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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 pursuantourconversation ofseveral minutes ago. In Larry Robinson's fax of April 13th while there is a waiver ofconfidential business information (CBI) claims in the identified studiesthere is a an assertion ofcopyrightprotections and some additional text that provides in part ... "Reproduction, reference, summarization, retransmission orotheruse ofthis copyrighted document...including electronic transmission, using the internet oremail....is strictlyprohibited...." While we understand the basisforthe copyrightprotections, we have a concernthat the language in the fax mightbe interpreted to meanthat ePMA is asserting that the studies submitted perthe TSCA activity are not tobemade available in an Agencye-docket (electronic docket) orbe included in EPA websites amongthe collection ofTSCAhealth 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 ofnon-CBI materials submitted by entities subjectto TSCA regulations (includingtheposting ofsuch materials ongovernmentwebsites) and submittedby such entities in orderto complywith a TSCA requirement, but are rather intended to limit entities outside the government from the unauthorized use or appropriation ofthe studies. Canyou please confirm CPMA's intent? Manythanks.
Scott M. Sherlock,Attorney Advisor Environmental Assistance Division Office ofPollution Prevention and Toxics

### RECEI 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. Necropsy 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.

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### APPENDIX 1
Evaluation -ofSkin 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 indepth) 4

U "ema 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