p. 1 

# •-BAS F RECEIVED OPPTCBI C Helpin g Mak e Product s Bette r Th e Chemica l Company 

## 20I3DEC2 6 AM!]:0 9

B y U S Firs tClas s Mail CBI C Contro l Numbe r ATTN : EPA-HQ-OPPT-200 9 

# 35750 1 Documen t Contro l Offic e (DCO ) (7407M ) Offic e o f Pollutio n Preventio

n an dToxic s (OPPT

) Environmenta

l Protectio n Agenc y 120 0 PennsylvaniaAve , N

W Washington , DC 20460-000 1 Pau l Lewis , Ph.D. , Chief

(an dvi aE-mai

l t o lewis.paul@epa.gov) Chemica l Informatio n an

dTestin g Branc h Chemica l Control Divisio n Offic e o f Pollutio n Preventio

n an dToxic s (M C 7405M) USEP A Headquarters , Arie l Rio s Buildin g 120 0 PennsylvaniaAvenue , N.W
. Washington , DC 2046

0 RE : Submissio

n o f HPV3 Stud

y Pla n

A s require

di n U S EPA' s Septembe

r 24,201 3 letter , BAS F submit s thi s Stud

y Pla n fo r U S EPA' s consideration
. I . HPV3 Stud

y Pla n fo r CASR N 70693-50-

4 Excep t a s otherwise providedbelo

w an dsummarize

di n Tabl e 1 , BAS F submit

s tha t th e informatio n describe di n 4 0 CF R§ 790.50(d)(1 ) i s not

currentl y availabl e and , pursuan

t t o 4 0 CF R§ 790.50(d)(2) , w

e agre e t o provid e tha t informatio n t

o th e Agenc y befor e th e initiatio n o f

an y testing
. Th e informatio n belo

w i s providedpursuan

t t o 4 0 CF R§ 790.50(c)(1 ) i n orde

r t o satisf y EPA' s requiremen

t tha t BAS F submi

t astud y pla n b y Decembe

r 23,2013 : (i ) Identit y o f th e tes t rule : 4 0 CF R§ 799.5089 Chenlica

l testing requirement

s fo r thir dgrou

p o f high production volum

e chemical s (HPV3) : CASR N 70693-50-4 ; Phenol , 2,4-bis(l-methyl-l-phenylethyl>6-[(2

- nitrophenyl)azo]

- (ii ) Th e specifi c tes

t requirement

s o f tha t rule to b e covere db v th e stud y pla n (a s specifiedi n Tabl

e 3 t o 4 0 CF R§ 799.5089 ) ar

e liste di n th

e attache d Tabl e 1: : (iii)(A)
. Th

e name s an daddresse

s o f th e tes t sponsors : BAS F Corporatio n 2670 1 Telegrap h Roa d Southfield , M l 4803 4 Tel : (248 ) 948-215 4 dian e pietrzyk@basf.co m 4

0 CF R§799.5089 : CASR

N 70693-50-

4 Dea r Dr
. Lewis :p . 2

BAS F Corporation , 10

0 Par k Avenue , Florha

mPark , N J 0793 2 (B ) Th e names , addresses , an

dtelephon e number s o f th e responsibl

e administrative official s an dproject managers') i n th

e principa l sponsor' s organization : Responsibl

e BAS F administrative official : KaraSpark

s , , Produc t Regulations an

dStewardshi

p Directo r Phone : 973-245-6689 , Mobile : 734-620-337 1 • E-Mail : kara.sparks@basf.co m BAS F Corporation , Florha mPark , N J 0793 2 US A Responsibl

e BAS F project

manager(s) : Ralp h Parod, Ph.D. , DAB T , , 1 Senio r Toxicolog i s

t < Phone : 734-324-6212 , Mobile : 734-347-4306 , Fax : 734-324-6774 , E-Mail : ralph.parod@basf.co m BAS F Corporation , Wyandotte , 48192 US A f C ) Th e name , address , an

