54 total days/year (43, 30 hour batches) **INDUSTRIAL RELEASE SUMMARY :**  **Media Daily Release** 

**(kg/site -** **day) Release Days** 

**per Year No**  **. of Sites** 

**of Release Total Annual Releases** 

**(kg/year -** **all site s)**  **Release Site I nformation**  **and Control Efficiency**  Incineration 34 43 1 1,460 Incineration; 99% Efficiency

**OCCUPATIONAL EXPOSURE SUMMARY :**  **Route Dose Rate**  **Days/yr No.**  **Workers Cancer LADD**  **Chronic ADD Acute APDR**  **Dermal** 1,480 43 1 1. 4 mg/kg
-day 2.5 mg/kg
-day 21 mg/kg
-day **Inhalation** N/A
– Low VP **Total number of Workers –**  **All Sites** 2 **GENERAL POPULATION EXPOSURE SUMMARY :**  **Cancer LADDpot Chronic ADDpot**  **Acute ADRpot Drinking Water**  **Fish Ingestion Fugitive Emissions**  **Inc ineration Emissions**  0 mg/kg
-day (VP below concern level for exposure) 0 mg/kg
-day (VP below concern level for exposure) 0 mg/kg
-day (VP below concern level for exposure) **Landfill Leaching Dermal**  **– Consumer Use**  **Inhalation –**  **Consumer Use**7 **Reco rd ID:**  **{** PPG }023 **Submitter: {**  PPG Industries, In c . } **INDUSTRIAL OPERATIONS INFORMATION: Operation Name**  Manufacture **Number of Sites** 1 **Location** { PPG Industries, Inc., Oak Creek, WI Facility} **Operating Days Per Year** 54 total days/year (43, 30 hour batches) **AQUATIC RISK ASSESSMENT Acute Profile**  **E ndpoint**  **Effect Level (ppb)**  **Assess ment** 

**Factor Acute COC** 

**(ppb) PEC (ppb)**  **Potential for Risk?**  Fish NES 5 N/A 0 Low Daphnid NES 5 N/A 0 Low Green Algae NES 4 N/A 0 Low **Chronic Profile**  **E ndpoint**  **Effect Level (ppb** **) Assess**  **ment**

**Factor Chronic**  **COC**

**(ppb) PEC** 

**(ppb) Days of**  **Exceedence Potential** 

**for Risk?** Fish NES 10 N/A 0 0 Low Daphnid NES 10 N/A 0 0 Low Green Algae NES 10 N/A 0 0 Low

**HUMAN HEALTH RISK ASSESSMENT Hazard Concern**  **NOAEL / LOAEL**  **(mg/kg -** **d) Exposure**  **Dose and**

**Source (mg/kg** **- d)**  **MOE Potential**  **for Risk? Occupational**  **Risk** Reproductive Effects 3 mg/kg
-day (NOAEL) 2.5 mg/kg
-day

(dermal exposure) 1.2 Yes

**General Population Risk**  Reproductive Effects 3 mg/kg
-day (NOAEL) 0 mg/kg
-day

(Incinerator E missi ons ADD ) N/A Low
**AQUATIC RISK**  **ASSESSMENT SUMMARY**  **Lowest Acute COC –**  **Aquatic Exposure** N/A
– Low Hazard **Lowest Chronic COC –**  **Aquatic Exposure** N/A
– Low Hazard **Predicted Environmental Concentration (PEC)** 0 ppb **PEC Exceeds Chronic COC (days / year)** 0 days/year **HEALTH RISK ASSESSMENT**  **SUMMARY MOE**  **– Acute Occupational Exposure**  N/A
– Low Hazard **MOE –**  **Chronic Occupational Exposure** 1.2 **MOE –**  **Acute General Population Exposure** N/A
– Low Hazard **MOE –**  **Chronic General Population Exposure** N/A
– Lack of Exposure8 **Record ID: {**  PPG }023 **Submitter: {**  PPG Industries, In c . **} INDUSTRIAL OPERATIONS INFORMATION:**  **Operation Name** Use **Number of Sites** 1 **Location** {Acus h net – BP3 New Bedford, MA} **Operating Days Per Year** 250
**INDUSTRIAL RELEASE SUMMARY: Media**  **Daily R elease** 

