PMID- 32625606
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240328
IS  - 1831-4732 (Electronic)
IS  - 1831-4732 (Linking)
VI  - 15
IP  - 8
DP  - 2017 Aug
TI  - Safety and efficacy of Avatec((R)) 150G (lasalocid A sodium) for chickens for 
      fattening and chickens reared for laying, and modification of the terms of 
      authorisation for chickens for fattening, chickens reared for laying, turkeys for 
      fattening, minor avian species (pheasants, guinea fowl, quails and partridges) 
      except laying birds.
PG  - e04857
LID - 10.2903/j.efsa.2017.4857 [doi]
LID - e04857
AB  - Avatec((R)) 150G is an anticoccidial feed additive containing 15% of the active 
      ingredient lasalocid A sodium, an ionophore anticoccidial. The tolerance study 
      indicated that oral administration of lasalocid A sodium via feed at doses at and 
      above the targeted lasalocid dose of 125 mg/kg was not tolerated in chickens for 
      fattening. Consequently, no safe dose can be established by the tolerance study 
      submitted. Concurrent administration of lasalocid with tiamulin and certain other 
      medicinal substances should be avoided. Lasalocid sodium has a selective 
      antimicrobial activity against Gram-positive bacterial species while many 
      Enterobacteriaceae are naturally resistant. Induction of resistance and/or 
      cross-resistance was not observed in experimental conditions. Lasalocid A sodium 
      is not genotoxic and not carcinogenic. The newly conducted cardiovascular study 
      in dogs indicated an acute no-observed-adverse-effect level (NOAEL) of 1 mg/kg 
      body weight (bw) per day. Since this NOAEL is above the lowest NOAEL of 0.5 mg/kg 
      bw per day previously identified in a 2-year toxicity study in rats and a 
      developmental study in rabbits, it is concluded that this NOAEL (0.5 mg/kg bw per 
      day) is an appropriate base for establishing an Acceptable Daily Intake of 
      0.005 mg lasalocid sodium/kg bw. The use of lasalocid A sodium from Avatec((R)) 
      150G at the highest proposed level of 125 mg/kg complete feed is safe for the 
      consumer. For compliance with the maximum residue limits (MRLs), a withdrawal 
      period of 3 days is necessary. No risk for the user is expected from the use of 
      Avatec((R)) 150G. The use of lasalocid A sodium from Avatec((R)) 150G in feed for 
      chickens for fattening and chickens reared for laying up to the highest proposed 
      dose does not pose a risk for the environment. Insufficient evidence of the 
      anticoccidial efficacy of lasalocid A sodium was provided in chickens for 
      fattening/reared for laying.
CI  - (c) 2017 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 - 20170818
PL  - United States
TA  - EFSA J
JT  - EFSA journal. European Food Safety Authority
JID - 101642076
PMC - PMC7010116
OTO - NOTNLM
OT  - Avatec
OT  - Coccidiostat
OT  - efficacy
OT  - lasalocid A sodium
OT  - poultry
OT  - safety
EDAT- 2017/08/18 00:00
MHDA- 2017/08/18 00:01
PMCR- 2017/08/18
CRDT- 2020/07/07 06:00
PHST- 2020/07/07 06:00 [entrez]
PHST- 2017/08/18 00:00 [pubmed]
PHST- 2017/08/18 00:01 [medline]
PHST- 2017/08/18 00:00 [pmc-release]
AID - EFS24857 [pii]
AID - 10.2903/j.efsa.2017.4857 [doi]
PST - epublish
SO  - EFSA J. 2017 Aug 18;15(8):e04857. doi: 10.2903/j.efsa.2017.4857. eCollection 2017 
      Aug.