Animal Residue Data Sheet - Cyclanilide

Cyclanilide is registered in Australia for use on cotton only. Details of the registered use patterns can be found on the approved labels of registered products containing cyclanilide as the active constituent. This Animal Residue Data Sheet provides information on the possible residues in feed commodities obtained from crops treated with cyclanilide. It also provides information on the anticipated maximum dietary exposure of animals fed treated commodities, which should not result in the violation of animal MRLs.

Current MRLs

The Australian MRLs for Cyclanilide in food and animal feed commodities, as listed in Table 1 and Table 4 of the MRL Standard (as at 29/6/02) are shown below. The residue definition of cyclanilide is sum of cyclanilide and its methyl ester, expressed as cyclanilide .

Code	Food	MRL, mg/kg
Food Commodities
SO 0691	Cotton seed	0.2
OC 0691	Cotton seed oil, crude	*0.01

Animal commodities
MO 0105	Edible offal (Mammalian)	2
PE 0112	Eggs	*0.01
MM 0095	Meat [Mammalian]	0.05
ML 0106	Milks	0.05
PM 0110	Poultry meat	*0.01
PO 0111	Poultry, Edible offal of	*0.01

Animal feed commodities
	No entries

Summary of maximum feeding levels and livestock dietary intakes

The Maximum Feeding Level (MFL, the feeding level at which the MRLs are based), the equivalent Daily Dietary Intake For Livestock (DDIL) and the equivalent daily intake of Cyclanilide are summarised below.

Species	MFL, ppm in diet	Equivalent DDIL, mg/kg bw	Equivalent intake of Cyclanilide, mg/animal/day
Cattle^a	5.6	0.224	112
Sheep^b	5.6	0.233	14
Pig^c	5.6	0.233	14
Poultry^d	NA	NA	NA
^a Based on available data from feeding studies with dairy cattle ^b Based on extrapolation from cattle data ^c Based on extrapolation from cattle data ^d No relevant data has been considered by the NRA that would allow the recommending of MFLs or DDILs

Detailed information

All feed commodities

Feed commodities that may contain residues of Cyclanilide are listed in the table below. The theoretical maximum proportion of the diet that the commodity can comprise, when residues are present at the MRL, without the significant risk of animal commodity MRLs being violated is also given. For instance, were apple pomace to be fed to cattle at 50% of the diet, the remainder of the diet would need to be free of residues of Cyclanilide to minimise the risk of cattle commodity MRLs being violated. It should be noted that the feeding levels assumed by the APVMA when setting animal commodity MRLs are theoretical values, and they should not be taken as recommendations of appropriate rations for livestock.

Commodity^a	Assumed Maximum proportion of diet (%)^b	Feed intake (kg/animal/day)^c	MRL (mg/kg)^d	Maximum intake of Cyclanilide from commodity (mg/animal/day)^e	Theoretical maximum proportion of diet (%)^f
Cattle (Based on a 500 kg animal consuming 20 kg DM/day)
Cotton seed	30	6	0.2	1.2	100

Sheep (Based on a 60 kg animal consuming 2.5 kg DM/day)
Cotton seed	30	0.75	0.2	0.15	100

Pigs (Based on a 60 kg animal consuming 2.5 kg DM/day)
Cotton seed	30	0.75	0.2	0.15	100

Poultry (Based on a 2 kg animal consuming 150 g DM/day)
Cotton seed meal	20	0.03	0.005^g	0.00015	100

^a The feed commodities that may contain residues of Cyclanilide, and may form more than 20% of an animals diet. ^b The maximum % of the diet that the commodity is assumed to comprise for the purposes of setting MRLs, based on Stockfeed Information Document 1 ^c The equivalent amount of feed for an animal of designated weight and feed intake that is assumed for the purposes of setting MRLs ^d The MRL for each feed commodity (correction for dry weight basis where required) ^e The maximum intake of Cyclanilide when the commodity is fed at the maximum assumed level (Column 1) in the absence of other sources of Cyclanilide. ^f The maximum % of the diet at which the commodity could theoretically be fed without significant risk of exceeding animal commodity MRLs. It is assumed that the residue in the feed commodity is present at the MRL (or dry weight equivalent) and other dietary sources of Cyclanilide are absent. ^g No MRL is set. However, there are no quantifiable residues in meal and this figure represents half the limit of quantitation.

Abbreviations and definitions

DM: Dry matter. The feed consumption for livestock and the residue levels in feed commodities are expressed on a dry matter basis.

