Ziram

Toxicity to birds

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to birds: reproduction test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 February 2000 - 7 December 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 206 (Avian Reproduction Test)

Qualifier:

according to guideline

Guideline:

other: FIFRA Guideline 71-4

GLP compliance:

yes

Dose method:

feed

Analytical monitoring:

yes

Details on preparation and analysis of diet:

DIET PREPARATION
- Description and nutrient analysis of basal diet provided in study report: yes
- Preparation of doses: Premix: 16.0714 g ziram Technical + 7083.9 g ration. Aliquots of the premix were weighed and incorporated into the final diet as follows:
0 ppm a.i. : 17.1 kg ration + 900 g limestone
125 ppm a.i.: 100 g premix + 16.1 kg ration + 900 g limestone
250 ppm a.i.: 2000 g premix + 15.1 kg ration + 900 g limestone
500 ppm a.i. : 4000 g premix + 13.1 kg ration + 900 g limestone
The final diet was mixed for approximately 20 minutes in a Patterson-Kelly Twin Shell Blender

Test organisms (species):

Colinus virginianus

Details on test organisms:

TEST ORGANISM
- Common name: Bobwhite quail
- Source: Trace Pheasantry, Inc., Douglassville, PA, USA
- Age at test initiation: 29 weeks
- Weight at test initiation: 175 to 229 g
- Sexes used: both
- Cultural background:
- Disease free: birds that did not appear healthy were excluded from the study
- Breeding population (e.g. reproductive history): The birds were from the same hatch, were approaching their first breeding season and had not been used in any previous testing.

Limit test:

no

Total exposure duration (if not single dose):

20 wk

No. of animals per sex per dose and/or stage:

16 (1 male + 1 female per pen, 16 pens per group)

Control animals:

yes, plain diet

Nominal and measured doses / concentrations:

Nominal: 125, 250 and 500 ppm a.i.
measured: 123 ± 12.8 ppm, 251 ± 31.0 ppm and 498 ± 54.4 ppm

Details on test conditions:

ACCLIMATION
- Acclimation period: 10 weeks

PEN SIZE AND CONSTRUCTION MATERIALS
- Description: Sloping floors that resulted in ceiling height ranging from 20 to 25 cm. The pens were constructed of galvanized wire mesh and galvanized sheeting.
- Compliant to good husbandry practices: yes
- Suitable to avoid crowding stress: yes
- Caging: individual / group 2

NO. OF BIRDS PER REPLICATE
- For negative control: 1 male+ 1 female
- For treated: 1 male+ 1 female


NO. OF REPLICATES PER GROUP
- For negative control: 16
- For treated: 16


TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: Room temperature: 17.6 ± 1.9 ºC
- Relative humidity (%): 57± 11 %
- Ventilation: 15 room air volumes were vent up every hour and replaced with fresh air.

Details on examinations and observations:

- Signs of toxicity or abnormal behaviour - daily.
- Adult body weights - at test initiation, on weeks 2, 4, 6, 8 and at adult termination.
- Feed consumption -daily for a four-day period each week throughout the test.

Details on reproductive parameters:

- At the beginning of week 8 the photoperiod was increased to induce egg production. Following the start of egg production, eggs were set weekly for incubation. Weekly eggs were selected by indiscriminate draw for egg shell thickness measurement and all remaining eggs were candled prior to incubation to detect infertile eggs or embryo mortality. On day 21 of incubation, the eggs were placed in a hatcher and allowed to hatch. Once hatching was complete, hatchlings were removed from the hatcher and the group body weight of the hatchlings by pen was determined. At 14 days of age, the average body weight by parental pen of all surviving offsprings was determined. Upon completion of the test, statistical analyses were performed to determine statistically significant differences between groups.

Reference substance (positive control):

no

Duration (if not single dose):

20 wk

Dose descriptor:

NOEC

Effect level:

500 mg/kg diet

Conc. / dose based on:

act. ingr.

