PROCAINE BENZYLPENICILLIN

Comments:

Because of the general lack of toxicity, rapid metabolism, and widespread use of the procaine moiety of procaine benzylpenicillin, the Committee considered residues of procaine benzylpenicillin to be equivalent to residues of benzylpenicillin. Among the adverse reactions which had been reported in people consuming food containing benzylpenicillin residues, hypersensitivity reactions were the most common. The overall prevalence of allergy to penicillin was estimated to be 3 - 10%. There was no evidence of sensitization caused by benzylpenicillin residues in food. The Committee evaluated the available data on allergic reactions caused by penicillin residues. Only four cases were considered to be adequately documented to demonstrate that hypersensitivity reactions could be caused by ingestion of less than 40 µg of the drug. The Committee concluded that allergy was the determinating factor in the safety evaluation of residues of benzylpenicillin. In the absence of adequate data to establish a no-effect level, the Committee recommended that the daily intake from food be kept as low as practicable, and in any case below 30 µg of the parent drug. The risk associated with the occurrence of mild hypersensitivity reactions at this level was considered to be insignificant.

MRL Comment:

Daily intake of residues of benzylpenicillin and procaine benzylpenicillin should be kept below 0.03 mg of the penicillin moiety. MRLs, expressed as benzylpenicillin, in mg/kg tissue, mg/l milk: Muscle (all species): 0.05; Liver (all species): 0.05; Kidney (all species): 0.05; Milk (all species): 0.004

Intake:

TMDI for benzylpenicillin residues: 29 µg/p/d total.

Meeting:

50

Report: 

Tox Monograph: 

Residues: