Document 2jy0aDDzznEY4rkv1oY4QBvOg

(\Rl%-osi5 ACUTE TOXICITY TO AQUATIC INVERTEBRATES (E.G.,DAPHNIA) TEST SUBSTANCE Identity: Perfluorooctylsulfonate, didecyldimethylammonium salt; may also be referred to as Fluoroalkyl ammonium derivative. [1Decaminium, N-decyl-N,N-dimethyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1octanesulfonic acid (1:1), CAS # 251099-16-8] Remarks: The 3M production lot number was Lot 1. The test sample is L-14394 referred to by the test laboratory as P3025. The sample was labeled F-11615, Lot 1. The test sample is a mixture of the test substance in water (approximately 30-40% test substance, 60-70% water, and 0-5% of residual perfluorochemicals). All values reported relate to this mixture. The test sample appears to be a 2-phase dispersion (clear liquid with opaque solid) which rapidly separates after agitation. No calculations were made to adjust for the actual concentration of the test substance in the test sample. METHOD Method: OECD 202 Test type: Static acute GLP: No Year Completed: 1996 Species: Daphnia magna Analytical monitoring: DO, pH, temperature and conductivity were monitored daily. Statistical methods: EL50 values calculated using Trimmed SpearmanKarber method. NOEL value calculated using Steel's Many-One Rank test. Test daphnid source: Obtained from cultures maintained by ASci Corporation, Duluth, MN. Test daphnid age at study initiation: < 24-hours Test conditions Dilution water: Dechlorinated City of Duluth, MN tap water. Water was aerated for 24-hours prior to use in the test. Dilution water chemistry: hardness: 44 mg/L as CaC0 3 pH: 8.04 004243 Lighting: Cool-white fluorescent bulbs. Photoperiod of 16-hours light, 8-hours dark. No transition period noted. Stock and test solutions preparation: Water-accommodated fractions. Test solutions were prepared individually for each concentration by mass addition of vigorously shaken test substance in 1 L of dilution water. The solutions were vigorously stirred for 23hours (vortex 1/2 to 1/3 solution depth). The aqueous phase was siphoned from the vessel at mid-depth after settling for 1-hour. Exposure vessels: 250 mL borosilicate glass beakers containing 200 mL of test solution. The solutions were kept covered during the test. Number of replicates: Four Number o f daphnids per replicate: Five Number of concentrations: five plus a negative control Water chemistry during the study: Dissolved oxygen range (0 - 48 hours): 8.6 - 9.1 mg/L (control exposure) 8.0 - 8.8 mg/L (50 mg/L exposure) pH range (0 - 48 hours) 8.04 - 8.11 (control exposure) 7.92 - 8.00 (50 mg/L exposure) Test temperature range (0 -4 8 hours) 20.9 - 21.0C Conductivity range (0 - 48 hours): 1 4 2 -1 5 5 pmhos/cm (control exposure) 1 2 0 -1 2 4 pmhos/cm (50 mg/L exposure) Element basis: mortality and immobilization RESULTS Nominal loading concentrations: Bk control, 3.13, 6.25, 12.5, 25, 50 mg/L Element value: 24-hour EL50 = 27.0 (18.7-39.0) mg/L 48-hour EL50 = 11.3 (9.6-13.2) mg/L 48-hour NOEL = 6.25 mg/L All element values based on nominal concentrations. Statistical Evaluation: The EL50 values and 95% confidence intervals were calculated by the Trimmed Spearman-Karber method. The N O EL was calculated using Steel's Many-One Rank test using the TOXSTAT statistical software Version 3.2, University of Wyoming. 004244 Biological observations: Daphnids in the negative control, and the 3.13 and 6.25 mg/L treatments appeared healthy and normal throughout the test with no mortality, immobility or overt clinical signs of toxicity. The effects noted in this study were mortality; no immobilization was noted at any test concentration. The number of surviving organisms were determined visually and recorded initially and after 24 and 48 hours. Cumulative percent mortality: N om inal Loading T est Cone., m g/L 24-hours 48-hours Neg. Control 3.13 6.25 12.5 25 50 0 0 0 5 50 75 0 0 0 70 95 100 Control response: satisfactory Remarks: Values reported are for the test sample. No calculations were made to adjust for the concentration of the test substance in the test sample. CONCLUSIONS