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A Data-based Perspective on the Environmental Risk Assessment of Human Pharmaceuticals I — Collation of Available Ecotoxicity Data

  • S. F. Webb

Abstract

There is a growing literature relating to observations of human pharmaceuticals in the environment. Discussions about the environmental consequences of the presence of such compounds have taken place in the general absence of a systematic analysis of the potential risk. This can partly be attributed to the lack of public domain information relating to the ecotoxicity of pharmaceuticals. The lack of such an analysis means that to date, decisions concerning environmental risk assessment criteria and/or regulatory thresholds have been somewhat arbitrary or based upon inappropriate groups of industrial chemicals such as pesticides. This study attempts to address that deficiency and collates examples of data relating to the ecotoxicity of existing human pharmaceuticals. The intention is to provide perspective that will prove useful during the further development of assessment criteria. The database may also prove useful in the context of the risk assessment of individual substances.

Keywords

Naproxen Sodium Etidronic Acid Safety Data Sheet Morone Saxatilis Webb Table 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. Anon (1993) Acute toxicity to bluegill (Lepomis macrochirus) of the test substance ketorolac tromethamine from Radian Corporation in a 96-hr static non-renewal test. Performed for Radian Corporation by AnaltiKEM Environmental Lab, Houston, USA (AnalytiKEM Test Number 01628)Google Scholar
  2. Baldwin WS, Milam DL, Leblanc GA (1995) Physiological and biochemical perturbations in Daphnia magna following exposure to the model environmental estrogen diethylstilbestrol. Environ. Toxicol Chem 14(6)945-952 Google Scholar
  3. Belfroid A, Leonards P (1996) Effect of ethinyl oestradiol on the development of snails and amphibians. SETAC 17th Annual Meeting November 1996, Washington DC (Abstract PO/508)Google Scholar
  4. Brambilla G, Civitareale C, Migliore L (1994) Experimental toxicity and analysis of bacitracin, flumequine and sulphadimethoxine in terrestrial and aquatic organisms as a predictive model for ecosystem damage. Qumica Analitica 13(Suppl 1 ): S73 - S77Google Scholar
  5. Bringmann G, Kühn R (1982) Ergebnisse der Schadwirkung wassergefährdender Stoffe gegen Daphnia magna in einem weiterentwickelten standardisierten Testverfahren. Z Wasser Abwasser Forsch 15(1): 1–6 (Results of the harmful effects of water pollutants to Daphnia magna in a further developed standardized test procedure)Google Scholar
  6. Budavari S (ed) (1989) The Merck index - An encyclopedia of chemicals, drugs and biologicals, 11th edn. Merck and Co. Inc. Rahway, N.J., USAGoogle Scholar
  7. Calleja MC, Personne G, Geladi P (1993) The predictive potential of a battery of ecotoxicological tests for human acute toxicity, as evaluated with the first 5o MEIC chemicals. ATLA 21:330–349Google Scholar
  8. Calleja MC, Geladi P, Personne G (1994a) Modelling of human acute toxicity from physicochemical properties and non-vertebrate acute toxicity of the 38 organic chemicals of the MEIC priority list by PLS regression and neural network. Fd Chem Toxic 32(10):923-941 Google Scholar
  9. Calleja MC, Personne G, Geladi P (1994b) Comparative acute toxicity of the first 5o Multicentre Evaluation of in vitro cytotoxicity chemicals to aquatic non-vertebrates. Arch Environ Contam Toxicol 26: 69–78Google Scholar
  10. Coats JR, Metcalf RL, Lu P-Y, Brown DD, Williams JF, Hansen LG (1976) Model ecosystem evaluation of the environmental impacts of the veterinary drugs phenothiazine, sulfametazine, clopidol and diethylstibestrol. Environ Health Perspect 1: 167–197CrossRefGoogle Scholar
  11. Di Delupis GD, Macri A, Civitareale C, Migliore L (1992) Antibiotics of zootechnical use: effects of acute high and low dose contamination on Daphnia magna Straus. Aquatic Toxicology 22: 53–60CrossRefGoogle Scholar
  12. ECETOC (1993) Aquatic toxicity data evaluation. European Centre for Ecotoxicology and Toxicity of Chemicals, Brussels (Technical Report 56)Google Scholar
  13. Enslein K, Tuzzeo TM, Borgstedt HH, Blake BW, Hart JB (1987) Prediction of rat oral LD5o from Daphnia magna LC50 and chemical structure. In: Kaiser KLE (ed) QSAR in environmental toxicology, vol II. D.D. Reidel Publishing Company, Dordrecht, pp 91–106CrossRefGoogle Scholar