**(kg/site -** **day) Release Days** 

**per Year No. of Sites** 

**of Release Total Annual Releases** 

**(kg/year -** **all sites) Release Site Information**  **and Control Efficiency** Water 87.6 250 1 21,900 POTW; 90% Removal { NPDES MA0100781 (New Bedford, MA POTW) }

**OCCUPATIONAL EXPOSURE SUMMARY: Route**  **Dose Rate Days/yr**  **No. Workers Cancer LADD**  **Chronic ADD Acute APDR**  **Dermal** 1,480 250 2 8.3 mg/kg
-day 14 mg/kg
-day 21 mg/kg
-day **Inhalation** N/A
– Low VP **Total number of Workers –**  **All Sites** 2 **GENERAL POPU LATION EXPOSURE SUMMARY:**  **Cancer LADDpot Chronic ADDpot**  **Acute ADRpot Drinking Water**  N/A
– Not Drinking Water N/A
– Not Drinking Water N/A
– Not Drinking Water **Fish Ingestion** 2. 2 x 10 - 5 mg/kg
-day 4.1 x 10 - 5 mg/kg
-day 1. 8 x 10 - 3 mg/kg
-day **Fugitive Emissi ons**  **Incineration Emissions Landfill Leaching**  **Dermal –**  **Consumer Use Inhalation**  **– Consumer Use** 9 **Record ID: {**  PPG }023 **Submitter: {**  PPG Industries, In c . } **INDUSTRIAL OPERATIONS INFORMATION: Operation Name**  Use **Number of Sites** 1 **Location** {Acus h net – BP3 New Bedford, MA} **Operating Days Per Year** 250 **AQUATIC RISK ASSESSMENT Acute Profile**  **E ndpoint**  **Effect Level (ppb)**  **Assess ment** 

**Factor Acute COC** 

**(ppb) PEC (ppb)**  **Potential for Risk?**  Fish NES 5 N/A 98 Low Daphnid NES 5 N/A 98 Low Green Al gae NES 4 N/A 98 Low **Chronic Profile**  **E ndpoint**  **Effect Level (ppb)**  **Assess ment** 

**Factor Chronic**  **COC**

**(ppb) PEC** 

**(ppb) Days of**  **Exceedence Potential** 

**for Risk?** Fish NES 10 N/A 98 0 Low Daphnid NES 10 N/A 98 0 Low Green Algae NES 10 N/A 98 0 Low

**HUMAN HEALTH RISK ASSESSMENT**  **Hazard Concern NOAEL** **/ LOAEL (mg/kg** **- d)**  **Exposure Dose and**

**Source (mg/kg** **- d)**  **MOE Potential**  **for Risk? Occupational**  **Risk** Reproductive Effects 3 mg/kg
-day (NOAEL) 14 mg/kg
-day

(dermal exposure ADD) 0.21 Yes

**General Population Risk**  Re productive Effects 3 mg/kg
-day (NOAEL) 4.1 x 10 - 5 mg/kg
-day

(Fish Ingestion ADD) 73,000 Low **AQUATIC RISK**  **ASSESSMENT SUMMARY**  **Lowest Acute COC –**  **Aquatic Exposure** N/A
– Low Hazard **Lowest Chronic COC –**  **Aquatic Exposure** N/A
– Low Hazard **Predicted En vironmental Concentration (PEC)**  0 ppb **PEC Exceeds Chronic COC (days / year)** 0 days/year **HEALTH RISK ASSESSMENT**  **SUMMARY MOE**  **– Acute Occupational Exposure**  N/A
– Low Hazard **MOE –**  **Chronic Occupational Exposure** 0.21 **MOE –**  **Acute General Population Exposure** N/A
– Low Hazard **MOE –**  **Chronic General Population Exposure** 73,000**Record ID: {**  PPG }023 **Submitter: {**  PPG Industries, Inc. **}**

