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## - ntUNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460

VIA FACSIMILE: 201-437-4801 April 19,2012 Attention: Glenn Merritt(201-437-4000) OFFICE OF PREVENTION, PESTICIDESAND TOXIC SUBSTANCES

Subject: Follow-upto fax transmissionof4/13/12 (ePMAremoval ofCBIclaimsregarding identified studies) 

### DearMr. Merritt: This is sentto you pursuantourconversationofseveralminutes ago. In Larry Robinson'sfax of April 13th while there is a waiverofconfidentialbusinessinformation (CBI)claimsin the identified studiesthere is a anassertion ofcopyrightprotections and some additional textthat providesin part ... "Reproduction,reference, summarization,retransmissionorotheruse ofthis copyrighted document...includingelectronic transmission,usingthe internetoremail....is strictlyprohibited...." Whileweunderstandthe basisforthecopyrightprotections, we have a concernthatthe language in the fax mightbeinterpreted to meanthatePMA isassertingthatthestudies submittedperthe TSCA activityarenottobemadeavailable inan Agencye-docket (electronic docket) orbe included in EPA websitesamongthecollectionofTSCAhealthand safety studies. Wearethinkingthat the identifiedlimitations noted inthe fax arenot intended to applyto EPA's normal procedures for thehandlingofnon-CBI materials submittedby entities subjectto TSCA regulations(includingthepostingofsuch materials ongovernmentwebsites) and submittedby such entitiesinorderto complywithaTSCArequirement, but are rather intended to limit entitiesoutside the government from the unauthorized useorappropriation ofthe studies. Canyou pleaseconfirm CPMA'sintent? Manythanks.
ScottM. Sherlock,Attorney Advisor Environmental AssistanceDivision OfficeofPollutionPrevention andToxicsSPRINGBORN INSTITUTE FOR 810RESEARCH. NC bPE14X #LL0"0 45887 FPONIE 419 047-4106 

### ACUTE INHALATION TOXICITY IN RATS Sample: Alkali Blue R Lot #f711-18033

Letter 1/21/81 

### Lab Study No.: 

### 3060.35 Report Date: 05/21/el
Protocol: .*.cute Inhalation Toxicity (LC5O) in Rats Sponsor: BASF Wyandotte Corporation Wyandotte, Michigan

Enclosed: Summary - 

### Page 2 GLP Requirements - if 

### 3 Quality Assurance Statements - 4 

### Raw Data Appendix - " 

### 5-12 Protocol- - *' 13-17 

### Protocol Amendmient - " 

### 15, 18 Signed: Laboratory T chnician

Richard A. Hiles, Ph.D. Jor

. 

### Fulfs, Ph.D. Vice President and E tive Vice Pres dent Director of Acute and an Director of Toxicology Subchronic Toxicology (Study Director)

Date

________ _____e_1


### /Iks 

# &SPRINGBORN GROUP LETTEPS & REPORTS Springborn institutefor 84oresebrch. Inc and Sco*.npborn Group. Inc letters and reports are issued fortheexclus-e use of the clents to -..ho- they aro addressed No Quotationls from reports or u"eof th~eSpr~npborn institute for Acoe- torch, Inc. and SPrimpborn Group. Inc name is Permitted except as expressly authoried on writing Letters aned reports applyoonly to Ive spec$.c materials. proidcjt or processes tested. eia-'med or sur~eyed and are not necessaroiy ndocat...e 01 tre-r uili~tes of apparenty identical or similar mratervais. prvcducts or pro-reseS The teab-letv y Spr.rngborfl Instietute for Beoresearch. Intc and Spmingborn Grouo. Inc withe respect to StrsceS rend-.ed Shsalt beWO AK .t.ffl 9 V".9-.W AM. A"C"4 U0C 

### ACUTE INHALATION TOXICITY - 

### SUMMARY Reprt-f-'-bi -i test performed at: Springborn Institute 

### for Bioresearch, Inc.



### 553 North Broadway Spencerville, Ohio 415887 During the period: 04/23/81 - 

### 05/21/81 According to the attached protocol and addenda (if any). Deviations from Protocol: None
Lab Study No.: 3060.35 Sponsor's DRD No.: Letter 1/21/81 Test Substance (TSIN): Alkali Blue R - 

