Animal Residue Data Sheet - Profenofos

Last updated: 28 March 2002

Profenofos is registered in Australia for use in the cotton industry. Details of the registered use patterns can be found on the approved labels of registered products containing profenofos as the active constituent. This Animal Residue Data Sheet provides information on the possible residues in feed commodities obtained from crops treated with profenofos. 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 profenofos in food and animal feed commodities, as listed in Table 1 and Table 4 of the MRL Standard (as at April 2002) are shown below. The residue definition of profenofos is the parent compound per se.

Code	Food	MRL, mg/kg
Food Commodities
SO 0691	Cotton seed	1
OR 0691	Cotton seed oil, edible	0.3
Animal commodities
ML 0812	Cattle Milk	*0.01
MO 0105	Edible offal (mammalian)	*0.05
PE 0112	Eggs	*0.02
MM 0095	Meat (mammalian)	*0.05
PO 0111	Poultry, Edible offal of	*0.05
PM 0110	Poultry meat	*0.05
Animal feed commodities
	Cotton seed meal and hulls	1

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 profenofos are summarised below.

Species	MFL, ppm in diet	Equivalent DDIL, mg/kg bw	Equivalent intake of profenofos, mg/animal/day
Cattle^a	25	1	500
Sheep ^b	25	1	60
Pig^c	25	1	60
Poultry ^d	1	0.08	0.15
^a Based on a 500 kg animal consuming 20 kg DM/day ^b Based on a 60 kg animal consuming 2.5 kg DM/day ^c Based on a 60 kg animal consuming 2.5 kg DM/day ^d Based on a 2 kg animal consuming 150 g DM/day

Detailed information

All feed commodities

Feed commodities that may contain residues of profenofos are listed in the table below. The theoretical maximum proportion of the diet that the commodity can compose, when residues are present at the MRL, without the significant risk of animal commodity MRLs being violated is also given. For instance, were cotton seed to be fed to cattle at 100% of the diet, there would be little 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 profenofos 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	1	6.0	100
Cotton seed oil	5	1	0.3	0.3	100
Cotton seed meal and hulls	30	6	1	6.0	100
Sheep (Based on a 60 kg animal consuming 2.5 kg DM/day)
Cotton seed	30	0.75	1	0.75	100
Cotton seed oil	5	0.125	0.3	0.04	100
Cotton seed meal and hulls	30	0.75	1	0.75	100
Pigs (Based on a 60 kg animal consuming 2.5 kg DM/day)
Cotton seed	30	0.75	1	0.75	100
Cotton seed oil	5	0.125	0.3	0.04	100
Cotton seed meal and hulls	20	0.5	1	0.50	100
Poultry (Based on a 2 kg animal consuming 150 g DM/day)
Cotton seed	30	0.045	1	0.05	100
Cotton seed oil	5	0.0075	0.3	0.002	100
Cotton seed meal and hulls	20	0.03	1	0.03	100
^a The feed commodities that may contain residues of profenofos, and may form more than 20% of an animals diet. ^b The maximum proportion 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 profenofos when the commodity is fed at the maximum assumed level (Column 1) in the absence of other sources of profenofos. ^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 profenofos are absent.

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. For example: a cow consumes 10 kg of grain containing 10 mg/kg of Profenofos and 10 kg of apple pomace containing 5 mg/kg of Profenofos. The total intake of Profenofos is 150 mg in 20 kg of feed. This is equivalent to 7.5 ppm in the feed [150÷20].

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 profenofos, mg/animal/day^c
Oilseeds [30% maximum]	Cotton seed	30	6	1	-	6
Total		30	6			6
^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:	6 mg/animal/day
equivalent to:	0.01 mg/kg bw
equivalent to:	0.3 ppm in the diet

MFL (Based on the available cattle feeding data (Attachment 2)):	25 ppm in the diet
equivalent DDIL:	1 mg/kg bw

Sheep

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	MRL, mg/kg	% DM^b	Intake of profenofos, mg/animal/day^c
Oilseeds [30% maximum]	Cotton seed	30	0.75	1	-	0.75
Total		30	0.75			0.75
^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:	0.75 mg/animal/day
equivalent to:	0.01 mg/kg bw
equivalent to:	0.3 ppm in the diet

