By US First Class Mail 

ATTN: EPA–HQ–OPPT–2009 

Document Control Office (DCO) (7407M) 

Office of Pollution Prevention and Toxics (OPPT) 

Environmental Protection Agency 

1200 Pennsylvania Ave, NW 

Washington, DC 20460–0001 

Paul Lewis, Ph.D., Chief (and via E-mail to lewis.paul@epa.gov ) 

Chemical Information and Testing Branch 

Chemical Control Division 

Office of Pollution Prevention and Toxics (MC 7405M) 

USEPA Headquarters, Ariel Rios Building 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20460 

RE: Submission of HPV3 Study Plan 

40 CFR § 799.5089: CASRN 70693-50-4 

Dear Dr. Lewis: 

As required in US EPA’s September 24, 2013 letter, submits this Study Plan for US EPA’s

consideration. 

I. HPV3 Study Plan for CASRN 70693-50-4 

Except as otherwise provided below and summarized in Table 1, submits that the information 

described in 40 CFR § 790.50(d)(1) is not currently available and, pursuant to 40 CFR § 790.50(d)(2), we 

agree to provide that information to the Agency before the initiation of any testing. 

The information below is provided pursuant to 40 CFR § 790.50(c)(1) in order to satisfy EPA’s requirement 

that submit a study plan by December 23, 2013: 

(i) Identity of the test rule: 

40 CFR § 799.5089 Chemical testing requirements for third group of high production volume 

chemicals (HPV3): CASRN 70693-50-4; Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[(2-

nitrophenyl)azo]- 

(ii) The specific test requirements of that rule to be covered by the study plan (as specified in Table 3 to 40 

CFR § 799.5089) are listed in the attached Table 1: : 

 

(iii)(A) The names and addresses of the test sponsors: 
(B) The names, addresses, and telephone numbers of the responsible administrative officials and project 

manager(s) in the principal sponsor’s organization: 

Responsible administrative official: 

Responsible project manager(s): 

 

 

(C) The name, address, and telephone number of the appropriate individual to contact for oral and written 

communications with EPA: 

II. Proposal to Provide Requested Data 

The test substance is not sold by into US commerce either by itself or as a component of another 

product and so there is no downstream industrial, commercial or consumer exposure. The test substance 

is a site-limited closed system intermediate that is used and fully consumed in closed systems; there is no 

off-site transport. Potential exposures are limited to occasional maintenance and sampling events to not 

more than 10 site personnel wearing personal protective equipment. There are no intentional releases to 

the environment. 

Given the low exposure potential, requests that the Agency consider filling its data requests with a 

combination of EPI Suite modeling for physical-chemical properties, fate and aquatic toxicity as well as 

existing data on a structural surrogate (70321-86-7) for the mammalian toxicity endpoints. Table 1 provides 

(a) a comparison of EPI Suite modeling for the test rule chemical (70693-50-4) with EPI Suite and measured 

values on the same endpoints for the surrogate chemical (70321-86-7), and (b) the existing mammalian 

toxicity data on the surrogate chemical (70321-86-7). Data on the surrogate were provided to EPA as part of 

the phenolic benzothiazoles category under the EPA HPV program 

(http://www.epa.gov/chemrtk/pubs/summaries/phenbenz/c13266tc.htm) and used by the Agency 

(http://www.epa.gov/chemrtk/hpvis/hazchar/Category_Phenolic%20Benzotriazoles_Sept2009.pdf) to 
characterize the hazards posed by these chemicals, including 70693-50-4. Included in this characterization 

was a determination by EPA that aquatic testing for the test rule substance was not required because an acute 

fish test for the most water soluble member of the phenolic benzothiazole category (ie.,measured solubility of 

0.17 mg/L) did not result in mortality or adverse effects at study termination. believes the EPA 

requirement for a test of repeated dose toxicity test combined with a reproduction/developmental screening 

test is met by results from a 90-day repeated dose study (OECD 408) in rats that did not affect the rat 

reproductive organs and a definitive developmental study (OECD 414) in rats.

Documentation of the EPI Suite modeling will be prepared by is President 

and founder of , providing expertise in toxicology, product safety and regulatory 

issues and risk assessment since 1997. She manages and provides technical expertise for projects that include 

toxicology testing and evaluation in humans, mammals and aquatic organisms, environmental fate studies, 

clinical exposures, exposure assessments, route-to-route extrapolation, development of risk-based remediation 

goals, and indoor air quality. Project work is conducted in support of global hazard and risk assessments 

under the ICCA OECD and USEPA High Production Volume Programs, REACh, USEPA TSCA and the 

USFDA, as well in support of requests from US State and EU Member States. experience 

includes training, preparation and communication of toxicology issues including evaluation of chemical 

hazards in industrial, commercial and consumer applications, regulatory expertise with TSCA, CERCLA, 

RCRA, DOT and OSHA regulations and chemical notifications in the United States, Canada, Europe and 

Japan. She has extensive expertise in human health and ecological risk assessments, Federal and State 

regulations and guidelines for air, soil and water and their relation to human and environmental health. She 

has extensive experience in communication of potential risk at public meetings and hearings and through 

written communications. prepared the SIDS document submissions for several fertilizer components 

and provided representation at the OECD SIAM for the fertilizer industry for a major US based trade 

association. For eleven years prior to founding was Vice President and Manager 

of the Health and Safety Assessment Division at a national consulting firm. In this role she supervised a staff 

of twenty professionals consisting of toxicologists, chemists, industrial hygienists, odor specialists, health and 

environmental scientists, and engineers. will provide the mammalian toxicity studies listed in Table 1 

to EPA with our copyright claim upon request since it is assumed these studies are already in the possession 

of EPA. 

believes the data described above and summarized in Table 1 will satisfy EPA’s test rule data 

requirements. Please contact me at should you have questions or 

require additional information. 

Sincerely, 
Cc: (By E-mail) Mr. John Schaeffer, US EPA (mailto:schaeffer.john@epa.gov)