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 PMN notification 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 form of the PMN substance 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 PROTECTION AGENCY 

A 

F P A ^."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 

c~~ . , ; _ : I 

',ES 

L~7 121 GENERAL INSTRUCTIONS Z'$ _ 0 u u Y 

. 539 

information 

Instructions 

corresponding 

Arm. 

You must provide all requested in this form to the extent that it is known to or reasonably ascertainable by you. Make reasonable estimates if you do not 

have actual data. 

Before you complete this form, you should read the "Instructions Manual for Premanufacture Notification" (the Manual is available from the Toxic 

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 CFR 700.45), indicate in the boxes above the TS-user fee identification number you have generated. Remember, 

your user fee ID number must also appear on your fee remittance, which is sent to EPA, HQ Accounting Operations Branch (PM-226), P.O . 360399M, 

Pittsburgh, PA 15251-6399, TSCA User fee. 

Part I- GENERAL INFORMATION 

confidential, 

You must provide the currently correct Chemical Abstracts (CA) Name of the new 

chemical substance, even if you claim the 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. 

Part II-HUMAN EXPOSURE AND ENVIRONMENTAL 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 form for 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 from later deviating from the information (except 

chemical identity) reported in the form 

CONFIDENTIALITY CLAIMS 

the 

confidential . you You 

also sanitized (including attachments) . 

You may claim any information in this notice as confidential. To assert a claim on 

form, mark (X) the confidential box next to the information that you claim as 

confidential. To assert a claim in an attachment, circle or bracket the information you 

claim as If claim information 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 AND OTHER 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 are related 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 §720.50 of the Premanufacture Notification Rule (40 CFR Part 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 

Form Approved. O.M.B . No. 2070-0012. 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) 

TMEA (Test Marketing Exemption Application) 

LVE (Low Volume Exemption) @ 40 CFR 723 .50(c)(1) 

LOREX (Low Release/Low Exposure Exemption) @ 40 CFR 723 .50(c)(2) 

LVE Modification 

: 20 

0 LOREX Modification 

IS THIS A CONSOLIDATED PMN? Yes 

# of chemicals 

(Prenotice Communication # required, enter # on page 3) 

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

Public reporting burden for this collection of information is estimated to average 110 hours 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 40 CFR 700.43 and has rVitted a fee of $100 in 

accordance with 40 CFR 700.45(b). 

If you are submitting a low volume exemption (LVE) application in accordance with 40 CFR 723.50(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. 

0 The manufacturer is familiar with the terms of this section and will comply with those terms ; and 

0 The 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 CFR 723.50(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 30 day 

review period . 

The accuracy of the statements you make in this notice should reflect your best prediction of the anticipated facts regarding the chemical substance 

described herein. An knowing and willful misinterpretation is subject to criminal penalty pursuant 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 2 
Part I -- GENERAL INFORMATION 

Section A -- SUBMTI'I'ER IDENTIFICATION 

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 a joint 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 

U.S .) X 

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 d PIvIN f hi b . y p y e a or t s su 

Mark (X) -1 ® 

stance enter the if none PMN number 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 Q the "Confidential" box next to an subsection ou claim as confidential 

p. 13 

Confidential 

EPA FORM 7710-25 (Rev. 5-95) Page 3 
p. 14 

Part I -- GENERAL INFORMATION -- Continued 

Section B -- CHEMICAL IDENTITY INFORMATION: You must provide a currently correct 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 item you claim as 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, comp any, and address of that person 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 4 
p. 15 
p. 16 
p. 17 
p. 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) below 500 and 

below 1,000 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) maximum weight % below 500 molecular weight: 

iii) maximum weight % below 1000 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 item you claim as 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 from CAS 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 5 
p. 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 mpurity. If there are unidentified impurities, estimate their total weight %. 

