c :.

- LV 

### April 23, 2008 Document Control Officer Office of Pollution Prevention and Toxic Substances, 7407 U .S . EPA 1201 Constitution Ave. NW Washington, DC 20460 Re: Premanufacture Notice (PMN) Submission: TS-08XYZ1 Dear Sir or Madam

: On behalf of the [

] is hereby submitting in accordance with 40 CFR Section 720 .50 the attached Premanufacture Notice (PMN) TS-08XYZ1 for review . In accordance with 40 CFR Section 700.45(b), the fee of $2500.00 has been submitted (see attached copy of check) . This PMNnotification does contain confidential business information (CBI) . The original PMN and two copies as well as a sanitized copy are enclosed for EPA review

. The inhalation study report included in this submission was not conducted on a formof the PMNsubstance that is representative of the commercial form

. [ ] has declared its intention to participate in the EPA Nanoscale Materials Stewardship Program(NMSP) . If there are any questions regarding this submission, please do not hesitate to contact me at [ ] . Sincerely,

Attachments 

# C [ t- i . . 

# ~as-~a

1 ]U .S. ENVIRONMENTAL PROTECTIONAGENCY 

# A F PA ^ ."1 

## I IIIiII Iilll Iillli ~Il~lli ~III~I~~~!II III~''. ~Iil', I~IIII il~lll'II'i

u.~ Lutat numner or pages ~ . .~~. in the Premanufacture Notice

. 

## PREMANUFACTURE NOTICE

. , I c~~ ; _ : ',ES

L~7 121 GENERAL INSTRUCTIONS Z'$ _ 0 u u Y . 539 information Instructions corresponding Arm . requested in this formto the extent that it is known to or reasonably ascertainable by you. Make reasonable estimates if you do not You must provide all have actual data. Manual is available from the Toxic Before you complete this form, you should read the "Instructions Manual for Premanufacture Notification" (the Substances Control Act (TSCA) Information Service by calling 202-554-1404, or faxing 202-554-5603)

. If a user fee has been remitted for this notice (40 CFR700 .45), indicate in the boxes above the TS-user fee identification number you have generated . Remember, fee remittance, which is sent to EPA, HQAccounting Operations Branch (PM-226), P .O. 360399M, your user fee ID number must also appear on your TSCA User fee. Pittsburgh, PA 15251-6399, GENERAL Part I- INFORMATION

confidential, You must provide the currently correct Chemical Abstracts (CA) Name of the new chemical substance, even if you claimthe identity as confidential . You may authorize another person to submit chemical identity information for you, but your submission will not be complete and the review will not begin until EPA receives this information. A letter in support of your submission should reference your TS user fee identification number . You must submit an original and two copies of this notice including all test data . If you claimed any information as a single sanitized copy must also be submitted . ENVIRONMENTAL Part II-HUMAN EXPOSURE AND RELEASE If there are several manufacture, processing, or use operations to be described in Part H, sections A and B of this notice, reproduce the sections as needed . Part III-LIST OF ATTACHMENTS

notice . Attach additional sheets if there is not enough space to answer a question fully . Label each continuation sheet with the corresponding section heading . In Part III, list these attachments, any test data or other data and any optional information included in the

OPTIONAL INFORMATION You may include any information that you want EPA to consider in evaluating the new substance . On page 11 of this form, space has been provided for you to described pollution prevention and recycling information you may have regarding the new substance . make production . . notification exemption this does So-called "binding" boxes are included throughout this formfor you to indicate your willingness to be bound to certain statements you in this section, such as use,

volume, protective equipment This option is intended to reduce delays that routinely accompany the development of consent orders or Significant New Use Rules . Except in the case of exemption applications (such as TMEA, LVE, LOREX) where certain information provided in such is binding on the submitter when the Agency approves the application, checking a binding box in notice not by itself prohibit the submitter fromlater deviating fromthe information (except chemical identity) reported in the form CONFIDENTIALITY CLAIMS the

confidential . you You also sanitized (including attachments) . You may claimany information in this notice as confidential . To assert a claimon form, mark (X) the confidential box next to the information that you claimas confidential . To assert a claimin an attachment, circle or bracket the information you claimas If claiminformation in the notices as confidential . must

_ provide a version of the notice . For additional instructions on claiming information as confidential, read the Instructions Manual . ® Mark (x) if any information in this notice is claimed as confidential . TEST DATA ANDOTHER DATA

English), they You are required to submit all test data in your possession or control and to provide a description of all other data known to or reasonably ascertainable by you, if these data arerelated to the health and environmental effects on the manufacture, processing, distribution in commerce, use, or disposal of the new chemical substance. Standard literature citations may be submitted for data in the open scientific literature . Complete test data (written in not summaries of data, must be submitted if do not appear in the open literature. You should clearly identify whether test data is on the substance or on an analog . Also, the chemical composition of the tested material should be characterized . Following are examples of test data and other data . Data should be submitted according to the requirements of §720 .50of thePremanufacture Notification Rule (40 CFRPart 720) .

Structure/activity Test Data (Check Below any included in this notice) " Environmental fate data ® Yes " Other data ® Yes " Health effects data ® Yes Risk assessments " Environmental effects data ® Yes relationships " Physical/Chemical Properties* ® Yes Test data not in the possession or control of the submitter * A physical and chemical properties worksheet is located on the last page of this form TYPE OF NOTICE (Check Only One) ® 

# a a p. 11

FormApproved. O

.M .B. No. 2070-0

012 . Appioval Expires 10-31-96.

I I receipt ( t' ;,r Date of 

### AGENCY USE ONLY 

# companY Sanitized PA u .W . r~ff_

PMN(Premanufacture Notice) INTERMEDIATE PMN (submitted in sequence with final product PMN) SNUN (Significant New Use Notice)

Application) TMEA (Test Marketing Exemption LVE (Low

Volume Exemption) @ 40 CFR 723.50(c)(1)

Exposure LOREX (Low

Release/Low Exemption) @ 40 CFR 723 .50(c)(2) LVE Modification 

## : 20



# 0 LOREX Modification CONSOLIDATED PMN? IS THIS A Yes # of chemicals (Prenotice Communication # required, enter # on page 3) EPA FORM

7710-25 (Rev. 5-95) Replaces previous editions of EPA Form7710-25.p. 12

Public reporting burden for this collection of information is estimated to average 110hours per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy Branch, PM-223, U .S. Environmental Protection Agency, 401 M . St ., S.W ., Washington, D

.C. 20460 ; and to the Office of Management and Budget, Paperwork Reduction Act (2070-0012), Washington, D .C . 20503 . 

### CERTIFICATION I certify that to the best of my knowledge and belief : 1 . The company named in Part I, section A, subsection la of this notice form intends to manufacture or import for a commercial purpose, other than in small quantities solely for research and development, the substance identified in Part I, Section B. 2. All information provided in this notice is complete and truthful as of the date of submission. 3. I am

submitting with this notice all test data in my possession or control and a description of all other data known to or reasonably ascertainable by me as required by §720.50 of the Premanufacture Notification Rule. Additional Certification Statements: If you are submitting a PMN, Intermediate PMN, Consolidated PMN, or SNUN, check the following user fee certification statement that applies: ® The Company named in Part I, Section A has remitted the fee of $2500 specified in 40 CFR 700 .45(b), or 0 The Company named in Part I, Section A has remitted the fee of $1000 for an Intermediate PMN (~fined @ 40 CFR 700.43) in accordance with 40 CFR 700 .45(b), or F-1 The Company named in Part I Section A is a small business concern under 40CFR 700 .43 and has rVitted a fee of $100 in accordance with 40CFR 700 .45(b) . If you are submitting a low volume exemption (LVE) application in accordance with 40 CFR723.50(c)(1) or a Low release and low

exposure exemption (LoRex) application in accordance with 40 CFR 723.50(c)(2), check the following certification statements :

~ The manufacturer submitting this notice intends to manufacture or import the new chemical substance for commercial purposes, other than in small quantities solely for research and development, under the terms of 40 CFR 723.50 . 0The manufacturer is familiar with the terms of this section and will comply with those terms ; and 0The new

chemical substance for which the notice is submitted meets all applicable exemption conditions. 0 If this application is for an LVE in accordance with 40 CFR723.50(c)(1), the manufacturer intends to commence manufacture of the exempted substance for commercial purposes within 1 year of the date of the expiration of the 30day reviewperiod. The accuracy of the statements you make in this notice should reflect your best prediction of the anticipated facts regarding thechemical substance described herein. An knowi ng and willful misinterpretation is sub j ect to criminal penalty p ursuant to 18 USC 1001 . Confidential Signature and title of Authorized Official (Original Signature Required) Date X Signature of agent - (if applicable) Date X

EPA FORM

7710-25 (Rev. 5-95) Page 2Part I -- GENERAL INFORMATION

Section A -- SUBMTI'I'ER IDENTI FICATION la. Person Name of authorized official Position Submitting Notice (in U

.S .) Company Mailing address (number and street) City, State, ZIP Code b. Agent (if Name of authorized official Position applicable) X

Company Mailing address (number and street) City, State, ZIP Code Telephone Area Code Number c. If you are submitting this notice as part of ajoint submission, mark (X) this box. Joint Submitter (if Name of authorized official Position applicable) Company

Mailing address (number and street) City, State, ZIP Code Telephone Area Code Number 2 . Technical Name of authorized official Position Contact (in X U.S.) Company

Mailing address (number and street) City, State, ZIP Code Telephone Area Code Number 3. If you have had a prenotice communication (PC) concerning this notice and EPA assigned a PC Number to the notice, enter the number . Mark (X) -i El X if none 4. If you previously submitted an exemption application for the chemical substance covered by this notice, enter the exemption number assigned by EPA If ou reviousl submitt PIvINf d hi b Mark (X) -1 ®

. y p y e a or t s su stance enterthe if none PMNnumber assigned by EPA(i .e . withdrawn or incompleee)---~ 5. If you have submitted a notice of Bona fide intent to manufacture or import for the chemical substance covered by this notice, enter the notice number assi ned b EPA Mark (X) ~-- El X g y . ~~ if none 6. Manufacture Type of Notice - Mark (X) 1 . u 2. ® Import Only Only 3. ~ Both Binding Option

. . .. a Binding Option rv~arK ~~~ Mark Qthe "Confidential" box next to an subsection ou claimas confidential p. 13

Confidential

EPA FORM

7710-25 (Rev. 5-95) Page 3p. 14 Part I -- GENERAL INFORMATION -- Continued Section B-- CHEMICAL IDENTITY INFORMATION : You must provide a currentlycorrect Chemical Abstracts (CA) name of the substance based on

the ninth Collective Index (9CI) of CA nomenclature rules and conventions . Mark (X) the "Confidential" box next to an itemyou claimas confidential Complete either item 1 (Class 1 or 2 substances) or 2 (Polymers) as appropriate. Complete all other items. If another person will submit chemical identity information for you (for either Item 1 or 2), mark (X) the box at the right. ConfiIdenti the name, com

pany, and address of that p erson in a continuation sheet . 0 dential 1 . Class 1 or 2 chemical substances (for definitions of class 1 and class 2 substances, see the Instructions Manual) a . Class of substance - Mark (X) 1 [ :] Class 1 or 2 [ :] Class 2 b. Chemical name (Currently correct Chemical Abstracts (CA) Name that is consistent with TSCA Inventory listings for similar substances . For Class 1 substances a CA Index Name must be provided. For Class 2 substances either a CA Index Name or CA Preferred Name must be provided, which ever is appropriate based on CA 9CI nomenclature rules and conventions) .

c. Please identify which method you used to develop or obtain the specified chemical identity information reported in this notice: (check one) .

