UTEROGEN

Overview

Chemical Names
GENTAMICIN
Synonyms
GENTAMAM; SEPTIGEN; BIGENTAL; UTEROGEN; GENTOCIN; GENTAVETINA
CAS number
1403-66-3
Functional Class
Veterinary Drug
ANTIMICROBIAL_AGENT

Evaluations

Evaluation year: 1999

ADI:
0-0.02 mg/kg bw

Comments:
The Committee established an ADI of 0-20 µg/kg bw on the basis of a microbiological end-point. The Committee noted that the lowest NOEL identified at the 43rd meeting in toxicological studies was 10 mg/ kg bw, 500 times the microbiological ADI. The ADI was calculated using the following formula: ADI (µg/kg bw) = (6 µg/g (MIC50) × 220 g (mass colonic content))/(1 (fractional bioavailability) x 1 (safety factor) x 60 kg (mass adult human)) = 22 µg/kg bw.
MRL Comment:
MRLs (expressed as parent drug, in mg/kg tissue, mg/l milk): Muscle and fat (cattle and pigs): 0.1; Liver (cattle and pigs): 2; Kidney (cattle and pigs): 5; Milk (cattle): 0.2
MRL Code:
TMRL
Intake:
TMDI: 0.785 mg/p/d
Meeting:
50
Report: 
TRS 888-JECFA 50/22
Tox Monograph: 
FAS 41-JECFA 50/29
Residues: 
FNP 41/11-JECFA 50/61

Toxicological study

Pivotal Study:
In vitro microbiological studies (Lohuis & Aerts, 1996): MIC values of gentamicin were determined for anaerobic and aerobic bacteria isolated from fresh stools of 25 healthy adult volunteers. Ten isolates each of Enterococcus spp., coliforms, Proteus spp., Bacteroides spp., Lactobacillus spp, Bifidobacterium spp, Prevotella spp, Eubacterium spp., Clostridium spp., Fusobacterium spp., and anaerobic gram-positive cocci were tested, including five control strains.
Animal Specie:
Human gut flora
Effect:
Growth inhibition
Point of departure:
6 µg/g (MIC50)
Previous Years:
1997, TRS 879-JECFA 48/43, FNP 41/7-JECFA 43/45 (1994), FAS 34-JECFA 43/85 (1994). 0-0.004 (TEMPORARY, EXTENDED UNTIL 1998). MRLs (TEMPORARY, EXTENDED UNTIL 1998; EXPRESSED AS PARENT DRUG): MUSCLE AND FAT (CATTLE AND PIGS): 0.1; LIVER (CATTLE AND PIGS): 0
1997, TRS 879-JECFA 48/43, FNP 41/7-JECFA 43/45 (1994), FAS 34-JECFA 43/85 (1994). 0-0.004 (TEMPORARY, EXTENDED UNTIL 1998). MRLs (TEMPORARY, EXTENDED UNTIL 1998; EXPRESSED AS PARENT DRUG): MUSCLE AND FAT (CATTLE AND PIGS): 0.1; LIVER (CATTLE AND PIGS): 0