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 claim chemical 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 from the 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 6 
p. 20 

Part I -- GENERAL INFORMATION -- Continued 

Section C -- PRODUCTION, IMPORT, AND USE INFORMATION: 

Mark (X) the "Confidential" box next to an item you claim as 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, if you choose to have your notice reviewed at a lower production volume than 10,000 

k r, specify the volume and mark (x) in the binding box. If anted, you are bound to this volume 

Maximum first 12-month production (kg/yr) Maximum 12-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 polyester fibers) (2) (3) (4) (5) (6) (7) limited sumer trial mercial Option (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 new chemical 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 claim any 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 7 
p. 21 

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE 

Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER Mark (x) the "Confidential" box next to any item you 

claim as 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 processin g or use operations after import. You must describe these operations . See instructions manual 

1 . Operation description Confia. Identity -- Enter the identity of the site at which the operation 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 -- Complete 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 interim storage 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 form of the new chemical substance, 

number of works exposed, and duration of activity. Mark (X) the "Confidential" box next to any item you claim as 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 item you claim as 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 new substance 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 9 
p. 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 B for each type of processing, or use operation involving the new chemical substance . If the same operation is performed at more than one site describe the 

typ ical o peration common to these sites . Identi fy additional sites on a continuation sheet. 

1 . Operation Description -- To claim information in this section as confidential, circle or bracket the specific information that you claim as 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 diagram above, 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 form of 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 diagram above, 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 new substance to the environment. (14) -- Identify byproducts which may result from the 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 

o 

ActWorkers 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 

14) -- Byproducts: ' T 

(15) 

X 

L ® Mark (X) this box if you attach a continuation sheet, 

EPA FORM 7710-25 (Rev. 5-95) Page 10 
Page 10a 
p. 25 

OPTIONAL POLLUTION PREVENTION INFORMATION 

To claim information in this section as confidential circle or bracket the specific information that you claim as 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 PMN substance. 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 

examples. 

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 poses 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 11 
p. 26 

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 form a sanitized 

version of an attachment in which you claim information 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 form documentation 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 12 
p. 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 form a sanitized 

version of an attachment in which you claim information 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 

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

EPA FORM 7710-25 (Rev . 5-95) Page 12 
p. 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 for the neat (100% pure) chemical substance. 

Properties that are measured for mixtures or formulations should be so noted (% PMN substance in _). You are not required to 

submit this worksheet; however, EPA strongly 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) 

Measured o 

Estimate 

(Ivt or E) 

Conf 

dent' 

Marl` (x) 

(d) 

Physical state of neat substance (s) - (1) - ( ) 

Vapor pressure 

@ Temperature °C Totr 

Density/relative densit y cm3 

Solubility 

@ Temperature °C 

Solvent 

Solubility in water @ Temperature oc 9/L 

Melting temperature oc 

Boiling / sublimation tem erature@ torr pressure oc 

Spectra 

Dissociation constant 

Particle size distribution 

Octanol / water partition coefficient 

Henry's Law constant 

Volitalization from water 

Volitalization from soil 

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 

QUALITY ASSURANCE STATEMENT 4 

RESPONSIBLE PERSONNEL 

SUMMARY 

INTRODUCTION 

PUBLIC 

7 

EXPERIMENTAL PROCEDURE 8 

MATERIALS AND METHODS 

- TEST ITEM 

- TEST ORGANISM 10 

- SYNTHETIC SEWAGE FEED 10 

- STUDY CONDITIONS 11 

- APPLIED SOP 12 

RESULTS 

COMMENTS 

ARCHIVATION OF DOCUMENTS AND TEST 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 

QUALITY ASSURANCE 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 of of study plan inspection : Date of QA report: 

S stud 

*"i 

fifi 

cafton, 

peci cation study plan 

to of 

Date of A inspection: Date o 

0 -V 

Inspection of experimental phase 

Version 2 

Date of report inspection: Date of A rt: 

7 

The results of this study have been examined on the basis of the valid SOPs and we confirm 

that, to the best of our knowledge, the raw data have been stated correctly. 

PUBLIC COPY 

Quality Assurance Unit: 
Study number 

Test item 

CAS number : - 

RESPONSIBLE PERSONNEL 

Date / Sipature 

page 5 of 21 

PUBLIC COPY 
p. 34 

Study number ] 

Test Item 

CAS number : 

A study was performed to assess the toxicity 

SUMMARY 

bacteria. 