dtelephone numbe

r o f th e appropriat

e individua

l t o contac t fo r ora l an dvmtten communications wit

h E£A : • • Dian e Pietrzy k Sr
. Produc t Regulatio n Specialis

t Produc t Regulatio n Cente r o f Expertis e . . 2670 1 Telegrap

h Roa d Southfield , Michiga

n 48034 Phone : 248-948-215 4 Email : dian

e .p i etrzvk@,basf

• co m II . Proposa

l t o Provid e Requeste

d Dat a Th e test substanc e i s not sol db y BAS F into US commerce eithe r b y itsel f o r a s acomponen

t o f anothe r product an ds o ther e i s n o downstrea

mindustrial , commercia

l o r consume r exposure . Th

e tes t substanc e i s asite-limite dclose

dsyste mintermediat

e tha t i s use d an dfull y consume

di n close dsystems ; ther

e i s n o off-sit e transport . Potentia l exposures ar

e limite dto occasiona

l maintenanc

e an dsampling event

s to no t mor e tha n 1 0 sit e personne

l wearin g persona

l protectiv e equipment
. Ther e ar e n o intentiona

l releases to th e environment
. Give n th e lo w exposur

e potential , BAS F request

s tha t th e Agenc y conside r fillin g it s dat

arequest s wit h a combinatio

n o f EP I Suit e modelin g fo r physical-chemica

l properties , fat

e an daquati c toxicit y a s wel l a s existing dat

ao n astructura

l surrogat e (70321-86-7 ) fo r

th e mammalia

n toxicit y endpoints
. Tabl

e 1 provide s (a ) acompariso

n o f EP I Suit e modelin g fo r th e tes t rul e chemica

l (70693-50-4) wit

h EP I Suit e an dmeasure

d values o n th e sam e endpoint

s fo r th e surrogat e chemica l (70321-86-7) , an

d(b ) th e existing mammalia

n toxicit y dat ao n th e surrogat e chemica

l (70321-86-7)
. Dat

ao n th e surrogat e wer e providedto EP

A a s par t o f th e phenoli c benzothiazole s categor

y unde r th e EP A HP V progra m (http://www.epa.gov/chgmrtk/pubs/summaries/phenbenz/cl3266tc.htm' ) an duse d b y th e Agenc y fhttp://www.epa.gov/chgmrtk/hpvis/hazchar/Categor v Phenolic%20Benzotriazole s Sept2009.pdf ) t o BAS F Corporatio n 2670 1 Telegrap h Roa d Southfield , M l 4803 4 Tel : (248 ) 948-215 4 dlane.pletrzyk@bas

f co m > \

I'l l T 1p . 3

characteriz

e th e hazard s pose d b y thes e chemicals , includin g 70693-50-4
. Include di n thi s characterizatio

n wa s adeterminatio

n b y EP A tha t aquati c testing fo r

th e tes t rul e substanc

e wa s no t require dbecaus e a n acut e fish tes t fo r th e mos t wate r solubl e membe r o f th e phenolic benzothiazol

e categor y (ie.,measure

dsolubilit

y o f 0.1 7 mg/L) di dno

t resul t i n mortalit

y o r advers e effect s a t stud y termination
. BAS F believes th e EP A requiremen

t fo r ates t o f repeate d dos e toxicit y test combine dwith areproduction/developmenta l screenin g tes t i s me t b y result s fro ma90-da

y repeate d dos e stud y (OEC D 408 ) i n rat

s tha t di dno t affec t th e ra t reproductiv

e organ s an dadefinitiv e developmenta l stud y (OECD 414) i n rats . Documentation o f

th e EPI Suit

e modeling wil l b

e prepare db y Dr
. Wend

y Koch
. Dr
. Koch i s Presiden t an dfounde r o f Epon aAssociates , LLC , providin g expertise i n toxicology , produc t safet y an dregulator

