Marbofloxacin (2^nd edition) (Veterinary Medicinal Products)

Area of Science:

• Veterinary Pharmacology
• Food Safety Risk Assessment
• Toxicology

Background:

• Marbofloxacin (MBFX) is an antibacterial fluoroquinolone used in veterinary medicine.
• The Food Safety Commission of Japan (FSCJ) previously assessed MBFX, and this is the second edition of the risk assessment.
• New pharmacokinetic and residue studies for cattle injection (Forcyl) were submitted for review.

Purpose of the Study:

• To update the risk assessment for marbofloxacin (MBFX).
• To establish an acceptable daily intake (ADI) for MBFX based on new data.
• To evaluate the safety of MBFX for use in cattle.

Main Methods:

• Review of newly submitted pharmacokinetic and residue studies in cattle.
• Evaluation of subacute toxicity studies in rats and dogs.
• Determination of the lowest no-observed-adverse-effect level (NOAEL).

Main Results:

• Adverse effects were observed in toxicity studies in rats and dogs.
• The lowest NOAEL was determined to be 4 mg/kg body weight per day.
• An ADI of 0.004 mg/kg body weight per day was established, considering data limitations.

Conclusions:

• The FSCJ concluded that the ADI for marbofloxacin (MBFX) should be 0.004 mg/kg body weight per day.
• This ADI is based on the lowest NOAEL from toxicity studies and considers the lack of chronic and carcinogenic data.
• The updated assessment ensures the safe use of MBFX in food-producing animals.