p.1 

•-BAS F RECEIVED 

OPPTCBIC Helping Make 

The Chemical Company Products Better 20I3DEC26 AM!]:09 

By US First Class Mail CBIC Control Number 

ATTN: EPA-HQ-OPPT-2009 357501 

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 

As required in US EPA's September 24,2013 letter, BASF 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, BASF 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 BASF submit a study plan by December 23,2013: 

(i) Identity of the test rule: 

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

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

nitrophenyl)azo]-

(ii) The specific test requirements of that rule to be covered bv 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: 

BASF Corporation 

26701 Telegraph Road 

Southfield, Ml 48034 

Tel: (248) 948-2154 

diane pietrzyk@basf.com 

40 CFR §799.5089: CASRN 70693-50-4 

Dear Dr. Lewis: 
p. 2 

BASF Corporation, 100 Park Avenue, Florham Park, NJ 07932 

(B) The names, addresses, and telephone numbers of the responsible administrative officials and project 

managers') in the principal sponsor's organization: 

Responsible BASF administrative official: 

Kara Sparks , , 

Product Regulations and Stewardship Director 

Phone: 973-245-6689, Mobile: 734-620-3371 • 

E-Mail: kara.sparks@basf.com 

BASF Corporation, Florham Park, NJ 07932 USA 

Responsible BASF project manager(s): 

Ralph Parod, Ph.D., DABT , , 

1

 Senior Toxicologi st < 

Phone: 734-324-6212, Mobile: 734-347-4306, Fax: 734-324-6774, 

E-Mail: ralph.parod@basf.com 

BASF Corporation, Wyandotte, 48192 USA 

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

communications with E£A: • • 

Diane Pietrzyk 

Sr. Product Regulation Specialist 

Product Regulation Center of Expertise . . 

26701 Telegraph Road 

Southfield, Michigan 48034 

Phone: 248-948-2154 

Email: diane .pi etrzvk@,basf• com 

II. Proposal to Provide Requested Data 

The test substance is not sold by BASF 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, BASF 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/chgmrtk/pubs/summaries/phenbenz/cl3266tc.htm') and used by the Agency 

fhttp://www.epa.gov/chgmrtk/hpvis/hazchar/Categorv Phenolic%20Benzotriazoles Sept2009.pdf) to 

BASF Corporation 

26701 Telegraph Road 

Southfield, Ml 48034 

Tel: (248) 948-2154 

dlane.pletrzyk@basf com 

> 

\ 

I'll T 1 
p. 3 

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. BASF 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 Dr. Wendy Koch. Dr. Koch is President 

and founder of Epona Associates, LLC, 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. Dr. Koch's 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 expertise1 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. Epona 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 Epona Associates Dr. Koch 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. BASF 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 

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

requirements. Please contact me at 248-948-2154 or diane.pietrzvkfgtbasf.com should you have questions or 

require additional information. 

BASF Corporation 

Diane Pietrzyk 

Sr. Product Regulation Specialist 

BASF Corporation 

26701 Telegraph Road 

Southfield, Ml 48034 

Tel: (248) 948-2154 

diane.pletrzyk@basf com 

of EPA. 

Sincerely, 
p. 4 

Cc: (By E-mail) Mr. John Schaeffer, US EPA Cmailto:schaeffer.iohnfg),epa.gov') 

Table 1. Summary of Data Requirements for 70693-50-4 and Data to be Provided 

CAS No Chemical Narre 

MW 

(B/nwl) Comment 

70693-50-4 

70321-86-7 

2,4-Bis (1 -ma th yl-! -ph cny lethyl>-6-((2-n iiro phenyl )a«) (phenol 

2-(2H-Bcn/o I riazoI-2-v lM.6-b is (1 -milhv 1-1 -pl.env lei h v ftphcnol 

479.58 

44758 

FR Test Material 

SurroHate 

Data Test Tost Data to be 

Data Request bv EPA Data Basis Method Substance Provided to EPA Data Source 

A l Melting Point 262 °C (drnfl) Estimate EPI Suite 70693-50-4 X Koch (2014)- Epona Associates l Melting Point 

259 *C Estimate EPI Suite 70321-86-7 BASF Corporation (2013) 

A l Melting Point 

139-143 °C Measured (not slated) 70321-86-7 EPA (2009)' 

A2: Boiling Point 606 °C (draft) Estimate EPI Suite 70693-50-4 X Koch (2014)- Epona Associates : Boiling Point 

600 "C Estimate EPI Suito 70321-86-7 EPA (2009)1 

A3. Vapor Pressure le-0I4 mmHB (ff 25°C (draft) Estimate EPI Suite 70693-50-1 X Koch (2014)- Epona Associates . Vapor Pressure 

l6c-014mniHK(fil25oC Estimate EPI Suite 70321-86-7 BASF Corporation (2013) 

A3. Vapor Pressure 

4 2e-013 miiHB (ff, 25*C Estimate EPI Suite 70321-86-7 EPA (2009)1 

A4' n-OcianolAVater 

Partition Coefficient 

A4 LORKOW . 9.95 (draft) Estimate EPI Suite 70693-50-4 X Koch (2014) - Epona Associates ' n-OcianolAVater 

Partition Coefficient LOR Ro w 7 67 Estimate EPI Suite 70321-86-7 BASF Corporation (2013) 

A5; Water Solubility 4.4e-06nWL (draft) Estimate EPI Suite 70693-50-4 X Koch (2014) - Epona Associates ; Water Solubility 

0,0016 mfi/L Estimate EPI Suite 70321-86-7 BASF Corporation (2013) 

A5; Water Solubility 

<0,04n>>/L(ffi 20°C Measured OECD 105 70321-86-7 EPA (2009? 

