Document 3JvE0KXMkYLZ41jee85B2b17E

/M ?22fe-O SI6 ACUTE TOXICITY TO FISH TEST SUBSTANCE Identity: Perfluorooctanoic acid, ammonium salt; may also be referred to as PFOA ammonium salt, Ammonium perfluorooctanoate, PFO, FC-116, FC-126, FC-169, FC-143, or as a major component of FX-1003. (Octanoic acid, pentadecafluoro-, ammonium salt, CAS #3825-26-1) Remarks: The 3M production lot number was 2327. The test sample is FX-1003. It's purity was not sufficiently characterized, though current information indicates it is a solution of <45% ammonium perfluorooctanoate, 50% water, <3% inert perfluorinated compound and 1 - 2% C5 and C7 perfluoro analogue compounds. The following summary applies to the test sample as a mixture of the test substance in water solution with incompletely characterized concentrations of impurities. Data may not accurately relate toxicity o f the test sample with that of the test substance. METHOD: Method: OECD 203 Type: Static acute GLP: Yes Year completed: 1990 Species: Pimephales promelas Supplier: Aquatic Research Organisms, Hampton, New Hampshire Analytical monitoring: Temperature, pH, conductivity, and dissolved oxygen Exposure period: 96-hours Statistical methods: Non-linear interpolation, moving average, and/or probit analysis Test fish age: Juvenile Length and weight: Average length = 3.8 cm Average weight = 0.45 g (wet) Pretreatment: None. Test conditions: Dilution water: Hampton, New Hampshire well water Dilution water chemistry: pH: 7.4 Conductivity: 1500 pmhos/cm Hardness: 88 mg/L (as CaCOa) 003886 Lighting: Cool-white fluorescent bulbs with an intensity of 35 uEs`1m'2. A daily photoperiod of 16 hours light and 8 hours dark was maintained throughout the testing period. Test conditions remarks: The fish were fed a commercial fish food once or twice daily during the acclimation period, food being withheld throughout the test period. Fish were acclimated to test temperature for 14 days prior to use in assays. Aeration was employed after 48 hours to maintain dissolved oxygen concentrations above acceptable levels. Stock and test solution preparation: Test solutions were created by direct individual weight additions. Concentrations dosing rate: Once Stability of the test chemical solutions: Not noted Exposure vessels: 19.6 L glass aquaria containing 15 liters test solution at an approximate depth of 17 cm. Number of replicates: two Number offish per replicate: 10 Loading rate: 0.30 g/L Number of concentrations: five plus a blank control Water chemistry during the study: Conductivity range: (0-96 hours) 1200 - 1 5 0 0 pmhos/cm (control exposure) 1300 - 1600 pmhos/cm (1,000 mg/L exposure pH range (0-96 hours): 7.4 - 8.4 (control exposure 7.8 - 8.2 (1,000 mg/L exposure) Temperature range (0-96 hours): 21.0 - 22.0 C (control exposure 21.0 - 22.0 C (1,000 mg/L exposure) Dissolved oxygen range (0-96 hours): 6.1 - 9.2 mg/L (control exposure 6.2 - 9.1 mg/L (1,000 mg/L exposure) RESULTS Nominal concentrations: Bk control, 150, 250, 400, 600, and 1,000 mg/L Element value: 96-hour LC50 = >1,000 mg/L Element value based on nominal concentrations Remarks: Testing was conducted on the mixture of the test substance as described in the test substance remarks field. The values reported apply to that mixture and not the test substance. CONCLUSIONS The test sample 96-hour LC50 for fathead minnow was determined to be >1,000 mg/L. Submitter: 3M Company, Environmental Laboratory, P.O. Box 33331, St. Paul, Minnesota, 55133 DATA QUALITY Reliability: Klimisch ranking 2. Testing meets the criteria for quality testing. However, sample purity was not properly characterized and it lacks analytical confirmation of test substance concentrations. REFERENCES Test was conducted by EnviroSystems, Inc. of Hampton, NH