The study was conducted in accordance with the Commission Directive 881302/EEC ; Official 

Journal of the EG L133 Part C.11(19 

The activated sludge was exposed different concentrations. The 

respiration rate of each mixture was aerathon periods of 3 hours. 

showed 19.6 % respiration inhibition of activated 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 of the EG L 133 Part C.11 (1988). This test method is in most parts identical with 

OECD Guideline 209. 

The method assesses the effect of a test item on microorganisms by measuring the respiration 

rate under defined conditions in the presence of different concentrations of the test item. 

The purpose of this 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 of a test item on microorganisms by measuring the 

respiration rate under defined conditions in the presence of different concentrations of the test 

item. The method is based on that described by ETAD (Ecological and Toxicological 

Association of the Dyestuffs Manufacturing Industry), in which activated sludge obtained 

from a sewage treatment plant is used as the microbial source. 

The purpose of this test method is to provide a rapid screening method whereby substances 

which may adversely affect aerobic microbial treatment plants can be identified, and to 

indicate suitable non-inhibitory concentrations of test items to be used in biodegradability 

tests. 

A range-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 item are included in the test design, one at the start and the other at 

the end of the test series. Each batch of activated 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 of the test item is additionally tested without activated sludge. 

The respiration rate of the activated sludge is measured after a contact time of 3 hours. The 

respiration rate of the same activated sludge in the presence of various concentrations of the 

test item, under otherwise identical conditions, is also measured. The inhibitory effect of the 

test item at a particular concentration is expressed as a percentage of the mean of the 

respiration rates of two controls. An EC50 value is calculated from the respiration rates at 

different test item concentrations . 

PUBLIC COPY 
Study number ~ 

Test Item 

CAS number : --- 

MATERIALS AND METHODS 

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 of the sponsor) 

Vapour pressure 

Chemical stability 

in water and light 

Stability of test 

concentration/s 

during exposure 

page 9 of 21 

PUBLIC COPY 
p. 38 

Study number 

Test Item 

CAS number : 

MATERIALS AND METHODS 

TEST ORGANL4M AND SYNTHETIC SEWAGE FEED 

page of 21 

Type . mixed population of aquatic microorganisms 

(activated sludge) 

Ario;  . 

