Use of acute and chronic ecotoxicity data in environmental risk assessment of pharmaceuticals

Environmental Toxicology and Chemistry

Volumn 35, Issue 5, 2016, Pages 1201-1212

  Vestel, Jessica ^a   Caldwell, Daniel J ^b   Constantine, Lisa ^c   D'Aco, Vincent J ^d   Davidson, Todd ^e   Dolan, David G ^f   Millard, Steven P ^g   Murray Smith, Richard ^h   Parke, Neil J ⁱ   Ryan, Jim J ^j   Straub, Jürg Oliver ^k   Wilson, Peter ^l  

^a MERCK RESEARCH LABORATORIES   (United States)

^b JOHNSON AND JOHNSON   (United States)

^c PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^d Quantum Management Group   (United States)

^e BRISTOL MYERS SQUIBB   (United States)

^f AMGEN INC   (United States)

^g Probability Stat and Information   (United States)

^h ASTRAZENECA   (United Kingdom)

ⁱ ELI LILLY AND COMPANY   (United States)

^j GLAXOSMITHKLINE   (United Kingdom)

^k F HOFFMANN LA ROCHE LTD   (Switzerland)

^l SANOFI   (France)

more..

Author keywords

Acute to chronic ratio; Aquatic toxicity; Environmental risk assessment; Pharmaceuticals; Predicted no effect concentration (PNEC)

Indexed keywords

ALCOHOLS; DRUG PRODUCTS; FISH; RISK ASSESSMENT;

ACTIVE PHARMACEUTICAL INGREDIENTS; ACUTE-TO-CHRONIC RATIOS; AQUATIC TOXICITY; DISTRIBUTION COEFFICIENT; ENVIRONMENTAL RISK ASSESSMENT; MANUFACTURING PROCESS; PHYSICOCHEMICAL PROPERTY; PREDICTED NO-EFFECT CONCENTRATIONS;

TOXICITY;

ABIRATERONE; ANTIESTROGEN; ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; ARIPIPRAZOLE; AZITHROMYCIN; CARDIOVASCULAR AGENT; CEFTOBIPROLE; CENTRAL NERVOUS SYSTEM AGENTS; CINACALCET; DALCETRAPIB; DORIPENEM; DRONEDARONE; ESTRADIOL; ESTROGEN; ETHINYLESTRADIOL; FLUOROURACIL; FULVESTRANT; MICONAZOLE; MONTELUKAST; OCTANOL; PROPRANOLOL; RIBAVIRIN; RIMONABANT; STEROID; SURFACE WATER; TAMOXIFEN; WATER; WATER POLLUTANT;

ALGA; CONCENTRATION (COMPOSITION); CRUSTACEAN; DATA ASSIMILATION; DRUG; ECOTOXICOLOGY; ENVIRONMENTAL RISK; EUROPEAN UNION; FISH; HORMONE; PHYSICOCHEMICAL PROPERTY; RISK ASSESSMENT; STEROID; WATER QUALITY;

ACUTE TOXICITY; ALGA; AQUATIC ENVIRONMENT; ARTICLE; CHRONIC TOXICITY; CONCENTRATION (PARAMETERS); DAPHNIA; EC50; ECOTOXICITY; ENVIRONMENTAL IMPACT ASSESSMENT; ENVIRONMENTAL RISK ASSESSMENT; EUROPEAN UNION; FISH; LC50; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; RISK ASSESSMENT; SCALE UP; TOXICITY TESTING; TROPHIC LEVEL; ADVERSE DRUG REACTION; ANIMAL; CHEMISTRY; CYANOBACTERIUM; DRUG EFFECTS; GREEN ALGA; TOXICITY; WATER POLLUTANT;

ALGAE; APIS; DAPHNIIDAE;

1-OCTANOL; ANIMALS; CHLOROPHYTA; CYANOBACTERIA; DAPHNIA; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FISHES; RISK ASSESSMENT; TOXICITY TESTS, ACUTE; TOXICITY TESTS, CHRONIC; WATER; WATER POLLUTANTS, CHEMICAL;

EID: 84959567626     PISSN: 07307268     EISSN: 15528618     Source Type: Journal    
DOI: 10.1002/etc.3260     Document Type: Article

References (58)

