# TSCA NON-CONFIDENTIAL BUSINESS INFORMATION DOCUMENT DESCRIPTION DOCUMENT CONTROL NUMBER DATE RECEIVED



### COMMENTS: 

# DEC LASS

DOUS NOT CONTAIN CBI

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460 OFFICE OF ~ PRO~CHEMICAL SAFETY AND POLLUTION PREVENTION 

## Notice of Change inCBI Chemical Identity Status Pre-Manufacture Notice (PMN) P-99-0669 Notice of commencement (NOC) received: 12/22/1999 Please be advised that the Confidential Business Information (CBI) claim for the above referenced substance was dropped by the information submitter inthe NOC. The identified non-confidential chemical name for this substance as provided in the NOC is: OXIRANE, METHYL-, POLYMER WITH OXIRANE, MONO(3,5,5- TRIMETHYLHEXYL)ETHER The current TSCA Inventory name is Oxirane, 2-methyl-, polymer with oxirane, mono(3,5,5-trimethylhexyl) ether CASRN: 204336-40-3

This notice as submitted to the NCIC files on 9/1/2011 Name of staffer: Jeffrey Santacroce Position: Asst. NOC Coordinator Branch: RDMB/IMD/OPPT/OCSPP 

# CONTAINS NO CB1____________________________________________________ Form Approved. 0.MB. No. 2070-0012. Approval Expires 10-31-96. U.S. ENVIRONMENTAL PROTECTION AGENCY AGENCY USE ONLY Date of receipt

~



# EPA FORPREMANUFACTURE 

## SntzdTI75 FRNEW CHEMICAL SUBSTANCES DOCUMENT CONTROL OFFICER 

## CompanySaize OFFICE OF POLLUTION PREVENTION AND TOXIC SUBSTANCES, 7407 U.S. E.P A. 401 M STREET, SW 

## ii i ~~k WASHINGTON, D.C.,06, Enter the total number of pa~ges 175 Docu. et control number PA case numb r in the Premanufacture Notice I 

## O--r P 7 GENERAL INSTRUCTIONS 

### TS -j"1jCLjC~jS 

### j0 ' 

## " You must provide all information requested in this form to the extent that it is known to or reasonably ascertainable by you. Make reasonable estimates ifyou do not have actual data. " Before you complete this form, you should read the "Instructions Manual for Premtanufacture Notification" (the Instructions Manual is available from theToxic 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 corresponding fee remittance, which is sent to EPA, HQ Accounting Operations Branch (PM-226), P.O. 360399M, Pittsburgh, PA 1525 1-6399, Attn. TSCA User fee.
Part I- GENERAL INFORMATION TEST DATA AND OTHER DATA You must provide the currently correct Chemical Abstracts (CA) Name ofthe new You are required to submit all test data in your possession or control and to provide a chemical substance, even ifyou claim the identity as confidential You may authorize description of all other data known to or reasonably ascertainable by you, if these another person to submit chemical identity information for you, but your submission will data arc related to the health and environmental effects on the manufacture, not be complete and the review will notbegin until EPA receives this information. A processing, distribution in commerce, use, or disposal ofthe new chemical letter in support of your submission should reference your TS user fee identification substance. Standard literature citations may be submitted for data in the open number. You must submit an original and two copies ofthis notice including all test data. If you clainmed any information s confidential, a single sanitized copy must also be scientific literature. Complete testdata (written inEnglish), not summaries ofdata, submitted. must besubmitted if they donotaooear inthe openliterature. You should clearly identify whether test data is on the substance or on an analog. Also, the chemical composition ofthe tested material should be characterized Following are examples Part RI - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE oftest data and other data. Data should be subitted according to the requirements of §720.50 ofthe Premanufacture Notification Rule (40 CFR Part720). Ifthere are several manufacture, processing, or use operations to be described in Part 11, sections A and B of this notice, reproduce the sections as needed.
Part IlIl- LIST OFATITACHMENTS Test Data (Check Below any included in this notice) Attach additional sheets ifthere is not enough space to answer a question fully. Label *Environmental fate data 0 Yes *Other data [: Yes each continuation sheet with the corresponding section heading. In Part III,tist these attachments, any test data or other data and any optional information included in the *Health effects data 0 Yes Risk assessments notice. *Environmental effects data 0 Yes Structure/activity relationships * Physical/Chiemical Properties* 0 Yes Test data not in the possession OPTIONAL INFORMATION or control of the submitter You may include any information that you want EPA to consider in evaluating the new *A physical and chemical properties worksheet is located on the last page ofthis form. substance. On page II of this form, space has beenprovided for you to described pollution prevention and recycling information you may have regarding the new TYPE OFNOTICE (Check Only One) substance. So-called "binding" boxes are included throughout this form for you to indicate your PMN (Premanufacture Notice) willingness to be bound to certain statements you make in this section, such as use, production volume, protective equipment.. . This option is intended to reduce delays Li INTERMEDIATE PMN (submitted in sequence with final product PMN) that routinely accompany the development of content orders or Significant New Use Rules. Except in the case of exemption applications (such as TMEA, LyE, LOREX) r where certain information provided in such notification isbinding onthe submitter when SNUN (Significant New Use Notice) the Agency approves the exemption application, checking a binding box in this notice t.0~ does not by itself prohibit the submitter from later deviating from the information (except L TMEA (Test Marketing Exemption Application) chemical identity) reported in the form ED LVE (Low Volume Exemption) @4 40 CFR 723.50(c)(1) j~ CONFIDENTIALITY CLAIMS 

## D LOREX (Low Release/Low Exposure Exemption) @40 CFR 723.5d (2) You may claim any information in this notice as confidential. To assert a claim on the form mark (X) the confidential box next to the information that you claim as mr confidential. To assert a claim in an attachment, circle or bracket the information you L.J LVE Modification ~ j LOREX Modification< claim as confidential. Ifyouclaim information inthenotices asconfidential. you must alsoprovide asanitized version ofthenotice.(includinizattachments). For additional ISTHIS A CONSOLIDATED PMN? 

## L Yes instructions on claiming information as confidential, read the Instructions Manual. # of chemicals

_________ 

### Z Mark (x) if any information in this notice is claimed as confidential. (Prenotice Communication #required, enter # on page 3) EPA FORM 7710-25 (Rev. 5-95) Replaces previous editions of EPA Form 7710-25.Public reporting burden forthis collection ofinformation 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 ofinformation. Send comments regarding the burden estimate or any other aspect ofthis collection ofinformation, 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 ofManagement and Budget, Paperwork Reduction Act (2070-00 12), Washington, D.C. 20503. CERTIFICATION Icertify that to the best ofmy knowledge and belief: 1 . The company named in Part 1,section A, subsection Ia ofthis 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 1, Section B. 2. All information provided in this notice is complete and truthful as ofthe date ofsubmission. 3. 1am submitting with this notice all test data in my possession or control and a description ofall other data known to or reasonably ascertainable by me as required by §720.50 ofthe Premanufacture Notification Rule.
Additional Certification Statements: If you are submitting a PMN, Intermediate PMN, Consolidated PMN, or SNUTN, check the following user fee certification statement that applies: Z The Company named in Part 1,Section A has remitted the fee of $2500 specified in 40 CFR 700.45(b), or



## LIThe Company named in Part 1,Section A has remitted the fee of $1000 for an Intermediate PMN (defined@ @40 CFR 700.43) in accordance with 40 CFR 700.45(b), or 

## LiThe Company named in Part I Section A is a small business concern under 40 CFR 700.43 and has remitted a fee of$100 in

accordance with 40 CFR 700.45(b). Ifyou 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:



## LIThe manufacturer submitting this notice intends to manufacture or import the new chemical substance for commercial

purposes, other than in small quantities solely forresearch and development, under the terms of40 CFR 723.50. 

## LIThe manufacturer is familiar with the terms ofthis section and will comply with those terms; and 

## LIThe new chemical substance forwhich the notice is submitted meets all applicable exemption conditions. 

## LIIfthis application is for an LVE in accordance with 40 CFR 723.50(c)(1), the manufacturer intends to commence

manufacture ofthe exempted substance for commercial purposes within Iyear ofthe date ofthe expiration ofthe 30 day review period.
The accuracy ofthe statements you make in this notice should reflect your best prediction of the anticipated facts regarding the chemical substance described herein. Aqxkowing and willfullmisinterpretation is subject to criminal penalty pursuant to 18 USC 1001. Confidential Signature andWttf tho ffc ~al au equired) Date R s4 ait an e ft Etnvironmental Compliance Signature of agent (if appicable) Date

EPAFORM7710O25 (Rev. 5-95) Page 2PartI -- GENERAL INFORMATION

Section A -- SUBMITTER IDENTIFICATION ConfiMark ()the "Confidential" box next to any subsection you claim as confidential dential l a Person Name ofauthorized official Position Submitting Notice (inU.S.) Russell B. Mait Manager, Environmental &Safety Compliance Company Goldschmidt Chemical Corporation Mailing address (number and street)

P.O. Box 1299, 914 E. Randolph Rd. City, State, ZIP Code

Hopewell, VA 23860 b. Agent (if Name ofauthorized official Position applicable) Company Mailing address (number and street) City, State, ZIP Code Telephone Area Code Number

c. Ifyou are submitting this notice as part of ajoint submission, mark (X) this box 

## ) I Joint Submitter (if Name ofauthorized 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 (inI U.S.) Russell B. Mait Manager, Environmental &Safety Compliance Company Goldschmidt Chemical Corporation Mailing address (number and street) P.O. Box 1299, 914 E.Randolph Road City, State, ZIP Code Telephone Area Code Number Hopewell, VA 23860 800 446-1809 3. Ifyou have had a prenotice communication (PC) concerning this notice and EPA assigned a PC Number to the notice, enter the number Mark (X) -0 ifnone 4. Ifyou previously submitted an exemption application for the chemical substance covered by this notice, enter the exemption number assigned by Mark (X)

- * EPA. If you previously submitted a PMN for this substance enter the inn PMN number assigned by EPA (i.e withdrawn or incomple-i nn 5. Ifyou have submitted a notice ofBona fide intent to manufacture or import for the chemical substance covered by this notice, enter the notice number Mark (X)

. - * assigned by EPA. ifnone 1. E: Manufacture 2 Import 6. Type ofNotice - Mark (X) Only Only 3. Both 

## D] Binding Option 

## D Binding Option Mark WX EPA FORM 7710-25 (Rev. 5-95) Page 3Part I -- GENERAL INFORMATION -- Continued Section B-- CHEMICAL IDENTITY INFORMATION: You must provide acurrently correct Chemical Abstracts (CA) name ofthe substance based on the ninth Collective Index (9Cl) ofCA nomenclature rules and conventions Mark (X) the "Confidential" box next to any item you claim as confidential Complete either item I (Class I or 2 substances) or 2 (Polymers) as appropriate. Complete allI other items. Ifanother person will submit chemical identity information for you (for either Item I or 2), mark (X) the box at the right. ConfiIdentify' the name, company, and address ofthat person in a continuation sheet. ~J dential I.Class 1or 2 chemical substances (for definitions of class I and class 2 substances, see the Instructions Manual)

a. Class ofsubstance - Mark (X) 1 0 Class I or 2 Z Class 2 X b. Chemical name (Currently correct Chemical Abstracts (CA) Name that is consistent with TSCA Inventory listings for similar substances. For Class I substances a CA Index Name must be provided. For Class 2 substances either a CA tndex Name or CA Preferred Name must x be provided, which ever is appropriate based on CA 9C1 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). Z Method 1(CAS Inventory Expert Service - a copy ofthe tdentification 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 (ifa number already exists for the substance) 

## x CAS4 

## x

e. For a class I 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 x range ofcomposition and the typical composition (where appropriate). (4) Provide a correct representative orpartial chemical structure diagram, as complete as can be known, ifone can be reasonably ascertained.



## DMark (X) this box ifyou attach a continuation sheet.
EPA FORM 7710-25 (Rev. 5-95) Page 4PartI -- GENERAL INFORMATION -- Continued Section B -- CHEMICAL IDENTITY INFORMATION -- Continued 2. Polymers (For a definition ofpolymer, see the Instructions Manual.) Confidential a. Indicate the number-average weight ofthe lowest molecular weight composition ofthe polymer you intend to manufacture. Indicate maximum weight percent oflow molecular weight species (not including residual monomers, reactants, or solvents) below 500 and x below 1,000 absolute molecular weight ofthat composition. Describe the methods ofmeasurement or the basis for your estimates: GPC Other E]: (Specify)

____________ i) lowest number average molecular weight:___________ ii) maximum weight %below 500 molecular weight.

_________ iii) maximum weight %below 1000 molecular weight-_________ Mark (X) this box ifyou 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) ofeach monomer or other reactant used in the manufacture of the polymer. (2) - Mark (X) this column ifentry in column (1)is confidential. (3) - Indicate the typical weight percent ofeach monomer or other reactant in the polymer (4) - Mark (X) the identity column ifyou want a monomer or other reactant used at two weight percent or less to be listed as part ofthe polymer description on the TSCA Chemical Substance tnventory. (5)
- Mark (X) this column ifentries in columns (3) and (4) are confidential. (6) - tndicate the maximum weight percent ofeach monomer or other reactant that may be present as a residual in the polymer as manufactured for commercial purposes. (7) - Mark (X) this column ifentry 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) X %X % X X %X % X X %X % X

E] Mark (X) this box ifyou 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 ofthe identification report F- 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.X

e. Provide a correct representative or partial chemical structure diagram, as complete as can be known, ifone can be reasonably ascertained.

SMark (X) this boxc ifyou attach a continutation sheet. EPA FORM 7710-25 (Rev. 5-95) Page 5

# ContainsTSCAConfidentialBusinessInformation

page 5aPartI -- GENERAL INFORMATION -- Continued Section B -- CHEMICAL IDENTITY INFORMATION -- Continued 3. Impurities (a)

- Identify each impurity that may be reasonably anticipated to be present inthe chemical substance as manufactured for commercial purpose. Provide the CAS Registry Number ifavailable. Ifthere are unidentified impurities, enter "unidentified." (b)

- Estimate the maximum weight %ofeach impurity. If there are unidentified impurities, estimate their total weight %. Impurity and CAS Registry Number Maximum Confipercent dential (a) (b) % X



## [] Mark (X) this box ifyou attach a continuation sheet. 4. Synonyms - Enter any chemical synonyms for the new chemical identified in subsection I or 2. Confidential None 

## D Mark (X)this box ifyou attach a continuation sheet. 5. Trade identification - List trade names for the new chemical substance identified in subsection I or 2. 

### x 

## D Mark (X) this box if you attach a continuation sheet. 6. Generic chemical name - Ifyou claim chemical identify as confidential, you must provide a generic name for your substance that reveals the specific chemical identity ofthe 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. Alcohol, alkoxylated 

## jZ Mark (X) this box ifyou attach a continuation sheet. 7. Byproducts - Describe any byproducts resulting from the manufacture, processing, use, or disposal ofthe new chemical substance. Provide the CAS Registry Number ifavailable. Byproduct CAS Registry Number Confi- (1) (2) dential 

# x

Dl Mark (X) this box ifyou attach a continuation sheet. EPA FORM 7710-25 (Rev. 5-95) Page 6PartI -- GENERAL INFORMATION -- Continued Section C -- PRODUCTION, IMPORT, AND USE INFORMATION: Mark (X) the "Confidential" box next to any item you claim as confidential. 1. Production volume --Estimate the maximum production volume during the first 12 months ofproduction. Also estimate the maximum production volume for any consecutive 12-month period during the first three years ofproduction. Estimates should be on 100% new chemical substance basis. For aLow Volume Exemption application, ifyou choose to have your notice reviewed at a lower production volume than 10,000 kg/yr. specify the volume and mark (x) in the binding box. If granted, 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

___________________________________________ ____________________________________ _MarkMar((x

2. Use Information -- You must make separate confidentiality claims for the description ofthe category ofuse, the percent ofproduction 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 ofuse ofthe new chemical substance by function and application.. (2) -- Mark (X) this column ifentry column (1) is confidential business information (CBI). (3) -- Indicate your willingness to have the information provided in column (1) binding. (4) -- Estimate the percent oftotal production for the first three years devoted to each category ofuse. (5)-- Mark (X) this column ifentry in column (4) is confidential business information (CBI). (6) -- Estimate the percent ofthe 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 ofuse. (7) -- Mark (X) this column ifentry in column (6) is confidential business information (CBI). (8) -- Indicate %ofproduct 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 ifentry(ies) in column (8) is (are) confidential business information (CBI). Category ofuse (1) CI Binding Produc- CBt %in CBI %ofsubstance expected per use CBI Option tion % Form- (8) (by fuinction and application i.e. adispersive dye Mark (x) ulation Site- Con-* tndus- Coin- Binding for finishing polyester fibers) (2) (3) (4) (5) (6) (7) limited sumer trial mercial Option (9) 

### x x Xx

%4 %

____ ____ __% %

*If you have identified a"consumer" use, please provide on a continuation sheetadetailed description ofthe use(s) ofthis chemical substance inconsumer products.

tn addition include estimates ofthe concentration ofthe new chemical substance as expected inconsumer products and describe the chemical reactions by which this substance loses its identity inthe consumer product. 

## DMark (X) this box ifyou attach a continuation sheet. b. Generic Ifyou claim any category ofuse description in subsection 2a as confidential, enter a generic description ofthat category. Read the use Instructions Manual for examples ofgeneric use descriptions. description Wetting agent 

## DMark (X)this box ifyou attach acontinuation sheet. 3. Hazard Information --Include in the notice a copy ofreasonable facsimile ofany hazard warning statement, label, material safety data sheet, or other Binding

information which will be provided to any person who isreasonably likely to be exposed to this substance regarding protective equipment or practices Option for the safe handing, transport, use, or disposal ofthe new substance. List inpart III hazard information you include. Mr x 

## Z Mark (X)this box ifyou attach hazard information. EPA FORM 7710-25 (Rev. 5-95) Page 7Part11-- 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 processing oruse 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 Not applicable as new substance will be imported Site address (number and street) City, County, State, ZIP code
Ifthe 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. 11Mark (X) this box ifyou attach a continuation sheet. b. Type -- Mark (X) EManufacturing EProcessing D]Use____ c. Amount and Duratio -- Complete I or 2 as appropriate_______________

______________ Maximum kg/batch (100% new chemical Hours/batch Batches/year

substance) 1. Batch Maximum kg/batch (100% new chemnical Hours/batch Batches/year 

# I substance) 2. Continuous d. Process description 

## [I] Mark (X) to indicate your willingness to have yourprocess 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 orkg/batch on a 100%new chemical substance basis), and entry point of all starting materials and feedstocks (including reactants, solvents, catalysts, etc.), and of allproducts, recycle streams, and wastes. Include cleaning chemicals (note frequency ifnot used dailyor per batch.). (3) Identify by number the points ofrelease, including small or intenmittent releases, to the environment ofthe new chemical substance. 

### Not applicable

SMark (X) this box if you attach a continuation sheet. EPA FORM 7710-25 (Rev. 5-95) Page 8Part11-- 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 ofworker activity, physical form ofthe new chemica substance, number ofworks 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 ifentry 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) ofthe new chemical substance (e.g., solid: crystal, granule, powder, or dust) and %new chemical substance (ifpart ofa mixture) at the time ofexposure. (7)

--Mark (X) this column ifentry in column (5)is confidential business information (CBI). (8) --Estimate the maximum number ofworkers involved in each activity for all sites combined. (9)

--Mark (X) this column ifentry in column (8) is confidential business information (C131). (10) and (11) --Estimate the maximum duration ofthe activity for any worker inhours per day and days peryear. (12)

--Mark (X) this column ifentries in columns (10) and (t1) are confidential business information (CBI).___________ Worker activity CBl Protective Equipment/ Binding Physical forns(s) Binding C131 # of CBIl Maximur duration CBI mn (i.e., bag dumping, filling drums) Engineering Controls Option and % new Option Worker Uirn/day Days/yr Mark (x) substance Mark (x) (1) (2) (3) (4) (5) (6) (7) Expose (9) (10) (It) (12) d ___________________________________(8)

_________ Not applicable



## DMark (X) this box ifyou attach a continuation sheet. 3. Environmental Release and Disposal --You must make separate confidentiality claims for the release number and the amount ofthe 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 11, section A, subsection Ild(3). (2) -Estimate the amount ofthe new substance released (a) directly to the environment or (b) into control technology (in kg/day or kg/batch) (3) -Mark (X) this column ifentries in columns (1) and (2) are confidential business information (CBI). (4)

-- Identify' the media (stack air, fu~gitive 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, ifany, and control efficiency that will be used to limit the release ofthe new substance to the environment. For releases disposed ofon land, characterize the disposal method and state whether it is approved for disposal ofRCRA 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 ifentries in columns (4) and (5) are confidential business information (C131). (7) -- Identify'the destination(s) ofreleases to water. Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct discharges or NPDES numbers ofthe POTW (Publicly Owned Treatment Works). Mark (X) ifthe POTW name orNPDES # is confidential business information (CBI). Release Amount ofnew substance CBII Media of Control technology and efficiency (you may wish to optionally attach efficiency data) CB1 Number released release

(I) (2a) (2b) eg.aackair Binding

_______ (3) (4) (5a) Mark (x) (5b) (6) not applicable

(7) Mark (X) the 

## D POTW provide name(s) below: CBI 0 Navigable E]Other - Specify provide NPDES # CII destination(s) of wtra releases to water.
1D Mark (X) this box ifyou attach a continuation sheet. EPA FORM 7710-25 (Rev. 5-95) Page 9Part 11-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued Section B -- INDUSTRIL 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 Bforeach type of processing,oruse operationinvolving the new chemical substance Ifthe same operation is performed at more than one site describe the typical operation common to these sites. Identify additional sites on acontinuation 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 miajor 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 descrnbe 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 ofall feedstocks (including reactants, solvents and catalysts, etc) and all products, recycle streams, and wastes. Include cleaning chemicals (note frequency ifnot used daily or per batch). (3) -- Identify by number the points ofrelease, including small or intermittent releases, to the environment ofthe new chemical substance. (4) Please enter the # of sites (remember to identify the locations of these sites on acontinuation sheet)
# ofsites



## DMark (X) this box ifyou 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 descrnbed. (2)

-- Estimate the number ofworkers 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)

-- Descnibe physical form ofexposure and %new chemical substance (if in mixture), and any protective equipment and engineering controls, if any, used to protect workers. (7) -Estimate the percent ofthe new substance as formulated when packaged or used as a final product. (9)

--From the process diagram above, enter the number ofeach release point Complete 9-13 for each release point identified. (10) -- Estimate the amount ofthe new substance released (a) directly to the environment or (b) into control technology to the environment (in kg/day or kg/batch).

(12) -- Descnibe media ofrelease i.e stack air, fugitive air (optional-see Instructions Manual), surface water, on-site or off-site land orincineration, POTW, or other (specify) and control technology, ifany, that will be used to limit the release ofthe new substance to the environment. (14) -- Identify byproducts which may result from the operation.

(3),(5), (8), (11), 13) and (15) -- Mark Xthis colum~n if any of the proceeding entries are confidential business inform-ation (CBI.

________ Letter # of CBI Duration CB1 Protective Equip. / %in CBI Release Amount of CBI Medis ofRelease CBI

of Workers of Engineening Controls/ Form- Number New &Control Act- Exposed Exposure Physical Form and % ulation Substance Technology ivity new substance Released (1) (2) (3) (4 (5) (6) (7) (8) (9) (lOs) -7(lob) (11) (12) (13) x -__

(14)- Byproducts: (15)



## D: Mark (X) this box ifyou attach a continuation sheet,

EPA FORM 77 10-25 (Rev. 5-95) Page 10

### 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 ofthe 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 ortoxicity ofchemical wastes by technological modification, process and procedure modification, product reform-ulation, raw materials substitution, and/or inventory control. Recycling refers to the reclamation ofuseful chemical components from wastes that would otherwise be treated orreleased as air emissions or water discharges, or land disposal. Descriptions ofpollution 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 ofrisks to other environmental media or non-environmental areas (e.g., occupational or consumer exposure). In addition, information on the relative cost or performance characteristics ofthe PM1N 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 environent; (2) a reduction inthe volume manufactured; (3) areduction in the generation ofwaste 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 ofproduction and/or improved operation efficiency ofthe 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 greater overall risk to human health or the environment.



