Document NE3Yzy3EBDmgdR8NDervvJYjD

DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE Report 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoroDaphnia magna Reproduction Test (21 d), Limit Test according to OECD Guideline 211 Page 1 of 4 Project-No. 020719CK Study-No. DRE84111 Robust Sum m ary A R 2 2 6 -1 643 Test Item Batch Number CAS RN Purity Testing Facility Method Method/Guideline followed Type GLP Year performed Test Conditions Species Test organism Culture Culture medium Feeding of the Culture Age of test organisms 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoroP00/001 678-39-7 C8-perfluoroalkylethanol: 99.3 % (a/a), sum perfluoroalkylethanol 99.9 % (a/a) DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE Kthe-Paulus-Str. 1, D-31157 Sarstedt Tel. +49(0)5066 70670, email: info@noack-lab.de OECD-Guideline No. 211 Semi-static Yes [X] No [ ] 2003 Daphnia magna STRAUS (Clone 5) In 2-3 L glass vessels with approximatively 1.8 L culture medium, at 21 C (temperatures of 20 - 25 C are tolerated), in an incubator, 16 h illumination, illumination strength max. 20 pmolm"2 s-1. Elendt M4, according to Elendt (1990), modified to a total hardness of 160 to 180 mg CaCO3/L. At least 5x weekly ad libitum with a mix of Desmodesmus subspicatus and Chlorella vulgaris, with an algae cell density of > 106cells/mL. 2 - 24 h old Daphnids were used for the test. Stock solution Dispersion treatment Vehicle Limit concentration Dilution water A stock solution of 1.3 g test item/L was prepared in methanol. The stock solution was not longer used than 21 d. Agitation Methanol, the concentration in the test replicates and the solvent control replicates was 0.1 mL/L. 0.13 mg 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10heptadecafluoro-/L dissolved in 0.1 mL methanol/L (0.1 mL of the stock solution were mixed with dilution water to give a final volume of 1 L). Elendt M4, according to Elendt (1990), modified to a total hardness of 160 to 180 mg CaCO3/L. DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE Report 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoroDaphnia magna Reproduction Test (21 d), Limit Test according to OECD Guideline 211 Page 2 of 4 Project-No. 020719CK Study-No. DRE84111 Illumination Photoperiod Temperature range pH Hardness O2 Exposure period Exposure vessel type Number of study organisms Number of replicates Max. 15 - 20 gmolm-2 s-1 16 / 8 hours light / dark cycle 18 - 22 C, 2 C constant The pH-value should be in the range of 6 - 9. Normally deviations of initial and final pH values should be < 1.5 units. > 140 mg/L CaCO3 The oxygen concentration should be > 3 mg/L at the beginning and during the test. 21 d Glass beakers (5 (ID) x 8 (H) cm), 100 mL volume will be used. 10 animals, individually held 10 per concentration, solvent control and control Endpoints assessed parental Measurements Analytical monitoring Measured concentration remarks Number of juveniles, immobile juveniles, aborted eggs, immobile occurrence of males and winter eggs. Dissolved oxygen concentration, pH-values, total hardness and water temperature were measured once a week, in fresh and old media, in one replicate of the control, the solvent control and the test item concentration. The test item concentration of the fresh and old media were analytically verified by gas gromatography with mass spectrometric detection (m/z = 463 and 395).The limit of detection (LOD) and limit of quantification (LOQ), calculated using the blind value method (according to DIN 32645) were determined to be 0.009 mg/L and 0.027 mg/L (threefold the LOD), respectively. The test item concentration of the fresh and old media were analytically verified three times within the study period after 0, 6, 12, 24 and 48 h. Test item concentrations were analysed in triplicates. The control, solvent control and stock solution were analysed after 0 and 48 h in one replicate. All results are based on the geometric mean exposure concentration. DR.U.NOACK-LABORATORIUM FUR ANGEWANDTE BIOLOGIE Report 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoroDaphnia magna Reproduction Test (21 d), Limit Test according to OECD Guideline 211 Page 3 of 4 Project-No. 020719CK Study-No. DRE84111 Results Validity criteria Water parameter were determined to be within the acceptable limits. Table 1: W ater Parameters During Test Exposure G.M.E.C. [pg a.i./L] Dissolved oxygen range img/Ll pH-value range 45.3 7.63 - 9.31 6.92 - 8.04 Solvent control 7.88 - 9.44 6.97 - 8.12 Temperature range [C] Total hardness range [mg/Ll 20.4 - 21.9 163 - 179 20.5 - 21.9 163 - 179 Control 7.94 - 9.57 7.33 - 8.62 20.1 - 22.0 160 - 177 Water quality criteria of pH-value: Deviations < 1.5 units between the initial and final pH-values are regarded to be not significant. The dissolved oxygen concentration should be above 3 mg/L. The total hardness should be more than 140 mg/L as CaCO3. The temperature should be within the range 18-22 C. G.M.E.C. = Geometric mean exposure concentration Endpoints assessed: Table 2: Test Item Related Effects Effects Number of Juveniles (Reproduction Rate) Control Solvent Control Geometric Mean Exposure Concentration 45.3 pg a.i./L no yes no Coefficient of Variation (CV) 1) Immobile Juveniles Aborted Eggs Immobilisation of the Parental 2) Occurrence of Males, Winter Eggs no no no no no no yes yes no no no yes yes no no no = no significant effect 1) = CV > 25 % yes = significant effect 2) = > 20 % after 21 days Mortality in the control and solvent control group did not exceed 20 % at the end of the test. The mean number of living offspring produced per parent animal surviving at the end of the test was > 60 in the control group. The coefficient of variation around the mean number of living offspring produced per parent in the control groups was < 25 %. DR.U.NOACK-LABORATORIUM FR ANGEWANDTE BIOLOGIE Report 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoroDaphnia magna Reproduction Test (21 d), Limit Test according to OECD Guideline 211 Page 4 of 4 Project-No. 020719CK Study-No. DRE84111 Conclusions Measured concentrations Evaluation Using the analytically verified concentrations the geometric mean exposure concentration was calculated to be 45.3 pg a.i./L. Alternatively, the time weiged mean measured concentration was calculated to be 64.3 pg a.i./L. The no observed effect concentration (NOEC) was determined to be the geometric mean exposure concentration 45.3 pg a.i./L.