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### fax: 202.564.8251 Phone: ,\--01..'

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# rI OCSPP OPPT EAD 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, PESTICIDESAND TOXIC SUBSTANCES



### Subject: Follow-upto fax transmission of4/13/12 (ePMA

### removal ofCBI claimsregarding identified studies) 

## DearMr. Merritt: This is sentto you pursuantourconversationofseveral minutes ago. In Larry Robinson's fax of April 13th 

### while there is a waiverofconfidential business information (CBI)claims in the identified studiesthere is a anassertion ofcopyrightprotections and some additional textthat provides in part ... "Reproduction, reference, summarization, retransmission orotheruse ofthis copyrighted document...includingelectronic transmission, using the internet oremail....is strictlyprohibited...." While we understandthe basisforthecopyrightprotections, we have a concernthat the language in the fax mightbe interpreted to meanthatePMA isassertingthatthe studies submitted perthe TSCA activity arenottobemade available in an Agencye-docket (electronic docket) orbe included in EPA websites amongthecollectionofTSCAhealth and safety studies. We are thinkingthat the identified limitations noted in the fax are not intended to applyto EPA's normal procedures for the handling ofnon-CBI materials submitted by entities subjectto TSCA regulations (includingthepostingofsuch materials ongovernmentwebsites) and submittedby such entities in orderto complywith a TSCA requirement, but are rather intended to limit entitiesoutside the government from the unauthorized use orappropriation ofthe studies. Canyou pleaseconfirm CPMA's intent? Manythanks.
Scott M. Sherlock,Attorney Advisor Environmental AssistanceDivision OfficeofPollution Prevention andToxics

# HoechstH

MI. Scheerer

________ ______Hoechmt Akliengeselischaft S.~~neSataiil:~-er Pharma Research 

### S atai70 

## 8/ 1 Exp.PstAhology Dr. Engelbart

Code-Nr. 458/81 A =Reflex-Blau R-FW-F8 Preflkuchen I*'C__

A MUTAGENICITY SCREENING OF 458 

### / 81 A IN BACTERIA 

### (A?:ES TEST) 

## DISCLAIMER This roen.r isthe propertyof Clarisati No mact. i iesfldda sod metforIfteralFuleu*. ft.i not allowed to afte &adreveal th reportorits ctalto a thid partwithoutprier wrtau appravalif Clariami.j
R.eport No. 71 

### / 81 December 4, 1981

This report contains the unpublished research findings of Hoechst scientists. It should not be published, in whole or in part, or referred to in any publication without authorisation from the company.

Vofslzendordes Auth1dhlsfat: OttoFlaritl Vmsland: Roll Sommot.Vonslzesdef: Kurt Lanz. stall. Vorstlzender; Erhaid SouilIon. Rudolf Frank. 01Manin Frfihaut. Wolfgang Hilger, Wills Hoerkefis. Woligang von P61niu. Manrs Reiniges. JWrgen Sdraattrauen, Hans ScIhiadhtet. KlausWeisselmolll "o VtOlN.: Hans Georg Janson, G.,nter Melz . S~lzdot iasellsdhall: Fnavlduf am,Man -Handesrogistmr: Frnankfurt am Main AM. 8 Nr. 1AdM1~m 

### ~ IL Wii Wiw TIF1771 I

Reor No 1 8



### and co-workers.

Andeutgenitiscreeng o e 458 81 A in cei
compnttound 458 4 81 A was examinhoed th mutagenic
activity.

Frankfurt/Miain, December 4, 1981)
Audited by Experimecntal Pathology Quality Assurance X-lep.-A c (Dr. K. Engelbart)
-2-Report No. 71 

### /81
Survey compound: 458 / 81 A Batch No. Test certificate: Type of study: Ames test Dosages: 4/ug - 10,000 ug Date of study: December 1981 Testing facilities + archives: Pharma Research, Hoechst AG, Frankfurt (Main) Responsibilities:

- Study director: Dr. Engelbart

- Head of department: Prof. Dr. Kief
-3-3- Report No. 71 

## /81
Introduction The Ames test is a well -establ ished screening method for mutagenic activity. Five strains of Salmonella typhimurium, auxotrophic for histidine, and one of Escherichia coli, auxotrophic for tryptophaie, are used. These bacteria respond to mutagenic substances by back mutation to the wild, histidine- or tryptophane- independent type. Such mutants will then grow on an amino acid deficient agar plate as single colonies against a background lawn of nonmutated bacteria. The number of such colonies can then be counted and compared with the spontaneous mutation rate. A chemical is considered to have a positive response if the number of induced revertants is more than double the spontaneous mutations.
Het hod The tester strains of Salmonella typhimurium TA98, TAlOG, TA1535, TA1537, TA1538 and Escherichia coli WP2 uvrA were maintained in liquid nitrogen and recultivated for the test in fresh nutrient broth. The S-9 fraction was prepared from the microsomes of a liver homogenate as follows. Sprague-Dawley rats were injected once with 500 mg/kg of polychlorinated biphenyl (PCB) = Aroclor 1254 (Monsanto, S. Louis, Mo., USA) in corn oil (200 mg/ml i.p.). Five days later the animals were killed, the livers removed and homogenised in three -4-

### 6- Report No. 71 

### /81 Compound: 458 

### /81 A ,ug/plate S-9 Mix Revertant colonies 

### Iplate TA 1537 10,000 -no colony growth P

2,500 -2 -4 - 4- 7 p Soo 50 2 - 3 -4 - 4 P 100 -2 - 3- 3 - S

20 -2 - 2 -4 - 5

4 2-3-4- S 10,000 +2

- 3

- 6

- 6 p

2,500 + 10 IS5 17 -20 p 500 + 13 -14 -17 -17 p 100 + 11 -14 -18 -20

20 + 10 -13 -15 -20

4 + 11 -13 -16 -21 P = at these concentrations the substance precipitated in soft agar
Control (DMSO) 0 2-3-4- 6 0 + 12 -16 -17 -20 Positive controls 9-Aminoacridine 100 368 -402 2-Aminoanthracene 1 3-5 2-Aminoanthracene I + 114 -122 -7

268810 'f1 I 11 L 1 I A

-

-7- Report No. 71 

### I81 Compound: 458 

### /81 A

,ug/plate S-9 Mix Revertant colonies /plate TA 98 10,000 -14 - 20 -25 - 27 p

2,*500 -16 - 18 18 - 22 p So00 21 - 26 -28 - 29 P 100 -21 - 23 -27 - 30

20 - is - 18 -25 - 26

4 - 24 - 26 -29 - 32 10,000 +34 - 36 -37 - 39 p

2,500 + 31 - 32 -38 - 40 P 500 + 34 -35-39 -39 P 100 + 30 -34-36 -38

20 + 27 -28-30 -38

4 + 35 - 36 -37 - 41 P =at these concentrations the substance precipitated in soft agar
Control (DMSO) 0 21-26 -30 -32 0 + 30-34 -34 -42 Positive controls Methylhydrazone Derivative 5 2870 - 3620 2-Aminoanthracene a's- 26 - 34 2-Aminoanthracene 0:5 516 - 610 L-8-

2688-8- Report No. 71 

### /81 Compound: 458 

### /81 A
1 

### uglplate S-9 Mix Revertant colonies 

### /plate TA 1538 10,000 -no colony growth P

2,500 -3 - 3- 4- 6 P So00 4 - 4- S-9 p 100 -5 - 6- 6- 7

20 -5 -5S- 6-9

4 9 -9 -11 -12 10,000 + 14 -14 -18 -23 p

2,500 + 16-23-28-32 p S00 + 14-19-19-20 P 100 + 14 -15 -16 -23

20 + 16 -20 -21-24

4 + 16 -23 -24-24 -F = at these concentrations the substance precipitated in soft agar
Control (DMSO) 0 10 -12 -12 -14 0 + 16 - 19 - 24 - 27 Positive controls Methyihydrazone Derivative S 2700 - 2820 2-Aminoanthracene 0.5 13 - 14 2-Aminoanthracene 0.5 + 670 - 810 -9-

