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    ANNEX 4.

    
    ANNEX 4.  RECOMMENDATIONS ON COMPOUNDS ON THE AGENDA
                                                                                             

    Substance           Acceptable Daily Intake (ADI) Recommended Maximum Residue Limit (MRL)
                        and other toxicological
                        recommendations
                                                                                             

     Anthelminthic agent

    Levamisole          0 - 6 g/kg bw                Cattle, sheep, pigs, and poultry:

                                                      Muscle, kidney and fat 10 g/kg1

                                                      Liver                  100 g/kg1
                                                                                             

     Antimicrobial agents

    Chloramphenicol     No ADI allocated2             No MRLs allocated3

    Flumequine          No ADI allocated4             Not evaluated5

    Olaquindox          Limited acceptance of         Insufficient information available to
                        residues6                     establish MRL in two tissues7

    Spectinomycin       0 - 40 g/kg bw               Cattle, pigs, and chickens:

                                                      Muscle                 300 g/kg1,8

                                                      Liver                  2000 g/kg1,8

                                                      Kidney                 5000 g/kg1,8

                                                      Fat                    500 g/kg1,8

                                                      Cattle: milk           200 g/l1,8

    Sulfadimidine       0 - 50 g/kg bw               Cattle, sheep, pigs, and poultry:

                                                      Muscle, liver, kidney  100 g/kg1
                                                      and fat

                                                      Cattle: milk           25 g/l1
                                                                                             

    ANNEX 4. cont'd
                                                                                             

    Substance           Acceptable Daily Intake (ADI) Recommended Maximum Residue Limit (MRL)
                        and other toxicological
                        recommendations
                                                                                             

     Antiprotozoal agent

    Ronidazole          Temporary ADI not extended    Not evaluated5
                                                                                             

     Glucocorticosteroid

    Dexamethasone       0 - 0.015 g/kg bw            Cattle and pigs:

                                                      Muscle and kidney      0.5 g/kg1,9

                                                      Liver                  2.5 g/kg1,9

                                                      Cattle: milk           0.3 g/l1,9

                                                                                             

     Trypanocide

    Dimazene            0 - 100 g/kg bw              Cattle:

                                                      Muscle                 500 g/kg1

                                                      Liver                  12 000 g/kg1

                                                      Kidney                 6000 g/kg1

                                                      Milk                   150 g/l1,10
                                                                                             
    
    NOTES

    1  Expressed as parent drug.

    2  An ADI was not established due to the lack of information to
       assess the carcinogenicity and effects on reproduction of
       chloramphenicol and because the compound was positive in a number
       of  in vitro and  in vivo genotoxicity test systems.

    3  MRLs were not allocated primarily because an ADI was not
       established. In addition, insufficient information was available
       to determine a suitable marker residue, particularly with cattle
       and pigs, in which there were insufficient radiodepletion
       studies.

    4  An ADI was not established due to the lack of information
       (a) that would identify no-observed levels for hepatotoxicity,
       (b) on the tumorigenic mechanism,
       (c) to ensure that arthropathy is not induced, and
       (d) on the microbiological safety of residues.

    5  No data were available to assess the residues.

    6  Insufficient information was available to establish an ADI. The
       Committee concluded that residues resulting from the use of
       olaquindox in pigs under conditions of good practice in the use
       of veterinary drugs were temporarily acceptable, pending
       submission of the results of the requested studies on residues.

    7  The Committee concluded that a residue level in muscle of 4
       g/kg, measured as 3-methylquinoxaline-2-carboxylic acid (MQCA),
       is consistent with the use of olaquindox in pigs under conditions
       of good practice in the use of veterinary drugs. However,
       insufficient information was available to recommend an MRL in a
       second tissue. The Committee requires the results of studies to
       determine residues in liver and kidney using MCQA as the marker
       residue for review by 1996.

    8  Temporary. Final reports of metabolism and residue studies in
       food-producing animals are required for review by 1996.

    9  Temporary. Suitable methods for regulatory monitoring at these
       MRLs are required for review by 1996.

    10 Limit of quantitation of the analytical method.





















    See Also:
       Toxicological Abbreviations