1. Heberer T. 2002. Occurrence, fate, and removal of pharmaceutical residues in the aquatic environment: A review of recent research data. Toxicol Lett 131:5-17.
2. Fent K, Weston AA, Caminada D. 2006. Ecotoxicology of human pharmaceuticals. Aquat Toxicol 76:122-159.
3. Phillips PJ, Smith SG, Kolpin DW, Zaugg SD, Buxton HT, Furlong ET, Esposito K, Stinson B. 2010. Pharmaceutical formulation facilities as sources of opioids and other pharmaceuticals to wastewater treatment plant effluents. Environ Sci Technol 44:4910-4916.
4. Larsson DG, de Pedro C, Paxeus N. 2007. Effluent from drug manufactures contains extremely high levels of pharmaceuticals. J Hazard Mater 148:751-755.
5. Li D, Yang M, Hu J, Ren L, Zhang Y, Li K. 2008. Determination and fate of oxytetracycline and related compounds in oxytetracycline production wastewater and the receiving river. Environ Toxicol Chem 27:80-86.
6. Larsson DG, Fick J. 2009. Transparency throughout the production chain-A way to reduce pollution from the manufacturing of pharmaceuticals? Regul Toxicol Pharm 53:161-163.
7. Brausch JM, Connors KA, Brooks BW, Rand GM. 2012. Human pharmaceuticals in the aquatic environment: A review of recent toxicological studies and considerations for toxicity testing. Rev Environ Contam Toxicol 218:1-99.
8. US Food and Drug Administration. 1998. Guidance for industry. Environmental assessment of human drug and biologics applications. CMC-6, Rev. 1, July 1998. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER), Rockville, MD.
9. European Medicines Agency. 2006. Guideline on the environmental risk assessment of medicinal products for human use. EMEA CHMP/SWP/4447/00. Committee for Medicinal Products for Human Use (CHMP), London, UK.
10. Tischler L, Buzby M, Finan DS, Cunningham VL. 2013. Landfill disposal of unused medicines reduces surface water releases. Integr Environ Assess Manage 9:142-154.
11. US Environmental Protection Agency. 1995. Final Water Quality Guidance for the Great Lakes System, Final Rule. 40 CFR Part 131. Fed Reg 60:15365-15425.
12. European Commission. 2011. Common implementation strategy for the Water Framework Directive (2000/60/EC), Technical guidance for deriving environmental quality standards, Guidance Document 27. Technical Report 2011-055. Brussels, Belgium.
13. Ohno Y. 2002. ICH guidelines-Implementation of the 3Rs (refinement, reduction, and replacement): Incorporating best scientific practices into the regulatory process. ILAR J 43:S95-98.
14. Hutchinson TH, Barrett S, Buzby M, Constable D, Hartmann A, Hayes E, Huggett D, Laenge R, Lillicrap AD, Straub JO, Thompson RS. 2003. A strategy to reduce the numbers of fish used in acute ecotoxicity testing of pharmaceuticals. Environ Toxicol Chem 22:3031-3036.
15. Jeram S, Sintes JMR, Halder M, Fentanes JB, Sokull-Kluttgen B, Hutchinson TH. 2005. A strategy to reduce the use of fish in acute ecotoxicity testing of new chemical substances notified in the European Union. Regul Toxicol Pharm 42:218-224.
16. European Chemicals Agency. 2008. Guidance on information requirements and chemical safety assessment. Chapter R.10: Dose [concentration]-response regarding environment. Table R.10-4, Assessment factors to derive PNECaquatic. Helsinki, Finland.
17. European Chemicals Agency. 2011. Guidance on information requirements and chemical safety assessment, Part B: Hazard assessment, Ver 2.1. Helsinki, Finland.
18. Forbes VE, Calow P. 2002. Extrapolation in ecological risk assessment: Balancing pragmatism and precaution in chemical controls legislation. Bioscience 52:249-257.
19. US Environmental Protection Agency. 1996. Estimating Toxicity of Industrial Chemicals to Aquatic Organisms Using Structure-Activity Relationships, 2nd ed. Washington, DC.
