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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 


FINAL 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:

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kidney.6 who~e head

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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 10956
1IEImI ~TI1[ M 7 "AR1 !uMli inMM MIMIfh IMII LL I

this-study- The- animals werejiiaintained- -on Puri na --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 in Figure 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 LC50 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

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