Basis for effect:

mortality

Remarks on result:

other: no overt signs of toxicity or effects upon adult body weight or feed consumption, no effects upon reproductive performance

Mortality and sub-lethal effects:

There were no treatment-related mortalities in any of the treatment groups. One incidental mortality occurred in the 125 ppm a.i. treatment group, while no mortalities occurred in the 250 and 500 ppm a.i. treatment groups.The single mortality in the 125 ppm a.i. treatment group was a male that was found dead on day 3 of week 15. Due to the nature of the lesions observed at necropsy the single mortality was considered to be unrelated to treatment.

Effects on reproduction:

There were no treatment-related effects upon reproductive performance at any of the concentrations tested. At the 500 ppm a.i. test concentration there was a slight, but statistically significant reduction in hatchability (hatchlings as a percentage of live three week embryos). However, the difference observed was the result of low hatchability that occurred in only two pens. If results of these two pens were excluded, hatchability in the 500 ppm a.i. treatment group was comparable to the control group.

Further details on results:

Clinical observations: No overt signs of toxicity were observed at any of the concentrations tested.
Gross necropsy: All surviving adults were subjected to gross necropsy following adult termination.
Adult body weight: There were no apparent treatment-related effects upon adult body weight at any of the concentrations tested.
Adult feed consumption: There were no apparent treatment-related effects upon feed consumption at any of the concentrations tested. However, at the 125 ppm a.i. test concentration there were very slight but statistically significant reductions in feed consumption during weeks 5 and 7. The differences observed were not considered to be related to treatment as they were small, not concentration responsive and not consistent over time.
Egg shell thickness: There were no apparent treatment related effects upon egg shell thickness at any of the concentrations tested.
Offspring body weight: There were no apparent treatment related effects upon offspring body weight at any of the concentrations tested.

Table 1: Validity criteria for OECD 206 (1984)

Criterion	Outcome	Criterion fulfilled
Mortality in the control < 10% at the end of the test.	No mortalities in control	yes
The average number of 14-day-old survivors per hen in the controls should be at least 12 (bobwhite quail)	34	yes
The average egg shell thickness for the control should be at least 0.19 mm (bobwhite quail)	0.228 ± 0.011	yes
There must be evidence that the concentration of the substance being tested has been satisfactorily maintained in the diet (it should be at least 80% of the nominal concentration) throughout the test period.	82 – 95%	yes

Validity criteria fulfilled:

yes

Remarks:

For more details refer to field "any other information on results incl. tables".

Executive summary:

Materials and methods: The effects (adult health, body weight and feed consumption) upon the adult northern bobwhite (Colinus virginianus) of dietary exposure to Ziram Technical were evaluated over a period of 20 weeks according to Environmental Protection Agency´s Registration Guidelines Pesticide Assessment Guidelines, FIFRA Subdivision E, Hazard Evaluation: Wildlife and Aquatic Organisms, Subsection 71-4, OECD Guideline 206 and the ASTM “Standard Practice for Conducting Reproductive Studies with Avian Species”.  In addition, the effects of adult exposure to Ziram Technical on the number of eggs laid, fertility, embryo viability, hatchability, offspring survival and egg shell thickness were observed.

The birds (64 males and 64 females) were randomly distributed into one control and three treatment groups. The test concentrations (125, 250 and 500 ppm a.i.) were selected in consultation with the Sponsor, based upon the results of a pilot reproduction study.

Results and discussion: There were no treatment-related mortalities, overt signs of toxicity or effects upon adult body weight or feed consumption at any of the test concentrations. Additionally, there were no effects upon reproductive performance at the 125, 250 and 500 ppm a.i. test concentrations. The no-observed-effect concentration for northern bobwhite exposed to Ziram Technical in the diet during this study was 500 ppm a.i., the highest concentration tested.