### Lot # 71141-8033 Description : Dark blue powder Ltorage Conditions: Room temperature Sponsor's Divisional Toxicologist: Sandra E. Reiss (SD)(BR) Rat Strain and Source of Animals: Harlan Industries. Ing. Concentration and Amount of Test Substance Dosed: 0.048 + 

### 0.026 mg/L for-l hour Mortality Summuary (Number of Deaths) Dosage Hours Days Level, 0-4 1 2 3 4 5 6 7-14 Totals M-F M F M F M F M F M F M F M F M-F_ Q0048 0-0 0-0 0-0 0-0 0-0 0-0 0-0 0-0 0-0 + 

### 0.026 rng/L

Conclusions: The test article produced no toxicity. No test article relatable tissue chan~es were observed at necropsy. The LC50 is greater than 0. 118 + 

### 0.026 mlLI - I 

### hr.

LETTERS A REPORTS' SpringbOfl fnstolule for Eltorc.earch. Inc and Sv~r~nhornGrcnop. Inc letiersan~d treortsart-end for 1Il.Cu%.rue 01 The CiperniS 1o .hom they are addressed NoOuO-attons from~ reports or u..e of The SO, ... zh~r^l~s idutefor FI-f. trArch.InC and %pr'npborn Group. Inc naMeris gperrned e.cepI as e.prCSly a,,Ihord in writing t etiers and reporls apply only 10 the-1C ifcc mnauer,.,k per~uCls or processeslsed. eParn~rdOf Surv.eyrd andi are noi rT.ec.%~rI ,n'ancc h 

### ~arso paentlyklenutcal or .M.lar Maier.. IIS.Prt-.cts 'T. .. 

### ~ r *.*q-rr~1 P .' 1-~rtI'ra Str-- - Crow,. Inc .r-th res*pe~ct IC -. C, .cr-s 4nPtr'rd %hMrI he

### (3) Study-No. 

### 3060-35_ GLP REPORT REQUIREMENTS GLP Requirement Page Name and Address of Test Facility 2 Date Study Initiated 2 Date Study Completed 2 Objective arnd Procedures 13-16 Statistical Methods Used NA Test and Control Article Identification 2 Stability of Test and Control Articles 13 Description of Methods 13-16 Description of Test System 14i Species, Strain, Substrain, Source of Supply, Age, 

### Sex, Body Weight Range, Number of Animals Used, and Procedure Used for Identification Dosage Information 2 Description of Circumstances Which May Have Affected the DataNA Name of" the Study Director 1 Names of Other Scientists, Professional, and Personnel 1 Involved in the Study Description of Operations Performed on the Data 

### 16 A Summary i:.nd Analysis of.the Data 2 A Statement of Conclusions Drawn from the Analysis 2 Signed and Dated Repnrts of Individual Scientfsts or 1 Other- rofessional Involved in the-Study Locations Where All Specimens, Raw Data, and Final Report 14 are to be Stored Quality Assurance Statement (signed) 14 NA = 

### not applicable

LEVT ES & RCPORTS Spr~ngborn lnTtlltPfr B,orec!.,'eh Inc nd SP',nt,o,nGra-rp. Inc leovr'.- and Yeport%^re '-.!....'d, or tlipe luow use of 11,1 r:I " to

10.-hoo they ale,artd-emse No cluotai.ons Illy.. reporm, or "w.e of the Speongborn In~,lui for F.Ore-."hrch. Inc .%nc4 Spr-,,'b rn roup. Inc 'Sae, p ntr- '( I cp s P.pr.Sty .s,,thor,zd -n -. ,,ft~ 'trs ,.d cn,, aasoly only to -~e %%-P: fc fae raI*r ucm Or pro.' ss

,,te. e.,.,edor ,re -d and are'not ntces5,. y Of m, ae Qu. s. . aop...ently ,cenlci -To 5.i,., %l.r~ .prodlucts or proco-sses The Isabsisy of~ *.r I"CS~ItufC fotr 

### ~.t;.e-ach. Inc and Ssranphorn Group. Inc with elstect to t -v-ces sereS .ttaii he(4i) 

### Quality Assurance Statement Study No. 3060.35 Test Substance Alkali Blue R Lot I 141-8033- 

### Type of Study Acute Inhalation Toxicity in Rats Listed below are dates that this study was inspected by the Quality Assurance Unit and the dates findings were reported to the Study Director and to Management. Dates Dates Findings Reported Dates Findings Reported of Inspection to Study Director- to M~anagement 05/19/81 05/21/81 05/21/81 05/20/81 05/21/81 05/21/81

Location of Raw Data Storage Statement The original copy of the final report and all raw data will be on file at the testing facility.