10 **SUMMARY CONCLUSIONS: Occupational Risk:**  **Risk of Non -** **Cancer Acute Effects from Occupational Exposure:** Low based on low hazard **Risk of**  **Non -** **Cancer Chronic**  **Effects from**  **Occupational Exposur** **e:** The potential for dermal risk exists based on calculated MOEs **Risk of Cancer Effects from Occupational Exposure:**  Low based on low hazard **General Population Risk: Risk of Non** **- Cancer Acute Effects to General Population:**  Low based on low hazard **Risk of No n** **- Cancer Chronic Effects to General Population:**  Low based on calculated MOEs **Risk of Cancer Effects to General Population:** Low based on low hazard **Aquatic Risk: Acute Risk to the Aquatic Environment:**  Low based on low hazard **Chronic Risk to the Aquatic Env ironment:**  Low based on low hazard **Notes on Polymer Size and Assessment Strategy** { PPG }023 is a polymer of Mn of 4,124 amu, with 5.1% of material with MW of <1,000 and 2.4% of material with MW of <500. Based on these MW consideration s, evaluation of the polymer is based on the overall size and not based on oligomeric structures. { However, as much as 17% of residual 4,4 ́
- Methylenedicyclohexyl diisocyanate (MDDI; CAS RN 5124-30- 1 ) monomer and 7.5% residual 1,6
- hexane diisocyanate homopo lymer ( CAS RN 28182 -81 -2) monomer may remain in the mixture. EPA guidance on assessment of isocyanate polymers indicates that if more than 50% of free isocyanate moieties exist in the polymeric mixture as the result of unreacted monomer, th e n human health assessment should be based on the monomer (EPA 2010). Calculations of isocyanate from polymer versus residual monomer for PPG023 indicate that >50% of free isocyanate equivalents are from residual monomer and the monomer will be considered in the human h ealth assessment and ecotoxicity assessments of the substance. Based on available data and other considerations, the 4,4 ́
- Methylenedicyclohexyl diisocyanate (MDDI; CAS RN 5124-30- 1 ) monomer was chosen as the basis for calculations and hazard assessment fo r PPG 023. Additional discussion of the assessment methodology will be discussed in the individual sections below. The PPG023 calculations of isocyanate per species are shown in Appendix 1 below. } **Note on Hydrolysis** { PPG }023 contains isocyanate end
-grou ps. Isocyanates are known to hydrolyze very rapidly in the presence of water, generally with a half
- life of <1 hour at room temperature. { PPG }023 is expected to be practically insoluble in water, which may reduce the hydrolysis rate; however, due to the sensitivity of the isocyanate functionality to hydrolysis, this reaction is still expected to be rapid for the polymer . U nreacted monomers and smaller materials are expected to hydrolyze very rapidly . Hydrolysis, as it pertains to the human health and ecotoxicity hazard assessments for { PPG }023, will be discussed in the assessment sections below.**Record ID: {**  PPG }023 **Submitter: {**  PPG Industries, Inc. **}**