MFL (Based on the available sheep feeding data (Attachment 2)):	25 ppm in the diet
equivalent DDIL:	1 mg/kg bw

Pigs

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	MRL, mg/kg	% DM^b	Intake of profenofos, mg/animal/day^c
Oilseeds [30% maximum]	Cotton seed	30	0.75	1	-	0.75
Total		30	0.75			0.75
^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 ^c Based on assumed bodyweight of 60 kg

Maximum anticipated dietary exposure:	0.75 mg/animal/day
equivalent to:	0.01 mg/kg bw
equivalent to:	0.3 ppm in the diet

MFL (Based on extrapolation from cattle and sheep (Attachment 2)):	25 ppm in the diet
equivalent DDIL:	1 mg/kg bw

Poultry

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	MRL, mg/kg	% DM^b	Intake of profenofos, mg/animal/day^c
Oilseeds [30% maximum]	Cotton seed	30	0.05	1	-	0.05
Total		30	0.05			0.05
^aased 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


Maximum anticipated dietary exposure:equivalent to:	0.02 mg/kg bw
equivalent to:	0.33 ppm in the diet

MFL (Based on the available poultry feeding data (Attachment 2)):	1 ppm in the diet
equivalent DDIL:	0.08 mg/kg bw

Attachment 2: Residue data

The residue definition of profenofos in Australia is the parent compound per se.

Selected residue data for animal feed commodities

Profenofos residues in cotton seed

Location, year, Ref	Rate, g ai/ha	No.	Volume, L/ha	PHI, days	% DM	Profenofos, mg/kg DM
Australia, 1975, JMPR 1990	750	11	NR	-1	NR	0.05
Australia, 1975, JMPR 1990				1		0.2
				3		0.24
				9		0.8
Australia, 1977, JMPR 1990 Data are means of 4 obs.	1000	7	NR	-1	NR	1.1
	(1x)			1		2.2
				3		2.1
				10		1.2
				14		1.2
				28		0.65
Australia, 1978, JMPR 1990	1000	11	NR	-1	NR	0.2
Australia, 1978, JMPR 1990	(1x)			1		0.8
				8		0.7
				14		0.8
				21		0.23
				28		0.1
				36		0.05
Australia, 1978, JMPR 1990	1000	11	NR	-1	NR	0.24
Australia, 1978, JMPR 1990	(1x)			1		0.2
				8		0.9
				14		0.1
				21		0.07
				28		0.03
USA 1975, JMPR 1990	1100	6	NR	0	NR	1.7
USA 1975, JMPR 1990	(1.1x)			7		0.53
				15		0.08
				21		0.25
USA 1975, JMPR 1990/95	1100	6	NR	0	NR	3.4
USA 1975, JMPR 1990/95	(1.1x)			7		4.1
				14		1
				21		0.47
				30		0.26
USA 1975, JMPR 1990	1100	6	NR	0	NR	1.4
USA 1975, JMPR 1990	(1.1x)			7		1.3
				14		1.1
				21		1.2

Profenofos residues in plant foliage.

Location, year, ref	Rate, g ai/ha	No.	PHI, days	% DM	Profenofos, mg/kg
Maize forage
JMPR 1990	200 - 1500	-	Some days	NR	2.7 — 8.7
JMPR 1990			56		0.3
Maize fodder
JMPR 1990	200 - 1500	-			<0.02 — 0.7
Soya bean fodder
JMPR 1990	1100 — 2200	-	14	NR	0.8 — 37
			21		1 — 5.8
			28		0.6 — 5
Sugar beet
JMPR 1990	400 — 800	1 - 4	0		1 — 4
			21 — 28		<0.02
Beans (green)
Italy 1985 JMPR 1990	750	1	0	NR	2.7
Italy 1985 JMPR 1990			7		0.08
			14		0.06
			21		0.02
Tea
Japan	1000	3	7	NR	23
JMPR 1990			14		1.4
			21		0.34

