Značaj i procena benchmark doze u toksikologiji

  • Katarina Baralić Univerzitet u Beogradu - Farmaceuski fakultet, Katedra za toksikologiju "Akademik Danilo Soldatović"
  • Dragana Javorac Univerzitet u Beogradu - Farmaceuski fakultet, Katedra za toksikologiju "Akademik Danilo Soldatović"
  • Evica Antonijević Univerzitet u Beogradu - Farmaceuski fakultet, Katedra za toksikologiju "Akademik Danilo Soldatović"
  • Aleksandra Buha Djordjevic Univerzitet u Beogradu - Farmaceuski fakultet, Katedra za toksikologiju "Akademik Danilo Soldatović"
  • Marijana Ćurčić Univerzitet u Beogradu - Farmaceuski fakultet, Katedra za toksikologiju "Akademik Danilo Soldatović"
  • Danijela Đukić-Ćosić Univerzitet u Beogradu - Farmaceuski fakultet, Katedra za toksikologiju "Akademik Danilo Soldatović"
  • Zorica Bulat Univerzitet u Beogradu - Farmaceuski fakultet, Katedra za toksikologiju "Akademik Danilo Soldatović"
  • Biljana Antonijević Univerzitet u Beogradu - Farmaceuski fakultet, Katedra za toksikologiju "Akademik Danilo Soldatović"
DOI: https://doi.org/10.5937/arch%20of%20pharm70-25988
Ključne reči: toksikologija, procena rizika, benchmark doza, PROAST, BMDS

Sažetak


Cilj ovog rada je da predstavi značaj granične benchmark doze (engl. benchmark dose, BMD) kao polaznog doznog nivoa (najniže doze ili koncentracije u eksperimentu koja odstupa od normalnog odgovora) u toksikološkoj proceni rizika, kao i da prikaže najčešće korišćene softvere za njeno izračunavanje (BMDS i PROAST). Benchmark doza predstavlja statističku donju granicu pouzdanosti doze koja dovodi do malog povećanja efekta (5-10%) u odnosu na kontrolnu vrednost. Benchmark pristup predstavlja alternativu NOAEL (engl. no observed adverse effects level, NOAEL) pristupu, u kome se u svrhu dobijanja referentnih vrednosti koristi najviša doza koja ne izaziva štetan efekat. Benchmark pristup naučno je napredniji metod od tradicionalnog NOAEL pristupa, jer je statistički utemeljen, daje širok opseg podataka o odnosu doza-odgovor i omogućava kvantifikaciju njihove nesigurnosti i varijabilnosti. Takođe, BMD pristup doprinosi smanjenju broja eksperimentalnih životinja u toksikološkim studijama. Samim tim, Evropska agencija za bezbednost hrane (EFSA) preporučuje primenu doza BMDL10 za kvantalne i BMDL05 za kontinuirane podatke.

Reference

National Research Council. Risk assessment in the federal government: managing the process. National Academies Press; 1983. 25p.

National Research Council. Science and judgment in risk assessment. National Academies Press; 1994. 18p.

Öberg M. Benchmark dose approaches in chemical health risk assessment in relation to number and distress of laboratory animals. Regul Toxicol Pharmacol. 2010;58(3):451–4.

Jensen SM, Kluxen FM, Ritz C. A Review of Recent Advances in Benchmark Dose Methodology. Risk Anal. 2019;39(10):2295–315.

Barnes DG, Dourson M, Dourson M, Preuss P, Barnes DG, Bellin J, et al. Reference dose (RfD): Description and use in health risk assessments. Regul Toxicol Pharmacol. 1988;8(4):471–86.

Đukić-Ćosić D, Antonijević B. Zašto je potrebna toksikološka procena rizika za kozmetički proizvod? Arh Farm (Belgr). 2018;971–89.

Crump KS. A new method for determining allowable daily intakes. Toxicol Sci. 1984;4(5):854–71.

Crump KS. Calculation of Benchmark Doses from Continuous Data. Risk Anal. 1995;15(1):79–89.

Edler L, Poirier K, Dourson M, Kleiner J, Mileson B, Nordmann H, et al. Mathematical modelling and quantitative methods. Food Chem Toxicol. 2002;40(2–3):283–326.

Wheeler MW, Park RM, Bailer AJ, Whittaker C. Historical Context and Recent Advances in Exposure-Response Estimation for Deriving Occupational Exposure Limits. J Occup Environ Hyg. 2015;12:S7–17.

European Food Safety Authority (EFSA). Opinion of the Scientific Committee on a request from EFSA related to A Harmonised Approach for Risk Assessment of Substances Which are both Genotoxic and Carcinogenic. EFSA J. 2005;3(10):282.

Barlow S, Chesson A, Collins J, Flynn A, Hardy A, Klaus-Dieter J, et al. Use of the benchmark dose approach in risk assessment. EFSA J. 2009;1150:1–72.

Bernauer U, Bodin L, Chaudry Q, Coenraads PJ, Dusinka M, Ezendam J, Gaffet E, Galli CL, Granum B, Panteri E, Rogiers V. " The SCCS note of Guidance for the testing of cosmetic ingredients and their safety evaluation–10th Revision" SCCS/1602/18-Final version (2018).

Smith M. Food Safety in Europe: Risk assessment of chemicals in food and diet. Food Chem Toxicol. 2002;40:2–3.

