thiacloprid (ISO);(Z)-3-(6-chloro-3-pyridylmethyl)-1,3-thiazolidin-2-ylidenecyanamide;{(2Z)-3-[(6-chloropyridin-3-yl)methyl]-1,3-thiazolidin-2-ylidene}cyanamide

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:

18 Jul - 16 Jan 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPP 71-4 (Avian Reproduction Test)

Version / remarks:

1982

GLP compliance:

yes (incl. QA statement)

Dose method:

homogenously mixed into feed (accounts for technical substances)

Analytical monitoring:

yes

Vehicle:

yes

Remarks:

acetone

Details on preparation and analysis of diet:

DIET PREPARATION
- Description and nutrient analysis of basal diet provided in study report: no
- Preparation of doses: Diets were prepared by dissolving the test compound in corn oil (max. concentration: 2%) and acetone. The compound solution, placed into a separatory funnel, was slowly added to the feed while mixing in a 30-quart bowl on a Hobart Mixer. The acetone subsequently evaporated from the feed.
- Type, identity and function of solvent/vehicle: acetone
- Amount of vehicle: 15.6 - 31.3 mL/kg feed

HOMOGENEITY AND STABILITY OF TEST MATERIAL IN DIET
- How often was homogeneity and stability tested: prior to study initiation (50 and 600 ppm)
- When and at what dose levels were samples of treated food analyzed for stability and concentration during the study: stability: An initial sample from each concentration batch (50 and 600 ppm) was taken immediately after the mixing was complete. The batch of ration was then divided into two portions that were both placed into the freezer for seven days. After seven days in the freezer one portion was removed for room temperature testing. The portion stored at room temperature was sampled on day 0 (7), 1 (8), 3 (10), 7 (14), and 14 (21). concentration during the study: Samples of ration were taken from each batch of ration prepared for weeks 1, 5, 10, 15 and 20 for concentration analysis.
- Results of homogeneity analysis: 87.5% (mean, 50 ppm), 83% (83%, 600 ppm)
- Nominal concentration (mg/kg feed): 0, 60, 173 or 500 ppm
- Concentration analysed (mg/kg feed): 47.6, 140 and 418 ppm
- % of nominal:
- Mixing procedure adequate and variance between nominal and actual dosage acceptable: yes

ANALYTICAL METHODS IN THE FEED
- Separation method: liquid chromatographic analysis
- Detection limits: LOQ = 1.0 ppm, LOD = 0.3 ppm
- Extraction recovery: 95.7 - 104%

Test organisms (species):

Anas platyrhynchos

Details on test organisms:

TEST ORGANISM
- Common name: mallard
- Source: obtained from Whistling Wings Inc., Hanover, USA
- Age at test initiation: 19 weeks
- Weight at test initiation(week 1, means of treatment groups): males: 1275 - 1307 g, females: 1082 - 1113 g
- Sexes used: mixed sex
- Disease free: yes

Limit test:

no

Total exposure duration (if not single dose):

20 wk

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

15 pairs of birds with one male and one female per cage

Control animals:

yes

Nominal and measured doses / concentrations:

Nominal concentrations: 0, 60, 173 and 500 ppm
Measured concentrations:< LOD (0), 47.6, 140 and 418 ppm

Details on test conditions:

ACCLIMATION
- Acclimation period: 33 d
- Acclimation conditions: same as test
- Feeding: not reported
- Health (any disease or mortality observed): no, the only finding was evidence of an intestinal parasite (cryptosporidia) in three birds.
not be a problem and no treatment was recommended.
- Fasting period before study: not reported

PEN SIZE AND CONSTRUCTION MATERIALS
- Description: for adults: cages constructed of stainless steel wire grid and stainless steel sheeting (81L X 61W X 51H cm), for hatchlings: cages of galvanized wire mesh and galvanized sheeting (91L X 71W X 23H)
- Floor covering: not reported
- Caging: pair