The test substance 48-hour EL50 for Daphnia magna was determined to be 11.3 mg/L with a 95% confidence interval of 9.6-13.2 mg/L. The 48hour no observed effect level (NOEL) was 6.25 mg/L. Submitter: 3M Company, Environmental Laboratory, P.O. Box 33331, St. Paul, Minnesota, 55133 DATA QUALITY Reliability: Klimisch ranking 2. The study lacks analytical measurement of test substance concentrations in the test solutions and sample purity is not sufficiently characterized. Additionally, data is for a mixture and toxicity cannot be positively attributed to didecyldimethylammonium Perfluorooctylsulfonate salt alone. REFERENCES 004245 This study was conducted at AScI Corporation, Environmental Testing Division, Duluth, MN, at the request of the 3M Company. OTHER__________________________________________________ Last changed: 5/24/00 004246 AScI Corporation/AScI-Duluth Environmental Testing Division AScI Study ID# 5010-068 STUDY TITLE ACUTE TOXICITY OF DEVELOPMENTAL MATERIAL TO DAPHNIA MAGNA DATA STANDARD OECD GUIDELINE 202 STUDY COMPLETED January 10, 1997 TESTING FACILITY AScI Corporation/AScI-Duluth Environmental Testing Division 4444 Airpark Boulevard Duluth, MN 55811 Tel. No. (218) 722-4040 Fax No. (218) 722-2592 STUDY IDENTIFICATION NUMBERS AScI Study ID# 5010-068 3M Company Lab Request# P3025 Sponsor: 3M Company Sponsor Study ID# P3025 1 004247 AScI Corporation/AScI-Duluth Environmental Testing Division AScl Study ID# 5010-068 1.0 GENERAL INFORMATION Study Title Data Standard Sponsor Sponsor's Representative Sponsor's Lab Request# Testing Facility Principal Investigator Project Director Testing Facility Director Definitive Test Dates Data Validation and Report Review Acute Toxicity of Developmental Material to Daphnia magna. OECD Guideline 202. 3M Environmental Technology and Safety Services, Building 2-3E-09, 935 Bush Avenue, St. Paul, MN 55133. Susan A. Beach, 3M Environmental Technology and Safety Services, Building 23E-09, 935 Bush Avenue, St. Paul, MN 55133; Tel No. (612) 778-7452. P3025. AScI Corporation/AScI-Duluth Environmental Testing Division, 4444 Airpark Boulevard, Duluth, MN 55811; Tel. No. (218) 722-4040. Joe Dierkes. Joe Amato. Donald Mount. December 11-13, 1996. Alan Mozol. Report Signature: Retention of Raw Data and Final Report Location of Raw Data and Final Report Two years from the date study is completed. AScI Corporation/AScI-Duluth Environmental Testing Division, 4444 Airpark Boulevard, Duluth, MN 55811; Tel. No. (218) 722-4040. Sponsor: 3M Company Sponsor Study ID# P3025 2 C04248 AScl Corporation/AScI-Duluth Environmental Testing Division AScl Study ID# 5010-068 2.0 OBJECTIVE(S) To determine the 48-h EL50 (effective loading) and 48-h NOEL (no observed effect loading) of the test substance, L-14394 Developmental Material, for Daphnia magna. This study was conducted according to the AScl study plan retained by the Sponsor and OECD Guideline 203 (OECD 1993). The test solutions were water-accommodated fractions (WAF) prepared following Girling, Whale, & Adema 1994. 3.0 TEST METHODS Test Substance Test Organisms Dilution Water Properties: two-phase liquid before agitated, light colored, nearly odorless slurry after agitation, specific gravity ca. 1.2 g/cc, and insoluble in water. Test loadings: 0 (dilution water control), 3.13 mg/L, 6.25 mg/L, 12.5 mg/L, 25 mg/L, and 50 mg/L. Test loading solutions were prepared individually for each concentration. The solutions were prepared by mass addition of vigorously shaken test substance in 1 L of dilution water. The solutions were vigorously stirred (vortex 1/3 to 1/2 solution depth) for 23 h. The aqueous phase was siphoned from the vessel at mid depth. Source: Healthy, less than 24-h old Daphnia magna neonates obtained from AScl stock cultures maintained in water of test dilution water quality. Use in test: Gravid adults isolated in dilution water 24 h before the test initiation. Used 5 organisms/replicate and 4 replicates/test concentration. Handled with a smooth bore pipet with an inside diameter of 6 mm. Did not feed during the test. Source: Dechlorinated City of Duluth, MN, tap water. The most recent chemical analysis is in Raw Data Package. Characteristics: At test time, the water had a hardness of 44 mg/L (as CaC03) and a pH of 8.04. Aerated for 24 h prior to using in the test. Sponsor: 3M Company Sponsor Study ID# P3025 3 AScl Corporation/AScI-Duluth Environmental Testing Division AScl Study ID# 5010-068 Exposure Chambers Incubation Observations Endpoint Calculations ..... Type'. 