LINCOMYCIN

Overview

Chemical Names
METHYL 6,8-DIDEOXY-6-[[(1-METHYL-4-PROPYL-2-PYRROLIDINYL)CARBONYL]AMINO-1-THIO-D-ERYTHRO-alpha-D-GALACTO-OCTOPYRANOSIDE, MONOHYDROCHLORIDE MONOHYDRATE; METHYL 6,8-DIDEOXY-6-(1-METHYL-trans-4-PROPYL-L-2-PYROLIDONE-CARBOXAMIDO)-1-THIO-D-ERYTHRO-alpha-D-GALACTO-OCTOPYRANOSIDE MONOHYDROCHLORIDE MONOHYDRATE
Synonyms
LINCOSIN; LINCOMYCIN HYDROCHLORIDE; PNU-10149A; ALBIOTIC®
Functional Class
Veterinary Drug
ANTIMICROBIAL_AGENT

Evaluations

Evaluation year: 2004

ADI:
0-0.03 mg/kg bw

Comments:
The Committee could have established a toxicological ADI of 300 µg/kg bw on the basis of the NOEL of 30 mg/kg bw/d for embryotoxicity in rats and a safety factor of 100. The Committee noted, however, that lincomycin belongs to a group of lincosaminides that is active against Gram-positive bacteria and that the human gastrointestinal flora are sensitive to therapeutic doses of this group of compounds. Because this is the most sensitive end-point, the Committee established an ADI of 0-30 µg/kg bw on the basis of the NOEL of 2.5 mg/kg bw/d (rounded to one significant figure) for the effects of clindaymcin on the gastrointestinal microflora and a safety factor of 100.
MRL Comment:
Previous MRLs (expressed as lincomycin) were maintained: Muscle (pigs and chickens): 0.2 mg/kg; liver (pigs and chickens): 0.5 mg/kg; kidney (pigs): 1.5 mg/kg; kidney (chickens): 0.5 mg/kg; fat (pigs and chickens): 0.1 mg/kg; milk (cattle): 0.15 mg/kg. MRLs for cattle tissues were considered at the present meeting but not recommended.
Meeting:
62
Report: 
TRS 925-JECFA 62/21
Tox Monograph: 
FAS 45-JECFA 54/3 (2000)
Residues: 
FNP 41/16-JECFA 62/41

Toxicological study

Pivotal Study:
Clinical study (Kotarski, 1995): Clindamycin at a daily oral dose of 150 mg had no adverse effects in 99 adults treated for up to 12 months (from a literature review).
Animal Specie:
Human
Effect:
Change in gut flora
NOEL:
2.5 mg/kg bw/d
Point of departure:
2.5 mg/kg bw/d
Previous Years:
2002, TRS 911-JECFA 58/28, FNP 41/14-JECFA 58/45, FAS 45-JECFA 54/3 (2000). 0-0.03 mg/kg bw (2000). MRLS: MUSCLE (PIGS AND CHICKENS): 0.2 mg/kg; LIVER (PIGS AND CHICKENS): 0.5 mg/kg; KIDNEY (PIGS): 1.5 mg/kg; KIDNEY (CHICKENS): 0.5 mg/kg; FAT (PIGS AND CH
2002, TRS 911-JECFA 58/28, FNP 41/14-JECFA 58/45, FAS 45-JECFA 54/3 (2000). 0-0.03 mg/kg bw (2000). MRLS: MUSCLE (PIGS AND CHICKENS): 0.2 mg/kg; LIVER (PIGS AND CHICKENS): 0.5 mg/kg; KIDNEY (PIGS): 1.5 mg/kg; KIDNEY (CHICKENS): 0.5 mg/kg; FAT (PIGS AND CH