11 **Physical/Chemical Properties** { PPG }023 is a large polymer with a Mn of 4,1 24 amu, 5.1% of material with MW of <1,000 and 2.4% of material s with MW of <500. The substance is maintained as a solution or dispersion during manufacture and use. The physical chemical property assessment of the substance is based on estimation for similar polymeric materials. Based on the size, { PPG }023 is expe cted to be a solid at room temperature when neat. The material is predicted to have a high boiling point and would likely decompose prior to boiling. I n addition, the vapor pressure is expected to be negligible, estimated at <10
-8 mm Hg at room temperatu re. The material is predicted to be nearly insoluble in water, with a water solubility of <1 mg/L. { PPG }023 is a large poly functional polymer and is predicted to have negligible solubility in water and in octanol, due to this the prediction of an accura te log Kow would be difficult and this property has not been estimated for the substance. **Bioconcentration Factor** { PPG }023 is a polymer with Mn of >1,000 and < 10% LMW (low molecular weight) component content; however, up to 17% unreacted isocyanate mono mer may be present. Th e polymeric substance is predicted to be too large to be readily bioavailable and will have a low concern for bioaccumulation (PGD 2010). The residual isocyanate monomer, evaluated as the fully hydrolyzed amide, is predicted by EPI Suite to have a low bioconcentration concern as well. Based on these considerations, { PPG }023 is predicted to have a low BCF concern. E - FAST requires a numeric BCF for modeling purposes and 10, which is within the range of low concern, was used . **Enviro nmental Fate**  { PPG }023 is a polymer with Mn of 4,124 amu, with a low incidence of LM W materials and significant residual monomer. In order to be consistent with a worst case scenario, t he environmental fate assessment of { PPG }0 23 will focus on the polymer itself, rather than residual monomer. Based on the size and structure of { PPG }0 23 , > 90% of the polymer is predicted to be removed during waste water treatment at a POTW ( Boethling et al. 1997 ). { PPG }0 23 is expected to exist solely as a particulate in t he atmosphere (air) and settling of the chemical to surfaces may occur. Due to the size of the substance and negligible water solubility, it is expected to bind strongly to soil and sediments and have negligible potential to migrate to groundwater. { PPG }023 is not expected to volatilize from water or moist soil at an appreciable rate, with an estimated half
- life for volatilization from the model lake or river of >1 year. { PPG }023, b ased on the above considerations, i s expected to partition mainly to soil and sediment in the environment . { PPG }023 is predicted to partition mainly to soil and sediment in the environment and degradation in these media will be most relevant to th e overall persistence of the chemical. As noted above, { PPG }0 23 contains isocyan ate end
groups that are expected to hydrolyze in the environment. D ue to the rapid predicted rate of the isocyanate hydrolysis, the material is expected to exist primarily in the hydrolyzed for m in the environment. The polymer also contains carbamate fun ctional groups, but these will not hydrolyze to an appreciable extent in the environment. Overall, since the isocyanate functionalities are contained on , or are end
-groups and hydrolysis of these does not significantly alter the large polymer, and given t he predicted lack of hydrolysis for the carbamate groups, hydrolysis is not considered a significant removal pathway for { PPG }023. The chemical will not partition to the atmosphere to a significant extent and atmospheric oxidation is not expected to be a major route of degradation. Due to partitioning and stability, the main route of environmental removal of the chemical is expected to be biodegradation. { PPG }0 23 is a polymer with Mn of 4,124; the substance is predicted to bind very strongly to soil and sediment, and partition significantly to those media. These factors indicate that the chemical is likely to biodegrade slowly, with a n estimated half
- life for biodegradation of >180 days; this is consistent with a high concern level for persistence.**Record ID: {**  PPG }023 **Submitter: {**  PPG Industries, Inc. **}**

12 Overall, { PPG }023 is expected to partition mainly to soil and sediment, where it will have a high concern for persistence.**Record ID: {**  PPG }023 **Submitter: {**  PPG Industries, Inc. **}**