y issue s an dris k assessmen

t sinc e 1997
. Sh

e manage s an dprovide s technica

l expertise fo r

projects tha

t includ e toxicolog y testing an

devaluatio

n i n humans , mammal

s an daquati c organisms , environmenta l fat e studies , clinica l exposures , exposur

e assessments , route-to-rout e extrapolation , developmen t o f risk-base dremediatio

n goals , an dindoo r ai r quality
. Project

wor k i s conducte

di n suppor

t o f globa l hazar dan dris k assessment

s unde r th e ICCA OEC

D an dUSEP A High Production Volum e Programs , REACh , USEP A TSC A an dth e USFDA , a

s wel l i n suppor

t o f request s fro mU S Stat e an dE U Membe r States
. Dr
. Koch' s experienc e include s training , preparatio n an dcommunicatio

n o f toxicolog y issue

s includin g evaluatio

n o f chemica l hazard s i n industrial , commercia

l an dconsume

r applications , regulator

y expertise with TSCA , CERCLA , RCRA , DOT an

dOSH A regulation s an

dchemica l notification s i n th

e UnitedStates , Canada

, Europ e an d Japan
. Sh e ha s extensiv e expertise1 i n huma

n healt h an decologica

l ris k assessments , Federa

l an dStat e regulation s an

dguideline s fo r

air , soi l an

dwate r an dthei r relatio n to huma

n an denvironmenta

l health
. Sh

e ha s extensiv e experienc

e i n communicatio

n o f potentia l ris k a t publi c meeting s an

dhearing s an

dthroug h writte n communications
. Epon aprepare dth e SID S documen

t submissions fo r

severa l fertilizer component

s an dprovidedrepresentatio

n a t th e OEC D SIA M fo r

th e fertilize r

industr y fo r amajor U S base d trad e association
. Fo

r eleve n year s prior to foundin g Epon

aAssociates Dr
. Koch wa s Vic e Presiden

t an dManage r o f th e Healt h an dSafet y Assessmen

t Divisio n a

t anationa l consulting firm. I n thi s rol e sh e supervise

dastaf f o f twent y professional s consistin

g o f toxicologists , chemists , industria l hygienists , odo

r specialists , healt

h an d environmenta

l scientists , an

dengineers
. BAS F wil l provid e th e mammalia

n toxicit y studie s listedi n Tabl

e 1 t o EP A with ou r copyrigh t claimupo n reques t sinc e i t i s assume d thes e studies ar

e alread y i n th e possessio

n
BAS F believe s th

e dat adescribe dabov e an dsummarize

di n Tabl e 1 wil l satisf

y EPA' s tes

t rul e dat a requirements
. Pleas

e contac t m e a t 248-948-2154 o

r diane.pietrzvkfgtbasf.co

mshoul dyo u hav e questions o

r requir e additiona

l information
.

BAS F Corporatio

n Dian e Pietrzy k Sr
. Produc t Regulatio n Specialist

BAS F Corporatio n 2670 1 Telegrap h Roa d Southfield , M l 4803 4 Tel : (248 ) 948-215 4 diane.pletrzyk@bas

f com o f EPA
.

Sincerely ,p . 4

Cc : (B y E-mail ) Mr
. Joh

n Schaeffer, U

S EP A Cmailto:schaeffer.iohnfg),epa.gov' )

