p. 1 

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, Room E6428 (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 

To Whom It May Concern : 

pill 1 : 39 

Aupu0 ~i~ui~i~0 iuiuiiuuupi~p 

RE : Testing of Certain High Production Volume Chemicals; Second Group of 

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, ETAD today is submitting the REACH registration 

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 follow up 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 

" A July 27, 2010 letter from the 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-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 A specified in the test rule as 

ASTM E 1148-02 (reapproved 2008). 

CONTAINS NO CE1 

Ecological and Toxicological Association of Dyes and Organic 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 (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 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 ASTM E 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 V79 cells) study report: 

OECD 476. 

" Repeated dose/reproduction/developmental toxicity (rats) study report of combined 

repeated dose toxicity study with 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. 

" A second 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 

heimestCaD-socma.com. 

Sincerely, 

C. Tuc er Helmes, Ph. 

Executive Director 

ETAD North America 

~~ l ~ lM~L1.~.. 

cc: Paul Campanella 
'~~-7_- r~~- ~ -A G~ 

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 ON YOUR REGISTRATION UNDER REGULATION (EC) NO 190712006 

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 for this 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 from the date of this decision . 

Please note that ECHA always 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 how to do this please consult 'Data Submission Manual 4' available at http ://echa.europa eu/help/help docs en asp. 

Annankatu 18 1 P.O . Box 400 1 FI-00121 Helsinki I Finland 

http ://echa. europa .eu 1/2 
If 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 400 1 FI-00121 Helsinki I Finland 

http ://echa.europa.eu 2/2