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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 transmission of4/13/12 (ePMAremoval ofCBI claimsregarding identified studies) 

### DearMr. Merritt: This is sentto you pursuantourconversationofseveral minutes ago. In Larry Robinson's fax of April 13th while there is a waiverofconfidential business information (CBI)claims in the identified studiesthere is a anassertion ofcopyrightprotections and some additional textthat provides in part ... "Reproduction, reference, summarization, retransmission orotheruse ofthis copyrighted document...includingelectronic transmission, usingthe internetoremail....is strictlyprohibited...." While we understandthe basisforthecopyrightprotections, we have a concernthat the language in the fax mightbe interpreted to meanthatePMA isassertingthatthe studies submitted perthe TSCA activity arenottobemade available in an Agencye-docket (electronic docket) orbe included in EPA websites amongthecollectionofTSCAhealth and safety studies. We are thinkingthat the identified limitations noted in the fax are not intended to applyto EPA's normal procedures for the handling ofnon-CBI materials submitted by entities subjectto TSCA regulations (includingthepostingofsuch materials ongovernmentwebsites) and submittedby such entities in orderto complywith a TSCA requirement, but are rather intended to limit entitiesoutside the government from the unauthorized use orappropriation ofthe studies. Canyou pleaseconfirm CPMA's intent? Manythanks.
Scott M. Sherlock,Attorney Advisor Environmental AssistanceDivision OfficeofPollution Prevention andToxicsFINAL REPORT- 

### RECEIVED PROJECT NUMBER G4226-11 AUG26 1976 

### E. D.C.

EVALUATION OF THE ACUTE INHALATION TOXICITY OF A COMPOUND CODED ALKALINE BLUE GG

SUBMITTED TO: Ms. Alicia Whatley : The Sherwin-Williams Company Chemicals Division 11541 South Champlain Avenue Chicago., Illinois 60628 SUBMITTED BY: Huntingdon Research Center 216 Congers Road New City, New York 10956
PRINCIPAL INVESTIGATOR: LABORATORY TECHNICIAN: 

# E~ .~z Charles E. Ulrich Daniel S. Ashenberg Manager Inhalation Toxicology Department
APPROVED BY:
Charles 0. Ward, Ph.D. Director, Toxicology August 18, 1976$ I. _OBJECTIVE__ The objective of this study was to evaluate the acute inhalation toxicity of a compound coded Alkaline Blue GG at 

### an aerosol concentration of two (2) milligrams per liter of air.
II. EXPERIMENTAL DESIGN One (1) group of animals consisting of ten (10) male and ten (10) female rats was used f~or this study. They received a single one (1)hour *exposure to an aerosol of Alkaline Blue GG at an actual concentration of

two (2) milligrams per liter of air. All animals were -held for fourteen (14) days post-exposure for observations of latent effects. All animals *were observed during the exposure and then daily during. the post-exposure

period for signs.of toxicity. Body weights were recorded prior to exposure and after seven, (7) and fourteen (14) days,. All animals that died or were sacrificed after the observation period were necropsied. The following tissues were stored in 10% neutral buffered formalin in the event histo- *pathology might be required: Zw296 + tAachea stonac~h keaA-t £)tteztne,6 tive~ goiwdz kidney.6 who~e head z6pZeen
III. MATLRIALS AND METHODS A. Animals Ten (10) male and ten (10) female Sprague-Dawley derived rats, obtained from Charles River Breeding Laboratories, were used for

HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 109561IEImI M 7 ~TI1[ "AR1 !uMli inMM MIMIfhIMII LL 

