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 µg/kg bw Cattle, sheep, pigs, and poultry:
Muscle, kidney and fat 10 µg/kg1
Liver 100 µg/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 µg/kg bw Cattle, pigs, and chickens:
Muscle 300 µg/kg1,8
Liver 2000 µg/kg1,8
Kidney 5000 µg/kg1,8
Fat 500 µg/kg1,8
Cattle: milk 200 µg/l1,8
Sulfadimidine 0 - 50 µg/kg bw Cattle, sheep, pigs, and poultry:
Muscle, liver, kidney 100 µg/kg1
and fat
Cattle: milk 25 µg/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 µg/kg bw Cattle and pigs:
Muscle and kidney 0.5 µg/kg1,9
Liver 2.5 µg/kg1,9
Cattle: milk 0.3 µg/l1,9
Trypanocide
Dimazene 0 - 100 µg/kg bw Cattle:
Muscle 500 µg/kg1
Liver 12 000 µg/kg1
Kidney 6000 µg/kg1
Milk 150 µg/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
µg/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