## LIMark (X) this box ifyou attach a continuation sheet. EPA FORM 77 10-25 (Rev. 5-95) Page 11I

### PartIII -- 

### LIST OF ATTACHMENTS Attach continuation sheets for sections ofthe 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 ofthe form to which it relates, ifappropriate. Number consecutively the pages ofthe attachments. In the column below, enter the inclusive page numbers ofeach 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 ofthe notice form a sanitized version ofany attachment in which you claim information as confidential. Attachment name Attachment Confipage number(s) dential 14-18 Material Safety Data Sheet (MSDS) 19-21 X 22-25 X 28-29 X

30 X CASIES Report 172 CMVA electronic PMVN documentation 173 PMVN fee documentation 174 5a X 26-27 X Acute Oral Toxicity Test in Rats 83-1 04 Acute Dermal Irritation/CorrosionTest 60-82 Acute Eye Irritation/Corrosion Test 34-59 Activated sludge, respiration inhibition test 131-153 Acute toxicity fish test 154-171 31-33 X Determination of ready biodegradability 105-1 30



## DMark (X)this box ifyou attach a continuation sheet. Enter the attachment name and number.
EPA FORM 7710-25 (Rev. 5-95) Page 12PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET To assist EPA's review ofphysical 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 ofthe notice on which the property appears, the value ofthe property, the units in which the property is measured (as necessary), and whether or not the property is claimed as confidential The physical state ofthe 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 (%PMIN substance in 9). You are not required to submit this worksheet; however, EPA strongly recommends that you do so, as itwill simplify review and ensure that confidential information isproperly protected You should submit this worksheet as a supplement to your submission oftest data. This worksheet is not a substitute for submission oftest data. Property Mark Page Value Measured or Confi- (X)if number Estimate dential providd (c)Mark (X) (a) prvdd (b) ()(M orE) (d) X 16 M Physical state ofneat substance __(s) X2 (1) _(g)

____ Vapor pressure @ Temperature

________ Torr X 16 M Density/relative DIN 51757 0.96 g/cm3 Solubility @ Temperature

_________

Solvent: X 16 Solubility in water @ Temperature 25 0C <_ <0.5 gI M Melting temperature 0 Boiling / sublimation temperature@_ to__rr pressure

_________________ X M X Spectra: IR, H-NMR, 13C-NMR, MALDI 26-33

_________ __ Dissociation constant Particle size distribution Octanol /water parttion coefficient Henry's Law constant Volitalization from water Volitalization from soil _pH@ concentration

Flammability DIN EN 22719 X 6 lshPin=>IO -Explodability

__ -Adsorption / coefficient Other
- Specify_____

_______ X 16 Approx. 150 mPas M -Viscosity 25'C DIN 53015

__ __________ __

ATTACHMENT PAGE 13

# ContainsTSCAConfidential Businec.':11ormZation

SAFETY DATA SHEET (91/155/EEC) Version 2 Revision date Zb.U1.98- Date :30.03.98 Page :1

1. Identification of the substance/preparation and company Trade name Information on manufacturer/supplier
Telephone no. i'Telefax:fInformation provided by Elehn o Teepoe o.^IjTelefax 

### :L7 

# J Emergency information Telephone no. -. -' Telefax 

# :

* 2. Composition/information on ingredients Chemical characterization Aloo, alkoxylated

* 3. Hazards identification Specific hazards for human health and environment No particular hazards known.

*4. First aid measures General information Remove contaminated clothing. After inhalation Ensure supply of fresh air. After contact with skin In case of contact with skin wash off immediately with soap and water After contact with eyes Flush eye immediately and thoroughly whilst protecting the unhurted eye. if irritation continues, consult a physician. After ingestion In the event of symptoms seek medical advice.

Page: 2

# ContainsTSCAConfidenti-IlCusiness 1Ilorimtion

SAFETY DATA SHEET (91/155/EEC) Version :2 Revision date 26.01 .98 Date :30.03.98 Page: 2

5. Fire-fighting measures Suitable extinguishing media foam, carbon dioxide, dry powder, water spray. Extinguishing media that must not be used for safety reasons not applicable Special hazards from the substance itself, its combustion products or from its vapours In the event of fire the following can be released:

-

- carbon dioxide, carbon monoxide Special protective equipment for firefighting Do not inhale explosion and/or combustion gases
6. Accidental release measures Personal precautions Use personal protective equipment. Environmental precautions Do not allow to enter drains or waterways Do not discharge into the subsoil/soil. Methods for cleaning up/taking up Take up with absorbent material (eg sand, kieselguhr, universal binder) Dispose of absorbed material in accordance with the regulations.
7. Handling and storage Handling Advice on protection against fire and explosion No special measures required. Storage Further information on storage conditions Keep container closed. Storage class 10
8. Exposure controls/personal protection
Personal protective equipment General protective measures Avoid contact with eyes and skin

Page :3

# ContainsTSCA Confidenit'lCusnor-~orat

SAFETY DATA SHEET (91/155/EEC) Version : 2 Revision date 26.01 .98- Date 30.03.98 Page: 3

Hygiene measures Do not eat, drink or smoke when working. Wash hands before breaks and after work. Remove soiled or soaked clothing immediately. Respiratory protection None required Hand protection PVC gloves Eye protection tightly fitting safety glasses Body protection light protective clothing
9. Physical and chemical properties Appearance Form : Liquid Colour : colourless, clear Odour : mild Data relevant to safety Changes in physical state Melting temperature not measured Boiling temperature not measured Flash point > 100 c Method :DIN EN 22719 (DIN 51758) Ignition temperature not measured Density 0.96 g/cm' at 20 O Method :DIN 51757 solubility in water < 0.5 g/l at 25 O pH value not measured Viscosi.ty approx. 150 mPa*s at 25 O Method : DIN 53015 (H~ppler)

Page: 4

# ContainsTSCAConfidential

# Businocs Infor niti/T 

# J

SAFETY DATA SHEET (91/155/EEC) Version :2 Revision date 26.01.98 

# iiDate :30.03.98 

# Pae]

10. Stability and reactivity Thermal decomposition Not measured Hazardous reactions No hazardous reactions with proper storage and handling. Hazardous decomposition products None with proper storage and handling.

*11. Toxicological information Acute oral toxicity ( LD50 > 2000 mg/kg Species rat Method OECD 401 Irritant effect on skin non- irritant Species :rabbit Method :OECD 404 Irritant effect on eyes slight irritant effectdoes not require labelling Species rabbit Method :OECD 405 Remarks Due to the composition of the product it cannot be excluded: Irritant to eyes.
12. Ecological information Data on elimination (persistence and degradability) Biodegradability not readily degradable Method : OECD 301 D Remarks The product is considered to be a weak water pollutant (German law) Do not allow to enter soil, waterways or waste water canal.

13. Disposal considerations

Page :5 

# Ar o

# ContainsTSCAConfi6didtalBusinessInformatio

SAFETY DATA SHEET (91/155/EEC) Version 2 Revision date :26.01.98 Date :30.03.98 Page: 5

Product In accordance with local authority regulations, take to special waste incineration plant Uncleaned packaging If empty contaminated containers are recycled or disposed of, the receiver must be informed about possible hazards.
14. Transport information Not classified as hazardous for transport

*15. Regulatory information
Labelling in accordance with GefStoffVIEC The product does not require a hazard warning label in accordance with EC directives/German regulations on dangerous substances. National regulations German regulations on flammable substances: is not subjected to the regulations on flammable substances. TA-Luft (Ger.) Class III Paragraph 3.1.7 Water Hazard Class (Germany) :1 Cself-classification (Germany) Other regulations none
16. Other information
none This information is based on our present state of knowledge. It should not therefore be construed as guaranteeing specific properties of the products described or their suitability for a particular application.

*Changes compared to the previous version are marked with an

asterisk before the section number!I Date :30.03.98

# 19:
-~ 1204 

# ContainsTSCAConfidentialBusinessInformation/

# ContainsISCAConfidentialBusinessInformation

# ContainsTSCAConfidentialBusinessInformation

# ContainsTSCAConfidentialBusinessInformation

# ContainsTSCAConfidentialBusinessInformation

# I

# I ContainsTSCA Confidential BusinessInformation

# ContainsTSCAConfidential BusinessInformation

# ContainsTSCAConfidential BusinessInformation

# ContainsTSCAConfidential BusinessInformation

# ContainsTSCAConfidentialBusinessInformation

### /c

/.
-t: 

# I In

# / 

# /
I 

# / 

# / 

# /

ContainsTSCAConfidential BusinessInformation 30

# ContainsTSCAConfidentialBusinessInformation

# ContainsTSCAConfidentialBusinessInformation '

# ContainsTSCAConfidentialBusinessInformationDaimlerstral~e 5b-D-76185 Karlsrhe 

# "BioChem Tel. 07.21/9737-0 -Fax 0721/9737-222 E-mail: biochem@biochem.de Labor fOr biologische und Internet: httO/ww.biochern.de e chemische Analytik GmbH 

### REPORT97 1042412 C AcuTE EYE IIuuTATioN/CoRROSION
Project No.: 971042412 Report No.: 97 10 42 412 C 

### Test substance: 

# [I1 Batch No: not stated BioChem sample designation: 137291 3001 Date ofarrival: November05, 1997 

### Sponsor.I 

## Monitor[2 Test facility: BioChem GmbH Daimlerstr. 5b D-76185 Karlsruhe Germany Management: Dr. W. Massmann Dr.M. Miller Study Director. Dr. H.-J. Kramer Quality Assurance Manager. Dr. H. Merten
Karlsruhe, December 23, 1997 BioChem GmbH
Page 1of26 pages R""", t710 42412C 

### )IAcute Eye Irritation/Corrosion 

# ContainsTSCA ConfidentialBusinessInformationPage 2 of26 pages Fteport97 1042412 C JAcute Eye hrritation/Cqrrosion


### Statement of GLP compliance We declare that all tests are made in accordance with the protocol and with the regulations ofthe OECD-Principles ofthe "Good Laboratory Practice" (GLP). GLP: "Good Laboratory Practice" Regulations ofthe European Communities, EC, enacted in Germany in the " Cheniikaliengesetz" (Chemicals Act), 2nd Amendment, dated July 25, 1994, BGBI I, pp. 1703, 1994 and "AndVO", dated May 14, 1997, BGBl. IL pp. 1060, 1997. The documented data correspond to the measured values. Management

Dr. Manfred Miller Date

Study Director

Dr. Hans-Joachim Kramer Date

Quality Assurance Manager

Dr. Hans Merten Date 

# ContainsTSCA Confidential BusinessInformationPage 3 of26 pages Report 97 1042412 C 

### Y

Acute Eye Irritation/Corrosion



# Umlweltminiserium Baden-Wirttemberg

GLP-Bescheinigunig
Bescheinigung Certificate Hiermit 

### wird best~tgt, daB die It is hereby certified that the testPrllftpgeinrichtung filility
in 76185SKarlsruhe in 76185Kadsruhe der BioChern, Labor Mr biologische und of BioChem, Labor firbiologische und chemische Analyti GmbH,

- cbemi che Analytik G~mbH, Daimlerstr. 5b

. Daimierstr. 5b

am 19J20.06.95, 27.09.95 und 26.01.96 on 19120. Tune 95, 27. September 95 and 26. January 96

von der far die Oberwachung zust~digen was inspected by the competent Behorde Uber die Einl~tung der Grund- authority regarding compliance with the sluze der Guten Laborpraids iaspi~iert .Principles ofGood Laboratory Practice. worden ist. Es wird hiermit bestafigt, daB3 folgende -It ishereby certified that studies inthis test Prafingen in dieser Pruifeinrchtung nach facility are conducted in compliance with the den Gnindsitzen der (3uten Laborpra~tis Principles ofGood Laboratory Practice. durchgefilhrt werden. BADEN, Stuttgart, den 6 qW)ERG Seite 1/2 page 112 

# ContainsISCA ConfidentialBusinessInformation k~/ Y* Page4of26 pages Reoort 97 1042412 C 

### L

Acute Eye Irritation/Corrosion * Scite 2/2 zur GL.P-Bescheinigung Priifungskategorie I Priifungen aufphysikalischchemische Eigenschzften and Gehatsbestimmungen Prfifungskategorie 2 PriUhngen auftoxikologische Eigenschaften Priifungskategorie 3 Prilfungen aufmutagene Eigenschaften (in vitro, in vivo) Priifungskategorfe 4 Umtwelttoikologische Prilfng~en zu Auswfrktungen auifaquatische and terrestrische Organismen. Priifungskategorie 5 Prilfungen xam Verhalten im Boden,imWasserandinder Luft; Bioakkuymulation; Metabotismus Prilfungskategorie 6 Prilfungen aufRfickstinde 

### Diesentspricht den Kategorien nach der Ailgemi Verv;wtngsvarscbrift mmn Verfahren der beh~rdlichen (Yberwachung der Einhaltung,der Guten Laborpaxs * (ChemVwV-4J1.P) vom29. Oktober 1990: 'Physikalisch-chemische Eigenschaften unci Gehaltsbestimmungen" "Toxikologische Eigenschaften" "Okotoxikologische Eigenschaften" "Verhaten 

### im Boden, im Wasser and in der Luft't IfRickst~iude" Stuttgart, den 26.02.1996



### A A(Xd c

# S 4

# V I.-1RTTEM8ERG

Dr. AlrechtContains 

# TSCA ConfidentialBusiness InformatioSeite 2/2 page 2/2

### Page 5of26 pages Report 97 10 42 412C 

# ( 1 Acute Eye I-itation/Corrosion

Translation ofpage 2ofthe GLP-Certificate by BioChem.
Test category 1: Tests onphysico-chemical properties and content determinations
Test category 2: Tests on toxicological properties
Test category 3: -Tests 

### on mutagenic properties (in vitro, in vivo)
Test category 4: Ecotoxicological tests on* effects on aquatic and terrestrial organisms
Test category 5: Tests on behaviour in soil, in water and in the air; bioaccumulation; metabolism
Test category 6: Tests on residues
This corresponds to the categories according to the General Administration Regulation of the Procedure ofthe Official Supervision of the Compliance with Good Laboratory Practice (Chem VwV-GLP) dated October 29, 1990: "Physico-chemical Properties and Content Determinations" 'Toxicological Properties" "Ecotoxicological Properties" "Behaviour in Soil, in Water and in the Air" "Residues" Stuttgart, February 26, 1996 Baden-Wirttemberg 

# ContainsTSCAConfidentialBusinessInforma 3Y Department of the EnvironmnentPage 6 of26 pages Report 97 10424120C 

# ( _iAcute Eye Irritation/Corrosion 

### Quality Assurance Unit Statement

Title: Final Report Acute Eye Irritation /Corrosion project number: 971042412 protocol number: 97 1042 412 C
Guideline: OECD-Guideline forTesting ofChemicals No. 405 "Acute Eye Irritation /Corrosion" Study 

### Itest system: Determination ofthe irritant and/or corrosive effects on eyes ofmammals/ albino rabbits
Test substance: Batch No.: not stated Sample designation: 137291 3001 Date ofarrival: November 05, 1997 Study Director: Dr. H.-J. Kramer



# Contains TSCAConfidential BusinessInformationPage 7 of26 pages Report97 1042 412C I/Acute Eye Irritation/Corrosion
The following checks were effected: reports to the Study Director and to the date verified procedure Management November 14, 1997 protocol November 14, 1997 December 10, 1997 audit 1 December 10, 1997 December 16, 1997 audit 2 December 16, 1997 December 22, 1997 final report inEnglish December 22, 1997

The data which were taken as a basis for this report were verified by the Quality Assurance Unit. The accordance ofthe study with its protocol, the OECD-Guideline for Testing of Chemicals No. 405 and the Principles ofGood Laboratory Practice (GLP) is guaranteed. The methods, procedures and observations are exactly described in the report. The Quality Assurance Unit ensures that the reported results exactly describe the raw data ofthe study. The Study Director and the Management are generally informed of any findings of the Quality Assurance Unit. As for this study no departures from the prescribed course ofthe test were ascertained.

Karlsruhe, December 23, 1997 Dr. H. Merten (Quality Asuwincc Manager)



# ContainsTSCAConfidentialBusiness InformationPage 8 of26 pages Report 97 10424120C ')tAcute Eye Irritation/Corrosiona 

## CONTENTrS page 1 Preface 9 

### 2 Summary 10 3 Guideline 11 4 Protocol II 5 Test Substance 11 6 Method "Acute Eye Irritation/Corrosion" 12 6.1 Animals and Laboratory Conditions 12 6.2 Composition ofDiet and Water 13 6.3 Acclimatization/Preparations 16 6.4 Study Procedures 17 6.5 Evaluation ofthe Ocular Reaction 18 7 Findings "Acute Eye Irritation/Corrosion" 20 7.1 Mortality/Toxicological Symptoms 20 7.2 Behaviour 20 7.3 Body Weight 20 7.4 Eye Reaction 21 8 Archiving 26



# ContainsTSCAConfidential Business Information 41'Page 9of26 pages Repor 97 1042 412 C I/Acute Eye Irritation/Corrosion
PREFACE
Test system: Acute Eye Irritation /Corrosion Laboratory animals: Albino rabbits
Guideline: OECD-Guideline for Testing of Chemicals Section 4, 405 "Acute Eye Irritation/ Corrosion" adopted February 24, 1987 GLP: Gesetz zumn Schutz vor gefdhrlichen Stoffen (Chemikaliengesetz ChemG, 

### § 19 a - d vom 25. Juli 1994) Project No.: 97 1042412 Report No.: 97 1042412 C 

### Test substance:L Sponsor.

Monitor: Test Facility: BioChem GmbH Daimlerstra~e 5 b D-76 185 Karlsruhe Germany Management: Dr. W. Massmann Dr. M. MIler Study Director. Dr. H.-J. Kramer Quality Assurance Manager. Dr. H. Merten



# ContainsTSCAConfidential Business Information4?Page 10 of26 pages Report97 1042412 C 

# (

)IAcute Eye Irritation/Corrosion i

2 SUMMARY Report: Acute Eye Irritation/Corrosion study of i compliance with OECD-Guideline 405 Sponsor:

Test Facility: BioChem,GmbH Daimlers-tra~e 5 b D-76185 Karlsruhe Germany ProjectNo.: 971042412 Protocol No.: 97 10 42 412 C Report No.: 97 1042 412C Findings: The test substance was applied in a single dose of0.1 ml into the conjunctival sac ofthe right eye to each of3 albino rabbits. Under the conditions of this experimnent >ld not cause any acute systemic toxicological signs or mortality./ After evaluation ofthe eye reaction according to table Iofthe OECD-Guideline 405, all three rabbits developed hyperaemnic blood vessels. This effect was estimated at grade 0.5 to 2.5 (maximum possible 3). Hyperaemnic blood vessels were not observed any more on day 5. All three rabbits showed swelling of lids. This effect was estimated at grade I to 3 (maximum possible 4). Swelling oflids was not observed any more on day 5. Two rabbits showed opacity ofthe cornea,48 hours after application. This effect was estimated at grade I (maximum possible 4). Opacity was not observed any more on day 3. Ocular lesions ofiris could notbe observed during the study. All lesions turned out to be completely reversible within 4 days. In the course ofthis experiment the body weight ofall three rabbits increased.



# NntainsTSCAConfidential BusinessInformationPage 11 of26 pages Report 97 10 42 412C 

# ( __-_ct Eye Irritation/Corrosion 3 GuEDELINE The study procedures were performed in compliance with the OECD-Guideline for Testing of Chemicals 405 "Acute Eye Irritation / Corrosion", adopted February 24, 1987. 

### 4. Protocol Project No.: 97 1042412 Protocol No.: 97 10 42 412C Date ofProtocol: November 14, 1997 Ratification: -November 20, 1997 

### Monitor:) 

### 5. Test Substance Name: Characterization of the test substance: alcohol alkoxylate 

### Main ingredients:( Date ofarrval: 'Nvember 05, 1997 Sample designation: 137291 3001 Purity: not stated Physical state: liquid Colour. colourless Homogeneity: homogeneous Stability: not stated Expiry date: not stated Storage conditions: not stated, storage class 10 (VCI)
In compliance with OECD-Guideline 405, areference substance was not tested.


# ContainsISCA Confidential Business Information 44Page 12 of26 pages t 97 1042412 C tAcute Eye Irrntation/Corrosion 

### 6 METHOD "ACUTE EYE mRRATION/CoRROSION" INCOM~PLIANCE WITH 

### OECD-GUEUENE 

### 405

6.1 ANIMALS AND LABORATORY CONDITIONS Species: Albino rabbit Identification numbers: 152, 153 and 154(all female) Breeding: Dr.Zimmermann Schweizer Hof D-73453 Untergrdningen/Aalen Veterinary preliminary examination: Without morbid signs Diet: Raiffeisen Ringfutter Kaninchen Trockenfutter 52/P Raiffeisen Kraftfutterwerk Kehl, ad libitum. Water: Community tap water from Karlsruhe; free access for the animals by daily changing of the watering-bottles. Husbandry: The rabbits housed individually in wire grating cages (area 2450 cmz, height 42 cm) without bedding. Temperature: 20-23 "C Relative humidity: 30-70 % Light-dark -rhythm: 12:12



# ContainsTSCA Confidential BusinessInformationPage 13 of26 pages Report 97 1042412 C 

# L ) Acutt Eye Irritation/Corrosion

6.2 Composition ofDiet and Water Composition ofdiet "Raiffeisen Ringfutter Kaninchen". Manufacturer. Raiffeisen Krallfutterwerke Said GmbH, Werk Kehl Manufacturer specification oflotNo. 5089 1/039
INGREDIENTS: crude protein 17 % crudefat 3 % crude fibres 17.5 % crude ash 8.5 % calcium 1 % phosphorus 0.6 % sodium 0.2 %
ADDED VITAMINS PER KG DIET vitamin A 12.000 I.E. vitamin D 3 1.000 I.E. vitamiinE 50mg flavophospholipol 4 mg BHT

Analysis performed on lot No. 5089 1/039 by Dr. Nedvidek /BioChem GmbH in December 1994/January 1995.
INGREDIENTS: moisture method: 115*C/ 5h 9.0% ash method: 550*C/ 16h 9.5% crude protein Kjeldahl method according toBioChemSOPL 10 15.3% crude fat Weibull Stoldt method in analogy to 

### §35 LM]BG L 01.00-20 3.1 % 

# ContainsISCA Confidential Business InformationPage 14 of26 pages Report.97 1042 412 C 

### J~ Acute Eye Irritation/Corrosion -l 

## CONTAMINANTS:Is a-HCH <0.01 mg/kg B-HCH < 0.01 mg/kg y-HCH <0.01 mg/kg 8-HCH <0.01 mg/kg pentachlorobenzene, <0.01 mg/kg hexachlorobenzene <0.01 mg/kg heptachlor <0.01 mg/kg aldrin <0.01 mng/kg bromnophos <0.01 mg/kg heptachiorepoxide A +B <0.01 mg/kg cc-endosulfan <0.01 mg/kg dieldrin <0.01 mg/kg o,p-DDT <0.01 mg/kg p,p'-DDT <0.01 mg/kg o,p-DDE <0.01 mg/kg p,p'-DDE <0.01 mg/kg o,p-DDD <0.01 mg/kg p,p'-DDD <0.01 mg/kg endrin <0.01 mg/kg 1-endosulfan <0.01 mg/kg methoxychlor <0.01 mg/kg rairex <0.01 mg/kg propazine <0.01 mg/kg atrazine <0.01 mng/kg atrazine-desethyl <0.01 mg/kg terbuthylazine <0.01 mg/kg prometryn <0.01 mg/kg amnetryn <0.01 mg/kg simetryn <0.01 mng/kg terbutryn <0.01 mng/kg malathion <0.01 mg/kg parathion-ethyl <0.01 mg/kg cyanazine <0.01 mg/kg simazine <0.01 mg/kg promecton <0.01 mng/kg quintozene <0.01 mg 

# ContainsTSCA Confidential BusinessInformation 4~7Page 15 of26 pages ~Report97 10 42 412C yAcute Eye Irritation/Corrosiona COMPOSITON OF DRINKIJNG WATER: according to the latest available information ofStadtwerke Karlsruhe (1995): average ofdeterminations aluminium <0.03 mg/i aqmmonium <0.05 mg/i antimony <0.01 mg/i 

### arsenic 

### <0.001 mg/I barium 0.09 mg/I boron 0.01 mg/i cadmium <0.0001 mg/i calcium 119 mg/I chromium <0.001 mg/i copper <0.01 mg/i iron <0.01 mg/i lead <0.001 mg/i magnesium 10.6 mg/i manganese <0.01 mg/i mercury <0.00004 mg/i nickel <0.003 mg/i potassium 1.7 mg/i selenium <0.01 mg/I silicon 5.7 mg/i silver <0.0005 mg/I1 sodium 11.3 mg/i zinc <0.02 mg/i chlorides 25 mg/i cyanides <0.01 mg/I fluorides 0.08 mg/i nitrites <0.01 mg/I nitrates 6.0 mg/i phosphates <0.02 mg/i sulfates 71 mg/i


# ContainsTSCA ConfidentialBusinessInformation Z,Page 16 of26 pages Report97 1042412 C 

# ( 1/ Acute Eye Irritation/Corrosion

dissolved organic carbon 1.4 mg/i pesticides not verificable polychlorinated biphenyls not venificable polycyclic aromatic hydrocarbons <0.00005 mg/i1 trihalogenmethane <0.0001 mg/i halogenated hydrocarbons <0.01 mg/i organic chlorinated compounds <0.0005 mg/i surfactants <0.01 mg/i 6.3. ACCLIATIZATION / PREPARATIONS The animals were acclimated to the test conditions for 5 days prior to the administration. 24 h prior to the administration all rabbits were checked to detect eye lesions. No defects were determined.



