# Final

**Testing of Certain High Production Volume Chemicals**  **; Third**  **Group of Chemicals (**  **Exposure Findings Supporting**  **Information )** 

U.S. Environmental Protection Agency Office of Pollution Prevention and Toxics Economics, Exposure and Technology Division

September 2011i 

# Table of Contents PREFACE 1.0 D ATA S OURCE D ESCRIPTIONS ................................ ................................ ................................ ........... 3 2.0 S UMMARY OF H PV3 C HEMI CALS AND F IND INGS ................................ ................................ ............... 4ii 

# P reface This findings document was prepared to support EPA’s Proposed TSCA Section 4 Test Rule for Certain High Production Volume Chemicals ; Third Group of Chemicals . Prior to promulgating a test rule under section 4 of the Toxic Substances Control Act (TSCA), 15 U.S.C. §§2601 et seq , EPA is required to make certain findings identified in section 4(a) of TSCA relating to the chemical’s risk and potential exposure, th e sufficiency of data to allow EPA to determine the human health or environmental effects of the chemical, and the need to conduct testing. Under TSCA section 4(a)(1)(B), EPA must make the following findings to support a test rule based on concerns for exposure: (1) that a chemical substance is or will be produced in substantial quantities and that it enters or may reasonably be anticipated to enter the environment in substantial quantities and/or that there is or may be substantial and/or significant human exposure to such substance; (2) that there are insufficient data and experience upon which the effects of the manufacture, distribution in commerce, processing, use or disposal of such substance or mixture or of any combination of such activities on he alth or the environment can reasonably be determined or predicted; and (3) that testing of the substance or mixture with respect to such effects is necessary to develop such data. The criteria and standards used by EPA for evaluating the terms “substantia l production,” “substantial release,” and “substantial or significant human exposure” as used in TSCA section 4(a)(1)(B)(i) are explained in EPA’s Final Statement of Policy; Criteria for Evaluating Substantial Production, Substantial Release, and Substanti al or Significant Human Exposure set forth at 58 FR 28736 (May 14, 1993) (hereinafter referred to as the “B Policy”). This document provides a detailed discussion of EPA’s evaluation of each of the chemical substances identified in the pr oposed test rule to determine that preliminary TSCA section 4(a)(1)(B) findings concerning “substantial production,” “substantial release,” and “substantial or significant human exposure” can be made.3

**1.0 D**  **ATA S**  **OURCE D**  **ESCRIPTIONS TSCA Inventory Update Reporti**  **ng Rule** : 

### In 1986, EPA promulgated the Inventory Update Reporting (IUR) regulations, under TSCA section 8(a), to facilitate the periodic updating of the TSCA Inventory database and to otherwise support activities associated with implementing TSCA. As origin ally promulgated, the IUR required chemical manufacturers (including importers) to report to EPA every

4 years the identity

of chemical substances manufactured (including imported) annually in quantities of 10,000 pounds or more at each plant site they own ed or controlled. In 2003 EPA adjusted the universe of chemicals and plant sites that are required to report, and the type of information reported. In 2005, EPA changed the reporting frequency to once every 5 years, revised the manner in which amounts of a chemical substance manufactured or imported must be reported, and changed the submission period for reporting after 2006. To protect the claims of confidential business information (CBI) asserted by some IUR submitters on the amount of the chemical substance manufactured (including imported) at a specific site, all production volumes reported by IUR submitters (i.e., CBI and non - CBI) for each chemical are combined by EPA for an aggregate total. Confidential business information claims are further protected by using eight ranges to identify the total for any specific chemical and then making available to the public the range that corresponds to the aggregate production volume. Publicly available information from the 1986, 1990, 1994, 1998, and 2002 (and 2006) IUR reporting cycles are available on line at: http://www.epa.gov/op pt/iur/index.htm The **Toxics Release Inventory (TRI)** contains information about releases of certain chemicals and management of wa stes at a wide variety of sources, including manufacturing operations, certain service businesses, and federal facilities. Pu

blicly - available information from the 2005 TRI reporting cycle is available on - line at: http://www.epa.gov/triexplorer/ The National Institute for Occupational Safety and Health (NIOSH) conducted the **National Occupational**  **Exposure Survey (NOES)** that collected data on potential occupational exposures to chemical, physical, and biological agents from 1981 to 1983. The survey involved on - site visits to 4,490 establishments in 522 industry ty pes employing approximately 1,800,000 workers in 377 occupational categories. Publicly - available information from the NOES is available on - line at: http://www.cdc.gov/noes/default.html The **National Library of Medicine (NLM)**  **H ousehold Products Database**  provides information on the chemical ingredients and their percentage in specific brands of household products. Information in the database is from a variety of publicly available sources including brand - specific labels and Mate rial Safety Data Sheets when available from manufacturers and manufacturers' web sites. Publicly - available information from the database is available on line at: http://householdproducts.nlm.nih.gov/ The **Prelim inary Assessment Inform**  **ation Rule (PAIR)** collects site specific information on the quantity of chemical produced and/or imported, the amount of chemical lost to the environment during production or im portation, the quantity of enclosed, controlled and open releases of the chemical, and per relea se, the number of workers exposed and the number of hours exposed. Publicly available information regarding PAIR is available on line at: http://www.epa.gov/oppt/itc/pubs/info.htm4 **2.0 S**  **UMMARY OF HPV**  **3 C**  **HEMICALS AND F**  **INDINGS** Table 2 - 1 below

presents a summary o f the H igh P roduction V olume (HPV) chemicals ( 1 5 ) and data collected to support an exposure based finding. Table 2 - 2 presents a chemical - by - chemical explanation of the supporting findings information. The Toxic Release Inventory (TRI) , National Library of Medicine (NLM) Household Products Database , and the Preliminary Assessment Information Rule (PAIR) dataset was checked for exposure findings information. There were no TRI data that met the substantial release criteria for the HPV3 chemicals. There w a s NLM * consumer exposure findings data found for 1 chemical (CAS# 98 - 56 - 6). That data is discussed in Table 2 - 2 in the chemical - by - chemical explanation. There was consumer exposure findings information for 3 chemicals in the PAIR dataset. That information is discussed in Table 2 - 2 in the chemical - by - chemical explanation. **Table 2 -**  **1 Summary of**  **Data Se arched for Exposure Based Findings** 

**CAS# Chemical Name**  **2006 IUR Production**  **Volume [Million**  **lbs] 2006 IUR** 

**Substantial Human**  **Exposure (>1,000**  **Work ers)**  **Met NOES** 

**Number of Work**  **ers Non**  **- CBI**  **2006 IUR Commercial/**  **Consumer Code**  **Description PAIR**  **-**

**Substantial Human**  **Exposure (Consumer**  **Use Indicated) Meet** 

**Exposure Based**  **Criteria for**  **Work ers**  **Meet Exposure**  **Based Criteria**  **for Consumers**  1 98 - 09 - 9 Benzenesulfonyl chloride 1 to < 10 C16 - Rubber and plastic products Yes Yes 2 98 - 56 - 6 Benzene, 1 - chloro - 4 -

(trifluoromethyl) - 10 to < 50 Code(s) claimed CBI Yes * Yes * 3 111 - 44 - 4 Ethane, 1,1' - oxybis[2 - chloro - ] 1 to < 10 C20 - Other; Code(s) claimed CBI Yes Yes 4 127 - 68 - 4 Benzenesulfonic acid, 3 - nitro - ,

sodium salt (1:1) 1 to < 10 9,386 Yes 5 515 - 40 - 2 Benzene, (2 - chloro - 1,1 -

dimethylethyl) - 1 to < 10 C02 - Agricultural products (non pesticidal) Yes Yes 6 2494 - 89 - 5 Ethanol, 2 - [(4 -

aminophenyl)sulfonyl] - , 1 - (hydrogen sulfate) 1 to < 10 Code(s) claimed CBI Yes Yes 7 5026 - 74 - 4 2 - Oxiranemethanamine, N - [4 - (2 -

oxiranylmethoxy)phenyl] - N - (2 - oxiranylmethyl) - 1 to < 10 Yes Yes 8 22527 - 63 - 5 Propanoic acid, 2 - methyl - , 3 -

