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fax: 202.564.8251 

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OCSPP OPPT EAD 

1200 Pennsylvania Ave. NW 

Washington, DC 20460 

202.564.8251 

Pages: 

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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 


HoechstH

MI. Scheerer ________ ______Hoechmt Akliengeselischaft

S.~~ne Sataiil:~-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 is the property of Clarisati No mact. i

iesfldda sod met for Ifteral Fuleu*. ft.i not

allowed to afte &ad reveal th report or its ctalto a

thid partwithout prier 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: Otto Flaritl 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. Klaus Weisselmolll

"o VtOlN.: Hans Georg Janson, G.,nter Melz . S~lz dot iasellsdhall: Fnavlduf am, Man - Handesrogistmr: Frnankfurt am Main AM. 8 Nr. 1AdM
1~m ~ Wii IL 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.

He t 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

2688
10 '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

1uglplate 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

2688
Report 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

Hoechst Aktiengesellschaft

Pharma Research

Quality Assurance (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 des Autsiclhtsfats: Otto Aantt Vorstand: plolf Seminal, Voisitzender; Kurt LanZ, stlli. VOvrinde,: Erhtardl Bouillon, Fludoll Frank. Martin F(Ohoul. Wolfgang Hilger. Wills Hoerirens, Wolfgang von Pdlrritz, Hans Flaintges., Juirgen Schaffhausen, Hans SchIaclar, Klaus Welssrmel: PONll.: Hans Georg Janson. Gr~rter MottS Silt der G03allsChatt: Fiankfrluf am Main -Hancleisregiler: Frankfurt am Main AMt B Hr. 14500