  14. Enslein K, Tuzzeo TM, Blake BW, Hart JB, Landis WG (1989) Prediction of Daphnia magna EC50 values from rat oral LD5o and structural parameters. In: Suter GW, Lewis MA (eds) Aquatic toxicology and environmental fate, vol XI. American Society for Testing and Materials, Philadelphia (ASTM STP 1007, pp 397–409)Google Scholar
  15. FDA-CDER (1996) Retrospective review of ecotoxicity data submitted in environmental assessments. FDA Center for Drug Evaluation and Research, Rockville, MD, USA (Docket No. 96N-oo57)Google Scholar
  16. Fong PP, Huminski PT, D’Urso LM (1998) Induction and potentiation of parturition in fingernail clams (Sphaerium striatinum) by selective serotonin re-uptake inhibitors ( SSRIs ). J Exper Zool 280: 260–264Google Scholar
  17. FWR (1992) Effects of trace organics on fish. Foundation for Water Research, Marlow (Bucks.), UK (October 1992 FR/D 0008 )Google Scholar
  18. FWR (1995) Effects of trace organics on fish - Phase 2. Foundation for Water Research, Marlow (Bucks.), UK (July 1995 FR/D 0022)Google Scholar
  19. Gledhill WE, Feijtel, TCJ (1992) Environmental properties and safety assessment of organic phosphonates used for detergent and water treatment. In: Oude NT de (ed) Detergents–Handbook of environmental chemistry, vol III. Springer-Verlag, New York, Berlin, Heidelberg ( Part F: Anthropogenic compounds, pp 261–285 )Google Scholar
  20. Halling-Sorensen B, Nors Nielsen S, Lanzky PF, Ingerslev F, Holten-Lützhoft HC, Jorgensen SE (1998) Occurrence, fate and effects of pharmaceutical substances in the environment - a review. Chemosphere 36(2)357–393Google Scholar
  21. Henschel KP, Wenzel A, Diederich M, Fliedner A (1997) Environmental hazard assessment of pharmaceuticals. Reg Toxicol Pharmacol 25: 220–225CrossRefGoogle Scholar
  22. Hobbs EJ (1975) Toxicity of polydimethylsiloxanes in certain environmental systems. Environ Res 10:397–406Google Scholar
  23. Holten Lützhoft HC, Halling-Sorensen B, Jorgensen SE (1998). Algal testing of antibiotics applied in Danish fish farming. SETAC-Europe 8th Annual Meeting 14th-18th April 1998, Bordeaux (Abstract 4I/004)Google Scholar
  24. Hughes JS (1973) Acute toxicity of thirty chemicals to stripped bass (Morone saxatilis). Presented at the Western Association of State Game and Fish Commissioners in Salt Lake City, Utah July 1973Google Scholar
  25. Jobling S, Sheahan D, Osborne J, Matthiessen P, Sumpter JP (1996) Inhibition of testicular growth in rainbow trout (Oncorhynchus mykiss) exposed to estrogenic alkylphenolic chemicals. Environ Toxicol Chem 15 (2): 194–202Google Scholar
  26. Johnson SK (1976) Twenty-four hour toxicity tests of six chemicals to mysis larvae of Penaeus setiferus. Texas A and M University Extension, Disease Laboratory (Publication No. FDDL-S8)Google Scholar
  27. Knoll/BASF (1995) Pharmaceutical safety data sheet (Issue/Revision 06/04/94). Knoll Pharmaceuticals, Nottingham, UK (quoted in Halling-Sorensen et al. 1998)Google Scholar
  28. Köpf W (1995) Wirkung endokriner Stoffe in Biotests mit Wasserorganismen. Vortrag bei der 50. Fachtagung des Bayerischen Landesamtes für Wasserwirtschaft: Stoffe mit endokriner Wirkung im Wasser (Abstract). (Effects of endocrine substances in bioassays with aquatic organisms. Presentation at the 5oth Seminar of the Bavarian Association for Waters Supply. Substances with endocrine effects in water) (quoted in Römbke et al. 1995)Google Scholar
  29. Kühn R, Pattard M, Pernak KD, Winter A (1989) Results of the harmful effects of selected water pollutants (anilines, phenols, aliphatic compounds) to Daphnia magna. Wat Res 23(4):495-499Google Scholar
  30. Länge R, Schweinfurth H, Croudace C, Panther G (1997) Growth and reproduction of fathead minnow (Pimephales promelas) exposed to the synthetic steroid hormone ethinylestradiol in a life cycle test (Abstract). Seventh Annual Meeting of SETAC - Europe, April 6–10,1997, Amsterdam, the NetherlandsGoogle Scholar
  31. Lanzky PF, Hailing-Sorensen B, (1997) The toxic effect of the antibiotic metronidazole on aquatic organisms. Chemosphere 35(11):2553-2561Google Scholar
  32. Lilius H, Isomaa B, Holmström T (1994) A comparison of the toxicity of 5o reference chemicals to freshly isolated rainbow trout hepatocytes and Daphnia magna. Aquatic Toxicology 30: 47–60Google Scholar