(benzoyloxy) - 2,2,4 - trimethylpentyl ester 1 to < 10 C16 - Rubber and plastic products; Code(s) claimed CBI Yes Yes Yes 9 25321 - 41 - 9 Benzenesulfonic acid, dimethyl - 1 to < 10 2,843 Yes**Table 2 -**  **1 (Continued)** 

5 **CAS# Chemical Name**  **2006 IUR Production**  **Volume [Million**  **lbs] 2006 IUR** 

**Substantial Human**  **Exposure (>1,000**  **Work ers)**  **Met NOES** 

**Number of Work**  **ers Non**  **- CBI**  **2006 IUR Commercial/**  **Consumer Code**  **Description PAIR**  **-**

**Substantial Human**  **Exposure (Consumer**  **Use Indicated) Meet** 

**Exposure Based**  **Criteria for**  **Work ers**  **Meet Exposure**  **Based Criteria**  **for Consumers**  10 52556 - 42 - 0 1 - Propanesulfonic acid, 2 - hydroxy - 3 - (2 - propen - 1 - yloxy) - , sodium salt (1:1) 1 to < 10 Yes C20 - Other Yes Yes 11 68082 - 78 - 0 La rd, oil, Me esters 1 to < 10 41,153 Yes 1 2 68442 - 60 - 4 Acetaldehyde, reaction products with formaldehyde, by- products from 1 to < 10 Code(s) claimed CBI Yes Yes Yes 1 3 68610 - 90 - 2 2 - Butenedioic acid (2E) - , di - C8 - 18 - alkyl esters 1 to < 10 Yes Yes 1 4 70693 - 50 - 4 Phenol, 2,4 -bis(1 - methyl - 1 - phenylethyl) - 6 - [2 - (2 - nitrophenyl)diazenyl] - 1 to < 10 Code(s) claimed CBI Yes Yes 1 5 72162 - 15 - 3 1 - Decene, sulfurized 1 to < 10 64,227 Yes6 **Table 2 -**  **2 Chemical**  **- by**  **- Chemical**  **Explanation of Findings**  CAS# Chemical Name Summary of Findings

1 98 - 09 - 9 Benzenesulfonyl chloride The IUR commercial/consumer product category C16 - Rubber and plastic products was reported for this chemical. Chemicals reporting in this category are contained in such products as tires, footw ear, flooring, bottles, sporting equipment, games, and toys. It is expected that these products will be widely used by consumers (including children) and hence, may likely exceed 10,000 people. Additionally, products such as tires and flooring are also used in a commercial setting, which may lead to exposure s of >1,000 commercial workers. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure.” (All stated IUR commercial/consumer product categories are non - CBI) This chemical me t exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 million - 10 million lb)

- Total workers potentially exceeding 1,000 based on the IUR commercial/consumer product categories (C16 )

- Consumers potentially exceeding 10, 000 people based on IUR commercial/consumer product category (C16) 2 98 - 56 - 6 Benzene, 1 - chloro - 4 - (trifluoromethyl) - The number of potentially exposed consumers is estimated to be very large based on the use (home maintenance product) cited in the NLM Household Chemicals Database. It is expected that home maintenance products will be widely used by consumers and hence, may likely exceed 10,000 people. The IUR commercial/consumer product category(s) was claimed CBI for this chemical. This chemical is present in an unknown number of commercial and consumer products that may potentially have a high number of exposures. Bas ed on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure.” This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 0 mi llion - 5 0 million lb)

- Consumers potentially exceeding 10,000 people based on NLM Household Chemicals Database

- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category claimed CBI**Table 2 -**  **2 (Continued)** 

7 CAS# Chemical Name Summary of Findings

3 111 - 44 - 4 Ethane, 1,1' - oxybis[2 - chloro - ] The IUR commercial/consumer product category C20 - Other ( chemicals contained in commercial and consumer products not elsewhere classified ) was reported for this chemical. This indicates that this chemical is present in an unknown numb er of commercial and consumer products that may potentially have a high number of exposures. Other product category(s) was claimed CBI. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure.” (All stated IUR commercial/consumer product categories are non - CBI) This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 million - 10 million lb)

- Total workers potentially exceeding 1,000 based on IUR commercial/consumer product category (C20)

- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category (C20)