13 **Aquatic Hazard** No measured ecotoxicity data were available for { PPG }0 23 and the aquatic toxicity hazard is based on professional judgm ent and predictive methods. As discussed above, { PPG }023 is a polymer with Mn of 4,124 and a low incidence of LMW material. I n addition, there may be up to 17% residual isocyanate monomer in the polymeric mixture. Due to these considerations, evaluation of { PPG }023 will be based on the polymer and residual isocyanate monomer. The { PPG }023 polymer itself is a large substance that is not expected to be bioavailable or soluble enough to result in toxicity hazard to aquatic organisms and is predicted to show no effects at saturation (NES) , which is consistent with a low hazard concern ( Boethling et al. 1997 )
. E COSAR was used to evaluate the hydrolyzed form of the residual { isocyanate monomer ( MDDI ) }; this results in estimated effect level s of >100 mg/L for acute and >10 mg/L for chronic, which is also consistent with a low hazard concern level for ecotoxicity . B ased on these considerations, { PPG }023 is predicted to have a low overall hazard concern level for aquatic effects. Overall, ba sed on evaluation of the polymer a nd residual monomer, { PPG }0 23 is predicted to have a low aquatic toxicity hazard concern level. **Human Health Non -** **Cancer Hazard** No anim al data are available for { PPG }023. However, { PPG }023 is a polymer containing {4,4’
- methylenedicyclohexyl diisocyanate (MDDI; CAS RN 5124-30- 1 ) with up to 17% } of the residual monomer remaining in the solution . In addition, calculations indicate that { >50% of the free isocyanate equivalents are from unreacted MDDI monomer }(EPA 2010). Due to the se considerat ions, the { PPG }023 human health assessment will be based primarily on { MDDI, } as well as studies on the isocyanates class, including occupational exposures to diisocyanates . Isocyanate based polymers are common in many occupational settings, and are well
-c haracterized in terms of exposure routes and hazards. The primary routes of exposure are inhalation and dermal. I socyanates can be absorbed through the skin, and this is a route of exposure that appears to cause asthma. Isocyanates can also be absorbed v ia inhalation, as has been demonstrated in both animal models and occupational biomarker studies. Compari sons of animal models to human biomarker studies ha ve indicated that animal models underestimate human absorption by the route (Monso 2001), and therefore animal data from this route must be used cautiously, especially since exposures are usually to several species of isocyanates . Although many isocyanates have relatively high acute toxicity, { MDDI } has relatively low acute toxicity either by oral or dermal exposure, with an LD 50 above 1 g/kg for both routes, and an inhalation LC 50 of 434 mg/m 3/4 hours in rats . Adverse effects after acute inhalation exposure appear to be confined to the respiratory tract. Based on { MDDI, PPG }023 is expected to have a low concern for acute toxicity. { MDDI } is a skin irritant with a Primary Irritation index of 5.5 in rabbits, and there are reports of contact dermatitis in individuals exposed to isocyanates in occupational settings. Based on subacute, repeat-dose inhala tion studies, [ MDD I } is considered a respiratory irritant as well (OECD 2005). Based on this, { PPG }023 is expected to be a skin and lung irritant. There have been consistent reports of respiratory sensitization following either inhalation or dermal exposu re, and an increased prevalence of asthma in occupations involving isocyanate exposure (Bello 2007). The general consensus is that { MDDI }specifically, and isocyanates in general, are sensitizers for humans in occupational settings. Isocyanates can be absorbed into systemic circulation through dermal exposure, although the rate of absorption ranges from 1 -2 percent for monomers (Hoffman 2010). Animal models have also indicated that dermal exposure to isocyanates can potentiate respiratory response (Stadler 1984); conversely, respiratory exposure can potentiate skin sensitivity (Sta dler 1985). A consistent finding of epidemiology studies in workers exposed to isocyanate polymers in settings similar to { PPG }023 is both increased asthma (prevalence rates of up to 15 percent) (Bello 2007) and cross-sensitization to isocyanates as a class. Based on this, { PPG }023 is considered to be to a skin and respiratory sensitizer, and the potential to cause respiratory sensitization following skin exposure is possible.**Record ID: {**  PPG }023 **Submitter: {**  PPG Industries, Inc. **}**

14 **Human Health Non -** **Cancer Hazar d (continued)**  Isocyan ates as a class have some potential to cause reproductive and developmental side effects. In rats exposed to { MDDI } via aerosol, there was a LOAEL of 6 mg/m3 for both reproductive and developmental side effects. Other isocyanates have been shown to have reproductive effects via inhalation, and toluene diisocyanate has a NOAEL for postnatal toxicity of 0.02 ppm (Tyl 1999 )
. Based on this, { PPG }023 is expected to have a moderate concern for both reproductive a nd developmental toxicity. There have been anecdotal reports of neurological symptoms (headaches, ataxia) following acute exposure to { MDDI } or toluene diisocyanate vapors, and while in some cases these effects may have been mediated by alterations in res piration , there has been limited evidence that isocyanate exposure can cause persistent symptoms after exposure (Reidy 1994) In the absence of an animal study with a neurological battery, it is difficult to draw any conclusions, but since hazard cannot be ruled out, { PPG }023 may have a moderate concern as a neurotoxin. Smaller isocyanates have shown some potential for mutagenicity, but generally { MDDI } has not been considered a mutagen or genotoxic. Although an earlier, non -guideline compliant Ames test of { MDDI } showed moderate mutagenicity at a high concentration, repeated Ames test done under compliant conditions have been negative for mutagenicity with and without activation at all doses. A Chinese Hamster Cell assay for chromosomal aberrations was al so negative (OECD 2005). Based on this, { PPG }023 is unlikely to be either a mutagen or genotoxic. In a subacute, repeat dose study, rats were dosed with concentrations of 1, 6, and 36 mg/m 3 for six hours a day for four weeks. { MDDI } was determined to b e easily respirable under these conditions, and at 6 mg/m 3 there were signs of irritation in in the nasal tract. This is consistent with observations in the reproductive studies that the major site of toxicity is the lungs. B ased on this, the NOAEL for re spiratory endpoints was 1 mg/m 3/6 hours or approximately 2 mg/kg
-day, but no systemic toxicity was observed. This is consistent with the reproductive study and the general findings that exposure to isocyanates in occupational settings causes lung irritatio n and respiratory illness, and is potentially sensitizing via either lung or dermal exposure. Therefore, { PPG }023 is expected to have low concern for systemic toxicity aside from the high hazard for respiratory toxicity. Overall, based on potential reprod uctive concerns for the residual monomer, { PPG }023 is predicted to have a moderate human health hazard concern level. **Human Health Cancer Hazard** B ased on { MDDI, PPG }023 is unlikely to be a mutagen or genotoxic. No long term animal studies have been condu cted on { MDDI } or its polymers to determine carcinogenicity; toluene diisocyanate (CAS RN 584-84-9 ) has been found to be positive in mutagenic assays, and has shown an increase rates of adenomas when administered by gavage, but did not indu ce cancer in eit her rats or mice when exposure was by inhalation (NTP 1986, Collins 2002)
. Epidemiology studies in occupational exposures have been inconclusive, with weak evidence for an increase in some types of cancer in some studies but no consistent findings. For iso cyanates that are not mutagenic or genotoxic, such as methyl isocyanate, animal studies have shown very limited evidence of carcinogenesis, with the mechanism likely the chronic irritation and inflammation caused by lung exposure. Since { PPG }023 is not l ikely genotoxic or mutagenic, any contribution would likely be via chronic inflammation. Therefore, { PPG }023 is considered to have a low overall cancer risk.**Record ID: {**  PPG }023 **Submitter: {**  PPG Industries, Inc. **}**