20. Hickey GL, Craig PS, Luttik R, de Zwart D. 2012. On the quantification of intertest variability in ecotoxicity data with application to species sensitivity distributions. Environ Toxicol Chem 31:1903-1910.
21. Organisation for Economic Co-operation and Development. 1995. Test No. 107: Partition coefficient (n-octanol/water)-Shake flask method. In OECD Guidelines for the Testing of Chemicals. Paris, France.
22. Organisation for Economic Co-operation and Development. 2004. Test No. 117: Partition coefficient (n-octanol/water), HPLC method. In OECD Guidelines for the Testing of Chemicals. Paris, France.
23. Organisation for Economic Co-operation and Development. 2006. Test No. 123: Partition coefficient (n-octanol/water), slow stirring method. In OECD Guidelines for the Testing of Chemicals. Paris, France.
24. Ankley GT, Schubauer-Berigan MK, Dierkes JR. 1991. Predicting the toxicity of bulk sediments to aquatic organisms with aqueous test fractions: Pore water vs. elutriate. Environ Sci Technol 10:1359-1366.
25. Di Toro DM. 2013. The interplay of environmental toxicology and chemistry in the development of sediment quality criteria. Environ Toxicol Chem 32:7-9.
26. Di Toro DM, Zarba CS, Hansen DJ, Berry WJ, Swartz RC, Cowan CE, Pavlou SP, Allen HE, Thomas NA, Paquin PR. 1991. Technical basis for establishing sediment quality criteria for nonionic organic chemicals using equilibrium partitioning. Environ Toxicol Chem 10:1541-1583.
27. Van Leeuwen CJ, Van der Zandt PT, Aldenberg T, Verhaar HJ, Hermens JL. 1991. The application of QSARs, extrapolation and equilibrium partitioning in aquatic effects assessment for narcotic pollutants. Sci Total Environ 109-110:681-690.
28. Chiou CT, Freed VH, Schmedding DW, Kohnert RL. 1977. Partition coefficient and bioaccumulation of selected organic chemicals. Environ Sci Technol 11:475-478.
29. Neely WB, Branson DR, Blau GE. 1974. Partition coefficient to measure bioconcentration potential of organic chemicals in fish. Environ Sci Technol 8:1113-1115.
30. Hodson PV, Dixon DG, Kaiser KLE. 1988. Estimating the acute toxicity of waterborne chemicals in trout from measurements of median lethal dose and the octanol-water partition coefficient. Environ Toxicol Chem 7:443-454.
31. Crane M, Watts C, Boucard T. 2006. Chronic aquatic environmental risks from exposure to human pharmaceuticals. Sci Total Environ 367:23-41.
32. Sanderson H, Thomsen M. 2009. Comparative analysis of pharmaceuticals versus industrial chemicals acute aquatic toxicity classification according to the United Nations classification system for chemicals. Assessment of the (Q)SAR predictability of pharmaceuticals acute aquatic toxicity and their predominant acute toxic mode-of-action. Toxicol Lett 187:84-93.
33. Webb SF. 2004. A data-based perspective on the environmental risk assessment of human pharmaceuticals I-Collation of available ecotoxicity data. In Kummerer K, ed, Pharmaceuticals in the Environment: Sources, Fate, Effects, and Risks, 2nd ed. Springer-Verlag, New York, NY, USA, pp 317-343.
34. US Food and Drug Administration. 2004. Comparison chart of FDA and EPA good laboratory practice (GLP) regulations and the OECD Principles of GLP. [cited 2015 July 26]. Available from: http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm135197.htm
35. American Society of Health-System Pharmacists. 2011. AHFS Drug Information 2011. Bethesda, MD.
36. Verhaar HJ, van Leeuwen CJ, Hermens JL. 1992. Classifying environmental pollutants: 1. Structure-activity relationships for prediction of aquatic toxicity. Chemosphere 25:471-491.
37. Enoch SJ, Hewitt M, Cronin MT, Azam S, Madden JC. 2008. Classification of chemicals according to mechanism of aquatic toxicity: An evaluation of the implementation of the Verhaar scheme in Toxtree. Chemosphere 73:243-248.