4 127 - 68 - 4 Benzenesulfonic acid, 3 - nitro - , sodium salt (1:1) The number of potentially exposed total workers exceeds 1,000 based on NOES data. The production volume data for the 2006 IUR data collection was com pared to the production volume data for the 1986 IUR data collection for this chemical to see if the produ ction volume stayed the same or increased, thereby indicating that the usage of these chemicals is no less than when NOES data w ere gathered . The 1986 reported IUR production volume range was 1 million - 10 million lbs. The 2006 IUR production volume range is 1 million - 10 million lbs **.** Based on this information, this chemical wo uld meet the exposure based findings criteria of "substantial or significant human exposure.” This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 million - 10 million lb)

- Total workers exceeding 1,000 based NOES data (9,386 workers)

5 515 - 40 - 2 Benzene, (2 - chloro - 1,1 - dimethylethyl) - The IUR commercial/consumer product category C02 - Agricultural products (non - pesticidal ) was reported for this chemical. Chemicals reporting in this category are used to increase the productivity and quality of farm crops; examples include fertilizers and soil conditioners. It is expected that these products will be widely used by commerci al workers and consumers and hence, may likely exceed 1,000 commercial workers and 10,000 consumers. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure.” (All stated IUR commercial/consumer product categories are non - CBI) This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 million - 10 million lb)

- Total workers potentially exceeding 1,000 based on the IUR commercial/cons umer product categories (C02 )

- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category (C02)**Table 2 -**  **2 (Continued)** 

8 CAS# Chemical Name Summary of Findings

6 2494 - 89 - 5 Ethanol, 2 - [(4 - aminophenyl)sulfonyl] - , 1 - (hydrogen sulfate) The IUR commercial/consumer product category(s) was claimed CBI for this chemical. This chemical is present in an unknown number of commercial and consumer products that may potentially have a high number of exposures. Based on this information, this chemi cal would meet the exposure based findings criteria of "substantial or significant human exposure.” This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 million - 10 million lb)

- Total workers potentially e xceeding 1,000 based on IUR commercial/consumer product category(s) claimed CBI

- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category claimed CBI 7 5026 - 74 - 4 2 - Oxiranemethanamine, N - [4 - (2 - oxiranylmethoxy)phenyl] - N - (2 - oxiranylmethyl) - The total number of potentially exposed workers exceeds 1,000 workers based on number of workers reported on the 2006 IUR. This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 million - 10 million lb)

- Total workers exceeding 1,000 based on IUR reported number of wo rkers

8 22527 - 63 - 5 Propanoic acid, 2 - me thyl - , 3 - (benzoyloxy) - 2,2,4 - trimethylpentyl ester The IUR commercial/consumer product category C16 - Rubber and plastic products was reported for this chemical. Chemicals reporting in this category are contained in such products as tires, footw ear, flooring, bottles, sporting equipment, games, and toys. It is expected that these products will be widely used by consumers (including children) and hence, may likely exceed 10,000 people. Additionally, products such as tires and flooring are also used in a commercial setting, which may lead to exposures of >1,00 0 commercial workers. Other product category(s) was claimed CBI. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure.” (All stated IUR commercial/consumer product catego ries are non - CBI) This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 million - 10 million lb)

- Total workers potentially exceeding 1,000 based on the IUR commercial/consumer product categories (C16 )

- C onsum ers potentially exceeding 10,000 people based on IUR commercial/consumer product category (C16)

- Consumers potentially exceeding 10,000 people based on PAIR**Table 2 -**  **2 (Continued)** 

9 CAS# Chemical Name Summary of Findings

9 25321 - 41 - 9 Benzenesulfonic acid, dimethyl The total number of potentially exposed workers exceeds 1,000 workers based on NOES data. The production volume data for the 2006 IUR data collection w as com pared to the production volume data for the 1986 IUR data collection for this chemical to see if th e production volume stayed the same or increased, thereby indicating that the usage of these chemicals is no less than when NOES data w ere gathered . The 1986 reported IUR production volume range was 1 million - 10 million lbs. The 2006 IUR production volume range is 1 million - 10 million lbs. Based on this information, this chemical wo uld meet the exposure based findings criteria of "substantial or significant human exposure.” This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 million - 10 million lb)

- Total workers exceeding 1,000 based NOES data (2,843 workers)

