15-Jun-12 

l(cport # I Test System I Comments ncsults 

<:omplctccl Stutlics 

GLP: 

The rat oral LDSO was greater than 5000 mg/k~ (limit dose). There.: were no ucuths 

0) Rut Guideline during the exposure recovery period. 

OLP: The male and female rat, whok·body inhalution 4-hr LCSO wus grcmcr than 15,/J()( 

4-hr LC50) Rat, whole· Not prm (the i~hest achievable vapor concentration). There were.: no dc:llhs during the exposure body Guidclmc or recovery period. Anesthetic eiTects were observed at concentrations greater than or Ctlu:ll to 9700 ppm 

D50) Rat OLI'. The rat uennal LD50 was greater than 5000 mglkg (I unit dosel. There were no Guideline de<~ths during the exposure recovery period. 

Rabbit GLP: was not a dermal irritant when tested in rabbits. No cllmcal sogns of toxocny was Guideline observed 10 the study. 

ion Mouse GLP, was not a dermal sensitizer when tested in mice. No ell meal Signs of tox1c11y W(IS Gutdcllne observed 10 the study. 

Rabbit GU', was not an eye irritant when tested in rabb1ts. No cllnocal s1gns oftoxicny was Gu1dclinc observed in the study. 

01.1'; was not mtllagenic in the Bacterial Reverse Mutation Assay (Amcs) ICSI usmg 

Mutmion A=y (Ames) l3actcria Salmonella strains TA98, TA I 00, TA 1535, and TA 1537 and E. coli Slrain WP2 11vr A en her Guideline in the presence or absence of an S9-activated test system. 

Chinese 

Gl.l': did not produce structural or numerical chromosome ullerrations in an in vttro 

me Aberration hamster ovury Guidclmc mammalian chromosome aberration test using Chinese h:unstcr ovnry (Cl iO) cells either in !Cl iO) cells the presence or ahsence of an S9-actrvated test system. 

Ma le and female rats were exposed 10 a single oral dose ofO, 500, 1000, or 2000 mg/kg 

leus RHI GLP; . No clinical signs of toxicity or mortality was observed in the study. IIFX· I IO did not Guideline induce biologically relevant increases m micronuckalcd rcticuiOC)'Ies in pcriphcml blood 

cells. 

Male and lcmale rats were exposed 10 0, 250, 500 or I 000 mglkg via oral gavngc 

Rm GLP, for 28 days. No test substance-related adverse effects were observed in climcal or anatormcul Gmdelinc pathology assessments. The no·observed-adverse-eflcctlcvcl (NOAEL) was 1000 

mglkg/day. i 

Male and female rats were exposed to 0, I 00, 250, or 1000 mg/kg vta oral g:rvagc I 

FOB'' ' R:u GLP. for 28 days. No test substance-related adverse effects were observed in climcal. , Ciuidcltnc ncurobehav1oral, or anatomical pathology assessments Tho; no-obscrved-adverse-ellcct level 

(NOAEI.) was 1000 mglkglday. 

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Male and female rats were exposed to 0, 250, 500 or I 000 mglkg 

for\)() uays. No test substance-related adverse efli:cts were observed i

90-Day Oral wllh FOO GLP; ncurobchnvioral, or anatomical pathology sses~mcnts tn females. A s

Rat Gutdeline severity , but nm incidence, of chronic progressive ncllhmpathy (CPN) 

pathology changes was observed in ma les at nil dose levels The no-ob

level (NOAEL) for female rats was 1000 mg/kgfuay. The NOAJ::L wa

i m:Jic rats. 

Pre-natal Oral Developmental I 

Female rats were exposed to 0, 250, 500, or I 000 mg(kg per 

Rot GI.P; during gestation day (GD) 6·20 No test substance-related maternal or 

Guideline was observed at any dose level. The no-observed-adverse-effect level (

• 

and fetal effects was 1000 mglkg. 

Intravenous Tolernbilit)' Study 

I 

Not GLP; Male and female rats were exposed to to a single tnt ravenous tnjection 

Rat Not No deaths, clinical signs, or body weight losses occurred m

GUideline days of observation. 