-- 

### ~~~-- ~DateCarol DaV-1s-7 Manager/Coordinator Quality Assurance Unit

LETTERS & REPORTS Springbotn In~totuie for B8aot'.earch. Int and SponphornGroup. Inc letters.and reorts a~ed
-- r,1 etIl of the cdents to -,om they are Addare. %ed No Quotaisons fromS rrpar1%or use at the Springhorn In%totuirfor 8.o#. Cot'Ch. Inc and Sr-.gtsrn Group. Inc nam~e %permolled cocep A a~cptessiv jauthoried .n - "Impn I ril'st~ and repot%~ ppl*v O 1 y It, the ,.re'fic P~ort'nd..t or processes t.-ted. e "mn.,.d or surv'eyed and are n.rt nece~sa-sly incdcat.sve o1 the quatlt.es of apparetly #dent-cala-srlh 5.MPIN- Atq.t Pfldu.rM n, p~c'ce - The Iab.irty Of Sprongb.,en Institute ;or 1e,0#e~carch. Inc ... d Sr,,.n~gtorn GrrAp. One ".ohfeSPVct to S '-coel, ,vfld,,,d 5haI he I~l,,led 1o ti., enrount nf con.e~aton paed for tuch ! ers .e and not inctuee any conr~equent.al earnsagesStudy No. 3060.35(5

N.

0 0-

9 ty V 0

-1 

### ~ -- - - o - - - -
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en k90 I4 94 4 L43 

### ~ 0 1N H
- go 

### ~ aE1 D O 4C el r: o f n n I .94- C .49 g (C0.4( N 0 oA (0 (N .14 (N 10 C4E) 0 0 di

- - -4 C4 c14 en fn

. 4 40 0= 0o e 0 0 N Li 0 

### ~~~- U4O ) A ( o~ 0 I).4 n 0 to ( 40 .94 q 4 (d

%c 0 0 0 0 0 U 00 0 0 En to 0 f- I am M9 94 $4 On 0 0) 0 0w Hq 0) H)Ot () .m~

### ~ ~ N 14E 14 r4 o r_ 0 a- "1 to .14 .,q 0 H4 (4 41 .- E-Vn___ Stud-yNo. 

### 3060.35 ()___ Particle Size Data Project # 3060.35 Date ~4/23/81 Group IICompound Iff Alkali Blue R Lot # 71141-8033 Sample Flow -ate 28 L/niin. Sample Duration 15m -mn.

Filter Pre-Wt.i Filter Post-Wt. Change in Wt. Stg gin. gin. g 0.3866 0.3982 24.L0 + 

### Preseparztor 0.3871 0.3979 ____.8____ 

### 0.3878 0.3957792 0.3816 0.3919 1. 0.3911 0.14005 .4 0.3926 0.3979535 0.3867 0.3885 1.8 6 0.3836 0.3836 0.0 7 0.-3718 0.3718 0.0 Filter Aerodynamic Diameter Average 

### 6 Microns_ Standard Geometric Deviation 2.8 Microns samples were collected using an 8 stage Anderson Cascade Impactor. Glass papers were used as collection Plates.Study 

### No. 3060.35(7 -project#__3060.35- Da -4/23/81

-

Group#_______ CCr'IX'IUrK1 Alkali Blue R Lot #I7141-8033 Sanplel__ 

### Particle Size Distribution Data: Source- Chanbor Atrrospbere How Collected- Anderson Cascade Inpactor * Data: Particle Diameter Percent in Size R~ange ulative Percent (microns) Less Than 

### -29.0 34.6 65.4 5.8-9.0 15.5 4. 4.7-5.8 11.4 38.5 

### 3.3-4.7 14.8 23.7 

### 2.1-3.3 13.5 

### 10.2 1.12.17.6 2.6 0.7-1.1 2.6 0.0 

### 0.4-0.7 0.0 0.0

< 0.4 0-. 0 0.0 Special Note: When the dust generator and the inhalation chamber were disassembled for cleaning, large quantities of test article were found on top of the scrapping plate and where the test article entered the chamber. Thus, the test article contained a large fraction of particles too large to become airborne kn the chamber. The above distribution represents only what was in the chamber and is not representative of the composition of the test arti-cle particle size distribution.Study NIo. 3060.35

