Document EdB3BY80dn8yNoKknOJGawy8L

ACUTE TOXICITY TO AQUATIC INVERTABRATES (DAPHNIA MAGNA) TEST SUBSTANCE Identity:Perfluorooctanesulfonylamido(ethyi)acmeatyaatles;obe referretdo as PFOSAA, FC-128 or as themajor component of FC-127,FC-129, FC-109, or FC-109-X. (Glycine,N-ethyl-N[(heptadecafluorooctyl)sulfopnoytla]s-s,iumsalt,CAS # 2991 51-7) Remarks: The testsample isFC-109-X referredto by thetest laboratorays E2566-2. Currentinformatioinndicateistisa mixtureof1923% testsubstance,61 % water,12% 2-methoxymethylethoxypropanol, 2% ethanol,and 2-6% C4-C7 fluoroalkacarboxylatecompounds. Test sample was from 3M productionlot2. The followingsummary is abbreviatedbecause the testsample Is a mixture of thetestsubstance in a waterlorgank solventsolution. Data may not accuratelyrelatetoxicityof the testsample with thatof the testsubstance. METHOD: Methods: OECD 202 Test type:Staticacute GLP: Yes Year Completed: 1988 Species: Daphnia magna Analyticalmonitoring:Temperature,pH, and DO RESULTS Nominal concentrations:Bk control1,.0,1.8,3.2,5.6,10,18,32 mg/L Element values: 24-hourLCso= >32 mg/L (estimated) 24-hourNOEL = 32 mg/L 48-hourLCw = 1.5(1.0-1.8m)g/L 48-hourNOEL = 1.0mg/L Allelementvaluesbased on nominalconcentrations. Remarks: Testingwas conducted on themixtureofthetestsubstance as describedinthetestsubstanceremarksfield.The valuereportedapplies tothatmixtureand notthetestsubstance.No attemptwas made to determinetheimpactofthe presenceoftheorganicsolventsorwhat portionofthetoxicitcyan be contributetdothe Perfluorooctanesulfonylamido(ethyl)acetate. 'CONCLUSIONS The FC-109-X 48-hour LC5o forDaphnia magna was determinedto be 1.5 mg/L witha 95% confidenceintervaolf1.0-1.8mg/L. The 48-hourno observed effectlevelwas 1.0mg/L. Submifter:3M Company, EnvironmentalLaboratory,P.O. Box 33331, St. Paul,Minnesota,55133 DATA QUALITY ReliabilityK:Jimischranking2. Testingmeets allcriteda.fqourality testingb,utlacksanalyticaclonfimiatioonftestsubstance concentrations. There isa lackofcharacterizatiofnthetestsample. REFERENCES This studywas conducted atAnalyticaBlio-ChemistryLaboratoriesI,nc.of Columbia, Missouriatthe requestofthe3M Company. OTHER Last changed: 5/18/00 SPONSOR 3M Company Attn: 4r. Mohamed Elnabarawy EE & PC Environmental Labs Building 21-2W-05. 900 Bush Avenue St. Paul. Minnesota 55106 STUDY TITLE Acute Toxicity of E2566-2 to Daphnia magna DATA REQUIRE-XNT OECD Guideline '102 AUT"HOR Scott,Frazier Biologist II STUDY,COMPLETED ON ,.-Januarv.9.- 1988 PERFOR.-ING I"RATORY.'Analytical Bio-Chemistry_Laboratori,es.,In.c@.. Aquatic Toxicology.Divis on East ABC Lane', P.O. 'Columbia,.Missouri" 2 ABC LABORATORY PROJE& ID #36616 I or '48 Submitted By: Analytical Bio-Cbemistry Laboratories. Inc. 72CO East ABC Lane P. 0. Box 1097 Columbia, t,,issouri 65205 (314) 474-8579 Prepared By: Michiiel Rudd@ Biological T;chnician;,,Il' Scott Frazier Biologist ll!Study D ilr"c'teor Approved By: Alan D. Forbis Supervisor, Invertebrate/ Bioconcentration investigations @ci @l Kathy L rnd@h o Quality'1,4surance Officer Date Date Date Date. Farl M. Thompson Aquatic Toxicology Manager :dab2g Date ABC LABS.#36616-2..o f 48 TABLE OF CONTENTS Ll&e Npt. LIST OF TABLES . . . . . . . . . . . . . . . . . . . . . . . . . 36616-4 PROJECT PERSOINNEL . . . . . . . . . . ... . . . . . . . . . . . 36616-5 INVERTEBRATE ACUTE TOXICITY COMPENDILT.4. . . . . . . . . . . . . 36616-6 SLN*URY . . . . . . . . . . . . . . . . . ... . . . . . . . . . 36616-7 INTRODUCTION . . . . . . . . . . . . . . . . . . . . 