NO. OF BIRDS PER STAGE OR REPLICATE
- For negative control: 1 male and 1 female per cage
- For vehicle control: 1 male and 1 female per cage
- For treated: 1 male and 1 female per cage

NO. OF STAGES OR REPLICATES PER GROUP
- For negative control: 15
- For vehicle control: 15
- For treated: 15

TEST CONDITIONS
- Temperature (mean) : 21 °C (adult room), 22 °C (hatchling room)
- Brooder temperature: 37 °C (mean)
- Relative humidity (%): 52 (adult room), 50% (hatchling room), 57 (booder)
- Photoperiod: 17 hours light/7 hours dark per day
- Ventilation: not reported

Details on examinations and observations:

MORTALITY / CLINICAL SIGNS
- Time schedule for examinations: at least once daily

BODY WEIGHT
- Time schedule for examinations: at study initiation (week l), on the first day of weeks 3, 5, 7, and 9, and at terminal adult sacrifice (beginning of week 21)

FOOD CONSUMPTION
- Time schedule for examinations: weekly by cage

PATHOLOGY
- Dose groups that were examined: All of the high dose and at least four males and four females in the remaining treatment groups (including the controls) were necropsied.

REGURGITATION
- Test material was regurgitated: not observed

Details on reproductive parameters:

The following parameters were examined per parental pen per week:
- Eggs laid
- Eggs cracked; eggs broken
- Egg abnormalities
- Eggs set
- Eggshell thickness or eggshell strength
- Eggs fertile
- Embryos viable
- Normal hatchlings
- Abnormal hatchlings
- Clinical signs of toxicity, abnormalities and mortality
- 14-day old surviving chicks
- Chick body weight at hatching and 14 days after hatching

Reference substance (positive control):

no

Duration (if not single dose):

20 wk

Dose descriptor:

NOEC

Effect level:

47.6 mg/kg diet

Conc. / dose based on:

act. ingr.

Basis for effect:

body weight

Duration (if not single dose):

20 wk

Dose descriptor:

NOEC

Effect level:

140 mg/kg diet

Conc. / dose based on:

act. ingr.

Basis for effect:

reproductive parameters

Remarks:

14-day survivor weight

Mortality and sub-lethal effects:

For details on cumulative mortality and sub-lethal effects see Table no. #.
MORTALITY: No overt signs of intoxication were observed during the study in any test group.

CLINICAL SIGNS
- Results: No overt signs of intoxication were observed during the study in any test group.

BODY WEIGHT
- Results: Terminal body weight of females exhibited a dose-response trend with the 140 and 418 ppm treatment levels being significantly less (p ≤ 0.05) than the controls. Male body weight exhibited a similar trend; however, the only statistically significant finding was in weight change of the 140 ppm level.

FOOD CONSUMPTION
- Results: no effects

PATHOLOGY
- Results: no apparent treatment related findings

Effects on reproduction:

There were no significant differences (p > 0.05) noted in any reproductive parameter when treatment groups were compared to controls.

Table 1:

Average Body Weight of Parental Birds
Treatment [ppm]	Males [g]			Females [g]			mean [g]
	initial	terminal	mean	initial	terminal	mean
0 (control)	1287	1305	1296.0	1113	1403	1258.0	1277.0
47.6	1301	1315	1308.0	1119	1347	1233.0	1270.5
140	1307	1245	1276.0	1103	1285 *	1194.0	1235.0
418	1275	1236	1255.5	1082	1226 *	1154.0	1204.8

Table 2: Reproductive parameters (absolute data)

Reproductive Performance per hen
Parameter	Control	47.6 ppm	140 ppm	418 ppm
# of eggs laid	696	675	606	648
# of eggs cracked	4	7	5	5
# of eggs defective	11	22	15	32
# of eggs set	632	598	545	565
# of fertile eggs	573	564	506	449
# of viable embryos	555	548	494	442
# of normal hatchlings	488	464	442	379
# of normal hatchlings per hen	32.5	33.1	34.0	25.3
# of 14 day survivors	479	457	433	377
# of 14 day survivors per hen	31.9	32.6	33.3	25.1
Eggshell strength [kg]	2.85	2.84	2.86	2.78
Eggshell thickness [mm]	0.37	0.37	0.37	0.37
Hatchling weight [g]	37.3	37.3	38.7	36.0
14-d survivor weight [g]	218.8	205.4	205.1	191.3 *