# Contains TSCA ConfidentialBusinessInformation 4Page 17 of26 pages Reoort97 10424120C t ' Acute Eye Irritation/co:rrosion

6.4 STUDY PROCEDURES Acclimatization: December 05, 1997
- December 09, 1997 Administration: December 10, 1997 The test substance was applied in a single dose of0.1 ml into the right eye to each of3albino rabbits. 

# [ ')was 

### placed into the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball. The lids were then gently hold together for about one second in order to prevent loss of the material. 24 h after administration the eye was carefulfly rinsed with NaCI 0.9 %in order to remove the residual test substance. The left eye was not treated and was used for control. Observation: December 10, 1997
- December 18, 1997 The study was finished on day8 afterthe application because no toxicological symptoms could be noted. Judgement: Mortality, toxicological symptoms, behaviour, body weight, eye reaction according to OECD-Guideline 405. The first examination was performed 1 hour after administration. On the first day after exposure the cornea was tested with fluorescein solution to detect defects. (Fluorescein SE Dr. Thilo & Co. GmbH; I ml contains 1.7 mg ofthe disodium salt offluorescein).



# ContainsTSCAConfidentialBusiness Information34Page 18 of26 pages Report 97 10 42 412C 

# C _~'Acute Eye Irritation/Corrosion
6.5 EVALUATION OF THE OCULAR REACTION ACCORDING TO TABLE 1 OF OECD-GUIDELINE 405 Table I CONJUNCTIVAE Redness (refers to palpebral and bulbar conjunctivae, cornea and iris). Blood vessels normal 0 Some blood vessels definitely hyperaemnic (injected) 1 Diffuse, crimson colour, individual vessels not easily discernible 2 Diffuse beefy red 3
Chemosis (Lids and/or nictatmng membranes) No swelling 0 Any swelling above normal (includes nictating membranes) I Obvious swelling with partial eversion oflids 2 Swelling with lids about halfclosed 3 Swelling with lids more thanhalfclosed 4



# ContainsTSCA Confidential BusinessInformationPage 19 of26 pages Report 97 1042412 C 

### J/ Acute Eye Irritation/Corrosion
CORNEA Opacity: degree ofdensity (area most dense taken for reading). No ulceration oropacity 0 Scattered or diffuse areas ofopacity (other than slight dulling ofnormal lustre), details ofiris clearly visible 1 Easily discernible translucent area, details ofiris slightly obscured 2 Nacreous area, no details ofiris visible, size ofpupil barely discernible 3 Opaque cornea, iris not discernible through the opacity 4

IRIS Normal 0 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection; any ofthese or combination ofany thereof; iris is still reacting to light (sluggish reaction is positive)1 No reaction to light, haemnorrhage, gross destruction (any or all ofthese) 2



# ContainsTSCA Confidential BusinessInformationPage 20 of26 pages Report 97 10 42 412C 

# ( iAcute Eye IrritationtCorrosion


### 7 FINDINGS "ACUTE EYE IRUITATION/CORROSION" 7.1 MORTALITY/TOXICOLOGICAL SYMPTOMS After the administration of0.1 ml test substance into the right eye none ofthe treated rabbits died during the experiment and observation period. Systemic toxicological symptoms could not be observed. 7.2 BEHAVIOUR The general behaviour of the rabbits treated was quiet and watchful. The behavioural pattern was not different to that ofother rabbits which were not in the test. 7-3 BODY WEIGHT During the experiment the body weight ofall three rabbits increased. The weight of each animal is specified in table 11. Table 11: Bodyweight (statements in g): Phase oftest day Rabbit No. 152 153 154 Acclimatization -5 2627 2817 2832 -4 2643 2818 2894 -3 -2 2733 2860 2922 -1 2778 2924 3002 Administration 0 2835 2901 2995 Observation 1 2857 2889 3047 2 2926 2949 3109 3 2951 2974 3095 4- 5 2989 3012 3135 6 3041 3057 3140 7 3085 3073 3270

_________ 8 3108 3079 3281



# ContainsTSCA Confidential Business InformationPage 21 of26 pages Report 97 10 42 412 C 

# (_( Acute Eye Irritation/Corrosion 7.4 EYE REACTON The test substance was applied in a single dose of0.1 ml into the right eye to each of 3 albino rabbits. After evaluation ofthe eye reaction according to table 1ofthe OECD-Guideline 405, all three rabbits developed hyperaemnic blood vessels. This effect was estimated at grade 0.5 to 2.5 (maximum possible 3). Hyperaemnic blood vessels were not observed any more on day 5. All three rabbits showed swelling of lids. This effect was estimated at grade I to 3 (maximum possible 4). Swelling oflids was not observed any more on day 5. Two rabbits showed opacity of the cornea 48 hours after application. This effect was estimated at grade 1(maximum possible 4). Opacity was not observed any more on day 3. Ocular lesions ofiris could not be observed during the study. Exsudation was observed in the eyes of all three rabbits after instillation of the test substance till day 1. The effects attributed to the administration of~ )Were completely reversible in the eyes ofall three~rabbits which was shown durinig thle iast four days ofthe study. In the untreated left eye which was used as control pathological symptoms could not be noted. The individual findings ofeach rabbit are specified in table 11-V. The tables VI and VII indicate the grade summary and the mean value of grades of ocular lesions of the animals.



# ContainsTSCA Confidential BusinessInformation 6Page 22 of26 pages Report 97 1042 412C 

### 11 Acute Eye Irritation/Corrosion
Table Ml: Findings, rabbit No. 152, female Grades ofocular lesions according to OECD-table Administration: test substance intheright eye Control: untreated left eye conjunctivae time after cornea iris redness chemosis admiinistration right left right left right left right left administration 0 0 0 0 0.5 0 0 0 ISthour 0 0 0 0 2 0 3 0 day 1 00- 00- 0 0 2 0 2 0 day2 1 0 0 0 2 0 1 0 day3 0 0 0 0 1 0 1 0 day4

- - - - - - - - day 5 0 0 0 0 0 0 0 0 day6 0 0 0 0 0 0 0 0 day 7 0 0 0 0 0 0 0 0 day8 0 0 0 0 0 0 0 0 *Afluorescein - test was performed in order to demonstrate defects ofthe cornea; in this case: day 1: right eye (test substance) negative() left eye (control) negative (-) Exsudation was observed in the eyes oftherabbit till day 1ofthe observation period.



# ContainsTSCA Confidential Business Information 6Page 23 of26 pages Report97 1042412 C 

# C cut Eye 

### Irnitation/Corrosion
Table IV: Findings, rabbit No. 153, female Grades ofocular lesions according to OECD-table Administration: test substance in the right eye Control: untreated left eye conjunctivae time after cornea iris redness chemosis administration right left right left right left right left administration 0 0 0 0 0.5 0 0 0 Isthour 0 0 0 0 1.5 0 2.5 0 day 1 00- 00- 0 0 2 0 2 0 day2 0 0 0 0 1.5 0 1 0 day3 0 0 0 0 1 0 1 0 day4 - - - - - - - - day 5 0 0 0 0 0 0 0 0 day6 0 0 0 0 0 0 0 0 day7 0 0 0 0 0 0 0 0 day8 0 0 0 0 0 0 0 0

_ 'Afluorescein - test was performed in order to demonstrate defects ofthe cornea; in this case: day 1: right eye (test substance) negative() left eye (control) negative(-
Exsudation was observed in the eyes ofthe rabbit till day 1ofthe observation period.



# ContainsTSCAConfidentialBusiness InformationPage 24 of26 pages Report97 1042 412C _) Acute Eye irritationicorrosion
Table V: Findings, rabbit No. 154, female Grades ofocular lesions according to OECD-table Administration: test substance in the right eye Control: untreated left eye conjunctivae time after cornea iris redness chemosis administration right left right left right left right left administration 0 0 0 0 0.5 0 0 0 1Sthour 0 0 0 0 2.5 0 3 0 dayl 1(00 00- 0 0 2 0 2.5 0 day 2 1 0 0 0 2 0 2.5 0 day3 0 0 0 0 1 0 2 0 day4 - - - - - - - - day 5 0 0 0 0 0 0 0 0 day6 0 0 0 0 0 0 0 0 day7 0 0 0 0 0 0 0 0 day8 0 0 0 0 0 0 0 0 *

A fluorescein - test was performed inorder to demonstrate defects ofthe cornea; in this case: day 1: right eye (test substance) negative(- left eye (control) negative(- Exsudation was observed in the eyes ofthe rabbit till day 1ofthe observation period.



# ContainsISCA Confideantial Business Information S7/Page 25 of26 pages Report 97 10 42 412C 

# ( -Acute Eye Irritation/Corrosion

Table VI: Findings, rabbit No. 152, 153 and 154 Grade summary ofocular lesions Administration: test sustance in the right eye Control: untreated left eye conjunctivae time after cornea iris redness chemosis administration right left right left right left right left administration 0 0 0 0 1.5 0 0 0 isthour 0 0 0 0 6 0 8.5 0 dayl1 0 0 0 0 6 0 6.5 0 day2 2 0 0 0 5.5 0 4.5 0 day3 0 0 0 0 3 0 4 0 day4

- - - - - - - - day 5 0 0 0 0 0 0 0O 0 day6 0 0 0 0 0 0 0 0 day7 0 0 0 0 0 0 0 0 day8 0 0 0 0 0 0 0 0

Table VII: Findings, rabbit No. 152, 153 and 154 Mean value ofgrades ofocular lesions Administration: test substance in the right eye Control: untreated lefteye conjunctivae time after cornea iris redness chemosis administration right left right left right left right left administration 0 0 0 0 0.5 0 0 0 isthour 0 0 0 0 2 0 2.8 0 dayl1 0 0 0 0 2 0 2.2 0 day2 0.7 0 0 0 1.8 0 1.5 0 day3 0 0 0 0 1 0 1.3 0 day 4

- - - - - - - - dayS5 0 0 0 0 0 0 0 0 day6 0 0 0 0 0 0 0 0 day7 0 0 0 0 0 0 0 0 da8 0 0 0 0 0 0 0 0



# ContainsTSCAConfid)n',inI Business htormationPage 26 of26 pages Report 97 1042412 C 1Acute Eye Irrtation/Corrosion

8 ARCHIVING BioChemn GmbH, 76185 Karlsruhe, Germany, will archive raw data, the protocol, a copy ofthe report and the test article archive sample for the stipulated period of time according to GLP regulations.



# ContainsTSCAConfideritiaI Busine~s Informationautacnment 9

Daimlerstral~e 5b-U-76185 Kartsnhe 

# BioChem Tel. 07.21/9737-0 :Fax0721/9737-222 E-mail: biochem@biochem.de Labor fOr biologische und Internet: http:/Avwwbiochem.de chemische Analytk GmbH 

### REPoRT97 

### 1042412 B AcuTE DERMAL IRRIATION/CORROSION 

# [E
Project No.: 971042412 Report No.: 97 1042412B 

### Test substance:() Batch No: not stated BioChemn sample designation: 137291 2001 Date ofarrival: November 05, 1997 Sponsor: 

## Monitor. Test facility: BioChem GmibH Daimlerstr. 

### 5b D-76 

### 185 Karlsruhe Germany Management: Dr. W. Massmann Dr. M. MUller Study Director. Dr. H.-J. Kramer Quality Assurance Manager. Dr. H. Merten

Karlsruhe, December 22, 1997 BioChem,GmbH
Page 1of23 pages Report 97 10 42 412B YAcute Dermal Irritation/Corrosion 

# ContainsTSCAConfidential BusinessInformation cPage 2 of23 pages Report ?7 1042412B Acute Dermal Irritation/Corrosion 

### Statement of GLP compliance We declare that all tests are made in accordance with the protocol and with the regulations ofthe OECD-Principles ofthe "Good Laboratory Practice" (GLP). GLP: "Good Laboratory Practice" Regulations of the European Communities, EC, enacted in Germany in the "Chemikaliengesetz" (Chemicals Act), 2nd Amendment, dated July 25, 1994, BGBI I,pp. 1703, 1994 and "AndVO" dated May 14, 1997, BGBI1. 1,pp. 1060, 1997. The documented data correspond to the measured values. Management

Dr. Manfred Miller Date

Study Director

Dr. Hans-Joachim Kramer Date

Quality Assurance Manager

Dr. Hans Merten Date


# ContainsTSCAConfidential BusinessInformation 

# 61Page 3of23 pages Report 97 10 42 412 B 

# (

- Acute Dermal Irritation/Corrosion



# TUmweltmii terium Baden-Wuarttemberg

GLP-Bescheinigung
Bescheinigung Certificate ~Flerm 

### wirdbestaWgt, daB die It ishereby certified tha the test Pnohzngseinrichtung fiacility
in 76185Kar~sruhe in 76185Karlsruhe der BioChem, Labor fllrbiologische und of BioChe2, Labor ffir biologische umd chemische Analytik GimbH, chemische Analytik GmbH, Daimlerst. .5b

. Daiinlerstr. .5b

am 19J20.06.95, 27.09.95 und 26.01.96 on 

### 19120. June 95, 

### 27. September 95 

### and26. Januiary96

von der fir die 10bei-wachung 

### zustgndigen was inspected by the competent Beharde Ober dieEinhaltung der(3rund- authority regarding compliance with the 

### s~tze der Guten Laborpra-,ds inspiziert -Principles ofGood Laboratory Practice. worden ist. Eswird biermit bestifigt, daB folgende It ishereby certified 

### that studies inthis test Prflmigen 

### indieserPnafeinzichtung nach facility are conducted in compliance with the den Girundsitzen der Guten Laborpra~ds Principles ofGood Laboratory Practice. durchgefMllrt werden. Sttgrden " R o Seite 1/2 page 1/2 

# ContainsISCA Confidential BQsinoss InformationTage 4 of23 pages Report 97 10 42 412B Acute Dermal Irritation/Corrosion Scite =/ zur GLP-Bescheinigung

Prluhngskategorie 1 Prifungen aufphysikalischchemische Eigenschzften und Gehaltsbestinzmungen Priifungskategorie 2 Prilungen auftoxikologische Eigenschaften Priifungskategorie 3 Pz:Afungen aufmutagene Eigenschaften (in vitro, in vivo) Priifuugskatcgorie 4 Umwelttoxikologische Pr~Ungen zu Auswirknngen aufaquatische and terrestrische Organismen Priifungskategorie 5 Prilfungen zum Verhalten im Boden, im 

### Wasser und in der Luft; Bioakkumulation; Metabolismus Priifungskateg-orie 6 Prilfungen aufRiickstinde Dies entspricht denKategorien nachder Ailgemeinen Verwaltungsvorschrift mim Verfahren der behdrdlichen O0berwacbnng der ihaltung der Guten Laborpraxds (ChemVwV-GLP) vom29. Oktober 1990: "Physikalisch-chemische Eigenschaften unci

Gehaltsbestimmungen" "Toxikologische Eigenschaften" "0 kotoxikologiche Eigeuschafteu" "Verhalten im Boden, im Wasser und in der Luft" "RrIckstfinde" Stuttgart, den 26.02.1996 

## 14.A- 

# 4 WORTM~BErG Dr. Albrecht 

# ContainsTSQAConfidential BusinessInformation Seite2/2 page212 

# 6 onIans

# TSCA rnf~i-oIflW

### Page 5of23 pages Report97 1042 412B 

# VAcute Dermal Irritation/Corrosion

Translation ofpage 2 ofthe GLP-Certificate by BioChem.
Test category 1: Tests on physico-chemical properties and content determinations
Test category 2: Tests ontoxicological properties
Test category 3: Tests on mutagenic properties (invitro, in vivo)
Test category 4: Ecotoicological tests on. effects on aquatic and terrestrial organisms
Test category 5: Tests on behaviour in soil, in water and in the air, bioaccumulation; metabolism
Test category 6: Tests on residues
T"his corresponds to the categories according to the General Administration Regulation of the Procedure ofthe Official Supervision of the Compliance with Good Laboratory Practice (Chem VwV-GLP) dated October 29, 1990: "Physico-chemical Properties and Content Determinations" "Toxicological Properties" "Ecotoxicological Properties" "Behaviour in Soil, in Water and in the Air" "Residues" Stuttgart February 26, 1996 Bade-WiittemergContains 

# TSCAConfidentialBusinessinformation Department ofthe EnvironmentPage 6 of23 pages oR

eport1042 412B YAueDermal Irritation/Corrosion

Quality Assurance Unit Statement

Title: Final Report Acute Dermial Irritation /Corrosion project number- 97 1042 412 protocol number- 97 1042412 B
Guideline: OECD-Guideline for Testing ofChemicals No. 404 "Acute Dermal Irritation/Corrosio&"
Study / test system: Determination ofthe potential 

### of[ Ito provoke skin irritation /corrosion /albino rabbits ~


### Test substance:Q Batch No.: not stated Sample designation: 137291 2001 Date ofarrival: November 05, 1997 Study Director: Dr. H.-J. Kramer



# ContainsTSCAConfidentialBusinessInformationPage 7 of23 pages Report 97 1042412 B !-~ Acute Dermal Irritation/Corrosion

The following checks were effected: reports to the Study Director and to the date verified procedure Management November 14, 1997 protocol November 14, 1997 December 09, 1997 audit 1 December 09, 1997 December 16, 1997 audit 2 December 16, 1997 December 19, 1997 final report in English December 19, 1997

The data which were taken as a basis for this report were verified by the Quality Assurance Unit. The accordance ofthe study with its protocol, the OECD-Guideline for Testing ofChemicals No. 404 and the Principles ofGood Laboratory Practice (GLP) is guaranteed. The methods, procedures and observations are exactly described in the report. The Quality Assurance Unit ensures that thereported results exactly describe the raw data ofthe study. The Study Director and the Management are generally informed of any findings of the Quality Assurance Unit. As for this study no departures from the prescribed course ofthe test were ascertained.

Karlsruhe, December 22, 1997 Dr. H. Merten (Quality Assurance Manager)


# ContainsTSCAConfidential BusinessInformationPage 8of23 pages Report 97 10 42 412B 

# (~



# )/Acute Dermal Irritation/Corrosion

Contents page 1 Preface 9 2 Summary 10 3 Guideline 11 4 Protocol 11 5 Test Substance I1I 6 Method "Acute Denmal Irritation /Corrosion" 12 6.1 Animals and laboratory conditions 12 6.2 Composition ofdiet and water 13 6.3 Acclimatizaion/preparations 16 6.4 Study procedures 17 6.5 Evaluation ofthe skin reaction 18
7 Findings "Acute Dermal Irritation /Corrosion" 19 8 Archiving 23



# ContainsTSCAConfidential BusinessInformationPage 9 of23 pages Report 97 10 42 412B ( '/Acute Dermal Irritation/Corrosion

I Preface Test system: Acute Dermal Irritation /Corrosion Laboratory animals: Albino rabbits
Guideline: OECD-Guideline for Testing of Chemicals, Section 4, 404 "Acute Dermal Irritation / Corrosion", adopted July 17, 1992 GLP: Gesetz zum Schutz vor gefdhrlichen Stoffen (Cheinikaliengesetz ChemG, 

### § 19 a-d yam 25. Juli 1994) Project No.: 971042412 ReportNo.: 97 1042 412B Test substance: Sponsor:

Monitor Test Facility: BioChem GmbH DaimlerstraBe 5b D-76 185 Karlsruhe Germany Management: Dr. W. Massmann Dr. M. Mailer Study Director. Dr. H.-J. Kramer Quality Assurance Manager: Dr. H. Merten


# ContainsTSCAConfidential BusinessInformationPage 10 of23 pages Repr97 1042412B 

# ( 'Acute Dermal Irritation/Corrosion

2 Summary Report: Acute Dermal Irritation /Corrosion of in compliance with OECD-Guideline 404 Sponsor:

Test Facility: BioChem GmbH DaimlerstraBe 5 b D-76 185 Karlsruhe Germany ProjectNo.: 971042412 Protocol No.: 97 1042412 B Report No.: 97 10 42 412B Findings: The test substance was applied in a single dose of0.5 ml dermally to each of3albino rabbits. Under the conditions of this experiment did not produce any acute systemic toxicological signs or mortality. After evaluation of table I in OECD Guideline 404 (grades of skin lesions
- page 18 ofthis report) in the following observation period none of the three rabbits showed a dermal irritation ofthe exposure area. During the experiment all rabbits showed a gain in body weight.



# ContainsISCAConfidential BusinessInformationPage I1I of23 pages Report97 1042412 B 

# (

)IAcute Dermal Irritation/Corrosion 

# 3 Guideline 

# I b

The study procedures were performed in compliance with the OECD-Guideline for Testing ofChemicals 404 "Acute Dermal Irritation /Corrosion", adopted July 17, 1992. 

### 4. Protocol ProjectNo.: 971042412 Protocol No.: 97 1042 412B Date ofProtocol: November 14, 1997 Ratification: November 20, 1997 

### Monitor. 

# '
5. Test Substance Name: Characterization of the test substance: alcohol alkoxylate 

### Mainingredients:() Date ofarrival: Yovember 05, 1997 Sample designation: 137291 2001 Purity: not stated Physical state: liquid Colour colorless Homogeneity: homogeneous Stability: not stated Expiry date: not stated Storage conditions: not stated, storage class 10 (VCI)
In compliance with OECD-Guideline 404, a reference substance was not tested. 