at the request of the 3M Company, 1990. The EnviroSystems study number was 9014-3 OTHER Last changed: 5/25/00 C3S38 C038S9 I. GOOD LABORATORY PRACTICE STATEMENT This study was conducted according to OECD Good Laboratory Practice Regulations. Neither the Study Director nor the sponsor are aware of any circumstances that would affect the integrity of this study. Food was not witheld from fish during the 24 hours prior to the test initiation. This deviation is not believed to have affected the study. No other deviations existed that significantly affected the validity of the study. 7 ~ rpt-- ____3 Robert L. Boeri Coauthor and Study Director 'M - Jeanne P. Magai t Aquatic Toxicologist si) s h o C03S90 V-* 003391 "M W H w W P B,uu IItiliHUdfllj l w p w w p p ^ ^ ^ III. TABLE Of CONTENTS SECTION: I. Good Laboratory Practice Stateaent II. Certification of Good Laboratory Practices ill. Table of Contents IV. Index of Tables and Figures V. Suaaary VI. Introduction VII. Methods and Materials VIII. Results IX. References Appendix A. Vater Quality Data froa Toxicity Test PAGE 2 3 4 5 6 7 7 i 13 14 'i ? jSISL 'S s "frf ,,,. v>4. " ;**y Ilf M?En*iroSysteas Study Nuaber^ f l p p a g e 4 of ** ^i 'W , ' j i s & f L ^ "f/' iV'V'' *i;. hS &rf*5 7` *r->` Vj'JJL'* t ft.'.K " ` feei! J's. ; f&A'- ^ RenucsAnalinlilnc^SuMdaryof MklFORE . `' 4 A B ^fr'uy Ji-tfr* K T^XSi^SS^SBW'l^J-S;t''? ' ^ ~Ss- ,,-.ifKi t5*'' ,*r ft:* > ,# ' .00$ 8 3 2 BEST COPY AWill ABLE IV. INDEX Or TABLES AND FIGURES Table 1. Chenical characterization of a representative sample of natural veil water used as dilution water for toxicity test Table.2. Survival data from toxicity test Table 3. Median lethal concentrations (LC50s) fro toxicity test Table A.l. Conductivity, pH, temperature, and dissolved oxygen concentration aeasured during toxicity test PAGE 8 11 12 15 T . SUMMARY The acute toxicity of FX-1003 to the fathead minnow, Piaephales pronelas, is described in this final report. The test was conducted for 3M Company for 96 hours during February 12 to 16, 1990, at the EnviroSysteas Division of Resource Analysts, Inc. in Baapton, New Hampshire. It was conducted by Jeanne Magazu, Peter Kowalski, Robert Boeri, and Tiaothy Ward according to the protocol developed for EnviroSysteas Study Nuaber 9014-3. The test was perforaed under static conditions with five concentrations 'of test substance and a dilution water control at a mean temperature of 21.8C. The dilution water was filtered natural well water collected from wells at Haapton, New Hampshire. Aeration was employed to maintain diTkolved oxygen concentrations above an acceptable level. Nominal concentrations of FX-1003 were: 0 mg/L (control), ISO mg/L, 250 mg/L, 400 mg/L, 600 ag/L, and 1,000 mg/L. Nominal concentrations were used for all calculations. Fish used in the test were purchased froa a commercial supplier (Aquatic Research Organisas, Hampton, New Hampshire) and acclimated under test conditions for 63 days. After 96 hours of exposure the control fish had an average wet weight (blotted dry) of 0.45 g (resulting in a loading rate of approximately 0.30 g/L), and an average total length of 3.8 cm. All fish were in good condition at the beginning of the study. Exposure of fathead minnows to the test substance resulted in a 96 hour LC50 of >1,000 ag/L FX-1003, the highest tested concentration. The 96 hour no observed effect concentration is estimated to be >1,000 mg/L. BEST COPY AVAI! ABLE VX. INTRODUCTION This study was sponsored by 3K Company, St. Paul, Minnesota. The objective of the study was to deteraine the acute toxicity of PX-1003 to the fathead ninnow, a freshwater fish. The report contains sections that describe the methods and naterials eaployed in the study, and the results of the