Table 3: Reproductive Performance (relative data)

Parameter	Control	47.6 ppm	140 ppm	418 ppm
% cracked eggs of eggs laid	0.7	1.0	0.9	0.8
% defective eggs of eggs laid	1.7	3.0	2.7	4.1
% fertile eggs of eggs set	90.3	94.5	92.0	77.3
% of viable embryos of fertile eggs	97.2	96.9	97.3	97.4
% of normal hatchlings of fertile eggs	85.8	80.5	85.6	82.1
% of normal hatchlings of viable embryos	88.1	83.0	87.9	84.1
% of 14-d survivors of normal hatchlings	98.2	98.3	97.9	97.9

Table 4: Validity criteria for OECD 20

Criterion	Outcome	Criterion fulfilled
Mortality in the control < 10% at the end of the test.	0%	yes
The average number of 14-day-old survivors per hen in the controls should be at least 14 (mallard duck)	31.9	yes
The average egg shell thickness for the control should be at least 0.34 mm (mallard duck)	0.37 mm	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.	79.3 - 83.6% (mean measured concentrations)	no, however. effect concentrations refer to measured concentrations and mean measured concentrations were only below 80% in the lowest effect concentration. Therefore, this deviation is considered to not affect the outcome of the study.

Validity criteria fulfilled:

yes

Remarks:

For further details please refer to “Any other information on results incl. tables”.

Conclusions:

The lowest derived NOEC of parental toxicity was determined to be 47.6 mg/kg feed in an avian reproduction test with mallard duck Anas platyrhynchos performed according to EPA OPP 71-4.

Reference 2

Endpoint:

long-term toxicity to birds: reproduction test

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 206 (Avian Reproduction Test)

Version / remarks:

1984

Qualifier:

according to guideline

Guideline:

EPA OPP 71-4 (Avian Reproduction Test)

Version / remarks:

1986

GLP compliance:

yes (incl. QA statement)

Dose method:

feed

Analytical monitoring:

yes

Vehicle:

no

Details on preparation and analysis of diet:

The test compound was added in the respective amounts to a small quantity of the basal diet and premixed by a high-speed homogenizer. Subsequently, this premix was transferred into the 125 litre Lödige Mixer "MGT 125", the remaining aliquot of the test diet added and agitated at 3000 Upm for five minutes. No carrier material was used. Fresh batches of diet were prepared in four-week-intervals during the 23 week exposure period. Each batch provided food for four study weeks. Directly after preparation, the batch of each diet concentration was partitioned into separate sub-samples corresponding to the amount required for half a week, and stored in a freezer until use.

Test organisms (species):

Colinus virginianus

Details on test organisms:

Pen-reared, 25 weeks old Bobwhite Quail (Colinus virginianus) that were apparently healthy and phenotypically indistinguishable from wild birds were obtained from Ed. G. Morris, 18370 S.W. 232 Street, Goulds, Florida. All birds were from the same hatch. They were approaching their first breeding season and had not been used in previous testing. After arrival, all birds 18 sqm were placed in a large-size aviary of for acclimatization to the new climatic conditions. Two weeks prior to initiation of the test, all birds were examined for physical injuries and general health. Birds that were injured or did not appear healthy were discarded. 160 well developed birds were selected from the remaining individuals for randomized assignment to the exposure groups.

Total exposure duration (if not single dose):

23 wk

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

Groups of 20 pairs of sexually mature Northern bobwhite (25 weeks old at test initiation) approaching their first breeding season. A control group was maintained concurrently with the treatment groups.

Control animals:

yes

Nominal and measured doses / concentrations:

Nominal: Dietary concentrations of 60, 173 and 500 ppm a.i.
Mean measured values: 53, 153 and 466 ppm a.i.

