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# rI OCSPP OPPT EAD 1200 Pennsylvania Ave. NW Washington, DC 20460 202.564.8251

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## - Please Recycle



## - 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 (ePMA

### removal 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.
..includingelectronic 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 arenot tobemade available in an Agencye-docket (electronic docket) orbe included in EPA websites amongthe collectionofTSCAhealth 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 orappropriation ofthe studies. Canyou please confirm CPMA's intent? Manythanks.

Scott M. Sherlock,Attorney Advisor Environmental AssistanceDivision Office ofPollution Prevention andToxicsSREPORT NO.: T-1550 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 Callandra1 2

. 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 

# productsafety lasReport- No. T-1 550- 

# aivialen ofnutrition 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

# productsafety 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 M340 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 Folds above normal, congestion, swelling, circumcorneal 

# 0 1 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 

## A0 X5 

## Total maximum -10 (3) Conjunct ivae 0 (A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris) Vessels normal ...................................................0 

# a 'Vessels 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.