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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 AssistanceDivision Office ofPollution Prevention and Toxics

### CONFT-DE4TIAU HRC #N-4-196-30 -- 

### E. D.C.

OCULAR IRRITATION STUDY INTHE RABBIT OF

-ALKALI BLUE-GG (CP-1816)

Sherwin Williams Company Huntingdon Research Center Chemicals Division 216 Congers Road 11541 Champlain Avenue New City, New York 10956 Chicago, Illinois 60628

### SUM14ARY Alkali Blue-GG (CP-1816) was evaluated for ocular irritation in the rabbit according to the Hazardous Substances Act. Six animals received Alkali Blue-GG (CP-1816) 100 mg full strength instillation to the right eye. The le-ft eye of each rabbit served as-the, untreated control. Based on the results of this study, Alkali Blue-GG (CP-1816) would not be considered an ocular irritant.

Principal investigator:_______

___________ Paul J.Upman Manager, Acute Toxicology

Approved by: Q 1Z Charles 0.Ward, Ph.D. Director, Toxicology April 27, 1976

.jcp__________________________ HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 10956___INTRODUCTION-- 

### Alkali Blue-GG (CP-1816) was received from the Sherwin Williams Company as black granular material and evaluated for irritation potential in the rabbit eye.
METHODS Experimental Animals Species: Six mature albino rabbits of the New Zealand variety. Condition of Eyes: Judged free of irritation and corneal damage as confirmed by sodium fluorescein examination prior to study. Diet: Purina Rabbit Chow and water ad t.Zbitum. Administration Asingle 100 mg application of Alkali Blue-GG (CP-1816) full strength was made into the conjunctival sac of the right eye of six rabbits. .The left eye served as the untreated control. The eyes were held closed for one second. Observations and Records The eyes were examined and the grade of ocular reaction recorded at 24, 48 and 72 hours (Table I)following application. Reading of reactions was facilitated by the use of an ophthalmoscope. After the recording of' observations, the eyes were stained with fluorescein and examined with an ultra-violet lamp to detect possible corneal damage. The reactions were scored from: "Illustrated Guide for Grading Eye Irritation by Hazardous Substances," Federal Hazardous Substances Act Regulations (Table 3).

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

### RESULTS. No signs of ocular irritation were noted at 24, 48 and 72 hours after instillation. Fluorescein examination was also negative (Table 1).
-CONCLUS ION Alkali Blue-GG (CP-1816) would not be considered an ocular irritant according to the guidelines of the Hazardous Substances Act.

HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 10956- -- TABLE I

_ Numerical scores awarded the ocular reactions elicited by: Alkali Blue-GG (CP-1816)

----------- ------------------------------------------------------- 

### Positive N+ Rabbit No. 24 48 72 INegative(- I-----------------------------------------------------------------------------I----------- --------------- 

### Cornea 0 0 0 *Iris 

### 0 0 0 51Conjunctiva Redness 0 0 0 Chemosis 0 0 0 Fluor. Exam - Cornea 0 0 0 Iris 0 0 0 

### 52Conjunctiva Redness 0 0 0 Chemosis 0 0 0

- Fluor. Exam - I--------------------------------------------------- ----------------------------------------------------- Cornea 0 0 0 *Iris 0 0 0 53Conjunctiva Redness 0 0 0 Chemosis

- 0 0 0- Fluor. Exam -

-------------------------------------------- --------------- I Cornea0 0 0 Iris 0 0 0 554 Conjunctiva Redness 0 0 0 Chemosis 0 0 0 Fluor. Exam -

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -.-- - - - - - - - - - - Cornea 0 0 0 *Iris 0 0 0 555 Conjunctiva Redness 1 0 0 

### Chemosis 0 0 0 

# : Fluor. Exam - Cornea 0 0 0

Iris 0 0. 0 :548 Conjunctiva Redness 0 0 0 Cheinosis 0 0 0- Fluor. Exam -I

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

### TABLE II GRADES FOR OCULAR LESIONS
From: "Illustrated -Guide for Grading Eye Irritation by Hazardous Substances" U. S. Department of Health, Education and Welfare Food and Drug 'Administration

. 

### Washington, D.C. 20204 Cornea No ulceration or opacity. 0 Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details or iris clearly visible. (1 * Easily discernible translucent areas, details of iris slightly obscured. 2 Nacreous areas, no details of iris visible, size of pupil barely discernible. 3 Complete corneal opacity, iris not discernible. 4 Iris Normal. 0 Markedly deepened folds, congestion, swelling, moderate circuincorneal injection (any of these or combination of any thereof), iris still reacting to light (sluggish reaction ispositive). (1* No reaction to light, hemorrhage, gross destruction (any or all of these). 2 Conjunctivae Redness (Refers to palpebral and bulbar conjunctivae excluding cornea and iris). Vessels normal. 0 Some vessels definitely injected. 1 Diffuse, crimson red, individual vessels not easily discernible. (2)* Diffuse beefy red. 3 Chemosis No swelling.0 Any swelling above normal (includes nictitating membrane). I Obvious swelling with partial eversion of lids. (2)* Swelling with lids about half closed. 3 Swelling with lids half closed to completely closed. 4

*Positive 

### reaction

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