Diclazuril Premix 0.5%

CAS NO.: 101831-37-2 EINECS: N

Molecular Formula: C₁₇H₉Cl₃N₄O₂ Molecular Weight: 407.64

Molecular Structure:

Property：

Diclazuril (2,6-dichloro-α-(4-chlorophenyl)-4-(4,5-dihydro-3,5-dioxo-1,2,4-triazin-2(3H)-yl)benzeneacetonitrile) a benzeneacetonitrile derivative is an anticoccidial intended for oral use inlambs. The therapeutic dosage is either a single administration of 1 mg diclazuril/kg bw (mostcommonly at about 6-8 weeks of age) or two administrations (the first at 3 to 4 weeks of age and the second about 3 weeks later).

Diclazuril has been registered as an anticoccidial feed additive for broilers with a withdrawal period of 5 days in the Council Directive 93/107/EC of 26 November 93 amending Council Directive 70/524/EEC.

Diclazuril was previously assessed by the CVMP and an acceptable daily intake (ADI) of 0.030 mg/kg bw (i.e. 1.8 mg/person) was established. . The same ADI value of 0-0.03 mg/kg bw was established by Joint WHO/FAO Expert Committee on Food Additives (JECFA) at its 50th meeting in 1998. Both Committees based the ADI on a NOEL of 3 mg/kg bw/day retained from the 2-year chronic toxicity/carcinogenicity study in mice applying a safety factor of 100.

Specifications：

Item	Index
Description	Yellow powder
Identification	Meet the criterion
Loss On Drying	10.0% max.
Heavy Metals	0.002% max.
Arsenic	0.0002% max.
Granularity	100% through screen No.2
Assay	0.45%-0.55%

Usage:

In piglets after a single oral administration of 5 mg/kg bw of diclazuril, the maximum plasma concentration 0.035 mg/l was observed 24 hours post administration (first sampling time).

In calves after a single oral administration of 5 mg/kg bw of diclazuril, the mean maximum plasma concentration 0.039 mg/l was observed 12 hours post administration. The very high value of the volume of distribution corrected by the bioavailability factor of 100 l/kg indicates that the bioavailability is low. Diclazuril is poorly absorbed in calves after oral administration. The metabolism of diclazuril in pigs was investigated with suspension cultures and primary cell cultures of swine hepatocytes. The analyses of incubate samples revealed that the metabolism of diclazuril was limited. The parent compound represented more than 98 and 59% in suspension culture or in primary culture, respectively.

In pigs, a non-radiometric depletion study was carried out. Twenty-four hours after a single oral administration of diclazuril at 5 mg/kg bw to 4-5 days-old piglets, 33.8 μg of diclazuril/kg were measured in muscle, 162 μg/kg in fat + skin in natural proportions, 45.2 μg/kg in liver and 43.1 μg/kg in kidney. Residue levels of diclazuril were below the limit of quantification of 25 μg/kg at day 3 for muscle, liver and kidney and day 5 for fat + skin.

In cattle, a non-radiometric depletion studies was carried out. Twenty-four hours after a single oral administration of diclazuril at 5 mg/kg bw to 3-5 days old calves, 25.8 μg of diclazuril/kg were measured in muscle, 361 μg/kg in fat, 108 μg/kg in liver and 75.2 μg

Package and Storage:

Keep in shaded, cool 25kg fiber drum and air places. The shelf time is 2 years.

Keyword：

Diclazuril

2,6-Dichloro-alpha-(4-chlorophenyl)-4-(4,5-dihydro-3,5-dioxo-1,2,4-triazin-2(3H)-yl)benzeneacetonitrile