Duration (if not single dose):

23 wk

Dose descriptor:

LC50

Effect level:

> 466 other: ppm

Conc. / dose based on:

act. ingr.

Remarks:

measured concentration

Basis for effect:

mortality

Duration (if not single dose):

23 wk

Dose descriptor:

NOEC

Effect level:

466 other: ppm

Conc. / dose based on:

act. ingr.

Remarks:

measured concentration

Basis for effect:

reproductive parameters

Mortality and sub-lethal effects:

Feed consumption was reduced at all concentration levels. However, since body mass of these birds was not adversely affected and no treatment-related effects were observed upon any of the examined reproductive parameters, the differences in feed consumption, although statistically significant, were not considered as relevant for birds health and welfare.

Effects on reproduction:

There were also no adverse effects recorded on the offspring which further supports the assumption that the reduced feed consumption had no relevant influence on the reproductive performance of the exposed birds.

Validity criteria fulfilled:

not specified

Conclusions:

The test substance was administered as libitum in the diet to groups of 20 pairs of sexually mature Northern bobwhite (25 weeks old at test initiation) approaching their first breeding season. Test birds received the test substance at nominal dietary concentrations of 60, 173 and 500 ppm a.i. (mean measured values: 53, 153 and 466 ppm) for 23 weeks. A control group was maintained concurrently with the treatment groups. The Northern bobwhite were observed daily for mortality, abnormal behavior, and signs of toxicity. Adult body mass was measured at test initiation, on weeks 2, 4, 6, 8 and at adult sacrifice. Feed consumption was measured weekly for each pen for a seven day period. Necropsies were performed on all adults surviving until adult sacrifice and on all adults that died during the test.
There were no treatment related mortalities, overt signs of toxicity or treatment related effects in body mass or reproductive parameters at any test concentration. Feed consumption was reduced at all concentration levels. However, since body mass of these birds was not adversely affected and no treatment-related effects were observed upon any of the examined reproductive parameters, the differences in feed consumption, although statistically significant, were not considered as relevant for birds health and welfare. There were also no adverse effects recorded on the offspring which further supports the assumption that the reduced feed consumption had no relevant influence on the reproductive performance of the exposed birds.
Based upon the results of the statistical exercises, the no observed effect concentration for Northern bobwhite exposed to the test substance in the diet during this study was 466 ppm a.i.

Reference 3

Endpoint:

short-term toxicity to birds: dietary toxicity test

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

10 Nov -18 Nov 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 205 (Avian Dietary Toxicity Test)

Version / remarks:

1984

Qualifier:

according to guideline

Guideline:

EPA OPP 71-2 (Avian Dietary Toxicity Test)

Version / remarks:

1982

GLP compliance:

yes (incl. QA statement)

Dose method:

feed

Analytical monitoring:

yes

Details on preparation and analysis of diet:

Before starting the main mixture by using a Lödige Mixer, the test compound was added to a small amount of the basal diet by using 2% peanut oil as carrier and premixed by a high-speed homogenizer. Subsequently, this premix was transferred into the 125-litre Lödige Mixer "MGT 125" and agitated at 3000 Upm for 5 minutes.

Test organisms (species):

Coturnix coturnix japonica

Details on test organisms:

Twelve days old Japanese Quails (Coturnix coturnix japonica) were obtained from "Gefügelzucht H.& E. Küberich", RüdernerstraBe 11, 97353 Geesdorf. They were from the same hatch and appeared phenotypically similar to birds from wild populations. All birds were apparently healthy after arrival in the test facility. All unsuitable birds (e.g., injured, deformed, etc.) were directly eliminated from inclusion in the test. Then 80 well developed birds were selected for randomized assignment to the exposure groups.

Limit test:

no

Total exposure duration (if not single dose):

5 d

Post exposure observation period:

Following exposure, all groups were held for a 3-day observation period on untreated feed.

