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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 (includingthe posting ofsuch materials ongovernment websites) 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-CONFIDENTIAL 

### HRC 

## 11756-167

1-9/ 

### EYE IRRITATION STUDY INTHE RABBIT OF ALKALI BLUE - 

### CP-1809 LOT 5R-456

Mr. L. A. Marti The Sherwin Williams Company Huntingdon Research Center Chemical Division- 216 Congers Road 11541 South Champlain Avenue New City, New York 10956 Chicago, Illinois 60628

### SUMMARY * Alkali Blue CP-1809 Lots' 5R-456 was tested for ocular irritation in *rabbits according to the Federal Hazardous Substances Act.

According to the results of this study, Alkali Blue CP-1809 -Lot# 5R-456 isconsidered to be a non-irritant.,

Kenneth E.McElroy

- 

### Supervisor, Toxicology

Paul J. Upinan Manager, Toxicology October 16, 1975
jk
muilngdon Rc~earcli Center Box 527 Jlrooklandville, Maryland 21022

### INTRODUCTION Alkali Blue CP-1809 Lot# 5R-456 was received from Sherwin-Williams Chemicals as a blue powder and was evaluated for primary eye irritation.
EXPERIMENTAL PROCEDURE Six female albino New Zealand rabbits were used. Both eyes of each animal were examined with the aid of an ophthalmoscope before testing. 100 mg of test material was placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The lids were gently held together for one second and 'the animal released. The other eye, remaining untreated, served as a control. The eyes were examined and the grade of ocular reaction recorded at 24, 48, and 72 hours (Table 1). Reading -of reactions was facilitated by the use of an ophthalmoscope. After the recording of observations at 24 hours, the eyes were stained with fluorescein and examined with an ultra-violet lamp to detect corneal damage ifpresent. The reactions were scored from: "Illustrated Guide for Grading Eye Irritation by Hazardous Substances",' Section 191.12 of the Federal Hazardous Substances Labeling Act Regulations (Table 2).
RESULTS Slight redness was noted in five of the six rabbits at 24 hours post dose. One rabbit exhibited a crimson red conjunctiva which constitutes a positive response. Slight chemosis was noted in four of the six tested. At 48 hours only two animals were noted to have a slight redness and at 72 hours all were negative. (Table 1) No corneal damage was noted and the flouroscein exams were negative.
CONCLUSIONS Based on the results of this test, Alkali Blue CP-1809 Lot# 5R-456 would not be considered an eye irritant since only one of the six animals tested showed apositive irritant response.

Hlutingdon Eleoeareb Center Box 6857 Baltimore, Maryland 21204

### TABLE I Numerical score's awarded the ocular reactions elicited by: Alkali Blue CP-1809 Lot#' 5R-456
------------------------------------------------ ------------------ 

# * :~Positive() 

### 'Rabbit No. 24 48 72 

# :Negative ) ---------------------------------------- --- --- L---------------------- J 

### Cornea 0 0 0. Iris 0 0. 0 161 Conjunctiva Redness 1 0 0

- aChemosis 

### 1 0 0 Fluor. Exam -

-- - - - - - - - - - - - - - - - - - - - - - - - - -- - - L-------------------- -aCornea 

### 0 0 0 a.Iris 

### 0 0 0 163 Conjunctiva Redness 1 0 0- Chemosis 0 0 0 

# LFluor. Exam -

------------- ---------------------- L----------------- 

### Cornea .0 0 0 Iris 0 0 0 a 

### :164 Cojnctiva Redness 1 0 0 a 

### onuIChemosis 0 0 

### 0 aa 

### IFluor. Exam -a
--------------------------------------------------------------------------------------- ---------------- aCornea 

### 0 0 0 165 Conjunctiva Redness 1 1 - 

### 0-a Chemosis 1 0 0 a 

# I ~Fluor. 

### Exam - ------------------------- --------------------------------- --------------- I aCornea 

### 0 0 0 Iris 0 0 0 179 Conjunctiva Redness 1 0 0- aChemosis 

### 1 0 0 a 

### Fluor. Exam -

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

### Cornea 0 0 0 a aIris 

### 0 0 0aa 180 Conjunctiva Redness 2 1 0 a+ a 

### ~Fluor. Exam -. a
------------------------------------------------------------------------------------- ------------------

ri^vet Condorh flox ."27 f~rooklandille, Afaryland 2 1022__ TABLE II GRADES FOR OCULAR LESIONS From: "Illustrated Guide f or 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 dif fuse areas of opacity (other than slight dulling of normal luster), details of 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 cor-neal opacity, iris not discernible 4
* Iris Normal 0 Markedly deepened folds, congestion, swelling, moderate circwcorneal injection (any of these or combination of-any thereof), 

### iris still reacting to light (sluggish reaction is positiv.3) (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) 1 Obvious swelling with partial eversion of lids (2)* Swelling with lids about half closed3 Swelling with lids half closed to completely closed 4

SPositive reaction 

### 3:-