Reference 2

Endpoint:

short-term toxicity to birds: acute oral toxicity test

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

26 January 1989 - 2 October 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPP 71-1 (Avian Acute Oral Toxicity Test)

GLP compliance:

yes

Dose method:

gavage

Test organisms (species):

Colinus virginianus

Details on test organisms:

TEST ORGANISM
- Common name: Bobwhite quail
- Source: D. R. and R.E. Wise, Monkfield, Bourn, Cambridgeshire, England
- Age at test initiation: young adult animals, over 16 weeks old
- Weight at test initiation: 186 to 206 grams
- Sexes used: males and females

Limit test:

no

Total exposure duration (if not single dose):

14 d

No. of animals per sex per dose and/or stage:

5 males+5 females per dose

Control animals:

yes

Nominal and measured doses / concentrations:

Nominal: 24, 42, 71, 120, 204, 346, 588 and 1000 mg a.i./kg bw

Details on test conditions:

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): Birds were housed in groups of 5 (males and females separately) according to treatment in tiered cages in a building which provided satisfactory environmental conditions for the species.
- Feeding: ad libitum
- Fasting period before study: overnight


FEED WITHHOLDING PERIOD BEFORE DOSING
- No. of days: 14


PEN SIZE AND CONSTRUCTION MATERIALS
- Description: Polythene coated steel wire cages (31 x 23 x 39 cm)
- Caging: individual / group


NO. OF BIRDS PER REPLICATE
- For negative control: 5 males+5 females
- For treated: 5 males+5 females


NO. OF REPLICATES PER GROUP
- For negative control: 2
- For treated: 1


TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: 20 - 23 °C
- Relative humidity (%): 76
- Photoperiod: 7/17 hour light/dark cycle
- Ventilation: No data
- Shielding: No data


RANGE FINDING STUDY
- Test concentrations: 250, 500, 1000 and 2000 mg/kg
- Test conditions: the same as for main study
- Results used to determine the conditions for the definitive study: All females died and 2 males died at the higher level concentrations. (1000 and 2000 mg/kg).

Details on examinations and observations:

MORTALITY / CLINICAL SIGNS
- Time schedule for examinations: Mortality and clinical symptoms daily. Postmortem examinations at study termination.

Reference substance (positive control):

no

Duration (if not single dose):

14 d

Dose descriptor:

LD50

Effect level:

97 mg/kg bw

Conc. / dose based on:

act. ingr.

Basis for effect:

mortality

Remarks on result:

other: 95% CL: 74-121 mg/kg

Mortalities in Bobwhite quail orally dosed with ziram

Group	Treatment [mg/kg]	No. of birds	Day of study					Total
			1	2	3	4	14
1	Control	10						0
7	Control	10						0
8	24	10						0
9	42	10						0
10	71	10	1	2			1	4
11	120	10	2	1	2	1		6
2	120	10	4	4				8
3	204	10	4	3	1			8
4	346	10	5	5				10
5	588	10	7	3				10
6	1000	10	9	1				10

Validity criteria fulfilled:

yes

Conclusions:

The mortality rate in the control was below 10% and the results can be considered as valid.

Executive summary:

Materials and Methods: Bobwhite quail (Colinus virginianus) were used to evaluate the acute oral toxicity of ziram. Nine test levels of ten birds each (five males and five females) with single oral doses of 0, 24, 42, 71, 120, 204, 346, 588 and 1000 mg a.i./kg bw. Birds were observed for mortality and symptoms for 14 days. Body weight and feed consumption were monitored during the 14 days.
The test complies with U.S. Environmental Protection Agency (EPA) Pesticide Assessment Guidelines, Subdivision E, Hazard Evaluation: Wildlife and Aquatic Organisms, Series 71 – Avian and Mammalian testing, Section 71-1 Avian single-dose oral LD₅₀test, pags 33 to 37, dated October 1982.

Results and discussion: Mortalities occurred in treatment groups receiving ≥ 71 mg a.i./kg bw. Treatment related symptoms were observed in levels ≥ 24 mg a.i./kg bw.At 24 mg a.i./kg bw birds passed watery excreta on day 2 after dosing. Otherwise, no effects were observed at this level.

