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## - 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 PREVE NTION, PESTICIDES AND TOXIC SUBSTANCES

Subject: Follow-up to fax transmission of4/13/12 (ePMAremoval ofCBI claimsregarding identified studies) 

### Dear Mr. Merritt: This is sent to you pursuant our conversation ofseveral minutes ago. In Larry Robinson's fax of April 13th while there is a waiver ofconfidential business information (CBI) claims in the identified studies there is a an assertion ofcopyright protections and some additional text that provides in part
... "Reproduction, reference, summarization, retransmission or other use ofthis copyrighted document.

..including electronic transmission, using the internet oremail

....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 perthe TSCA activity are not to be made available in an Agency e-docket (electronic docket) orbe included in EPA websites among the collection ofTSCAhealth 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 subject to TSCA regulations (including the posting ofsuch materials on government websites) and submittedby 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 ofthe studies. Can you please confirm CPMA's intent? Many thanks.

Scott M. Sherlock, Attorney Advisor Environmental Assistance Division Office ofPollution 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 Dosierung -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 Beginn 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 itaninchenflanke 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 geprUften 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 Thisreport isthe property of Clariait. Itse nti Confidentialand metfor gemeral ruloea. itis metJ allowed totits and reveal 111 report ofitl eentaut tea tird partywitent prirWrittenapprvalef Clarinet. IATA 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 Gextrapowder 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 VRedH 4 B 13.) Permanent Bordo FGR powder 14.) PermnanentRed E 3 B extra powder PV Fast Red E 3 B Thbepigments are intended for technical applications. We havetested the pigment Reflex Blue 2024 previously in another context.Thus, arepeattest ofthis pigment is not necessary, and we are providing you with acopy ofthe results from this earlier test. Our investigations ofthe remaining pigments yielded the following results: 1.) Acute toxicity We tested the acute toxicity by admzinistering the pigments in astarch suspension to white mice via afeeding tube. The maximum adiiisterable amount of10 g/kg was tolerated by all animals without any reaction. A more accurate determination ofLD 50 was thus not possible. The LD 50 value for all ofthe 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 ata dose of500 mg/kg via afeeding tube. The behavior ofthe 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 atthe conclusion ofthe 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 ofthe 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 testfor skin and mucous membrane irritation was conducted bymeans ofaBarail intracutan test on rabbits aswell as bytreating 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 

### inthe Barai) test as well as undiluted viaa one-time application of0.5 mlto the intact depilated flank ofarabbit uind one-time instilling of0.25 nil into the conjunctival sac ofa rabbit's eye. No signs ofirritation whatsoever were observed in any ofthe tests. Surnxa~y and conclusions: On thebasis ofthe results from our investigations regarding acute toxicity and in accordance with the guidelines contained in the "Handbook ofToxicology" by W. S. Spencer, thepigments investigated can be designated as practically non-toxic. The subchronic feeding tests as well as the skin and mucous membrane irritation tests indicated that thepigments testedproduced no adverse effects. From the industrial toxicology standpoint, there are no objections to use ofthepigments. We have charged your account in the amount ofDM. 5530.-
INDUSTRIAL TOXICOLOGY LABORATORY CH28 (stamped Dr. Schoiz) (stamped Dr. Weigand)
(see original forDISCLAIMER

- already in English)