Method 1 (CAS Inventory Expert Service - a copy of the Identification ® Method 2 (Other Source) report obtained from

the CAS Inventory Expert Services must be submitted as an attachment to this notice) d. Molecular formula and CAS Registry Number (if a number already exists for the substance) X CAS# X e. For a class 1 substance, provide a complete and correct chemical structure diagram . For a class 2 substance - (1) List the immediate precursor substances with their respective CAS Registry Numbers . (2) Describe the nature of the reaction or process. (3) Indicate the range of composition and the typical composition (where appropriate) . (4) Provide a correct representative or partial chemical structure diaQram, as complete as can be known, if one can be reasonablv ascertained .

® Mark (X) this box if you attach a continuation sheet. EPA FORM

7710-25 (Rev. 5-95) Page 4p. 15p. 16p. 17p. 18 Part I -- GENERAL INFORMATION -- Continued Section B -- CHEMICAL IDENTITY INFORMATION -- Continued 2. Polymers (For a definition of polymer, see the Instructions Manual .) Confidential a . Indicate the number-average weight of the lowest molecular weight composition of the polymer you intend to manufacture. Indicate maximum

weight percent of low

molecular weight species (not including residual monomers, reactants, or solvents) below500 and below1,000 absolute molecular weight of that composition. Describe the methods of measurement or the basis for your estimates : GPC ~ Other E] : (Specify) not applicable i) lowest number average molecular weight : ii) maximumweight % below500 molecular weight: iii) maximum

weight %

below1000 molecular weight : Mark (X) this box if you attach a continuation sheet . b. You must make separate confidentiality claims for monomer or other reactant identity, composition information, and residual information. Mark (X) the "Confidential" box next to any itemyou claimas confidential (1) - Provide the specific chemical name and CAS Registry Number (if a number exists) of each monomer or other reactant used in the manufacture of

the polymer. (2) - Mark (X) this column if entry in column (1) is confidential . (3) - Indicate the typical weight percent of each monomer or other reactant in the polymer. (4) - Mark (X) the identity column if you want a monomer or other reactant used at two weight percent or less to be listed as part of the polymer

description on the TSCA Chemical Substance Inventory . (5) - Mark (X) this column if entries in columns (3) and (4) are confidential . (6) - Indicate the maximum weight percent of each monomer or other reactant that may be present as a residual in the polymer as manufactured for commercial purposes. (7) - Mark (X) this column if en in column (6) is confidential . Monomer or other reactant and CAS Registry Number Confi- Typical Identity Confi- Maximum Confidential composition Mark (X dential residual dential (1) (2) (3) (4) (5) (6) (7)

% % Mark (X) this box if you attach a continuation sheet . c . Please identify which method you used to develop or obtain the specified chemical identity information reported in this notice (check one) .

Method 1 (CAS Inventory Expert Service - a copy of the identification report ~ Method 2 (other source) obtained fromCAS Inventory Expert Service must be submitted as as attachment to this notice) d. The currently correct Chemical Abstracts (CA) name for the polymer that is consistent with TSCA Inventory listings for similar polymers . e. Provide a correct representative or partial chemical structure diagram, as complete as can be known, if one can be reasonably ascertained .

~ Mark (X) this box if you attach a continutation sheet . EPA FORM

7710-25 (Rev. 5-95) Page 5p. 19 

### Part I -- GENERAL INFORMATION -- Continued Section B -- CHEMICAL IDENTITY INFORMATION -- Continued 3. Impurities (a) - Identify each impurity that may be reasonably anticipated to be present in the chemical substance as manufactured for commercial purpose.

CAS Registry Number if available. If there are unidentified impurities, enter "unidentified." (b) - Estimate the maximum wei ght %

of each i mp

urity. If there are unidentified im purities, estimate their total wei ght % . Provide the Impurity and CAS Registry Number

(a) Maximum percent (b) Confidential % X

%

°Io % Mark (X) this box if you attach a continuation sheet . 4 . Synonyms - Enter any chemical synonyms for the new chemical identified in subsection 1 or 2. Confidential Mark (X) this box if you attach a continuation sheet. 5. Trade identification - List trade names for the new chemical substance identified in subsection I or 2.

Mark (X) this box if you attach a continuation sheet. X

6. Generic chemical name - If you claimchemical identify as confidential, you must provide a generic name for your substance that reveals the specific chemical identity of the new chemical substance to the maximum extent possible. Refer to the TSCA Chemical Substance Inventory, 1985 Edition, Appendix B for guidance on developing generic names . Carbon nanomaterial

Mark (X) this box if you attach a continuation sheet . 7. Byproducts - Describe any byproducts resulting fromthe manufacture, processing, use, or disposal of the new chemical substance. Provide the CAS Registry Number if available . Byproduct (1) CAS Registry Number (2) Confidential 

### X

Mark (X) this box if you attach a continuation sheet. EPA FORM

7710-25 (Rev. 5-95) Page 6p. 20 

### Part I -- GENERAL INFORMATION -- Continued Section C -- PRODUCTION, IMPORT, AND USE INFORMATION:

Mark (X) the "Confidential" box next to an itemyou claimas confidential . 1 . Production volume -- Estimate the maximum production volume during the first 12 months of production . Also estimate the maximum production volume for any consecutive 12-month period during the first three years of production . Estimates should be on 100%new chemical substance basis. For a Low Volume Exemption application, ifyou choose to have your notice reviewed at a lower production volume than 10,000 k r, speci fy the volume and mark (x) in the binding box. If anted, y ou are bound to this volume Maximum

first 12-month production (kg/yr) Maximum12-month production (kg/yr) Confi- Binding (100%new

chemical substance basis) (100%new chemical substance basis) dential Option Mark (x) X 2 . Use Information -- You must make separate confidentiality claims for the description of the category of use, the percent of production volume devoted to each category, the formulation of the new substance, and other use information. Mark (X) the "Confidential" Box next to any item you claim

as confidential . a . (1) -- Describe each intended category of use of the new chemical substance by function and application. . (2) -- Mark (X) this column if entry column (1) is confidential business information (CBI) . (3) -- Indicate your willingness to have the information provided in column (1) binding. (4) -- Estimate the percent of total production for the first three years devoted to each category of use . (5) -- Mark (X) this column if entry in column (4) is confidential business information (CBI) . (6) -- Estimate the percent of the new substance as formulated in mixtures, suspensions, emulsions, solutions, or gels as manufactured for commercial purposes at sites under your control associated with each category of use . (7) -- Mark (X) this column if entry in column (6) is confidential business information (CBI) . (8) -- Indicate %

of product volume expected for the listed "use" sectors. Mark more than one box if appropriate. Mark (X) to indicate your willingness to have the use type provided in (8) binding. (9) -- Mark (X) this column if en (ies) in column (8) is (are) confidential business information (CBI) . Category of use (1) CBI Bindi g Produc- CBI %in CBI % of substance expected per use CBI Option tion % Form- (8) (by function and application i .e. a dispersive dye Muk (x) ulation Site- Con-* Indus- Com- Binding for finishing p

ol yester fibers) (2) (3) (4) (5) (6) (7) limited sumer trial mercial Op tion (9) X X X X X X X X X X X X

* If you have identified a "consumer" use, please provide on a continuation sheet a detailed description of the use(s) of this chemical substance in consumer products . In addition include estimates of the concentration of the newchemical substance as expected in consumer products and describe the chemical reactions by which this substance loses its identity in the consumer product . aMark (X) this box if you attach a continuation sheet. b. Generic If you claimany category of use description in subsection 2a as confidential, enter a generic description of that category. Read the use Instructions Manual for examples of generic use descriptions . description antistatic, reinforcement additive

E] Mark (X) this box if you attach a continuation sheet . 3. Hazard Information -- Include in the notice a copy of reasonable facsimile of any hazard warning statement, label, material safety data sheet, or other Binding information which will be provided to any person who is reasonably likely to be exposed to this substance regarding protective equipment or practices Option for the safe handing, transport, use, or disposal of the new substance. List in part III hazard information you include. Mark (x) ® Mark (X) this box if you attach hazard information . EPA FORM

7710-25 (Rev. 5-95) Page 7p. 21 

### Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER Mark (x) the "Confidential" box next to any itemyou claimas confidential Complete section A for each type of manufacture, processing, or use operation involving the new chemical substance at industrial sites you control . Importers do not have to complete this section for operations outside the U .S. ; however, you may still have reporting requirements if there are further industrial p rocessin g or use o

perations after im

p ort . You must describe these o p erations . See instructions manual 1 . Operation description Confia . Identity -- Enter the identity of the site at which the o peration will occur . dential Name Import for Direct Resale Site address (number and street) City, County, State, ZIP code If the same operation will occur at more than one site, enter the number of sites. Identify the additional sites on a continuation sheet, and if any of the sites have significantly different production rates or operations, include all the information requested in this section for those sites as attachments .

Mark (X) this box if you attach a continuation sheet. b . Type -- Mark (X) DManufacturing E]Processing E]Use c. Amount and Duration -- Com p lete 1 or 2 as appropriate Maximum

kg/batch (i00st new

chemical Hours/batch Batches/year substarce) 1 . Batch Maximum kg/batch (t00%new

chemical Hours/batch Batches/year substance) 2. Continuous d . Process description U Mark (X) to indicate your willingness to have your process description binding. (1) Diagram

the major unit operation steps and chemical conversions . Include interimstorage and transport containers (specify- e .g. 5 gallon pails, 55 gallon drum, rail car, tank truck, etc.) . (2) Provide the identity , the approximate weight (by kg/day or kg/batch on a 100% new chemical substance basis), and entry point of all starting materials and feedstocks (including reactants, solvents, catalysts, etc.), and of all products, recycle streams, and wastes . Include cleaning chemicals (note frequency if not used daily or per batch.) . (3) Identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance

. Import for Direct Resale

~ Mark (X) this box if you attach a continuation sheet . EPA FORM

7710-25 (Rev . 5-95) Page 8

### Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER -- Continued 2 . Occupational Exposure -- You must make separate confidentiality claims for the description of worker activity, physical formof the new chemical substance, number of works exposed, and duration of activity. Mark (X) the "Confidential" box next to any itemyou claimas confidential . (1) --Describe the activities (i .e. bag dumping, tote filling, unloading drums, sampling, cleaning, etc .) in which workers may be exposed to the substance. (2) --Mark (X) this column if entry in column (1) is confidential business information (CBI) . (3) -- Describe any protective equipment and engineering controls used to protect workers. (4) and (6) -- Indicate your willingness to have the information provided in column (3) or (5) binding. (5) -- Indicate the physical form(s) of the new chemical substance (e .g ., solid : crystal, granule, powder, or dust) and % new chemical substance (if part of a mixture) at the time of exposure . (7) --Mark (X) this column if entry in column (5) is confidential business information (CBI) . (8) --Estimate the maximum number of workers involved in each activity for all sites combined . (9) -- Mark (X) this column if entry in column (8) is confidential business information (CBI) . (10) and (11) -- Estimate the maximum duration of the activity for any worker in hours per day and days per year. (12) --Mark (X) this column if entries in columns (10) and (11) are confidential business information (CBI) .