No statistically significant decreases in body weight and no overall significant decreases in feed consumption were observed up to the concentrations of 71 and 120 mg a.i./kg bw, respectively.

Over days 0 and 7 following dosing, large bodyweight decreases were observed in the females from groups 10 and 11 (ziram at 71 and 120 mg/kg , respectively) and the males from groups 11, 2 and 3 (ziram at 120, 120 and 204 mg/kg, respectively). Over days 7 to 14 a large compensatory increase in bodyweight was observed in the one surviving female from group 11 and the males from groups 11 and 3.

Over days 1 to 7 following dosing, food comsuption was greatly reduced in females from groups 11, 3, 4 and 5 (ziram at 120, 204, 346 and 588 mg/kg, respectively), and males from groups 3 and 4 (ziram at 204 and 346 mg/kg, respectively).

Reference 3

Endpoint:

short-term toxicity to birds: dietary toxicity test

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

26 January 1989 - 7 January 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPP 71-2 (Avian Dietary Toxicity Test)

GLP compliance:

yes

Dose method:

feed

Analytical monitoring:

yes

Vehicle:

yes

Details on preparation and analysis of diet:

The composition of the standard HRC chick diet was as follows:
Ground wheat - 30 %
Ground maize - 25 %
Ground barley - 10 %
Provimi 66 fish meal - 15 %
Extracted soya bean meal - 13.75 %
Weatings (wheat feed) - 5 %
Pantoribin 537 - 1.25 %

DIET PREPARATION
- Description and nutrient analysis of basal diet provided in study report: yes
- Preparation of doses: A premix of suitable strength was prepared by grinding the required quantity of test substance with untreated basal diet. Blending of the premix was achieved by mixing in a turbula mixer for a minimum period of two minutes. The required concentrations were prepared by direct dilution of the premix. Blending of the inclusion levels for feeding was achieved by mixing in a double-cone blender for a minimum period of seven minutes.
Immediately after preparation, the test and control diets were frozen at -20 ºC. Diet in the food hoppers was replaced daily during the treatment period with diet from the freezer.
- Type and function of solvent/vehicle: The diet sample was refluxed (60 minutes) with the digestion solution (stannous chloride solution (5 mL) mixed with hydrochloric acid solution (1M, 250 mL)) in an inert atmosphere and the carbon disulphide liberated was collected in absorber V containing an appropriate volume of Cullens reagent (cupric acetate solution (5 mL) and diethanolamine (AR, 25 g) mixed and diluted to volume (250 mL) with ethanol (AR)). The contents of absorver V were quantitatively transferred to a volumetric flask, diluted to volume using Cullens reagent and further diluted as appropriate using ethanol.


HOMOGENEITY AND STABILITY OF TEST MATERIAL IN DIET
- How often was homogeneity and stability tested: twice per concentration
- When and at what dose levels were samples of treated food analyzed for stability and concentration during the study:
- Results of homogeneity analysis (range of values):
- Nominal concentration: 650, 1300, 2600 and 5200 ppm
- Concentration analysed: 627, 1270, 2530 and 5060 ppm

Test organisms (species):

Anas platyrhynchos

Details on test organisms:

TEST ORGANISM
- Common name: Mallard duck
- Source: Mr. John Coles, The country Game Farms, Ashford, Kent, England.
- Age at test initiation: six days
- Weight at test initiation (mean and range, SD): Group mean bodyweights ranged from 76 to 77 g
- Sexes used: not specified
- Cultural background:
- Disease free: no data
- Kept according to standard practices: yes
- Breeding population (e.g. reproductive history): no data

Limit test:

no

Total exposure duration (if not single dose):

5 d

Post exposure observation period:

7 days

No. of animals per sex per dose and/or stage:

Four dose groups, each with 10 birds

Control animals:

yes, plain diet

Nominal and measured doses / concentrations:

Nominal: 650, 1300, 2600 and 5200 ppm

Details on test conditions:

ACCLIMATION
- Acclimation period: 3 days
- Feeding: standard HRC chick (batch 4101) in meal form
- Health (any disease or mortality observed): Good
- Fasting period before study: No


FEED WITHHOLDING PERIOD BEFORE DOSING
- No. of days: 3 days


PEN SIZE AND CONSTRUCTION MATERIALS
- Description: Galvanised steel, tiered brooders with wire mesh floors (84 x 57 x 27 cm)


NO. OF BIRDS PER REPLICATE
- For negative control: 10
- For treated: 10


NO. OF REPLICATES PER GROUP
- For negative control: 3
- For treated: 1

TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: 26 to 28 ºC
- Relative humidity (%): 64
- Photoperiod: continuous illumination
- Ventilation: Yes, Fans


RANGE FINDING STUDY
- Test concentrations: 0, 10, 100, 500, 1000 and 5200 ppm
- Test conditions: no data
- Results used to determine the conditions for the definitive study: yes

Details on examinations and observations:

MORTALITY / CLINICAL SIGNS
- Time schedule for examinations: Mortalities, bird health and clinical observations were recorded daily.
Remarks: All birds which died during the study were examined post-mortem.

BODY WEIGHT
- Time schedule for examinations:days -3, 0, 5, 8 and 12

FOOD CONSUMPTION
- Time schedule for examinations: Feed consumption for each group was recorded at the intervals: days -3 to -1, 1 to 5 (daily) and 6 to 12.

Reference substance (positive control):

no

Duration (if not single dose):

5 d

Dose descriptor:

LC50

Effect level:

5 156 other: ppm

Conc. / dose based on:

act. ingr.

Basis for effect:

mortality

Remarks on result:

other: lower 95% CL: 3740 ppm

Group	Treatment [ppm]	Initial no. of birds	Day of study			Total
			5	6	10
1	Control	10	0	0	0	0
2	Control	10	0	0	0	0
3	Control	10	0	0	0	0
4	650	10	0	0	0	0
5	1300	10	0	0	0	0
6	2600	10	1	0	0	1
7	5200	10	2	2	1	5

Group	Treatment[ppm]	Days of study
		Bodyweight (g/bird)					Bodyweight change (g/bird)*
		-3	0**	5	8	12	-3 to 0	0 to 5	5 to 8	8 to 12
1	control	77	122	215	316	411	45	93	101	95
2	control	77	127	198	301	386	50	71	103	85
3	control	76	123	203	296	367	47	80	93	71
4	650	76	123	158	215	297	47	35	57	82
5	1300	77	118	134	178	283	41	16	44	105
6	2600	77	124	112	176	263	47	-12	64	87
7	5200	76	125	81	161	293	49	-44	80	132

* All values are positive unless otherwise indicated
** Time 0 is that time point immediately prior to introduction of the test diets, indicating the start od day 1, the first 24-hour period of exposure to test diets. For convenience, this point is referred to as day 0 in the table.

Group	Treatment[ppm]	Days of study
		Bodyweight (g/bird)					Bodyweight change (g/bird)*
		-3	0**	5	8	12	-3 to 0	0 to 5	5 to 8	8 to 12
1	control	77	122	215	316	411	45	93	101	95
2	control	77	127	198	301	386	50	71	103	85
3	control	76	123	203	296	367	47	80	93	71
4	650	76	123	158	215	297	47	35	57	82
5	1300	77	118	134	178	283	41	16	44	105
6	2600	77	124	112	176	263	47	-12	64	87
7	5200	76	125	81	161	293	49	-44	80	132

* All values are positive unless otherwise indicated
** Time 0 is that time point immediately prior to introduction of the test diets, indicating the start od day 1, the first 24-hour period of exposure to test diets. For convenience, this point is referred to as day 0 in the table.

Validity criteria fulfilled:

yes

Conclusions:

The mortality rate in the control was below 10 % and the study can be considered as valid.