Environmental Fate 

B, Ready Biodegradalio Biodegradalion Not Readily Biodegradable (draft) Estimate EPI Suite 70693-50-4 X Koch (2014) - Epona Associates 

Not Readilv Biodegradable Estimate EPI Suite 70321-86-7 BASF Corporation (2013) 

B, Ready Biodegradalion 

3-8%after28davs -Not Readilv Biodejjradable Measured OECD301B 70321-86-7 EPA (2009)1 

CI: Acute Toxicity to Fish 96-h LC50 (ma/Ll No Effects Expected at Saturation (draft) Estimate EPI Suite 70693-50-4 X Koch (2014) - Epona Associates : Acute Toxicity to Fish 

96-h LC50 (rm/L) 1 No Effects Ejected at Saturation Estimate EPI Suite 70321-86-7 BASF Corporation (2013) 

CI: Acute Toxicity to Fish 

Aquatic Test in a not required Measured1 70321-86-7 EPA (2009)1 

CI: Acute Toxicity to Daphnla 48-h EC50 (ma/L) No Effects Expected at Saturation (draft) Est unite EPI Suite 70693-50-4 X Koch (2014)- Epona Associates Acute Toxicity to Daphnla 

48-h EC50 (m/L) : No Effects Expected at Saturation Estimate EPI Suite 70321-86-7 BASF Corporation (2013) 

CI: Acute Toxicity to Daphnla 

Aquatic Testinti not required Measured1 70321-86-7 EPA (2009)1 

CI'Toxicit CI'Toxicity to Plants (algae) 96-h EC50(mg/L). No Effects Expected at Saturation (draft) Estimate EPI Suite 70693-50-4 X Koch (2014)- Epona Associates 

96-h EC50(nw/L) No Effects Expected at Saturation Estimate EPI Suite 70321-86-7 BASF Corporation (2013) 

CI'Toxicity to Plants (algae) 

Aquatic Test in a not required Measured1 70321-86-7 EPA (2009)1 

CI Chronic Chronic Toxicity Toxicity to Daphnla Daphnla Chronic Value (me/L): No Effects Ejected at Saturation (draft) Estimate EPI Suite 70693-5O4 X Koch (2014)- Epona Associates 

Chronic Value (HK/L ) 0 001 to No Effects Expected al Saturation Estimate EPI Suite 70321-86-7 BASF Corporation (2013) 

CI Chronic Toxicity to Daphnla 

Aquatic Test in a not required Measured1 EPI Suite 70321-86-7 EPA (2009)3 

Mammalian Toxicity • Acute 

| D Acute Oral Toxicity (rat) |LDS0:>7750inR/kH by. Measured I -OECD401 | 70321-86-7 [ Xfuponrequest)|Bathe(1978)-Ciba-G:iay 

Mammalian Toxicity • Genotoxicily 

El Bactcnal Reverse Mutation Test Neitative +/-S9 Mens ured -OECD 471 70321-86-7 Xfupon request) (1982) - Ciba-Cfciav 

E2: Chromosome Aberration Test Negative (In vivo) Measured ~OECD474 70321-8(1-7 X (upon request) Miller(l983)-Ciba-0;iRV 

Mammalian Toxicity - Repeated Dose/Reproduclion/Development 

F I. Repealed Dose Toxicity with Ihe No effects on reproductive organs Measured OECD 408 (90 d) 70321-86-7 X (upon request) Basler (1987) - Ciba-Ccigy 

Reproduction / Developmental 

Toxicity ScreenmH Test 

OR 

Fl 28-Dav Oral Studv in Rodents NOAEL/LOAEL 2.5/15 nw/kg-d (liver eftetts) Measured OECD 408 (90 d) 70321-86-7 X (upon request) Basler (1987) - Ciba-Ceiflv 

AND 

F l 1 Repro./Develon mental Screen Maternal / Develop nun! al NOAEL = 3000 / 300 ma/ka-d Measured OECD 414 70321-86-7 X(upon request) FriK(1987)-CibB-CeiRV 

1

 Testing not required by EPA (2009) based on absence of mortality and ad veiso effects in an acute fish study for a more water soluble (0,17 mg/L) phenolic benzolhiazole (2440-22-4) 

1

 http.//>TOW.epn.Bov/chemr1k-/hpvis/ha?char/Cateeorv Phcnolic%20Bcn rot na relet Sopt2009.pdf 

BASF Corporation 

26701 Telegraph Road 

Southfield, Mi 48034 

Tel: (248) 948-2154 

diane p[etrzyk@basf com 

I T~ I