PMID- 32625743
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240328
IS  - 1831-4732 (Electronic)
IS  - 1831-4732 (Linking)
VI  - 16
IP  - 11
DP  - 2018 Nov
TI  - Safety and efficacy of Monimax((R)) (monensin sodium and nicarbazin) for chickens 
      for fattening and chickens reared for laying.
PG  - e05459
LID - 10.2903/j.efsa.2018.5459 [doi]
LID - e05459
AB  - The coccidiostat Monimax((R)) (monensin sodium and nicarbazin) is considered safe 
      for chickens for fattening and chickens reared for laying at the highest use 
      level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is 
      extended to chickens reared for laying. For both active substances, the metabolic 
      pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, 
      when ingested, is rapidly split in its two components dinitrocarbanilide (DNC) 
      and 2-hydroxy-4,6-dimethylpyrimidine (HDP) which behave independently. Monimax((R)) 
      does not represent a genotoxic risk. No safety concerns would arise from the 
      nicarbazin impurities p-nitroaniline and methyl(4-nitrophenyl) carbamate. The 
      lowest no observed effect level (NOEL) identified for monensin sodium in a 
      developmental study in rabbits is 0.3 mg monensin sodium/kg body weight (bw) per 
      day for maternal toxicity in rabbits. The lowest no observed adverse effect level 
      (NOAEL) identified in a 52-week study in rat using DNC + HDP was 20 mg DNC + 8 mg 
      HDP/kg bw per day based on the absence of microcrystals in urine and related 
      microscopic renal observations. No significant interaction between monensin 
      sodium and nicarbazin is expected from toxicological studies. The use of 
      Monimax((R)) at the highest proposed dose will not pose a risk to persons consuming 
      animal products from treated chickens for fattening. This conclusion is extended 
      to chickens reared for laying. No withdrawal time is required for Monimax((R)) in 
      chickens for fattening. Residue data comply with the established maximum residue 
      limits (MRLs) for monensin and DNC. Based on the available data, the FEEDAP 
      Panel cannot conclude on the safety of Monimax((R)) for the environment. Monimax((R)) 
      has the potential to control coccidiosis in chickens for fattening at a minimum 
      concentration of 40 mg monensin and 40 mg nicarbazin/kg complete feed.
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 - Bampidis, Vasileios
AU  - Bampidis V
FAU - Azimonti, Giovanna
AU  - Azimonti G
FAU - Bastos, Maria de Lourdes
AU  - Bastos ML
FAU - Christensen, Henrik
AU  - Christensen H
FAU - Dusemund, Birgit
AU  - Dusemund B
FAU - Kouba, Maryline
AU  - Kouba M
FAU - Kos Durjava, Mojca
AU  - Kos Durjava M
FAU - Lopez-Alonso, Marta
AU  - Lopez-Alonso M
FAU - Lopez Puente, Secundino
AU  - Lopez Puente S
FAU - Marcon, Francesca
AU  - Marcon F
FAU - Mayo, Baltasar
AU  - Mayo B
FAU - Pechova, Alena
AU  - Pechova A
FAU - Petkova, Mariana
AU  - Petkova M
FAU - Ramos, Fernando
AU  - Ramos F
FAU - Sanz, Yolanda
AU  - Sanz Y
FAU - Villa, Roberto
AU  - Villa R
FAU - Woutersen, Ruud
AU  - Woutersen R
FAU - Aquilina, Gabriele
AU  - Aquilina G
FAU - Bories, Georges
AU  - Bories G
FAU - Brantom, Paul
AU  - Brantom P
FAU - Cocconcelli, Pier Sandro
AU  - Cocconcelli PS
FAU - Halle, Ingrid
AU  - Halle I
FAU - Kolar, Boris
AU  - Kolar B
FAU - van Beelen, Patrick
AU  - van Beelen P
FAU - Wester, Pieter
AU  - Wester P
FAU - Holczknecht, Orsolya
AU  - Holczknecht O
FAU - Vittoria Vettori, Maria
AU  - Vittoria Vettori M
FAU - Gropp, Jurgen
AU  - Gropp J
LA  - eng
PT  - Journal Article
DEP - 20181114
PL  - United States
TA  - EFSA J
JT  - EFSA journal. European Food Safety Authority
JID - 101642076
PMC - PMC7009504
OTO - NOTNLM
OT  - Monimax
OT  - chickens for fattening
OT  - chickens reared for laying
OT  - coccidiostat
OT  - efficacy
OT  - monensin sodium
OT  - nicarbazin
OT  - safety
EDAT- 2018/11/14 00:00
MHDA- 2018/11/14 00:01
PMCR- 2018/11/14
CRDT- 2020/07/07 06:00
PHST- 2020/07/07 06:00 [entrez]
PHST- 2018/11/14 00:00 [pubmed]
PHST- 2018/11/14 00:01 [medline]
PHST- 2018/11/14 00:00 [pmc-release]
AID - EFS25459 [pii]
AID - 10.2903/j.efsa.2018.5459 [doi]
PST - epublish
SO  - EFSA J. 2018 Nov 14;16(11):e05459. doi: 10.2903/j.efsa.2018.5459. eCollection 
      2018 Nov.