FAX 

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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 

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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 -

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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 


D. Repeated Dose Toxicity
lb

ATA P -P

22/60

Gewerbetoxikol. Lab. Dr. Scbo/We 12.9.1960u

'Wir erhialten von Thnen folgende Farbstoffe zur toxi-kologischen

Pr~ifung :

R. efjeXb'au G eitra Pir.

2. Re xblau 2024

3. ettgelb 5 G

4.Bril2.antgelb EFF far Lack

5.Pe manentgelb FGL extra tlv,

6. FeMnentgelb 10 GL extra lv. P-V Gelb 10 G L

7.Hansageib 8 G extra stark lv.

8. ansarot 3 B lv.

9. Lackorange R R lv.,

10, Fiuoreszenzorange H 3 G

11, Permenezitrot E 5 B extra Plv. - PV-Echt-Rot E 5 B

12.) P V-RotHK4 B

13.) Permanentbordo PGR Plv.

14.) Permanentrot E 3 B ezctra lv. = PV-Echt-Rot E 3 B.

Die Parbstoffe solien fUr technische Zwecke eingesetzt werden.

Der Parbatoff 4ef~exbiLau 2024 wurde von uns bereits OrU'her in einem

anderen Zusarnmenhang geprilft. Eine nochmalige Untersuchung dieses

Farbstoffes er~brigt sich de§A,1b, und wir geben Ihnen sine Kopie

des danaligen Untersuchungsbefundes. Unsere tntersuchungen mit den

Ubrigen Parbstof.Len filrten zu folgenden Ergebnissen:

10) Akute Toxicit~t:

Die akute Giftigkelt' prtlften wfr durch Verabreichung der Farbst-offe

in einer Stgrkeschleimaufachwemmung mit der Schlundsonde an weisse

Idhuse. Die b~chatzuftibrbare Menge von 10 g/kg wurde von alien Tieren

reaktionslos vertragen. Zine genauere Beetixnung der LD 50 war

deshaib nicht rnglicb. Die LD 50 dUrfte aber bei alien Farbstoffen

llber 10 g/kg liegen.

2,) Chroniuche Giftlgkeit:

In eimem subcHronlachen FUtterungsversuch erhielt je eine Gruppe

von 10 m~n22iichen mischrassiget Albino-Ratten einen Farbstoff

14mal in 18 Tagen in der Dosi erung -von 500 ~Jg mit der Schiundsone. an erhalten der Tiere wbbrend des erauches und elner an

schliessenden Beobacbtungazeit von 4 Tagen war normal. Die Far-batoffe vurden ir lot aungeschiedon. Blutbild und Urin wurden zu

B eginn und nach Absch-luss des Versuches untersucht. Es fanden sich

keine patbologlachen Ver~nderungen. Wach der Beobachtungszeit

wurden alle Tiere getbitet und seziert. Die Sektion zeigte weder

makroakopisch noch bei der histologischen Untersuchung der Organe

Hers, lunge, Leber, Siere und Miilz (Beurteilung: Doz, Dr, Benoit)

krankhafte Verdnderungen, die auf die verfUtterten Farbstoffe

zurUckzuflihren w~ren*,
22/60

-2 -

3,) taut- und Schleimnhutvertr&lichkeit:.

Dlie IrUTMgen-aU -aUt- Und S heimhautertrglichkeit erfolgten in Intracutan-Test nach Barail, an Kaninchen sowie

durcb b8ehandlung der it

aninchenflanke und der Schleimhaut

an~ Kuninchenauge. Von jedem Farbetoff wurde nach 1ettndigem Digerieren bei 4000 in 0,9Aiger Na Cl-L~5aung ein Piltrat

gewonnen. Diese Filtrate wurden in abgestuften Verdiinnungen iiuj Barail-Test sowie unverdizunt durch imaliges Auftragen

von 095 ml aif die enthaarte uml unverletzt40e Kaninchenflanke

.md durch lm-alige Applikation von 0,25 ml in den Bindehautsack am Kaninchenauge goprtift. Es ergalcen sich in keiner

1Jntereuchung irgendwelche R1eizerschelnungen.

Zusa-n enfassung und Beurteilung: 4ach den E--rgebniseen unserer Un-tersuchungen auf ak-.te Giftigkeit und, enteprechend den Rlichtlinien im "Handbook of

Toxikolog4~" von F.S. Spector w~ren die geprUf ten Parbetoffe

akut als pfaktisch ungiftig zu bezeichnen.