### I
this-study- The- animals werejiiaintained--on Purina--cubed--diet and tap water-ad t.LbZitum. The animals were caged in groups of ten (10) and allowed at least seven (7) days to accommodate to the -laboratory environment prior to the study. B. Experimental Material The experimental compound, coded CP 1816/346, was supplied by the sponsor. .The compound was a fine, bright blue powder, and was assigned an internal identification number of INHC-062. C. Aerosol Generation System An aerosol of the experimental compound was generated by a system shown schematically in Figure 1. This system operates as follows: The glass flask is periodically charged with a feg grams of the experimental compound. The vibrator maintains a flow of compound to the auger. Thus with the auger turning at a constant speed, powder is delivered at a constant rate to the funnel of the dust ejector assembly. Dry, filtered, compressed air applied to the jet in the dust ejector creates a negative pressure in'the funnel which pulls dust down into a high velocity air stream. This dust-laden air was then piped to a 56-liter all glass exposure chamber. 0. Determination of Exposure Concentration Exposure concentration was determined on both a nominal and actual basis. Nominal concentrations were calculated as the ratio' of the rate at which the auger delivered compound to the dust ejector (mg/mmn) to the total air flow through the exposure chamber (L/min).

-2- HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 109SA

### -Actual -expo-,sur-e-concentratioDns-were- de-t-ermi-ned by drawi-ng: - known volume of chamber air through a pre-weighed glass fiber filter held in an open-face filter holder. The filter was then re-weighed and the aerosol concentration calculated by dividing the filter weight gain by the sample volume. Four (4)such samples were taken during the one-hour exposure. The following table presents the exposure concentration data:
-------- ---------------------------------------------------------------- Chamber Concentration - 

### mg/L Grop o.Nominal Actual 1 49.50 2.48

------------------------------------------------------------------------ E. Evaluation of Aerosol Particle Size Particle size analysis was conducted 

### utilizing the Andersen Cascade impactor. Pre-weighed glass fiber filter material, specially cut to fit the impactor, was used for collecting the aerosol on each. stage. * After sampling, these filters were again weighed. The difference in weight for each stage was then used to construct the particle size distribution graph, shown inFigure 2. The aerosol had an Equivalent Aerodynamic Diameter (EAD) of 9.2 with a geometric standard deviation (cyg) of 3.56.

-. 3- HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 10956

### A. Observations for signs of toxicity No apparent' signs of toxicity were observed either during the *exposure or the fourteen day observation period. There were no deaths. B. Body weights All animals gained weight normally throughout the experiment. Tables 1 and 2 present the individual and mean body weight data. C. Observations at Necropsy The majority of lungs from both male and female rats exposed to Alkaline Blue GG exhibited a blue/black tint due to the inhalation of experimental compound. This discoloration was'the only gross abnormality noted. All other major organs appeared healthy upon inspection. SUMMARY ten male and ten female rats were exposed for one hour to an :d-sol of Alkaline Blue GG at a concentration of 2.48 milligrams per liter. There were no deaths or signs of toxicity during the exposure or' :Tihe fourteen day observation period. All animals gained weight normally throughout the experiment. Upon inspection, the lungs from the majority of male and female rats exhibited a blue/black tint. The one hour LC 50 

### for Alkaline Blue GG is considerably greater than 2.48 milligrams per liter of air.

-4- HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD t~~ mv~r.TABLE1 INDIVIDUAL AND MEAN BODY WEIGHT DATA FOR MALE RATS EXPOSED TO 2.48 mg/L OF ALKALINE BLUE GG

BODY WEIGHTS - GRAMS 7 DAYS 14 DAYS ANIMAL NO. PRE-EXPOSURE POST-EXPOSURE POST-EXPOSURE MALE

1 170 210 270 2 255 315 375 3 180. 225 295 4 183 245 340 5 163 215 280 * 6 250- 305 360 7 180 *245 320 8 160 235 330 9 163 220 280 10 180 240 325- ----- TABLE 2
INDIVIDUAL AND MEAN BODY WEIGHT DATA FOR FEMALE RATS EXPOSED TO 2.48 mg/L OF ALKALINE BLUE G6.

-------------------------------------------------------------- BODY WEIGHTS - GRAMS 7 DAYS 14 DAYS ANIMAL*NO. PRE-EXPOSURE POST-EXPOSURE POST-EXPOSURE FEMALE 11 195 220 240 12 165 190 215' 13 218 250 280 14 173 190 220 15 208 235 258 16 205 240 .255 17 210 245 275 18 210 235 280 19 205 230 270 20 165 200' 220 15224 2514- 4-0)-o4-) CL L)S o n "'.- =3 S4- 0 S-~ - 4- o) E) '

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