2661-9- Report No. 71 

### /81 Compound: 458 

### /81 A

,ug/plate S-9 M1ix Revertant colonies 

### /plate TA 100 10,000 -16 - 24 - 28 -39 P

2,500 -69 - 80- 88- 97 p 500 95 - 98 - 108 -114 p 100 -107 - 110 - 115 -124

20 -95 -106 - 108 -110

4 -104 -105 - 108 - 116 10,000 + 7- 10 - 14 - 14 p

2,500 56 -62 - 80 - 85 p 500 + 104 -109 - 109 - 121 p 100 + 118 - 129 - 14S - 148

20 + 103 - 104 - 117 - 12S

4 + 126 - 127 - 129 - 145 P = at these concentrations the substance precipitated in soft agar

Methyihydrazone Derivative 5 4280 - 4800 2-Puinoanthracene 0.5 102 - 122 2-Aminoanthracene 0.5 + 560 - S90

- 10-

268

### Bet;,-hi NF. TO I/

-10- Report No. 71 

### /81 compound: 458 

### /81 A /ug/plate S-9 Mix Pevertant colonies 

### /plate TA 1S35 10,000 -7 - 8 - 12 - 15 P

2,500 -7 - 14 - 15 - 15 P 500 10 - 12 - 15 - 22 p 100 -10 - 1S - 16 - 17

20 -8 - 9 -10 -12

4 -9 - 11 - 12 - 20 10,000 + 5 - 6 - 8 -10 p

2,500 + 9 - 12 - 12 - 16 p 500 + 8 -10 -12 -21 p 100 + 9 - 11 - 14 - 1S

20 + 9 - 15 - 16 - 19

4 + 13 - 16 - 18 - 19 P= at these concentrations the substance precipitated in soft agar
Control (DMSO) 0 14 - 1S - 18 - 20 0 + 16 - 17 - 19 - 19 Positive controls Streptocotocine 5 3970 - 4440 2-Aminoanthracene 1 15 - 20 2-Aminoanthracene 1 + 143 - 160

2688Report No. 71 

### /81 Compound: 458 

### /81 A /ug/plate S-9 M!ix Rev'ertant colonies 

### /plate E. coli WP 2 uvr A 10,000 16 -20 -2i- 22 P,

2,500 18 - 20 - 2S - 30 P 500 21 - 22 - 24 - 30 p 100 21 - 21 - 22 - 27

20 18 - 21 - ZS - 30

4 18 -22 -30 -32 10,000 +28 - 32 - 33 - 33 p

2,500 + Z7 - 36 - 39 - 45 p S00 + 36 -38 -41 - 4S P 100 + 27 - 37 - 38 - 42

20 + 27 -33 -41 -42

4 + 33 - 39 - 41 - 47 P = at these concentrations the substance precipitated in soft agar
Control (DMSO) 0 18 -20 -29 -33 0 + 29 - 39 - 42 - 42 Positive controls ENNG 2 375 - 419 2-Aminoanthracene 10 27 - 29 2-Amino anthi-acene 10 +1590 - 1770

### Bendd tNf. 7H 

# Hoechst HoechstAktiengesellschaft Pharma Research QualityAssurance (GLP) 12 -9.12.i19811

Title A NIUTAGENICITY SCREENING OF 458/ 81 A IN 

### BACTERIA (AMES TEST) Date : December 4, 1981 Study No.: 71/ 81
This study was periodically inspected and properly signed records of these inspections were submitted to testing facility management and the study director as shown below: Inspection Report 30.11.1981 30.11.1981

9.12.1981 9.12.1981

Pha-rma Research Quality Assurance (GLP)

Vorsizeflde desAutsiclhtsfats: Otto Aantt Vorstand: plolfSeminal, Voisitzender; Kurt LanZ,stlli. VOvrinde,: Erhtardl Bouillon, Fludoll Frank. Martin F(Ohoul. WolfgangHilger. Wills Hoerirens, Wolfgang vonPdlrritz, Hans Flaintges., Juirgen Schaffhausen, Hans SchIaclar, Klaus Welssrmel: PONll.: HansGeorg Janson. Gr~rter MottS Siltder G03allsChatt: Fiankfrluf am Main-Hancleisregiler: Frankfurt am Main AMt B Hr. 14500