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OCSPP OPPT EAD 

1200 Pennsylvania Ave. NW 

Washington, DC 20460 

202.564.8251 

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

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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 


SREPORT NO.: T-1 550 Mac ,18

CUDATES OF TEST: February 6 - February 9, 1981

CLIENT: BASF WYANDOTTE CORPORATION

Wyandotte, X!ichigan 1.8192

I-PRODUCT IDENTIFICATION: Code BT-7150, Alkali Blue R Powder

Lot 17141 -8033

PRODUCT DESCRIPTION: A dark blue powder.

PSI NO.: E10202-1 (I)DATE RECEIVED: February 2, 1981

ANIMALS: Six New Zealand Albino Rabbits from

T. Hanna Colony. Ooo: DIET: Fisher Rabbit Pellets

QUALITY ASSURANCE REFERENCE: Q.A. 1, 2, 3

cc NOTEBOOK NO.: 81-1; page 1,040

ENVIRONMENTAL CONDITIONS:

'BDuring the test period the animals were individually housed In wire

bottomed cages In an environmentally controlled room with a 12 hour

light/dark cycle. Feed and water were provided ad-libitum after dosing.

0 . ~ PROCEDURE:

Primary Eye Irritation. FHSLA 16 CFR 1500.42. Six healthy young adult

albino rabbits were each uniquely Identified. One-tenth of a gram

of the test material was placed on the everted lower IId of one eye of

each rabbit. The upper and lower lids were gently held together for 1

second before releasing, to prevent loss of the test material. The other

eye of each rabbit remained untreated and served as a control. Ocular

lesions were evaluated by the method of Dralzell. The Draize scores were

then classI'fied according to Kay and Callandra12 . Lesions were evaluated

at 24. 48 and 72 hours.

REFERENCE:

1Draize et al. J. Pharmacol. Exp. Ther. 83 :377-390, 1944.

2/ Kay and Callandra, J. Soc. Cos. Chem. 13. 281-289, 1962.
I1 I !1ITY~irIr

product safety lasReport- No. T-1 550-

a ivialen of nutrition International

OBSERVATIONS: Not remarkable.

CONCLUSION: The M1MTS of the test material in the

unwashed eye within 24 hours Is 3.3.

The test material is classifiled as a

minimal eye Irritant (M d.

Catherine Wo -Ph.D. Ralph Shapiro, Ph.D.'

Study Supervisor Director

Toxicologist

C~A%.9J, ~j~eY~Lf-9

rlRe stern Date

Quality Assurance Unit
prod uct safety labs-Pg3

a diidonof r~tin IrtmadnalReport No. T-1550

RESULTS: (Draize Scores) 1

Rabbit No.: 3356 3357 3358 3359 3448 3361

Hours: 24 48 72 24 48 72 24 48 72 24 48 72 24 48 72 24 48 7:

1. Cornea

A. Opacity 0 0 0 0 0 0 0 a 0 0 0 0 0 0 0 0 0

8. Area 4f 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4

AxBx5 0 0 0 0 0 0 0 0 a 0 0 0 0 0 0 0 0

11. Iris

A. Values 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Ax5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Ill. Conjunctivae

A. Hyperemnia I 1 0 0 1 0 2 0 0 2 1 1 1 1 1 2 1

B. Chemosis 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0

C. Discharge 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

(A+B+C)x2 2 2 0 0 2 0 4 0 0 6 2 2 2 2 2 6 2

Total: 2 2 0 0 2 0 4 0 0 6 2 2 2 2 2 6 2

Total Possible: 110

MTS (24 hr.) 2 204626

Average MMTS (24 hr.) 3'.3

MMTS Classification Smo

0.0 - 0.5 Non-irritating N

0.6 - 2.5 Practically non-irritating PN

z.6 - 15.0 Minimally irritating 1

15.1 - 25.0 Mildly irritating M 2

25.1 - 50.0 Moderately irritating M 3

50.1 - 80.0 Severely irritating S

80.1 - 100. Extremely irritating E

100.1 - 110.0 Maximally irritating M
340 Commerial Avenue RABBIT EYE IRRITATION - TEST

Now Bwunwcki, N.J. 08901

201-54571704Scl o-crn c-aLeis

(1) Cornea

(A) Opacity-degree of density (area most dense taken for reading)

CU No Opacity....................................... ....... 0

Scattered or diffuse area, details of iris clearly visible ........1

Easily discernible translucent areas, details of iris

slightly obscured ........................................... 2

Opalescent areas, no details of iris visible, size of pupil

barely discernible................................ 3

______Opaque. Iris invisible .................... *.. ****..........

(B) Area of cornea involved ' )One quarter (or less) but not zero ...............................1

Greater than one quarter, but less than half .....................2

Greater than half, but less than three quarters ........... 3

Greater than three quarters, up to whole area ................... 4

A XBX 5 Total maximum - 80 Co(2) Iris

(A) Values

4 Normal .......................................................... 0

0 1 Folds above normal, congestion, swelling, circumcorneal

injection (any or all 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

A0X5 Total maximum -10

(3) Conjunct ivae

0 (A) Redness (refers to palpebral and bulbar conjunctivae

excluding cornea and iris) a 'Vessels Vessels normal ................................................... 0

definitely injected above normal ......................... 1 More diffuse, deeper crimson red, individual vessels not

easily discernible ........................................... 2

Diffuse beefy red ................................................ 3

(8) 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 closed ............................. 3

Swellingi with lids about half closed to completely closed .... 54

(C) Discharge

No discharge ..................................................... 0

Any amount different from normal (does not include small

amounts observed in inner canthus of normal animals) ..... 1

Discharge with moistening of the IIds and hairs just

adjacent to lids ..............................................2

Discharge with moistening of the lids and hairs, and

considerable area around the eye ............................. 3

Score (A + B + C) X 2 Total maximum - 20

Total Maximum Score: 110 represents the sum of all scores obtained for the cornea,

Iris and conjunctivae.