Animal Residue Data Sheet - Bitertanol

Last updated 28 March 2002

Bitertanol is registered in Australia for use on beans (Phaseolus vulgaris) and various ornamentals. Phaseolus vulgaris includes the common bean, French bean, kidney bean, field bean, snap bean and string bean. Details of the registered use patterns can be found on the approved labels of registered products containing bitertanol as the active constituent. This Animal Residue Data Sheet provides information on the possible residues in feed commodities obtained from crops treated with bitertanol. 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 bitertanol in food and animal feed commodities, as listed in Table 1 and Table 4 of the MRL Standard [as at 8 February 2002] are shown below with the proposed MRLs. The residue definition of bitertanol is the parent compound per se.

Code	Food	Proposed MRL, mg/kg
Food Commodities
VP 0061	Beans, except broad bean and soya bean	0.5
FB 0275	Strawberry	*0.05

Animal commodities
MO 0105	Edible offal (mammalian)	3
PE 0112	Eggs	*0.01
MM 0095	Meat [mammalian] [in the fat]	0.3
ML 0106	Milks [in the fat]	0.2
PO 0111	Poultry, Edible offal of	*0.01
PM 0110	Poultry meat	*0.01

Animal feed commodities
AL 1030	Bean forage	50
AL 0061	Bean fodder	50

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 bitertanol are summarised below.

Species	MFL, ppm in diet	Equivalent DDIL, mg/kg bw	Equivalent intake of bitertanol, mg/animal/day
Cattle^a	75	1.88	840
Sheep^b	75	3.1	186
Pig^b	75	3.1	186
Poultry^c	1	0.075	0.15
^a Based on actual animal transfer study data ^b Based on a 60 kg animal consuming 2.5 kg DM/day and cattle transfer study data ^c Based on a 2 kg animal consuming 150 g DM/day

Detailed information

All feed commodities

Feed commodities that may contain residues of bitertanol are listed in the table below. Only feed items from approved or registered uses of the chemical are included. 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. 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 bitertanol from commodity (mg/animal/day)e	Theoretical maximum proportion of diet (%)^f
Cattle (Based on a 500 kg animal consuming 20 kg DM/day)
Bean forage	100	20	50	1000	100
Bean fodder	100	20	50	1000	100
Beans	100	20	0.5	10	100
Sheep (Based on a 60 kg animal consuming 2.5 kg DM/day)
Bean forage	100	2.5	50	125	100
Bean fodder	100	2.5	50	125	100
Beans	100	2.5	0.5	1.25	100
Pigs (Based on a 60 kg animal consuming 2.5 kg DM/day)
Beans	100	2.5	0.5	1.25	100
Poultry (Based on a 2 kg animal consuming 150 g DM/day)
Beans	100	0.15	0.5	0.075	100
^a The feed commodities that may contain residues of bitertanol, 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 bitertanol when the commodity is fed at the maximum assumed level (Column 1) in the absence of other sources of bitertanol. ^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 bitertanol 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 Chemical X and 10 kg of apple pomace containing 5 mg/kg of Chemical X. The total intake of Chemical X 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 bitertanol, mg/animal/day^c
Bean	Forage	100	20	50		1000
	Fodder	100	20	50		1000
	Bean	100	20	0.5		10
Total		100	20			1000
^a Based on assumed feed consumption of 20 kg dry matter/day ^bEstimate of percentage dry matter. Applied to MRLs expressed on a fresh weight basis ^c Based on assumed bodyweight of 500 kg

Maximum anticipated dietary exposure:	1000 mg/animal/day
equivalent to:	2 mg/kg bw
equivalent to:	50 ppm in the diet

MFL (Based on the available animal feeding data (Attachment 2)):	75 ppm in the diet
equivalent DDIL:	1.88 mg/kg bw*

* DDIL taken from feeding study

Sheep

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day ^a	MRL, mg/kg	% DM^b	Intake of bitertanol, mg/animal/day ^c
Bean	Forage	100	2.5	50		125
	Fodder	100	2.5	50		125
	Bean	100	2.5	0.5		1.25
Total		100	2.5			125
^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:	125 mg/animal/day
equivalent to:	2.08 mg/kg bw
equivalent to:	50 ppm in the diet

MFL (Based on the cattle feeding data (Attachment 2)):	75 ppm in the diet
equivalent DDIL:	3.13 mg/kg bw

Pigs

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day ^a	MRL, mg/kg	% DM^b	Intake of bitertanol, mg/animal/day ^c
Bean	Bean	100	2.5	0.5		1.25
Total		100	2.5			1.25
^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:	1.25 mg/animal/day
equivalent to:	0.02 mg/kg bw
equivalent to:	0.5 ppm in the diet

MFL (Based on the cattle feeding data (Attachment 2)):	75 ppm in the diet
equivalent DDIL:	3.13 mg/kg bw

Poultry

Feed group	Feed commodity	% in the diet	Feed intake, kg/animal/day^a	MRL, mg/kg	% DM^b	Intake of bitertanol, mg/animal/day^c
Bean	Bean	100	0.15	0.5		0.075
Total		100	0.15			0.075
^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

