CHLORAMPHENICOL

Overview

Chemical Names
2,2-DICHLORO-N-[2-HYDROXY-1-(HYDROXYMETHYL)-2-(4-NITROPHENYL)ETHYL] ACETAMIDE
CAS number
56-75-7
Functional Class
Veterinary Drug
ANTIMICROBIAL_AGENT

Evaluations

Evaluation year: 2004

ADI:
NO ADI ALLOCATED

Comments:
Chloramphenicol was previously evaluated at the Committee's 12th, 32nd, and 42nd meetings. Concerns have been expressed about the genotoxicity of chloramphenicol and its metabolites, its embryo- and fetotoxicity, its carcinogenic potential in humans and the lack of a dose response for the induction of aplastic anaemia, which may be fatal. The Committee noted that aplastic anaemia induced by chloramphenicol is a rare idiosyncratic response in humans, which may have an immunological component.As such, no animal model could be developed. Due to these factors and the lack of data concerning the mechanism o chloramphenicol-induced aplastic anaemia, the Committee could not identify any studies in animals or epidemiological studies that would assist the further toxicological evaluation and concluded that it was not appropriate to establish an ADI for chloramphenicol. The Committee was also unable to propose options for regulating traces of chloramphenicol in foods. The human exposure which may have resulted from consumption of contaminated seafood in the years 2001–2003 was probably lower than the systemic exposure resulting from the use of ophthalmic formulations. However, the resulting risk could not be estimated.
MRL Comment:
No MRLs allocated
MRL Code:
O
Meeting:
62
Report: 
TRS 925-JECFA 62/49
Tox Monograph: 
FAS 53-JECFA 62/7
Residues: 
FNP 41/6-JECFA 42/1 (1994)
Previous Years:
1994, TRS 851-JECFA 42/12, FNP 41/6-JECFA 42/1, FAS 33-JECFA 42/19. NO ADI OR MRLS ALLOCATED. NO. O 1987, TRS 763-JECFA 32/16, FNP 41-JECFA 32/1, FAS 23-JECFA 32/1. NO ADI ALLOCATED. ACCEPTABLE RESIDUE LEVEL: NOT ALLOCATED. NO. O 1968, NMRS 45/TRS 430-J
1994, TRS 851-JECFA 42/12, FNP 41/6-JECFA 42/1, FAS 33-JECFA 42/19. NO ADI OR MRLS ALLOCATED. NO. O 1987, TRS 763-JECFA 32/16, FNP 41-JECFA 32/1, FAS 23-JECFA 32/1. NO ADI ALLOCATED. ACCEPTABLE RESIDUE LEVEL: NOT ALLOCATED. NO. O 1968, NMRS 45/TRS 430-J