.k Die subchronischen Pi~tterungeversuche sowie die -vrUfungen auf Haut- und SchleimhautvertrEaglichkeit ergaben keine Schddigung durch die geprUften PFirbetoffe.

GeRen den Eineatz der Parbstoffe ist von gewerbetoxikologischer Seite nichts einzuwenden.

WYir haben Konto mit dem Betrare von 'Lld. 5 530.-

belastet.

G7-'iErIBETCXIKCICGI SCHE-S LA3COR."TRIN~ CH 28

DISCLAIMER "'Clrin

This report is the property of Clariait. Itse nti

Confidential and met for gemeral ruloea. it is metJ

allowed to tits and reveal 111 report of itl eentaut tea

tird party witent prir Written apprval ef Clarinet. I
ATA F-P

22/60

Industrial Toxicology Lab. Dr. SchlWe Sept. 9, 1960

We received the following pigments from you for toxicological testing:

1.) Reflex Blue G extra powder

2.) Reflex Blue 2024

3.) Oil-soluble Yellow 5 G

4.) Brilliant Yellow HFF for paint

5.) Permanenti Yellow FCIL extra powder

6.) Permanent Yellow 10 GL extra powder = P-V yellow 10 G L.

7.) Hlansa Yellow 8 G extra strong powder

8.) Hansa Red 3 B powder

9.) Lake Orange R R powder

10.) Fluorescent Orange H 3 G3

11.) Permanent Red E 5 B extra powder PV Fast Red E 5 B

12.) P V Red H 4 B

13.) Permanent Bordo FGR powder

14.) Permnanent Red E 3 B extra powder PV Fast Red E 3 B

Thbe pigments are intended for technical applications. We have tested the pigment Reflex

Blue 2024 previously in another context. Thus, a repeat test of this pigment is not

necessary, and we are providing you with a copy of the results from this earlier test. Our

investigations of the remaining pigments yielded the following results:

1.) Acute toxicity

We tested the acute toxicity by admzinistering the pigments in a starch suspension to white

mice via a feeding tube. The maximum adiiisterable amount of 10 g/kg was tolerated

by all animals without any reaction. A more accurate determination of LD 50 was thus

not possible. The LD 50 value for all of the pigments is probably greater than 10 &gg

2.) Chronic toxicity

In a subscbronic feeding test, each individual group of 10 male, mixed-race albino rats

received one pigment 14 times in 18 days at a dose of 500 mg/kg via a feeding tube. The

behavior of the animals during the test and a subsequent 4-day observation period was

normal. The pigments were excreted in the stool. Blood count and urine were examined

at the beginning and at the conclusion of the test. No pathological changes were

observed. After the observation period, all animals were killed and dissected. The

sections displayed no abnormal changes either mnacroscopically or during the histological

examination of the organs heart, lungs, liver, kidneys and spleen (evaluated by: Doc. Dr.

Benoit) that could be attributed to tbe pigments fed.

3.) Skin and mucous membrane irritation:
The test for skin and mucous membrane irritation was conducted by means of a Barail

intracutan test on rabbits as well as by treating a rabbit's flank and the mucous membrane

in a rabbit's eye. After each pigiment was digested in 0.9% NaCI solution at 40 degrees C

for one hour, a filtrate was obtained. This filtrate was tested in successive dilutions in the

Barai) test as well as undiluted via a one-time application of 0.5 ml to the intact depilated

flank of a rabbit uind one-time instilling of 0.25 nil into the conjunctival sac of a rabbit's

eye. No signs of irritation whatsoever were observed in any of the tests.

Surnxa~y and conclusions:

On the basis of the results from our investigations regarding acute toxicity and in

accordance with the guidelines contained in the "Handbook of Toxicology" by W. S.

Spencer, the pigments investigated can be designated as practically non-toxic.

The subchronic feeding tests as well as the skin and mucous membrane irritation tests

indicated that the pigments tested produced no adverse effects.

From the industrial toxicology standpoint, there are no objections to use of the pigments.

We have charged your account in the amount of DM. 5 530.-

INDUSTRIAL TOXICOLOGY LABORATORY CH 28

(stamped Dr. Schoiz) (stamped Dr. Weigand)

(see original for DISCLAIMER - already in English)