Worker activity CBI Protective Equipment/ Binding Pbysical forms(s) Binding CBI # of CBI Maxinru duration CBI m (i .e ., bag dumping, filling drums)

(1) (2) Engineering Controls (3) Option

Mark (x) (4) and 96 new

substance (5) Option

Mark (x) (6) (7) Worker

s Expose 9) Hrs/day

(10) Days/yr

(11) 12) d (8) not applicable, PMN substance will be

U Mark (X) this box if you attach a continuation sheet. 3. Environmental Release and Disposal -- You must make separate confidentiality claims for the release number and the amount of the new chemical substance released and other release and disposal information . Mark (X) the "Confidential" box next to each itemyou claimas confidential . (1) -- Enter the number of each release point identified in the process description, part II, section A, subsection ld(3) . (2) -- Estimate the amount of the newsubstance released (a) directly to the environment or (b) into control technology (in kg/day or kg/batch) . (3) --Mark (X) this column if entries in columns (1) and (2) are confidential business information (CBI) . (4) -- Identify the media (stack air, fugitive air (optional-see Instruction Manual), surface water, on-site or off-site land or incineration, POTW, or other (specify)) to which the new

substance will be released from that release point . (5) --a . Describe control technology, if any, and control efficiency that will be used to limit the release of the new substance to the environment. For releases disposed of on land, characterize the disposal method and state whether it is approved for disposal of RCRA hazardous waste. On a continuation sheet, for each site describe any additional disposal methods that will be used and whether the waste is subject to secondary or tertiary on-site treatment . b . Estimate the amount released to the environment after control technology (in kg/day) . (6) -- Mark (X) this column if entries in columns (4) and (5) are confidential business information (CBn. (7) -- Identify the destination(s) of releases to water . Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct discharges or NPDES numbers of the POTW (Pubflcl Owned Treatment Works) . Mark (X) if the POTW name or NPDES # is confidential business information (CBI) . Release Number Amount of new substance released CBI Media of release Control technology and efficiency (you may wish to optionally attach efficiency data) CBl (1) (2a) (2b) (3) e.8 .swkW (4) (Sa) Binding Mark (X) (5b) (6) not applicable, PMN substance will be imported

(7) Mark (X) the a POTVV provide name(s) below : CBI 11 Navigable u Other - Specify provide NPDES # CBI destination(s) of releases to water. waterway Lf Mark (X) this box if you attach a continuation sheet. . 22

EPA FORM

7710-25 (Rev . 5-95) Page 9p. 23



### Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued Section B -- INDUSTRIAL SITES CONTROLLED BY OTHERS Complete section B for typical processing or use operations involving the new chemical substance at sites you do not control . Importers do not have to complete this section for operations outside the U.S.; however, you must report any processing or use activities after import . See the Instructions Manual . Complete a separate section Bfor each type ofprocessing, or use operation involving the new chemical substance. If the same operation is performed at more than one site describe the typ ical o p

eration common to these sites . Identi fy additional sites on a continuation sheet. 1 . Operation Description -- To claiminformation in this section as confidential, circle or bracket the specific information that you claimas confidential . (1) -- Diagram

the major unit operation steps and chemical conversions, including interim storage and transport containers (specify - e .g. 5 gallon pails, 55 gallon drums, rail cars, tank trucks, etc) . On the diagram, identify by letter and briefly describe each worker activity. (2) -- Provide the identity, the approximate weight (by kg/day or kg/batch, on an 100% new chemical substance basis), and entry point of all feedstocks (including reactants, solvents and catalysts, etc) and all products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch) . (3) -- Identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance. (4) Please enter the # of sites (remember to identify the locations of these sites on a continuation sheet) : 40-50 # of sites 

## See page 10a

®Mark (X) this box if you attach a continuation sheet . 2 . Worker Exposure/Environmental Release (1) -- From

the diagramabove, provide the letter for each worker activity. Complete 2-8 for each worker activity described. (2) -- Estimate the number of workers exposed for all sites combined . (4) -- Estimate the typical duration of exposure per worker in (a) hours per day and (b) days per year . (6) --Describe physical formof exposure and %new chemical substance (if in mixture), and any protective equipment and engineering controls, if any, used to protect workers . (7) --Estimate the percent of the new substance as formulated when packaged or used as a final product. (9) -- From

the process diagramabove, enter the number of each release point. Complete 9-13 for each release point identified. (10) --Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology to the environment (in kg/day or kg/batch) . (12) -- Describe media of release i .e. stack air, fugitive air (optional-see Instructions Manual), surface water, on-site or off-site land or incineration, POTW, or other (specify) and control technology, if any, that will be used to fin-lit the release of the newsubstance to the environment. (14) -- Identify byproducts which may result fromthe operation. (3), (5), (8), (11), (13) and (15) -- Mark (X) this column if an of the p roceeding entries are confidential business infomnation (CBI) . Letter f # of CBI Duration CBI Protective Equip. / 96 in CBI Release Amount of CBI Media of Release CBI oActWorkers

Exposed of Engineering Controls/ Form- Number New & Control ivity Exposure Physical Form and % ulation Substance Technology new substance Released (1) (2) (3) (4a) (4b) (5) (6) (7) (8) (9) (l0a) (lOb) (11) (12) (13)

X X X X X see pages 464-467 for raft safe-handling guidelines 

# T ' 14) -- Byproducts: (15) X L ® Mark (X) this box if you attach a continuation sheet, EPA FORM

7710-25 (Rev. 5-95) Page 10

### Page 10ap. 25



## OPTIONAL POLLUTION PREVENTION INFORMATION To claiminformation in this section as confidential circle or bracket the s p ecific information that y ou claimas confidential . 

### In this section you may provide information not reported elsewhere in this form regarding your efforts to reduce or minimize potential risks associated with activities surrounding manufacturing, processing, use and disposal of the PMNsubstance. Please include new information pertinent to pollution prevention, including source reduction, recycling activities and safer processes or products available due to the new chemical substance. Source reduction includes the reduction in the amount or toxicity of chemical wastes by technological modification, process and procedure modification, product reformulation, raw materials substitution, and/or inventory control . Recycling refers to the reclamation of useful chemical components from wastes that would otherwise be treated or released as air emissions or water discharges, or land disposal . Descriptions of pollution prevention, source reduction and recycling should emphasize potential risk reduction subsequent to compliance with existing regulatory requirements and can be either quantitative or qualitative. The EPA is interested in the information to assess overall net reductions in toxicity or environmental releases and exposures, not the shifting of risks to other environmental media or non-environmental areas (e.g., occupational or consumer exposure) . In addition, information on the relative cost or performance characteristics of the PMN substance to potential alternatives may be provided. All information provided in this section will be taken into consideration during the review of this substance. See Instructions Manual and Pollution Prevention Guidance manual for guidance and exam p les. Describe the expected net benefits, such as (1) an overall reduction in risk to human health or the environment ; (2) a reduction in the volume manufactured ; (3) a reduction in the generation of waste materials through recycling, source reduction or other means; (4) a reduction in potential toxicity or human exposure and/or environmental release; (5) an increase in product performance, a decrease in the cost of production and/or improved operation efficiency of the new chemical substance in comparison to existing chemical substances used in similar application; or (6) the extent to which the new chemical substance may be a substitute for an existing substance that p

oses a eater overall risk to human health or the environment.

Ll Mark (X) this box if you attach a continuation sheet. EPA FORM

7710-25 (Rev. 5-95) Page 11p. 26 

## Part III -- LIST OF ATTACHMENTS Attach continuation sheets for sections of the formand test data and other data (including physical/chemical properties and structure/activity information), and optional information after this page. Clearly identify the attachment and the section of the form to which it relates, if appropriate. Number consecutively the pages of the attachments. In the column below, enter the inclusive page numbers of each attachment . Mark (X) the "Confidential" box next to any attachment name you claimas confidential . Read the Instructions Manual for guidance on how to claim any information in an attachment as confidential . You must include with the sanitized copy of the notice forma sanitized version of an attachment in which y ou claiminformation as confidential .

Attachment name Attachment a e number(s) Confidential Material Safe Data Sheet SDS [ ] Toxicity to Bacteria 14-34 [ ]Biodegradation 35-56 ( ] Acute Daphnia Toxicity 57-73 [ ] Acute Fish Toxicity 74-90 [ ] Alga, Growth Inhibition Test 91-131 [ ] Study for the Skin Sensitization Effect in Guinea Pigs 132-156 [ ] Acute Toxicity in the Rat After Dermal Application 157-183 [ ] Acute Toxicity in the Rat After Oral Administration 184-211 [ ] Acute Eye Irritation on Rabbits 212-231 [ ] Acute Skin Irritation/Corrosion on Rabbits 232-252 [ ] Evaluation of Corrosive Properties by Using an Artificial 3-D Skin Model 253-270 [ ] In-Vitro Chromosome Aberration Test with Chinese Hamster V79 Cells 271-316 [ ] Salmonella/Microsome Test Plate Incorporation and Pre-Incubation Method 317-374 [ ] Structural, Physical , Manufacturing Process Information 375-427 [ ] Additional Structural, Manufacturing Process Information 428-450 [ ] Additional Structural Information 451-453 [ ] Material Safety Data Sheet ' 454-461 PMN fee documentation 462 CMA electronic PMN formdocumentation 463 Use and exposure information 10a Chemical description information 4a, 4b, 4c f ] Safe Handling Guidelines (draft) 464-467 [ ] Workplace exposure studies (1/17/08) 468-475

~ Mark (X) this box if you attach a continuation sheet . Enter the attachment name and number . EPA FORM

7710-25 (Rev . 5-95) Page 12p. 27 

## Part III -- LIST OF ATTACHMENTS Attach continuation sheets for sections of the form and test data and other data (including physical/chemical properties and structure/activity information), and optional information after this page. Clearly identify the attachment and the section of the form to which it relates, if appropriate. Number consecutively the pages of the attachments . In the column below, enter the inclusive page numbers of each attachment . Mark (X) the "Confidential" box next to any attachment name you claim as confidential . Read the Instructions Manual for guidance on how to claim any information in an attachment as confidential . You must include with the sanitized copy of the notice forma sanitized version of an attachment in which you claiminformation as confidential . Attachment name Attachment a e number(s) Confidential Material Safe Data Sheet SDS [ ] Workplace exposure studies (1/15/08) 476-488 [ ] Workplace exposure studies (1/24/08) 489-496 [ J Workplace exposure studies (1/13/08) 497-511 [ ] Workplace exposure studies (1/23/08) 512-520 [ ] Dust analysis (1/14/08) 521-528 Attachment page 2 12a [ J inhalation study summary report and human risk analysis 529-534

UMark (X) this box if you attach a continuation sheet . Enter the attachment name and number. EPA FORM

7710-25 (Rev . 5-95) Page 12p. 28 PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET To assist EPA's review of physical and chemical properties data, please complete the following worksheet for data you provide and include it in the notice . Identify the property measured, the page of the notice on which the property appears, the value of the property, the units in which the property is measured (as necessary), and whether or not the property is claimed as confidential . The physical state of the neat substance should be provided. These measured properties should be forthe neat (100% pure) chemical substance . Properties that are measured for mixtures or formulations should be so noted (% PMNsubstance in _) . You are not required to submit this worksheet; however, EPAstrongly recommends that you do so, as it will simplify review and ensure that confidential information is properly protected . You should submit this worksheet as a supplement to your submission of test data. This worksheet is not a substitute for submission of test data . Property (a) Mark (X) if provided Page

number b ( ) Value c) M easured o Estimate (Ivt or E) Conf

dent' Marl` (x) (d) Phy sical state of neat substance (s) - (1) - ( ) Vapor pressure @ Tem p erature °C Totr Density /relative densit y cm3 Solubility @ Temperature °C Solvent Solubility in water @