Selected processing data

Location, year, ref	Rate, g ai/ha	No.	PHI, days	Profenofos, mg/kg / Processing factor (from seed)
Location, year, ref	Rate, g ai/ha	No.	PHI, days	Seed	Hulls	Meal	Crude oil	Refined oil	RBDH^a oil
Australia, JMPR 1990	1	-	-	0.08/1	0.16/2		0.31/3.9
	Spike						1.8	0.72	0.14
USA, JMPR 1990	1.1	6	15	0.6/1	0.65/1.1	0.09/0.2	1.1/1.8	0.11/0.2	<0.05/ 0.1
USA, JMPR 1990	2.2	6	15	0.9/1	1.9/2.1	0.16/0.2	2.3/2.6	0.47/0.5	< 0.05/ 0.1
USA, JMPR 1990	1.1	6	14	0.6/1	0.54/0.9	0.07/0.1	1.6/2.7	0.7/1.2	< 0.05/ 0.1
USA, JMPR 1990	2.2	6	14	1.1/1	1.7/1.6	0.39/0.4	7.2/6.5	4.0/3.6	< 0.05/ 0.1
^arefined, bleached, deodorised, hydrogenised

Delinted cottonseed is approximately 40% meal and 45 % hull. The weighted average processing factor for hull + meal is 0.9.

Selected animal transfer data

Lactating cows (JMPR 1990)

Lactating cows (8) were fed a diet containing 0.75, 2.5 and 25 ppm profenofos for up to 28 days. Residues in milk could not be detected (<0.01 mg/L) at any feeding level. A summary of tissue residues is given below.

Matrix	Feeding level, ppm	Day	Residue, mg/kg
Muscle^(a)	0.75	21	< 0.05
		28	< 0.05
	2.5	21	< 0.05
		28	< 0.05
	25	28	< 0.05
Liver	0.75	21	< 0.05
		28	< 0.05
	2.5	21	< 0.05
		28	< 0.05
	25	28	< 0.05
Kidney	0.75	21	< 0.05
		28	< 0.05
	2.5	14	< 0.05
		21	< 0.05
		28	< 0.05
	25	28	< 0.05
Fat(^b)	0.75	21	< 0.05
		28	< 0.05
	2.5	21	< 0.05
		28	< 0.05
	25	28	< 0.05
^aSamples of both round and loin muscle were analysed ^b Samples of both omental and perirenal fat were analysed

Sheep (JMPR 1990)

Sheep (4) were fed a diet containing 25 ppm profenofos for up to 14 days. Total residues (profenofos and metabolites) were determined.

Matrix	Feeding level, ppm	Day	Residue, mg/kg (as profenofos)
Muscle	25	7	< 0.01, < 0.01
		14	< 0.01, < 0.01
Liver	25	7	0.06, 0.03
		14	0.04, 0.03
Kidney	25	7	< 0.01, < 0.01
		14	< 0.01, < 0.01
Fat	25	7	< 0.01, < 0.01
		14	< 0.01, < 0.01

In a goat metabolism study (JMPR 1990) a major part of the residue in liver was noted to be a metabolite of profenofos. As such, it is assumed that the profenofos residue in liver at a feeding level of 25 ppm would not exceed an LOQ of 0.5 mg/kg.

Poultry (JMPR 1990)

Laying birds were fed a diet containing 0.3 or 1 ppm profenofos for up to 28 days. Profenofos (below) and total residues (profenofos and metabolites) were determined. No residues were observed in tissues or in eggs.

Matrix	Feeding level, ppm	Day	Residue, mg/kg
Muscle^a	0.3	21	< 0.05
		28	< 0.05
	1	21	< 0.05
		28	< 0.05
Liver	0.3	21	< 0.05
		28	< 0.05
	1	21	< 0.05
		28	< 0.05
Fat	0.3	21	< 0.05
		28	< 0.05
	1	21	< 0.05
		28	< 0.05
Eggs	0.3	21	< 0.02
		28	< 0.02
	1	21	< 0.02
		28	< 0.02
^aSamples of both breast and thigh were analysed