Document p2Rd6zox8zMk38RXQx6L0dZgj

AR226-2974 TRAPS ^gORgr SWRtts STATtC, ACUTE. 48-HOUR EC50 OF H-19,516 TO Daphnia magna DatajBfiouiEBaiant Organisation for Economic Co-OperatiOR and Development (OECD) ^mdeh'ne^fQFTes^n@-CB8Bweas: 202- Author Kevin N. Baer. Ph.D. Study Completed On June 16.1992 Performmo Laboratory E. I. du Pont de Nemours and Company Hasked Laboratory for Toxicology and Industrial Medicine Bktonftoad, Post Office-Box 50 Newark, Delaware 19714 Laboratory Project ID Haskell Laboratory Report No. 422-92 Company Sanitized. Does not eonfam TSCA P- . Page 1 of !8 v^ THIS PAGE RESERVED FOR SPECIFIC COUNTRY REQUHiaiBNTB ;<S!ffK;?fi-, ,i3.-(..ySt^:-.:.._ frofeti^.il'.l--'"-- - SoeaH, 1contain TSCACE. 2 .';" ~rf-;- .-.'. Du Font HLR 422-92 GOOD LABORATORY PRACTI6 STATEMENT TWs study was conducted according So ERA FTOA Good Laboratory PracBc Standards {40 CFR 160). ONCD Pn.nciples of Qwa^ss^asy Practice (C(81)30(F?naI). Annex 2), and MAPF Japan Good Laboratory Practice Standarcis (59 NohSan No. 3850). Solubility and stability of the test substance in dilution water and under storage conditions warn not determined. Concentrations of the test substance in dilution water ware not measured. Protocol amendments and/or SOP deuations appear in Appendix i Areas of noncompHance (if any) are also documented in the study records. No deviations existed that affected the scientific validity of the study. Submitter: Sponsor: STUDY DIRECTOR: E. I. du Pont de Nemours and Company Du Font Chemicals E. I. du Poni de Nemours and Company /ri<^ ^' jScu^ ^//&/?a. D.Md/Day/Year Kevin N. Baer, Ph Research Toxicologist Environmental Sciences '^^Wiy.SanBfzed Does not contain TSCACBI 3 Du Font HLR 422-92 TABLE OF CONTENTS Page Specific Country Requirements.............................................. -..............................................2 <3(Kdfc^raloiyPi^^ceStatemen{...............................................................................^ TaKe of Contents.............--"....................................--..""--.""-"--"."""---"--" ..--4 5 GeneratlRformatton...........................................--...................................................................... Suniflnary......~..~..".~..--......."------"--"""""- --.--...--...".---".--""""--""""--""""--"7 Quality Assurance Documentation.........................--.........----................--..."....................-8 I. Purpose.............--....."-----"----.....................................................................9 B. Records.--..----.--..----""----"--""""""""--"""""""----"--""""--"--""9 8il. Materials and Methoc(s..............-........-..-............--..-.------..-..".----".."9 A. Test Substance.--------------.--------..------..------......................9 B. DilutionWater.--.--...--.....--.--."..--..----..--..--""--.----""--"--"----.9 C. Animal Culture..........................................................................................................9 D. Test Methods ..............-....-...........".-"----.....................................................9 E. ChemicatAna(ysis................-............................................-....----"."."--."...10 P. ^atisficaSAnaiysis............................................."........-.--...................................10 (V. Results and Discussion ........................................-................................."..-.............10 V. VI. VH. Vill. Conclusion..........................................--..---"--.--"""--"-"--------""11 literature Cited.--..,,..................--.................--...----...--.....------.....---11 T1.abC'ehesm...i.c.a..l..C..h..a.r..a"c.t.e..r.i-s.t--ics--o--f H--as--ke--H --La--bo"r"ato--ry--W.--il..W--at--er.....--....--.............,....................1122 2. Water Chemistry of the Water Control at Test Start.......... .----..,,.........--...... 13 3. Pnystcat and CrieiTiical Cnaraetenstics^ Of H-19,516 Test Sotutions.............14 4. Observed Immobility of Daphnia magna Exposed to H-19,516 for 24 and 5. 