Maximum anticipated dietary exposure:	0.075 mg/animal/day
equivalent to:	0.0375 mg/kg bw
equivalent to:	0.5 ppm in the diet

MFL (Based on the available animal feeding data (Attachment 2)):	1 ppm in the diet
equivalent DDIL:	0.075 mg/kg bw

Attachment 2: Residue data

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

Selected residue data for animal feed commodities

Report no.	Country	Crop	Formulation	Rate (g ai/ha)	No sprays (interval)	Commodity	PHI	Residues (mg/kg)
Mobay 87140	USA	Snap beans	300 EC	280.2	2 (14)	Green vines	0 3	6.89 3.11
Mobay 87215	USA	Snap beans	300 EC	280.2	2 (10)	Green vines	15 18	2.66 0.51
Mobay 87237	USA	Beans, dry	300 EC	280.2	2 (14)	Dry vines	21	3.24
Mobay 87236	USA	Beans, dry	300 EC	280.2	2 (10)	Dry vines	42	0.07
Mobay 87235	USA	Beans, dry	300 EC	280.2	2 (10)	Dry vines	14	6.25
Mobay 87214	USA	Snap beans	500 WP	280.2	2 (15)	Green vines	0 3	3.03 2.54
311/88006/U10	South Africa	Beans	300 EC	125.1	1	Plants	1 4 8 16	23, 40 2.5, 3.4 3.7, 3.8 0.36, 0.30
311/88006/U10	South Africa	Beans	300 EC	250.2	1	Plants	1 4 8 16	43, 39 6.0, 6.8 4.4, 5.0 0.36, 0.32
311/88059/U201	South Africa	Kidney Beans	300 EC	252	1	Plants	0 3 8 22	20 8.8 8.4, 10.4 6.0
311/88059/U201	South Africa	Kidney Beans	300 EC	504	1	Plants	0 3 8 22	24 9.9 14.3, 12.6 9.3

Source: Bayer Australia Ltd submission, Baycor 300 Fungicide Spray, file 329-1-619, 21/11/86. South African trials also reported in JMPR.

Residues in bean vines at 0 — 1 days after the last application at 250 — 280 g ai/ha (approximately 2´ label rate) were 3.03, 6.89, 20, 39 and 43 mg/kg. At 125 g ai/ha residues in bean plants were 23 and 40 mg/kg while at 504 g ai/ha residues in bean plants were 24 mg/kg. Residues in plants decline rapidly after application. It is estimated that bitertanol residues decline with a half life of approximately 3 days over the 0-3 DAT period.

Residues in green beans from Australian trials

Trial year	1982		1984		1984		1985
Study no	16/82		27/84		28/84		30/85
Formulation	300 g/L EC		300 g/L EC		300 g/L EC		300 g/L EC
Appln method, timing	Hi volume, in pod		Hand boom, late pod		Hand boom, late pod		Hi volume, fruiting
PHI (days)	120 g ai/ha	240 g ai/ha	240 g ai/ha	480 g ai/ha	240 g ai/ha	480 g ai/ha	240 g ai/ha	480 g ai/ha
1	0.51	1.02	0.44	1.03	0.56	1.27	0.28	0.47
2	0.31	0.34
3	0.22	0.16	0.50	0.97	0.56	1.43	0.24	0.15
4	0.21	0.36
5	0.22	0.21	0.20	1.07	0.86	0.76	0.06	0.20
7			0.15	0.57	0.33	0.27	0.09	0.18
10			0.14	0.26	0.23	0.20	ND	0.13
14			0.08	0.19	0.24	0.11	ND	0.12

Source: PACC meeting 79, February 1988, Item 10.9.

Report no.	Country	Crop	Formulation	Rate (g ai/ha)	No sprays (interval)	Commodity	PHI	Residues (mg/kg)
Mobay 87140	USA	Snap beans	300 EC	280.2	2 (14)	Beans in pod	0 3	0.46 0.63
Mobay 87215	USA	Snap beans	300 EC	280.2	2 (10)	Beans in pod	15 18	0.19 0.23
Mobay 87237	USA	Beans, dry	300 EC	280.2	2 (14)	Beans, dry	21	0.18
Mobay 87236	USA	Beans, dry	300 EC	280.2	2 (10)	Beans, dry	42	<0.01
Mobay 87235	USA	Beans, dry	300 EC	280.2	2 (10)	Beans, dry	14	0.02
Mobay 87214	USA	Snap beans	500 WP	280.2	2 (15)	Beans in pod	0 3	0.80 0.28
311/88007/S172	South Africa	Beans	200 EC	190	1	Beans	0 3 5 7 10 14	0.57 0.06 0.06 0.05 0.05 <0.05
311/88006/U10	South Africa	Beans	300 EC	125.1	1	Beans	1 4 8 16	2.55 0.16 0.14 0.14
311/88006/U10	South Africa	Beans	300 EC	250.2	1	Beans	1 4 8 16	3.05 0.13 0.40 0.22
311/88059/U201	South Africa	Kidney Beans	300 EC	252	1	Kidney beans	0 3 8 22	0.12 0.1 <0.1 <0.1
311/88059/U201	South Africa	Kidney Beans	300 EC	504	1	Kidney beans	0 3 8 22	0.65 0.37 0.25 0.12
311/88869/B541	South Africa	Green beans	300 EC	150	1	Blanched	0 2 4 6	0.06 0.15 0.09 <0.05
311/88869/B541	South Africa	Green beans	300 EC	150	1	Unblanched	0 2 4 6	0.29 0.34 0.16 0.07