15 **Release and Exposure Sources** { PPG }02 3 is a polymer for use in a two component system { in the ma nufacture of golf balls }
. There are two operations associated with { PPG }02 3 that are the subject of the PMN and this assessment; Manufacture and Use . { PPG }02 3 will be in a liquid formulation or suspension form during all activities that require handling of the chemical. { PPG }023 has been predicted to have >90% removal via POTW, BCF of 10, and negligible potential for groundwater migration from landfills based on the size and other properties of the substance. The vapor pressure estimated for the substan ce is below 10- 6 mm Hg . S ubstances with vapor pressures below this level are generally not considered a concern for occupation or general population vapor exposure. I n some cases, exposure to mists, dusts, or other particulates may occur; however, in the case of { PPG }023, no particulate exposure is expected or modeled. Occupation dermal exposure from transfer and cleaning operations, as well as general population ingestion exposure from disposal of the material, has been predicted and modeled for { PPG }02 3 . { PPG }023 is manufactured as an approximately 84% liquid packaged into drums for transport and storage (manufacture). The substance is blended with a second component of a resin mixture and used { in the manufacture of golf balls }(use). The site at which { PPG }02 3 will be manufactured is controlled by { PPG Industries, Inc. } and { PPG } maintains “zero discharge” at these facilities at these sites. A ll cleaning residuals are recycled into the process, landfilled, or incinerated. I n the case of { PPG }02 3, all rinsate s from cleaning activities are collected and incinerated. B ased on these considerations, no releases to surface water or other routes leading to general popul ation exposure from manufacture have been estimated for { PPG }02 3 . The Use operation will occur at a single ide ntified customer site not controlled by { PPG }, identified in the PMN as {Acushnet – BP3 } located in { New Bedford, MA}
. { PPG }023, as received in drums, is pumped directly into the use process, where it is mixed with the second co mponent of the resin and used directly; the use process is automated and, once removed from the drums used for transport and storage, no exposure is predicted. It should be noted that once the substance has been mixed with the second component of the resi n, an irreversible curing process will begin, which will effectively destroy the { PPG }023. Potential worker exposure for unloading and cleaning drums, as well as potential release and general population exposure from disposal of residuals in drums, have be en estimated and modeled for { PPG }023. Release from the disposal of residual has been estimated as occurring to the { New Bedford, MA POTW with NPDES permit number MA0100781 }
. The PMN notes that “The customer has an active EH&S program which includes written programs for handling isocyanate containing materials, industrial hygiene monitoring and facility hazard evaluation assessments to control potential exposures. ” This EH&S program is expected to significantly reduce potential occupation exposure and release of the substance; however, as the specific details of this program were not known, defaults for exposure and release were used for modeling activities associated with the use of { PPG }023. Predicted releases, occupational, general population, and a quatic environmental exposure from operations modeled for { PPG }02 3 are listed on the pages above.**Record ID: {**  PPG }023 **Submitter: {**  PPG Industries, Inc. **}**