4N8omhoinuarel iHn-a19S,t5a1ti5c, CUonnaceeinattreadtiToensst.C..a..u..s..in..g....i.m..m...o..b..i.l.i.t.y..t.o...5.--0%....(..E.--C5.--0)--of--16 Daphnia magna at Specific Time intervals.........................--..----..--..--17 Appenuix..................................--...--..".----.-------.--..--.......-------- .18 1. Protoco1 Amendments and SOP Deviations..........--.......................................18 Sanlfeetf. Does not eonfaEn TSCA CBf 4 Du Mn _JL.S.NLl.-t EMBS^ MS..-1>Q^^KtB1r5pw J- 5 DB Font HLR 422-92 Coatamipaqts; ^ CAS Registry Number- Not Supplied by sponsor Sponsor: Study initiated/Cp^^pt^in-Life Study Initiated/Complftte^; DuPbnt C}iemi(^s E. (. du Font de Nemours and Company Wilmjnr*on, Delaware 19898 5-11-92/6-16-92 5-12-92 / 6-7-92 Rompany Sanitized. Does not contain T8CA CR 6 Du Font HLR 422-92 STATIC, ACUTE. 48 HOUR EC50 OF H-19,516 TO Daphnia magna SUMMARY H-19,516 was slightly toxic to Daphnia magna neonates (iess than 24 hours old) in an unaerafou, static, 48-hourtest. Nominal concentrations were 65,108,180, 300, and 500 mg/L. The 48-hour EC50, based on nominal concentrations and immobility was 130 mc/L with a 85% confidence interval of 110 to 150 mg/L Work By: . / / ^ ^ 6^&C^a~ Chanes L Hall Aquatic Technician 6 /^/?3- Mo/Day/Year THIS REPORT IS APPROVED FOR ISSUE. !\^> Kevin N. Baer, PH.D. Research Toxteotogist Environmental Sciences ^/W9J? Mo/Day/Year Eompany Sanitized. Does not contain TSCA CB1 7 Du Pent HLR 422-92 QUALITY ASSURANCE DOCUMENTATION (H-19516) Daie. of inspection: Conduct - 6/5/92 Records, Report(s) - 6/15/92 Findings reported for Study Director - 6/16/92 Manage>',iBrn - 6/16/92 BrebnerDate Reported by: Vu^K^AjUlB. Bre^/rf^ Kimberiy ^ Quality Assurance Auditor ^{^.hc. riot TSCA cm 8 Du Font HLR 422-92 I. PURPOSE The goaf of this study was to assess the acute toxicity of H 19,516 to Daphnia magna neonates less than 24 hours old. II. RECORDS AiJ data and the final report will be maintained either at Haskeli Laboratory for Toxicology and Industrial Medicine (Newark, Delaware) or be archived at the Du Pont Records Management Center (Wilmington, Delaware). HI. MATERIALS AND METHODS A. Test Substance So rce and composition of the test substance ire described under General Information. A solution of each test concentration was prepared by pipetting the appropriate amount of H-19,516 and directly adding it into dilution water for immediate use. The stability and solubility of H-19,516 in dilution water (see below) was not conducted. B. Dilution Water Water (Table 1) originated from the Masked Laboratory well and flowed through aquaria containing fathead minnows. Pimephales promelas, prior to use in this daphnia test. C. Animal Culture Parent Daphnia magna were reared at Haskeil Laboratory in 250 mL Pyrex beakers (1 per beaker) which contained 200 mL cf filtered dilution water or autodaved filtered dilution water held at approximately 20C. Daphnids were fed two algal species, Ankistrodesmus fglcalLlS and Selenastrum capricomutum. at a rate of 75.000 cells/mL of each species three times weekly during the dilution water renewal process. Neonates (less than 24 hours old) were collected from 9-23 day old parent daphnids for use in this te?t. Sickness, injury, and abnormality were not observed. Daphnia magna were identified by labels on the beakers and test vessels. D. Test Methods [1J Five test concentrations and a water control were used. Nominal test concentrations were 65, 108,180, 300, and 500 mg/L. Pyrex beakers (250 mL; 7-cm diameter) containing 200 mL of test solution (6.8-cm depth) were used. Each replicate (four per concentration) contained five daphnids poWpsny SanliSzed. Does not contain TSCA CBS 9 Du Font HLR 422-92 (1 daphnid/40 mL) for a total of 20 daphnids per test concentration. Daphrdswere added to the control and test beakers using random numbers. Test solutions were held between 19.8 to 20.1C (mean 2fyC). were unaarated, and vessels were covered with a giasspiate. Daphnids