# ContainsTSCA ConfidentialBusinessInformationPage 12 of23 pages Report 97 1042412 B /Acute Dermal Irritation/Corrosion 

### 6 Method "Acute Dermal Irritation/Corrosion"in Compliance with OECD-Guideline 404
6.1 Animals and Laboratory Conditions Species: Young albino rabbits Identification numbers: 149, 150, 151 (all male) Breeding: Dr. Zimmermann Schweizer Hof D-73453 Untergrdningen/Aalen Veterinary preliminaryGemn examination: Without morbid signs Diet: Raiffeisen-Ringfu~tter, Kaninchen Trockenfutter 52/P, Raiffeisen Kraftfutterwerk Kehl, ad libitum. Water- Community tap water from Karlsruhe; free access for the animals by daily changing ofthe watering-bottles. Husbandry: The rabbits housed individually in wire grating cages (area 2450 c&, height 42 cm) without bedding. Temperature: 20
- 23 0C Relative humidity: 30-70 % Light-dark-rhythm: 12: 12



# ContainsTSCAConfidentialBusiness lnforrn,,luonPage 13 of23 pages Report 97 1042412 B 

# L Acute Dermal Irritation/Corrosion

6.2 Composition ofDiet and Water Composition ofdiet "Raiffeisen Ringfutter Kaninchen". Manufacturer. Raiffeisen Kraftfutterwerke Sold GmbH, Werk Kehl Manufacturer specification oflotNo. 50891/039

INGREDIENTS: crude protein 17 % crude

### fat 3 % crude fibres 17.5 % crude ash

- 8.5 % calcium I % phosphorus 0.6 % sodium 0.2 %

ADDED VITAMINS PER KG DIET vitamin A 12.000 I.E. vitamin D 3 1.000 I.E. vitamninE 50mg fiavophospholipol 4 mg BHT

Analysis performed on lot No. 50891/039 by Dr. Nedvidek /BioChem GmbH in December 1994/January 1995.
INGREDIENTS: moisture method: 115*C/ 5h 9.0% ash method: 550'C /16 h 9.5% crude protein Kjeldahl method according to BioChem.SOP L 10 15.3 % crude fat Weibull Stoldt method in analogy to§35 LMBGL01.00-20 3.1 % 

# ContainsTSCAConfidential Business InformationPage 14 of23 pages Report 97 10 42 412B



# ( Acute Dermal Irritation/Corrosion CONTAMINANTS: oc-HCH <0.01 mg/kg 1-HCH <0.01 mg/kg y-HCH <0.01 mg/kg 8-HCH <0.01 mg/kg pentachlorobenzene <0.01 mg/kg hexachlorobenzene <0.01 mg/kg heptachlor <0.01 mg/kg aldrin <0.01 mg/kg bromophos <0.01 mg/kg heptachiorepoxide A +B <0.01 mg/kg cc-endosulfan <0.01 mg/kg dieidrin <0.01 mg/kg o,p-DDT <0.01 mg/kg p,p'-DDT <0.01 mg/kg o,p-DDE <0.01 mg/kg p,p'-DDE <0.01 mg/kg o,p-DDD <0.01 mg/kg p,p'-DDD <0.01 mg/kg endrin <0.01 mg/kg f3-endosulfan <0.01 mg/kg methoxychlor <0.01 mg/kg mirex <0.01 mg/kg propazine <0.01 mg/kg atrazine <0.01 mg/kg atrazine-desethyl <0.01 mg/kg terbuthylazine <0.01 mg/kg prometlyn <0.01 mg/kg ametryn. <0.01 mg/kg simetryn <0.01 mg/kg terbutryn <0.01 mg/kg malathion <0.01 mg/kg parathion-ethyl <0.01 mg/kg cyanazine <0.01 mg,/kg simazine <0.01 mg/kg prometon <0.01 mg/kg quintozene <0.01 mg/kg 

# ContainsTSCA Confl~ntiAic'oe 1mm-nn 

# 7Page 15 of23 pages 

### (eport 97 10 42 412 B 

### )Acute Dermal Irritation/Corrosion
COMPOSrrON OF DRINKING WATER: according to the latest available information ofStadtwerke Karlsruhe (1995): average ofdeterminations aluminium <0.03 mg/i ammonium <0.05 mg/I antimony <0.01 mg/i arsenic <0.001 mg/I barium 0.09 mg/I boron 0.01 mg/I cadmium <0.0001 mg/I calcium 119 mg/I chromium <0.001 mg/I copper <0.01 mg/i iron <0.01 mg/I lead <0.001 mg/I magnesium 10.6 mg/i manganese <0.01 mg/i mercury <0.00004 mg/I nickel <0.003 mg/i potassium 1.7 mg/I selenium <0.01 mg/i silicon 5.7 mg/i silver <0.0005 mg/i sodium 11.3 mg/I zinc <0.02 mg/i chlorides 25 mg/i cyanides <0.01 mg/I fluorides 0.08 mg/i nitrites <0.01 mg/I nitrates 6.0 mg/I phosphates <0.02 mg/I sulfates 71 mg/l 

# ContainsTSCAConfidential BusinessInformationPage 16 of23 pages Report 97 1042 412B 

# ( Acute Dermal Irritation/Corrosion 

# Ps.

dissolved organic carbon 1.4 mg/i pesticides not verificable polychlorinated biphenyls not verificable polycyclic aromatic hydrocarbons <0.00005 mg/i trihalogenmethane <0.0001 mg/i halogenated hydrocarbons <0.01 mg/I organic chlorinated compounds <0.0005 mg/I surfactants <0.01 mg/I 6.3 Acclimatization /Preparations The animals were acclimated to the test conditions for 5 days prior to the administration. Onthefifthdaythedorsal areaof thetrunkwasshavedinanareaof3x5cm'.



# ContainsTSCAConfidentialBusinessInformationPage 17 of23 pages Report97 1042412 B 

# (

_Acute Dermal Ir-ritat on/Corrosion
6.4 Study Procedures
Acclimatization: December 04, 1997
- December 08, 1997 Administration: December 09, 1997 The test substance was applied undiluted dermally in a single dose of 0.5 mllanimal onto the dorso-lumbar ,region of 3 albino rabbits. The region treated was protected with a patch (width 6cm) (Werovil, No. 15 0020, WERO-MEDICAL, D-65232 Taunusstein). It was held in place for a period of4 hours by an occlusive bandage made from a dressing (width 8 cm, with selvages, coated completely with cellophane) (No. 09 00 22, WERO-MEDICAL). The bandage was fixed with 1.25 cm broad strips of Adhesive Tape ST (WERO-MEDICAL). After removal of the bandage at the end ofthe exposure period the residual test substance was removed by gently washing with water. Observation: December 09, 1997
- December 18, 1997 The study was finished on day 9 afterthe application because no toxicological symptoms could be noted Judgement: Mortality, toxicological symptoms, behaviour, body weight, skin reactions.



# ContainsTSCAConfidential BusinessInformationPage 18 of23 pages Report 97 1042412B



# t Acute Dermal Irritation/Corrosion 6.5 Evaluation ofthe SkinReaction (according to table 1in OECD-Guideline Table I
- 1: Erythema and eschar formation Value No erythema 0 Very slight erythema (barely perceptible) I Well-defined erythema 2 Moderate to severe erythema 3 Severe erythema (beet redness) to eschar formation preventing grading oferythema 4 maximum possible 4 Table 1-2: Oedema formation Value No oedemna 0 Very slight oedema, (barely perceptible) I Slight oedema (edges ofarea well defined by definite raising) 2 Moderate oedema. (raised approximately 1mm) 3 Severe oedema (raised more than 1mm and extending beyond area ofexposure) 4 maximum possible 4 

# ContainsTSCAConfidential Business InformationPage 19 of23 pages Report 97 1042 412B 

# L Acute Dermal Irritation/Corrosion

7 Findings "Acute Dermal Irritation/Corrosion" 

### Mortality: After the dermal administration of 0.5 nml

# ( )per animal for a period of4 hours none ofthe 3 rabbits died. Toxicological symptoms: During the observation period of9 days none of the animals showed any systemic toxicological symptoms.

Behaviour: The reaction of the rabbits treated was quiet and watchful. The behavioural pattern was not different to that ofother rabbits which were not in the test. Body weight: During the experiment the body weight of all six rabbits had an increase in weight.



# ContainsTSCAConfidential BusinessInformationPage 20 of23 pages Report 97 1042412 B 

# CIAcute Dermal Irritation/Corrosion
Table 11: Body weight (statements in g): 3 rabbits, male Identification numbers: 149
- 151

______________ Rabbit No.

________ phase oftest day 149 150 151 acclimatization -5 2772 2580 2770 -4 2795 2646 2879 -3 2879 2669 2914 -2

_________ -l 2875 2670 2978 administration 0 2848 2733 3042 observation 1 2946 2783 3166 2 2998 2819 3142 3 3110 2851 3286 4 3116 2940 3357 5- 6 3219 2932 3356 7 3214 3016 3386 8 3221 3028 3469

________ 9 3307 3080 3478



# ContainsTSCAConfidential BusinessInformationPage 21 of23 pages Report 97 10 42 412B 

# ( _/ Acute Dermal Irritation/Corrosion 

# Is®

Skin reaction: After removing the occlusive bandage after a period of 4 hours, the exposure area was washed and cleaned with water. In the following observation period all three rabbits showed no dermal irritation ofthe exposure area. The findings ofthe animals 149, 150, and 151 are specified intable M-V. Table VI shows themean value ofall assessments.
Table Ill: Acute Dermal Irritation/Corrosion. Evaluation ofthe sin reaction. Rabbit 149, male Time after administration Test substance Control

_____________ Erytema Oedema Erytema Oedema Ibhrafterbandageremoval 0 0 0 0 dayl1 0 0 0 0 day 2 0 0 0 0 day 3 0 0 0 0 day 4 0 0 0 0 day 5 - day 6 0 0 0 0 day 7 0 0 0 0 day 8 0 0 0 0 day 9 0 0 0 0

Skin reaction control: Table III, IV, V and VI The shaved area close to the exposure area was used as the control. The control area did not show any pathological skin reaction. According to table IofOECD-Guideline 404, the value was always classified as 0.



# ContainsTSCAConfidential Business Infor=6O
efoPage 22 of23 pages Report 97 10 42 412 B JAcute Dermal Irritation/Corrosiona

Table IV: Acute Dermal Irritation/Corrosion. Evaluation ofthe skin reaction. Rabbit 150, male Time after administration Test substance Control

___________ Erytema, Oedemna Erytema Oedema Ilhrafterbandageremoval 0 0 0 0 dayl1 0 0 0 0 day 2 0 0 0 0 day 3 0 0 0 0 day 4 0 0 0 0 day 5 - day 6 0 0 0 0 day 7 0 0 0 0 day 8 0 0 0 0 day 9 0 0 0 0

Table V: Acute Dermal Irritation/Corrosion. Evaluation ofthe skin reaction. Rabbit 151, male Time after administration Test substance Control
______Eryth_____ema Oedema Erytema Oedema Ilhrafterbandageremoval 0 0 0 0 dayl1 0 0 0 0 day 2 0 0 0 0 day 3 0 0 0 0 day 4 0 0 0 0 day 5 - day 6 0 0 0 0 day 7 0 0 0 0 day 8 0 0 0 0 day 9 0 0 0 0 

# ContainsISCAConfiential BusinessInformation-- - -L_
_ _ _ _ __ __ _ _ _ _ _ _ Page 23 of23 pages Reprt97 10 42 412B 

# ('Acute Dermal Irritation/Corrosion 

# Is,

Table VI: Acute Dermal Irritation/Corrosion. Evaluation ofthe skin reaction. Mean values ofsin irritation scores ofall three animals Time after administration

_ Test substance Control

_____________ Erytema Oedema E ema Qedemna Ibhrafterbandageremoval 0 0 0 0 dayl1 0 0 0 0 day 2 0 0 0 0 day 3 0 0 0 0 day 4 0 0 0 0 day 5 - day 6 0 0 0 0 day 7 0 0 0 0 day 8 0 0 0 0 day 9 0 0 0 0

9 Archiving BioChemn GmbH, D-76185 Karlsruhe, Germany, will archive raw data, the protocol, a copy ofthe report and the test article archive sample for the stipulated period of time according to GLP regulations.



# ContainsTSCAConfidentialBusinessInformation-~ attachment 10

Daimlerstrafle 5 b-D-76185 Karisrhe. 

# Bioh- Tel.07.21/9737-0 

### -Fax0721/9737-222Bi 

# he E-mail: biochem~biochem.de Labor fOr bialagische und Internet: htpiMwmbiochem.de chemische Analytik GmbH 

### Report 97 1042412 A

Acute OralToxicity

Project No.: 971042412 

### Report No.: 97 1 At2412

### A Test substance: 1 Batch No: not stated BioChem sample designation: 137291 1001 Date ofarrival: November 05, 1997 Sponsor


### Monitor.) Test facility: BioChem GmbH Daixnlerstr. 5b D-76 185 Karlsruhe Germany Management: Dr. W. Massmaxm Dr. M. Miller Study Director. Dr. H.-J. Kramer Quality Assurance Manager Dr. H. Merten

Karlsruhe, January 07, 1998 BioChem GmbH
Page 1of22 pages Report 97 1042412 ACotisTCCofdnalBies 

### frm (j '/Acute 

### Oral Toxicity 

# CVtiSTC ofdnilBsns 

# nom:Page 2 of22 pages 

# reort 97 1042 412A

~/Acute Oral Toxicity


### Statement of GLP compliance We declare that all tests are made in accordance with the protocol and with the regulations of the OECD-Principles ofthe "Good Laboratory Practice" (GLP). GLP: "Good Laboratory Practice" Regulations ofthe European Communities, EC, enacted in Germany in the "Chemikaliengesetz" (Chemicals Act), 2nd Amendment, datedJuly 25, 1994, BGBI 1,pp. 1703, 1994 and "AndVO" dated May 14, 1997, BGBl. 1,pp. 1060, 1997. The documented data correspond to the measured values. Management



# ... 

# . 

# 6........................... Dr. Manfred Mfiller Date

Study Director

Dr. H-ans-Joachim Kramer Date

Quality Assurance Manager

Dr. Hans Merten Date 

# ContainsTSCAConfidential BusinessInformation

### Page 3of22 pages

-. Reoort97l1042412A 

# ( 'fAcute 

### Oral Toxicity


# Umweltministerium Baden-Wfirttemberg

GLP-Beschem*Iigung Bescheinigung Certificate Hermit wirdbestktgt, daB die Itishereby certified that the test Prilfungseinrichtung ficlity
in 76185Krisruhe in 

### 76185Karlsruhe der BioChem, Labor frbiologiche und of BioChezn, Labor farbiologiche und chemische Analytik GmbH, chemische Analytik GmbH, 

### Daimlerstr. 5b

. 

### Daimlerstr. 5b

am 19J20.06.95, 27.09.95 und 26.01.96 'on 19J20. June 95, 27. September 95 and26.IJanuary 96

von der ffir die Oberwachung mistandigen was inspected by the competent Beharde Ober dieEinhaltung der Glrund- authorityregarding compliance with the sA~e der Guten Laborpraxis inspiziert .Principles ofGood Laboratory Practice. worden ist. Es wird hiermit bestltigt, daB folgende It ishereby certified that studi~s in this test Pnifingen in dieser Prafeinxichtung nach facility are conducted in compliance with the den Grundsitzen der Guten Laborpraxis Principles ofGood Laboratory Practice. durchgeflhrt werden. BADEN- -Stuttgart, den RMERG Seite 1/2 page 1/2 4- 

# ContainsTSCAConfidentialBusinessinformation'Page 4 of22 pages Report 97 10 42 412A 

# ( Acute Oral Toxicity Seite 2/2 mir GLP-Bescheinigung

Prilfungskategorie 1 Pilfungen aufphysikalischchemische Eigenschaften umd Gehaltsbestimmangen Priifungskategorie 2 Prifungen iuftoxikologische Eigenschaften Priifungskategorie 3 Piflfungen aufmutagene Eigenschaften (Cm vitro, in vivo) Priifungskategorie 4 Umweittoxikologische Priffun-en zu Auswikngen aufaquaibche and terrestrische Organismen. Priifungskategorie 5 Priifungen zam Verhalten im Boden, im Wasser und in der Luft;.Bioakkumulatdou; Metabolismus Priifungskategorie 6 Prifungen aufRfickstinde
* Dies entsprichf den Kategorien 

### nachder Ailgemeinen Verwaltungsvorscbrift mmn Verfabren der behdrdlichen tOberachung der Ezinhaltung der Guten Laborpaxs (ChemVwV-43LP) vom29. Qlctober 1990: "Physkalsch-chemische Elgenschaften and

Gehaltsbestimmungen" "Toxikologische Eigenschaften" "OkotoxikologischeEigenschaften" "Verhalten im Boden, im Wasser und in derLuft" "Rickstfinde" Stuttgart, den 26.02.1996

MODEN. Dr. lbreht 

# ontans SCAConfidenltial Business

# 1nfor-m--'

Seite2/2 4- ~page 212

### Page 5of22pages Revort97 10 42 412A 

### /

Acute Oral Toxicitya 

# Is,

Translation ofpage 2 ofthe GLP-Certificate by BioChem. Test category 1: Tests on physico-chemical properties and content determinations
Test category 2: Tests on toxicological properties
Test category 3: Tests on mutagenic properties (in vitro, in vivo)
Test category 4: Ecotoxicological tests on* effects on aquatic and terrestrial organisms
Test category 5: Tests on behaviour in soil, in water and inthe air, bioaccumulation; metabolism
Test category 6: Tests on residues This corresponds to the categories according to the General Administration Regulation ofthe Procedure ofthe Official Supervision of the Compliance with Good Laboratory Practice (Chem VwV-GLP) dated October 29, 1990: "Physico-chernical Properties and Content Determinations" "ToxicologicalProperties" "Ecotoxicological Properties" "Behaviour in Soil, in Water and in the Air" "Residues" Stutgar, F

brury 6, 996Contains 

# TSCAConfid,.ntcl~Business

# lnform t,:c Baden-Wiirttemberg Department of the EnvironmentPage 6 of22 pages Report 97 1042412 A 

## -(

'/Acute Oral Toxicity 

# Is,

Quality Assurance Unit Statement

Title: Final Report Acute Oral Toxicity 

# E -7'- project numbe 971042412 protocol numbe 97 1042412 A
Guideline: OECD-Guideline for Testing ofChemicals No. 401 "Acute Oral Toxicity", adopted February 24, 1987
Study Itest system: Judgement ofthe acute oral toxicity/Albino rats (SpragueDawley)
Test substance: Batch No.: not stated Sample designation: 137291 1001 Date ofarrival: November 05, 1997 Study Director: Dr. H.-J. Kramer



# containsISCAConfidenl BuinessinformationPage 7 of22 pages Report 97 10 42 412A 

# ( Acute Oral Toxicity

The following checks were effected: reports to the Study Director and to the date verified procedure Management November 14, 1997 protocol November 14, 1997 December 16, 1997 audit 1 December 16, 1997 December 20, 1997 audit 2 December 20, 1997 January 02, 1998 final report in English January 02, 1998

The data which were taken as a basis for this report were verified by the Quality Assurance Unit. The accordance of the study with its protocol, the OECD-Guideline for Testing of Chemicals No. 401 and the Principles ofGood Laboratory Practice (GLP) is guaranteed. The methods, procedures and observations are exactly described in the report. The Quality Assurance Unit ensures that the reported results exactly describe theraw data ofthe study. The Study Director and the Management are generally informed ofany findings ofthe Quality Assurance Unit. As for this study no departures from the prescribed course ofthe test were ascertained.

Karlsruhe, January 07, 1998 Dr. H. Merten (Quality As-ac Manager)



# C~nafSTSCAConf-def,1 Business nomOfPage 8of22 pages Report 97 10 42 412A Acute Oral Toxicity



### Contents Page
1. Preface 9 2. Summary 10 3. Guideline 11 4. Protocol 11 5. Test substance 11 6. Method "Acute Oral Toxicity" 12 6.1 Animals and laboratory conditions 12 6.2 Composition ofdiet and water 13 6.3 Acclimatization /Preparations 16 6.4 Study procedures 16 7. Findings "Acute Oral Toxicity" 17 7.1 Mortality/LD 50 17 7.2 Body weight 18 7.3 Toxicological symptoms 20 7.4 Pathological-anatomical findings (macroscopic) 22 8. Archiving 22



# ContainsISCAConfidential BusinessInIorrnatiOflPage 9 of22 pages Report 7 10 42 412A 

# (VAcute Oral Toxicity


### 1. Preface Study: Acute Oral Toxicity Laboratory animals: Albino rats, Sprague-Dawley breed Guideline: OECD-Guideline for Testing of Chemicals, Section 4, 401 "Acute Oral Toxicity", adopted February 24, 1987 GLP: Gesetz zumn Schutz vor gefahrlichen Stoffen (Chemnikaliengesetz ChemG, 

### § 19 a-d vomn 25. Juli 1994) [Chemicals Act ofGermany] Project No.: 971042412 ReportNo.: 971042 412A Test substance: Sponsor:



### Monitor. Test Facility: BioChem GmbH DaimlerstraBe 5b D-76185 Karlsruhe Germany Management: Dr. W. Massmann Dr. M. Miller Study Director- Dr. H.-J. Kramer Quality Assurance Manager Dr. H. Merten



# ContainsTSCAConfidefl MIM Business .Page 10 of22 pages Report97 1042412A Acute Oral Toxicity


### 2. 

### Summary Report: Acute Oral Toxicity of( in compliance with OECDGuideline 401 Sponsor:

Test Facility: BioChemn GmbH DaimlerstraBe 5b D-76 185 Karlsruhe Germany Project No.: 971042412 Protocol No.: 971042 412A Report No.: 97 1042412 A Findings: The test substance was administered orally in a single dose of2000 mg per kg weight to one group of 5 male and 5 female Sprague-Dawley rats. Under the conditions ofthis ex

### periment 

# ( )caused no mortality. The experiment was finished as limit test (LD50 (oral) more than 2000 mng per kg weight). Acute toxicological symptoms attributed to the exposure to )could not be observed in all rats on the day ofadministration and during the observation period. All rats had an increase in body weight during the 15-day observation period.
The post-mortemn findings after euthanasia did not show any macroscopic organ changes.


# ContainsTSCAConfidential BusinessInformationPage I11 of22 pages Renort7 1042412A 

# S I/ Acute Oral Toxicity0


### 3. Guideline The study procedures were performed in compliance with the OECD-Guideline for Testing ofChemicals 401 "Acute Oral Toxicity", adopted February 24, 1987.


### 4. 

### Protocol Project No.: 971042412 Protocol No.: 97 10 42 412A Date ofProtocol: November 14, 1997 Ratification: November 20, 1997 

### Monitor:( 

### 5. Test Substance Name: Characterization of the test substance: alcohol alkoxylate 

### Main ingredients:Q Date ofarrival: November 05, 1997 Sample designation: 137291 1001 Purity: not stated Physical state: liquid Colour: colourless Homogeneity: homogeneous Stability: not stated Expiry date: not stated Storage conditions: not stated, storage class 10 (VC1) In compliance with the OECD-Guideline 401, a reference substance was not tested. 