investigation. The report also contains an appendix that presents the water quality data collected during the test. VII. METHODS AMD MATERIALS TEST SUBSTANCE: FX-1003 (EnviroSysteas Sample Number 2308E) was delivered to EnviroSystems on January 29, 1990. It was contained in a 500 aL plastic bottle that was labelled with the following inforaation: C2882-1. FX-1003 (a yellow liquid) was supplied by 3M Company, 935 Bush Avenue, St. Paul, Minnesota. Prior to use the test material was stored in the dark at room temperature. A reserve sample (approximately 1 graa) will be archived at EnviroSystems for a minimum of 10 years. DILUTION WATER: Water used for acclimation of test organisas and for all toxicity testing was well water collected froa wells at EnviroSysteas in Haapton, New Hampshire. Water was adjusted to a hardness of 88 ag/L as CaCOi and stored in 500-gallon polyethylene tanks, where it was aerated. Results of chemical analysis of a representative saaple of water are presented in Table 1. TEST ORGANISM: Juvenile fathead minnows employed as test organisas were from a single source and were identified using an appropriate taxonoaic key. They were purchased from a commercial supplier (Aquatic Research Organisms, Hampton, New Hampshire) and acclimated at the EnviroSysteas facility for 63 days. Control fish were weighed at the conclusion of the toxic'ty test. Prior to testing, fish were maintained in 100% dilution water under flow through conditions in an all glass aquarium.' 'During acclimation fish were not treated for disease and they were free of apparent sickness, injuries, and abnormalities at the beginning of the test. ;; During the acclimation period 14 days prior to the test initiation the temperature ranged fro m 21.0 to 23.5C, and the dissolved'oxygen concentration was maintained above 8.0 mg/L. Fish were fed a .commercial fish food / (EnviroSyste lot number TM01) once or/.twice 'daily. - - .* K'IiVrAk''-' I'r--*' EnviroSysteas Study Number 9014Page 7 of 16 BaaouoeAnotytti kit. SuMdtatyd MUJPORE %W '1 ! M S I COPY AVAILABLE Table 1: Cheaical characterization of a representative saaple of natural well water used as dilution water for toxicity test Paraseter PH Conductivity Hardness Organochlorine pesticides Organophosphorus pesticides Polychlorinated biphenyls Unit of Heasureeent Reporting hiait pH units -- uahos/ca -- ag/L as CaCOi -- ug/L 0.5 ug/L 0.5 ug/L 0.5 Measured Value 7.4 1500 88 ND* TO* TO Not detected above the reporting liait * Mi* i.i` ; m : 1. r&v - 4;. \ 3t ^ A v-;4 ... _ .. .. w! <.4^ ^ " " ' ( >' 1 v; , ( *,, ' V-- * - - > 7 i v- - ,, V >"ii-V4 4 V'lUV. 4 - -?** v -- ' :r.i Reiou*#^lnCj'sUw^oiMUiOfi ,, -V* '- -v-.v'$ -s; 003896 -fef'fev'..:'->:,i' -v.N BEST COPY AVAII ABLE TOXICITY TESTING: A screening test with the test substance was conducted during February 6 - 10, 1990. Nominal concentrations of test substance were 0.1 mg/L, 1 mg/L, 10 mg/L, 100 mg/L, and 1,000 ag/L. After 96 hours of exposure there was 100% survival at all tested concentrations. The definitive toxicity test was perforaed during February 12 16, 1990, according to EnviroSysteas Test Protocol 9014-3 (Acute Toxicity of FX-1003 To The Fathead Minnow Piaepbales proaelas), which was signed by the Study Director on February 6, 1990. It is based on procedures of the OECD (1984). The test was conducted at a target teaperature of 23 2C with five concentrations of test substance and a dilution water control. Ho stock solution was prepared as test aaterial was added directly to dilution water contained in tbe test vessels without the use of a solvent. Nominal concentrations of the test aaterial were: 0 ag/L (control), 150 mg/L, 250 mg/L, 400 ag/L, 600 ag/L, and 1,000 ag/L. Twenty fish were randomly and equally distributed among