# - ETAD 31 b--3 b3 ETAD North America Representing the North American Dyes Industry 

### June 25, 2012 p. 1



### Document Control Office (7407 M) Office of Pollution Prevention and Toxics (OPPT) Environmental Protection Agency EPAEast Building, RoomE6428 (202-564-8930) 1201 Constitution Avenue, NW , Washington, DC 20460 Attention: TSCA Section 4 40 CFR 799.5087 Docket ID Number EPA-HQ-OPPT-2007-0531 c~C :) w To WhomIt May Concern: N RE: Testing of Certain High Production Volume Chemicals; Second Group of Chemicals. Federal Register 76 (5), 1067-1093, January 7, 2011 . C .I . Leuco Sulphur Black 1 (CAS No. 66241-11 -0) . In reference to our letter of May 24, 2012 pertaining to the subject test rule, this is to state that ETAD, on behalf of Clariant Corporation, is not claiming as CBI any of information submitted with that May 24 letter. This includes all subject matter, hard copies, and CDs contained in the May 24, 2012 submission. A letter fromClariant Corporation, enclosed here, confirms that none of the information submitted on May 24 is being claimed as CBI . Our May 24 letter of submission is also enclosed here for reference. The Ecological and Toxicological Association of Dyes and Organic Pigments Manufactures (ETAD) is an international technical organization that addresses the health, environmental and safety aspects of the global colorants industry. Headquartered in Basel, Switzerland, its members include the leading colorant manufacturers in Europe, Asia, and North America. Clariant Corporation is a member of ETAD . For further information concerning this submission to satisfy the requirements of the subject test rule, please contact the undersigned directly at 202-721-4154 or helmestO-socma .com . 

### Sincerely, C . Tucker Hetmes, Ph.D. Executive Director ETAD North America cc: Paul Campanella 

# CONTAINS NOCBI

Ecological and ToxicologicalAssociation of Dyes and Organic Pigments Manufacturers 1850 M Street, N.W

., Suite 700 9 Washington, D .C. 20036 . (202) 721-4100 . Fax (202) 296-8120 9 www .etad .com

# ETAD ETAD North America Representing the North American Dyes Industry May 24, 2012 Document Control Office (7407 M) Office of Pollution Prevention and Toxics (OPPT) Environmental Protection Agency EPA East Building, RoomE6428 (202-564-8930) 1201 Constitution Avenue, NW 

### Washington, DC20460 Attention: TSCASection 4 40CFR 799.5087 Docket ID Number EPA-HQ-OPPT-2007-0531 

### To WhomIt May Concern: RE: Testing of Certain High Production Volume Chemicals; Second Group of Chemicals. Federal Register 76 (5), 1067-1093, January 7, 2011 . C .I . Leuco Sulphur Black 1 (CAS No. 66241 -11-0) . N O_ rN N -~a w N

On behalf of Clariant Corporation, ETADtoday is submitting the REACHregistration dossier and associated study reports in compliance with the subject test rule for C .I . Leuco Sulphur Black 1 (CAS No. 66241-11-0) . This submission is followup to the study plan ETAD submitted by letter on May 4, 2012 (a copy of that letter is enclosed here) . 

### Accordingly, the following documents are included with this cover letter: " The May 4, 2012 study plan letter submitted by ETAD " AJuly 27, 2010 letter fromthe European Chemicals Agency (ECHA) confirming the completeness of Clariant's REACH registration dossier and REACH registration for C .I . Leuco Sulphur Black 1 (CAS No . 66241-11-0) " Clariant's REACH registration dossier submitted July 13, 2010 " Freezing point study report : OECD 102 (melting point/melting range) - equivalent to : ASTM E 324-99 (capillary tube) " Vapor pressure study report: OECD 104 - equivalent to ASTM E 1782-08 (thermal analysis) 