250-ml borosilicate glass beakers. Use in test'. 200 ml of dilution water or test solution/chamber. During the test, kept covered, except when experimental observations were made. Duration: 48 h. Daily photoperiod: 16 h light and 8 h dark, maintained using cool-white fluorescent bulbs. Temperature: 21 C. Biological: Daily- gently agitated the exposure chambers and then counted immobilized and dead test organisms (immobilized organisms were those that did not swim within 15 seconds after exposure chambers were gently agitated). Did not remove any daphnids from the exposure chambers at 24 h. Water chemistry: (1) At test initiation- total hardness and alkalinity, (2) daily- temperature, pH, DO, and conductivity. All determinations were made according to APHA methods (1995). ELS0: Trimmed Spearman-Karber method. NOEL: Steel's Many-One Rank Test (TOXSTAT statistical software, Version 3.2, University of Wyoming). Sponsor: 3M Company Sponsor Study ID# P3025 4 004250 AScI Corporation/AScI-Duluth Environmental Testing Division AScl Study ID# 5010-068 3.0 RESULTS Test Substance Toxicity (Pertinent data are in Table 1) Ranges of Water Chemistry Parameters 24-h EL50: 27.0 mg/L (18.7-39.0 mg/L). 48-h ELS0: 11.3 mg/L (9.6-13.2 mg/L). 48-h NOEL: 6.25 mg/L. Total hardness (as CaC03 mg/L): 41-44. Alkalinity (as CaC03 mg/L): 42-45. Temperature (C): 20.9-21.0C. DO (mg/L): 7.9-9.1. pH: 7.92-8.11. Specific conductivity (timhos/cm): 120-155. 4.0 TEST QA/QC QA/QC Criteria Test organism dead, immobilized or trapped in control exposure must not be more than 10%. The lowest DO concentration at test termination must be at least 60% of the air saturation value at test temperature. Test duration must be 48 h. Reference substance toxicity test (this test is optional). Data 0% dead, immobilized or trapped. The lowest DO concentration measured was 89% of the air saturation value at 21.0C. The test duration was 48 h. Current control chart for D. magna acute testing is included in the raw data package. Sponsor: 3M Company Sponsor Study ID# P3025 5 004251 AScI Corporation/AScl-Duluth Environmental Testing Division AScl Study ID# 5010-068 5.0 REFERENCES American Public Health Association (APHA). 1995. Standard Methods for the Examination of Water and Wastewater. APHA, Washington, D.C. Girling, A.E., G.F. Whale, and D.M.M. Adema. 1994. A Guideline Supplement for Determining the Aquatic Toxicity of Poorly Water-Soluble Complex Mixtures Using WaterAccommodated Fractions. Chemosphere 29(12):2645-2649. Hamilton, M .A ., R.C. Russo, and R.V. Thurston. 1977. Trimmed Spearman-Karber Method for Estimating Median Lethal Concentrations in Toxicity Bioassays. Environ. Sci. Technol. 11(7):714-719; Correction 12(4):417 (1978). Organization for Economic Cooperation and Development (OECD). 1993. OECD Guidelines for Testing of Chemicals. OECD Publication Information Center, Washington, D.C. University of Wyoming. Toxstat Version 3.2. Cheyenne, Wyoming 82001. Sponsor: 3M Company Sponsor Study ID# P3025 6 004252 AScI Corporation/AScI-Duluth Environmental Testing Division AScI Study ID// 5010-068 TABLE 1. ACUTE TOXICITY OF MAGNA DEVELOPMENTAL MATERIAL TO DAPHN1A Test Substance Loading (mg/L) 0 3.13 6.25 12.5 25 50 Cumulative Number and Percent of Affected Organisms* 24 h 48 h 0(0) 0(0) 0(0) 1 (5) 10 (50) 15 (75) 0(0) 0(0) 0(0) 14 (70) 19 (95) 20 (100) * Percentages are in parenthesis. EFFECT AND NO-EFFECT LOADINGS WITH CORRESPONDING 95% CONFIDENCE INTERVALS 1 ELjq and NOEL I 24-h EL50 I 48-h EL50 1 48-h NOEL Data (mg/L) 27.0 11.3 6.25 95 % Confidence Interval 18.7-39.0 9.6-13.2 Not Applicable Sponsor: 3M Company Sponsor Study ID// P3025 7 004253