Source: Bayer Australia Ltd submission, Baycor 300 Fungicide Spray, file 329-1-619, 21/11/86. South African trials also reported in JMPR.

Residues in beans following application approximating GAP (120 — 190 g ai/ha or 0.8 — 1.3´ label rate) were, in rank order, 0.06, 0.15, 0.16, 0.22 and 0.34 mg/kg (PHI 2-4 days). Following application at 240 — 280 g ai/ha (1.6 — 1.9´ label rate) residues in beans were 0.10, 0.13, 0.16, 0.24,0.28, 0.50, 0.56 and 0.63 mg/kg (PHI 2-4 days).

Selected animal transfer data

Laying hens

Forty laying hens (10 birds per group) were fed daily rations containing bitertanol at 1, 3 and 100 ppm in the feed for 28 consecutive days.

Residues of bitertanol and 1,2,4-trizole metabolites in poultry tissues after 28 days consecutive feeding at 1, 3 or 100 ppm in feed.

		Bitertanol residues (mg/kg)(¹⁾
Sample	Treatment day	1 ppm	3 ppm	100 ppm
Liver	28 42 56	<0.01	0.21	1.03 0.05 0.04
Muscle	28 42 56	NA	0.01	0.07 0.07 <0.01
Fat	28 42 56	NA	<0.01	0.07 <0.01 <0.01
Eggs	7 14 21 28 35 42 49 56	NA	<0.01 <0.01 <0.01 <0.01	0.07 0.05 0.05 0.11 <0.01 <0.01 <0.01 <0.01

⁽¹⁾ 28 DAT samples are composite of 10 animals. 42 and 56 DAT samples are composite of 5 animals.

Bitertanol residues show no preference for accumulation in fat compared to muscle.

Source: Effect of feeding BAYCOR TM to chickens, W. H. Leimkuhler, K. S. Cain, S. L. Whitfield and V. E. Clay, Mobay Chemical Corporation Agricultural Chemicals Division, 27 January 1984.

Lactating cows — milk and tissues

Nine lactating dairy cows (3 per group) were fed bitertanol by bolus capsule equivalent to 25, 75 and 250 ppm in the feed for 28 consecutive days. Capsules were prepared for each animal according to individual body weight and were administered as two half doses per day. Based on initial weights of animals the total daily doses correspond to 0.63, 1.88 and 6.25 mg/kg bw/day.

Residues of bitertanol and 1,2,4-triazole metabolites in cow tissues after 28 days consecutive feeding at 25, 75 and 250 ppm in feed.

Tissue	Treatment day	25 ppm	75 ppm	250 ppm
Milk	0 7 14 21 28	NA NA NA NA <0.01, <0.01, 0.01	<0.01^a 0.09^a 0.10^a 0.13^a 0.07, 0.03, 0.02	<0.01^a 0.11^a 0.19^a 0.17^a 0.07, 0.03, 0.02
Fat^b	28	0.06	0.18	1.28
Muscle^b	28	0.06	0.09	0.44
Liver^b	28	0.78	1.91	3.65
Kidney^b	28	0.05	0.36	1.07

^acomposite of 3 animals analysed

^b highest residue in the three animals shown

Source: Effect of feeding BAYCOR TM to dairy cows, W. H. Leimkuhler, K. S. Cain, S. L. Whitfield and V. E. Clay, Mobay Chemical Corporation Agricultural Chemicals Division, 25 January 1984.

Three lactating dairy cows were fed a diet containing bitertanol at 150 ppm in the diet for 7 days. Full details of the dosing regime and body weights of the animals were not reported.

Residues in milk following dosing at 150 ppm in the diet for 7 days:

Day of study	Skim milk	Milk fat	Day of study	Skim milk	Milk fat
0	<0.01	<0.3	8 (+1)	<0.01	1.4
1	<0.01	0.8	9 (+2)	<0.01	0.9
2	<0.01	1.4	10 (+3)	<0.01	0.3
3	<0.01	0.8	11 (+4)	<0.01	<0.3
4	<0.01	1.6	12 (+5)	<0.01	<0.3
5	<0.01	2.2	13 (+6)	<0.01	<0.3
6	<0.01	2.0	14 (+7)	<0.01	<0.3

Source: PACC meeting November 1989, item 12.5

Residues preferentially accumulate in milk fat, however no data for whole milk were reported. No record of the percentage fat in milk was reported.