### " N-OctanoUwater partition coefficient study report. " Water solubility study report : Test method A6 of EU Regulation 440/2008 (i .e. OECD 105) -- a "shake flask" method equivalent to the Method A specified in the test rule as ASTM E 1148-02 (reapproved 2008) . Ecological and Toxicological Association ofDyes and Organic Pigments Manufacturers 1850 M Street, N.W

., Suite 700 " Washington, D .C 20036 " (202) 721-4100 . Fax (202) 296-8120 " www .etad.com 't7 ("+"1

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## CONTAINS NOCE3I" Ready biodegradation study report: C.4-D of EU Regulation 44012008 (OECD 301 F) . This is a manometric respirometry test method equivalent to test method ISO 9408:1999(E) listed in the test rule. Justification for the test method is provided in the accompanying dossier. " Acute toxicity tofish (Test Group 1) study report : OECD 203 - equivalent to ASTM E 729-96 (reapproved 2007) . " Acute toxicity to Daphnia (Test Group 1) study report: OECD 202 - equivalent to ASTM E 729-96 (reapproved 2007) . Alg 04e' al toxicity (Test Group 1) study report : OECD 201 - equivalent to ASTME 1218- " " Acute (up/down) oral toxicity (rat) study report : OECD423 -- equivalent to 40CFR 799.9110(d)(1)(i)(A)) . 

### " Bacterial reverse mutation test (Ames test) study report: OECD471 - equivalent to 40 C FR 799.9510

. " In vitro mammalian cell gene mutation test (Chinese hamster V79cells) study report: OECD476

. " Repeated dose/reproduction/developmental toxicity (rats) study report of combined repeated dose toxicity studywith reproduction/developmental toxicity screening test: OECD 422 (equivalent to 40 CFR 799.9365) . " A CD containing electronic files of the ECHA letter and each of the specific study reports cited above. 

### " Asecond CD containing electronic files of this cover letter, ETAD's May 4, 2012 study plan letter, and Clariant's REACH registration dossier. The Ecological and Toxicological Association of Dyes and Organic Pigments Manufactures (ETAD) is an international technical organization that addresses the health, environmental and safety aspects of the global colorants industry. Headquartered in Basel, Switzerland, its members include the leading colorant manufacturers in Europe, Asia, and North America. In North America, ETAD represents the dyes industry. Clariant Corporation is a member of ETAD

. For further information concerning this submission to satisfy the requirements of the subject test rule, please contact the undersigned directly at 202-721-4154 or helmest(cD-socma.com

. Sincerely, 

### C . Tuc er Helmes, Ph. Executive Director ETAD North America 

## (I

cc: Paul Campanella

# ~ Clariant

June 22, 2012 Dr. C . T . Helmes Executive Director ETADNorth America 1850 M Street, NW

Suite 700 Washington, DC20036 Te1202-721-4154/Fax 202-296-8120 helmest(a)socma.com Clariant Corporation 4000 Monroe Road Charlotte, NC 28205

Daria Church Daria.churohlclariant .com

.-_ 704 .331 .7715 N O~ na ~-~ - r 

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### RE: Sulfur Black 1 - May 24 submission: Testing of Certain High Production Volume Chemicals; Second Group of Chemicals. Federal Register 76 (5), 1067-1093, January 7, 2011 . C .I . Leuco Sulphur Black 1 (CAS No. 66241-11-0) . Dear Tucker: The information contained in our May 24 submission is now publicly available on the ECHAdatabase under REACH . Clariantwill make public the data contained in the EPA submission. Clariant maintains all intellectual property rights related to this data, including any copyright in underlying studies. All data compensation rights for use of this data are reserved. Please informEPA that information submitted on May 24, relating to CL Leuco Sulphur Black 1 can be treated as non-CBI by the EPA. Please let me know

if you have any questions. Sincerely, Daria E. Church Product Stewardship - NA Clariant Corporation 4000 Monroe Road Charlotte, NC28025 704.331 .7720