Date of collection A"* 

~~~~t . aeration of the activated sludge, 

daily fed with synthetic medium 

pH of the suspension before 

application 6.6 

Synthetic sewage feed . A synthetic sewage feed is nude by dissolving 

the following amounts of substance 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 of the synthetic sewage feed . 7.5 .+0.5 

PUBLIC COPY 

,~-3 

aaradon tank of a 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 

in physico-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 of application . direct weighing 

Test concentration of the 

activated sludge . 840.0 mglL suspended solids 

Test temperature . 20 t 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 of the test item is additionally tested 

without activated sludge . 

r y 
p. 40 

page 1 oT~l 

Study number :' 

Test item ~. 

CAS number : --- 

MATERIALS AND METHODS 

APPLIED SOP 

SOP-No. Function Validity 

2030-660050402 D Toxicity to bacteria 2002-08-19 

Deviations from the SOP with reasons : none 

PUBLIC COPY 
p. 41 

Study number 

Test Item 

CAS number : --- 

RESULTS 

Oxygen content temperature, and pH values 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 7.6 

Physicochemical oxygen 10000 6.5 6.5 8 21 .7 7.7 

consumption 

control 

Comments: The test item has been added to about 130 mL deionized water and 

stirred overnight before testing (equilibration phase). 

Start of stirring period of test item : 2.30 p.m 

End of stirring period of test item : 6.30 a.m. 

PUBLIC COPY 
Study number : 

Test Item 

CAS number : 

p. 42 

PB S e O 

RESULTS 

Oxygen content, temperature, and pH values during exposure phase (reference substance) 

Test O, start O, end Time Temp. pH 

concentra 

don [mg O=/L] [mg O,/L] end) [°C] 

[MR/L1 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 item concentrations. 
Study number : 

Test item 

CAS number : --- 

RESULTS 

Reference substance : 3.5-Dichlorophenol 

p. 44 

pageof 21 

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 from the 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 item concentration 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 of the 2 controls differ less than 15 % 

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

- ECso of the reference substance 3.5-dichlorophenol is in the range 5 - 30 mg/L 
Study number 

Test item is 

CAS number : --- 

.47 

page 19 o 21 

PUBLIC COPY 

ARCHIVATION OF DOCUMENTS AND TEST ARTICLES 

raw data, and final reports are archived in the GLP arc , _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 of the test item used where sampling has not been 

performod b 
Study number 

Test 

CAS 

Item 

number V&i~ 

: --- 

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 EC values are determined by probit analysisIn 

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 

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wnq,w.,roe.qn r e~wrarn wrrr+.n WSM" .r+~ a~ ..wr w" 

i 
p. 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 

GLP DECLARATION 3 

QUALITY ASSURANCE STATEMENT q 

RESPONSIBLE PERSONNEL 

SUNIIViARY 

7 INTRODUCTION PUBLIC Cop EXPERIIVIENTAL PROCEDURE y g 

MATERIALS AND METHODS 

TEST ITEM 

TBST ORaANI.4M 10 

MINERAL MEDIUM 11 

PRETREATMENT OF THE TEST IrEM 12 

REFEREwcE coMPourm 12 

EXPOSURE CONDMONS 12 

CHEMICAL ANALYSIS 13 

APPLIED SOPS AND METHODS 13 

RESULTS 1419 

COMMENTS 19 

DEGRADATION CURVES 20 

ARCHIVATION OF DOCUMENTS AND TEST ARTICLES 21 

GLP CERTIFICATE 22 
p. 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 Law on Hazardous Substances (German Chemicals Law _ 

according to the respective valid issue). 

Date / Signature 

Study director 

2006-11-21 

page 3 of 22 

PUBLIC COPY 
p. 53 

2006-11-21 

page 4 of 22 

Study number 

Test Item 

CAS number 

QUALITY ASSURANCE 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 of stud plan inspection : 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 inspection : Date of report: 

Mj1g@jMji 

.9- 006 ~I1-I-2CF 

The results of this study have been examined on the basis of the valid SOPs and methods and we 

confirm that, to the best of our knowledge, the raw data have been stated correctly. 

Date: ,,20f7 6 ~ W f' ;? -0 / Quality Assurance Unit: 

PUBLIC COPY 
p. 54 

Study number " 

Test Item 

CAS number : - 

RESPONSIBLE PERSONNEL 

Date / Signature 

2006-11-21 

page 5 of 22 

Study Director 

( 

"RYMOMM vMMwMdvMw_ 

77 

PUBLIC COPY 
p. 55 

Study number : 

Test item 

CAS number : 

2006-11-21 

page 6 of 22 

SUMMARY 

A study 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. 

A solution o a mineral medium was inoculated and incubated for 28 d 

under aerobic co . risgtfiis period, degration was followed by BOD determinations. 

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 COPY 
p. 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. 

A measured volume of inoculated mineral medium, containing a known concentration of the test 

item (usually 100 mg/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 of oxygen (BOD) was determined by measuring the quantity of oxygen 

(produced electrolydcally) required to maintain constant gas volume in the respirometer flask. 

Evolved carbon dioxide was absorbed in a solution of potassium hydroxide. The amount of 

oxygen taken up by the test item (corrected for uptake by blank inoculum, run in parallel) was 

expressed as a percentage of theoretical 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 COPY 
p. 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. 

A suspension of 100 mg/L test item in a mineral medium was inoculated and incubated under 

aerobic conditions in the dark. The endogenous activity of the inoculum was checked running 

parallel blanks with inoculum but without test item. A reference compound (sodium benzoate) 

was run in parallel to check the operation of the procedures. 

A toxicity control (test item and reference compound mixed) was run in parallel, to ensure that 

the chosen concentration of the test item was not inhibitory to microorganisms . 

Degradation was followed by the determination of oxygen 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 of the mixed bacterial populations used as inoculum, 

determinations were carried out at least in duplicate. 

The oxygen uptake was calculated from the readings taken at regular and frequent intervals, 

using the method given by the manufacturer of the equipment. At the end of incubation, the pH 

of the contents of the flasks was measured. 

Start of the incubation period . 2006-10-05 

1 End of the incubation period . 2006-11-02 PUBLI COPY 
p. 58 

Study number 

Test Item 

CAS number : -- 

Test item 

MATERIALS AND METHODS 

CAS number 

CAS preferred name . ----

Chemical name : 

Article number . -- 

Batch 

Empirical formula . 

Structural formula . 

Molecular weight _ ---- 

2006-11-21 

page 9 of 22 

Purity : 95.8% 

Major impurities , .--- 

Water solubility : unsoluble (according to data of the sponsor) 

Vapour prmsnre 

Chemical stability 

in water and light 

Stability of test , ----

concentration/s 

during exposure PUBLIC Copy 
p. 59 

Study number : 

Test Item 

CAS number : 

2006-11-21 

page 10 of 22 

MATERIALS AND METHODS 

Test ora_anisms 

Type : mixed population of aquatic microorganisms 

(activated sludge) 

Origin : aeration tank of a wastewater plant treating 

predominantly domestic sewage 

(Wupper area water authority, ST? Odenthal) 

Date of collection 2006-10-02 

Concentration of inoculum : 30 mg/L ss 

Pro-treatment of the inoculum : - the sludge was washed twice by adding mineral 

medium, centrifuging (15 min at 4500 rpm and 20 °C) 

and decanting off the supernatant 

- 0.726 g of the wet sludge was dried in order to calculate 

the amount of wet sludge to achieve a concentration of 

activated sludge of 3 g/L (dry wet) suspended solids 

- the calculated amount of sludge 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 COPY 
p. 60 

Study number ~ 

Test item 

CAS number : 

2006-11-21 

page 11 of 22 

MATERIALS AND METHODS 

Mineral medium : The mineral medium was prepared from stock solutions of 

mineral components described as follows. 

1 . Mineral salt solution : Potassium dihydrogen phosphate (KHzP04) 85.0 g 

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 ' 6 H20) 0.25 g 

The substance was dissolved in deionised water and filled 

up to 1 litre . 

To prepare the mineral medium 10 mL of the mineral salt solution were mixed with 

800 mL 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 aluminium foil. Test item and aluminium foil 

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 100 mg 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 250 mL with mineral medium containing 

inoculurn to give a test concentration of 100 mg reference compound /L. 

Exposure conditions 

Test volume 

Test apparatus 

Mixing 

Incubation time 

Incubation temperature 

250 mL 

Oxi Top System (WTVIT) 

1 magnetic stirrer per test vessel 

28 days 

22 t 2°C 

PUBLIC COPY 
p. 62 

Study number : 

2006-11-21 

page 13 of 22 

Test item 

CAS number 

MATERIALS AND METHODS 

Chemical ans,ivsis 

COD 

Method : Determination of Chemical Oxygen Demand of solids and 

substances which am not water-soluble (COD). 

Calibration Standard : Potassium hydrogen 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 of Chemical Oxygen Demand 2000-12-18 

of solids and substances which are not water 

soluble 

Deviations : As a deviation from SOP 2030-6600306-02 D the 

experiment was performed with the "OxiTop" device of 

WTW company instead of the "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 compound 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 days 

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 COPY 
p. 65 

Study number 

Test Item 

CAS number 

RESULTS 

Degradation of test item 

Test concentration 

Empirical formula 

Molecular weight 

Chemical oxygen demand 

(analytically 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: none 
p. 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 

s1 
p. 67 

Study number : 

Test Item " 

CAS number : 

2006-11-21 

page 18 of 22 

RESULTS 

Toxicit,y control 

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 item did 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 of the test item was observed in the toxicity control. 

At the end of the test, biodegradation (%) in parallels with test item did not differ by more than 

20 percentage points . 

The oxygen uptake of the inocuhun blank was 5 60 mg/L. 

In cases where the degradation was :5 60 %, the pH was between 6.0 and 8.5 at the end of the test 

(and thus poor degradation was not caused by the pH). 
p. 69 

Study number 

Test item 

2006-11-21 

page 20 of 22 

CAS number : 

DEGRADATION CURVES 

-+-a.r.~.b. 

--F r..a .M 

PUBLIC COPY 
p. 70 

Study number : 

2006-11-21 

page 21 of 22 

Test item 

CAS number : 

ARCHIVATION OF DOCUMENTS AND TEST ARTICLES 

Study plans, raw data and final reports hived in the GLP archiv 

Test articles are archived 4110MMW -

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 customer le of the test item used where sampling has not been 

performed 1 

PUBLIC COPY 
p. 71 

Study number 

Test Item 

CAS number : 

2006-11-21 

page 22 of 22 

GLP CERTIFICATE 

PUBLIC CO t 

Or Umwelt nod NdwvdwM . t.mdwir4chaR imd 

ValxauchmacMnz 

des Tandem NoAheiwWathim 

IM. law~ aY .arrva.n .u .ur 

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ou~aaeYe~hwdwa..w~ of ov e..piYn.. 

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-how QMddWPMHdVAlftKWMW* 

!"AYlO owth "wwO~lIN 

® "Ib 

arrry 

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rararrwata, up~r~ Yww"a.Yw~w.tso" m.rw~ 

lmlyrr t a

. 

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~Y~+rw Y~" 

wor,"4 

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A~irrw wI ~~d» Yn/ Yw~llldn IYiwrY a~ll~ 

ItrqoiY " arpry " 

r tYIIm le~ wArb Y~ w.rnnr Y waw.~ YIwr~Y~ wr, w.,a,r, 

&=A= ar wsdlurrlm und r Ww.iem 

uwwft" or,W,~ " 

MeAwrrdwwe.~wewdr~MwrYUn wwr".d MW ae"rd.w" r." 

t)dtim d" r Inmp"mun Dab d IYrp"ellan 

a..r.w" w..+s..n 

u. a. It s.pwmn.r on 14 urww 1e a.orrmew .ea an se ww sa 

told 21L Ws 2!. OIAObW 3M6 CCIO4M1006 

oY ----- NwY1~r"qe,lrr rorY~ .rrrftn nYrw.nwrdrMioYYSmwY"Ymtir 

BMI 

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Ad OW o~niy~ d. Yp~r~ldw VAd IlWi i~IwbY~~on~r"w~0~~/iw{ hIFY 

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OriiYY~4~Y1 

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w~AMR 

s6 
p. 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 

- APPLIED SOPS AND METHODS 

RESULTS 

COMMENTS 

ARCHIVATION OF DOCUMENTS AND TEST ARTICLES 

GLP CERTIFICATE 

Page 

3 

4 

5 

PUBLIC COPY ; 

8 

9 

9 

10 

10 

11 

11 

12 

13 

15 

16 

17 
p. 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 COPY 
p. 75 

Study number : 

Test item 

CAS number : 

December 18, 2006 

Page 4 of 17 

ptg 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 of study plan inspection: Date of A rt : 

specification study plan 

November 10, 2006 200 6 - 114 ---t 0 

Date of A i tion : Date of A report: 

process-based inspection 

SOP 00001 

August 15, 2006 ~00 6 - D Cr - /4S 

Date of r port inspection : Date of A report: _ 

,Zons-,~z-,~9 .Zoo 6 -~~-'9 

The results of this study have been examined on the basis of the valid SOPs and methods and 

we confirm that, to the best of our knowledge, the raw data have been stated correctly. 

Date: ~Od 6 -/! .~ ~ I 9 Quality Assurance Unit: 

60 
p. 76 

Study number 

Test Item 

December 18, 2006 

Page 5 of 17 

CAS number : 

RESPONSIBLE PERSONNEL 

Date / Signature 

-- , 

Study Director 

cc Utit 

PUBLIC COPY 
p. 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 ECSO Acute 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 a magnetic stirrer. 

Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure . The following values were determined: 

Tlme EC 50 

(bI [Mg/L] 

24 > 100 

48 > 100 

No toxic effects against daphnia at 100 mg/L. 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 of the flask content, indicating very fine dispersal of the test item. In the first hours of the test, fine flocs of test item formed and partly settled 

on the bottom of 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. 

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

The hardness of the 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 100 mg/L (or at the limit of water 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 COPY 
p. 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 item will lead to a 

certain percentage proportion of immobilized Daphnia at the end of the 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 maximum temperature fluctuation of +/- 1°C in 

each individual test. pH and oxygen values are measured at the end of the test . 

The main test is either conducted as 

" static test in which no flow of test solution occurs and solutions remain unchanged 

throughout the duration of the test 

" semi-static test without flow of 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 COPY 
p. 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 : ---- PUBLIC COPY 
p. 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 from their 

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 COPY 
p. 82 

Study number 

Test Item 

CAS number : 

December 18, 2006 

Page 11 of 17 

MATERIALS AND METHODS 

Pre-treatment of the teat item 

To produce the desired test concentration 105.1 mg of the test item were added to 

1 litre of dilution water, treated with an ultrasonic bath for 1 hour and stinsed for 

1 hour on a magnetic stirrer. 

Exposure conditions 

Test vessels 

Experimental design 

Method of initiation 

Photoperiod 

Temperature 

Aeration 

Test item concentration/s 

Method of administration 

Medium renewal 

Duration of exposure 

Criteria of etffects 

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 

67 
p. 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 of water Jan. 20, 2003 

Deviations : No chemical analysis was performed. 

PUBLIC COPY 
p. 84 

Study num 

Test Item 

CAS number 

RESULTS 

Test item concentration [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 COPY 
p. 85 

Study number 

Test Item 

December 18, 2006 

Page 14 of 17 

CAS number : 

RESULTS 

Test item concentration (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 COPY 
p. 86 

Study number 

CAS 

Item 

number 0 -: -- Mob 

RESULTS 

Analysis of the 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 of the 

flask content, indicating very fine dispersal of the test item. In the first hours of the test, fine 

flocs of test item formed and partly settled on the bottom of 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 COPY 
p. 87 

Study number 

Test item 

CAS number 00 

December 18, 2006 

Page 16 of 17 

ARCHIVATION OF DOCUMENTS AND TEST 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 customer ug a1jQM~a sample of the test item used where sampling has not been 

performed - 

PUBLIC COPY 
p. 88 

Study number 

Test item 

CAS number : 

December 18, 2006 

Page 17 of 17 

GLP CERTIFICATE 

for Umwelt md NahaschWz, Landwihecha8 und 

Vabnuc6ascMufz 

dea Lwdd No*fiein-Watfabn 

r:r+r .w ~ arw.t ~w.r+s wan.os~r 

o.w L.r. .pr..ldn.d Laboratory Prow"a 

aLP"nwr.iaiwsNtaumert .f GLP crwMi"ftr 

s~ a~wwrn r u~wa~.~ ~ aw+w s ~.r.r.r.4w,r air.r+r,w 

wbrioo.wwwMrrw r 

aK~a, " 

FroAuqm ndl K.homYe N. .. a 6o"W. 

,wa~ .wwar~.usaew.r w..wo.wwa~.».uaes..r~ 

wrrr+ rw"r+ 

AOluW aN ftelikowwN dor /OV+M1dMOM No" 

d~r11rC11w1 ~wall~l~ YII~ Orl~r~lll~I~w 

OrWaboriirpr0lwPnarYYwwwArr wMawmYInr4sYoiir on eyuellawal 

hwYYwP~Ow~rnMwewYroa IrsYYa~rYr~r 

Op~~lww 

IwOqOib f " arwY~/ s 

PRYIMY17w0 V&IIWrI lm Ydr4 YoYriivt ur Yn WWnmbMwXrI h aCW wn0 air 

dw l&M FIIk/Ipen /Y YOadaAnwhiloll w10 S/ MO/OwAI~ 

u.rosrI e~woo~ra 

ArNYwI" h0luW m bld81 - w~ LYIWIYre rw1Yd1 ow ddnl ~wYY~ WIYp 

AM1111 dK kMp"011 D/b CI IMp~C11011 