Tem p erature oc 9/L Melting tem

p erature oc Boiling / sublimation tem erature@ torr p ressure oc S p ectra Dissociation constant Particle size distribution Octanol / water partition coefficient Henry's Law

constant Volitalization fromwater Volitalization fromsoil H@ concentration Flammability Ex lodabilit Adsorption / coefficient Other - Specify

L ATTACHMENT PAGE 13

### page 1 of 21 

# PUBLIC COPY

Toxic=To aACMRU

### Study numberl Test Item CAS number : --- CONTENTS

GLP DECLARATION page 10

pap 3 QUALITYASSURANCE STATEMENT 4 RESPONSIBLE PERSONNEL SUMMARY 

# PU B

# LIC INTRODUCTION 7 EXPERIMENTAL PROCEDURE 8 MATERIALS ANDMETHODS

- TEST ITEM

- TEST ORGANISM 10

- SYNTHETICSEWAGE FEED 10

- STUDY CONDITIONS 11

- APPLIED SOP 12 

### RESULTS COMMENTS ARCHIVATION OF DOCUMENTS ANDTEST ARTICLES APPENDIX 1 : EC5o - Determination of Reference Substance GLP CERTIFICATE 13-17 18 19 20 21. 31 

# A Study number " Test Item : CAS number : --- page 3 of 21



## GLP-Declaration

This study was performed in accordance with the principles of Good Laboratory Practice (GLP) as specified in Annex I of the Law on Hazardous Substances (German Chemicals Law - according to the respective valid issue) . Date / Signature Study director 

# PUBLIC COPY

### p 4 oi Study number " Test Item . CAS number : -

STUDY NUMBER TEST ITEM QUALITYASSURANCE STATEMENT

TITLE . Toxicity to bacteria The Quality Assurance Unit inspected the performance of selected phases of this study and examined the final report . The head of the test facility was informed on the results of these inspections at the dates mentioned below . Date ofstudy plan inspection: Date of QAreport : ofstud S *"i fificafton, cation study plan peci to of

inspection: Date of A Date o 

### 0 -V Inspection of experimental phase

Version 2 Date of report i nspection: Date of A rt: 

# 7 The results of this study have been examined on the basis ofthe valid SOPs and we confirm that, to the best ofour knowledge, the raw data have been stated correctly. 

# PUBLIC COPY QualityAssurance Unit :

### Study number Test item CAS number : - RESPONSIBLE PERSONNEL



### Date / Sipature page 5 of 21



# PUBLIC COPYp. 34 

### Study number ] Test Item CAS number :

Astudy was performed to assess the toxicity 

### SUMMARY bacteria. 

### The study was conducted in accordance with the Commission Directive 881302/EEC; Official Journal ofthe EG L133 Part C .11(19 The activated sludge was exposed different concentrations. The respiration rate ofeach mixture was aerathon periods of 3 hours.

showed 19

.6 % respiration inhibition ofactivated sludge at a test item mg/L. The ECs, is bigber t6an10000 mg/L. The effect value related to nominal concentration, since no analytical monitoring was performed. 

# PUBLIC COPY

### Study number Test Item : CAS number : - page 7 of 21

INTRODUCTION This study was designed to assess the toxicity to bacteria. The study was conducted according to the Commission Directive 88/3U2/EEC ; Official Journal ofthe EGL 133Part C .11 (1988) . This test method is in most parts identical with OECDGuideline 209

. The method assesses the effect ofa test itemon microorganisms by measuring the respiration rate under defined conditions in the presence ofdifferent concentrations ofthe test item . The purpose ofthis method is to identify substances which may adversely affect aerobic biological treatment systems and to indicate suitable non inhibitory concentrations of test items to be used in biodegradability too . 

# PUBLIC COPY

### Study number Test item " CAS number : -- 

### page 8 of 21

EXPERIMENTAL PROCEDURE The method described in the Commission Directive 88/302/EEC; Official Journal of the EG L 133 Part C

.11(1988) assesses the effect ofa test itemon microorganisms by measuring the respiration rate under defined conditions in the presence ofdifferent concentrations of the test item . The method is based on that described by ETAD (Ecological and Toxicological Association ofthe Dyestuffs Manufacturing Industry), in which activated sludge obtained froma sewage treatment plant is used as the microbial source. The purpose ofthis test method is to provide a rapid screening method whereby substances which mayadversely affect aerobic microbial treatment plants can be identified, and to indicate suitable non-inhibitory concentrations oftest items to be used in biodegradability tests. Arange-finding test may precede a definitive test. This provides information about the range of concentrations to be used in the main test. Two controls without test itemare included in the test design, one at the start and the other at the end ofthe test series. Each batch ofactivated sludge is checked using 3.5- Dichlorophenol as a reference substance. The physico-chemical oxygen consumption control is carried out, since some substances may consume oxygen by chemical reactivity. In order to be able to differentiate between physicochemical oxygen consumption and biological oxygen consamption (respiration), at least the maximum

concentration ofthe test item is additionally tested without activated sludge. The respiration rate ofthe activated sludge is measured after a contact time of 3 hours. The respiration rate ofthe same activated sludge in the presence ofvarious concentrations of the test item, under otherwise identical conditions, is also measured. The inhibitory effect ofthe test itemat a particular concentration is expressed as a percentage ofthe mean ofthe 

### respiration rates oftwo controls. An EC50 value is calculated fromthe respiration rates at different test itemconcentrations. 

# PUBLIC COPY

### Study number ~ Test Item CAS number : --- MATERIALS ANDMETHODS TEST TTEM CAS number CAS preferred name Chemical name

-- Article number . Batch . Empirical formula . Structural formula 

# - -~s .

Molecular weight , Purity . ---- Major impurities . ---- Water solubility : unsoluble (according to data ofthe sponsor) Vapour pressure Chemical stability in water and light Stability oftest concentration/s during exposure page 9 of 21



# PUBLIC COPYp. 38 

### Study number Test Item CAS number : MATERIALS ANDMETHODS



### TEST ORGANL4M

ANDSYNTHETIC SEWAGE FEED page of 21

Type . mixed population ofaquatic microorganisms (activated sludge) Ario ; . 

### Date ofcollection 

# A"* ~~~~t . aeration of the activated sludge, daily fed with synthetic medium pHof the suspension before application 6 .6 Synthetic sewage feed . Asynthetic sewage feed is nude by dissolving the following amounts ofsubstance in 1 litre of water. 16 .0 g peptone 11-O g meat extract 3.0 g urea 

### 0 .7 g NaCl 0 .4 g CaC11 " 2H20 0 .2 g MgS04" 7H20 2 .8 g ICzHP04 pH ofthe synthetic sewage feed . 7.5 .+0 .5 

# PUBLIC COPY ,~-3 aaradon tank ofa domestic sewage treatment plant (Municipal SIP Cologne-Stammheim)p. 39 

### Study number : Test Item CAS number :q 

### MATERIALS AND METHODS STUDY CONDITIONS Test concentrations (mg/L) . 100 1000 10000 ** Test item

concentration inphysico-chemical oxygen consumption control (mglL) : 10000 

# PUBLIC COPY

Concentration reference substance (3.5-Dichlorophenol, mglL) . 5 10 20 The teat item

and reference substance concentrations are not confirmed by analytical methods ; they are based on nominal concentrations. Type ofapplication . direct weighing 

### Test concentration ofthe activated sludge . 840.0 mglL suspended solids Test temperature . 20t 2° C Stirring period of test item before start of incubation time . 16 hours Incubation time . 3 hours with permanent aeration 

### ** The physico-chemical oxygen consumption control is carried out, since some substances may consume oxygen by chemical reactivity. In order to be able to differentiate between physico-chemical oxygen consumption and biological oxygen consumption (respiration), at least the maximum concentration ofthe test itemis additionally tested without activated sludge. 

# r yp. 40 

### page 1 oT~l Study number :' Test item ~

. CAS number : --- 

### MATERIALS AND METHODS

APPLIEDSOP

SOP-No . Function Validity 2030-660050402 D Toxicity to bacteria 2002-08-19

Deviations fromthe SOPwith reasons : none



# PUBLIC COPYp. 41 

### Study number Test Item CAS number : --- RESULTS Oxygen content temperature, and pHvalues during exposure phase (test item) page of 21

Test %

start O,end Time Temp. pH concentrat (start-end) 

## ion (mg 0-JLl 1mg 0A1 [min.] loci m L 

### Test item 100 4.4 3.0 3 21 .5 7 .7 1000 4

.8 3.4 3 21 .6 7 .7 10000 4

.5 3.0 4 21 .7' 8 .0 Control 1 4 .0 2

.6 3 20.8 7.7 Control 2 4 .9 3.5 3 21 .7 7.6Physicochemical oxygen 10000 6 .5 6

.5 8 21 .7 7 .7 consumption 

### control Comments: The test item has been added to about 130mL deionized water and stirred overnight before testing (equilibration phase) . Start ofstirring period oftest item: 2 .30p.m End ofstirring period oftest item : 6 .30 a.m . 

# PUBLIC COPY

### Study number : 

### Test Item CAS number : p. 42 S e O PB



### RESULTS Oxygen content, temperature, and pHvalues during exposure phase (reference substance)

Test O, start O,end Time Temp. pH concentra 

### don [mg O=/L] [mg O,/L] end) [°C] [ M 

### R/ L

### 1 mIn, 

### Referenco- 5 3.7 2 .6 3 20.8 7 .6 substance 10 4 .8 3.8 4 20.9 7 .3 20 6

.1 5.9 3 20.9 7.2 

# m°° PUBLIC COPY

### Study number Test Item CAS number : RESULTS . 43 page of 21 

# PUBLIC COPY, Test Item -

Test concentration m Respiratory rate

test item -h Phys.-chem . O, consumption

" h Respiratory rate - phys.-chem

. 0, consumption

" h Inhibition

[°/s 100 28 .0 *0

.0 28

.0 0

.0 1000 28.0 *0.0 28 .0 0

.0 10000 22.5 0 .0 22.5 19.6 

### Control, mean 28 .0 Control l 28.0 Control 2 28.0 Comments relevant to result: Test concentrations are given as nominal concentrations and have not been confirmed by analytical methods. * The physico-chemical oxygen consumption has been detennined at 10000 mg/L test item concentration. As no physico-chemical oxygen consumption was observed at that test item concentration this observation also holds true for the lower test itemconcentrations.

### Study number : Test item CAS number : --- RESULTS Reference substance : 3.5-Dichlorophenol p. 44 pageof21 

# PUBLIC COPY

Test concentration

m 

### Respiratory rate m -b 

### Inhibition % 

### 5 22.0 21 .4 10 15.0 46 .4 20 4 .0 85.7 Control, mean 28.0 Control 1 28.0 

### Control 2 28.0

Reference compound Reference compound name : 3.5 Dichlorophenol (Aldrich) Purity . 97% Batch number . 4" Comments: The reference substance concentrations result fromthe quantities used in the

preparations and have not been confirmed by analytical methods .