DDIL: Daily Dietary Intake for Livestock. The level of dietary exposure for a specified chemical in a specified species that should not result in exceedance of the relevant animal commodity MRLs. Expressed in mg chemical/kg bodyweight.

MFL: Maximum Feeding Level. The level of dietary exposure for a specified chemical in a specified species that should not result in exceedance of the relevant animal commodity MRLs. Expressed in terms of ppm in the feed.

MRL: The concentration of a chemical residue, in units of mg/kg, that is legally permitted in or on a food or food commodity.

ppm in the feed: Parts per million in the feed. An alternate way of expressing the level of dietary exposure for a chemical. The level of chemical intake is calculated as though it were present uniformly in the total feed intake. The ppm in the feed is calculated using the following formula: DDIL (mg chemical/kg bw) _ body weight (kg) ¸ daily feed intake (kg).

STMR-P: Supervised Trial Median Residue of the processed commodity. The highest residue that livestock are likely to be exposed to in practice when fed processed commodities over a prolonged period. This is derived from the STMR of the whole commodity multiplied by the processing factor.

Attachment 1: Anticipated maximum dietary exposure

The following calculations outline the theoretical diet used to calculate the maximum anticipated dietary exposure, maximum feeding level (MFL) and the daily dietary intake for livestock (DDIL) for cattle, sheep, pigs and poultry.

Cattle

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	MRL, mg/kg	% DM^b	Intake of Cyclanilide, mg/animal/day^c
Oilseed	Cotton seed	30	6	0.2	90	1.2

Total			6			1.2
^aBased on assumed feed consumption of 20 kg dry matter/day ^bEstimate of percentage dry matter. Applied to MRLs expressed on a fresh weight basis ^cBased on assumed bodyweight of 500 kg

Maximum anticipated dietary exposure:	1.2 mg/animal/day
equivalent to:	0.0024 mg/kg bw
equivalent to:	0.06 ppm in the diet

MFL (Based on the available animal feeding data (Attachment 2)):	5.6 ppm in the diet
equivalent DDIL:	0.224 mg/kg bw

Sheep

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	MRL, mg/kg	% DM^b	Intake of Cyclanilide, mg/animal/day^c
Oilseed	Cotton seed	30	0.75	0.2	90	0.15

Total		30				0.15
^aBased on assumed feed consumption of 2.5 kg dry matter/day ^bEstimate of percentage dry matter. Applied to MRLs expressed on a fresh weight basis ^cBased on assumed bodyweight of 60 kg

Maximum anticipated dietary exposure:	0.15 mg/animal/day
equivalent to:	0.0025 mg/kg bw
equivalent to:	0.06 ppm in the diet

MFL (Based on extrapolation from cattle feeding data (Attachment 2)):	5.6 ppm in the diet
equivalent DDIL:	0.233 mg/kg bw

Pigs

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	MRL, mg/kg	% DM^b	Intake of Cyclanilide, mg/animal/day^c
Oilseed	Cotton seed	30	0.75	0.2	90	0.15


Total		30				0.15
^aBased on assumed feed consumption of 2.5 kg dry matter/day ^bEstimate of percentage dry matter. Applied to MRLs expressed on a fresh weight basis ^cBased on assumed bodyweight of 60 kg

Maximum anticipated dietary exposure:	0.15 mg/animal/day
equivalent to:	0.0025 mg/kg bw
equivalent to:	0.06 ppm in the diet

MFL (Based on extrapolation from cattle feeding data (Attachment 2)):	5.6 ppm in the diet
equivalent DDIL:	0.233 mg/kg bw

Poultry

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	MRL, mg/kg	% DM^b	Intake of Cyclanilide, mg/animal/day^c
Plant protein meal	Cotton seed meal	20	0.03	0.005^d	90	0.00015


Total		20				0.00015
^aBased on assumed feed consumption of 0.150 kg dry matter/day ^bEstimate of percentage dry matter. Applied to MRLs expressed on a fresh weight basis ^cBased on assumed bodyweight of 2 kg ^d No MRL is set. However, there are no quantifiable residues in meal and this figure represents half the limit of quantitation.

Maximum anticipated dietary exposure:	0.006 mg/animal/day
equivalent to:	0.003 mg/kg bw
equivalent to:	0.04 ppm in the diet

MFL (Based on the available animal feeding data (Attachment 2)):	No data has been considered by the NRA that would allow the recommending of either MRLs or MFLs.
equivalent DDIL:	NA