Ampicillin

Overview

Chemical Names
α-aminobenzylpenicillin
CAS number
69-53-4
JECFA number
85
Functional Class
Veterinary Drug
ANTIMICROBIAL_AGENT
Veterinary Drug

Evaluations

Evaluation year: 2017

ADI:
0–0.003 mg/kg bw

Comments:
Overall mADI of 0–0.003 mg/kg bw based on the increase in population of ampicillin-resistant bacteria in humans, and using a safety factor of 10, as this microbiological end-point is lower than the microbiological ADI for effects on colonization barrier disruption. ARfD: 0.012 mg/kg bw based on the microbiological end-point
MRL Comment:
50 μg/kg for ampicillin in finfish muscle and in finfish fillet.
Intake:
GECDE: 0.29 μg/kg bw per day for general population. GEADE: 1.9 μg/kgbw per day for the general population and 1.7 μg/kg bw per day for children (representing respectively 16% and 14% of the ARfD).
Report: 
JECFA 85 report

Toxicological study

Pivotal Study:
Studies of microbiological activity of ampicillin in human.
Animal Specie:
Human
Effect:
increase in population(s) of ampicillin-resistant bacteria in the gastrointestinal tract in humans
NOAEL:
0.025 mg/kg bw per day