Control animals:

yes

Nominal and measured doses / concentrations:

Nominal: Nominal dietary concentrations were set at 625, 1250, 2500, 5000 and 10000 mg/kg feed
Measured: 102 to 108 % of nominal concentrations

Duration (if not single dose):

5 d

Dose descriptor:

LC50

Effect level:

2 500 mg/kg diet

Conc. / dose based on:

act. ingr.

Basis for effect:

mortality

Mortality and sub-lethal effects:

Mortalities and partly severe symptoms of intoxication (narcosis, apathy, loss of equilibrium, tremors and lying on the side) occured during the first 24 hours of the study in animals exposed to 10000, 5000, or 2500 mg a.i./kg diet. Additionally, the animals of the 1250 mg a.i./kg diet group suffered from severe symptoms of intoxication (narcosis, apathy, loss of equilibrium, tremors and lying on the side) and animals exposed to 625 mg a.i./kg diet exhibited slight signs of toxicity (loss of equilibrium, slight apathy) but none of them died.

Validity criteria fulfilled:

not specified

Conclusions:

Young (14 days old) Japanese Quail (Coturnix coturnix japonica) were used to evaluate the dietary toxicity of the test substance (97.2% active ingredient (a.L). 5 groups of 10 birds were exposed for 5 days to dietary concentrations of 625, 1250, 2500, 5000 or 10000 mg a.i./kg feed (ppm). All dose preparations were corrected to 100% active ingredient. Three additional groups of ten birds were similarly given untreated feed only and maintained as concomitant control. Following exposure, all groups were held for a 3-day observation period on untreated feed.
Based on the results of this study, the subacute dietary LC50 of the test substance to Japanese Quail was determined to be 2500 mg a.i./kg feed.
The lowest observed effect concentration (LOEC) was < 625 mg a.i./kg feed based on signs of intoxication (slight apathy / tumbling), reduced feed consumption and a decrease in body weight gain in the lowest tested concentration.

Reference 4

Endpoint:

short-term toxicity to birds: dietary toxicity test

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

18 - 26 Nov 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 205 (Avian Dietary Toxicity Test)

Version / remarks:

1984

Qualifier:

according to guideline

Guideline:

EPA OPP 71-2 (Avian Dietary Toxicity Test)

Version / remarks:

1982

GLP compliance:

yes (incl. QA statement)

Dose method:

feed

Analytical monitoring:

yes

Details on preparation and analysis of diet:

Before starting the main mixture by using a Lödige Mixer, the test compound was added to a small amount of the basal diet by using 2 % peanut oil as carrier and premixed by a high-speed homogenizer. Subsequently, this premix was transferred into the 125-litre Lödige Mixer "MGT 125" and agitated at 3000 Upm for 5 minutes. The diets were kept deep-frozen at -18 °C in portions. Each day a freshly thawed portion was offered to the birds. The uneaten feed from the day before was weighed back and discarded.
Samples from all prepared diets were taken for a.i. concentration analysis. Estimation of diet homogeneity and stability was obtained by analyzing feed mixtures of 50 and 10000 ppm nominal dietary levels.

Test organisms (species):

Colinus virginianus

Details on test organisms:

Fresh breeding-eggs from Bobwhite Quails were breeded in the test facility. All hatched birds were transferred in temperated breeding cages. Hatchlings were examined after hatching and periodically until used for tests. During the 14-day pre-test period they were observed daily on working days. All unsuitable birds (e.g., injured, deformed, etc.) were eliminated from inclusion in the test prior to assignment to test groups. Three days prior to test initiation 80 well developed birds were selected for randomized assignment to the exposure groups. No mortalities were noted during the three days immediately prior to test initiation.

Total exposure duration (if not single dose):

5 d

Post exposure observation period:

Following exposure, all groups were held for a 3-day observation period on untreated feed.

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

5 groups of 10 birds were exposed for 5 days to dietary concentrations of 625, 1250, 2500, 5000 or 10000 mg a.i./kg feed. Three additional groups of ten birds were similarly given untreated feed only and maintained as concomitant control.

