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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 


R E C E I V L

CONFIDENTIAL . 0 HRC #N-41 96-28

E. D.C.

-ACUTE DERMAL TOXICITY

IN THE RABBIT OF

ALKALI BLUE

GG (CP-1816)

The Sherwin Williams Company Huntingdon Research Center

Chemicals Division 216 ConQers Road

11541 South Champlain Avenue New City, New York 10956

Chicago, IL 60628
SUMMARY

Alkali Blue GG (CP-1816) was evaluated for its dermal toxicity in

the rabbit according to the Federal Hazardous Substances Act. The

compound was applied at 2 gm/kg of body weight to the intact and

abraded skin.

No dermal response was elicited by Alkali Blue GG (CP-1816) during

the observation period. Body weight gain and general appearance of

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

* Based on the results of this study, Alkali Blue GG (CP-1816) would be

considered dennally non-toxic.

Principal .Investigator:________________

Paul J. Upman

Manager, Non-Rodent Toxicology

Approved By:

Charled 0. Ward, Ph.D.

Director, Toxicology

May 5, 1976

jab

HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 10956
INTRODUCTION

Alkali Blue GG (CP-1816) was evaluated for Acute Dermal toxicity in

rabbits according to the guidelines of the Federal H-azardo~is Substances Act.

MATERIAL

Alkali Blue GG (CP-1816) was received as a blue-black qranular material

and assumed to be 1OO%-active.

METHODS

Ten mature albino rabbits of-New Zealand variety were selected from

the stock colony for this study. The compound was applied at 2 gm/kg

body weight to the moistened, clipped skin of ten rabbits (5 abraded and

5 intact). The rabbits were then wrapped with a dam. After -24 hours,

the wrapping--was removed and the resi-due gently washed off. The

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

daily for fourteen days. Body weights were recorded on Days- 0, 3, 7,

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

rabbits sacrificed at fourteen days.

HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 10956
RESULTS

Daily Observations (Table I)

No dermal response was elicited by Alkali Blue GG (CIP-1816) during

the 14-day observation period. No mortality or unusual behavior or

appearance was noted.

Body Weight Gain (Table 11)

Body weight gain was acceptable for all rabbits during the 14-day

study.

Nec ropsy

Gross examination of the viscera revealed no compound related observations in those rabbits sacrificed after 14 days.

CONCLUSION

Alkali Blue GG (CP-1816) would be considered dermally non-toxic according to the Federal Hazardous Substances Act.

The dermal LD50 would be estimated at greater than 2 gm/kg-of body

we i g h t.

HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 10956
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APPENDIX 1

Evaluation -of Skin Reaction Value'

Erythema and eschar formation:

No erythema0

Very slight erythema (barely perceptible) 1

Well -defi ned erythema 2

Moderate to severe erythema 3

Severe erythema (beet redness) to slight

eschar -formation (injuries in depth) 4

"ema U formation:

No edema 0

Very slight e.dema (barely perceptible) 1

Slight edemaj*edges of area well defined by

definite raising) 2

Moderate edema (raised approximately

1 millimeter) 3

'Severe edema (raised more than 1 millimeter

-and extending beyond the area of exposure) 4

HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 10956