Ready Oiodegradahility th) NA GLP; i~ not rcadtly biotlcgradable. No transformation product was 

GUideline condilions of the test. 

i Medaka were exposed to 0.005 or 0.05 mg/L in a conlinuous 

system for 60 days followed by a 14-day dcpurmion period. The steady

Bioconcentration Study '"1 Fish GLP; ranged from II 00 10 22l0 forthe 0.05 mg(L level and from 1560 to 28

Guideline level. The concentration of in lhe fish decreased with time d

periotl. The biological half-lives ranged from 3.1 to 6.6 days for the 0.0

2.5 to 4. 7 days forthe 0.005 mgfL level Average BCF for 12 datapoim

The green algae 72-hr EsC50 was greater than 0.00().177 mg!

concentrnl!on lested). The no observed em:ct concentration (NOECr) a

Algae Growth lnhthtllon Tcst lhl Green algae GLP; 0.000477 mg/L (the highest dose lested). The concentralion was the tim

Guideline the limil of sol ubi lily (0.16 mg!L) after 72-hours. During the course of

dclennmed !hut the test subs1ance was volutilt zcd from the rest solution

llenry's law constant of 4. 75E6 nh mol. 

Algae Growth Inhibition Test 

Not GLP; The green algae 72-hr ErC50 wus greater I han 120 mg(L (the 

Green algae Not 

Guideline lestcd). 

fish Acute Toxtclly Test 1" 1 GLP; The Medakn 96-hr LCSO was greater !han 0.0.960 mgfL (lhe 

Mcdaka Guideline tested) The concentmtion was the time-weighted mean of the limit of s

after 96-hours. The test solution was renewed every 24 hours. 

Fish Acute Toxicity Test Fathead Not GLP, The fathead minnow 96-hr LC50 was greater than 120 mg(L 

Not Minnow Guideline concentration tested). 

Daphnia Acute Immobilization Test '''l Daphnia GLP; The Daphnia magna 48-hr ECSO was grea1cr than 0.157 mg!L 

concentraltOn ICSted). The concenlration was the tune-weighled mean o

magna Guideline 

sol ubi lily (0.17 mg/L) after 48-hours. The lest soluuon was renewed af

Daphnia Acute lmmohtlozation Test Daphnia No1 GLP; The Daphma magna 48-hr ECSO was grea1cr than 120 mg!L (

Not 

magna Guideline conccnt rat ion tcsled ). 

Activated Sludge Respiration lnhibi11on Test Mtcrobtal GLP, The microbial respiralion inhibitton ECSO was greater than 10

Guideline tested). No inhibition was noted at any concentration. 

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The study was conducted using the IIPLC Method for determining a s

Adsorption Cocnlcicnt (Log Koc) NA GLP: coefftcicnt (soil organic c~rbon wa ) on soil and sewage sludge. Th

Guidelin.: (log Koc) value of the test ub ancc was calculated to be 4.50 (ln sot I 

sludge 

KOWWIN vl.68 was used to t:Stltnnte LogKow. compone

LogKow (modelled) 

Not GLP, training set's structural domain req111 rcments completely, however, oth

NA Not related analogues and water solubility infonnation provide corroborat

Guideline estimates made by the model arc reasonable. LogKow predictiOn rang

for A weighted averasc hased on the typtcal componcn1 pe

estimated LogKow values was calculated to be approximate ly 4.97. 

On-J,!oing Stutlil'S ll FX'- 110 

----- ------ ---

Daphnia Reproduction Test t•l Daphma Guideline in progress, re110rl CX IICCied IS,Junc magna 

Zebra fish 14-day Growth Study«> 7.cbrafish Guidelme in rtrogr·css, rcporl eXIlCCtcd end of l\l:1y 

EtSCilHl 

The Eisenoa foctida 14-dny LC50 was greater than 1000 mgl

Eanhworm Acute Toxicity Test <• > foetidu Guideline and only concentration tested) 

in l>rOJ.!rCSS, reuort ex peeled end or 1\'lny 

GLP; ts inherently biodegmdablc. Biodegmdation was 44 J% afie

Inherent Biodcgmdabtlit)' Test1d1 NA Guideline conditions of the test. in pro~:ress, rcporl ex peeled end of 1\l:ty 

Not GLP; 

Toxicokinetics Test 1"' Rut Not pcntllng 

Guideline 

LogKow (measured) <hi NA GUideline llCn<ling 

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