Tabl e 1
. Summar

y o f Dat aRequirements fo r

70693-50- 4 an

dDatato b

e Provide d

CA S N o Chemica l Narr e M W (B/nwl) Commen t 70693-50-

4 70321-86-

7 2,4-Bi s ( 1 -m at h yl- ! -p h cn y lethyl>-6-((2-

n iiro pheny

l )a« ) (pheno

l 2-(2H-Bcn/

o IriazoI-2-v lM.6- b i

s ( 1 -milh v 1-

1 -pl.en v le i h v ftphcnol 479.5 8

4475 8 F

RTes t Materia l SurroHat e Dat a Tes t Tos t Dat a t o b e Dat a Reques t b vEP A Dat a Basi s Metho d Substanc e Provide d t o EP A Dat a Sourc e A l Meltin g Poin t 26 2 ° C (drnfl ) Estimat e EP I Suit e 70693-50- 4 X Koc h (2014) - Epon a Associate s l Meltin g Poin t 25 9 * C Estimat e EP I Suit e 70321-86- 7 BAS F Corporatio n (2013 ) A l Meltin g Poin t 139-14 3 ° C Measure d (no t slated ) 70321-86- 7 EP A (2009) ' A2 : Boilin g Poin t 60 6 ° C (draft ) Estimat e EP I Suit e 70693-50- 4 X Koc h (2014) - Epon a Associate s : Boilin g Poin t 60 0 " C Estimat e EP I Suit o 70321-86- 7 EP A (2009) 1 A3
. Vapo rPressur e le-0I 4 mmH B (f f 25° C (draft ) Estimat e EP I Suit e 70693-50- 1 X Koc h (2014) - Epon a Associate s
. Vapo rPressur e l6c-014mniHK(fil25 o C Estimat e EP I Suit e 70321-86- 7 BAS F Corporatio n (2013 ) A3
. Vapo rPressur e 4 2e-01 3 miiH B (ff , 25* C Estimat e EP I Suit e 70321-86- 7 EP A (2009) 1 A4 ' n-OcianolAVate r Partitio n Coefficien t LORKOW

. 9.9 5 (draft ) Estimat e EP I Suit e 70693-50- 4 X Koc h (2014 ) - Epon a Associate s A4 ' n-OcianolAVate r Partitio n Coefficien t LO R Ro w 7 6 7 Estimat e EP I Suit e 70321-86- 7 BAS F Corporatio n (2013 ) A5 ; Wate rSolubilit y 4.4e-06nW L (draft ) Estimat e EP I Suit e 70693-50- 4 X Koc h (2014 ) - Epon a Associate s ; Wate rSolubilit y 0,001 6 mfi/ L Estimat e EP I Suit e 70321-86- 7 BAS F Corporatio n (2013 ) A5 ; Wate rSolubilit y <0,04n>>/L(ff i 20° C Measure d OEC D 10 5 70321-86- 7 EP A (2009 ? Environmenta

l Fat e B , Read y Biodegradalio

n No

t Readil y Biodegradabl

e (draft ) Estimat e EP

I Suit e 70693-50-

4 X Koc h (2014 ) - Epon aAssociate s Biodegradalio No t Readil v Biodegradabl

e Estimat e EP

I Suit e 70321-86-

7 BAS F Corporatio n (2013 ) B , Read y Biodegradalio

n 3-8%after28dav s -No t Readil v Biodejjradabl

e Measure d OECD301 B 70321-86- 7 EP A (2009) 1 CI : Acut e Toxicit y t o Fis h 96- h LC5 0 (ma/L l N o Effect s Expecte d a t Saturatio n (draft ) Estimat e EP I Suit e 70693-50- 4 X Koc h (2014 ) - Epon a Associate s : Acut e Toxicit y t o Fis h 96- h LC5 0 (rm/L) 1 N o Effect s Ejecte d a t Saturatio n Estimat e EP I Suit e 70321-86- 7 BAS F Corporatio n (2013 ) CI : Acut e Toxicit y t o Fis h Aquati c Tes t i n a no t require d Measured 1 70321-86- 7 EP A (2009) 1 CI: Acute Toxicity to Daphnla 48- h EC5 0 (ma/L ) N o Effect s Expecte d a t Saturatio n (draft ) Es t unit e EP I Suit e 70693-50- 4 X Koc h (2014) - Epon a Associate s Acute Toxicity to Daphnla 48- h EC5 0 (m/L) : N o Effect s Expecte d a t Saturatio n Estimat e EP I Suit e 70321-86- 7 BAS F Corporatio n (2013 ) CI: Acute Toxicity to Daphnla Aquati c Testint i no t require d Measured 1 70321-86- 7 EP A (2009) 1 CI'Toxicit y t o Plant s (algae ) 96- h EC50(mg/L)

