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## 3N 5155 

# ETAD ETAD North America Representing the North American Dyes Industry 20121 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, DC 20460 Attention: TSCASection 4 40 CFR 799

.5087 Docket ID Number EPA-HQ-OPPT-2007-0531 ToWhomIt May Concern: 

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RE: Testing of Certain High Production Volume Chemicals; Second Groupof Chemicals. Federal Register 76 (5), 1067-1093, January 7, 2011 . C .I . Leuco SuIDhur Black 1 (CAS No. 66241-11-0) 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 REACHregistration dossier and REACH registration for C .I . Leuco Sulphur Black 1 (CAS No. 66241-11-0) " Clariant's REACHregistration 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-Octanol/water 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 Aspecified in the test rule as ASTM E 1148-02 (reapproved 2008) .



## CONTAINS NOCE1 Ecological and ToxicologicalAssociation of Dyes andOrganic Pigments Manufacturers 1850 M Street, N.W

., Suite 700 9 Washington, D .C. 20036 " (202) 721-4100 9 Fax (202) 296-8120 " www .etad.com" Ready biodegradation study report: C .4-D of EU Regulation 440/2008 (OECD301 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 to fish (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) . " Algal toxicity (Test Group 1) study report: OECD 201 - equivalent to ASTME 1218- 0 el 4 " Acute (up/down) oral toxicity (rat) study report : OECD 423-- equivalent to 40 CFR 799 .9110(d)(1)(i)(A)) . " Bacterial reverse mutation test (Ames test) study report: OECD 471 - equivalent to 40 CFR 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: OECD422 (equivalent to 40 CFR 799.9365) . " A CDcontaining electronic files of the ECHA letter and each of the specific study reports cited above. " Asecond CDcontaining electronic files of this cover letter, ETAD's May 4, 2012 study plan letter, and Clariant's REACHregistration 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 heimestCaD-socma.com

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

## ~~ l ~ lM~L1 .~. .

cc: Paul Campanella'~~-7_- r~~- ~ -AG~ European Chemicals Agency Clariant Iberica Produccion S.A . ZAL - Prat c/ Cal Coracero, 46-56 08820, El Prat de Llobregat (Barcelona) Spain Submission date: 19107/2010 Submission number: UT864837-85 Decision number : SUB-D-2114117009-59-O11F 

## 2012 ~ :~ F~a 1: 39 Helsinki, 27/07/2010

DECISION ONYOUR REGISTRATION UNDERREGULATION (EC) NO190712006 Dear Sir/Madam, In accordance with Article 20(2) of Regulation (EC) No 1907/2006 ("the REACH Regulation"), the European Chemicals Agency (ECHA) has concluded the completeness check of your registration dossier for phenol,2,4-dinitro-,sulfurized, leuco derivatives_LR_RDB_00011687_TLP_JR. This registration by Clariant Iberica Produccion S .A. includes: " a substance in quantities over 1000 tonnes/year The registration was considered complete. The registration number forthis registration: 01-2119456261-45-0000 The registration date for this registration: 19/0712010 This registration entitles you to manufacture/import this substance (or, if relevant, use in the production of articles) . If, however, you have been informed by ECHA that a previous registrant has requested a 4-month extension of your waiting period, you may only start to manufacture/import (or use) the substance 4 months fromthe date of this decision. Please note that ECHAalways informs registrants that: In accordance with Article 20(2) of the REACH Regulation, the completeness check ascertains that all the elements required and the fee payment has been provided . However, this completeness check does not include an assessment of the quality or the adequacy of any data or justifications submitted. Such an assessment may occur during a later stage in a compliance check. In accordance with Article 22(1) of the REACH Regulation, registrants are on their own initiative required to update their registrations without undue delay with relevant new information and submit them to ECHA in the cases described in this Article (for instance, change in status, substance composition or quantities) . Note that, if your IUCLID dossier did not include an EC number in section 1 .1, REACH-IT will have automatically generated one because substances in dossier updates always have to be identified with the relevant EC number. In this case, before proceeding with an update dossier you have to export from REACH-IT the EC entry that has been created and import it into your IUCLID installation inventory

. Failure to do so will result in your dossier being automatically rejected by the system . For detailed instructions on howto do this please consult 'Data Submission Manual 4' available at http://echa.europa eu/help/help docs en a sp.

Annankatu 18 1 P

.O. Box400 1 FI-00121 Helsinki I Finland http://echa. europa .eu 1/2If you have a specific concern about the content of this message you can contact ECHA using the webform at http://echa eurocaa eu/about/contact-form en .asg and then selecting the menu item 'Enquiry on specific submission to ECHA' . Yours faithfully,

Kevin Pollard Head of Unit C3 Directorate of Registration & IT Tools



## OI'J IUNOO

Annankatu 18 1 P

.O . Box 4001 FI-00121 Helsinki I Finland http://echa.europa.eu 2/2