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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 


CONFIDENTIAL HRC #7512-266

ACUTE DERMAL TOXICITY

OF

ALKALI BLUE FLUSHINGS

FL-14-637

IN RABBITS

R EC E IV F

JAN 2 0

Ms. Alicia Whatley Huntingdon Research Center

The Sherwin-Williams Company 216 Congers Road

Chemical Division New City, New York 10956

11541 South Champlain Avenue

Chicago, Illinois 60628
S UMM4ARY

Alkali Blue Flushings FL-14-637 was evaluated for its dermal

toxicit' in the rabbit according to The Federal Hazardous Substances

Act. The paste was applied at 2 gm/kg of body'weight to the intact

and abraded skin. 1%

Rabbit #338 died on Day 10 which is believed not compound related.

No dermal reactions were noted. Body weight gain and general appearance

of the rabbits remained good throughout the 14-day observation period.

Alkali Blue Flushings FL-14-637 would be considered dermally nontoxic.

Kenneth E. McElroy U

Supervisor, Toxicology

SN

Paul J. Up ma n

Managecr, Toxicology

January 16, 1976

j cp

HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEWA CITY, NEW YORK 10956
I NTRODUCT ION

Alkali B lue Flushings FL-14-637 was evaluated for Acute Dermal

toxicity in rabbits according to the guidelineq of The Federal Hazardous

Substances Act.

MATER IAL

Alkali Blue Flushings FL-14-637 was received as a blue paste assumed to be 100% active.

METHODS

Ten mature albino rabbits of the New Zealand variety were selected from the stock colony for this study. The Alkali Blue Flushings

FL-14-637 was applied at 2 gm/kg to the clipped skin of five intact

and five abraded rabbits. The rabbits were wrapped with a dam. After

24 hours, the wrapping was removed and the residue gently washed off.

The test site was examined for erythema and edema and scores were

recorded daily for 14 days. Bodyweights were recorded on Days 0, 3,

7, 10 and 14. A gross examination of the viscera was conducted on

all rabbits sacrificed at 14 days.

RESULTS

Daily Observations (Table 1, 3)

No erythema or edema were noted during the 14-day observation

* period. The general appearance of the rabbits remained good throughout.

Bodyweight Gain (Table 2)

Bodyweight gain was acceptable for all rabbits during the 14-day

s tudy.

Mortality

Day 10 rabbit #338 died. Due to advanced autolysis, reason for

death was not determined. No gross pathology was noted in the rabbits

sacrificed at 14 days.

HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 10956
RESULTS (cont'd)

Necropsy (Table 3)-

Gross examination of the viscera revealed'no compound related

observations. Yellow foci noted in the liver o'f four rabbits is believed

to be a parasitic condition not uncommon in the rabbit.

CONCLUS ION

Alkali Blue Flushings FL-13-637 at 2 gm/kg of bodyweight would

be considered non-toxic dermally.

HUNTINGDON RESEARCH CENTER 2146 CONGERS ROAD NEW CITY, NEW YORK 10956
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TABLE 3

INDIVIDUAL OBSERVATIONS'

Rabbit No. Daily At Necropsy

324 Appears normal No gross path noted

326 Appears normal No gross path noted

335 Appears normal No gross path noted

337 Appears normal Mo gross path noted

338 Appears normal Died - Day 10

333 Appears normal Yellow foci in liver

322 Appears normal Yellow foci in liver

323 Appears normal No gross path noted

325 Appears normal Yellow foci in liver

339 Appears normal Yellow foci in liver
APPENDIX 1

Evaluation of Skin Reaction Value

Erythema and eschar formation:

No erythema0

Very slight erythema (barely perceptible) 1

Well1-defined erythema 2

Moderate to severe erythema 3

Severe erythema (beet redness) to slight

eschar formation (injuries in depth) 4

Edema formation:

No edema0

Very slight edema (barely perceptible) 1

Slight edema (edges of area well defined by

definite raising) 2

Moderate edema (raised approximately

I millimeter) 3

Severe edema (raised more than 1 millimeter

and extending beyond the area of exposure) 4

imaiiuIagdon iemearcil Center [lox .527 JloknivIe Ir~ad2 10122