# ContainsTSCAConfidential Business Information qJ3Page 12 of22 pages cenort97 1042 412A Acute Oral Toxicitya 

### 6. Method "Acute Oral Toxicity" 6.1 Animals and Laboratory Conditions Species: Albino rat Breed: Sprague-Dawley Breeding: Harlan Winkelmann GmbH Gartenstra~e 27 D-33178 Borchen Quantity: 1group of 10 rats (5males and 5females) Identification numbers: 156
- 160 (female) 161
- 165 (male) Veterinary preliminary examination: without morbid signs; females are nulliparous and non-pregnant Diet: Haltungsdilt "ALMA 0801 H 1003" twice 8g daily Water~ Free access by daily changing of the watering bottles Husbandry: The rats housed individually in Makrolon cages (area 800 cm2, height 17 cm) Temperature: 19-23 *C Relative humidity: 30-70 % Light-dark-rhythm: 12: 12



# ContainsISCAConfidentialBusiness Inform@111Page 13 of22 pages R Mort ?7 1042412 A Acute Oral ToxicityPl
6.2 Composition ofDiet and Water Composition ofdiet "ALMA 0801 H 1003": Manufacturer- ALMA-Futter Friedrich Botzenhardt KG D-87437 Kempten/Allgiu Manufacturer specification oflotNo. 6984
INGREDIENTS: crude protein 20.00 % lysine, 1.25 % methionine, 0.45 % crude fat 4.00% crude fibres 5.00 % crude ash 7.00% calcium 1.00 % phosphorus 0.80% sodium 0.50 % magnesium 0.25 %
ADDED VITAMINS PER KG DIET: vitamin A 15.000 I.E. vitamin D3 500 I.E. vitamilnE 150mg vitaminC 100mg Analysis performed on lotNo. 6984by Dr. Nedvidek /BioChem GmbH in March 1994 INGREDIENTS: moisture method: 105 *C/17 h 12.9 % ash method. 550 'C/ 6h 7.1% crude protein Kjeldahl method according to BioChemn SOP L 10 24.9 % crude fat Weibull method in analogy 

### -to 

### §35 LMBG L01.00-20 4.7 % 

# ContainsTSCAConfidential BusinessInformation 96-Page 14 of22 pages Report ?71042412A 

### j

- 

## Y Acute Oral Toxicity,

CONTAMINANTS: lindane 0.012 mg/kg a-HCH <0.01 mg/kg f3-HCH <0.01 mg/kg y-HCH <0.01 mg/kg heptachlor <0.01 mg/kg aldrin <0.01 mg/kg bromophos <0.01 mg/kg heptachlorepoxide <0.01 mg/kg ac-endosulfan <0.01 mg/kg dieldrin <0.01 mg/kg p,p'-DDT <0.01 mg/kg p,p'-DDE <0.01 mg/kg p,p'-DDD <0.01 mg/kg endrin <0.01 mg/kg f3-endosulfan <0.01 mg/kg methoxychlor <0.01 mg/kg mirex <0.01 mg/kg propazine <0.01 mg/kg atrazine <0.01 mg/kg terbuthylazine <0.01 mg/kg prometryn <0.01 mg/kg ametryn <0.01 mg/kg simetryn <0.01 mg/kg terbutryn <0.01 mg/kg malathion <0.01 mg/kg parathion <0.01 mg/kg cyanazine <0.01 mg/kg



# ContainsTSCAConfidential BusinessInformation q6Page 15 of22 pages 1eor97 1042412 A / Acute Oral Toxicity

COMPOSITON OF DRINKING WATER: according to the latest available information ofStadtwerke Karlsruhe (1995): average ofdeterminations alum'num <0.03 mg/I ammonium <0.05 mg/I antimony <0.01 mg/i arsenic < 0.001 mg/i barium 0.09 mg/i boron 0.01 mg/i cadmium <0.0001 mg/i calcium 119 mg/i chromium <0.001 mng/I copper <0.01 mg/i iron <0.01 mg/I lead <0.001 mg/i magnesium 10.6 mg/i manganese <0.01 mg/i mercury <0.00004 mg/I nickel <0.003 mg/I potassium 1.7 mg/I selenium <0.01 mg/I silicon 5.7 mg/I silver <0.0005 mg/i sodium 11.3 mg/I zinc <0.02 mg/i chlorides 25 mg/i cyanides <0.01 mg/i fluorides 0.08 mg/i nitrites <0.01 mg/I nitrates 6.0 mg/i phosphates <0.02 mg/i sulfates 71 mg/I dissolved organic carbon 1.4 mg/I pesticides not verificable polychiorinated biphenyls not verificable polycyclic aromatic hydrocarbons <0.00005 mg/i trihalogenmethane <0.0001 mg/l halogenated hydrocarbons <0.01 mg/l organic chlorinated compounds <0.0005 mg/i surfactants <0.01 mg/i 

# ContainsTSCAConfidential BusinessInformationPage 16 of22 pages 

### 9Ceor,7 1042 412A /Acute Oral Toxicity

6.3 Acclimatization / Preparations After randomization the animals were acclimated to the test conditions for 5days prior to the administration.

6.4 Study Procedures Acclimatization: Group (2000 mg/kg): December I1I
- December 15, 1997 Animal No.: 156- 165 Food was withheld overnight before the day ofadministration. Administration: December 16, 1997 (1.30 p.m. - 2.02 p.m.) AnixnalNo.: 156- *165 

### Calculated amounts of( 

# I according to the dosage of2*000 mg/kg were administered with the aid of a stomach tube to the rats. Food was withheld for fuirther 4 hours after the administration. Observation: December 16- December 31, 1997 Animal No.: 156- 165 Judgement: Mortality, LD50, body weight, behaviour, toxicological symnptoms and at the end ofthe observation period pathological findings. Pathology: December31, 1997 AnimalNo.: 156- 165



# ContainsTSCAConfidential BusinessInformationPage 17 of22 pages Repor 97 10 42 412A /Acute Oral Toxicity

7. Findings "Acute Oral Toxicity"
7.1 Mortality / LDSO
Table 1: Mortality The test group consists of5male and 5female Sprague-Dawley rats

sex male female dosage (mg/ kg) 2000 2000 mortality 0 0 numberof rats 0 outof5 0outof5 %0 0

Table 2: LD 5

0 (Sprague-Dawley rat)
- Test substance: 

# [LD 5 0 

### (mg/kg) 95 % confidence interval 

# I___________ lowerlimit upperlimit Sprague-Dawley; male > 2000-ISprague-Dawley female > 2000

After the oral administration of2000 mg( iper kg bodyweight none ofthe rats died during the observation period of 15 days.
The LD 5

0 of "p1 the acute oral toxicity study in rats ofboth sexes was estimated to be greater than 2000 mg/kg. Therefore, the study was finished as limit test.


# ContainsTSCAConfidentialBusinessInformationPage 18 of22 pages ReportR7 10 42 412A 

# C 'Acute Oral Toxicity--

7.2 Body Weight Table 3: Body weight (statements in g) 5 Sprague-Dawley rats, female Identification numbers: 156
- 160 phase oftest day 156 157 158 159 160 acclimatization -5 208 210 209 210 210 -4 212 213 211 210 214 -3 205 206 206 205 209 -2

-

_______ -1 204 200 202 204 -208 administration 0 195 192 199 194 199 1 205 204 210 186 209

_______ 2 212 208 223 197 214

_______ 3 219 214 223 202 215 4 220 216 226 207 221 5

--- 6 233 224 235 218 228

_______ 7 232 223 237 220 230

_______ 9 241 234 246 229 237

_______ 10

- - - -

______ 11 239 230 242 227 237

_______ 12

- - - -

_______ 13 240 234 250 234 247

_______ 14 242 235 250 238 245 pathology 115 1 245 1 240 251 240 1 246



# ContainsISCAConfidential BusinessInformatioPage 19 of22 pages Revort 7 10 42 412A -Acute Oral ToxicityTable 4: Body weight (statements in g) 5 Sprague-Dawley rats, male Identification numbers: 161
- 165 phase oftest day 161 162 163 164 165 acclimatization -5 216 218 212 221 211

______-4 224' 215 213 227 224 -3 223 219 228 223 226

_______ ______ -2-

-- -l 215 214 221 219
- 215 administration 0- 206 202 214 211 208 1 209 224 223 220 208 2 214 228 235 227 223 3 226 245 243 242 232

_______ 4 232 252 243 250 239

_______ 6 254 262 263 260 250 7 252 265 264 260 259 8-

-- 9 264 272 269 267 261 10

- - - - 11 278 286 290 276 278

_______ 12

- - - -

_______ 13 289 304 307 304 295

_______ 14 299 307 312 304 294 pathology 1 15 302, 308 1 315 307 302



# ContainsTSCAConfidential BusinessInformationPage 20 of22 pages Rep~ort,97 10 42 412A 

# c Acute Oral Toxicity.-

7.3 Toxicological Symptoms The observed behavioural pattern and the toxicological symptoms ofrats ofthe different groups are shown in table 5
- 6, page 20 -21. The criteria ofjudgement were changes ofhair, skin, nose and mouth with mucous membrane, eye, anal region, excrements, urine (macroscopic), respiration, circulation, nervous system andbehaviour.

Table 5: Toxicological symptoms, rat No. 156
- 160, female symptom day rat No. (maximum grade)_

___ _ 156 157 158 159 160 0. (5min) 0 0 0 1 0 0.(12Omin) 0 0 0 0 0 1 . 0 0 0 0 0 2. 0 0 0 0 0 3. 0 0 0 0 0 4. 0 0 0 0 0 5.----- 6. 0 0 0 0 0 apathy (3) 7. 0 0 0 0 0 8.----- 9. 0 0 0 0 0 10.

- - - - - 11. 0 0 0 0 0 12.

- - - - - 13. 0 0 0 0 0 14 0 0 0 0 0 1

_ _ _ _ __ _ _ _ 115. 0 1 0 1 0 1 0 1 0

_ 0 sign not observed 0. further observations during day ofadministration I slight symptom 1.- 14. days ofobservation 2 moderate symptom 3 severe symptom + death



# ContainsTSCAConfidential BusinessInformationPage 21 of22 pages ReportP7 10 42 412A
.- I 

### Acute Oral Toxicity~-

Table 6: Toxicological symptoms, rat No. 161
- 165, male symptom day rat No. (maximum grade)____ 161 162 163 164 165 0. (5 min) 0 0 0 0 0 0. (12O min) 0 0 0 0 0 1. 0 0 0 0 0 2. 0 0 0 0 0 3. 0 0 0 0 0 4. 0 0 0 0 0 5.-

--- 6. 0 0 0 0 0 no symptomsobserved 7. 0 0 0 0 0 8.

- - 9. 0 0 0 0 0 10.

- - - - - 11. 0 0 0 0 0 12.

- - - - - 13. 0 0 0 0 0 14 0 0 0 0 0 ._________15. 0 0 0 0 0 0 sign not observed 0. fuirther observations during day ofadministration I slight symptom 1.- 14. days ofobservation 2 moderate symptom 3 severe symptom + death



# ContainsTSCAConfidential BusinessInforM~tionPage 22 of22 pages Report97 10 42 412A I/Acute OralToxicity

7.4 Pathological
- anatomical Findings (Macroscopic)

No animal died during the observation period. The narcotization and euthanasia of all animals were performed in an atmosphere ofapproximately 80 %per cent CO2 at the end ofthe observation period.

Table 7: Macroscopical pathological findings, test group macroscopical individual finding rat No. sex organ chaniges 156 female

___________ 157' female
- 158 female

___________ 159 female

___________ 160 female

___________ no pathological findings noted

_ _ ____________ 161 male

___________ 162 male

___________ 163 male

___________ 164 male

___________

___________________ 165 male

__________



### 8. 

### Archiving BioChem GmbH. D- 76185 Karlsruhe, Germany, will archive raw data, the protocol, a copy ofthe report and the test article archive sample for the stipulated period oftime according to GLP regulations.


# ContainsTSCAConfidential BusinessInformationauacnmenm 1-

Oaimlerstrafe 5 b -0-76185 Kartsrhe, 

# i~ e Tel. 0721/9737-0 

### -Fox 0721/9737-222I 

# s
E-mail: biochem~biochern.de Labor fOr biologische und Internet: http./Awwbtochem.de ch &emische =ntlk GmbH



### Determination ofReady Biodegradability of

"Closed Bottle Test" According to OECD Guideline 301 D

StudyNo.: 975040420 Sponsor:



### Test substance:( Lot No.: not stated BioChem sample designation: 1372915S001 Date ofarrival: November 05,1997

BioChern GmbH Karlsruhe, January 23, 1998 HW/HW Page Iof26 pages Report 97 5040420 S Ready Biodegradability 

# ContainsTSCA ConfidentialBusiness InformationPage 2 of 26 pages Report ?7 5040 420



# ( 1' Ready Biodegradability Specification ofthe GLP-Regulations as follows:
We declare that all tests are made in accordance with the regulations ofthe OECD-principles of Good Laboratory Practice (GLP). GLP: "Good Laboratory Practice" Regulation ofthe European Communities, EC, enacted in Germany in the "Chernikaliengesetz" (Chemicals Act) 2nd Amendment, dated July 25, 1994, BGBI

1pp. 1703, 1994 and ,,AndVO", dated May 14, 1997, BGBI. 1,pp. 1060, 1997. The documented data correspond to the measured values.

Study Director

____ ___ ___ aL'" 2 H. Werle ate
Management



### "7 2 3L tI' Dr. Massmann Date
Quality Assurance Manager

Dr. Merten Date 

# ContainsTSCAConfidentialBusinessInformationPage 3 of 26 pages Reprto Inhibition Test



# U~mweltministerium Baden-Wuirttemberg

GLP-Besclieinigung
Bescheinigung Certificate Hierinit wird bestatigt, daB die It is hereby certified that the test PrOflingeinrichting ficility
in 76185SKarisruhe in 76185SKarlsruhe der BioChem, Labor fi~rbiologische und of BioChern, Labor far biologische umd chemische Analytik GmbH, chemiache Analytic GmbH, Daiznlerstr. 5b

. Daimlerstr. Sb

am 19J20.06.95, 27.09.95 und 26.0 1.96 on 19120. June 95, 27. September 95 and 26. January 96

von der far die 13berwachung zustAridigen was inspected by the competent Behorde a±ber die Einhaltung der GJrand- authority regarding compliance with the s~te der Guten Laborpraxis inspiziert -Principles ofGood Laboratory Practice. worden it Es wird hierxnit bestatigt;daB folgende It ishereby certified that studies inThfis test Priftingen in dieser Prffinrichtung; nach facility are conducted in compliance with the den Grundsa±zen der Guten Laborprawds Principles ofGood Laboratory Practice. durcbgef~hrt werden. den BADEN,4 Stut0gaM den r"ERG 0 Seite 1/2 page 1/2 ; 

# ninsTSCAConfidential Business Information* Page 4 of 26 pages Report 97 50 40 420 /Ready Biodegradability-- *Seite 2/2 zur GLP-Bescheimigung Priifungskategorie 1 Priifungen aufphysikaischchemische Eigenschzften und Gehltsbestimmungen Prifungskategorie 2 Prilfungen auftoikologische Eigenschaften Prilfungskategorie 3 Prfifungen aufmutagene Eigenschaften (in vitro, in vivo) Priifungskategorie 4 Umwelttozikologische Prifiunen zu Auswirknngen anfaquatisdie und terrestrische Orgaismen Priifungskategorie 5 Priifungen zum Verhalten in Boden, imWasser und in der Luft;.Bioakkumulation;. Metabolismus Priifungskategorie 6 Prifungen aufRiickstinde Dies entspricht dea Kategoxien nach der Ailgemeinen Verwaltungsvorschriftm * Verfibren der behdrdlichen O0berwachung der Binhaltung der Guxten Laborpra-ds

* (ChemVwV-GLP) vom 29. Oktober 1990: "Physikalisch-chemische Eigenschaften and

Gehaltsbestimmungen" "Toxikologische Eigenschaften" "Okotoxikologische Eigenschaften" 

### "Verhalten im Boden, iM Wasser 

### und inder Luft" "Rfickstinde" Stuttgart, den 26.02.1996


## et4.4< WTJRTTEMBERG 

# ContainsBu~es Dr. Albrecht '$'SCCofdnalBsesIno Seite 2/2 page 212

### Page 5of 26 pages Repot 97 50 40 420 SIRespiration 

### Inhibition Test

Translation ofpage 2 ofthe GLP-Certificate by BioChem,
Test category 1:TeTs on physico-chernical properties and content determinations
Test category 2: Tests on toxicological properties
Test category 3: Tests on inutagenic properties (in vitro, in vivo) Test category 4: Ecotoxicological tests on* effects on aquatic and terrestrial organisms
Test category 5: Tests on behaviour in soiL in water and in the air-, bioaccumulation; metabolism
Test category 6: Tests on residues This corresponds to the categories according to the General Administration Regulation of the Procedure ofthe Official Supervision of the Compliance with Good Laboratory Practice (Chem VwV-GLP) dated October 29, 1990: "Physico-chemical Properties and Content Determinations" "ToxicologicalProperties" "Ecotoxicological1 Properties" "Behaviour in Soil, in Water and in the Air" "Residues" Stuttgart, February 26, 1996 

# ContainsTSCAConfidential BusinessInforui .I
Baden-Wiirttemberg Department of the EnvironmentPage 6 of 26 pages Report 975040420 

# (~ /Ready Biodegradability_

Quality Assurance Unit Statement Final Report

Title: Determination ofReady Biodegradability of[ I.-Closed Bottle Test" according to OECD Guideline ko. 301'D study number. 97 5040420

Guideline: OECD Guideline -for Testing of Chemicals No. 301 D, "Ready Biodegradability: Closed Bottle Test", Adopted July 17, 1992. Study /test system: ready biodegradability of( oxygen meter

Test substance: Lot No.: not stated BioChem sample designation: 137291 5001 Date ofarrival: November 05, 1997
Study Director: H. Werle


# ContainsTSCAConfidentialBusinessInformationPage 7 of 26 pages Report 97 5040420 

# Y

Respiration Inhibition Test

The following checks were effected: reports to the Study Director date verified procedure and to the Management November 27, 1997 protocol November 27, 1997 December 09, 1997 audit 1 December 09, 1997 December 23, 1997 audit 2 December 23, 1997 January 21, 1998 finalireport January 22,1998

The data which were taken as a basis for this report were verified by the Quality Assurance Unit. The accordance ofthe study with the protocol, the OECD Guideline for Testing ofChemicals No. 301 D, "Ready Biodegradability: Closed Bottle Test", Adopted July 17, 1992 and the Principles of Good Laboratory Practice (GLP) is guaranteed. The methods, procedures and observations are exactly described in the report. The Quality Assurance Unit ensures that the reported results fully comply with the raw data ofthe study. The Study Director and the Management are generally informed of any findings of the Quality Assurance Unit. As for this study no deviations from the prescribed course ofthe test were ascertained.

Karlsruhe, January 23, 1998 Dr. Merten (Quality Assurance Manager) 

# ContainsTSCAConfidential BusinessInformationPage 8of 26 pages Report97 50 40 420 

# ( /Ready Biodegradability


## CONTENTS
I Study Identification
2 Test / Guideline
3 Summary
4 Test Material
5 Test Procedure 5.1 Principle 5.2 Equipment and Reagents 5.2.1 Equipment 5.2.2 Reagents 5.3 Performance ofthe Test 5.3.1 Test Controls 5.3.2 Test Solutions 5.4 TestProcedure 5.5 Test Criteria
6 Results 6.1 Toxicity Evaluation
- Inhibition Test 

### 6.2 

# ( Determination ofThOD/COD 6.3 Reference Materials, Determination ofThOD 6.4 Percentage ofBiological Degradation (Calculations) 6.5 Conclusion 6.5.1 Biochemical Degradation ofReference Substances 6.5.2 Toxicity Test 6.5.3 Biochemical Degradation of 

# ContainsTSCAConfidential Business InformatiomPage 9 of 26 pages Report 97 5040420 

# (1

VRespiration Inhibition Test
STUDY IDENTIFCATION Test: Determination ofReady Biodegradability Guideline: The study procedures described in this report arebased on the following guideline: OECD Guideline for Testing of Chemicals No. 301 D, "Ready Biodegradability: Closed Bottle Test", Adopted July 17, 1992. Sponsor:-



### Monitor:() Test facility: BioChem,GmbH Daimlerstr. 5b D-76 185 Karlsruhe Germany Management: Dr. Massmann, Dr. Mailer Quality Assurance Manager: Dr. Merten Study Director: Mr. H. Werle Project staff: Mr. Hufliagel Study number: 97 5040420 Date ofprotocol: November 28, 1997 Test substance: Homogeneity: homogeneous Expiration date/stability: not stated Packing: 30 ml in brown glass container 

# ContainsTSCAConfidential BusinessInformation fl/3Page 10 of 26 pages Report 97 50 40 420 /Roady Biodegradability 

# Is,
Storage conditions: dark storage at room temperature Safety precautions: wear gloves and protective goggles, avoid inhalation and skin contact Experimental start date: November 26, 1997 (determination ofCOD) Experimental termination date: December 30, 1997 Literature: OECD Guideline for Testing of Chemicals No. 301 D, "Ready Biodegradability: Closed Bottle Test", Adopted July 17, 1992, and German standard methods for the examination of water, waste water and sludge: "Deutsche Einheitsverfahren zur Wasser-, Abwasser- und Schlanimuntersuchung", VCH Verlagsgesellschaft; Norm H 43-1. Bestimmung des Cheniischen Sauerstoflbedarfs (CSB)-Kurzzeitverfabren, and EC Directive 92/69/EEC of 31 July 1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling ofdangerous substances, Annex Part C, Methods for Determination of Ecotoxicity; Method C.4-E, "Closed Bottle Test", Official Journal of the European Communities No. L 383 A/179, dated December 29, 1992. Archiving: BioChemn GmbH will archive the following data for 15 years: protocol, raw data, report, audits (QAU). Test substance reference samples will be archived for 12 years. 

# ContainsTSCA Confidential BusinessInformationPage I1I of 26 pages Report 97 5040420 

# ( /Respiration 

### Inhibition Test

2 TEST / GUIDELIN Determination ofReady Biodegradability OECD Guideline for Testing of Chemicals No. 301 D, "Ready Biodegradability: Closed Bottle Test", Adopted July 17, 1992.



# ContainsTSCA Confidential BusinessInformationPage 12 of 26 pages Report 975040420 Ready Biodegradability
- 3 SUMMARY 

### Determination of Ready Biodegradability of( according to OECD Guideline No. 301 D Study objectives The objective ofthis study is to determine the Ready Biode raabilityof(1 The determination of the Ready Biodegradability of

### ( )~as performed in accordance with the OECD Guideline for Testing of Chemicals Po. 301 D, "Ready Biodegradability: Closed Bottle Test", Adopted July 17, 1992. 

### Conclusion Validity ofthe test Both reference samples, potassium hydrogen phthalate and sodium acetate, reached a degradation level ofmore than 60 %within 10 days alter the substance degradation had reached a 10 %threshold degradation level. So the performed test on biodegradability of 

# [ ]according to OECD-Guideline No. 301 D is valid. Measured temperatures and 02 consumption ofblank solutions are within the range demanded by the guideline. Toxicity Test Since the presence of )h}ad no influence on the sodium acetate degradation by the inoculum, lacking test substance degradation is not due to any toxicity of[ to inoculumn bacteria. Biochemical Degradation ofL The observed degradation ofC was below 10 %in the course ofthe test. On account of this observation the test sample( can not be classified as ready biodegradable according to the "Closed Bottle Test" (OECI) Guideline No. 301 D).



# ContainsTSCAConfidential BusinessInformaticvPage 13 of 26 pages Report 97 5040420 

# L

)/Respiration Inhibition Test
4 TEST MATERIAL Name: N Active ingredient: alcohol alkoxylate 

### Ingredients:() Colour: colourless, clear Homogeneity: homogeneous Purity (declaration): not stated Expiry date/stability: not stated BioChem sample designation: 137291 5001 Date ofarrival at BioChem: November 05, 1997
5 TEST PROCEDURE
5.1 PRINCIPLE Aqueous solutions of the test substance in different concentrations, including inorganic nutrient salts, are inoculated with the effluent from a municipal sewage plant. The solutions are incubated in the dark at 22 0C ± 2 *Cfor 28 days in closed bottles. The oxygen content is measured on several days and the biochemical oxygen demand (BOD) is calculated. The oxygen content of two readily degradable reference substances without test substance is determined to check the validity ofthe test. Also a control with inoculuni, but without any test material as well as a control with pure mineral nutrient solution are run in parallel for the determination of oxygen blanks. Furthermore, a toxicity control is included in the test design by analyzing test substance, sodium acetate (reference chemical) and inoculumnjointly. A microbiological inhibition test is furthermore performed to exclude inhibitory effects in the closed bottle test. The theoretical oxygen demand (ThOD) of the test substance is calculated via the molecular formula. Moreover, especially with substances of unknown composition or limited purity the chemical oxygen demand (COD) is analytically determined. The COD is the maximum possible oxygen consumption during degradation. 