____ 

### tlest Article: Alkali Blue R Lot 7141-8033 

# 'I:O4 ~: ParticleSize Distribution Data: 1.Source: Inhalation Chamber 11:52-12:07 on 4/23/81 2. Method of Determination: .Gravimetric Dat-a: Average Aerodynamic Diameter +Standard Geometric Deviation -6 ;L 2.8 microns Particle Diameter Percent In Size Range Cumulative Percent (Microns) LessThan 7p 9.0 34.6 65.4 5.8-9.0 lb.!5 4.7-5.8 11.4 38.5 3.3-4.7 14.8 23.7 2.1-3.3 13.5 10.2 1.1-2.1 7.6 2.6 0.7-1.1 2.6 0.0 

# 00.4-0.7 0.0 0.0 -<0. 4 0.0 0.0

TOA 1 111 1fl il I III1 1111tl l!11 Hl 

### IifilffillIi~fii H~ l, ifli 

### Hil" L1;L.uQY 149. 3060.35

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### ~ 4~ Enu 0- ) 0 0 a,-4 ) $.ar 3,0w0a)0Q4J J MW f ( M 1090 4 0 4 H.q0P 4-) 0 0 rW-4 >1v4 1554 tSHx 0) *HE- X- m 4c c <a r U0 In In

### Study No.-30160.35 (10)-

BODY WEIGHTS Animal Number Sex Day-0 wt (gmn) Day-7 wt (gin) Day-14 wt (gmn) *R-1388-81. M 273.0 321.7 360.14

R-1389-81 M 268.1 315.-5 3146.14 R-1390-8. M 2144.o 262.3 282.8 R-1-391-81 M 227.8 269.3 300.9 R-1392-81 M 237.3 281.8 316.8 R-1 1

### 4oo-81 F 230.7 250.7 2614.6 R-114oi-81 F 208.1 2241.0 236.6 R-1'402-81 F 211.3 236.8 2314.2 R-14,03-81 F 210.1 222.6 233.8 R-1'4041-81 F 218.14 2314.1 2148.14 Avg. 232.8 261.9 282.5

LETTERS A REPORTS Sp-tzbwn In~tlyi W&for .e.g'hIt ,. b~~o~.Ie c,-.~1 

### ~ .c~~~ of Ithe ci....,l to -homt II.ey ale .ddt.sed No 1Cnai~,. from regn'?s ci-we0' thn Sp-,91to.- In, U ir..d t *i,. Grou.p. inC nflI e 5 permnl.t-ed e.c;MPT ... 

### ~ .~to~ n -, :-n L.,Tlw,~ ind Pn i .,nmv . . . .

### Study No. 3060.35 (11)
NECROPSY RIEPORT SHEET
Animal Number Necropsy Observations Males: R-1 388-8. Not remarkable R-1389-81 R-1390-81 Severe congestion and 

### edema 

### of lungs R-1391-81 Not remarkable R-1392-81
Females: R-14f00-81 Notremarkable R-14Iol-81 1 

### R1-14I02-81 R-1.403-81 R-lL404-81

LETTE RS WPHIF S~ Pt 11 5~ o' 1" tv for Rt. . rch. J tic I c o . nIc ctIle.. ;.d erg~.. . 1 1 twe ., of I f'r ce t'nt to vh,,,n,'Ihi.y t v s.Pd No fi :' I.,,, ,m , - ., .j.e of I -n 5 or -t~n rn I r. st Iut v ft-. Ei-~., 4 .n: j ct 'c :, n r i Groupi .nC rmnt.~ *s p rrntifd ". a.'I "'vte y Athot,,, d on wroino eI e- at9.gnd *(;(9t..ppli, pn1, ts ,. - . 0o

09'1r9...'t t h I otI 'v t g'nbr. 1-9 9)nc .j ,.... -c,. I cfitr~ Sn,,,h,, f.p -1:g -~ut -,"p.r. ... . . . .... j'_9,tEd tIl 'it o:f I 

### ~~l.ls~ ,, I..' ... :h ;f' ,-£'d ftol io.n etatrgn C, 'ton ,

### Study No. 32060.35 (12)-

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### Study No. 3060.35 (13) 

# .O1

. P-CUt 

### ACUTE 'I"VHALATION- 

### TOXICIT-Y LIC

### 5) 0 1NRA

### TS 

### r PURPOSE To assess the toxicity of a test article in rats when exposure is by inhalation so that it might be compared to more familiar test articles. TEST ARTICLE All test articles are furnished by the sponsor. They are identified as follows:

