Initial Risk-Based Prioritization of High Production Volume Chemicals 2-[Ethyl(3-methylphenyl)amino]-acetonitrile (CASRN 63133-74-4) (9th CI Name: Acetonitrile, [ethyl(3-methylphenyl)amino]-)

U.S. Environmental Protection Agency
Risk-Based Prioritization Document

September 2008

Initial Risk-Based Prioritization of High Production Volume Chemicals

2-[Ethyl(3-methylphenyl)amino]-acetonitrile (CASRN 63133-74-4)

(9th CI Name: Acetonitrile, [ethyl(3-methylphenyl)amino]-)

This document is based on screening-level characterizations done by EPA on the environmental
fate, hazard, and exposure of the listed chemical. The information used by EPA includes data
submitted under the HPV Challenge Program1 and the 2006 Inventory Update Reporting (IUR)2,
and data publicly available through other selected sources3. This screening-level prioritization
presents EPA's initial thinking regarding the potential risks presented by this chemical and future
possible actions that may be needed. These initial characterization and prioritization documents
do not constitute a final Agency determination as to risk, nor do they determine whether
sufficient data are available to characterize risk. Rather, they are interim evaluations.
Recommended actions may be considered by EPA in the future based on a relative judgment
regarding this chemical in comparison with others evaluated under this program, and in light of
the uncertainties presented by gaps in the available data that may be determined to exist. These
evaluations contribute to meeting U.S. commitments under the chemicals cooperation work
being done in North America4 through the EPA Chemical Assessment and Management Program
(ChAMP)5.

This chemical was considered in 2005 to have met the HPV Challenge Program guidance for a
closed-system intermediate, a chemical manufactured and processed only in closed systems to
produce other chemicals. Because closed-system intermediates have a limited potential for
exposure generally attributable only to isolated accidental releases, toxicity testing elements in
the HPV Challenge Program were reduced for those chemicals, and consisted of the Screening
Information Data Set (SIDS) minus the tests for repeated dose toxicity and reproductive toxicity,
but including a developmental toxicity test6. For this chemical, the sponsor provided more than
the reduced set of information, including a combined reproductive/developmental toxicity test.

Hazard and Fate Summary:

• Human Health: An acute oral study in rats showed moderate toxicity and a dermal study
on guinea pigs showed low toxicity. In a combined reproductive/developmental study in
rats, there were body weight reductions in the mid- and high-dose parental males, and
clinical signs of toxicity at the high doses in both sexes. There was no evidence of
reproductive or developmental toxicity. It was not mutagenic and did not induce
chromosomal aberrations.

• Environment: Available aquatic toxicity data indicate the acute hazard of this chemical is
low to fish and aquatic invertebrates and moderate to aquatic plants.

1 US EPA, HPV Challenge Program information: http://epa. gov/hpv/.

2 US EPA, IUR information: http://www.epa.gov/oppt/iur/index.htm.

3 US EPA, Information on additional public databases used: http://www.epa.gov/hpvis/pubdtsum.htm.

4 US EPA, U.S. Commitments to North American Chemicals Cooperation:

http://www.epa.gov/hpv/pubs/general/sppframework.htm.

5 US EPA, ChAMP information: http://www.epa. gov/champ/.

6 US EPA, Guidance for Testing Closed System Intermediates:
http://www.epa.gov/chemrtk/pubs/general/closed9.htm.

-------
U.S. Environmental Protection Agency
Risk-Based Prioritization Document

September 2008

• Persistence and Bioaccumulation:

o Available data indicate that this chemical has moderate persistence,
o Available data indicate that this chemical has low bioaccumulation potential.

Exposure Summary:

• Both Confidential Business Information (CBI) and non-confidential information from
IUR and other sources were used in developing this initial prioritization.

• Production Volume: Based on the 2006 IUR submissions, this chemical is currently a
moderate production volume (MPV) chemical with an aggregated production and/or
import volume in the United States of 10,000 to 500,000 pounds. It was included in the
HPV Challenge program because it was reported at HPV levels in earlier years.

• Uses: Non-confidential IUR information indicates that the chemical is used as an
industrial intermediate in manufacturing other basic organic compounds. There are no
reported commercial uses.

• General Population and Environment: EPA identifies a low potential that the general
population or the environment might be exposed to this chemical.

• Workers: EPA identifies a low relative ranking for potential worker exposure.

• Consumers: EPA identifies a low potential that consumers might be exposed.

• Children: EPA identifies a low potential that children might be exposed.

Risk Characterization Summary:

EPA reviewed the information in the HPV submission, test plan, and subsequent revisions and

correspondence, and determined that it met the guidance for a closed-system intermediate.

Therefore, there is a low concern for potential risk to aquatic organisms and the general

population from environmental releases, and also to workers, consumers, and children.

• Potential Risk to Aquatic Organisms from Environmental Releases: LOW CONCERN.

• Potential Risk to the General Population from Environmental Releases: LOW
CONCERN.

• Potential Risk to Workers: LOW CONCERN.

• Potential Risk to Consumers from Known Uses: LOW CONCERN.

• Potential Risk to Children: LOW CONCERN.

Regulatory and Related Information Summary:

• This chemical is listed on the TSCA Inventory. It is not otherwise regulated under
TSCA.

Assumptions and Uncertainties:

• EPA assumes that potential exposures are very limited, based on the reported use.

-------
U.S. Environmental Protection Agency
Risk-Based Prioritization Document

September 2008

Rationale Leading To Prioritization Decision:

•	The manufacture and processing of this chemical only as an intermediate to produce
other chemicals in systems that are expected to reduce the potential for worker exposure
and environmental releases lead to a low concern for risk.

Prioritization Decision:

•	LOW PRIORITY - Follow-up action not suggested at this time.

Supporting Documentation:

Screening-Level Risk Characterization: September 2008
Screening-Level Hazard Characterization: September 2008
Screening-Level Exposure Characterization: September 2008

3

-------