36616-8 .ETHODS AND PATERIALS . . . . . . . . . . . . . . . . . . . . . 36616-8 Test Organis=s . . . . . . . . . . . . . . . . . . . . 36616-8 ii. Test Procedure . . . . . . . . . . . . . . . . . . . . 36616-8 III. Test Compound . . . . . . . . . . . . . . . . . . . . 36616-9 . . . . . . . . . . . . . . .... . . . . . 36616-9 IV.. Statistics RESULTS . . . . . . . . . . . . . . . . . . . . . . . 36616-9 LITERATURE CITED . . . . . . . . . . . . . . . . . . . 36616-13 QUALITY ASSURANCE STATL%OT . . . . . . . . . .... . . . . . . 36616-14 STUDY COMPLIANCE STATEHENT . . . . . . ... .. . . . . . ... . . 36616-15 APPENDIX RA7v; DATA . . . . . . . . . . . . . . . . . . 36616-16 ABC LABS #36616-3 of 48 Table No. 1 2 LIST OF TABLES. Page No. Chemical Characteristics of Well Water Used by ABC's Aquatic Toxicology Division . . . . . . . . 36616-10 Acute Toxicity of E'.566-2to Daphnia =agna. 36616-11 Percent Mortality and Water Quality Measurements During the Acute Toxicity Test of E2566-2 to Daphnia magna . . . . . . . . . . . . 36616-12 ABC LABS #36616-4 of 48. PROJECT PERSONNEL The Study Director of the project for Analytical Bic-Che=is,.rv Laboratories, Inc. was Scott Frazier, Biologist II. Super,.,isingthe conduct of the study for 3,4 Company was Mr. Yohamed Elnabaraury. The followin@ ABC personnel assisted with various phases of the studv. .Name Michael Ruddy Fiizi6r @'effrey Latliam Title Biological Technician ri Biologist 11 Biological Technician I Tr!itials ABC LABS #36616-5 of 48 INVERT;-:BRATE ACUTE TOXICITY COMPEII-DIL'K Subject: "Acute Toxicity of E2566-2 to Daphnia magna," ABC Study Number 36616. Sponsor: 3H Company Testing Facility. I Analy ticilBio-Chemistry Laboratories. Iic. Aquatic Toxicology Division P.O. Box 1097 Columbia. Missouri 65205 (314-474-65.7 ,.. Location of Original Raw Data and Final Report: 3'.4Company FE & PC Environmental Labs Buildin*g 21-2W-05. 900 Bush St. Paul, Minnesota Avenue Test Material: E2566-2 Test Concentrations: Control, 1.0. 1.8. 3.2p 5.6. 10, 18 and 32 mg/l. Dilution Water: 246, @g/l:thar*a-n':es's')i*m.g1t7l8 (alkali,,.it%,-) 9-Cl (pH).-' Test Dates: Inittatio.n @.,Jat&ua'r '7 1988 "i 9 19 Tersl,Lriation,-,a..! Y: Length of Study. 48 'Results 24-hour LIC '24-hour dE@@" 48.-hour LC 5 0 48-hotirNOEL:; 'ii'/(lestimted) @12,@ ii9 ;'5i'iiii(-952 C' mg/1) Test Species-. DaEhni Source of Organisms ABC Laborstorie"s@,'tn-houseculture.. Age of orj;anisms at Study InitiatLot%: ","Firte-instar ( 4 hours old) ABC I.ABS 436616-6 of 48 SUMMRY The acute toxicity of E2566-2 to Daphnia magna was assessed using the met%ods outlined by the Comittee on Methods f.orToxicity Tests with Aquat-ic- 11'rga-.iisms.Water quality parameters of temperature, dissolved oxygen and pH were measured at the terminatien of the test and were within acceptable limits. The results of the 48-hour static Daphnia magna toxicity study are summarized below. All reported values were based upoi-,nominal concentratiotts. Compound E2566-2 24-Hour LC so >32 mg/l (estimated) 4S-hour LC,,, (95:C.I.)' .1.5 ig/i The '-'4an,-48 hour no-effect levels of E2566-2 based on the absence of mort;ilityand abnormal effects were 31@and 1.0 mg/l. respectively. ABC LABS 036616-7 of 48 INTRODUCTION This definitive static bioassay was performed by the Aquatic Toxicology Division of Analytical Bio-Chemistry Laboratories, Inc. . : Columbia, Missouri, for 3M Company, from January 7, 1988 to January 9, 1988. The purpose of this test was to determine the 24- and 48-hour LC levels for E2566-2 to Daphnin magna. The study was performed using AB@oprotocol #7806 as appr6v-ed by Mr. Mohamed Elnabarau-y:.3M Company. on January 1988. METHODS A:.'DYATERIALS The procedures for static bloassay, aa described In Methods of Acute Toxicitv Tests with Fish. Macroinvertebrates and Amphibians (1) dnd Standard Methods for Examination of Water and Waste-.:ater(2), were used in this experiment. 