16 **Environmental (Aquatic) Risk Assessment** Assessment of aquatic risk is based on comparison of the concentration of the chemical in the environment, referred to as the predicted environmental concentration (PEC), to any acute and/or chronic concentrations of concern (COCs) established for the chemical. Acute risk potential is determined by direct comparison of the PEC to an acute COC, with the potential for risk being indicated if the PEC is larger than the acute COC. C hronic risk is determined both by comparison of the PEC to the chronic COC, similar to the acute risk assessment, and by E - FAST estimation of the number of days the PEC will exceed the chronic COC, with risk potential indicated if the PEC exceeds the chronic COC for 20 days or more. Risk is a function of hazard and exposure; if the hazard concern level is low, th e n the risk will generally also be low. In the case of { PPG }023, the chemical is e stimated to pose a low ecotoxicity hazard based evaluation of the polymer and residual monomer. Based on this, the risk is also predicted to be low. Overall, based on low hazard, { PPG }023 is expected to pose a low potential for risk to the aquatic enviro nment. **Human Health Risk Assessment** Human health risk potential is established by comparison of the potential health effect levels to the occupational and general population dose rates estimated for the chemical. The health effect is divided by the largest dose rate for either occupational or general population exposure to give a margin of exposure (MOE). Acute risk is only evaluated if the acute LD 50 is found to be <50 mg/kg. C hronic risk is evaluated for each effect level identified in the human hea lth hazard assessment that has a moderate or greater hazard concern. The magnitude of the MOE determines if the potential for risk exists; when based on a LOAEL (lowest observed adverse effect level) a MOE of <1,000 indicates the potential for human healt h risk exists, and when based on a NOAEL (no observed adverse effect level) a MOE of <100 indicates the potential for risk exists. Risk is a function of hazard and exposure; if the hazard concern level is low, th e n the risk will generally also be low. In the case of { PPG }02 3 , the chemical is estimated to pose low human health acute and cancer hazard concern level s . However, the potential for chronic human health hazard, based on evaluation of { MDDI } is moderate. P redicted effect level include a reproductive NOAEL of 3 mg/kg
-day; this value was used in the { PPG }023 risk assessment to establish potential occupational and general population risk from the modeled potential exposure. It should also be noted that { PPG }023 is predicted to be a potential skin a nd respiratory sensitizer; these hazards are not used to quantify risk, but are noted. In the case of the occupational risk assessment, only dermal exposure was predicted. For both manufacture and use, calculated MOEs for the dermal exposure are <100. This indicates that the potential for occupation dermal risk from exists for { PPG }0 2 3. In the case of the general population risk assessment, exposure is predicted only for the use operation. Since there is no potential general population exposure from ma nufacture, the potential risk is also low. The calculated MOE for the use operation is 73,000; this indicates a low potential for risk from the use operation. B ased on these considerations, there is a low potential for general population risk from the ma nufacture and use of { PPG }023. Overall, based on the MOEs calculated risk assessment of { PPG }02 3 , the potential for occupational dermal risk exists.**Record ID: {**  PPG }023 **Submitter: {**  PPG Industries, Inc. **}**