# ContainsISCAConfidential BusinessInformatiemPage 14 of 26 pages Report 97 5040420 

# C/Ready Biodegradability

The biological degradability ofthe test material isstated as a percentage ofthe BOD/COD or BOD/ThOD ratio. Test materials giving a measured BOD greater than 60 %ofthe ThOD or COD within 28 days should be regarded as readily biodegradable. This level must be reached within 10 days ofbiodegradation exceeding a 10 %biodegradation threshold.

5.2 EQUIPMENT AND REAGENTS 5.2.1 Equipment Standard laboratory glassware and tools glass bottles: 250 ml volume, glass stoppered Pipettes: Eppendorf Analytical balances: Mettler AT 261 Delta Range Sartorius Analytic A200S pH-meter: knick calimatic 02-meter: oximeter 196 inclusive thermoelement, WTW Determination ofCOD: Radiometer Titralab VIT 90 Video Titrator and ABU93 Triburette

5.2.2 Reagents Water Millipore Milfi-Q Trypton Soya Broth (Caso bouillon): caseine peptone-soja flour peptone bouillon, Merck, order No. 5459



# ContainsTSCAConfidentialBusinessInformal2-IPage 15 of 26 pages Report 97 50 40420 

# ( / Respiration Inhibition Test Nl Mineral nutrient (All ofthe following reagents were p.a. grade) Stock solutions for mineral nutrient: 

### (a): 8.50 g KH2PO4

### , potassium dihydrogen phosphate 23.61 g K 2BPO4 x 3 H,O, dipotassium hydrogen phosphate trihydrate 33.40 g Na2HPO4 x 2 H,0, disodium hydrogen phosphate dihydrate 

### 0.50 gNH4CI, 

### ammonium chloride dissolved in11 H20 (b): 36.40 g CaC12 x 2H 20, calcium chloride dihydrate, 

### dissolved inI1I H2 0 

### (c): 22.50 g MgSO4 

### x 7 H 2

### 0, magnesium sulfate heptahydrate, dissolved in 11I H20 

### (d): 0.25 gFeC13

### x6H20 

### iron (M1) chloride hexahydrate, dissolved in 11I H20 Preparation ofmineral nutrient: 32 ml ofeach ofthe solutions (a)
- (d) were added to 32 1purified water. The mineral medium was aerated for 45 minutes. The pH was determined to about 7.1.
Reference material: Sodium acetate, anhydrous, Fluka, lot No. 298125 1090, order No. 71180 Potassium hydrogen phthalate, Fluka, p.a., lot No. 287995/1 992, order No. 60359)

Inoculum: Sewage plant effluent from municipal sewage plant KarlsruhelNeureut Date ofsampling: December 01, 1997 The sewage was filtered through glass wool and was stored aerobe overnight at +4 *C until start ofthe closed bottle test on December 02, 1997. 

# ContainsTSCAConfidential BusinessInformationlPage 16 of 26 pages Report 97 5040420 

### )/'j Ready Biodegradability& 5.3 PERFORMANCE OF THE TEST
5.3.1 Test Controls Inhibition test: A test for inhibitory effects on the development ofthe bacteria was performed by cultivation of the activated sludge in a culture medium (Trypton Soya Broth) in presence of the test substance in its highest concentration made use of inthe Closed Bottle Test (24 h; 20
- 25 0C). The development ofthe bacteria was compared visually with acontrol without test material.

5.3.2 Test Solutions Ifthe test substance has an unknown stoichiometric composition like

## ( 

# ).theCOD of this solution was determined (see section 6.1).
N Test solutions of As the test substance is not anitrogen-containing compound, no correction for nitrification was made An aliquot of a f~ solution was mixed with water containing mineral salts and bacteria from a municipal sewage plant (inoculum). The aliquot was fixed to ensure a remaining concentration of at least 2 mg 02/1 H 20 in the test solution after complete biotic degradation at the end ofthe test. For that, 34.5 mg 

## ( )was weighed into a 250 mal volumetric flask. The sample was dissolved with purified water and the flask was made up to volume with this solvent. Content: 138 mgfl (= stock solution) Four different test concentrations were prepared by dilution of aliquots of this stock solution with mineral medium in separate volumetric; flasks: test conctr t on stock soln. final volume

[M.\ /I m][l 0.69 15 3000 1.38 30 3000 2.76 60 3000 14.14 90 3000 Each flask was fortified with three drops of inoculum and the solutions were shaken. Thereafter the test procedure (see section 5.4) was performed immediately. 

# ContainsISCAConfidential BusinessInformationPage 17 of 26 pages Report 97 5040420 

# L Respiration Inhibition Test 

# I

0 Test solutions ofreference material Sodium acetate: 252.2 mg sodium acetate was weighed into a I Ivolumetric flask which was filled up to volume with purified water. 60 ml of this stock solution were pipetted into a 3 1 volumetric flask. The sample was diluted with mineral nutrient and the flask was made up to volume with this solvent. concentration: 5.044 mg/i. Potassiumhydrogenphthalate 170.0 mg potassium hydrogen phthalate was weighed into a I1Ivolumetric flask which was filled up to volume with purified water. 60 ml of this stock solution were pipetted into a 3 1 volumetric flask. The sample was diluted with mineral nutrient and the flask was made up to volume with this solvent. concentration: 3.400 mg/i. Each of both flasks was fortified with three drops of inoculum and the solutions were shaken. Thereafter the test procedure (see section 5.4) was performed immediately.

5.4 TEST PROCEDURE
Test 

### Sample'( Reference Material The test solutions of , 4nd the reference solutions (see section 5.3.2) were each filled bubble-free into ten 250 ml glass bottles up to their maximum capacity. The bottles were closed airtight with glass stoppers. Subsequently the bottles were stored for 28 days in darkness at a temperature of 22 ± 2 *C.On day 0, 7, 14, 21 and 28 two bottles per sample were opened and the oxygen content was measured using an 02 electrode. The contents of each bottle were poured off after oxygen measurement with exception ofthe bottles ofday 0. These bottles were refilled with their corresponding test solution and they were stored in darkness as the others as reserve. The BOD ofLA 409 was determined via the decrease ofoxygen in the bottles. Additional Samples (Test Control) Degradation test: The biological degradability of sodium acetate and potassium hydrogen phthalate in the closed bottle test was determined (see above). The degradability had to reach at least a level of60 per cent, i.e. sodium acetate and potassium hydrogen phthalate had to exhibit a BOD which was greater than 60 per cent oftheir ThOD within 14 days. 

# ContainsTSCAConfidential BusinessInformationPage 18 of 26 pages Report 97 5040420

_ 

# (

'/Ready 

### Biodegradability

Toxicity test: To remove any trace ofdoubt about the test substance toxicity to bacteria,( )nits highest tested concentration was fortified with sodium acetate stock solution: 90 ml of (- )stock solution and 60 ml sodium acetate stock solution were pipetted into a 3 1volumetric flask. The sample was diluted with mineral nutrient and the flask was made up to volume with this solvent. 

### concentration: 

# L4.14 mg/I, sodium acetate: 5.044 mgfl The flask was fortified with three drops of inoculum and the solution was shaken. Thereafter the test procedure (see above) was performed immediately. Any indication o( 1toxicity would have resulted in a decreased sodium acetate BOD level. Blank control: For test control two additional samples were prepared: Pure mineral nutrient and mineral nutrient fortified with 3drops inoculumn per 31(test performance see above).

5.5 TEST CRITERIA Test substances reaching a pass level of 60 %removal of ThOD within 28 days are so called "ready biodegradable". Pass-level-criterion: 60% degradation must be reached within at least 10 days after exceeding the 10% degradation level. * Validity ofstudy: 1.Oxygen depletion in the inoculum blank must not exceed 1.5 mgdissolved 02/1 after 28 days. 2. The residual concentration ofoxygen in the test bottles must not fall below 0.5 mg 02/I at any time. 3. Difference of extremes of replicate values of the removal of the test substance at the plateau or at the end oftest :5 20 % 4. Percentage degradation ofreference compound reaching pass level by day 14.


# ContainsTSCAConfidential BusinessInformationPage 19 of 26 pages Report 97 5040420 

### I/1 Respiration Inhibition Test


### 6 RESULTS
6.1 Toxicity Evaluation
- Inhibition Test Test concentration: 0.84 mg( )and 200 ml caso-bouillon; added volume of activated sludge: 50 jgd per flask (double determination) sample evaluation ofbacteria development after 24 h incubation time at 20
- 25*C control test sample, 4.2 mg

-no growth, + = low, -H- =middle, +- high growth There are no inhibitory effects on the development ofthe bacteria by the test material in its highest concentration or test blank used in the Closed Bottle Test. Moreover, a respiration inhibition test carried out with activated sludge accor~ing to OECD Guideline No. 209 revealed no inhibitory effect to bacteria attributed to 

# ( ',This outcome was recorded in detail in BioChemn Report 975040 806, dated January 20, 1998.



### 6.2 

# ( ,Determination ofThOD/COD
Theoretical Oxygen Demand (ThOD) Due to the unknown exact stoichiometric composition of( )the theoretical oxygen demand (ThOD) was not used as a basis for degradation determination. Therefore, the chemical oxygen demand was determined experimentally.
Chemical Oxygen Demand (COD) German'Standard Methods of Water Analysis ("Deutsche Einheitsverfahren zur Wasseruntersuchung"), Method H 43-1 was used for COD determination. 52.9 mg ) was weighed into a 250 ml volumetric flask. The sample was dissolved with purified water and the flask was made up to volume with this solvent. Concentration: 211.6 mg/l. Used device: Radiometer Titralab VIT 90 Video Titrator and ABU93 Triburette 

# ContainsTSCAConfidential Business Information APage 20 of 26 pages Report 97 5040420 

# ( /Ready 

### Biodegradability A fourfold determination of COD of )was performed after equilibrium of l titrimetric system: 

### sample No. COD [Mg 02/11 

### COD [mg 02/ Mg1 1 

### 469.1 2 476.3 3 471.5 4 472.0 mean 472.2 2.23 calculation: COD [Mg 02/1] )conc. (mg/I] = COD [mg O 2Img] The chemical oxygen demand of( 

# )was determined to 2.23 g 02 /g test substance.

6.3 Reference Materials, Determination ofThOD
Sodium acetate, Determination oftheoretical oxygen demand (ThiOD) Calculated according to OECD Guideline for Testing ofChemicals 301 D, Annex IV Substance: sodium acetate, anhydrous 

### Formula: C2H3NaO2 element mol/formula molecular mass g/mol g/mol substance carbon, C 2 12.011 24.022 hydrogen. H 3 1.0079 3.024 sodium, Na 1 22.9898 22.990 oxygen,O0 2 15.9994 31.999 molecular weight (g/mol) 82.04 ThOD (mg O,/g substance) 780 The theoretical oxygen demand (ThOD) ofsodium acetate was calculated to 780 Mg 0 2 /g or 0.78 g 0 2 /g sodium acetate.



# Contains TSCA ConfidentialBusinessInformationPage 21 of 26 pages Report 97 50 40 420 

### )l~ Respiration Inhibition Test Potassium hydrogen phthalate, Determination oftheoretical oxygen dema~s Calculated according to OECD Guideline for Testing ofChemicals 301 D, Annex IV Substance: potassium hydrogen phthalate, anhydrous Formula: CsH5KO4 element mol/formula molecular mass g/mol g/mol substance carbon, C 8 12.011 96.088 hydrogen, H 5 1.0079 5.0395 potassiumn,K 1 39.0983 39.0983

- oxygen, 0 4 15.9994 63.9976 molecular weight (g/mol) 204.22 ThOD (mg 

### 0,/g substance) 1175 The theoretical oxygen demand (ThOD) ofpotassium hydrogen phthalate was calculated to 1175 mg 02/g or 1. 175 g 02/g potassium hydrogen phthalate.

6.4 Percentage ofBiological Degradation (Calculations)
* 02 decrease (mg oxygen/I) afterx days: oxygen consumption [mg 02/I] =(m,~, - nj- (mbo

- mb.)

M0= 02 value in mg/l at day 0 (test substance) Ml,= 02 value in mg/I at day x (test substance) MbO =02 

### value inmg/I at day 0(mean ofblanks with inoculum) =b 02 value in mg/i at day x (mean ofblanks with inoculum)
MBiological oxygen demand (ROD) in mg oxygen /g substance BOD [mgO2/g substance] = (oxygen consumption / c(test substance)) .1000

- oxygen consumption inmg oxygen / I

- c(test substance) = concentration oftest substance inmg/I 

# ContainsTSCA Confidential BusinessInformationPage 22 of 26 pages Report 97 5040420 

# ( '/Ready Biodegradability N Calculation ofthe percentage ofbiological degradation BODinmg/g - 100 %biological degradation=

________ COD* inmg/g *or ThOD, respectively



# ContainsTSCA Confid,.ninIBusiness InformationPage 23 of 26 pages 

# Reprto Inhibition TestIs

c r

Vh d

a ~E

P vi
I-t

0* CDN0

- -M 0 a -L ft ft 0

0.0 V at-tN t E " .daW a iaa F

-0 01

I- I E -x

a 2c

o :: Rg

Cotan TC Cofdeta Busnes InformationPage 24 of 26 pages Report 97 50 40 420 

# ( Ready Biodegradability

8~~~~~~ 0gr qc 0C)c 0)

C ' -0)- " ( 0 -E C. 0 cc0 x 0C3 0 00 

### E

a)~I 00n 0 E
N" 0~ 'On0 Pf 4)0 2d 00 (N 0 0 &.d c E~~a 00 E U)

0)
W C M r: C4 C C c 0 M oM4)C ) 4wU

Do E

_ _ _~ 0

_ _ . _ _ ' 4) '

0 - (0 oo 00 v V._ 

### E 8 (U - 4)U4 ) -w 0) (D 'ai + I0- E ~

___ E__

__ _ 

# _ 2 o~~~~~~~c en__ ~'.-W-~

___ _ 

# CoVisTC ofdnilBsns nomtoPage 25 of 26 pages Report 97 50 40 420 '~iRespiration inhibition Test

ca W

to

- t-4

010 0


### oo

050

0) 0 U& 2 -- ) '

E + CL < . 0 z Cotan oSC CofdnilBsns nomtoPage 26 of 26 pages Report 975040420 

### )/ Ready Biodegradability 6.5 Conclusion 6.5.1 Biochemical Degradation ofthe Reference Substances

Sodium acetate Within 7 days after start ofthe test the biodegradability ofsodium acetate had reached a plateau ofabout 70 %degradation. The degradation already exceeded the required minimum of60 %at this time. A final degradation ofabout 81 %was determined after 28 days. Potassium hydrogen phthalate Within 7 days after start ofthe test the biodegradability ofpotassium hydrogen phthalate had reached aplateau ofabout 70 %degradation. The degradation already exceeded the required minimum of60 %at this time. A final degradation ofabout 81 %was determined after 28 days. Summary: Both reference samples, potassium hydrogen phthalate and sodium acetate, reached a degradation level ofmore than 60 %within 10 days after the substance degradation had reached a 10 %threshold degradation level. So the performed test on biodegradability of f-J according to OECD-Guideline No. 301 D is valid. '"Measuied temperatures and 02 consumption ofblank solutions are within the range

demanded bythe guideline. 6.5.2 Toxicity Test Since the presence of( 

## > hadno influence on the sodium acetate degradation by the inoculum, lacking test substance degradation is notdue to any toxicity of( -0 inoculumn bacteria.
6.5.3 Biochemical Degradation of( The observed degradation of(_ )was below 10 %in the course ofthe test. Since this observation the test sample 

## (-

- )can notbe classified as ready biodegradable according to the "Closed Bottle Test" (OECD Guideline No. 301 D).



# ContainsTSCAConfidential BusinessInformation

### attachment 12

Daimlerstralfe 5 b-D-76185 Kadruhe 

# i he Tel. 07.21/97 37-0O- Fax 0721/9737-222Bi 

# he E-mail: biochrObiochem.de Labor fOrbiologische und Internet: http-/wvwbiohem.de chemish MAioyik GmbH



### Activated Sludge, Respiration Inhibition Test According to OECD Guideline No. 209 

## of(

Study No.: 975040806 Sponsor:

Test substance: ) Lot No.: not stated BioChem sample designation: 137291 7001 Date ofarrival: November 05,1997

BioChemn GmbH Karlsruhe, January 20, 1998 HWIHW
Page Iof 23 pages Report 97 50 40 806 

# C

~IRespiration Inhbition 

### Test 

# ContainsTSCAConfidentialBusinessInformationPage 2 of 23 pages Report 97 5040 806 

# ( Respiration Inhibition TestIs Specification ofthe GLP-Regulations as follows:
We declare that all tests are made in accordance with the regulations ofthe OECD-principles of Good Laboratory Practice (GLP). GLP: "Good Laboratory Practice" Regulation ofthe European Communities, EC, enacted in Germany in the "Chemikaiiengesetz" (Chemicals Act) 2nd Amendment, dated July 25, 1994, BGBI1I, pp. 1703, 1994 and ,,ndVO", dated May 14, 1997, BOBI. 1,pp. 1060, 1997. The documented data correspond to the measured values.

Study Director

______________ uaw f 

# o /S0 H. Werle Date
Management

Dr. Mfiller Dae 1
Quality Assurance Manager

Dr. Merten Date ,zc7 

# ContainsISCAConfidential BusinessInformationPage 3 of 23 pages Report 97 50 40 806 S 

### Respiration Inhibition Test 

# I

Umweltm=nisterium Baden-Wfirttemberg

GLP-Beschehuigunig
Bescheinigung Certificate lflerinit wird bestitigt, daB die Itis hereby certified that the test Profungseinrichtung: flility
in 7618SKrisruhe in 76185Karsruhe der BioChem, Labor ffir biologische und of BioChem, Labor fdr biologische und cheisheAnalytik GmbH,

- chemiscite Analytik G~mbH, Dainlerstr. 5b

. Daimerstr. 5b

am 19J20.06.95, 27.09.95 und 26.0 1.96 on 19J20. Tune 95, 27. September 95 and26. January96

von der fir die Oberwachung nist~ndigen was inspected by the competent Beharde Qber die Einhaltuing der Giund- authority regarding compliance with the satze der Guten Laborprawds inspiziert Principles ofGood Laboratory Practice. worden ist -Es wird hiermit bestAtigt, daB3 folgende It ishereby certified that studies in this test Pra1fungen in dieser Prafeinuichtung nach facility are conducted in compliance with the den Grunds~tzen der Guten Laborpraxis Principles ofGood Laboratory Practice. durchgefihfrt werden. 

# Contains

# ISCAConfidential B snttss 

# Inlormation Sttgtdn 6 RfER Seite 1/2pae12j page11/2*Page4-of23 Pages Report 97 5040 806 

# ()/Respiration Inhibition Test *Seite 2/2 mur GLP-Bescheinigung r Priifungskategorie 1 Pxiifungen aufphysikaichchemische Eigenschateu urid Gehaltsbestimmungen Priifungskategorie 2 Prilfungen auftoikologische Eigenschaften Prifungskategorie 3 Prg~fungen aufmutagene Eigenschnften (in vitro, in vivo) Priifungskateg-orie 4 Umwelttoxikologische Prilfungen zu Auswikngen aufaquatische und terresfrische Organismen Prtifungskategorie 5 Priifungen zam Verhalten im Boden, imWasser und in der Luft;'Bioakkumulation;. Metabolismus Priifungskategorie 6 Priifungen aufRiickstiinde
Dies entspricht denKategorien 

### nachderAilgemeinen Ve waltumgsvorschrift 71M Ver~bren der behard~ichen Oberwachtng der Einhl~tung der Guten Labo rads * (ChemVwV-GLP) voam 29. Oktober 1990: IlPhysik- 1 ich-chmische Eigenschaften und

Gehaltsbestimmungen" "Toxikologische Eigenschaften"

't6kotoklogische Eigenschaften" "Verhalten im Boden, im Wasser und in der Luft" "Rickstlinde" Stuttgart, den 26.02.1996

Dr. Albrecht 

### Cnan SACniefB u~ns nomf
Seite 2/2 page 212

### Page 5of 23 pages Report 975040806 /Respiration Inhibition Test

Translation ofpage 2 ofthe GLP-Certificate by BioChem. Test category 1: Tests on physico-chemicat properties and content determinations
Test category 2: Tests on toicological properties
Test category 3: Tests on mutagenic properties (invitro, in vivo) Test category 4: Ecotoxidcological tests on* effects on aquatic and terrestrial organisms
Test category 5: Tests on behaviour in soil, in water and in the air; bioaccumulation; metabolism
Test category 6: Tests on residues This corresponds to the categories according to the General Administration Regulation of the Procedure ofthe Official Supervision ofthe Compliance with Good Laboratory Practice (Chem VwV-GLP) dated October 29, 1990: "Physico-chernical Properties and Content Determinations" 1?oxicological Properties" "Ecotoxicological Properties" "Behaviour in Soil, in Water and in the Air" "Residues" Stuttgart, February 26, 1996 

# ContainsTSCAConfidentialBusinessInformallOl Baden-Wilrtemberg Department of the Environment134Page 6 of 23 pages Report 97 5040 806 

# ( /Respiration 

### Inhibition Test

Quality Assurance Unit Statement Final Report

Title: Respiration Inhibition Test of( 

# )according to OECD Guideline No. 209 study number: 97 50 40 806

Guideline: OECD-Guideline for Testing of Chemicals No. 209, "Activated Sludge, Respiration Inhibition Test", adopted April 04, 1984. Study / test system: respiration rate of activated sludge in presence of LA 409/ oxygen meter



### Test substance: Lot No.: not stated BioChemn sample designation: 137291 7 001 Date ofarrival: November 05, 1997
Study Director. H. Werle



# ContainsTSCAConfidential BusinessInformationPage 7 of 23 pages Report 975040806 

# ( Respiration Inhibition Test

The following checks were effected:
dateveriied roceurereports to the Study Director dateveriied roceureand to the Management December 16, 1997 protocol December 16, 1997 December 23, 1997 audit December 23, 1997 January 19, 1998 final report January 19,1998

The data which were taken as a basis for this report were verified by the Quality Assurance Unit. The accordance ofthe study with the protocol, the OECD-Guideline for Testing ofChemicals No. 209, "Activated Sludge, Respiration Inhibition Test", adopted April 04, 1984 and the Principles of Good Laboratory Practice (GLP) is guaranteed. The methods, procedures and observations are exactly described in the report. The Quality Assurance Unit ensures that the reported results fully comply with the raw data ofthe study. The Study Director and the Management are generally informed of any findings of the Quality Assurance Unit. As for this study no deviations from theprescribed course ofthe test were ascertained.