1. Test Organisc@s The Daphnia marna used in the test were cultured at the ABC facilities in well water (Table 1). The adult daphnids were fed algae (Selenastrum capricornutim) at least every three days prior to testing and.supplamented with a suspension of Tetramine, cereal leaves, vitamin solution and yeast.*..The daphnids were identified to species using the taxonomic'-key presented by Pennak (3). !I. Test Procedure The static Daphnis bioassay was conducted in'250-ml'gfAksa. beakers containing 200 ml of daphnld ciulture/,testwater.'.@.,All test vessels were covered with loose-fitting petri dish covers to minimize evaporation. and protect. -,against contamination during the study. These vessels were kept at,.20.1!2.0) *@C-in a temperature controlled area. The'lighting was maintained at' 50-70 footcandles on a 16-hour diylight..,,photolieriowdith 30-minute simulated dawn and dusk periods. An Initial range-finding experiment was conducti4.'.us:Lng. teu Daphnis each In exposure. concentr&tLons'-of;,@1.0o,.l'O 100 mg/l. From these results. seven treatment concitntrp6iiont: in duplicate with ten Daphnia (first. lnstar'-i'oss'than @.24ho'@urs,,-.. old) per beaker were selected for the definitive bidassay. These concentrations were a logarithmic series I ranging rom I.i'to 32 mg/l and included a control. All @-c oticentrati.ons' wert; observed once every 24 hours for mortality. andi abuol'rm*'ai.",@.',@'..:.,.@,-*@.',effects such as surfacing, clumping of the daphnide tog'-other and daphnids tending to the bottom of test chambers water chemistry parameters -of temperature, dissolved oxygen and pH:were measured in the control. low. middle and high 'concen-'.".; trations at 0 and 48 liours. of ABC LABS #36616-8, :48 111. Test Compound The F2566-2 sample was received on December 29. 1987 as a ooam@. yellow liquid and was stored at room temperature in darkness. Sample purity was unspecified. Test concentrations wore prepared based on. total product. All standard weights and dilutions can be found In the Appendix. Daphi.,id culture/test water was used In the preparation of all working stock solutions. IV. Statistics Statistical analysis of the concentration vs. effect data (generally mortality) was obtained by employing -icomputerized LC, program developed by Stephan et al. (4). This program 0 cafculated the LC statistic and its 95 percent coniidence limits using the rB'?nomial,the tolving average and the probit tests. Three different methods of analyzing the data wei-e used since no one method of analysis is appropriiite for all possible sets of data that may be obtained. The method of calculation selected for presentation in this report was that which gave the narrowest confidence limits for the LC 50 (4, 5) although all three models are valid. flowever,If no mortality occurred or if a dose response could not be demonstrated over a reasonable range (<37 to 5,,63%)an LC jo and/or its 95 percent confidence limits could not be calcula ed. RESLTLTS Table presents the 'estimated and calculated LC values and 95-percent confidence intervals for. E2566-2. The 24- an3o48-hour LC values were >32 (estimted) and .I @5.. mg/ 1. respectively. All resuliorb were based on the nominal concentrations of 1.0, 1.8. 