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1200 Pennsylvania Ave. NW 

Washington, DC 20460 

202.564.8251 

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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 


-CONFIDENTIAL HRC 11756-167

1-9/

EYE IRRITATION STUDY IN THE 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

is considered 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 if present.

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 a positive 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

Conj unctivae

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

Ch emo sis

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:-