Karlsruhe, January 20, 1998 Dr. Merten (Quality Assurance Manager) 

# ContainsTSCAConfidential BusinessInformationPage 8 of 23 pages Report 97 5040 806 

# ( )/Respiration Inhibition Test I


### CONTENTS
I Study Identification
2 Test/ Guideline
3 Summary
4 Test Material
5 Test Procedure 5.1 Principle 5.2 Equipment and Reagents 5.2.1 Equipment 5.2.2 Reagents 5.3 Performance ofthe Test 5.3.1 Reference Material 5.3.2 Solutions ofthe Test Substance 5.3.3 Solutions ofthe Reference Substance 5.3.4 Test Concentrations 5.3.5 Synthetic Sewage Feed 5.3.6 Activated Sludge 5.3.7 Test Conditions 5.3.8 Test Procedure 5.3.9 Test Validity
6 Results 6.1 Activated Sludge
- Determination ofDry Matter 6.2 Observations /Treatment ofResults 6.3 Table ofResults 6.4 Graphic Evaluation ofEC50 ofthe Reference Substance 6.5 Exemplary Recorder Plots 

# ContainsTSCA Confidential BusinessInformationPage 9 of 23 pages Report 97 50 40 806 

### Il/ Respiration Inhibition Test r 1 STUDY IDENTIFICATION Test: Activated Sludge, Respiration Inhibition Test Guideline: The study procedures described in this report are based on the following guideline: OECD-Guideline for Testing of Chemicals No. 209, "Activated Sludge, Respiration Inhibition Test", adopted April 04, 1984. Sponsor:

Monitor: r ) Test facility: BioChem GmbH Dainilerstr. 5b D-76185 Karlsruhe Germany Management: Dr. Massmann, Dr. MUler Quality Assurance Manager: Dr. Merten Study Director: Mr. H. Werle Project staff- Mr. Hufniagel Study number: 97 50-40806 Date ofprotocol: December 17, 1997 

### Test substance:( Homogeneity: homogeneous Expiration date/stability: not stated Packing: 30 ml in brown glass container 

# ContainsTSCAConfidential BusinessInformationPage 10 of 23 pages Report 97 5040 806 

# ()IRespiration Inhibition Test Storage conditions: dark storage at room temperature 

# I

Safety precautions: wear gloves and protective goggles, avoid inhalation and skin contact Experimental start date: December 15, 1997 (weight ofsynthetic sewage feed ingredients) Experimental termination date: December 23, 1997 (performance of respiration inhibition test) Literature: OECD-Guideline for Testing ofChemicals No. 209, 'Activated Sludge, Respiration Inhibition Test", adopted April 04, 1984, EC Directive 88/302/EEC of November 18, 1987 adapting to technical progress for the ninth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, Annex Part C, Methods for Determination of Ecotoxicity; Official Journal of the European Communities No. L 133 All, dated May 30, 1988 and corrected in L 136 A/20. Archiving: BioChemn GmbH will archive the following data for 15 years: protocol, raw data, report, audits (QAU). Test substance reference samples will be archived for 12 years.
2 TEST

### / GUIDELINE Activated Sludge, Respiration Inhibition Test. OECD-Guideline for Testing of Chemicals No. 209, "Activated Sludge, Respiration Inhibition Test", adopted April 04, 1984.

# ContainsTSCA Confidential Business InformationPage I1I of 23 pages Report 97 50 40 806 

# ( /Respiration 

### Inhibition Test 

# 3 SUMMARYIs Activated Sludge, Respiration Inhibition Test of )according to OECD-Guideline No. 209 Study objectives The objective ofthis study isto determine the potential respiration inhibition oft The determination of the respiration inhibition of( )vas performed in accordance with the OECD-Guideline for Testing of Chemicals No. 209, "Activated Sludge, Respiration Inhibition Test", adopted April 04, 1984. 

### Conclusion Results ofthe Test Control: The test controls document the correct progress ofthe respiration inhibition test. The respiration rates ofthe two controls are within 15 per cent ofeach other. The EC5 0 (3 h) value ofthe reference substance is in the accepted range of5 to 30 mg/I (19.4 mg/l 3,5-dichlorophenol determined from the course ofalinear regression curve).


### Results ofthe Test: The study on respiration inhibition of five concentrations ofthe test substance shows 

### no inhibitory effect. The tested concentrations had a respiration rate higher than the control samples. Following this findings, no EC5 0 value can be deduced from this result. 

### In summary, it was found that )lot No. not stated, is not a respiration inhibitory agent according to the OECD Guideline No. 209.



# ContainsTSCAConfidential BusinessInformationPage 12 of 23 pages Report 97 5040806 ~)/ Respiration Inhibition Test 

## 4 TESTMATERIALIs Name:( Active ingredient: alcohol alkoxylate 

### Ingredients:() Colour: colourless, clear Homogeneity: homogeneous Purity (declaration): not stated Expiry date/stability: not stated BioChemn sample designation: 137291 7001 Date ofarrival at BioChem: November 05, 1997

5 TEST PROCEDURE
5.1 PRI"cIPLE The respiration rate of an activated sludge fed with a standard amount of synthetic sewage feed is measured after a contact time of 30 minutes or 3 hours, or both. The respiration rate ofthe same activated sludge in the presence ofvarious concentrations of the test substance under otherwise identical conditions is also measured. The inhibitory effect ofthe test substance at a particular concentr-ation is expressed as apercentage ofthe mean respiration rates oftwo controls. An EC 5

0 value is calculated from determination at differrent concentrations.
Defnitions The respiration rate is the oxygen consumption of aerobic sludge or waste-water microorganisms expressed generally as Mg 02 per litre perhour. EC 5

0 in this study is the concentration ofthe test substance at which the respiration rate is 50 per cent ofthat shown by the control under conditions described in this report. 

# ContainsTSCAConfidential BusinessInformationP age 13 of 23 pages Renort 97 5040806



# L~ Respiration Inhibition Test 

## Applicability 

# I b

Chemicals which are non-volatile and are soluble in water are assessed by this method. For test substances with limited solubility in the test media, it may not be possible to determine the EC 5

0. 

### 5.2 EquipmentandReagents 5.2.1 Equipment Standard Laboratory Equipment and Glassware Analytical balance: Mettler AT 261 Delta Range Sartorius Analytic 

### A200S Centrifuige: SIGMA 3-1 Air supply: Behromat membrane pump 06002, airflow 7-9 1/min, distributed on 12 outlets resulting in airflows of0.58
- 0.75 I/min per vessel Air flow meter: Rota M40 2
- 16 1/min pH-meter: Knick Calimatic (deviation from protocol) Oxygen meter: WTW OXI 537 with electrode EO 96 connected to aLavmann, Mini 220N xy-plotter Measuring apparatus: BOD flask Vessels: PE bottles (deviation from protocol) Autoclave: Webeco GmbH 5.2.2 Reagents Sodium hydroxide: Merck, p.a., Lot No. K22393704 551 Sulfuric acid: 0.5 M, Merck, p.a. Sodium hydroxide: I mol/l, Merck, p.a., Lot No. 70234 255 3,5-dichlorophenol 97 %: Aldrich No. D 7,060-0, LotNo. 00410-055 Peptone: Merck, Lot No. V 778513 618 Meat extract: Fluka, Lot No. 354902/1 12897 Urea: Fluka, p.a., Lot No. 283942 389 Sodium chloride, NaCi: Merck 1.06404 p.a., LotNo. K22393704 551 Calcium chloride, CaCI2 - 2H 20: Merck, p.a., Lot No. 129TA129682 Magnesium sulfate, MgSO4 - 7H 20: Merck, p.a., Lot No. A918686630 Dipotassium hydrogen phosphate: Merck, p.a., Lot No. A913699633 

### K,

2

### HP0 4 

### - 3H 20: Potable water: tap water Karlsruhe 

# ContainsTSCAConfidential Business InformationPage 14 of 23 pages Report V7 50 40 806 

# f VRespiration Inhibition Test



### 5.3 PERFORMANCEOFTHE TEST 5-3.1 Reference Material 3,5-dichiorophenol as a known inhibitor ofrespiration was used as reference compound and tested for EC50 in order to check that the sensitivity of the used sludge was not abnormal.
5.3.2 Solutions of the Test Substance Solutions ofthe test substance was freshly prepared at the startofthe study using astock solution. A stock solution concentration of 0.150 g/l was prepared. Due to the low solubility of the test substance a higher concentration (e.g. 0.5 g/l as cited in the guideline) was not appicable: 37.5 mg(- ?lwas filled into a 250 ml volumetric flask. The sample was dissolved with purified water and the flask was made up to volume with this solvent. concentration: 150 mg/l(
5.3.3 Solutions of the Reference Substance 0.5000 g 3,5-dichiorophenol was weighed into a 100 ml beaker. The sample was dissolved by addition of 10 ml I M NaOH. After addition of approximately 20 ml purified water, 0.5 M sulfuric acid was added under stirring until the point of incipient precipitation (about 8.5
- 9 ml of 0.5 M sulfuric acid was required) was reached. Thereafter the solution was quantitatively transferred into a 11I volumetric flask and the flask was made to volume with purified water. The pH of the resulting solution was determined to 7.80.
5.3.4 Test Concentrations Five concentrations ofthe test substance, spaced by a constant factor not exceeding 3.2, were used for the test: From the stock solution with a content of 150 mg/l five concentrations were made (factor 2): 100, 50, 25, 12.5 and 6.25 ml ofthe stock solution were diluted each to test solutions of 500 ml volume corresponding to concentrations of 30, 15, 7.5, 3.75 and 1.88 mg/l in the test solutions. Three concentrations of the reference substance were used: 10, 25 and 50 mg/I (made from 10, 25 and 50 ml ofa stock solution with the concentration of0.5 g/l). 

# ContainsTSCAConfidential BusinessInformation /4Page 15 of 23 pages Report 97 50 40 806 

# ( 'Respiration Inhibition Test
5.3.5 Synthetic Sewage Feed A synthetic sewage feed was prepared by dissolving the following amounts of substances in I litre ofwater: 16.00 g peptone 11.00 g meat extract

3.00 g urea 0.70 g sodium chloride, NaCI 0.40 g calcium chloride, CaCI2 - 2 H20 

### 0.20 g magnesium sulfate, MgSO4 

### -7 H20 2.80 g dipotassium hydrogen phosphate, K 2 BPO4 - 3H20* C... This sewage feed was prepared on December 19, 1997, filled into 100 ml PE-bottles and was autoclaved. The tightened bottles were held at + 4*C in the dark until start of the respiration inhibition test (December 23, 1997). The pH value of the sewage feed was determined to 8.0. 5-3.6 Activated Sludge A fresh sample of activated sludge (suspended in approximately 8 1 water) -of the municipal sewage plant Neureut/Karlsruhe taken on December 22, 1997 was treated as mentioned in the cited guideline: The sludge was precipitated. The sludge was washed with potable water, the supernatant liquid was sucked off using a tube connected with a water jet pump (deviation from protocol). This procedure was repeated three times. A small amount ofthe sludge was filled into a glass dish in duplicate, weighed and dried overnight at 105 IC in order to obtain the dry matter. From this result the amount ofwet sludge was calculated which had to be suspended in water in order to obtain an activated sludge with a mixed liquor suspended solids level of 4 g/l. This level gave a concentration of 1.6 g/I in the test medium following the procedure listed below. The so prepared sludge was kept aerated. Due to the fact that it could not be used on the day of sampling, 50 ml of synthetic sewage feed was added to each litre ofthe activated sludge prepared as described above; this mixture was then aerated overnight at 20 ±2*C.

*Deviation from protocol: K 2 HPO4*-3H20 instead ofK 2HPO, was used. 

# ContainsTSCAConfidential Business InformationPage 16 of 23 pages Report 97 5040 806 

# (

)/Respiration Inhibition Test 

# Ies

5.3.7 Test Conditions Duration/contact time: 3hours, during which aeration took place Vessels: PE bottles Water: Potable water Karlsruhe Air supply: Bebromat membrane pump 06002 pH meter. Knick calimatic Measuring apparatus: BOD flask Oxygen meter: WTW OXI 537 connected to an xy-plotter Nutrient solution: Synthetic sewage feed (see above) Test substance: Freshly prepared test solution (5 different concentrations) Reference substance: 3,5-dichlorophenol (3 different concentrations) Controls: Inoculated samples without test substance (2samples) Temperature: 20.3
- 22.6 0C 5.3.8 Test Procedure 10 PE-bottles (in deviation from protocol) were used. Control At time "0" 16 ml ofthe synthetic sewage feed was made up to 300 ml with water. 200 ml ofmicrobial inoculum was added and the total mixture (500 ml) was poured into the first bottle (first control). Aeration was started. Testsubstance/ referencesubstance At time "15 min" the above was repeated except that 100 ml of the test substance (reference substance, respectively) stock solution was added to the 16 ml of sythetic sewage feed before adding water to 300 ml and microbial inoculumn to make a volume of 500 ml. This mixture was then poured into the second vessel and aerated as above. This procedure was repeated at 15-minute intervals with different volumes of the test substance stock solution and the reference substance stock solution to give a series of vessels containing 5different concentrations oftest substance and three for the reference substance. Finally, a second control was prepared. After three hours the pH ofthe solutions was measured. Then contents ofthe first vessel were poured into the BOD flask and the oxygen consumption was measured over aperiod of 10 minutes. This determination was repeated on the contents of each vessel at 15- minute intervals, in such a way that the contact time in each vessel was three hours. 

### 5.3.9 TEST VALIDITY The test results are considered to be valid if the two control respiration rates are within 15 per cent ofeach other, the EC50 (3 hours) of3,5-dichlorophenol is in the accepted range5 to 30 mg/I. 

# ContainsTSCAConfidentialBusinessInformationPage 17 of 23 pages Report 97 

### 50 40 806 )/Respiration Inhibition Test I



### 6 RESULTS 

### 6.1 ActivatedSludge
- 

### Determinationof Thy Matter Initial weights before drying Test No. glass dish/ glass dish + sample tare sample weight 114.2411 g 24.7516g 10.5105 g 2 13.8688 g 22.1165 g 8.2477g

Final weights after drying overnight at 

### 105 0C Test No. glass dish / glass dish + sample weight dry matter

___ ___ ___ tare sample

_ _ _ _ _ _ _ _ _ _ _ _

1 14.2411 g 14.4244 g 0.1833g 1.74% 2 13.8688 g 14.0138 g 0.1450 g 1.76% The dry matter (mean value) of the activated sludge was determined to about 1.8 % From this result the amount ofwet sludge was calculated which had to suspended in water in order to obtain an activated sludge with a mixed liquor suspended solids level of 4g/l: 

### 555.69 g activated sludge was diluted to a volume of2.5 1with water.



# ContainsTSCAConfidential BusinessInformation 

# A/7Page 18 of 23 pages Report 97 5040806 

# ( /Respiration Inhibition Test 

# Is

6.2 Observations / Treatmentof Results Oxygen Consumption was measured and recorded after an aeration time of 3 hours (contact time) by means ofan oxygen meter connected with an xy recorder. The respiration rate was calculated from the recorder trace as mg 02/1 and h between approximately 6.5 mg 02/1 and 2.5 mg 02/, or over a 6 minute period (in deviation from protocol) when the respiration rate was low. The respiration rate was measured over the linear portion ofthe respiration curve. The respiration rate was expressed as a percentage of the mean of the two control respiration rates: 2Rs 1 -_______ *100 =percent inhibition

Rc1 + Rc2 where Rs oxygen-consumption rate at tested concentration oftest substance Rc, oxygen-consumption rate, Control I RC 2 oxygen-consumption rate, Control 2

OECD No. 209: The respiration rates ofthe two control samples must be within 15 per cent of each other. The EC 5

0 value (3 h) of the reference substance must be in the accepted range. Otherwise the test is invalid and has to be repeated. The per cent inhibition was calculated at each test concentration as above. The per cent inhibition was plotted against the logarithm ofconcentration and the EC 5

0was derived.



# ContainsTSCAConfidentialBusiness InformationPage 19 of 23 pages Report 97 5040 806 

# ( IRespiration 

### Inhibition Test 

### 6.3 Tableof Results I

Tabellel 

# C J- Respiration inhibition Test (OECD 209)

stock soin. stock samn. sample content volume sample conc. temperature start time control 1I

- - 20,3 10:45 a.m. reference 1 500 10 10 20.8 11:00 a.m. reference 2 500 25 25 21,3 11:15 a.m.

rerence 3 500 50 50 21.5 11:30 a.m. 150IS 6,25 1,88 22,1 11:45a.m. /2 150 12,5 3,75 22,3 12:00 a.m. /3 150 25 7,5 22,2 0:15 P.M. /4 150 50 15 22,4 0:30p.m. 150 IS 100 30 22,6 0:45 p.m. n o12 1
- I
- 122,3 1:00p.m.I 

### pH determinations:

- syntheticsewage feed: 8.0

- reference sample /stock. soln.: 7.8 I stocksoln.: 7.5

- aerated sewage: 7.75

measurement ofoxygen content evaluation sample time duration from to difference consumption inhibition

____ f~m min] 1mjA [m/1 [m [mgl(irh)] 

### A1%
. control1 1:45 p.m. 6 5.1 1,6 3,5 35
- reference 1 2:00 p.m. 6 5.8 3,4 2,4 24 34.2 reference2 2:15p.m. 6 7,0 5,4 1,6 16 56,2 r~mfernce,3 2:30p.m. 6 7,3 6,3 1 10 72,6 1 l 2:45 p.m. 6 5,5 1,0 4,5 45 -23.3 1 /2 3:00p.m. 6 5,8 1,7 4,1 41 -12,3 1 /3 3:15p.m. 6 5,1 1,1 4 40 -9,6 (4 3:30p.m. 6 5,6 1,3 4,3 43 -17.8 conol 2 4:00 p.m. 1 6 1 5,5 1,7j 3.8 38 1
- 

# ContainsTSCAConfidential Business InformationPage 20 of 23 pages Report 97 5040 806 

# ()/ Respiration Inhibition Test 

### 6.4 Graphical Evaluationof EC,, of theReference Substance I

Tabelle2


### Reference sample 3,5-dichiorophenol Calculation of EC5O 10~coflc.. inhibition N .,000 34,2xcofiin: 5,6 13858,2 constnt: 0,72 1.699 72,6 correl. coeff.: 0,999992
3,5 dichlorophenol

70

s.~ ..... C30-

0.000 0,500 1,000 1,500 2,000 log (com-.)

Determination of ECSO at 50% inhibition via graphical evaluation: inhibition 

### [%] = (Iog(conc.) *54.956).- 20.72 Iog(conc.) = (inhibition [%] + 20.72) / 54.956 log(conc.) = (50 + 20.72) / 54.956 Iog(conc.) = 1.287 concentration (EC5O) = 19,36 mg/I 

# ContainsTSCAConfidential BusinessInformationPage 21 of 23 pages Report 97 5040 806 

# (\/Respiration Inhibition Test 

### 6.5S ExemplaryRecorderPlots Control I

10.4 1111IIT1


# IIi~ I

ContainsTSCAConfidential BusinessInformationPage 22 of 23 pages Report 97 50 40 806 

# t)/Respiration Inhibition Test

Reference 2 25 mg/I 3,5-dichiorophenol



# IN II It 

# I 

# I

11 11 1111%-4 H il I I I I 1 1 1 !1



# ContainsTSCA Confidentil Busine~p fnforrna'tionPage 23 of 23 pages Report ~7 5040 806 ~Respiration Inhibition Test

/3 7.5 mg/I LA409

44 ' I! KI



# ContainsTSCAConfidential BusinessInformation

### attachment 13 

# BioChem Am Wieseneck 7 

### -D-04451 Cunnersdorf 

# I s gr Tel. 034291/416-0 -Fax 0342 91/41622Lao rbilgshun E-mail: biochem@ btiochemn.de Laborch furbilgih undH Internet: http:/Avww.biochem.dechmseAaltkGb
Final report 97 10 48078 Acute Toxicity Fish Test Zebra rish
- Brachydanio rerio according to OECD Guideline 203 (1992)

BioChemn project No.: 97 1048078 Date oforder: 30.10.97 

### Test substance:( Manufacturing date: 30.06.97 Sponsor:
Monitor: TESTIN FAciLrry: BioChem,agrar Am Wieseneck 7 D-0445 1Cunnersdorf Testing Facility Management: Dr. 1.Winkler StudyDirector: Dr. R. Kleiner Quality Assurance Manager: A-Kistner ANALYTICAL LABORATORY: 

### BioChemn GmbH Karlsruhe Daimlerstrale 5b D-76 175 Karlsruhe Responsible scientist: Dr. Walter Quality Assurance Manager: Dr. Merten Study completion date: 12.03.98
Final report 97 10 48 078 Acute Toxicity Fish Test( Original 2of2 Page Iof 18 

# ContainsISCAConfidentialBusiness InformationFinal report 97 1048078 Acute Toxicitiy Fish Test Original 2 of 2 i Page 2 of 18



# .. ISACHSISCHES 

### STAATSMILNTSTERRJMI FUR UMWELT .IND LANPESENTWICKLUNG

GLF-aescheinigung
Elescheinlgung Crtificate Hiemfnit wird best~ligt. dali die Prfifungseinrichtung(en) It is h~ereby certified that the test facflity(ies) 04451- Cunnersdorf.,V 04451 CunnersdCrE in ~ AM illne c 7

. ar iseneq*c< 7 de................................ . ..................................... 27./28.02.1996 und ain 

### .2 1 05 1996 -Februai Y.27-23,1990'and '..ay 21,139; tO.2tum) (date) von derfOr die Ciberwachung :uslAndigen Sehfrde Ober was (were) inspected by the competent authority regarale Einhaltung der Geundsdtze der Guten Laborpraxis ding compliance with U'.e Priicacles ci Good Laboratory inspiziert warden ist (sind). Practice. Es wird hierrnit bestatigt. dali folgende Pri~fungen in It is hereby certified that szudies inthis test facility are dieser Prlifeinnichtung nach den Grundsdtzen der Guten conducted in compliance with the Principles or Good Laborpraxis durchge(Ohrt werden.

. Laboratory Practice. PrUfkatagoria 4 Umwelttoxikalogiscna PrUfungan zu Auswirkungen auf aquatische und4 tercastrische Crganismner ?riifkategorie 5 Pri~fung3n zu.n Van't!- :.T, v ;assar und i.n z.az LuEt; ?rjE a gorie '6 Pr,'fungan aur -C.s tan= Crasden, den 13.06.1995



# R

I(LatrSA HE ContainsTSCAConfidentialBusiness InformationFinal report 97 1048 078 Acute Toxicitiy Fish Test(~ Origina 2 of2S Page 3of 18

GLP Compliance Statement Project No.: 97 1048 078 Title: Acute Toxicity Fish Test Zebra fish
- Brachydanlorerio according to OECD Guideline 203 (1992)

I hereby declare that this study was performed according to the study plan by the procedure described in compliance with the "Principles of Good Laboratory Practice (GLP)" ("Chemikafiengesetz, Juli 1994, Anhang 1"). The documented data correspond to the experimentally determined values. There were no circumstances that may have adversely affected the quality or integrity ofthe data. Study Director: D..R .Ken ........... Quality Assurance Statement Procedures ofthis study were periodically inspected by the Quality Assurance Manager and the results reported to the Study Director and to the Testing Facility Management. Inspections/ Dates ofinspections/ Datesofreport audits audits Studyplan 20.10.97 20.10.97 Experiments 05.109.12.97 12.12.97 Final report 09.03.98 12.03.98 I herewith attest the authenticity and the correct and accurate performance ofthis study according to the "Principles of Good Laboratory Practice (GLP)" ("Chemikaliengesetz, 

### Juli 1994, Anhang 1"). Quality Assurance Manager: ............. ........ A.Kiistner Date Testing Facility Management: L:& 

### >. ................. .-..... 4....... Dr. J.Winkler Date



# ContainsTSCAConfidential Business InformationAcute Toxicitiy Fish Test Original2of2 Page 4of 18

Table of contents Page Title page I GLP Certificate 2 GLP Compliance Statement 3 Quality Assurance Statement 3 Table ofcontents 4 Summary 5 1. General information 6 1.

