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 2011
i

Table of Contents

PREFACE

1.0 DATA SOURCE DESCRIPTIONS ...........................................................................................................3

2.0 SUMMARY OF HPV3 CHEMICALS AND FINDINGS...............................................................................4
ii

Preface

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, the 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 health 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 “substantial 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 

Substantial 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 proposed 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. 
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1.0 DATA SOURCE DESCRIPTIONS

TSCA Inventory Update Reporting 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 

originally 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 owned 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. Publiclyavailable information from the 1986, 1990, 1994, 1998, and 2002 (and 2006) IUR reporting cycles are available online at: http://www.epa.gov/oppt/iur/index.htm

The Toxics Release Inventory (TRI) contains information about releases of certain chemicals and management of 

wastes at a wide variety of sources, including manufacturing operations, certain service businesses, and federal 

facilities. Publicly-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 

types 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) Household 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 Material Safety Data Sheets when available 

from manufacturers and manufacturers' web sites. Publicly-available information from the database is available online at: http://householdproducts.nlm.nih.gov/

The Preliminary Assessment Information 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 

importation, the quantity of enclosed, controlled and open releases of the chemical, and per release, the number of 

workers exposed and the number of hours exposed. Publicly available information regarding PAIR is available online at: http://www.epa.gov/oppt/itc/pubs/info.htm
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2.0 SUMMARY OF HPV3 CHEMICALS AND FINDINGS

Table 2-1 below presents a summary of the High Production Volume (HPV) chemicals (15) 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 was 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 Searched for Exposure Based Findings

CAS# Chemical Name

2006 IUR 

Production 

Volume

[Million 

lbs]

2006 IUR 

Substantial 

Human 

Exposure 

(>1,000 

Workers) 

Met

NOES 

Number of 

Workers

Non-CBI 

2006 IUR 

Commercial/ 

Consumer 

Code 

Description

PAIR -

Substantial 

Human 

Exposure 

(Consumer 

Use Indicated)

Meet 

Exposure 

Based 

Criteria

for 

Workers

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 

(nonpesticidal)

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 

Workers) 

Met

NOES 

Number of 

Workers

Non-CBI 

2006 IUR 

Commercial/ 

Consumer 

Code 

Description

PAIR -

Substantial 

Human 

Exposure 

(Consumer 

Use Indicated)

Meet 

Exposure 

Based 

Criteria

for 

Workers

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 Lard, oil, Me esters 1 to < 10 41,153 Yes

12 68442-60-4

Acetaldehyde, reaction products 

with formaldehyde, by-products 

from

1 to < 10 Code(s) 

claimed CBI Yes Yes Yes

13 68610-90-2

2-Butenedioic acid (2E)-, di-C8-

18-alkyl esters 1 to < 10 Yes Yes

14 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

15 72162-15-3 1-Decene, sulfurized 1 to < 10 64,227 Yes
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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, footwear, 

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 >1,000 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 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 ) 

- 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. 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 (10 million - 50 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 number 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 compared 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 were 

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 

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 (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 commercial 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/consumer 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 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 potentially exceeding 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 workers

8 22527-63-5

Propanoic acid, 2-methyl-, 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, footwear, 

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 >1,000 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 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/consumer product 

categories (C16 ) 

- Consumers 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, dimethylThe total number of potentially exposed workers exceeds 1,000 workers based on NOES data. The 

production volume data for the 2006 IUR data collection was compared 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 were 

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 

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 (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 million - 10 million lb)

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

- 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)
Table 2-2 (Continued)

 

10

CAS# Chemical Name Summary of Findings

11

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 was compared 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 were 

gathered. The 1986 reported 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)

12

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 exposures. Additionally, PAIR indicates consumer use. It is possible that products 

containing this chemical may be used by >10,000 consumers. 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 potentially exceeding 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

13 68610-90-2

2-Butenedioic acid (2E)-, di-C8-18-

alkyl esters

PAIR indicates consumer use. It is possible that products containing this chemical may be used by 

>10,000 consumers. 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)

- 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-methyl-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 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 potentially exceeding 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 was compared 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 were 

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 

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 (64,227 workers)