were not fed during this test. Aphotopenodof 16hours!ight (366-413 Lux) versus 8 nours darkness was employed v.'i'h approximately 25 minutes of transitional iight (approximately 2 Lux) preceding and fr -.wing the 16 hour Sight interval Observations were made once daily. The criterion for the effect (immobility) was the inability to swim at least two body lengths in any one direction within 15 seconds after gentle prodding with a glass rod. Dissolved oxygen (YSI Model 54A, Yellow Springs Instruments, Yellow Springs, OH), pH (Corning Model 61 OA. Coming Scientific Instruments, MedfieSd, MA), and temperature (registered American Society of Testing Materials mercury thermometer) were measured daily in all replicates of the water control and all test concentrations betere^aphnidswere^dded^^e-beginning^MXI^tthe^nd-oMhfrtest^T^ alkalinity (Kach kit, Hach Chemical Company, Loveland, CO). EDTA hardness (Hach kit, Hach Chemical Company, Loveland. CO), and conductivity (YS! Model S3, Yellow Springs Instruments, Yellow Springs, OH) of Ihe dilution water were measured before daphnids were added at the beginning of the test. E. Chemical Analysis Analysis of the active ingredients in H-19,516 were not conducted. F. Statistical Analysis The 24 and 48-hour EC50 and their associated 95% confidence limits were calculated oy the moving average-angle program [2}. IV. RESULTS AND DISCUSSION An uncovered rangefinding study was conducted using two replicates per concentration, five unfed daphnids per replicate, exposed to control dilution water, 1.0, 100,500, and 1000 mg/L of H-19,516. Immobiiities were 0,0,0,100%, and 100%, respectively, were observed. An eariier uncovered definitive study was conducted but was repeated using a covered test system. Ail chemical and physical parameters (Tables 2 & 3) in the definitive t9oi were within expected ranges. Nominal test concentrations were 65, 108,180,300, and 500 mg/L All test solutions were clear. Except 500 mg/L was slightly cloudy. Test vessels were covered to prevent possible volatilization of the components in this mixture. The 48-hour EC50, based on nominal concentrations and immobility (Table 4) was 130 mg/L with a 95% confidence interval of 110 to 150 mg/L (Table 5). ^.&B)pafl)a_aNfc<ad. iJoes rfoi eonte?n TSCA CE 10 Do Font HLR 422-92 V. CONCLUSEON H-19.515 was slightly toxicity to Daphnia magna naonates {less than 24 hours oN) In an unaerated, static, 48-hour test. VI. UTERATURE CfTED 1. Organisatson for Economic Co-OperaUon and D@vSopm@n(tOECD). Guideline for Testing Chemicals: 202. 4 Aprii 1984. 2. Pettier. W. H. and C, I. Weber. 1985. Methods for Measuring the Acute Tea-gity ^f Effluents to Freshwater and Marina Organisms. EPA/600/4-85/013. United States Environmenta! Protection Agency; Cincinnati, OH., Appendix E, p. 170. fc^P-anyganitfeeD-do.es not contain TSCA cm 1 1 Du Font HLR 422-92 STATIC, ACUTE. 48-HOUR EC50 OP H-19,516 TO Daphnia magna TABLE 1 Chemical Characteristics of Haskelf Laboratory Weft Water1 Parameter Concentration Parameter Concentration BOD, mg/L COD, mg/L DOC, mg/L TOC2, mg/L Total Kjeldahl N, m^/L Ammonia N. mg/L Turbidity, NTU Phenolics, mg/L Color. Co/Pt Solids total suspended, mq/L Aluminum, mg/L Antimony, mg/L Arsenic, mg/L Beryllium, mQ/L Cadmium. mg/L Calcium, mg/L Chloride3. mg/L Chromium, mg/L Cobalt, mg/L Copper, mg/L Cyanide, mg/L Iron3, mg/L Pluoride3 <2 <10 2.8 <0.5 <0.2 <0.05 1.6 <0.050 <5 <4 <0.100 <0.060 <0.010 <0.001 <0.002 24.5 6.2 <0.010 <0.020 <0.010 <0.025 0.025 <0.1 Lead, mg/L Magnesium, mg/L MBAS/LAS, mg/L Mercury, mg/L Nickel, mg/L Nitrite3, mg/L Nitrate3, mg/L Phosphate3, mg/L Potassium, mg/L Selenium, mg/L Silver, mg/L Sodium, mg/L Sulfate3, mg/L Sulfide, mg/L Thallium, mg/L Zinc4, mg/L Volatile priority pollutants Acid extractablei priority pollutants Base/neutral priority pollutants Pesticides/PCBs Organophosphate pesticides5, pg/L <0.075 3.8 <0.05 <0.00020 <0.020 <0.1 2.1 <0.1 1.8 <0.005 <0.010 8.0 4.8 <0.05 <0.01 <0.020 NDS ND6 ND ND <0.50 ^Date of sample collection 