1(38) 2014

DOI xxxxxxxx

Kirsenko V. V., Yastrub T. A., Kovalenko V. F., Demchenko V. F., Aleksandrova L. G.


SI «Institute for Occupational Health of NAMS of Ukraine», Kyiv

Full article (PDF), RUS

Background. A substantiation of an acceptable daily intake (ADI), development of hygienic norms and regulations is an obligatory condition for the state registration of new pesticides in Ukraine. The most significant stage in this procedure is substantiation of ADI, where a combination of toxicological data by an acting ingredient of a pesticide is used, covering the data on acute, subacute, sibchronic and chronic toxicity, absorption, distribution, elimination and metabolism of a pesticide, its delayed effects and genotoxicity. The established significance of ADI, in combination with other hygienic standards (threshold limit values for a pesticide in compartments of the environment and work conditions, maximum acceptable levels in food products) and regulations, create an information support, showing a distinct representation on the degree of safe use of a pesticide, and, in the final, the possibility of its state registration and application as means of plant protection.
Purpose. To ground the ADI and hygienic standards for Dodin- (an active ingredient of the fungicide «Silitt 400 SC») by the results of studies, conducted in state trials in Ukraine.
Methods. Analysis of materials on Dodin toxicological dossiers submitted by the International Programme on Chemical Safety and the European food safety agency, the results of research carried out at the State Institution «Institute for Occupational Health of NAMS of Ukraine» and National Medical University by A.A. Bogomolets on substantiation of hygienic standards and regulations on safe use of the formulation «Sillit 400 SC» with guidelines for hygienic evaluation of new pesticides. Results. The acceptable daily intake of Dodin — 0,1 mg/kg/day has been grounded, based on no observed effect levels (NOEL) = 10 mg/kg, established by the results of chronic experiments on dogs and a safety coefficient = 100. For the implementation of the sanitary control on application of «Sillit 400 SC» in conditions of agricultural production it is necessary to keep to the following hygienic standards and regulations: ADI — 0,1 mg/kg/day; OEL for the air of the working zone — 0,4 mg/m3; OEL for the atmospheric air — 0,01 mg/m3; MAC for water reservoirs — 0,003 mg/dm3 (general sanitary regulations); AAC for the soil — 1,0 mg/kg; MRL for apples — 0,9 mg/kg (limit for quantification by HPLC — 0,4 mg/kg); for apple juice it is not per¬mitted (the limit of quantification by HPLC — 0,025 mg/kg). The re-entry time for gathering apples — 60 days, for workers for mechanized operations in the apple orchards - 3 days, for manual work — 7 days.
Conclusions: "Sillit 400 SC" (a.i. dodin, 400 g/l) — a systemic fungicide of preventive and therapeutic action by "Agrifar S.A." (Belgium), used to protect apple trees from a combination of fungal diseases. It is recommended for permanent registration in Ukraine at the rate of 1,7—2,25 l/ha and the maximum number of treatments — 2. The Class of hazard — 2 (limiting crite¬rion — inhalation toxicity); it is dangerous for contacts with eye mucous membranes.

Key words: substantiation, ADI, safety, fungicide, apple trees, spraying, MRL


  1. Melnik, N. N. 1968, Chemistry of pesticides. Moscow: Chemistry, pp. 261-262 (in Russian).
  2. Ovchinnikov, Yu. 1987, Bioorganic Chemistry. Moskow: Education, pp. 760-773 (in Russian).
  3. Acceptable doses, concentrations, quantity and levels of pesticides in agricultural raw material, food, air of the working zone, atmospheric air, water of reservoir, soil. Sanitary standards N8., Resolu­tion No30 of 14.11.2012. (in Ukrainian).
  4. Pesticide residues in food.2001, Joint FAO / WHO Mee­ting on Pesticides Residues, EVALUATION 2000, Part II-Toxo- cology. World Health Organization.Geneva, pp.111-132.
  5. EFSA - Conclusion on Peer Review: Conclusion on peer review on pesticides risk assessment on the active substan- sce DODINE. 2010 EFSA Journal, V 8, no. 6, pp. 1631-1685.
  6. Materials on substantiation of hygienic standards and regulations on safe use of the fungicide «Sillit 400 SC» (a.i. dodin, 400 g/ l), produced by the company «Agrifar S.A.» (Belgium), for agricultural sector on apple trees. Substantiation of the acceptable daily intake for Dodin. Research report of the SI «Institute for Occupational Health of NAMS of Ukraine», Kiev, 2013, pp. 1-48 (in Russian).
  7. Materials for substantiation of hygienic standards and regulations on the safe use of the fungicide «Sillit 400SC» (a.i. dodin, 400 g /l) produced by the company «Agrifar C,A.» (Belgium) in agrobusiness on apple trees. Research report of the SI «Institute for Occupational Health of NAMS of Ukraine», 2013, Kiev, pp. 1-60 (in Russian).
  8. Sanitary and hygienic studies on substantiation of the maximum allowable concentration for Dodin (a.i. «Sillit 400 SC», manufactured by the company «Agrifar S. A.», Belgium) for water reservoirs of the household use. Research report of the National Medical University named after A.A. Bogomoletz ), 2013, Kiev, p.1-24 (in Russian).
  9. Methodological guidelines on hygienic evaluation of new pesticides. 1988, Kiev, pp. 36 -39 (in Russian).
  10. WHO Codex Alimerntarius, 2013.
  11. Regulation (EC) No 396/2005 of the European Parliament and the Council of the 23 February 2005 on maximum residues levels of pesticides in food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70 , 16.3.2005, pp. 1-16.
  12. EFSA: MRL team www.efsa.europa/eu/en/mris/ mriteam.htp
  13. Reasoned opinion on modification of the existing MRLs for dodine various fruit crops. EFSA, Journal, 2013, V. 11, no. 1, pp. 3077.
  14. Temporary methodological guidance on the use of the calculated method for substantiation of approximate safe levels of pesticides in soil (№ 2283-81 of 14.01.81).