PMID- 32625863
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 1831-4732 (Electronic)
IS  - 1831-4732 (Linking)
VI  - 16
IP  - 4
DP  - 2018 Apr
TI  - Safety and efficacy of Coxar((R)) (nicarbazin) for turkeys for fattening.
PG  - e05214
LID - 10.2903/j.efsa.2018.5214 [doi]
LID - e05214
AB  - The coccidiostat Coxar((R)) is safe for turkeys for fattening at the use level of 
      100 mg nicarbazin/kg complete feed, with a margin of safety of about 1.25. 
      Nicarbazin, when ingested, is rapidly split in its two components 
      2-hydroxy-4,6-dimethylpyrimidine (HDP) and dinitrocarbanilide (DNC), which behave 
      independently. HDP-related residues are much lower than those of DNC. DNC is the 
      marker residue. Liver is the target tissue. Nicarbazin is not genotoxic. The 
      primary toxicity resulting from the oral use of nicarbazin is renal toxicity. The 
      lowest no observed adverse effect level (NOAEL) identified in a 52-week study in 
      rat using DNC+HDP is 20 mg DNC + 8 mg HDP/kg body weight (bw) per day based on 
      the absence of microcrystals in urine and related microscopic renal observations. 
      The use of 100 mg nicarbazin from Coxar((R))/kg complete feed for turkeys for 
      fattening will not pose a risk to consumers, provided that maximum contents in 
      nicarbazin of 0.1% p-nitroaniline (PNA) and 0.4% methyl(4-nitrophenyl) carbamate 
      (M4NPC) would be respected. No withdrawal time is required. Residue data comply 
      with the established maximum residue limits (MRLs). Nicarbazin is not a skin or 
      eye irritant and not a skin sensitiser. These conclusions also apply to the 
      additive Coxar((R)). Inhalation toxicity of nicarbazin is limited; the granulated 
      additive has a low dusting potential. No risk for users is identified. Based on 
      the available data, the FEEDAP Panel cannot conclude on the safety of Coxar((R)) 
      for the environment. The efficacy of 100 mg nicarbazin from Coxar((R))/kg feed was 
      demonstrated in three anticoccidial sensitivity tests (AST), but only in one 
      floor pen study. The floor pen study with 75 mg nicarbazin failed to demonstrate 
      evidence of efficacy. No final conclusions on the efficacy of nicarbazin from 
      Coxar((R)) for turkeys for fattening can be drawn.
CI  - (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and 
      Sons Ltd on behalf of European Food Safety Authority.
CN  - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
FAU - Rychen, Guido
AU  - Rychen G
FAU - Aquilina, Gabriele
AU  - Aquilina G
FAU - Azimonti, Giovanna
AU  - Azimonti G
FAU - Bampidis, Vasileios
AU  - Bampidis V
FAU - Bastos, Maria de Lourdes
AU  - Bastos ML
FAU - Bories, Georges
AU  - Bories G
FAU - Chesson, Andrew
AU  - Chesson A
FAU - Cocconcelli, Pier Sandro
AU  - Cocconcelli PS
FAU - Flachowsky, Gerhard
AU  - Flachowsky G
FAU - Kolar, Boris
AU  - Kolar B
FAU - Kouba, Maryline
AU  - Kouba M
FAU - Lopez Alonso, Marta
AU  - Lopez Alonso M
FAU - Lopez Puente, Secundino
AU  - Lopez Puente S
FAU - Mantovani, Alberto
AU  - Mantovani A
FAU - Mayo, Baltasar
AU  - Mayo B
FAU - Ramos, Fernando
AU  - Ramos F
FAU - Saarela, Maria
AU  - Saarela M
FAU - Villa, Roberto Edoardo
AU  - Villa RE
FAU - Wallace, Robert John
AU  - Wallace RJ
FAU - Wester, Pieter
AU  - Wester P
FAU - Brantom, Paul
AU  - Brantom P
FAU - Halle, Ingrid
AU  - Halle I
FAU - van Beelen, Patrick
AU  - van Beelen P
FAU - Holczknecht, Orsolya
AU  - Holczknecht O
FAU - Vettori, Maria Vittoria
AU  - Vettori MV
FAU - Gropp, Jurgen
AU  - Gropp J
LA  - eng
PT  - Journal Article
DEP - 20180418
PL  - United States
TA  - EFSA J
JT  - EFSA journal. European Food Safety Authority
JID - 101642076
PMC - PMC7009516
OTO - NOTNLM
OT  - Coxar(R)
OT  - coccidiostats
OT  - efficacy
OT  - nicarbazin
OT  - safety
OT  - turkeys for fattening
EDAT- 2018/04/18 00:00
MHDA- 2018/04/18 00:01
PMCR- 2018/04/18
CRDT- 2020/07/07 06:00
PHST- 2020/07/07 06:00 [entrez]
PHST- 2018/04/18 00:00 [pubmed]
PHST- 2018/04/18 00:01 [medline]
PHST- 2018/04/18 00:00 [pmc-release]
AID - EFS25214 [pii]
AID - 10.2903/j.efsa.2018.5214 [doi]
PST - epublish
SO  - EFSA J. 2018 Apr 18;16(4):e05214. doi: 10.2903/j.efsa.2018.5214. eCollection 2018 
      Apr.