Executive summary:

Materials and methods. Mallard duck (Anas platyrhynchos) were used to evaluate the dietary toxicity of ziram. Five test levels of ten birds each were offered food at oral doses of 0, 650, 1300, 2600 and 5200 mg a.i./kg feed. Birds were observed for mortality and symptoms of poisoning for 12 days (5 days of exposition plus 7 days of observation) after a 3-day pre-treatment period for acclimatisation. Body weight and feed consumption were monitored during the 15 days.
The test complies withU.S. Environmental Protection Agency (EPA) Pesticide Assessment Guidelines, Subdivision E, Hazard Evaluation: Wildlife and Aquatic Organisms, Series 71 – Avian and Mammalian testing, Section 71-2 Avian dietary LC₅₀test, pags 37 to 43, dated October 1982.

Results and discussion: Mortalities occurred in treatment groups receiving ≥ 2600 mg a.i./kg feed. Treatment related symptoms were observed in all treatment levels. During the first five days a body weight reduction was observed at the concentration levels of 2600 and 5200 mg a.i./kg feed. Between days 5 and 8 all treated levels showed reduction of feed consumption, whereas after day 8 no statistically significant decreases in body weight were observed. A reduction of the feed consumption occurred at all concentrations showing a palatative problem

Reference 4

Endpoint:

short-term toxicity to birds: dietary toxicity test

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

13 May 1989 - 13 January 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study

Qualifier:

according to guideline

Guideline:

EPA OPP 71-2 (Avian Dietary Toxicity Test)

GLP compliance:

yes

Dose method:

feed

Analytical monitoring:

yes

Details on preparation and analysis of diet:

The composition of the standard HRC chick diet was as follows:
Ground wheat - 30 %
Ground maize - 25 %
Ground barley - 10 %
Provimi 66 fish meal - 15 %
Extracted soya bean meal - 13.75 %
Weatings (wheat feed) - 5 %
Pantoribin 537 - 1.25 %

DIET PREPARATION
- Description and nutrient analysis of basal diet provided in study report: yes
- Preparation of doses: A premix of suitable strength was prepared by grinding the required quantity of test substance with untreated basal diet. Blending of the premix was achieved by mixing in a turbula mixer for a minimum period of two minutes. The required concentrations were prepared by direct dilution of the premix. Blending of the inclusion levels for feeding was achieved by mixing in a double-cone blender for a minimum period of seven minutes.
Immediately after preparation, the test and control diets were frozen at -20 ºC. Diet in the food hoppers was replaced daily during the treatment period with diet from the freezer.
- Type and function of solvent/vehicle: The diet sample was refluxed (60 minutes) with the digestion solution (stannous chloride solution (5 mL) mixed with hydrochloric acid solution (1M, 250 mL)) in an inert atmosphere and the carbon disulphide liberated was collected in absorber V containing an appropriate volume of Cullens reagent (cupric acetate solution (5 mL) and diethanolamine (AR, 25 g) mixed and diluted to volume (250 mL) with ethanol (AR)). The contents of absorver V were quantitatively transferred to a volumetric flask, diluted to volume using Cullens reagent and further diluted as appropriate using ethanol.


HOMOGENEITY AND STABILITY OF TEST MATERIAL IN DIET
- How often was homogeneity and stability tested: twice per concentration
- When and at what dose levels were samples of treated food analyzed for stability and concentration during the study:
- Results of homogeneity analysis (range of values):
- Nominal concentration: 650, 1300, 2600 and 5200 ppm
- Concentration analysed: 659, 1250, 2550 and 5210 ppm

Test organisms (species):

Colinus virginianus

Details on test organisms:

TEST ORGANISM
- Common name: Bobwhite quail
- Source: D.R. and R.E. Wise, Monkfield, Bourn, Cambridgeshire, England
- Age at test initiation: 7 days
- Weight at test initiation: 11.6 to 12.2 g at the start of the pre-treatment period.
- Sexes used: not determined
- Cultural background:
- Disease free: unkown
- Kept according to standard practices: yes

Limit test:

no

Total exposure duration (if not single dose):

5 d

Post exposure observation period:

5

No. of animals per sex per dose and/or stage:

4 dose groups each with 10 animals

Control animals:

yes, plain diet

Nominal and measured doses / concentrations:

Nominal: 650, 1300, 2600 and 5200 ppm a.i.