Gaylor DW. Incidence of developmental defects at the no observed adverse effect level (NOAEL). Regul Toxicol Pharmacol. 1992;15(part 2):151–60.

Allen B. Dose-Response Assessment for Developmental Toxicity II. Comparison of Generic Benchmark Dose Estimates with No Observed Adverse Effect Levels. Vol. 23, Fundamental and Applied Toxicology. 1994. p. 487–95.

Krewski D, Zhu Y, Fung KY. Benchmark doses for developmental toxicants. Inhal Toxicol. 1999;11(6–7):579–91.

Filipsson AF, Sand S, Nilsson J, Victorin K. The Benchmark Dose Method - Review of Available Models, and Recommendations for Application in Health Risk Assessment. Crit Rev Toxicol. 2003;33(5):505–42.

Gaylor DW, Slikker W. Modeling for Risk Assessment of Neurotoxic Effects. Risk Anal. 1994;14(3):333–8.

Fechter LD, Chen G Di, Rao D, Larabee J. Predicting exposure conditions that facilitate the potentiation of noise-induced hearing loss by carbon monoxide. Toxicol Sci. 2000;58(2):315–23.

Markowski VP, Zareba G, Stern S, Cox C, Weiss B. Altered operant responding for motor reinforcement and the determination of benchmark doses following perinatal exposure to low-level 2,3,7,8-tetrachlorodibenzo-p-dioxin. Environ Health Perspect. 2001;109(6):621–7.

Luyendyk JP, Shores KC, Ganey PE, Roth RA. Bacterial lipopolysaccharide exposure alters aflatoxin B1 hepatotoxicity: Benchmark dose analysis for markers of liver injury. Toxicol Sci. 2002;68(1):220–5.

Buha A, Antonijević B, Bulat Z, Jaćević V, Milovanović V, Matović V. The impact of prolonged cadmium exposure and co-exposure with polychlorinated biphenyls on thyroid function in rats. Toxicol Lett. 2013;221(2):83–90.

Antonijevic E, Musilek K, Kuca K, Djukic-Cosic D, Andjelkovic M, Djordjevic AB, et al. Comparison of oximes K203 and K027 based on Benchmark dose analysis of rat diaphragmal acetylcholinesterase reactivation. Chem Biol Interact. 2019;308(May):385–91.

Ćurčić M, Tanasković S, Stanković S, Janković S, Antunović M, Djordjević S, et al. Odnos hepatotoksičnosti i doze dekabromovanog difeniletra u ciljnom tkivu kod subakutno izloženih Wistar pacova. Vojnosanit Pregl. 2015;72(5):405–13.

Antonijevic E, Musilek K, Kuca K, Djukic-Cosic D, Curcic M, Miladinovic DC, et al. Dose-response modeling of reactivating potency of oximes K027 and K203 against a direct acetylcholinesterase inhibitor in rat erythrocytes. Food Chem Toxicol. 2018;121(August):224–30.

Buha A, Antonijević B, Milovanović V, Janković S, Bulat Z, Matović V. Polychlorinated biphenyls as oxidative stress inducers in liver of subacutely exposed rats: Implication for dose-dependence toxicity and benchmark dose concept. Environ Res. 2015;136:309–17.

Ćurčić M. Subakutna toksičnost smeše dekabromovanog difeniletra i kadmijuma kod pacova. 2015. (Doctoral dissertation, Univerzitet u Beogradu-Farmaceutski fakultet).

Antonijević E. Antidotska efikasnost novosintetisanih oksima k203 i k027 kod pacova akutno trovanih dihlorvosom. 2019. (Doctoral dissertation, Univerzitet u Beogradu-Farmaceutski fakultet).

EMA. Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. 2014;44(November).

Bailer AJ, Oris JT. Modeling reproductive toxicity in Ceriodaphnia tests. Environ Toxicol Chem. 1993;12(4):787–91.

Haber LT, Dourson ML, Allen BC, Hertzberg RC, Parker A, Vincent MJ, et al. Benchmark dose (BMD) modeling: current practice, issues, and challenges. Crit Rev Toxicol. 2018;48(5):387–415.

Hardy A, Benford D, Halldorsson T, Jeger MJ, Knutsen KH, More S, et al. Update: use of the benchmark dose approach in risk assessment. EFSA J. 2017;15(1):1–41.

Use of BMDS and PROAST software packages by EFSA Scientific Panels and Units for applying the Benchmark Dose (BMD) approach in risk assessment. EFSA Support Publ. 2017;8(2).

Slob W. Benchmark dose and the three Rs. Part I. Getting more information from the same number of animals. Crit Rev Toxicol. 2014;44(7):557–67.

Slob W. Benchmark dose and the three Rs. Part II. Consequences for study design and animal use. Crit Rev Toxicol. 2014;44(7):568–80.

Davis JA, Gift JS, Zhao QJ. Introduction to benchmark dose methods and U . S . EPA’ s benchmark dose software ( BMDS ) version 2.1.1. Toxicol Appl Pharmacol. 2011;254(2):181–91.

Objavljeno
2020/07/02
Broj časopisa
Vol. 70 Br. Notebook 3 (2020): Arhiv za farmaciju
Rubrika
Pregledni (Revijalni) rad
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