FAX 

To: 6'-& NN (VI <':"1 VI \ \ -, 

Fax: '}..O \ ll'?1,LI~ I 

Date: <J 11"1 II <)/ 

Re: C: \> (VI A. 

From: '7C::D~ S'" ~,,,, t '"" 

fax: 202.564.8251 

Phone: ,\--01..' Sb~ . ~~ S I 

Cc: 

Comments: \'~ "', ,t.v,)\\ '" rI 

OCSPP OPPT EAD 

1200 Pennsylvania Ave. NW 

Washington, DC 20460 

202.564.8251 

Pages: 

'Y 

r- Urgent I- For Review I- Please Comme - Please Reply - Please Recycle -

nt 
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 


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

E. D.C.

OCULAR IRRITATION STUDY

IN THE 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

A single 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 is positive). (1*

No reaction to light, hemorrhage, gross destruction (any or all of

these). 2

Conjuncti vae

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