### page 17 of 21 Study number ~ Test item CAS number : --- RESULTS 

# PUBLIC COPY

- 

## howed 19

.6 % respiration inhibition of ct~va e s u

On at O a test itemconcentration of 10000 mg/L. EC50 > 10000 mg/L

### Study number Test item CAS number : CONIIVICNTS All validity criteria of the test method were met: ppaggeoTrl 

# -1b 

# PUBLIC COPY

- respiratory rates ofthe 2 controls differ less than 15 %

- respiratory rate ofthe controls < 60 mg 02 /L ~ h

- ECso ofthe reference substance 3.5-dichlorophenol is in the range 5 - 30 mg/L

### Study number is Test item CAS number : --- .47 page 19o 21 

# PUBLIC COPY

ARCHIVATION OF DOCUMENTS ANDTEST ARTICLES

raw data, and final reports are archived in the GLParc , _0 Test articles are archiv The sponsor must ensure that information submitted about the test item(identity testing or information about physical and chemical properties) is complete and that it complies to the principles of Good Laboratory Practice. The cuetom st also retain a sample ofthe test itemused where sampling has not been performod b

### Study number

Test Item V&i~ CAS number : --- page 20 of 21



# PUBLIC COPY

, APPENDIX 1 : EC50 - Determination of Reference Substance Toxicity of the reference substance 3.5-Dichlorophenol to bacteria : ECso = 9 .7 mg/L The ECvalues are determined by probit analysis

### In 96 88 78 68 58 40 30 20 14 Concentration effect relation (semilogarithmic scale) Inhibition [%]



### , f f

ECle EM Eme E05 ~ Concentration (mg/L] 3 .7 5 .8 9 .7 16 25 (semi-logarithmic scale

: Gau8's integral) 

# 33

### Study number

Test item CAS, number : GLP CERTIFICATE 

# PUBLIC COP'

ft umwelt nnd NaUaschutz, LmdwirCrcLaft uad dea Laada Nordrbtia-Weatfilen r ,~ r,~ww orrrr n m ,wa.s1 .nisr auto LaYarraldO

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led v wrwwti a+~n, I °'y .'Ya wnq,w .,roe.qn r e~wrarn wrrr+.n WSM" .r+~a~ . .wr w" 

### ip. 50 page 1 of 22 

# PUBLIC COPY BIODEGRADATION

Author:



# 3,5"-p. 51 

### Study numbe, Teat Item 2006-11-21 page 2 of 22 CAS number : CONTENTS page GLPDECLARATION 3 QUALITY ASSURANCE STATEMENT q RESPONSIBLE PERSONNEL SUNIIViARY 7 INTRODUCTION 

# PUBLI C 

### C 

# op EXPERIIVIENTAL PROCEDURE y g 

### MATERIALS ANDMETHODS

TEST ITEM 

### TBST ORaANI .4M 10 MINERAL MEDIUM 11 PRETREATMENT OF THE TEST IrEM 12 REFEREwcE coMPourm 12 EXPOSURE CONDMONS 12 CHEMICAL ANALYSIS 13 APPLIEDSOPS AND METHODS 13 RESULTS 1419 COMMENTS 19 DEGRADATIONCURVES 20 ARCHIVATION OF DOCUMENTS AND TEST ARTICLES 21 GLP CERTIFICATE 22p. 52 

### Study number Teat Item CAS number :



## GLP-Declaration 

# I

This study was performed in accordance with the principles of Good Laboratory Practice (GLP) as specified in Annex I of the Lawon Hazardous Substances (German Chemicals Law_ according to the respective valid issue) .

Date / Signature Study director 2006-11-21 page 3 of 22



# PUBLIC COPYp. 53 

### 2006-11-21 page 4of 22 Study number Test Item CAS number QUALITYASSURANCE STATEMENT STUDY NUMBER TEST ITEM TITLE . Biodegradation The Quality Assurance Unit inspected the performance of selected phases of this study and examined the final report . The head of the test facility was informed on the results of these inspections at the dates mentioned below . Date ofstud p

lan i nsp ection: Date of report: specification study plan 

### fav - .0 9 ? ~? Date of A' ection: Date of report: p ed inspection 

### o2t :1J6 O~-O~ 

# __

Date of report i nsp

ection: Date of report: 

# Mj1g@jMji

.9- 006 ~I1-I-2CF The results of this study have been examined on the basis ofthe valid SOPs and methods and we confirmthat, to the best ofour knowledge, the raw data have been stated correctly. Date: ,,20f7 6~ W

f' ;? -0 /Quality Assurance Unit : 

# PUBLIC COPYp. 54 

### Study number " Test Item CAS number : - RESPONSIBLE PERSONNEL

Date / Signature 2006-11-21 page 5 of 22

Study Director 

# ("RYMOMMvMMwMdvMw_ 77 

# PUBLIC COPYp. 55 

### Study number : Test item CAS number : 2006-11-21 page 6 of 22

SUMMARY Astudy was performed to assess the ready biodegradability The study was conducted in accordance with the Council Directive 92/69/EEC Method C .4-D "Manometric Respirometry Test" . This test method is in all essential parts identical with OECD Guideline 301 F. Asolution o a mineral medium was inoculated and incubated for 28 d under aerobic co . risgtfiis period, degration was followed by BODdeterminations.

owed: 0 .0 % degradation after 7 days 0 .0 % degradation after 14 days 0 .0 % degradation after 21 days 0 .0 % degradation after 28 days Therefo NNOW considered to be "Not Readily Biodegradable" . The reference compound showed 86 .3 % degradation after 14 days. 

# PUBLIC COPYp. 56 

### Study number Test item CAS number : INTRODUCTION 2006-11-21 page 7 of 22

This study was designed to assess the ready biodegradabili 3 *"CEO The study was conducted in accordance with the Council Directive 92/69/EEC Method C .4-D "Manometric Respirometry Test" . This test method is in all essential parts identical with OECD Guideline 301 F

. Ameasured volume of inoculated mineral medium, containing a known concentration ofthe test item(usually 100mg/Litre), to give at least 50-100 mg ThOD/Litre as the nominal sole source of organic carbon, was stirred in a closed flask at a constant temperature (22 t 2°C) for up to 28 days. The consumption ofoxygen (BOD) was determined by measuring the quantity ofoxygen (produced electrolydcally) required to maintain constant gas volume in the respirometer flask . Evolved carbon dioxide was absorbed in a solution of potassiumhydroxide. The amount of oxygen taken up by the test item(corrected for uptake byblank inoculum, run in parallel) was expressed as a percentage oftheoretical oxygen demand (ThOD) or chemical oxygen demand (COD) . The study was commissioned d undertaken between 2006-09-26 and 2006-11-21(ex . -02 to 2006-11-21) .



# PUBLIC COPYp. 57 

### Study number Test Item CAS number 2006-11-21 page 8 of 22

EXPERIMENTAL PROCEDURE The method described in the Council Directive 92/69/EEC (O .J . No. 383 A, 29.12.92) Part C .4D"Manometric Respirometry Test" assesses the ready biodegradability of a test item under aerobic conditions. Asuspension of 100 mg/L test itemin a mineral medium was inoculated and incubated under aerobic conditions in the dark. The endogenous activity ofthe inoculumwas checked running parallel blanks with inoculum but without test item

. Areference compound (sodiumbenzoate) was run in parallel to check the operation ofthe procedures. Atoxicity control (test itemand reference compound mixed) was run in parallel, to ensure that the chosen concentration ofthe test itemwas not inhibitory to microorganisms . Degradation was followed by the determination ofoxygen uptake and measurements were taken at frequent intervals to allow the identification of the beginning and end of biodegradation . The test lasted for 28 days. Because of the nature of biodegradation and ofthe mixed bacterial populations used as inoculum, determinations were carried out at least in duplicate. The oxygen uptake was calculated fromthe readings taken at regular and frequent intervals, using the method given by the manufacturer ofthe equipment. At the end of incubation, the pH ofthe contents ofthe flasks was measured. Start ofthe incubation period . 2006-10-05 1 

### End of the incubation period . 2006-11-02 

# PUBLI COPYp. 58 

### Study number Test Item CAS number : --

Test item MATERIALSANDMETHODS

CAS number CAS preferred name . ---- Chemical name : Article number . -- Batch Empirical formula . Structural formula . Molecular weight _ ---- 2006-11-21 page 9of 22

Purity : 95.8% Major impurities , .--- Water solubility : unsoluble (according to data ofthe sponsor) Vapour prmsnre Chemical stability in water and light Stability of test , ---- concentration/s during exposure 

# PUBLIC C 

# opyp. 59 

### Study number : Test Item CAS number : 2006-11-21 page 10 of 22

MATERIALS AND METHODS Test ora_a nisms Type : mixed population of aquatic microorganisms (activated sludge) Origin : aeration tank ofa wastewater plant treating predominantly domestic sewage (Wupper area water authority, ST? Odenthal) Date of collection 

# 2006-10-02 Concentration of inoculum : 30mg/L ss Pro-treatment ofthe inoculum : - the sludge was washed twice by adding mineral medium, centrifuging (15 minat 4500 rpm and 20 °C) and decanting offthe supernatant - 0 .726 gof the wet sludge was dried in order to calculate the amount ofwet sludge to achieve a concentration of activated sludge of 3 g/L (dry wet) suspended solids - the calculated amount ofsludge was first dissolved in mineral medium

and than filled up to a defined and volume - the inoculum

was stored at room

temperature under continuous shalcing with aeratation until use for max . 3 days. 

# PUBLIC COPYp. 60 

### Study number ~ Test item CAS number : 2006-11-21 page 11 of 22

MATERIALS ANDMETHODS Mineral medium : The mineral medium was prepared fromstock solutions of mineral components described as follows. 1 . Mineral salt solution : Potassiumdihydrogen phosphate (KHzP04) 85 .0g Dipotassium

hydrogenphosphate (KZHP04) 217 .5 g Disodium

hydrogenphosphate dihydrate (Na2HP04 ~ 2 H20) 334 .0 g Ammonium

chloride (NH4C1) 5.0 g The components were dissolved in deionised water and filled up to 10 litres. The pH of the solution was adjusted to 7.4. 2 . Magnesium

sulphate solution : Magnesium sulphate heptahydrate (MgS04 ~ 7 Hz0) 22.5 g The substance was dissolved in deionised water and filled up to 1 litre. 3. Calcium

chloride solution : Calcium chloride dihydrate (CaC12 ~ 2 H20) 36 .4 g The substance was dissolved in deionised water and filled up to 1 litre. 4 . Iron (III) chloride solution : Iron (III) chloride hexahydrate (FeC13 ' 6H20) 0 .25 g The substance was dissolved in deionised water and filled up to 1 litre. To prepare the mineral medium10 mL ofthe mineral salt solution were mixed with 800mL deionised water. Then 1 mL each of the magnesium sulphate-, calcium

chlorideand the iron (III) chloride solution were added and filled up to 1 litre with deionised water . 