. N o Effect s Expecte d a t Saturatio n (draft ) Estimat e EP I Suit e 70693-50- 4 X Koc h (2014) - Epon a Associate s CI'Toxicit 96- h EC50(nw/L ) N o Effect s Expecte d a t Saturatio n Estimat e EP I Suit e 70321-86- 7 BAS F Corporatio n (2013 ) CI'Toxicit y t o Plant s (algae ) Aquati c Tes t i n a no t require d Measured 1 70321-86- 7 EP A (2009) 1 CI Chronic

Toxicity to Daphnla Chroni c Valu e (me/L) : N o Effect s Ejecte d a t Saturatio n (draft ) Estimat e EP I Suit e 70693-5O 4 X Koc h (2014) - Epon a Associate s Chronic

Toxicity Daphnla Chroni c Valu e (HK/L ) 0 00 1 t o N o Effect s Expecte d a l Saturatio n Estimat e EP I Suit e 70321-86- 7 BAS F Corporatio n (2013 ) CI Chronic

Toxicity to Daphnla Aquati c Tes t i n a no t require d Measured 1 EP I Suit e 70321-86- 7 EP A (2009) 3 Mammalia

n Toxicit

y • Acut e Measure d I -OECD40 1 | 70321-86- 7 [ Xfuponrequest)|Bathe(1978)-Ciba-G:ia y | D Acut e Ora l Toxicit y (rat ) |LDS0:>7750inR/k H by
. Mammalia n Toxicit

y • Genotoxicil y E l Bactcna l Revers e Mutatio n Tes t Neitativ e +/-S 9 Men s ure d -OEC D 47 1 70321-86- 7 Xfupo n request ) (1982 ) - Ciba-Cfcia v E2 : Chromosom e Aberratio n Tes t Negativ e (I n vivo ) Measure d ~OECD47 4 70321-8(1- 7 X (upo n request ) Miller(l983)-Ciba-0;iR V Mammalia n Toxicit y - Repeate d Dose/Reproduclion/Developmen t F I
. Repeale d Dos e Toxicit y wit h Ih e N o effect s o n reproductiv e organ s Measure d OEC D 40 8 (9 0 d ) 70321-86- 7 X (upo n request ) Basle r(1987 ) - Ciba-Ccig y Reproductio n /

Developmenta l Toxicit y Screenm H Tes t O R F l 28-Da vOra l Stud vi n Rodent s NOAEL/LOAE L 2.5/1 5 nw/kg- d (live reftetts ) Measure d OEC D 40 8 (9 0 d ) 70321-86- 7 X (upo n request ) Basle r(1987 ) - Ciba-Ceifl v AN D F l 1 Repro./Develo n menta l Scree n Materna l / Develo p nun ! a l NOAE L = 300 0 / 30 0 ma/ka- d Measure d OEC D 41 4 70321-86- 7 X(upo n request ) FriK(1987)-CibB-CeiR V

1 Testin g not require d b y EP A (2009 ) base d on absenc

e o f mortalit y an d a d veis o effects i

n a n acut e fish stud

y fo r amor e wate r soluble (0,1 7 mg/L

) phenoli

c benzolhiazol

e (2440-22-4

)

1 http.//>TOW.epn.Bov/chemr1k-/hpvis/ha?char/Cateeor v Phcnolic%20Bc

n rot n arelet Sopt2009.pd

f

BAS F Corporatio n 2670 1 Telegrap h Roa d Southfield , M i 4803 4 Tel : (248 ) 948-215 4 dian e p[etrzyk@bas f co m

I T ~ I