two replicates of each treatment. The test was performed in 19.6 liter glass aquaria (approximately 20 ca in width, 40 cm in length, and 25 cm in height) that contained 15 liters of test solution (water depth was approximately 17 cm). Test vessels were randoaly arranged in a water bath during the 96 hour test (a random numbers table was used to select the location of each vessel). A 16 hour light and 8 hour dark photoperiod was automatically aaintained with cool-white fluorescent lights that provided a light intensity of 35 uEs-*n-*. Aeration was employed after 48 hours to maintain dissolved oxygen concentrations above acceptable levels. Fish were not fed during the test. The number of surviving organises and the occurrence of sublethal effects (loss of equilibriua, erratic swimming, loss of reflex, excitability, discoloration, or change in behavior) were determined visually and recorded initially and after 24, 48, 72, and 96 hours. Dead test organisms were removed when first observed. Dissolved oxygen (YSI Model 57 meter; instrument number PRL-3), pH (Beckman mod'-l pHI 12 meter; instrument number PRL-4), conductivity (Labcoap SCT meter, instrument number PRL-9), and temperature (ASTM mercury thermometer; thermometer number 2040) were measured and recorded daily in each test chamber that contained live animals. STATISTICAL METHODS: Results of vtbe toxicity .test, could '.not be :interpreted by standard statistical techniques, due . t o l O O t survival at the highest tested concentration. . C03S97 best copy avau able VIII. RESULTS All test vessels containing FA-1003 regained clear throughout the test. Biological and water quality data generated by the acute toxicity test are presented in Table 2 and Appendix A, respectively. One hundred percent survival occurred in the control exposure. Control fish had an average total length of 3.8 ca, and an average vet weight (blotted dry) of 0.45 g at the end of the test. Loading rate during the toxicity test was approximately 0.30 g/L. The 24, 48, 72, and 96 hour LC50s for fish exposed to FA-1003 are presented in Table 3. The 96 hour LC50 is >1,000 ng/L FA-1003, the highest ' tested concentration. The estimated 96 hour no observed effect 'concentration is >1,000 ag/L FA-1003. f I f j. ( jt ! j > t GO-3898 Table 2. Survival data fro toxicity test Noainal Concentration (ag/t) rep. Nunber Alive Ohr 24hr 48hr 72hr 96hr Nuaber Affected Ohr 24hr 48hr 72hr 96hr 0 (control) i 2 150 1 2 250 -- 1 2 400 1 2 600 1,000 1 2 1 2 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 ,10 10 10 10 10 10 10 10 10 10 10 10 00000 0000 0 0000 0 0000 0 0000 0 0 000 0 0 000 0 00 00 0 00000 00000 00000 00000 Note: Sublethal effects include loss of equilibriua, erratic swiaaing, loss of reflex, excitability, discoloration, and change in behavior 003899 BEST COPY AVAILABLE Table 3. hedian lethal concentrations (LC50s) froa toxicity test Exposure period LC50 95 percent confidence limits 24 hours >1,000 eg/I. -- 48 hours >1,000 ag/I, -- 72 hours >1,000 mg/L -- 96 hours >1,000 ag/L -- 1X50 calculation method -- ' '-- C03900 BEST COPY AVAIlABLt IX. REFERENCES 093901 BEST COPY AVAIl ABLE BESICO PIM M U BU Table A.l. Conductivity, pH, teaperature, and dissolved oxygen concentration aeasured during toxicity test Noainal concentration (ng/M Rep. Conductivity (uaho/ca) -----------------------0 24 48 72 96 hr hr hr hr hr pH ------------- 0 24 48 72 96 hr hr hr hr hr 0 (control) 150 250 400 600 1,000 1 1500 1300 1200 1400 1300 2 1500 1300 1200 1400 1300 1 1500 1300 1200 1400 1300 2 1500 1300 1200 1400 1300 1 1500 1400 1200 1400 1300 2 1500 1400 1200 1400 1300 1 1500 1400 1200 1400 1300 2 1500 1400 1200 1400 1300 1 1500 1400 1300 1400 1300 2 1500 1400 1300 1400 1300 1 1600 1400 1300 1500 1400 2 1600 1400 1300 1500 1400 7.4 7.7 8.0 8.3 8.4 7.4 7.5 8.0 8.3 8.4 7.4 7.6 7.9 8.0 8.3 7.4 7.6 7.9 8.1 8.3 7.4 7.6 7.9 8.1 8.3 7.5 7.6 7.9 8.1 8.3 7.5 7.6 7.9 8.2 8.3 7.5 7.6 7.9 8.1 8.3 7.6 7.7 8.0 8.1 8.2 7.6 7.8 8.0 8.2 8.3 7.8 7.8 8.0 8.1 8.2 7.8 7.8 8.0 8.1 8.2 003903 BEST COPY AVA11ABL Table A.l. Continued. Koainal ' concentration (ag/L) Rep. Teaperature (C) -----------------------0 24 43 72 96 hr hr h r h r hr Dissolved Oxygen (ag/L) ---- !