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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...includingelectronic 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 arenot tobemade available in an Agencye-docket (electronic docket) orbe included in EPA websites amongthe collectionofTSCAhealth 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 orappropriation ofthe studies. Canyou please confirm CPMA's intent? Manythanks.
Scott M. Sherlock,Attorney Advisor Environmental AssistanceDivision Office ofPollution Prevention andToxics

### RE CE E ED CONFIDENTIAL ~ ~HRC IN-386-1 

### E~.D.C.

.ACUTE DERMAL TOXICITY IN THE RABBIT OF ALKALI BLUE FLUSHINGS .#FLX-140-443

The Sherwin Williams Comipany Huntingdon Research Center Chemical Division 216 Congers Road 11541 South Champlain Avenue New City, NY 10956 Chicago, IL 60628

### SUMMARY Alkali Blue #FLX-140-443 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. Slight erythema was elicited by the compound in four of ten rabbits 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 #FLX-140-443 would be considered dermally non-toxic.

Principal Investigator: Y________________ Paul J. Upman Manager, Non-Rode.nt Toxicology

Approved By: 

### 6~~ Charles 0. Ward, Ph.D. * Director-, Toxicology May 4, 1976

jab -INIKDNRESEARCH CENTER 21,6 CONGERS ROAD NEW CITY, NEW YORK 10956

### INTRODUCTI ON Alkali Blue RFLX-14O-443, was evaluated for Acute Dermal toxicity in rabbits according to the guidelines of the Federal Hazardous Sub- *stances Act.
MATERIAL Alkal'i Blue i#FLX-14O-443 was received as a dark blue paste and assumed to be 100% active.
METHODS Ten mature albino rabbits of Ilew Zealand variety were selected from the stock colony forthis study. The compound was applied at 2 gm/kg body weight 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 thie residue 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.

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

### RESULTS Daily Observations (Table 1) Four of ten rabbits exhibited slight erythema through day 3 of 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 #FLX-140-443 would be considered derrnally non-toxic according to the Federal Hazardous Substances Act. The dermal LD 50 

### would be estimated at greater than 2 gm/kg body weight.

HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 10956I~-C C- C__ __ _ __ _
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### APPENDIX 1 Evaluation of Skin Reaction Value Erythema and eschar formation: No erythema 0 Very slight erythemna -(barely perceptible) 1 Well-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 1millimeter) 3 Severe edema (raised more than 1millimeter and extending beyond the area of exposure) 4

-iUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 10956