  33. Macrì A, Sbardella E (1984) Toxicological evaluation of nitrofurazone and furazolidone on Selenastrum capricornutum, Daphnia magna and Musca domestica. Ecotoxicol Environ Safety 8: 115–105CrossRefGoogle Scholar
  34. Marking L, Howe GE, Crowther JR (1988) Toxicity of erythromycin, oxytetracycline and tetracycline administered to Lake Trout in water baths, by injection or by feeding. The Progressive Fish-Culturist 50: 197–201CrossRefGoogle Scholar
  35. Migliore L, Brambilla G, Grassitellis A, Di Delupis GD (1993) Toxicity and bioaccumulation of sulphadimethoxine in Artemia (Crustacea, Anostraca). Int J Salt Lake Res 2 (2): 141–152CrossRefGoogle Scholar
  36. Migliore L, Civitareale C, Brambilla G, Di Delupis GD (1997) Toxicity of several important agricultural antibiotics to Artemia. Wat Res 31(7)a8o1–1806Google Scholar
  37. Panter GH, Thompson RS, Beresford N, Sumpter JP (1999) Transformation of a non-oestrogenic steroid metabolite to an oestrogenically active substance by minimal bacterial activity. Chemosphere 38(15):3579-3596 Google Scholar
  38. Peterson SM, Batley GE, Scammell MS (1993) Tetracycline in antifouling paints. Mar Pollut Bull 26(2):96–100Google Scholar
  39. Purdom CE, Hardiman PA, Bye VJ, Eno NC, Tyler CR, Sumpter JP (1994) Estrogenic effects of effluents from sewage treatment works. Chem Ecol 8: 275–285Google Scholar
  40. Rodriguez C, Chellman K, Gomez S, Marple L (1992) Environmental assessment report pursuant to 21 CFR 25.31(a) submitted to the US FDA in support of the New Drug Application (NDA) for naproxen for over-the-counter use. Hamilton Pharmaceuticals Limited, Puerto RicoGoogle Scholar
  41. Römbke J, et al. (1996) Minutes of the round table discussion: medicines in the environment held at the Federal German Bureau of the Environment (Berlin) on 15th December 1995 on behalf of the Federal German Bureau of the Environment (UBA)Google Scholar
  42. Russom CL, Bradbury SP, Broderius SJ, Hammermeister DE, Drummond RA (1997) Predicting modes of toxic action from chemical structure: acute toxicity in the fathead minnow (Pimephales promelas). Environ Toxicol Chem 16(5):948–967Google Scholar
  43. Sanofi (1996) Tiludronate disodium material safety data sheet SR 41319B. Sanofi Research Schweinfurth H, Länge R, Schneider PW (1996a) Environmental risk assessment in the pharmaceutical industry. Presentation at the 3rd Eurolab Symposium - Testing and Analysis for Industrial Competitiveness and Sustainability, 5–7th June, 1996, BerlinGoogle Scholar
  44. Schweinfurth H, Länge R, Günzel P (1996b) Environmental fate and ecological effects of steroidal estrogens. Presentation at the Oestrogenic Chemicals in the Environment conference organised by IBC Technical Services Ltd in London on 9th and loth May, 1996Google Scholar
  45. Sheahan DA, Bucke D, Matthiessen P, Sumpter JP, Kirby MF, Neall P, Waldock M (1994) The effects of low levels of 17a-ethynylestradiol upon plasma vitellogenin levels in male and female rainbow trout, Oncorhynchus mykiss,held at two acclimation temperatures. In: Müller R, Lloyd R (eds) Sublethal and chronic effects of pollutants on freshwater fish. Blackwell Science, Oxford (Fishing News Books, pp 99-112)Google Scholar
  46. Tooby TE, Hursey PA, Alabaster JS (1975) The acute toxicity of 102 pesticides and miscellaneous substances to fish. Chemistry and Industry 6/1975:523–526Google Scholar
  47. Wang WH, Lay JP (1989) Fate and effects of salicylic acid compounds in freshwater systems. Ecotoxicol Environ Safety 17 (3): 308–316CrossRefGoogle Scholar
  48. Welborn TL (1969) The toxicity of nine therapeutic and herbicidal compounds to stripped bass. The Progressive Fish Culturist 31 (1): 27–32CrossRefGoogle Scholar
  49. Wilford WA (1966) Toxicity of 22 therapeutic compounds to six fishes. US Dept. of the Interior, Fish and Wildlife Service, Bureau of Sports Fisheries and Wildlife, Washington DC (Resource Publication 35 )Google Scholar
  50. Zou E, Fingerman (1997) Synthetic estrogenic agents do not interfere with sex differentiation but do inhibit molting of the cladoceran Daphnia magna. Bull Environ Contam Toxicol 58: 596–602Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2004

Authors and Affiliations

  • S. F. Webb

There are no affiliations available

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