FASCINEX®

Overview

Chemical Names
5-CHLORO-6-(2,3-DICHLOROPHENOXY)-2-METHYLTHIO-1H-BENZIMIDAZOLE; 6-CHLORO-5- (2,3-DICHLOROPHENOXY)-2-METHYLTHIO-BENZIMIDAZOLE
Synonyms
CGA89317; CGP23030; FASINEX®; FASCINEX®; SOFOREN®; ENDEX®; COMBINEX®; PARSIFAL®; FASIMEC®; GENESIS ™ ULTRA
CAS number
68786-66-3
Functional Class
Veterinary Drug
ANTHELMINTHIC_AGENT

Evaluations

Evaluation year: 2012

ADI:
0–3mg/kg bw

Comments:
The Committee previously reviewed triclabendazole at its 40th, 66th, and 70th meetings. The 70th meeting recommended revised MRLs for muscle, liver, kidney and fat of cattle and sheep. The present Committee reviewed triclabendazole again at the request of the19th Session of CCRVDF, which had asked whether MRLs for goat tissues could be established by extrapolation considering data used for recommending MRLs for cattle and sheep tissues. The Committee concluded that the procedure for deriving MRLs adopted at the 66th meeting could not be used, as the available data on the residues of triclabendazole in goat did not allow a scientifically justifiable extrapolation of MRLs to this species.
Report: 
TRS 969/JECFA 75
Residues: 
FNP 12/12-JECFA 75

Evaluation year: 2008

ADI:
0–3μg/kg body weight
Comments:
The Committee established an ADI of 0–3μg/kg body weight at its 40th meeting (WHO TRS No. 832, 1993)
MRL Comment:
Recommended maximum residue limits (MRLs) for Cattle of : - Fat 100 (μg/kg), - Kidney 400 (μg/kg), - Liver 850 (μg/kg), - Muscle 250 (μg/kg) and for sheep of : - Fat 100 (μg/kg), - Kidney 200 (μg/kg), - Liver 300 (μg/kg), - Muscle 200 (μg/kg)
Report: 
TRS 954-JECFA 70
Residues: 
FAO Monograph

Evaluation year: 2006

ADI:
0-0.003 mg/kg bw (1992)
Comments:
The database in support of the safety evaluation of triclabendazole is substantial. The lowest NOEL was 0.27 mg/kg bw/day, based on increased liver weight in the long-term study in mice. Using a safety factor of 100, the Committee established an ADI for triclabendazole of 0-3 µg/kg bw.
MRL Comment:
MRLs for edible tissues of cattle, sheep and goats, expressed as the marker residue, keto-triclabendazole: muscle, 0.15 mg/kg; liver, 0.2 mg/kg; kidney, 0.1 mg/kg; and fat, 0.1 mg/kg.
MRL Code:
MRL
Intake:
EDI calculated using median values of residue data used to derive MRLs: 0.121 mg/p/d (67.2% of ADI)
Meeting:
40
Report: 
TRS 939-JECFA 66/59
Tox Monograph: 
FAS 31-JECFA 40/63 (1992)
Residues: 
FAO JECFA MONOGRAPHS 6-JECFA70

Toxicological study

Pivotal Study:
Chronic dietary study in mice (Basler et al., 1988a): Albino Tif:MAGf mice (80/sex/group) were fed diets containing 0, 3, 15, 60 or 300 ppm triclabendazole (0.29, 1.44, 5.7 or 29.6 mg/kg bw/day (males) & 0.27, 1.39, 5.35 or 28.7 mg/kg bw/day (females)) for 2 years. Treated mice showed no overt signs of toxicity and mortality was comparable to controls. At the end of the study, absolute and relative liver weights were increased at 15 ppm and above. Hepatomas were increased in all treated female groups, with no dose-response relationship. Significance at the 99% level, which is widely used to assess the significance of tumours that occur at a high background rate, was not reached for this common benign mouse tumour. In addition, there was no significant increase in the incidence of hepatocellular carcinomas at any dose level. The NOEL was 3 ppm, equal to 0.27 mg/kg bw/day .
Animal Specie:
Mice
Effect:
Increased liver weight
NOEL:
0.27 mg/kg bw/d
Point of departure:
0.27 mg/kg bw/d
Previous Years:
1992, TRS 832-JECFA 40/25, FNP 41/5-JECFA 40/63, FAS 31-JECFA 40/63. 0-0.003. MRLs (expressed as 5-chloro-6-(2',3'-dichlorophenoxy)-benzimidazole-2-one, in mg/kg): Muscle (cattle): 0.2; Liver and kidney (cattle): 0.3; Fat (cattle): 0.1; Edible tissues (sh
1992, TRS 832-JECFA 40/25, FNP 41/5-JECFA 40/63, FAS 31-JECFA 40/63. 0-0.003. MRLs (expressed as 5-chloro-6-(2',3'-dichlorophenoxy)-benzimidazole-2-one, in mg/kg): Muscle (cattle): 0.2; Liver and kidney (cattle): 0.3; Fat (cattle): 0.1; Edible tissues (sh