Details on test conditions:

- Acclimation period: 4 days
- Feeding: standard HRC chick (batch 4101) in meal form
- Health (any disease or mortality observed): Good
- Fasting period before study: No


FEED WITHHOLDING PERIOD BEFORE DOSING
- No. of days: 4 days


PEN SIZE AND CONSTRUCTION MATERIALS
- Description: Wooden boxes (83 x 52 x 51 cm) with wire mesh lids


NO. OF BIRDS PER REPLICATE
- For negative control: 10
- For treated: 10


NO. OF REPLICATES PER GROUP
- For negative control: 3
- For treated: 1

TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: 25 to 28 ºC
- Relative humidity (%): 68
- Photoperiod: continuous illumination
- Ventilation: Yes, Fans


RANGE FINDING STUDY
- Test concentrations: 0, 10, 100, 500, 1000 and 5200 ppm
- Test conditions: no data
- Results used to determine the conditions for the definitive study: yes

Details on examinations and observations:

MORTALITY / CLINICAL SIGNS
- Time schedule for examinations: Mortalities, bird health and clinical observations were recorded daily.
Remarks: All birds which died during the study were examined post-mortem.

BODY WEIGHT
- Time schedule for examinations: days -4, 0, 5, 8 and 10

FOOD CONSUMPTION
- Time schedule for examinations: Feed consumption for each group was recorded at the intervals: days -4 to -1, 1 to 5 (daily) and 6 to 9 and 9 to 10.

Duration (if not single dose):

14 d

Dose descriptor:

LC50

Effect level:

> 5 200 other: ppm

Conc. / dose based on:

act. ingr.

Basis for effect:

mortality

Duration (if not single dose):

14 d

Dose descriptor:

NOEL

Effect level:

1 300

Conc. / dose based on:

act. ingr.

Basis for effect:

mortality

Group	Treatment [ppm]	Initial no. of birds	Day of study			Total
			3	6	7
1	Control	10	0	0	0	0
2	Control	10	0	0	0	0
3	Control	10	0	0	0	0
4	650	10	0	0	0	0
5	1300	10	0	0	0	0
6	2600	10	0	1	0	1
7	5200	10	2	0	1	3

Group	Treatment [ppm]	Days of study
		Bodyweight					Bodyweight change*
		-4	0	5	8	10	-4 to 0	0 to 5	5 to 8	8 to 10
1	Control	11.7	16.2	22.5	30.6	35.8	4.5	6.3	8.1	5.2
2	Control	11.7	17.2	27.7	36.6	41.6	5.5	10.5	8.9	5.0
3	Control	12.2	18.1	27.2	35.7	41.1	5.9	9.1	8.5	5.4
4	650	11.6	17.8	27.2	36.3	40.5	6.2	9.4	9.1	4.2
5	1300	11.8	17.5	23.4	32.9	38.0	5.7	5.9	9.5	5.1
6	2600	12.1	17.3	18.5	26.3	31.4	5.2	1.2	7.8	5.1
7	5200	11.9	17.0	13.9	21.9	26.0	5.1	-3.1	8.0	4.1

Group	Treatment [ppm]	Days of study
		-4 to -1	1	2	3	4	5	1 to 5	6 to 8	9 to 10
1	Control	3.1	4.0	4.3	4.1	4.2	4.7	4.3	4.7	4.7
2	Control	2.7	3.9	5.0	4.8	5.6	6.4	5.1	5.0	4.5
3	Control	3.1	5.1	5.0	5.8	6.4	6.7	5.8	5.3	5.7
4	650	2.6	3.9	4.9	4.7	4.9	5.9	4.9	5.1	5.1
5	1300	3.2	3.5	4.7	4.6	4.3	5.2	4.5	4.8	4.2
6	2600	2.8	2.5	2.5	2.2	3.0	3.7	2.8	4.0	3.8
7	5200	2.5	2.3	2.6	2.4	3.4	3.6	2.8	3.7	4.1