# PUBLIC COPY L/~p. 61 

### Study number Test Item 2006-11-21 page 12 of 22 CAS number : MATERIALS AND METHODS Pre-treatment of the test item 25 mg of the test item

were weighed out on aluminiumfoil . Test itemand aluminiumfoil were added to the test flasks, which had already been filled with 200 mL of mineral medium . Afterwards the flask content was made up to 250 mL with mineral medium containing inoculum

to give a test concentration of 100mg test item/L . Pro-treatment of the reference compound Reference compound name : sodium benzoate (Fluka-BioChemika) Purity : 99% Batch-no . : 1206115 50306102 25 mg of the reference compound were weighed out on aluminium foil . Both were added into the test flasks, which had already been filled with 200 mL of mineral medium . Afterwards the flasks were made up to 250mL with mineral medium containing inoculurn to give a test concentration of 100mg reference compound /L. Exposure conditions Test volume Test apparatus Mixing Incubation time Incubation temperature 250mL Oxi Top System(WTVIT) 1 magnetic stirrer per test vessel 28 days 22 t 2°C 

# PUBLIC COPYp. 62 

### Study number : 2006-11-21 page 13 of 22 Test item CAS number

MATERIALS ANDMETHODS Chemical ans,i vsis COD Method : Determination ofChemical Oxygen Demand ofsolids and substances which am

not water-soluble (COD) . Calibration Standard : Potassiumhydrogen phthalate Test apparatus : Behrotest / Mettler DL 70 ES with Rondo 60 

### Applied SOPs and methods SOP/ methods Function Validity 

### 2030-6600306-02 D Manom . Respirometry Test 2002-08-01 2030-1110503-00 D Determination ofChemical Oxygen Demand 2000-12-18 ofsolids and substances which are not water 

### soluble Deviations : As a deviation fromSOP 2030-6600306-02 Dthe experiment was performed with the "OxiTop" device of WTW company instead ofthe "Sapromat", in order to increase efficiency. All resulting deviations were documented in the raw

data and in the report 

# PUBLIC COPY

### Study number Test Item CAS number

RESULTS

BOD (mg O?/L) after n days test item blank blank reference toxicity mean com

pound control flask no . code* time d 15

al 16 a2 1 bl 2 b2 3 b3 bm 4

rl 5 r2 17 tl 0 0.0 0.0 0.0 0.0 0.0 0 .0 0 .0 0.0 0

.0 1 1 .4 -1 .4 2.8 1 .4 4 .2 2.8 57.3 55.9 43 .3 2 4

.2 0 .0 5 .6 5 .8 7.0 6.1 93.7 93 .7 98

.5 3 5.8 1 .4 7.0 5 .8 7.0 6.5 117.0 _ 113 .0 115.0 4 5.6 1 .4 7.0 7.0 7.0 7.0 129.0 127.0 124.0 5 5

.8 1 .4 7.0 7.0 8 .4 7.5 134.0 134.0 130 .0 6 5.6 2.8 8 .4 8 .4 8.4 8.4 140.0 140.0 134.0 7 5.6 1 .4 8.4 7.0 8.4 7.9 141 .0 141 .0 138.0 8 7.0 2.8 8.4 8.4 8 .4 8 .4 144 .0 144 .0 138

.0 9 7.0 2.8 8.4 8 .4 8 .4 8 .4 147.0 147.0 140 .0 10 8

.4 4.2 8

.4 8 .4 9.8 8.9 148

.0 147.0 141 .0 11 8.4 2

.8 9 .8 9 .8 8.4 9.3 150

.0 150 .0 143.0 12 8.4 4

.2 9.8 9.8 9

.8 9 .8 152.0 151 .0 144.0 13 9.8 4.2 11 .2 9.8 9 .8 10 .3 154.0 152.0 145 .0 14 8.4 4.2 11 .2 9 .8 11 .2 10.7 154.0 155.0 145 .0 15 8.4 4

.2 11 .2 11 .2 11 .2 11 .2 157.0 157.0 147.0 16 9.8 4.2 11 .2 11 .2 11 .2 11 .2 157.0 157.0 147.0 17 9

.8 4.2 11 .2 11 .2 11 .2 11 .2 158.0 158.0 148 .0 18 9

.8 5 .8 12.6 12

.6 11 .2 12.1 159

.0 159 .0 148.0 19 9.8 4.2 11 .2 12.8 12 .8 12.1 159.0 181 .0 150.0 20 11 .2 5.8 14 .0 12 .6 12.8 13.1 181 .0 182 .0 150

.0 21 9.8 5

.8 14.0 12.8 12.8 13 .1 162 .0 184 .0 151 .0 22 9.8 5.8 12.8 12.6 12.8 12.8 182 .0 184.0 151 .0 23 11 .2 5.6 14 .0 12.6 12.8 13.1 184.0 184.0 151 .0 24 11 .2 5

.8 14.0 12

.8 14.0 13.5 165.0 185 .0 152.0 25 11 .2 5

.8 14.0 14.0 12.6 13 .5 168 .0 185.0 152.0 26 11 .2 5.8 14 .0 14.0 12

.8 13.5 188.0 185.0 152.0 27 12

.8 7.0 15

.4 14 .0 _14.0 14.5 1 168.0 186.0 1 152 .0 28 ~ 12.81 7.01 15.4 t 14.0 1 14.0 14 .5 168 . 0 166 .0 154. 0 

### Comments: none

*Abbreviations according to test guideline. p. 63 

### 2006-11-21 page 14 of 22



# // q-p. 64 

### Study number Test item CAS number 2006-11-21 page 15 of 22

RESULTS

flask no . H

valne after 28 day

s 1 7.4 2 7.4 3 7 .4 4 7.9 5 8 .0 15 7 .6 16 7.6 17 8.2 

# PUBLIC COPYp. 65



### Study number Test Item CAS number RESULTS Degradation oftest item Test concentration Empirical formula Molecular weight Chemical oxygen demand ( anal yticall y determined) 100 mg/L g/mol 2 .482 mg 02/mg 2006-11-21 page 16 of 22 

# PUBLIC COPY

teat item corrected BOD test item(a-bm) % degradation %

degradation m mean time d al a2 al a2 0 0.0 0 .0 0.0 0.0 0.0 1 0.0 0 .0 0.0 0.0 0.0 2 0.0 0 .0 0.0 0.0 0.0 3 0.0 0.0 0.0 0.0 0.0 4 0.0 0.0 0.0 0.0 0.0 5 0.0 0.0 0.0 0.0 0.0 6 0.0 0 .0 0.0 0.0 0.0 7 0.0 0 .0 0.0 0.0 0.0 8 0.0 0 .0 0.0 0.0 0.0 9 0.0 0 .0 0

.0 0.0 0.0 10 0.0 0.0 0 .0 0.0 0.0 11 0.0 0.0 0.0 0.0 0.0 12 0.0 0 .0 0.0 0.0 0.0 13 0.0 0 .0 0.0 0.0 0.0 14 0.0 0 .0 0

.0 0

.0 0.0 15 0.0 0 .0 0.0 0 .0 0.0 16 0.0 0 .0 0

.0 0

.0 0.0 17 0.0 0 .0 0

.0 0

.0 0.0 18 0.0 0 .0 0

.0 0

.0 0

.0 19 0.0 0 .0 0

.0 0.0 0 .0 20 0.0 0 .0 0.0 0.0 0 .0 2 1 0.0 0 .0 0

.0 0.0 0.0 22 0.0 0.0 0.0 0.0 0.0 23 0.0 0 .0 0.0 0.0 0.0 24 0.0 0.0 0.0 0.0 0.0 25 0.0 0.0 0.0 0.0 0.0

A 26 0

.0 0.0 0.0 0 .01 P 

### 0

.0 0.0 0.0- 0 .01 0.0 28 I 0 .0 0

.01 0

.0 0

.01 0 .0 

### Comments: nonep. 66 

### 2006-11-21 page 17 of 22 Study number I Test item . CAS number : RESULTS Deondation of reference compound Test concentration : 100 mg/L Empirical formula : C7 Hs Na Oz Molecular weight : 144 .1 g/mol Theoretical oxygen demand : 1 .665 mg 0)mg 

# PUBLIC COP

reference compound cerrected BOD refernce compound % degradation (r-bm) % degradation 02/I, mean time d rl fZ rl r2 0 0

.0 0

.0 0.0 0.0 0 .0 1 54.5 53 .1 32.7 31 .9 32 .3 2 87.8 87.8 52.8 52.8 52 .8 3 110.5 108 .5 88.3 83.9 85 .1 4 122.0 120 .0 73.3 72.1 72 .7 5 128.5 128 .5 78.0 78.0 78 .0 6 131 .8 131 .8 79.0 79.0 79 .0 7 133

.1 133.1 79.9 79.9 79 .9 8 135

.8 135

.8 81 .4 81 .4 81 .4 9 138.8 138.8 83.2 83 .2 83

.2 10 139.1 138.1 83.8 83 .0 83.3 11 140.7 140.7 84.5 84 .5 84.5 12 142.2 141 .2 85.4 84 .8 85.1 13 143

.7 141 .7 88.3 85 .1 85.7 14 143.3 144.3 88 .0 88

.8 88.3 15 145

.8 145.8 87.8 87.8 87.8 16 145

.8 145.8 87.8 87.8 87.8 17 148

.8 148.8 88.2 88.2 88 .2 l8 148

.9 148.9 88.2 88.2 88 .2 19 148

.9 148.9 88.2 89.4 88 .8 20 147.9 148.9 88.8 89 .4 89

.1 21 148

.9 150.9 89.4 90 .7 90

.1 22 149

.4 151 .4 89.7 90 .9 90.3 23 150

.9 150.9 90.7 90 .7 90.7 24 151 .5 151 .5 91 .0 91 .0 91 .0 25 152.5 151 .5 91 .8 91 .0 91 .3 26 152.5 151 .5 91 .8 91 .0 91 .3 27 151 .5 151 .5 91 .0 91 .0 91 .0 28 153.5 151 .5 92 .2 91 .0 91 .8 

### Comments : none 

# s1p. 67 

### Study number : Test Item " CAS number : 2006-11-21 page 18 of 22

RESULTS Toxicit,ycontrol Test concentration test item Chemical oxygen demand test item Test concentration reference compound Theoretical oxygen demand reference comlound

toxicity control corrected BOD toxicity control (t-bm) % degradation m Oz/L time d tl tl 0 0 .0 0.0 1 40 .5 9.8 2 90.4 21 .8 3 108.5 28.2 4 117.0 28.2 5 122.5 29.5 6 125.8 30 .3 7 128 .1 30

.9 8 129 .8 31 .3 9 131 .8 31 .7 10 132.1 31 .9 11 133.7 32 .2 

### 12 134.2 32.4 13 134.7 32.5 14 134 .3 32.4 15 135.8 32.7 16 135 .8 32

.7 17 138.8 33 .0 18 135.9 32.8 19 137.9 33.2 20 138 .9 33.0 21 137.9 33 .3 22 138.4 33 .4 23 137.9 33 .3 24 138.5 33.4 25 138.5 33.4 26 138 .5 33.4 27 137.5 33.2 28 _ ~ 139.5 33 .8 

### . 100 mgIL : 2.482 mg 02/mg

. 100 mg/L 1 .665 rng 02/mg 

# PUBLIC COPY

Comments: The used concentrations of the test itemdid not show toxic effects to bacteria.p. 68 

### Study number ~ Test item CAS number : RESULTS 2006-11-21 page 19 of 22 

# PUBLIC COPY

deQradation of 0

.0 % was determined for considered to be "Not Readily Biodegradable" .