pywnarn ft--@4-4 

14. EI,1e. a.p.nbn on ts un111e a .p .ee.r .na on 2e un112e 

und 40. bb 7!. OUblw 2006 October 2005 

w nr.ra+war~+r+aw~rrrw t~.rrw .rrrrrrqrirrrwr.~rrr 

pV0 A~Ya wd id ngdwlw w1 Q1dn~bw~hero s~rY~elda~wpd~ 

Fyy~~y~~ at Y1r. 

Ad do anw~ w wp~wrr~rldiw +M M." Nw+aft ~rw- malmwmemmaoom 

e

~

.rrK arr~u~ .w~ .a~ rr nwrw~w~I a, ,um rrarrrrua~r.wiw~rw.w.rwrrr 

.~ rr a~rwi rr au. mw~.+rr.n~+,r.~ar. 

IresgYesNNIM to § t9r Are. t ChowILdheMNo1s) 

PUBLIC COPY 

~'f^.:3~ 

73 
PUBLIC COPY 

ACUTE FISH TOXICITY 

Sponsor: e s 5 Iacllity: 
Stady namber 

Test Item 

CAS number : - - 

CONTENTS 

p. 90 

Page 2 of 17 

Page 

OLP DECLARATION 3 

QUALITY ASSURANCE STATEMENT 4 

RESPONSIBLE PERSONNEL 5 

SUMMARY 6 

INTRODUCTION 7 

EXPERII4ENTAL PROCEDURE 8 

MATERIALS AND METHODS 9 

- TEST ITEM 

- TEST spEcms 

- HOLDING AND DILUTION WATER 

- PRE-TREATMENT OF THE TEST ITEM 

- EXPOSURB CONDITTONs 

- APPLIED SOPS AND METHODS 

9 

10 

10 

11 

11 

12 

RESULTS 13 

ARCHIVATION OF DOCUIVIENTS AND TEST 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 

QUALITY ASSURANCE 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 of the test facility was informed on the results of these inspections 

at the dates mentioned below. 

Date of stud lan inspection: Date of A report: 

specification study plan 2007-05-04 

Date of A inspection : Date of A report : 

process-based inspection 

SOP 00001 

2007-02-12 

2007-02-12 

Date of rt inspection : Date of A report : 

-?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 confirm that, to the best of our knowledge, the raw data have been stated correctly. 

Date: a26a~7- 06 - f3 Quality Assurance Unit: 

77 
Study numbe 

Test Item 

CAS number 

p. 93 

Page 5 of 17 

RESPONSIBLE PERSONNEL 

Date / Signature 

PUBLIC COPY 
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 EEC Methods 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, Acute Toxicity Test'. 

Groups of ten fish of the 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 of exposure. The following 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 100 mg/L. 

PUBLIC COPY 

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 of the 

aquarium content, indicating very fine dispersal of the test item. In the first hours of the test, 

fine flocs of test item formed and partly settled on the bottom of the test vessel . 

The results are expressed in terms of nominal concentrations . 

The hardness of the dilution water used was 13.8 °dH (= 246 mg/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). 

PUBLIC COPY 
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 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, fish are exposed to the test item added 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 from the 

study, while the LC 50 is calculated or read from the 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 of the test and every 24 hours thereafter. 

The main test is either conducted as 

" static test in which no flow of test solution occurs and solutions remain unchanged 

throughout the duration of the test 

" semi-static test without flow of 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 of the 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. 

PUBLIC COPY 
p. 97 

Study number 

Test Item 

CAS number -0 ---- 

MATERraLS AND METHODS 

Test item 

CAS number 

GAS preferred 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 : 

MATERIALS AND 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 

of the test item. 

The total hardness of the dilution water, measured at test start, was 13.8 °dH 

(= 246 mg/L CaCO3). 

PUBLIC COPY 

9-3 
p. 99 

Page 11 of 17 

Study nuniber 

Test item 

CAS number : 

MATERIALS AND METHODS 

Prer-treatment Of the test item 

To produce the only test concentration 500.3 mg of the test item were added to 

S litres of dilution 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 of test 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 item concentration/s : 100 mg/L 

Method of administration . direct weighing 

Medium renewal : none 

Duration of exposure : 96 hours 

Criteria of effects : 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. 

PUBLIC COPY 
Study numbe 

Test Item 

CAS number 

p. 100 

Page 12 of 17 

MATERIALS AND METHODS 

Applied SON and methnds 

SOP / Method Function V 

SOP 00139 Versionl Acute Fish test 2006-12-01 

2030-1110601-03 D Hardness of water 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, 

PUBLIC COPY