___________________ 0 24 48 72 96 h r hr h r h r hr 0 (control) 150 250 400 600 1,000 1 21.0 22.0 22.0 22.0 21.8 2 21.0 22.0 22.0 22.0 21.8 1 21.0 22.0 22.0 22.0 21.8 2 21.0 22.0 22.0 22.0 21.8 1 21.0 22.0 22.0 22.0 21.8 2 21.0 22.0 22.0 22.0 21.8 1 21.0 22.0 22.0 22.0 21.8 2 21.0 22.0 22.0 22.0 21.8 1 21.0 22.0 22.0 22.0 21.8 2 21.0 22.0 22.0 22.0 21.8 1 21.0 22.0 22.0 22.0 21.8 2 21.0 22.0 22.0 22.0 21.8 9.1 8.5 6.1 8.6 9.2 9.1 8.3 6.3 8.8 9.2 9.1 8.0 6.0 8.5 9.2 9.1 8.1 6.5 8.7 9.2 9.1 8.1 6.1 8.6 9.0 9.1 8.0 6.7 8.6 8.8 9.1 8.2 6.4 8.6 8.9 9.1 8.1 6.4 8.9 9.0 9.1 8.0 6.8 8.8 9.0 9.1 8.1 6.5 9.0 9.0 9.1 8.2 6.2 8.9 9.1 9.1 8.2 6.2 8.9 9.0 C03904 I T COPY AVAII ABLE EnviroSysteas Study Hunber 9014-3 Effective Date: January, 1990 :RESOURCE ANALYSTS, INCORPORATED .. ENVIROSYSTEMS DIVISION i' PRODUCT REGISTRATION LABORATORY AQUATIC TOXICOLOGY STUDY PROTOCOL Acute Toxicity of FX-1003 To the Fathead Minnow, Pisephales proaelas Sponsor 3M Conpany PO Box 33428 St. Paul, Minnesota 55133 Sponsor Approval of Protocol - P pojcI ^ THIS IS A CERTIFIED TRUE COPY. I, SIGNATURE DATEa MS pacfAJ BEST COPY AVAABLE EnviroSystems Study Number 9014-3 l. TITLE Acute Toxicity of FX-1003 to the Fathead Minnow, Pimepbales promelts 2.0 PURPOSE ' TO 'determine the 24, 48, 72, and 96 hour median lethal concentrations (LC50s), of test substance to fish exposed under static conditions. 3.0 TEST MATERIAL 3.1 The test substance and related stability and purity data will be supplied by the sponsor. Test material will be stored at 2-4C in the original shipping container, unless alternate storage conditions are specified by the -sponsor. Handling of the test material will be in accordance with information contained in the sponsor-supplied Material S a f e t y Data' Sheet and RAI Standard Operating Procedure 01-02-1106. A subsample' of test substance (approximately 1 gram) will be removed from the original container and transferred to a glass vial for archiving. All unused test substance will be returned to the sponsor. 3.2 Calculations are based on nominal concentrations of the test substance. Test material stock solutions are prepared in deionized or dilution water without the use of a solvent (carrier) if possible. If a solvent is required, dimethylformamide, triethylene glycol, or acetone will be used. The concentration of solvent will be limited to 100 mg/L. 4.0 TEST SPECIES 4.1 The selection of test species is determined by the sponsor. Healthy juveniles from a single source will be used to initiate the test. They will be obtained from a commercial supplier. Fish should be 1-3 cm long at the start of the test. The length and wet weight of control organisms will be determined at the end of the test. 4.2 Identification of the test animals shall be verified using appropriate taxonomic keys. 5.0 PRETEST OBSERVATIONS AND PROCEDURES - V ' " * 5.1 Pretest observation data concerning the source, handling procedures, receipt date, disease treatment, (if any), health, feeding, and mortality : :of test anioals will be recorded and .reported. ,. . . \ fefe ; . i- V w '' r i 'iw -ft ''Fish will be maintained under static,`replacement, or flow-through*??- W T O * 3 5 cottditions prior to ;test j;initiation i):in^the same water and at the ''vfPhotoperiod -and ' temperature ;|.that^will1 be used for testing. ; T h e !'aninalsY{^^X `-will be fed a t l e a s t - once?d a i l y with'`commercial fish food and/or;brine bbriap w nauplii during '^acclimation'ffexcept ^ for the 24 -hour period 'immediately , preceeding -the -'testi|initiation?! Each batch of foodvilT: ^ `.analyzed .to verify -that it X isjfifree`i of measurable concentrations?of pesticides. Fish will be maintained in dilution water at testconditions| (temperature, hardness,', and photoperiod)*for at least 12-15 days'prior) to ; testing. .Page 2 of 6 l'''" .......... BEST COPY AVAll ABLE EnviroSysteas Study Number 9014-3 6.to EXPOSURE CONDITIONS 6.1 The study vill be conducted under static conditions and test media vill only be provided at the beginning of the test. The test anisals will . be added to test media after the toxicant is added to the test aedia. 6.2 Dilution water will be natural ground water. It will have a hardness of 50-250 mg/L as CaCOi, a pH of 6.0-8.5, be free of aeasurable concentrations of pesticides, and aeet the requireaents specified in U.S.EPA (1986,1987). Hater will be passed through a (20 aicron filter and chemically characterized (at least twice yearly analysis at RAI) prior to use* " '~4 6.3 Vater teaperature-will be 23 + 2C. 6.4 Dissolved oxygen concentration will be maintained above 80% saturation. If aeration is required it vill be supplied to all test chambers. Sponsor approval will be obtained prior to aeration. 6.5 Photoperiod will be automatically controlled and adjusted to 16 hours light and 8 hours dark. 6.6 The test vessels will be 19.6 L glass aquaria containing at least 15 1 of solution. Loading rate will be less than 1.0 g/L. 7.0 STUDY CONDUCT 7.1 Range Finding Investigation 7.1.1 The results of the range finding investigation and/or previous testing data will be used to select the concentration range needed for determination of the definitive LC50s. 7.1.2 If a range finding test is conducted, the animals will be exposed to a series of concentrations of test substance plus a control \ (dilution water without test substance) and a solvent control (if necessary). - . ;' 7 . 1 . 3 / t V A t least 10 animals will be exposed to each treatment. The animals 'will ,,'be exposed in groups of 10 anisals per vessel, each |containing*: at least 15 L of solution. :,.The, animals will be equally ' and irandomly "assigned to the test vessels^la random numbers table '> ,, wilslm,-, vb.e !.u.s.eda to choose the test vessel forjeadh specimen), and they' J f f'r>' `<c' 7 A f - V ' <- < r' *>' Mil. - v j* -r 'v> i M ? 7 .2.1 T h e 7-animals will be exposed for 96 hours to a series of at :7/-:&J<f2east^ five concentrations of test substance,^ control, and a solvent ' ? :,P**,y,;.'control A'(if / necessary) under static conditions. The highest tested concentration - will be 1 g/L. ;,*!The dilution factor between '^"'concentrations will be S I . 8 / ' ' :, Page 3 of.'6 . I.?', ... : 'f e -* , ,. 1 v' r .,V,*v1v.--*-,.v.!!. ` xvTrA7-RDeasowuercremAAnnal/il.Inc.SubsxSaiy a l MUJPORE - . J j'1: A 'T--/-V-iy ?"' sVv.._... C03307 KSICOPY AVAILABLE EnviroSystems Study Number yvii-j 7.2.2 Each treatment group will consist of 20 animals with 10 animals per duplicate test vessel. The animals ill be randomly assigned to the test vessels. 7.2.1 Dissolved oxygen concentration, pH, temperature, and conductivity will be measured and recorded at the beginning of the test and daily thereafter in all test vessels, as long as living animals are present in those vessels. 7.2.4 , hours. Hardness in the dilution water will be measured at 0 and 96 7 .-2.5 Horiality and sublethal effects (loss of equilibrium, erratic swimming, loss of reflex, excitability, discoloration, or " change of behavior) will be recorded at 24 hour intervals during the test. Dead animals will be removed when first observed. 