# -COMMENTS All validity criteria of the test method were met: The roference compound reached the level for ready biodegradability within 14 days. No toxicity ofthe test item was observed in the toxicity control . At the end ofthe test, biodegradation (%) in parallels with test itemdid not differ by more than 20 percentage points. The oxygen uptake ofthe inocuhun blank was 5 60 mg/L. In cases where the degradation was :5 60 %, the pHwas between 6 .0 and 8 .5 at the end ofthe test (and thus poor degradation was not caused by the pH) .p. 69 

### Study number Test item 2006-11-21 page 20of 22 

### CAS number : DEGRADATIONCURVES

-+-a.r.~.b. --F r. .a .M 

# PUBLIC COPYp. 70 

### Study number : 2006-11-21 page 21 of 22 Test item CAS number :

ARCHIVATIONOF DOCUMENTS AND TEST ARTICLES

Study plans, raw

data and final reports hived in the GLParchiv Test articles are archived 

# - 4110MMW The sponsormust ensure that information submitted about the test item(identity testing or information about physical and chemical properties) is complete and that it complies with the principles of Good Laboratory Practice. The customer le of the test itemused where sampling has not been performed 1 

# PUBLIC COPYp. 71 

### Study number Test Item CAS number : 2006-11-21 page 22 of 22

GLP CERTIFICATE 

# PUBLI C C



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# s6p. 72 

### Page 1 of 17 

# PUBLIC COPY

ACUTE DAPHNIA TOXICITY

Author:p. 73 

### Study number Test Item 

### CAS number : December 18, 2006 Page 2 of 17 i



### CONTENTS

GLP DECLARATION QUALITY ASSURANCE STATEMENT RESPONSIBLE PERSONNEL SUMMARY INTRODUCTION EXPERIMENTAL PROCEDURE MATERIALS AND METHODS

- TEST ITEM

- TEST SPECIES

- CULTURE AND DILUTION WATER - PRE-TREATMENT OF THE TEST ITEM - EXPOSURE coNDrrioNs

- APPLIEDSOPS AND METHODS 

### RESULTS COMMENTS ARCHIVATION OF DOCUMENTS ANDTEST ARTICLES GLP CERTIFICATE Page 3 4 5 

# PUBLIC COPY ; 8 

### 9 9 10 10 11 11 12 13 15 16 17p. 74 

### Study number Test Item CAS number December 18, 2006 Page 3 of 17



### GLP DECLARATION This study was performed in accordance with the principles of Good Laboratory Practice ((3LP) as specified in Annex I of Law on Hazardous Substances (German Chemicals Law - according to the respective valid issue) .

Date / Signature Study director 

# PUBLIC COPYp. 75



### Study number : Test item CAS number : December 18, 2006 Page 4of 17 

# p tg

# i i r- r- n oy QUALITY ASSURANCE STATEMENT STUDY NUMBER TEST ITEM TITLE : 

# 4"kas Acute Daphnia Toxicity The Quality Assurance Unit inspected the performing of phases of this study and examined the study report . The head of the test facility was informed on the results of these inspections at the dates mentioned below . Date ofstu

dy plan i nspection: Date of A rt : specification study plan November 10, 2006 

### 2006 - 114 ---t 0 Date of Ai tion: Date of Areport: process-based inspection SOP 00001 August 15, 2006 ~006- D Cr -/4S port inspection: Date of r Date of Areport: _ 

## ,Zons-,~z-,~9 .Zoo 6 -~~-'9 The results of this study have been examined on the basis ofthe valid SOPs and methods and we confirm

that, to the best ofour knowledge, the raw data have been stated correctly. Date: ~Od 6 -/! .~ ~ I 9 Quality Assurance Unit :



# 60p. 76 

### Study number Test Item December 18, 2006 Page 5 of 17 CAS number : 

### RESPONSIBLE PERSONNEL

Date / Signature

-- , Study Director

cc Utit 

# PUBLIC COPYp. 77 

### December 18, 2006 Page 6 of 17



### SUMMARY A study was performed to assess the acute toxicity to Daphnia magna STRAUS under static conditions . The study was conducted in accordance with EEC Methods for Determination of Ecotoxicity Annex to Directive 92/69/EEC (O .J. No. L383A, 29

.12.92) Part C, Method 2 'Acute toxicity for Daphnia' which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 202 'Daphnia sp ., Acute Immobilisation Test and Reproduction Test, Part I - The 24h ECSOAcute Immobilisation Test' .

exposed to a limit test concentration of nominally 100 mg/L of .ssolved m

water. Auxiliaries used to prepare the test media were an and amagnetic stirrer. Observations were made on the swimming ability and the immobilisation rate, respectively, after 24and 48 hours ofexposure. Thefollowing values were determined: Tlme EC 50 

## (bI [Mg/L] 24 > 100 48 > 100 No toxic effects against daphnia at 100 mg/L. The test itemwas insoluble in water. After addition to water, it formed small lumps that did not disperse by stirring. Treatment in an ultrasonic bath resulted in black colouration of the flask content, indicating very fine dispersal of the test item

. In the first hours ofthe test, fine flocs oftest item formed and partly settled on the bottomofthe test vessels. In the test, all daphnids in the treatment had black gut content, indicating that the test itemhad been taken up, without any apparent effect on the Daphnia. 

### The results are expressed in terms of nominal concentrations at 24 h and 48 h. The hardness ofthe dilution water used was 15.1 °dH (= 270 mg/L CaC03) .



# PUBLIC COPY 6 -~,-

### Study numbe Test Item CAS number :



### This report contains a descriptio ; to investigate the acute toxicity December 18, 2006 Page 7 of 17



### INTRODUCTION the results obtained during a study 

### static conditions. Acute toxicity ii-the ~emff within a short time of exposure to an item . In the present test, acute toxicity is expressed as the median effective concentration (EC 50) which immobilizes 50% of a test batch of Daphnia w'thin a continuous 48 hour period of exposure. In those cases where the slope of the concentration/percentage response curve is too steep to permit calculation of the EC 50, this value is estimated graphically. In items of minor toxicity (or low aqueous solubility) a limit test is performed at 100mg/L (or at the limit ofwater solubility) in order to demonstrate that the EC 50 is greater than this concentration. The study was commissioned . ~undertaken between Nov . 09, 2006 and Dec. 18, 2 . ov. 13, 2006 to Dec . 14, 2006) . Daphnia magna STRAUS under 

### erse effect induced in an organism 

# PUBLIC COPYp. 79 

### December 18, 2006 Page 8 of 17 Study number~ Test Item 

### CAS number :

EXPEREWENTAL PROCEDURE The method described in the Council Directive 92/69/EEC (O .I . No . L383A, 29

.12.92) Part C, Method 2 'Daphnia sp., Acute Immobilisation Test and Reproduction Test' assesses the acute toxic effects (immobilisation) of various concentrations of a test item to a freshwater micro crustacean species. The purpose of this method is to determine that concentration which causes a 50% immobilisation rate (= EC 50) or, if conducted as a limit test, to determine the acute toxic effects at a maximum test concentration of 100 mg/L or at the limit of water solubility, respectively. A range-finding test may precede the main test. It provides information about the range of concentrations to be used in the main test . In the main test, Daphnia are exposed to the test item added to water at a range of concentrations for a period of 48 hours. Defined concentrations of the test itemwill lead to a certain percentage proportion of immobilized Daphnia at the end ofthe 48 hour study period. Immobilisation rates are recorded at 24-hour intervals. The EC 0 and the EC 100 are determined directly from the study, while the EC 50 is calculated or read from the concentration/percentage response curve . During the test a temperature range of 18 - 22°C is to be maintained in the test vessels, with a maximumtemperature fluctuation of +/- 1°C in each individual test. pH and oxygen values are measured at the end ofthe test . The main test is either conducted as " static test in which no flowof test solution occurs and solutions remain unchanged throughout the duration ofthe test " semi-static test without flowof test solution, but with a renewal of test solutions after 24-hours of exposure. 

### The immobilisation in the controls must not exceed 10%by the end of the test. The dissolved oxygen concentration should remain above 3 mg/L throughout the exposure period. The concentration of the test item shall ideally be maintained to within 80%of the initial concentration throughout the study. The maintenance of concentrations is proved by analytical measurements. 

# 6y PUBLIC COPYp. 80 

### December 18, 2006 Page 9 of 17 Study number Test Item CAS number : -



### MATERIALS AND METHODS Test fteu} CAS number . ---- CAS preferred name . - -.- Chemical name Article number . - Batch Empirical formula . ---- Structural formula . ---- Molecular weight . ---- Purity : 95.8% Major impurities . ---- Water solubility : unsoluble (according to data of the sponsor) Vapour pressure . --- Chemical stability 

### in water and light Stability of test concentration/s during exposure : ---- 

# PUBLI C C 

# OPYp. 81 

### December 18, 2006 Page 10 of 17 Study number : Test Item CAS number : ---- 

### MATERIALS AND METHODS Test sDecies Name : Daphnia magna STRAUS, parthenogenetic females Source : Strain of Bundesgesundheitsamt Berlin Maintenance and Acclimatisation : A population of parthenogenetic females of synchronized age structure is maintained since more than 15 years in the test facility under constant temperature conditions (20 +/- 1 °C) at a 16 : 8 hour light-dark photoperiod (illumination: < 1000 lux) . The culture water (so-called 'M4 medium') is partly renewed once a week. The Daphnia are exclusively fed with unicellular green algae (Desmodesmus subspicatu9) 'ad libiturn' . Mortalities of parent Daphnia during the culture period are recorded daily in a semiquantitative way. The neonates are separated fromtheir parent Daphnia by filtration prior to the acute test. Culture and dtion water Reconstituted water (so-called 'M4 medium', originally described in Water Research 24 (9), September 1990

: 1157-1167), prepared according to the recommendations of Bundesgesundheitsamt Berlin. This standard dilution water is used for both, the maintenance of the test animals and the preparation of stock and test solutions of the test item . The total hardness of the dilution water, measured at test start, was 15. 1 °dH (= 270 mg/L CaC03) . 

# PUBLIC COPYp. 82 

### Study number Test Item CAS number : December 18, 2006 Page 11 of 17



### MATERIALS AND METHODS Pre-tre atment of the teat item To produce the desired test concentration 105.1 mg of the test itemwere added to 1 litre of dilution water, treated with an ultrasonic bath for 1 hour and stinsed for 1 hour on a magnetic stirrer . E xposure conditions Test vessels Experimental design

Method of initiation Photoperiod Temperature Aeration Test itemconcentration/s Method of administration Medium renewal Duration of exposure Criteria ofetffects 50 ml glass beakers holding 10 neonates in 20 ml :, of test medium 1 test concentration plus 1 control 10 neonates per vessel, 2 replicates per concentration/control no feeding during the exposure period static system neonates were placed in prepared media 16 h light : 8 h dark 

### mean +/-1 °C (in the temperature range 18-22 °C) none 100 mg/L direct weighing none 48 hours The criterion of adverse effects used in this study was the item-induced alteration of the normal mobility behaviour and the loss of locomotory actions of the neonates, observed at 24 and 48 hours. 

# PUBLIC COPY

67p. 83 

### Study number Test Item CAS number : -- - 

### MATERIALS AND METHODS Aoulled SOPS and methQ& December 18, 2006 Page 12 of 17

SOP / Method Function Validity 2030-7000204-00 D Acute Daphnia test July 5, 2000 2030-1110601-03 D Hardness ofwater Jan . 20, 2003 Deviations : No chemical analysis was performed.



# PUBLIC COPYp. 84 

### Study num Test Item 

### CAS number 

## RESULTS

Test itemconcentration [mg/L] : Control December 18, 2006 Page 13 of 17

Abiodc parameters 24 h 48 h Temperature [°C] ---- 21 .1 Oxygen [mgR-] ---- 8 .4 Oxygen [%saturation] ----- 96 pH value ----- 8 .2 Immobilisation for Daphnia Magna (initial population: ZO) 

### 24 h 48 h Absolute 0 0 

### Cumulative 0 0 Cumulative [%] 0 0 Comments: none 

# PUBLIC COPYp. 85



### Study number Test Item December 18, 2006 Page 14 of 17 CAS number : 

### RESULTS

Test itemconcentration (mg/L] : 100 Abiotic parameters 24 b 48 b Temperature [°C] ---- 21 .0 Oxygen [mg/1:,] ---- 8 .5 Oxygen [%saturation] ---- 97 pH value ---- 8 .0 Immobilisatlon for Daphnia magna (Initial population: 20) 24 h 48 h 

### Absolute 0 0 Cumulative 0 0 Cumulative [%] 0 0 Comments: none 

# PUBLIC COPYp. 86



### Study number 0

- Mob Item CAS number : --



### RESULTS Analysis ofthe immobilisation rates gives the following results: Time EC 50 

## [hl [mll/Ll 24 > 100 48 > 100

.f No toxic effects against Daphnia at 100 mg/L. December 18, 2006 Page 15 of 17

The results are expressed in terms of nominal concentrations at 24 h and 48 h. 

