ANNEX 4 RECOMMENDATIONS ON COMPOUNDS ON THE AGENDA Substances Acceptable Daily Recommended Maximum Intake (ADI) for Residue Limit (MRL) human beings and other toxicological recommendations Anthelminthic agents Closantel Not evaluated1 Muscle and liver (sheep): 1500 µg/kg2 Kidney (sheep): 5000 µg/kg2 Fat (sheep): 2000 µg/kg2 Muscle and liver (cattle): 1000 µg/kg2 Kidney and fat (cattle): 3000 µg/kg2 Flubendazole 0-12 µg per kg Muscle and liver of body weight (pigs): 10 µg/kg2 Muscle (poultry): 200 µg/kg2 Liver (poultry): 500 µg/kg2 Eggs: 400 µg/kg2 Ivermectin 0-1 µg per kg of Liver (cattle): 100 µg/kg3 body weight Fat (cattle): 40 µg/kg3 Tiabendazole 0-100 µg per kg Edible tissues4 (cattle, pigs, (Thiabendazole) of body weight goats and sheep) and milk (cattle and goats): 100 µg/kg5 RECOMMENDATIONS ON COMPOUNDS ON THE AGENDA Substances Acceptable Daily Recommended Maximum Intake (ADI) for Residue Limit (MRL) human beings and other toxicological recommendations Triclabendazole 0-3 µg per kg of Muscle (cattle): 200 µg/kg6 body weight Liver and kidney (cattle): 300 µg/kg6 Fat (cattle): 100 µg/kg6 Edible tissues4 (sheep): 100 µg/kg6 Antimicrobial agents Furazolidone Not allocated7 No MRLs allocated8 Nitrofural (Nitrofurazone) Not allocated9 No MRLs allocated8 Production aids Bovine Not specified10 Milk and edible somatotropins tissues4 (cattle): Not specified11 Ractopamine Not allocated12 No MRLs allocated13 Trypanocide Isometamidium 0-100 µg per kg of body Muscle, fat, and milk weight (cattle): 100 µg/kg2 Liver (cattle): 500 µg/kg2 Kidney (cattle): 1000 µg/kg2 Notes to Annex 4 1 An ADI of 0-30 µg per kg of body weight was established at the thirty-sixth meeting of the Committee (WHO Technical Report Series 799, 1990). 2 Expressed as parent drug. 3 Expressed as 22,23-dilydroavermectin B1a (H2B1a) 4 Edible tissues are defined as muscle, fat, liver, and kidney. 5 Expressed as the sum of thiabendazole and 5-hydroxythiabendazole. 6 Expressed as 5-chloro-6-(2',3'-dichlorophenoxy)-benzimadazole-2-one. 7 An ADI could not be established because of evidence of genotoxicity and carcinogenicity and lack of information on the nature of the metabolites. 8 MRLs were not allocated because: a. No ADI was established; b. Data on residues were not sufficient for the Committee to identify a marker residue; and c. Insufficient information was available on the quantity and nature of the total residues. 9 An ADI could not be established because no-effect levels were not observed for the tumorigenic effects. 10 The ADI applies to somagrebove, sometribove, somavubove, and somidobove. ADI "not specified" means that available data on the toxicity and intake of the veterinary drug indicate a large margin of safety for the consumption of its residues in food when the drug is used according to good practice in the use of veterinary drugs. For that reason, and for the reasons stated in the individual evaluation, the Committee has concluded that use of the veterinary drug does not represent a hazard to human health and that there is no need to specify a numerical ADI. 11 The MRLs apply to somagrebove, sometribove, somavubove, and somidobove. MRL "not specified" means that available data on the identity and concentration of residues of the veterinary drug in animal tissues indicate a large margin of safety for consumption of residues in food when the drug is used according to good practice in the use of veterinary drugs. For that reason, and for the reasons stated in the individual evaluation, the Committee has concluded that the presence of drug residues in the named animal product does not present a health concern and that there is no need to specify a numerical MRL. 12 An ADI could not be established because a clear no-effect level was observed for pharmacological effects and the issue of carcinogenicity has not been resolved. 13 MRLs were not allocated because: a. An ADI was not established, and b. Sufficient information was not available for the Committee to establish a marker residue in animal tissues.
See Also: Toxicological Abbreviations