FREE BENZYLPENICILLIN

Comments:

No toxicological studies were available for review. 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. Estimated maximum daily intake values for benzylpenicillin residues at the MRLs are 15 µg/p/d (muscle), 5 µg (liver), 3 µg/p/d (kidney), and 6 µg/p/d (milk), or 29 µg/p/d total.

MRL Comment:

Daily intake of the parent drug should be kept below 0.03 mg/person; MRLs: Liver, kidney and muscle (all species): 0.05 mg/kg; Milk: 0.004 mg/l

MRL Code:

MRL

Intake:

Estimated maximum daily intake values at the MRLs: 15 µg/p/d (muscle), 5 µg/p/d (liver), 3 µg (kidney), and 6 µ/p/d (milk), or 29 µg/p/d total.

Meeting:

36

Report: 

Tox Monograph: 

Residues: 

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