7.3 Data'Analysis and Statistical Methods The 24, 48, 72 and 96-hour LC50 values and their 95% confidence intervals will be calculated by the non-linear interpolation, moving average and/or probit methods. If toxicity occurs the slope of the dose-response curve will be provided. 8.0 QUALITY ASSURANCE AMD QUALITY CONTROL 8.1 The test will be repeated if any of the following conditions occur: 8.1.1 Control survival at the end of the test is less than 90%, or if behavioral abnormalities are observed in the controls. 8.1.2 Temperature in any test vessel is outside of the acceptable range or dissolved oxygen concentrations fall below 80% saturation. 8.2 The test will be conducted according to OECD Good Laboratory Practice Standards. . : - ->: :- 8.3 All critical phases of the test conducted at Resource Analysts Inc. will be audited by the Quality Assurance Unit. , 8 . 4 The ^tudy.Director will be responsible for reviewing all data and for -recording- a n y ^ changes to procedures outlined e.injj|,this :protocol in a -protocol amendment.-Protocol amendments will be approved by the sponsor. r-'8.5 Original { d a t a will be archived at Resource Analysts Inc. for at least 10 years or it'will'be transferred to the sponsor.for<archiving. -> 'i *V'.f ' yfir r j-v"? ;1 _f > ^ R e so u rce Analyst*. Inc. S uM tforyolM lIJPO R E v-' V ~'Mr 1 / ' 003908 fK tC N M M lA B li EnviroSysteas Study Number 9014-3 9!o REPORT 9.1 Three original reports will be prepared after review of a draft report by the sponsor. The final report will be signed by the Study Director' and staff that conducted the study and prepared the report, and by the Quality Assurance Unit Representative. 9.2 The final report will consist of at least the following inforaation: 9.2.1 * Title_ page, including the study title, data requirement, author, study coapletion date, testing facility, and . sponsor. 9.2.2 Sponsor-supplied confidentiality claims. 9.2.3 Good Laboratory Practice Stateaent. 9.2.4 Certification of Good Laboratory Practices. 9.2.5 Table of Contents. 9.2.6 Suaaary of test procedures and results. 9.2.7 Introduction. 9.2.8 Methods and Materials, including a description of test methods, organisas, dilution water, and statistical techniques. 9.2.9 Results, including all data from range-finding and definitive tests, and LC50 values. 9.2.10 References. 9.2.11 Appendices, including all water quality data and the test * protocol with amendments (if any). 10.0 REFERENCES %. OECD. 1984. OECD Guidelines for Testing of Chemicals. Section 2: Effects on Biotic > Systems. Method 203, Fish Acute Toxicity Test. Adopteu April 4 ^4 9 U.S. EPA^f^1986;^p^40 y C F R y Part 797. ;Toxic Substances^Control Act Test Cuidelines;*Final&Rules. S Federal Register,! Monday .-January 6, 1986. . '; Section > 7 9 7 f l 4 0 0 . m & i , " . u ^ 4 " V > ~Vr ' U.S. EPA. 1987:> CFR 'Part 797. 'Toxic Substances Control Act Test iGuidelines; 'Amendments. Federal Register, Wednesday', May 20, 1987. Section 797.1400.^.^ it1 - ' n.'< V . * , - v- 'f'''* ~ : ... K. n J; i. Pag? 5 of 6 '"V ' ,X '*V i -*l? * -'5 ^ r- y ^ fp ^ o jic A n Sy i* In c.SubK tay et MUPORE ' 093909 BESTCOPY AVAUABLE Acceptable Species: Reference: Test Type: Duration: : Flow Rate: Dilution Vater: Age/Size of Test Organisas: Acclimation Period: -- Temperature: 'Pfiotopriod: Light Intensity: Number of Concentrations: Dilution Factor: ' Number of Replicates: Number of Organisms/Replicate Test Vessel Size: Test Vessel Volume: Solvent: Loading Rate: Feeding: Dissolved Oxygen Levels: Effects Measured: Test Concentration Analysis: Vater Quality Measurements: Acceptability Criteria ; r; > .r., 8*j.''&J,'H ffi Resouce Andystv Inc. Sutm Soiy 01M U PO B t fer.* * 03910 > A- * ", * )y