3.2, 5.6. 10, 18 and 12 mg/l. The uo-effect,.concentratLen based on the absence of mortality and abnormal offects,w&a.'32 mg/l a t 24 hours., At 48 hours the no-effect level was 1.0 mg/.L., The..abnormal effect of mortality was observed in the 1.8, 3.2 5.6,.10. 18 and 32 mg/l test concentrations.,. The 10. 18 a nd 32 mg/l test concentrations were observed at 24 and 48 hours to have a surface film and precipitate present. Table 3 bresent*s the pe're'entaorta iit'y and water quality parameters awasured during the test. @The.. dissolved oxygen concentrations ranged between 8.7 and 9.5 mg/l. These values.represented 100 and 107-pereent, saturation at 20 and 19 *C (corrected for,.localaltitudinal pressure), -..retepect@.ively,and were considered adequate for testing (1).,, The ph.:tl va ues of the test solutions ranged.from 8.2,to -8.4 an d were co n sistent* wite,'thi-.ntrol. T'ke study was conducted following the Intent of the.Good Laboratory. Practico Regulations (6) and the finnl report was reviewed by Analytical Bio-Chemistry Laboratories' Quality Assurance Llnit. All original raw 4sts were provided to 3M Company, with a copy retained at Analytical, bio-ntmlstry Laboratories. ABC LABS #36616-1) of 48 TABLE I ChemicalCharacteristicosf Well Water Used by@ ABC's Aquatic Toxicology Division. Parameter Temperature Dissolved Oxygen a pH Hardness (CACO3) Alkalinity (CaC,o Conductivity Total Organic Carbon Suspended Solids Aluminum Arsenic Boron Cadmium Chromium Cobalt Copper Iron Lead Mercury Nickel silver Zinc Measured organopliosphorus p e stlcides Measured organ ochlorine,'?,''.. pe sticides plus PCB's Concentration 17 - 22*Cb 7.4 - 9.1 pp@b b 7.6 - 8.4 206 - 275 ppm b b 224 - 336 ppm b 500 - 650 umhoo/cm 1.4 ppm c d (0.9 - 2.8 ppm) b 0 - 1.3 ppm <10 ppb <1 ppb 2.25 ppm <3 ppb c7.ppb -c3 ppb <3 ppb 14 ppb <30,ppb 0.43 ppb <8 pp b 4 pp b. ...2ppb <0.14 p@b -cl.0 ppb@'.@ aAfter &eration.. b Represents seasonal"variation,-:"differencefrom one month to he nert, will not exceed 10%, cAverage of all well wate r values from January-Siptember. 1987 Total monthly range of organic carbon Sample dates; Trace. elements w,Juns 3. 1987, org'snophosphate and organochlorine analysea May 28, 1987. %BC 03(j6l6-10of 48 TABLE 2 Acute Toxicity of E2a566-2 to Daphnis maigna Compoukid 24 hours LC 50 (mg/1) >31.(estimated) b 48 hours 1.5 aBioassay conducted at 200C (12-0)-b05@"Confidence limits could not be established. c S'*Zconfidence limits. The 24- and 48-hour no-effect concentrations were 32 and 1.0 mg/l. respectively, based on the absence of mortality and abnormal effects. All values were rounded to two significant figures' following the technique provided in ABC S.O.P...tB.I. LC 50 czlculated.using Binomial Method. ABC LABS #36616-11 of 48 TABI.E 3 Percent MortAlLty and Water Quality Measurements Duri-igthe Acute Toxicity le6t of E2566-2 to I)aphniamagna. Water Rualitv Nominal Concentrctlion (mg/1) rt!rceiit Yortatity 24 hr 48 tir Temp. L Coiirrol 0 19 0 0 0 liourt; D.O. b c miz/I kE 9.3 8.2 .4 8.1@ 48 hours Temp. oc D.O. ML7/1 20 8.7 8.3 20 8.11 8.3 (i so 0 100 5.@ 0 100 19 9.4 5.2 20 8.7 9.3 10 0 LOO 0 100 32 0 loo 19 9.5 8.2 20 8 'S.4 a, lemperature merctirvthermometer. bDissolved oxygen concentrationfi YSI 54 ARC dissolved oxygen cpH Corning 140 pH/mV meter with Beckman 39831 electrode..