17 **References** (Bello 2006) Bello D, Smith TJ, Woskie SR, Streicher RP, Boeniger MF, Redlich CA, Liu Y. An FTIR investigation of isocyanate skin absorption using in vitro guinea pig skin. J Environ Monit . 2006 May;8(5):523
-9. (Bello 2007) Bello D, et al. Skin Exposure to Isocyanates: Reasons for Concern. Environ Health Perspect. 2007 March; 115(3) : 328–335. Published online 2006 November 28. (Collins 2002) Toxicology of toluene diisocyanate. Appl Occup Environ Hyg. 2002 Dec;17(12):846
-55 (Boethling et al. 1997) B oethling, Robert S. and Nabholz, J. Vincent “Environmental Assessment of Polymers under the U.S. Toxic Substances Control Act”, pp. 187- 234, in Ecological Assessment of Polymers Strategies for Product Stewardship and Regulatory Programs, Hamilton, John D. and Sutcliffe, Roger (eds.), (1997) Van Nostrand Reinhold ( EPA 2010) US EPA Office of Pollution Prevention and Toxics, TSCA New Chemicals Program Chemical Categories, revised A ugust 2010, Diisocyanate Category. Available online at: http://www.epa.gov/oppt/newchems/pubs/chemcat.htm (Frick 2003) Malin Frick, Björkner, Hamnerius, Z imerson. Contact dermatitis from di cyclohexylmethane
-4,4ʹ
diisocyanate. Contact Dermatitis, 48: 305–309. (Hoffman 2010) Hoffmann HD, Leibold E, Ehnes C, Fabian E, Landsiedel R, Gamer A, Poole A. Dermal uptake and excretion of 14C
-toluene diisocyanate (TDI) and 14C
- methylene diphenyl diisocyanate (MDI) in male rats. Clinical signs and histopathology following dermal exposure of male rats to TDI. Toxicol Lett. 2010 Dec 15; 199(3):364
-71 (IUCLID 2004) IUCLID Report for CAS RN 5124-30- 1 . Accessed at: http://echa.europa.eu/reach/software/iuclid5_en.asp (NTP 1986 ) Report on Carcinogens, Eleventh Edition; U .S. Department of Health and Human Services, Public Health Service, National Toxicology Program . (OECD 2005) SIDS Initi al Assessment Report for 4,4 ́
- Methylenedicyclohexyl diisocyanate – Draft Report. Accessed at http://www.alipa.org/uploads/Modules/Publications/OECD_DraftSIDS_5124301.pdf (PGD 2010) Interpretive Guidance Document for Sustainable Futures Assessment of Poly mers, an EPA Sustainable Futures/P2 Guidance Document, revised 2010. Available online at: http://www.epa.gov/oppt/sf/
. Reidy TJ , Bolter JF Neuropsychological toxicology of methylene diphenyl diisocyanate: a report of five cases . Brain Inj. 1994 Apr;8 (3):285
-94. (Stadler 1984) Stadler JC, Karol MH. Experimental delayed hypersensitivity following inhalation of dicyclohexylmethane
-4,4'
-diisocyanate: a concentration
- response relationship. Toxicol Appl Pharmacol. 1984 Jun 30;74(2):244
-9. (Stadler 1985) Stadler JC, Karol MH . Use of dose
- response data to compare the skin sensitizing abilities of dicyclohexylmethane
-4,4'
-diisocyanate and picryl chloride in two animal species. Toxicol Appl Pharmacol. 1985 May;78(3):445
-50. (Tyl 1999) Two
-generation reproductive toxicity study of inhale d toluene diisocyanate vapor in CD rats. Toxicol Sci. 1999 Dec;52(2):258
-68.**Record ID: {**  PPG }023 **Submitter: {**  PPG Industries, Inc. **}**

18 **Appendix 1: {**  **PPG }** **023 Estimation of Iso cyanates per species** 
Mn = 4,124 Daltons 1 7% maximum residual { MDDI } Monomer { PPG }023 contains a monomer that has two to three potential chain carrying sites per monomer unit (see structure above). As the of the polymer Mn increases, the amount of bran ching will also increase, which will increase the number of isocyanate units per polymer species. H owever, In order to look at the worst case scenario, an average number of isocyanate units per polymer molecule of 2.5, which is based on a single potential ly branched monomer per polymer unit, will be used for these calculations. Isocyanates per species: Assuming 1 gram total weight for mixture containing 830 mg (83% by weight) { PPG }023 and 170 mg (17% by weight) { MDDI } Monomer Isocyanates from { MDDI } Monomer: 170 mg x 1 mmol/420.49 mg x 2 eq isocyanates/ mmol
= 0.8 eq isocyanate from MONOMER Isocyanates from { PPG }0 23 Polymer: 830 mg x 1 mmol/4,124 mg x 3 eq isocyanates (estimated based on monomers)/ mmol = 0. 5 eq isocyanate from POLYMER > 5 0% isocyanate comes from MONOMER