1. Objective 6 1.2. Project staff 6 1.3. Time schedule 6 1.4. Test guidelines 6 1.5. Amendments to the study plan 6 1.6. Archiving 6 2. Performance ofthe test 7 2.1. Test substance 7 2.2. Test system 8 2.3. Experimental procedure 9 2.3.1. Preparation ofthe test solutions 9 2.3.2. Course ofthe trial (chronological schedule) 10 2.3.3. Assessment ofthe test 11 2.4. Calculation I1I 3. Results 12 3.1. Cumulative mortality ofeach concentration 12 3.2. Abnormal responses ofthe fish

., 13 3.3. Results ofthe analytical determination of( 

# ) 13 inthe test solutions 3.4. Oxygen concentrations, pH values and temperatures 14 3.5. Length and weight offish 16 4. Conditions for the validity ofthe test 17 5. References 17 Appendix: Analysis ofthe tap water 18


# ContainsTSCAConfidential BusinessInformationFinal report97 1048078 AcuteToxicitiy Fish TM(t Origina 2of2 Page 5of18
Summary 

### Acute toxicity fish test J Test substance: Manufacturing date: 30,06.97 Chemical name: Solution stability: not stated Fish species: zebra fish
- Brachydanio rerlo Test procedure: statically Analytical method: H1igh Performance Liquid Chromatography The method and the results ofthe analytical determination ofthe test concentrations are described in the related report "Determination ofTest Sample Concentration in Combination with the Acute Toxicity Fish Test of( " dated March 04, 1998 (as separate annex to this report).
Results Nominal concentrations of( ),nominal / measured, all inmg/I) 48 h afterapplication 96 ii after application NOEC 19.8 / 13.7 29.6 / 20.0 LC 0 29.6 / 21.2 29.6 / 20.0 LC50 36.3 / 27.4 36.3 / 26.8 LCo 44.4 / 35.4 44.4 I36.0 The LC,0 values are determined according to the statement ofthe EC Directive 92/69/EEC, C.1: "When two consecutive concentrations
... give only 0 and 100 %mortality, these two values are sufficient to indicate the range within which the LCso falls." Only moderate degradation was observed at relevant concentrations.


# ContainsTSCA Confidential BusinessInformationFinal report 971048 078 Acute Toxicitiy Fish Test, Original 2of2 Page 6of18
1. General information 1.1. Objective The objective ofthe study was to determine the acute toxicity of the test substance 

# ) characterized bythe median lethal concentration at 96 hours after application (96 hours L 5o). The examination ofthe toxic effects was performed with the zebra fish (Brachydano rerio) as a representative test organism for aquatic vertebrates according to OECD Guideline for Testing of Chemidcals 203. 1.2. Project staff Study Director: Dr. agr. RalfKleiner Personnel: Martina Mittag (laboratory assistant) Responsible scientist for analysis: Dr. Walter Mr. Werle was the responsible technical assistant for the analytical examidnations (Labor Karlsruhe). 1.3. Time schedule Study initiation date: 14.11.97 Signature ofthe study plan by the sponsor: 20.11.97 Experimental start date: 05.12.97 Experimental termination date: 13.12.97 Study completion date: 12.03.98 1.4. Test guidelines

- OECD Guideline for Testing ofChemicals 203 (1992) "Fish, Acute Toxicity Test"

- Standard operative procedures (SOPs) ofthe testing facility 1.5. Amendments to the study plan The study was performed in compliance with the study plan. 1.6. Archiving Study plan and final report as well as the raw data are kept in the GLP archives ofBioChemn agrar in compliance with the GLP principles. A retention sample ofthe test substance is stored for 5years. Destruction ofany data or retention sample ofthe test substance requires the sponsor's consent.


# ContainsISCA

# Confidential BusinessinformationFinal report 97 10 48078 Acute Taxicitly Fish Test,( Origina 2of2 Page 7of 18

2. Performance ofthe test 2.1. Test substance 

### Code No.:() Manufacturing date: 30.06.97 Expiry date: no information 

### Active ingredient:( Density (20 *C): 0.96 g/cm 3 Appearance: colourless clear liquid Solubility in water: <~ 0.5 g/l (25 -C) Storage conditions: room temperature, container keep closed, class ofstorage (VCI): 10 Stability/homogeneity: not stated Classification: designation according to EC-Classification/GefStoffV: "30'
- Irritant; R 36/3 8; S24/25, 36/37/3 9 Further details: "Sicherheitsdatenblatt" (91/1S5/EWG) of03.11.97



# ContainsTSCAConfidential BusinessInform~tionFinal report97 1048078 Acute Toxicitiy Fish Test,.( Original 2of2 Page 8of 18

2.2. Test system Test organism: zebra fish
- Brachydaniorenio Origin ofthe animals used in the test: purchase from the fish farmning Erfiirter Neon GbR Total length ofthe test fish: 2.5
- 3.7 cm Holding conditions The test fish were in good health and were acclimatized for 15 days, ofwhich the last 7 days they were kept inwater ofthe same quality used in the test. Light-dark-cycle: 16 h fight : 8 hdark, daily Temperature: 21
- 25 0C Oxygen concentration: at least 80 %ofair saturation value Feeding: daily (Tetra Mmi Hauptfutter) until 24 hours before the test was started Tap water ofCunnersdorfofthe following quality was used during the holding time and the first period ofacclimatization (see appendix): 

### acid capacity K. 4.3: 

### 1.26 mmol/l sum ofcalcium and magnesium ions: 77 mg/l calcium Ca 2': 63.1 mg/I magnesium Mg'*: 13.9 mg/I sodium Nae: 25.2 mg/I potassium K~: 6.8 mg/i pH: 7.3 During the acclimatization period the fish were not treated. Not any fish died. Test conditions Test vessel (pool): 10-l-aquarium (40 cm x 25 cm x25 cm) Test volume/vessel: 101 Number offish/vessel (= concentration or control): 10 Loading: maximum loading of 1.0 g fish/i Test procedure: static test Use ofvehicles: none Climatic conditions Temperature: 22.5
- 23.2 0C Oxygen concentration: 8.5
- 9.1 mg/I (i. e. 93-100 %air saturation value) Feeding: none Light-dark-cycle: 16 h light : 8h dark, daily Test duration: 96 hours 

# ContainsTSCAConfidential Business lnformi-tionFinal report 97 10 48 078 Acute Toxicitiy Fish Test,() 

## Original 2 of2kIs Page 9of 18

Test water Conductivity ofdeionized water: 0.4- 1.5 pS/cm Dilution water used inthe test period was reconstituted water: CaCI2 2 rnnol/l MgSO 4 

### 0.5 mmol/l NaHCO 3 0.75 minol/I KCI 0.075 mmol/l The sum ofcalcium and magnesium ions in the dilution water was 2.5 mmol/l. The proportion of Ca : Mg ions was 4 : 1and ofNa :K ions 10 : 1. The acid capacity K. 4.3 of the solution was 0.8 mmol Derived from the CaCl2 addition, the hardness of water was equal to 2 mmol/l CaCO3, which corresponds to a hardness of200 mg/l CaCO3 (valid: 10
- 250 mg/l). pH value oftest water: light basic (8.5
- 9.1) 2.3. Experimental procedure 2.3.1. Preparation ofthe test solution The solubility of the active ingredient

# ( )in potable water is <0.5 g/l (as stated by the sponsor). Each pool contained 10 1dilution water. The control pool (pool No. 1)contained dilution water only. In a range finding test the concentration range of 10 to 100 mg/l was determined for the maintest. The fac~or for dilution used was 1.5. 3 gL 

# ( vas,transferred into a 3000 ml volumetric flask and filled up to volume with dilution water This solution was stirred overnight for the purpose ofsaturation. Stock solution A: 1000 mg/I The preparation ofthe test solutions is summarized in the following tables: Preparation ofthe stocksolutions solution amount total amount stock solution amount name ofdilution water of solution name concentration 21 A + 1 3 1 B 667mg/I 21 B + 1 31 C 444mg/i 21 C + 1 3 1 D 296mg/I 21 D + 1 3 1 E 198mg/I 21 E + 1 3 1 F 132mgfi 

# ContainsTSCAConfidential BusinessInformationFinal report 97 10 48 078 Acute Toxicitiy Fish Test,( Original2of2 Page 10 of 18
Fillingof the testvessels (pools) pool concentration of 

### (amount of stock solution No. (mg/I) dilution water amount name 1 0(control) 10 1 2 100 91 + I11 A 3 66.7 91 + I1I B 4 44.4 91 + I11 C 5 29.6 91 + II D 6 19.8 91 + I11 E 7 13.2 91 + I1I F The saturated solution and the dilution water as well were prepared the day before (in the afternoon). They were stirred overnight inthe same cabinet and at the same temperatures as the fish test was performed. The pools were permanently aerated by an aeration pump (type SP 402 SLR). 

### Not dissolved )~was not discernible inthe pools. 2.3.2. Course of the trial(chronological schedule) The chronological schedule is valid for each performed test. 7days before thestartof the test

- Transferring ofthe fish infresh dilution water 24 hoursbefore the startof the test

- Determination ofphysico-chemnical measured values ofthe prepared dilution water and adaptation to the methodical requirements (pH, oxygen concentration, temperature)

- Preparing ofthe stock solutions ofthe test substance At the beginningofthe test

- Control ofpHL oxygen concentration and temperature ofthe dilution water

- Preparing ofthe test vessels and filling ofthe dilution water into the test vessels

- Preparing ofthe required test concentrations by addition ofthe corresponding volumes ofthe stock solutions into the test vessels 

### (= application)

- Sampling ofthe test solution ofeach test concentration for analysis (main-test)

- Transferring ofthe test animals into the test solutions 

# ContainsTSCAConfidential BusinessInformatiOnFinal report 971048078 Acute Toxicitiy FishTest,( Origi"a 2of2 Page 11 of 18
3, 6,24, 48, 72 and96 hoursafterapplication

- Determination ofthe number ofimmobile fish 0, 24, 48, 72 and96 hoursafterapplication

- Measurements ofpH, oxcygen concentration and temperature

- Sampling ofthe test solution ofeach test variant for analysis (main-test, only 48 and 96 hours)

- Waste disposal 2.3.3. Assessment ofthe test Time:

-3, 6, 24, 48, 72 and 96 hours after application Parameters: at the beginning ofthe test: pH*) oxygen concentration~ temperature substance concentration *3,6, 24, 72 and 96 hours after application: number ofimmobile fish in each test vessel *24,48, 72 and 96 hours after application: pH*) oxygen concentration temperature substance concentration~

=determination ofeach test concentration 2.4. Calculation The LDso values (48 and 96 h) were derived from calculation (par example: 41 29.6 * 44.4) being considered the geometric means ofLCo and LCtoo concentrations. The LC5ovalue (3 h)was graphically obtained resulting from the plot on probit paper.



# ContainsTSCAConfidential Business InformationFinal report 97 10 48 078 Acute Toxicitiy Fish Test( Original 2 of2 Page 12 of 18

3. Results 3.1. Cumulative mortality at each concentration after 3, 6, 24, 48, 72 and 96 hours Number.of dead fish LA 409 3h 6h 24h 48h 72h 96h noinal concentr.___________ control 0 0 0 0 0 0 100.0 mg/I 10 10 10 10 10 10 66.7mg/I 10 10 10 10 10 10 44.4mg/I 9 10 10 10 10 10 29.6mg/I 0 0 0 0 0 0 19.8mrg/I 0 0 0 0 0 0 1 13.2mg/i 0 1 0 1 0 1 0 1 0 1 0 The NOEC (no observed effect concentration) after 96 hours was 20 mg<l )(measured concentration). e

hghest tested concentration causing no mortality after 96 hours (96 h LCo) was 20 mg/I Ymeauredconcentration). The lowest tested concentration causing 100 %mortality after 96 hours (96 hLC100) was 36 mg/i 

# (-measured concentration). The 3 h median lethal concentration of (3 h Ljie.the concentration which proved lethal to 50 %offish at the time of3 hwL~35o) mg drie rphicaly). The median lethal concentration of

## f 

# ),i.e.the concentration which oroved lethal to 50 %of fish was 27.4 mg/l~ at the timie o 48 hours and 26.8 mgA( ) t 96 hours (derived arithmetically). The fish were inspected at least daily. Fish were considered to be dead iftouching the caudal peduncle produced no reaction. Dead fish were removed when observed. The control fish showed neither mortality nor any visible sign ofabnormality during the test time of96 hours. Incidents inthe course ofthe test which might have influenced the results could not be observed during the test period.



# ContainsISCAConfidentialBusiness InformationFinalreport97 1048O078 AcuteToxicitiy FishTes/ Original 2 of2 Page 13 of18 a 3.2. Abnormal responses of the fish observation time concentration of( N)visible signs ofabnormalities / ofsurviving test fish 3h 66.7and 10mg/I 10fishperished 44.4 mg/I 1fishlies upside downon the bottom of the pool. wvith respiration movements 6h 29.6 mg/I 2fish shows intensive respiration activity and uncontrolled movements 24 h 29.6 mg/I 2fish shows intensive respiration activity and uncontrolled movements 48 h 29.6 mg/i Ifish shows intensive respiration activity and uncontrolled movements At any other time of inspection no visible signs of abnormalities of surviving test fish were observed. 3.3. Results ofthe analytical determination of( ')n the test solution Concentrationof( the testwater Date ofmeasurement: 18. - 21.02.98 nominal mean ofmeasured concentrations (mg/I) concentration at thetime of (Mt)0h 48hI 96h control <0.5 <0.5 <0.5

100.0 100.4 96.4 93.7 66.7 65.6 61.8 61.2 44. 41.4 35.4 36.0 29.6 25.6 21.2 20.0 19.8 16.9 13.7 13.1 13.2 10.4 8.8 8.5



# ContainsISCAConfidential BusinessInformationFinal report 97 10 48078 Acute Toxicidy Fish Test,( Original 2 of2 Page 14 of 18
Degradationof

nominal( recovery in %of recovery after 96 h in %

concentrtion the nominal ( bae)ntemaue

control

-

100.0 100.4 93.7 93.3 66.7 98.4 91.8 93.3 44.4 93.2 81.1 87.0 29.6 86.5 67.6 78.1 19.8 85.4 66.2 77.5 13.2 78.8 64.1 81.3
Forprecise statements see the related analytical report. 3.4. Oxygen concentrations, pH values and temperatures The dissolved oxygen concentrations ofthe control and ofthe test solutions were checked daily at 24 hours intervals. Dissolvedoxygen concentrationof the testwater(mg/i1): concentrations (nominal) 0 h 24 ht 48 ht 72 ht 96 h control 9.1 8.9 8.6 8.6 8.6 100.0 mg/I 9.1 8.9 8.6 8.6 8.6

66.7 mg/i 9.0 8.9 8.6 8.6 8.6 44.4 mg/I 9.0 8.9 8.6 8.5 8.5 29.6 mg/I 9.0 9.0 9.0 8.9 8.9 19.8 mg/I 9.0 9.0 9.0 8.9 8.9 13.2 mg/I 9.0 9.0 9.0 8.9 8.9
volumetric instrument: 02-meter OXI 96 WTW Wissenschaftlich-Technische Werkstatten GmibH D-82362 Wejiheim



# /97Final report 97 10 48 078 Acute Toxicitly Fish Test Original2of2 1 Page 15 of 181 

# Is

The pH values ofthe control and ofthe test solutions were checked daily at 24 hours intervals. The pH values ofthe test solutions were not adjusted.
pHvalue Oh 24h 48h 72h 96 h control 7.79 7.79 7.76 7.76 7.77 100.0 mg/I 7.79 7.79 7.76 7.76 7.76 66.7 mg/i 7.79 7.79 7.76 7.77 7.76 44.4 mng/i 7.79 7.80 7.78 7.76 7.76 29.6 mg/i 7.79 7.86 7.78 7.77 7.76 19.8 mg/I 7.78 7.89 7.83 7.86 7.86 13.2 mng/I 7.89 7.90 7.86 7.86 7.86
volumnetric instrument: pH-meter pH 95 WTW Wissenschaftfich-Technische Werkstitten GmnbH D-82362 Weilheirn During the test period the following water temperatures were measured: Oh: 22.50 C 24h: 22.7 OC 48h: 23.00 C 72h: 23.20C 96 h: 23.0 0C



# ContainsTSCAConfidential BusinessInformationFinalreport 97 1048078 Acute Toxicitiy Fish Test,( Original 2 of2 Page 16 of18

3.5. Length and weight ofthe fish Length of fish total length of 10 fish (cm) control -nominal concentration (mg/I) 100 66.7 44.4 29.6 19.6 13.2 2.5 3.1 3.3 3.4 3.1 3.5 3.1 2.9 3.4 3.4 3.5 3.3 3.5 3.0 2.8 3.0 3.4 3.5 3.1 3.4 3.1 3.0 3.4 3.6 3.2 3.2 3.1 3.1 353.3 3.5 3.5 3.1 3.0 3.2 3.0 3.6 3.1 3.4 3.5 2.8 3.3 3.1 2.7 3.4 3.1 3.4 3.0 3.2 3.4 3.4 3.4 3.4 2.7 3.0 3.2 3.2 3.2 3.5 3.3 3.1 3.5 3.0 3.0 3.7 3.1 2.8 3.2 3.1 3.4 average 3.04 3.28 3.37 3.31 3.17 3.19 3.16
Weightoffish total weight of 10 fish (mg) control 

# (-nominal concentration (mg/I) 100 66.7 44.4 29.6 19.6 13.2 134 245 281 307 248 471 248 166 289 308 293 321 407 228 164 174 299 312 310 426 277 200 298 392 231 298 303 290 301 254 345 340 247 256 276 212 422 229 235 313 178 318 257 177 283 244 346 253 306 301 228 304 269 157 240 326 234 246 267 288 279 453 212 175 385 252 195 283 276 349 average 214.4 271.8 296.0 271.4 280.2 326.3 283.0 

# ContainsTSCA ConfldtntiadC,,.ness Informat10,Final report 97 10 48 078 Acute Toxicitiy Fish Test, Original 2of2 Page 17 of 18

4. Conditions for the validity ofthe test Constant conditions had been maintained throughout the test. There was no mortality in the control. The dissolved oxygen concentration had been at least 60 per cent ofair saturation value. In all test solutions the measured pH-fluctuation was below 1pH-unit during 96 hours. There was analytical evidence that the( 

# )concentration had been satisfactorily maintained during the test period. 5. References OECD Guideline for Testing ofChemicals, 203 "Fish, Acute Toxicity Test". OECD July 17, 1992. EC Directive 92/69/EEC, Annex, Method C. 1., Official Journal of the European Communities No. L 383 A, December 29, 1992. DIN 38412, Teil 15: Testverfahren mit Wasserorganismen (Gruppe L). Bestimmung der Wvirkung von Wasserinhaltsstoffen aufFische. Deutsche Norm, Deutsches Institut turNormung e.V. Berlin, Juni 1982. Letale Wirkcung beimn ZebrabIrbling Brachydanforenao (LCO, LC5O, LC100; 48-96 Stunden). Verfahrensvorschlag der ad hoc-Arbeitsgruppe des Tjmweltbundesamtes zur Entwicklung 6kotoxikologischer Testverfahren inaqjuatischen Systemen, Mai 1984. LrrcHFMEL, J.T. and WILCOXoN, F.: A simpled method ofevaluating dose effect experiments. J.Pharm. Exper. Ther. 9-6 99-113, 1949.



# ContainsTSCA ConfidenIt;,l Business InformationFinal report 97l1048 078 Acute Toxicitiy Fish Test,( Orignal 2 of2 Page 18 of 18 Appendix: Analysis ofthe tap water Kocturas Waaksw Leipzg CjmbL

Wauta hc PnmfxdlIc

Triakwusgfabm Duizbsazamogym 1996 Emahmvicie. %WTbiuft
cinhch nub T%".a

AntaI dr OWC bei cli.KaiIn, in% 0 " d. RWt Koc2 b .C in% V.0 7.9U d. RWC Xalos~a'jhI&36C m %

PH-wen 6.9.0 12 p11-Wot &. CaCVWdmzq &. Deb apX .0.2 .0.3 L*US;~da P$'cm 2000 37S 1I.-bmng T~rl L5 0.3 Fkbua Eam 0.3 C0.2 OXierakagbI m4e/ 5 1.76 QUvdm~.cheijmwt 3 < Aauiomauma 0.5 <0.05 .Ninit mgW 0.1 -0.0 1 ?'1iti M&O s 13.1 L-Alcdd Mal 250 35 m4an LS 0.79 Sufit -ngl 24m .4 Phoiphae SOIt 6.7 00 Natrtw MVSO5 23.2 Kalium =91v 12 6.: K~um z' 00 $3.1 I"aali Sw s .13.9 fr.gumCO2 ~ 69 gm.Kjsm Mql 0.2 0.05 U.aaga owl 0.011 O.C0I Aluuu 0.2 0402 Sbc LIM 10 Dau e1 0.05 w,'1 I z 0.2 g&eaL.-CWI XcwIwwma& RIC 0.01 <0.0 1 C)=d U1 140 <10 Oberflicmnaktive Subdaza-vocib SLO& C401 0.2 <0.01 ~L140

.. 4 1LUI 0.71 Nlmkti 940 50 C.1 Quedrealbcr ;L84 I1 .a.)1 SONGs ;iL 10 AnoM410 <1 Kuizp Mal 3 1 0.05 Zink Mal1 5 0.15 Swumm Tnhmioqawchac )W 10 V? I TanmJddmJica A9l 3 <0.5 'wLrmPIv 0.3 <0.02 SUOI f""Yarb )wl .s < 0.03 

# Contafns&odb pestCAd Cofienia <uins Inr.05~ 1 ContainsTSCA Confidential Business In~rat= l~rM P e0. .00 gq~~~~rm/1 /-vv-xr -

# LC O InventoryExpertService
A division of the American Chemical Society Phone: 800-631 -1884, 614-447-3600 (ext.2308) Fax:614-447-3747 E-mail: answers@cas.org

INVENTORY EXPERT SERVICE REPORT

IES-ORDER NUMBER: 33902
REGISTRY NUMBER:(

CA INDEX NAME

Please print the above CA Index Name on the appropriate page of your PMN. 

# V If this box is checked, CAS has made correction(s) marked in red to

___ your IES order. Please make the same correction(s) to your PMN before submitting it to the EPA. 

# ContainsTSCAConfidential BusinessInformation

2540 Olentangy River Road

- P.O. Box 3343 Columbus, Ohio 43210-0334

# PreManufacture Notice and Notice of Commencement Forms EPA Form 7710-25 (Rev. 5-95)

EPA Form 7710-56 (Rev. -96)



# Installationand Use Instructions MS Word6.Ofor Windows

U.S. EPA Approved December 12, 1996 by Anthony Cheatham TSCA Data Administration Section 

# Lw r "401riil ResponsibleCares ~,A 

# Public

# Commitment

Page 173

# 6h GOLDSCHMIDT CHEMICAL CORPORATION

March 10, 1999
Environmental Protection Agency HQ Accounting Operations Board Attention: TSIPMN P.O. Box360277M Pittsburgh, PA 15251 Gentlelnen: Please find enclosed our check for $20,000.00 for submission ofour Premanufacture Notices (reference TS-199901; TS-199902; TS-199903; TS-199904; TS-199905; TS-199906; TS-199907; TS-199908) sent to the Environmental Protection Agency, Washington, D.C. Sincerely,
Kelly C. Tiller Safety &Environmental Technician Safety &Environmental Compliance

1004 1 6R~0CECK DATE

10044'~~- 002577 03/10/1999

t, ~ ,~.-.___ ___ __ ____t K. CHECKAMOUNT
S2<0,000-0 O1~OE ~' rIY -. 5s'rA>Th EPA tf-f,;A 0ONI OPERATQNS- 8ARD

- 

### P0 3'63027'M -', 111100 2577116 nOS0L.OL865t: 0U80?o?~" / 

# Vp 4 1'1 f4 17(