30 December 1991 unless Indicated otherwise, analyses performed at Environmental Testing and Certification Corporation, Edison, New Jersey; 'Date of sample collection 15 January 1992, performed at Du Pont Engineering Test Center, Newark, Delaware; SDate of analyses 13 January 1992, analyses performed at Du Font Chemicals. Jackson Laboratory, Deepwaier, New Jersey; ^elow the Published Method Detection Limit (BMDL); SAnalyses performed at Hazleton Laboratories, Inc., Madison. Wl; ^None detected. CfiE Sarsifeea, ot 12 TSCA CBi Du Post HLR 422-92 STATIC, ACUTE, 48-HOUR EC50 OF H-19.516 TO Daphnia magna TABLE 2 Water Chemistry of the Water Control at Test Start Total Alkalinity (nig/L as CaCQs) 78 ECTA Hardness (mg/L as CaCOs) 76 Conductivity (^mhos/cm) 180 jEpmpanySanitized. Does not contain TSCA CBi 13 Du Pom HLR 422-92 STATIC, ACUTE, 48-HOUR EC50 OF H-19,516 TO Dapbnia magna TABLE 3 Physical and Chanifcat Characteristics of H-19,516 Test Solutions Start Nominal Concentrations (mg/L) Aa Ba Ca D3 48 Hours M B3 0 D8 Dissolved Oxygen. mo/L H^O Control 65 108 180 300 500 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 9.2 PJd HzO Control 65 108 180 300 500 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 7.7 9.1 9.1 9.1 9.2* 9.2* 9.2* 9.1 9.1 9.2 9.2* 9.2* 9.2* 9.2 9.1 9.1 9.2* 9.2* 9.2 9.1 9.1 9.2 9.2* 9.2 9.2* 8.0 8.0 8.0 8.0 8.0 8.0 8.0 8.0 8.0 8.0 8.0 8.1 7.9* 7.9* 7.9* 7.9* 7.9* 7.9* 7.9* 8.0 7.9* 7,9* 8.0 7.9* A, B, C, and O represent replicate test vessels containing five daphnids each at test start. Measurements taken at 24 hours due to total immobility. ^^i^norco^ 14 Du Pont HLR 422-92 STATIC, ACUTE, 48-HOUR C50 OF H-19.516 TO Daphnia magna TABLE 3 Continued Physical and Chemical Characteristics of H-19,516 Test Solutions Nominal Concentrations (mg/L) Start ______________ Aa Ba C* D9 48 Hours ______________ A8 B<* C9 Da Temperature. C HzOContro! 65 108 180 300 500 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 20.1 19.8 19.8 19.8 19.8* 19.8* 19.8* 19.8 19.8 19.8 19.8* 19.8* 19.8* 19.8 19.8 19.8 19.8* 19.8* 19.8 19.8 19.8 19.8 19.8* 19.8 19.8* a^, B. C, and D represent replicate test vessel? containing five daphnids each at test start. Measurements taken at 24 hours due to total immobility. ^PanySanftfeed n ^^-----sc.es, !5 Du Pent HLR 422-92 STATIC. ACSWE, 4S-H@VR EG50 OF M-t&^IS T^ Oalii" TABLE 4 (Observeid hnmol3ilityofEiactiaiamilyia Expose dtoH-113,516 1or 24 amd48Hoiins in a Stafio, UnaeratedTest Observed Immo biiity in Pencent 24 ^tours Nominal Concentrations (mg/L) A B" Ca D" 481-fours A BO C8 Da Water Control 0 0 0 0 65 0 0 0 0 108 0 0 0 0 180 100 100 100 100 300 100 100 100 80 500 100 100 80 100 0 0 0 0 0 0 0 0 20 0 20 0 100 100 100 100 100 100 100 100 100 100 100 100 "A, B, C and D represent replicate test vessels containing five daphnids each at test start. 'Company 5am%-ed, Does net contain TSCfi C.W 16 Du Font HLR 422-92 Time STA^C. H-tS>,51 TABLE 5 Nominal H-19,St6 Concentrates Causing Immobility to 50% (EC50) of Daphnia magnaai Specific time intervals EC50 (mg/U*) 95% Confidence interval (mg/L) Slope Y-interoept 24 Hours 140 MJifims 130 120 170 NA NA 110 150 NA NA Based upon nominai concentrations. ^A means not available; parameters could not be generated by the moving average- angle method. eompany Sanitized. Does not contain TSCA CB? 17 Du Font HLR 422-92 STATIC, ACUTE, 4B-HOUR EC50 OF H-19,516 TO Daphniaenagna APPENDIX I PROTOCOL AMENDMENTS AND SOP DEVIATIONS There were a total of 2 Protocol deviations and 1 SOP deviations. Protocol amendments 1. Oaphnid cultures will be fed green algae; spedes and rate unit be at the discretion of the Study Director. Raason for change: Algae is food of choice; SOP in progress. 2. Water samples for analysis wiit not be f :ken. Reason for change: Sponsor request. SQP deyjatjpns 1. Beakers were acclimated for 48 hours. Reason for Change: Test was delayed for 24 hours. SIIT^Sm^I^f'l^S'SfytHf^Sf'CS^aOwisimH?s'?u';^-U^j rwtSS^ifff.l f^ff.tW^ t^iirf^Ui^m^SaSiiS?^l 1i r^?ifw*AA ^s"'rEB^U" 18