@@. NOTE: Dissolved oxygen saturations it the test temperatures. d 20*C are 8.9 and 8.7 mg/l. respectively (corrected for altitudiriil@- Press ure at ABC Labs). ABC LABS 636bl6-1.2 of 48 LITEKATVRE CITED (1) Committee on @lethods for Toxicity Tests with Aquatic Organisms. Methods of Acute Toxicit@ Tests wLth.Pishe Macroinvertebrates and ,N=phibians. 1975. U.S. EPA, Ecol. Res. Set. 660/3-75-009. Ar-erlcan Public Ilealth Association.. 1980. Standard Mathods for titeFxininatLtin of Water and Wastewater, 15th ad. Washington, PC. 11,1.6P. (3) Pennak, R. W. 1978. Freshwater Invertebrates of the United States. J*-J.IWinley & Sons, New Yoik, 2nd ad. 803 p. 44).,Stephan, C. E., K. A.. Busch, R. Smith, J. Burke and R. W. Andrews. 1978. A Computer Program for Calculating an LC 50 . L!.S. Envirenmenta'& Protection Agency, ,Duluth.' Minn esota, pre-publication mai-.u.-:criptA,ueust, 1.976. Stephan. (.. 1977. Methods for Calculating an LC 50 . p. 65-8-4. Ln F. I.. Mayer ar.LlJ. L. Hamelink (eds.). Aquatic Toxicolegy and llizard Evaluation. ASTI,4Special Technical Publicaticr. (;34. ASTM. Plailade'Aphia. (1))Org;ii-.I.-atiofnor Economic Cooperation:and Development. 1981. OECD Guidelines for lestitigof Chamicalsi Principles of Good Labora-.orv Practice Annex 2. C(81) 30(FLnal):7-@26.* ABC LABS f36616-13 of 4S QUALITY ASSURANCE STATEMENT Quality Assurance Statement for report 436616 entitled, "Acute Toxicity of E2566-2 to Daplinta ma$tna." for Mr. Mohai-.etElliiabarawy. 14M Company, St. Paul. Minnesota. In accordance with ABC Laboratories' intent that all studies conducted at our facilities are designed and function ir conformance with good laboratory practice regulations and the rrotoculs ior individual laboratory studies, an inspection of the final report ior E2566-2 was conducted and found to be in an acceptable form by a member of our Quality Assurance Unit. A procedure audit was cunducted on December 14, 1987. The study director was notified of the results on the same day. The results of this audit were reportetito ABC Laboratories'.management on December 30, 1987. A final inspection of all data and records on -January14, 1986. indicated that the report submitted to you is an accurate reflection of the study as it was corducted by ABC Laboratories. Should you have any questions relatiiigto the infomation provided in this statement or the function oi our Quality Assurance Unit, please contact the Quality Assurance Unit at your convenience. Kathy Landholt Quality..kssuranceOfficer @Date ABC LABS #36616-14 of 48 -'Stt!D@ C!OMPLIANCF STATEKEHT Study Compliance Statement for ABC report #36616 entitled. "Acute Toxicity of E2566-2 to Daphnia magna." for Mr. Mohismed Elnobarawy, 3.%1 jCompAnv, St. Paul, Minnesota. In accordance with ABC LaboratorIC3' Intent that all aquatic toxicity tests conducted by our facilitv follow good laboratory practices. ABC's study director for the abov@ test herein confirms that tite study was conducted in compliance with the OECD Guidelines for Testing of Chemicals. Principles of Good Laboratory Practice Annex 2. C(81) 30(Final):7-28. All original raw data were provided to 3H Company, and a copy retained at Analytical Blo-Chemistry.Laboratories. Scott Frazier ABC Study Director rate ABC LAB.", #36516-15 of 48 APIIE.%IDIX RAW DAIA NOTE: Some of the records which appear in this raw data appendix have be@riprovided an photocopies of original records on file at ABC. This has been done by necessity for certain data which are used commonly in several studies at ABC. Such records may include analytical, standard solution preparation sheets, organism cuittire logs and well water chemical screen results. ABCLAOS#03bb b. pg-0 0 1 bof0048