10 52556 - 42 - 0 1 - Propanesulfonic acid, 2 - hydroxy - 3 - (2 - propen - 1 - yloxy) - , sodium salt (1:1) The total number of potentially exposed workers exceeds 1,000 workers based on number of workers reported on the 2006 IUR. The IUR commercial/consumer product category C20 - Other ( chemicals contained in commercial and consumer products not elsewhere classified ) was reported for this chemical. This indicates that this chemical is present in an unknown number of commercial and consumer products that may potentially have a high number of exposures. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure.” (All stated IUR commercial/consumer product categories are non - CBI) This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 milli on - 10 million lb)

- Total workers exceeding 1,000 based on IUR reported number of wo rkers

- Total workers potentially exceeding 1,000 based on IUR commercial/consumer product category (C20)

- Consumers potentially exceeding 10,000 people based on IUR co mmercial/consumer product category (C20)**Table 2 -**  **2 (Continued)** 

10 CAS# Chemical Name Summary of Findings

1 1 68082 - 78 - 0 Lard, oil, Me esters The total number of potentially exposed workers exceeds 1,000 workers based on NOES data. The production volume data for the 2006 IUR data collection w as com pared to the production volume data for the 1986 IUR data collection for this chemical to see if the production volume stayed the same or increased, thereby indicating that the usage of these chemicals is no less than when NOES data w ere gathered . The 1986 reporte d IUR production volume range was 500 thousand - 1 million lbs. The 2006 IUR production volume range is 1 million - 10 million lbs **.** Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure.” This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 million - 10 million lb)

- Total workers exceeding 1,000 based NOES data (41,153 workers)

1 2 68442 - 60 - 4 Acetaldehyde, reaction products with formaldehyde, by - products from The IUR commercial/consumer product category(s) was claimed CBI for this chemical. This chemical is present in an unknown number of commercial and consumer products that may potentially have a high number of exp osures. Additionally, PAIR indicates consumer use . I t is possible that products containing this chemical may be used by >10,000 consumers. Based on this information, this chemical wo uld meet the exposure based findings criteria of "substantial or signific ant human exposure.” This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 million - 10 million lb)

- Total workers potentially exceeding 1,000 based on IUR commercial/consumer product category(s) claimed CB I

- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category claimed CBI 13 68610 - 90 - 2 2 - Butenedioic acid (2E) - , di - C8 - 18 - alkyl esters PAIR indicates consumer use . I t is possible that products containing this chemical may be used by >10,000 consumers. Based on this information, this chemical w ould m eet the exposure based findings criteria of "substantial or significant human exposure.” This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 million - 10 million lb)

- Consumers potentially exceeding 10,000 people based on PAIR**Table 2 -**  **2 (Continued)** 

11 CAS# Chemical Name Summary of Findings

14 70693 - 50 - 4 Phenol, 2,4 - bis(1 - me thyl - 1 - phenylethyl) - 6 - [2 - (2 - nitrophenyl)diazenyl] - The IUR commercial/consumer product category(s) was claimed CBI for this chemical. This chemical is present in an unknown number of commercial and consumer products that may potentially have a high number of exposures. Based on this information, this chemi cal would meet the exposure based findings criteria of "substantial or significant human exposure.” This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 million - 10 million lb)

- Total workers potentially e xceeding 1,000 based on IUR commercial/consumer product category(s) claimed CBI

- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category claimed CBI

15 72162 - 15 - 3 1 - Decene, sulfurized The total number of potentially exposed workers exceeds 1,000 workers based on NOES data. The production volume data for the 2006 IUR data collection w as com pared to the production volume data for the 1986 IUR data collection for this chemical to see if th e production volume stayed the same or increased, thereby indicating that the usage of these chemicals is no less than when NOES data w ere gathered . The 1986 reported IUR production volume range was 1 million - 10 million lbs. The 2006 IUR production volume range is 1 million - 10 million lbs **.** Based on this information, this chemical wo uld meet the exposure based findings criteria of "substantial or significant human exposure.” This chemical met exposure based findings criteria based on:

- 2006 IUR Production Volume Range (1 million - 10 million lb)

- Total workers exceeding 1,000 based NOES data (64,227 workers)