FAX 

To: 6'-& NN (VI <':"1 VI \ \ -, 

Fax: '}..O \ ll'?1,LI~ I 

Date: <J 11"1 II <)/ 

Re: C: \> (VI A. 

From: '7C::D~ S'" ~,,,, t '"" 

fax: 202.564.8251 

Phone: ,\--01..' Sb~ . ~~ S I 

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Comments: \'~ "', ,t.v,)\\ '" rI 

OCSPP OPPT EAD 

1200 Pennsylvania Ave. NW 

Washington, DC 20460 

202.564.8251 

Pages: 

'Y 

r- Urgent I- For Review I- Please Comme - Please Reply - Please Recycle -

nt 
UNITED 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, PESTICIDES AND 

TOXIC SUBSTANCES 

Subject: Follow-up to fax transmission of 4/13/12 (ePMA removal ofCBI claims regarding 

identified studies) 

Dear Mr. Merritt: 

This is sent to you pursuant our conversation of several minutes ago. In Larry Robinson's fax of 

April 13th while there is a waiver of confidential business information (CBI) claims in the 

identified studies there is a an assertion of copyright protections and some additional text that 

provides in part ... "Reproduction, reference, summarization, retransmission or other use of this 

copyrighted document. .. including electronic transmission, using the internet or email .... is 

strictly prohibited .... " 

While we understand the basis for the copyright protections, we have a concern that the language 

in the fax might be interpreted to mean that ePMA is asserting that the studies submitted per the 

TSCA activity are not to be made available in an Agency e-docket (electronic docket) or be 

included in EPA websites among the collection of TSCA health and safety studies. 

We are thinking that the identified limitations noted in the fax are not intended to apply to EPA's 

normal procedures for the handling of non-CBI materials submitted by entities subject to TSCA 

regulations (including the posting of such materials on government websites) and submitted by 

such entities in order to comply with a TSCA requirement, but are rather intended to limit 

entities outside the government from the unauthorized use or appropriation of the studies. 

Can you please confirm CPMA's intent? Many thanks. 

Scott M. Sherlock, Attorney Advisor 

Environmental Assistance Division 

Office of Pollution Prevention and Toxics 


SPRINGBORN INSTITUTE FOR 810RE SEARCH. NC

bPE1 4X #LL0"0 45887

FPONIE 419 047-4106

ACUTE INHALATION TOXICITY

IN RATS

Sample: Alkali Blue R

Lot #f 711-18033

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 institute for 84oresebrch. Inc and Sco*.npborn Group. Inc letters and reports are issued for the exclus-e use

of the clents to -..ho- they aro addressed No Quotationls from reports or u"e of th~e Spr~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 be
WO AK .t.ffl 9 V". 9-.W AM. A"C"4 U0C

ACUTE INHALATION TOXICITY - SUMMARY

Reprt-f-'-b i -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 RE PORTS' 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 No OuO-attons from~ reports or u..e of The SO, ... zh~r^ l~s idute for 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~rd Of Surv.eyrd andi are noi rT.ec.%~rI ,n'ancc h ~arso paently klenutcal or .M.lar Maier.. IIS. Prt-.cts 'T. .. ~ r *.*q-rr~1 P .' 1-~rt I'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 lnTtlltP fr B,orec!.,'eh I nc nd SP',nt,o,n Gra-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.' ,,te. ss e.,.,edor ,re -d and are' not ntces5,. y Of m, ae Qu. s. . aop...ently ,cenlci 5.i,., -To %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 Sponphorn Group. 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%totuir for 8.o# . Cot'Ch. Inc and Sr-.gtsrn

Group. I nc 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-cal a-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 ".oh feSPVct 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 earnsages
Study No. 3060.35(5

N.

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9 ty

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___ 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 #I 7141-8033

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 ~:

Particle Size 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) Less Than

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

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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-114oo-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. i nC 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 Not remarkable

R-14Iol-81 1

R1-14I02-81

R-1.403-81

R-lL404-81

L E T T E RS WPHIF S~ Pt 11 5~ o' 1" tv for Rt. . rc h. 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 rmn t.~ *s p rrntifd ". a.'I "'vte y Athot,,, d on wroino eI e- at9.gnd *(;(9t..ppli, pn1, ts ,. - .

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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 I DENTIFI CATION

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) 0 Az.ii~.lL' 0.

DOSE LEE 1 AND EXPOSURETIM4E

option A: Using a nominal concentration of C&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

rane tuy.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 06035(16) N. In~halation LC5 0

r CMD f'*O*41 24t £*.CeI W

T:ERMI NATI 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.

NOTI CE

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 ~ Da t e ,~i

P // :U