Validity criteria fulfilled:

yes

Conclusions:

Due to the limited number of mortalities, the LC50 value of ziram technical could not be determined. This value must lie slightly in excess of 5200 ppm.
The clinical symptoms and the mortality in the 2600 and 5200 dose groups may be induced by the decrease of food consumption.
The mortality rate in the control was below 10 % and the study can be considered as valid.

Executive summary:

Materials and methods:Bobwhite quail(Colinus virginianus) were used to evaluate the dietary toxicity of ziram. Test birds were fed with untreated food for 4 days (pre-treatment period). The following 5 days, four test levels of ten birds each were fed with daily dietary doses of 650, 1300, 2600 and 5200 mg a.i./kg feed. Three groups of 10 birds each were fed with untreated food (control groups) (treatment period). In the post-treatment period, birds were fed again with untreated food for 5 days. Quails were observed for mortality and symptoms of toxication for the 14 days. Furthermore, the body weight and feed consumption were monitored during the test.
The test complies withU.S. Environmental Protection Agency (EPA) Pesticide Assessment Guidelines, Subdivision E, Hazard Evaluation: Wildlife and Aquatic Organisms, Series 71 – Avian and Mammalian testing, Section 71-2 Avian dietary LC₅₀test, pages 37 to 43, dated October 1982.

Results and discussion:Due to the limited number of mortalities, the dietary toxicity (LC₅₀value) of ziram technical to the Bobwhite quail was not determined. At 650 and 1300 ppm no mortalities occurred, no clinical signs of toxicity were shown and bodyweights and food consumption were unaffected. Therefore, under the conditions of this study 1300 ppm is considered to be the no effect level.

Description of key information

NOEC (20 wk) = 500 mg a.i./kg diet (reproduction, Colinus virginianus, OECD 206)

LD50 (14 d) = 97 mg a.i./kg bw (acute oral, Colinus virginianus, EPA OPP 71-1)

LC50 (5 d) = 5156 ppm a.i. (dietary, Anas platyrhynchos, EPA OPP 71-2)

Key value for chemical safety assessment

Short-term EC50 or LC50 for birds:

97 mg/kg bw

Long-term EC10, LC10 or NOEC for birds:

500 mg/kg food

Additional information

The acute and chronic effects of zinc bis dimethyldithiocarbamate (CAS No. 137-30-4) on bird species has been investigated in several studies.

The acute oral and the dietary toxicity of the substance was tested (1990, 1992) onColinus virginianus, after 14 and 5 days exposure, respectively. These tests were conducted according to EPA OPP Guidelines 71-1 and 71-2, Avian Acute Oral Toxicity Test and Avian Dietary Toxicity Test (1982) and under GLP conditions. Birds mortality was observed in the acute oral test, resulting in an LD50 of 97 mg a.i./kg body weight. The results from the 5 days-dietary test showed absence of lethal effects and therefore the LC50 was estimated to be over 5200 ppm. An additional dietary toxicity study (1992) is available and was conducted for 5 days according to the EPA OPP Guideline 71-2 and GLP withAnas platyrhynchosas test organism. Mortality occurred at the two highest concentrations tested and an LC50 of 5156 ppm a.i. was determined.

The chronic effects of zinc bis dimethyldithiocarbamate on bird species were investigated (2000), following the OECD Guideline No. 206, Avian Reproduction Test (1984) and GLP. After 20 weeks of exposure to the test material, no effects on the reproductive performance ofColinus virginianuswere reported up to the highest concentration tested (NOEC (20 w)≥500 mg a.i./kg diet or 36.6 mg a.i./kg bw/d).