### COMMENTS The test item

was insoluble in water. After addition to water, it formed small lumps that did not disperse by stirring. Treatment in an ultrasonic bath resulted in black colouration ofthe flask content, indicating very fine dispersal ofthe test item . In the first hours of the test, fine flocs oftest itemformed and partly settled on the bottomof the test vessels. In the test, all daphnids in the treatment had black gut content, indicating that the test item had been taken up, without any apparent effect on the Daphnia. In a preliminary test (no original data shown), the test item(100 mg/1 nominal) was added to 1 litre of dilution water, treated for 1 h in an ultrasonic bath and then stirred for 24 h on a magnetic stirrer . Finally, undissolved particles of the test item were removed by filtration using a folded filter of pore size 7-12 pm . The clear filtrate had no effect on mobility of the Daphnia after 48 h. 

# PUBLIC COPYp. 87 

### Study number Test item CAS number 0

0 December 18, 2006 Page 16 of 17



### ARCHIVATION OF DOCUMENTS ANDTEST ARTICLES Study plans, raw

data and study reports are archived at the GLP archives of the test facility. Test articles are archiv The sponsor must ensure that information submitted about the test item (identity testing or information about physical and chemical properties) is complete and that it complies with the principles of Good Laboratory Practice. The custom

er ug a1jQM~a

sample of the test itemused where sampling has not been performed - 

# PUBLIC COPYp. 88



### Study number Test item CAS number : December 18, 2006 Page 17 of 17



### GLP CERTIFICATE

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# PUBLIC COPY

~'f^ . :3~



# 73

# PUBLIC COPY

ACUTE FISH TOXICITY

Sponsor : 

### es 5 Iacllity:

### Stady namber Test Item CAS number : - - CONTENTS p. 90 Page 2 of 17



### Page OLP DECLARATION 3 QUALITYASSURANCE STATEMENT 4 RESPONSIBLE PERSONNEL 5 SUMMARY 6 INTRODUCTION 7 EXPERII4ENTAL PROCEDURE 8 MATERIALSANDMETHODS 9



### - TEST ITEM - TEST spEcms - HOLDINGANDDILUTIONWATER

- PRE-TREATMENT OF THE TEST ITEM

- EXPOSURB CONDITTONs

- APPLIED SOPS ANDMETHODS 

### 9 10 10 11 11 12 

### RESULTS 13 ARCHIVATION OF DOCUIVIENTS ANDTEST ARTICLES 16 OLP CERTIFICATE 17 

# PUBLIC COPY

### Study number Test Item 

### CAS number : p. 91 Page 3 of 17



### GLP DECLARATION This study was performed in accordance with the principles of Good Laboratory Practice (GLP) as specified in Annex I of Law on Hazardous Substances (German Chemicals Law - according to the respective valid issue) .

Date / Signature Study director 

# PUBLIC COPY

### Study number Test item CAS number p. 92 Page 4 of 17 

# P-1 &LIe rsopy QUALITYASSURANCE STATEMENT STUDY NUMBER TEST ITEM . TITLE : Acute Flab Toxicity The Quality Assurance Unit inspected the performing of phases of this study and examined the study report . The head ofthe test facility was informed on the results of these inspections at the dates mentioned below . Date of stud lan inspec tion: Date of Areport: specification study plan 2007-05-04 Date of Ainspec

tion: Date of Areport : process-based inspection SOP 00001 2007-02-12 2007-02-12

Date of rt inspec

tion: Date of Areport : 

## -?00? - 0 E ~ -f3 02061 - 06 -'3 The results of this study have been examined on the basis of the valid SOPs and methods and we confirmthat, to the best ofour knowledge, the raw data have been stated correctly. Date: a26a~7- 06- f3 Quality Assurance Unit :



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### Study numbe Test Item CAS number p. 93 Page 5 of 17



### RESPONSIBLE PERSONNEL

Date / Signature



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### Study number Test Item CAS number p. 94 Page 6 of 17



### SUMMARY A study was performed to assess the acute toxicityV Danio rerfo under static conditions. The study was conducted in accordance with EECMethods for Determination of Ecotoxicity Annex to Directive 92169/EEC (O .J. No. L383A, 29

.12 .92) Part C, Method 1 'Acute toxicity for Fish' which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 'Fish, AcuteToxicity Test' . Groups often fish ofthe e ' were exposed to a limit test concentration of nominally 100 mg/L ' solved in water. Auxiliaries used to prepare the test medium

were an c a magnetic stirrer . Observations were made on the number of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 hours ofexposure. Thefollowing values were determined: Time LC SO [h] [mg/i .] 2 > 100 24 > 100 48 > 100 72 > 100 96 > 100 No toxic effects against fish at 100mg/L. 

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The test itemwas insoluble in water. After addition to water, it formed small lumps that did not disperse by stirring. Treatment in an ultrasonic bath resulted in black colouration of the aquariumcontent, indicating very fine dispersal of the test item . In the first hours of the test, fine flocs oftest itemformed and partly settled on the bottomof the test vessel . 

### The results are expressed in terms of nominal concentrations. The hardness of the dilution water used was 13.8 °dH(= 246mg/L CaC03) .

### Study number

Teat Item CAS number : INTRODUCTION p. 95 Page 7 of 17



### This report contains a descripti and the results obtained during a study to investigate the acute toxicity Danio rerio under static conditions . Acute toxicity is the discernible e ~nduced in an organism within a short time of exposure to an item

. In the present test, acute toxicity is expressed as the median lethal concentration (LC 50), that is the concentration in water which kills 50%of a test batch of fish within a continuous 96 hour period of exposure. In those cases where the slope of the concentration/percentage response curve is too steep to permit calculation of the LC 50, this value is estimated graphically . In items of minor toxicity (or low aqueous solubility) a limit test is performed at 100 mg/L (or at the limit of water solubility) in order to demonstrate that the LC 50 is greater than this concentration. 

### The study was commissioned 2007-05-04 and 2007-05-31(experm d undertaken between 

### -05-31) . 

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### p. 96 Page 8 of 17 

### Study number~ Test Item CAS number :

EXPERIMENTAL PROCEDURE The method described in the Council Directive 92l69/EEC (O .J. No. L383A, 29

.12.92) Part C, Method 1 'Acute toxicity for Fish' assesses the acute toxic effects (mortality) of various concentrations of a test item to a fieshwater ft species. The purpose of this method is to determine that concentration which causes a 50%mortality rate (= LC 50) or, if conducted as a limit test, to determine the acute toxic effects at a maximum

test concentration of 100 mg/L or at the limit ofwater solubility, respectively . A range-finding test may precede the main test It provides information about the range of concentrations to be used in the main test. In the main test, fish are exposed to the test itemadded to water at a range of concentrations for a period of 96 hours. Defined concentrations of the test item will lead to a certain percentage proportion of dead fish at the end of the 96 hour study period. Mortalities are recorded at 24-hour intervals. The LC 0 and the LC 100 are determined directly fromthe study, while the LC 50 is calculated or read fromthe concentration/percentage response curve. During the test a temperature range of 20 - 24°C is to be maintained in the test vessels, with a maximum

temperature fluctuation of +/- 1°C in each individual test. pH and oxygen values are measured at the beginning ofthe test and every 24 hours thereafter. The main test is either conducted as " static test in which no flowoftest solution occurs and solutions remain unchanged throughout the duration ofthe test 

### " semi-static test without flowof test solution, but with regular batch wise renewal of test solutions after 24-hour periods. " flow-through test in which the water is renewed constantly in the test vessels, the test chemical being transported with the water used to renew the test medium

. 

### The mortality in the controls should not exceed 10% by the end ofthe test The dissolved oxygen concentration must have been more than 60% of the air-saturation value throughout the study. The pH should not vary by more than 1 unit. 

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### Study number Test Item CAS number -0

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# MATERraLS ANDMETHODS Test item CAS number GASpreferred narne Chemical name Article number Batch Empirical formula Structural formula Page 9 of 17



### !

Molecular weight . ---- 

# PUBLIC COPY Putity : 95.8% Major impurities . ---- Water solubility : insoluble (according to data of the sponsor) Vapour pressure . ---- Chemical stability 

### in water and light . Stability of test concen tration/s during exposure :

### Study nam Test Item CAS number : MATERIALSAND METHODS Test spates p. 98 Page 10 of 17



### Name : Zebra fish (Danio rerio) Source : Aqua K18Ger (Germany) Date of birth . ---- Date supplied : 2007-02-13 Acclimatisation : Stock held since 2007-02-13 and acclimatised to the test conditions since then. Temperature: 20 - 24 °C Dissolved oxygen: > 5 mg/L 

### Feeding: Commercial fish food, daily.

Discontinued 24 h prior to tesL Mortalities during acclimatisation period <5% Medication: none Mean standard length (n = 20) : 3.3 cm (S.D . = 0.20 cm) Holdinn and dilndon water Reconstituted water prepared according to the recommendations of ISO 7346 . This fi+eshly prepared standard dilution water is used for both, the maintenance of the test animals under flow-through conditions and the preparation of stock and test solutions ofthe test item

. 

### The total hardness of the dilution water, measured at test start, was 13.8 °dH (= 246 mg/L CaCO3) . 

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9-3p. 99 Page 11 of 17 

### Study nuniber Test item CAS number : MATERIALS AND METHODS

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### To produce the only test concentration 500.3 mg of the test item were added to S litres ofdilution water, treated for 1 hour in an ultrasonic bath and afterwards stirred for 1 hour on a magnetic stIrra. Exposure conditions Test vessels : glass aquaria holding 5 L oftest media Experimental design : 1 test concentration plus 1 control 10 animals per test concentration no feeding during the exposure period static system Method of initiation . ani .mals were placed in prepared media Loading : 0 .57 g body weight (wet weight) per litre Photaperiod : 16 h light : 8 h dark Temperature : . mean +/-1 °C (in the temperature range 20 - 24 °C) Aeration : gentle aeration via narrow glass tubes Test itemconcentration/s : 100mg/L Method ofadministration . direct weighing Medium renewal : none Duration ofexposure : 96 hours Criteria ofeffects : The criterion of death used in this study was the absence of response to physical stimulation . In addition to observations on mortality at 2, 24, 48, 72 and 96 hours, subjective assessments were made on the type and incidence of sub-lethal effects compared with control fish. 

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### Study numbe Test Item CAS number p. 100 Page 12 of 17



### MATERIALS AND METHODS Applied SONand methnds SOP/ Method Function V SOP 00139Versionl Acute Fish test 2006-12-01 2030-1110601-03 D Hardness ofwater 2003-01-20 2030-0131703-03 D Determination of acid capacity 2003-01-27 2011-0479301-94 D Determination of metals- 1994-12-20 Deviations : No chemical analysis was performed,



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