38. Ideaconsult. 2014. Toxtree. 2.6.6 ed. Sofia, Bulgaria.
39. Harrell FE. 2014. rms: Regression Modeling Strategies, R Package Ver 4. 2-0. [cited 2015 March 10]. Available from: http://CRAN.R-project.org/package=rms
40. Kienzler A, Halder M, Burton J, Crane M, Worth A. 2014. Waiving chronic fish tests: Possible use of acute-to-chronic relationships and interspecies correlations (Poster). Abstracts, SETAC Europe, 24th Annual Meeting, May 11-15, 2014, Basel, Switzerland, pp 338-339.
41. Zhang XJ, Qin HW, Su LM, Qin WC, Zou MY, Sheng LX, Zhao YH, Abraham MH. 2010. Interspecies correlations of toxicity to eight aquatic organisms: Theoretical considerations. Sci Total Environ 408:4549-4555.
42. Kar S, Roy K. 2010. First report on interspecies quantitative correlation of ecotoxicity of pharmaceuticals. Chemosphere 81:738-747.
43. Tukey JW. 1994. The problem of multiple comparisons. In Braum HI, ed, The Collected Works of John W. Tukey. Vol 8, Chapman & Hall, New York, NY, USA.
44. Bretz F, Hothorn T, Westfall P. 2011. Multiple Comparisons Using R. CRC, Boca Raton, FL, USA.
45. Klein JP, Moeschberger ML. 2005. Survival Analysis: Techniques for Censored and Truncated Data, 2nd ed. Springer, New York, NY, USA.
46. Kalbfleisch JD, Prentice RL. 2002. The Statistical Analysis of Failure Time Data, 2nd ed. John Wiley & Sons, Hoboken, NJ, USA.
47. Hosmer DW, Lemeshow S, May S. 2008. Applied Survival Analysis: Regression Modeling of Time to Event Data, 2nd ed. John Wiley & Sons, Hoboken, NJ, USA.
48. Akritas MG, Murphy SA, LaValley MP. 1995. The Theil-Sen estimator with doubly censored data and applications to astronomy. J Am Stat Assoc 90:170-177.
49. Harrell FE. 2001. Regression Modeling Strategies. Springer, New York, NY, USA.
50. Olejniczak K, Spindler P. 2004. Environmental risk assessment of medicinal products for human use: Aspects of its regulations in the European Union, Canada and United States. In Kummerer K, ed, Pharmaceuticals in the Environment: Sources, Fate, Effects and Risks, 2nd ed. Springer-Verlag, New York, NY, USA, pp 269-287.
51. Hulzebos E, Sijm D, Traas T, Posthumus R, Maslankiewicz L. 2005. Validity and validation of expert (Q)SAR systems. SAR QSAR Environ Res 16:385-401.
52. European Centre for Ecotoxicology and Toxicology of Chemicals. 2007. Intelligent testing strategies in ecotoxicology: Mode of action approach for specifically acting chemicals. Technical Report 102. Brussels, Belgium.
53. Ewer J. 2005. How the ecdysozoan changed its coat. PLoS Biol 3:e349.
54. Caldwell DJ, Mastrocco FJ, Hutchinson TH, Lange R, Heijerick D, Janssen CR, Anderson PD, Sumpter JP. 2008. Derivation of an aquatic predicted no-effect-concentration for the synthetic hormone, 17a-ethinyl estradiol. Environ Sci Technol 42:7046-7054.
55. Ahlers J, Riedhammer C, Vogliano M, Ebert RU, Kuhne R, Schuurmann G. 2006. Acute to chronic ratios in aquatic toxicity-Variation across trophic levels and relationship with chemical structure. Environ Toxicol Chem 25:2937-2945.
56. Farmaceutiska Specialiteter i Sverige. 2012. Environmental classification of pharmaceuticals in www.fass.se-Guidance for pharmaceutical companies. [cited 2015 July 26]. Available from: http://www.fass.se/pdf/Environmental_classification_of_pharmaceuticals-120816.pdf
57. Agerstrand M, Ruden C. 2010. Evaluation of the accuracy and consistency of the Swedish environmental classification and information system for pharmaceuticals. Sci Total Environ 408:2327-2339.
58. Caldwell DJ, Mastrocco F, Margiotta-Casaluci L, Brooks BW. 2014. An integrated approach for prioritizing pharmaceuticals found in the environment for risk assessment, monitoring and advanced research. Chemosphere 115:4-12.