__ 

# il771L-- The sponsor assumes responsibility for any necessary evaluations for purity, strength, stauility, etc. Storage Conditions. z ~ .~~7(4Y~/' 

### Preparaticn for dosing:

Known Hazards:

________ C__ 

### SPONSOR BASF Wyandotte Wyandotte, ;*,ichigan 48192 TESTING FACITITY Scringborn Institute for Bioresearch, Inc. Soencerville, Ohio '58 (41)64.7-49 PROPOSED STARTING DATE

__ __(to be completed by SIB) 

### PROPOSED COMPLETION DATE

- 

### (to be completed by SIB) (10 wr 'ks from v~ceipt of test article and signed protocol)

### StttdjrNo. 3060.35 (114) Irnhation LC5 

### 0 2 

# 400tz TEST SYSTEM JUSTIFICATION The rat is the system of choice since it has been used historically for this type of study and will allow the data to be compared to those for other compounds. ANIMALS Sprague Dawley Rats, Harlan Industries 

### 5 males and 

### 5 females per group 180 - 300 g 

### Acclimnate 

### 1 days Healthy ANIMAL IDENTIFICATION Metal ear tags HOUSING AND ANIMAL CARE One/cage In elevated wire mesh cages. 12/12 hr. light/dark cycle. Other Items according to AAATJAC standards. They are housed in rooms reserved for rats on acute tests. FOODANDWATER Commercial feed and water are freely available except prior to dosing when food is withheld. METHOD 'v 

### ADMiNISTRATION -The exposure will be by innalation of the test article as: 

# LUI1 vapor 

# L]mist [jvolatile gases 

# j~ldust fJ ot!)'r

- - - -- -- -

### Study No. 3060.35 (15) Az.ii~.lL' 0 

### 0.
DOSE LEE 1 

### AND EXPOSURETIM4E option A: Using a nominal concentration ofC&mg/1, expose one group of animals for 1 hour. (IC.~~g, 

### option B: Using a nominal concentration of -mg/l for1 hour as the highest dose, run an appropriate dose ~i ranetuy.Based on these results, select 4I Ca' dose levels (generally at a 1.41 geometric progression) to be administered 

### to 4J groups of 10 animals each for an exposure time of 1 hour.



# . ACTUAL DOSE LEVELS Sarnoles of the atmosphere will be taken for chemical analysis: 

# iXiNo L]Yes if "Yes"l:

### a. 

# ff]return samples to sponsor b. ~]analyze by the attached sponsor-supplied method c. 

# []develop an appropriate analytical procedure and analyze the samples Samples of the atmosphere will be taken for particle analysis: 

# [I] No 

# [ Y Ye's INHEALATION CHAMBER * A 270 1 stainless steel chamber designed for inhalation studies will be used. Air flow, temperature, and humidity will be monitored. OBSERVATIONS Observe the animals individu'ally three times during the first day and daily thereafter for 14l days. Record mortality and overt symptoms of toxicity. Necropsy all animals which die during the study. Weg sring

-. c*. 2

### Stuy N. 

### 06035(16) In~halation LC5 

### 0

rCMD f'*O*4124t £*.CeI W 

### T:ERMINATI ON At 141 days all surviving animals are weighed, sacrificed and necropsied. Tissues will be saved only upon special request. REPORT Sample preparation, dosing, all observations, and the LC50 with 

### 95% confidence limits, if possible. NOTICE This study is run according to GLP's. If, after a study is under way, it becomes necessary to mrake chan-es on the approved protocol, the revisions and reasons for change are to be documented, reported to the sponsor and are to become part of the permanent file for that study. Similarly the sponsor is to be notified as soon as is practical whenever an event occurs that is unexpected and-may have an effect on the validity of' the study. DATA RETENTION The raw data and the original of the final report will be on file at the testing facility. Tne sponsor will be notified before final-disposition of' these items. 'Un'used test ar-ticles will be destroyed unless requested otherwise.
REGULATORY AGENCY This study wil~yrobably not be submitted 

# 57ZJ, will probably be submitted 

# FLi to a regulatory agency (agency______

(SIB) Study Director (BASF Wyandotte) Sponsor 

### Date Z6t 

### ~ 

### Date 

# ,~i

// :U P