United States Premanufacture Notification Environmental Protection Agency Number: P-12-0282-0284 Office of Chemical Safety and Pollution Prevention TSCA NEW CHEMICALS REVIEW PROGRAM STANDARD REVIEW RISK ASSESSMENT ON MEDIUM-CHAIN CHLORINATED PARAFFINS (PMN P-12-0282, P-12-0283) AND LONG-CHAIN CHLORINATED PARAFFINS (PMN P-12-0284) This assessment was conducted under EPA’s TSCA Section 5 New Chemicals Program. EPA is assessing Medium-chain Chlorinated Paraffin (MCCP) and Long-Chain Chlorinated Paraffin (LCCP) chemicals as part of its New Chemicals Review program. As with all Premanufacture Notice (PMN) submissions, EPA followed the approaches, methods and statutory provisions of TSCA section 5 for the chlorinated paraffin PMNs assessments. 1 CONCLUSIONS Based on its assessment of the available hazard and exposure information on P-12-0282, P-12- 0283, and P-12-0284, EPA/OPPT concludes the following pertaining to the manufacturing, processing and use1 of these PMN substances: 1. Occupational Exposures: given the assumptions, data and scenarios evaluated in this assessment, there were low 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 low risks found to humans from environmental releases via exposure to drinking water or fish ingestion. 3. Environmental Assessment: a. Using estimated environmental concentrations, the PMN substances may present an unreasonable risk following acute and chronic exposures to aquatic organisms. i. The two exceptions are the low-end estimates for aquatic concentrations for water releases from plastic converting use and commercial use of solvents, paints and adhesives (for the MCCP PMN P-12-0283) b. Using available measured concentrations of MCCP and LCCP congener groups in the environment as supporting information, the PMN substances: i. Are expected to partition to sediment and may partition to soil through land application of biosolids, and ii. May be released to the environment at levels at or above estimated concentrations of MCCP and LCCP congener groups that may present an unreasonable risk following acute and chronic exposures to aquatic organisms. 4. PBT Assessment: The PMN substances may be very persistent and very bioaccumulative. 1 The two MCCP PMNs (P-12-0282 and 0283) have six different uses, but the three major uses are: as an additive to plastics as a flame retardant and as a secondary plasticizer [43% of total production volume] and as an additive to rubber as a flame retardant and plasticizer [24%], and as an extreme pressure additive to lubricants [30%]. The LCCP PMN (P-12-0284) is used exclusively as an extreme pressure additive to metalworking fluids. 2 TABLE OF CONTENTS TABLE OF CONTENTS ............................................................................................................. 3 1 INTRODUCTION .............................................................................................................. 6 1.1 PMNS RECEIVED............................................................................................................................................ 6 1.2 CHEMISTRY ................................................................................................................................................... 6 1.3 USES ............................................................................................................................................................. 9 2 ENVIRONMENTAL FATE ................................................................................................ 10 2.1 ENVIRONMENTAL PERSISTENCE ................................................................................................................. 10 2.2 BIOCONCENTRATION AND BIOACCUMULATION ........................................................................................ 12 3 ECOLOGICAL HAZARD OVERVIEW ................................................................................. 13 4 HUMAN HEALTH HAZARD OVERVIEW ........................................................................... 16 4.1 MCCP HEALTH DATA REVIEW ..................................................................................................................... 16 4.2 LCCP HEALTH DATA REVIEW ....................................................................................................................... 18 5 EXPOSURE INFORMATION ............................................................................................ 19 5.1 ENVIRONMENTAL MONITORING................................................................................................................ 19 5.2 MODELED ENVIRONMENTAL RELEASES ..................................................................................................... 22 5.3 EXPOSURE ESTIMATES................................................................................................................................ 25 5.3.1 OCCUPATIONAL EXPOSURE ESTIMATES ................................................................................................. 25 5.3.2 CONSUMER EXPOSURE ........................................................................................................................... 28 6 RISK ASSESSMENT ........................................................................................................ 29 6.1 ENVIRONMENTAL ASSESSMENT................................................................................................................. 29 6.1.1 Risk Estimates Using Environmental Monitoring Data ........................................................................... 29 6.1.2 Risk Estimates Using Modeled Exposures ............................................................................................... 31 6.2 HUMAN HEALTH ......................................................................................................................................... 33 6.2.1 Workers .................................................................................................................................................. 34 6.2.2 General Population (from Environmental Releases) .............................................................................. 36 6.2.3 Consumer ............................................................................................................................................... 39 7 CONCLUSIONS .............................................................................................................. 40 8 REFERENCES ................................................................................................................. 41 9 APPENDICES ................................................................................................................. 55 Appendix A ENVIRONMENTAL FATE AND BIOACCUMULATION STUDY SUMMARIES .................................................................................................................... 56 A-1 ENVIRONMENTAL PERSISTENCE ..................................................................................................... 56 A-1-1 Abiotic Degradation .............................................................................................................................. 56 A-1-1-1 Fate in Air ....................................................................................................................................................... 56 A-1-2 Biodegradation ...................................................................................................................................... 57 A-1-2-1 Fate in Wastewater Treatment ........................................................................................................................ 57 A-1-2-2 Fate in Surface and Groundwater ................................................................................................................... 58 A-1-2-3 Fate in Soil ...................................................................................................................................................... 58 3 A-2 BIOCONCENTRATION AND BIOACCUMULATION ........................................................................ 63 Appendix B ECOTOXICITY STUDY SUMMARIES ..................................................... 69 B-1 MCCP ECOTOXICITY DATA ................................................................................................................ 69 B-1-1 Acute Fish Toxicity .................................................................................................................................. 69 B-1-2 Acute Aquatic Invertebrate Toxicity ....................................................................................................... 70 B-1-3 Algae Toxicity ......................................................................................................................................... 73 B-1-4 Chronic Fish Toxicity ............................................................................................................................... 74 B-1-5 Chronic Aquatic Invertebrate Toxicity .................................................................................................... 76 B-1-6 Chronic Aquatic Sediment Invertebrate Toxicity .................................................................................... 79 B-1-7 Avian Toxicity ........................................................................................................................................