Control animals:

yes

Nominal and measured doses / concentrations:

Nominal: Based on results from a range finding study the test substance nominal dietary concentrations were set at 625, 1250, 2500, 5000 and 10000 mg/kg feed.
Measured: 102 to 108 % of nominal concentrations

Duration (if not single dose):

5 d

Dose descriptor:

LC50

Effect level:

5 459 mg/kg diet

Conc. / dose based on:

act. ingr.

Basis for effect:

mortality

Duration (if not single dose):

5 d

Dose descriptor:

LOEC

Effect level:

2 500 mg/kg diet

Conc. / dose based on:

act. ingr.

Basis for effect:

signs of toxicity

Duration (if not single dose):

5 d

Dose descriptor:

NOEC

Effect level:

1 250 mg/kg diet

Conc. / dose based on:

act. ingr.

Basis for effect:

signs of toxicity

Repellency factors (if applicable):

During the 5-day exposure period, a dose-related reduction in feed intake was evident in groups treated with 2500, 5000 and 10000 mg a.i./kg diet. This reduced feed intake led to diminished body weight gain of the surviving birds from 10000, 5000 and 2500 mg a.i./kg diet treatment level. This growth depression could not be compensated by the surviving birds during the following 3-day observation period on untreated feed.

Mortality and sub-lethal effects:

Additionally mortalities and symptoms of intoxication (light apathy, loss of equilibrium) occurred during the first 24 hours in animals exposed to 5000 and 10000 mg a.i./kg diet. Likewise, animals exposed to 2500 mg a.i./kg diet suffered from symptoms of intoxication (apathy, loss of equilibrium), but none of them died. In the concentration levels <2500 mg a.i./kg diet, no visible signs of toxicity occurred.

Validity criteria fulfilled:

not specified

Conclusions:

Young (14 days old) Bobwhite Quail (Colinus virginianus) were used to evaluate the dietary toxicity of the test substance (97.2% active ingredient (a.i.)). 5 groups of 10 birds were exposed for 5 days to dietary concentrations of 625, 1250, 2500, 5000 or 10000 mg a.i./kg feed. All dose preparations were corrected to 100 % active ingredient. Three additional groups of ten birds were similarly given untreated feed only and maintained as concomitant control. Following exposure, all groups were held for a 3-day observation period on untreated feed.
Based on the results of this study, the subacute dietary LC50 of technical grade test substance (97.2 % a.i.) to Bobwhite Quail was determined to be 5459 mg a.i./kg feed. The lowest observed effect concentration (LOEC) was 2500 mg a.i./kg feed based on signs of intoxication (lying on side / tumbling). The no observed effect concentration (NOEC) was determined to be 1250 mg a.i./kg feed.

Reference 5

Endpoint:

short-term toxicity to birds: dietary toxicity test

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

11 - 19 Nov 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 205 (Avian Dietary Toxicity Test)

Qualifier:

according to guideline

Guideline:

EPA OPP 71-2 (Avian Dietary Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Dose method:

feed

Analytical monitoring:

yes

Details on preparation and analysis of diet:

The diet used for the study was a full value diet. The test compound was added in the respective amounts to a small quantity of the basal diet and premixed by a high-speed homogenizer. Subsequently, this premix was transferred into the 125 litre Lödige Mixer "MGT 125", the remaining aliquot of the test diet added and the food mixture agitated at 3000 UPM for five minutes. Peanut oil (2% per weight) was added to facilitate the homogeneous distribution of the test compound within the diet. The amount of diet required for the entire study was prepared in one batch and stored at -18°C in preweighed individual portions. Each day a freshly thawed portion was given to the birds.
Homogeneity of the test substance in the diet was evaluated by collecting three samples each from respective batches. Homogeneity samples were collected from the top, middle and bottom of the respective diet batch. Study-specific test substance concentrations in the test diets were verified by analyzing duplicate samples from the prepared batches.

Test organisms (species):

Anas platyrhynchos

Details on test organisms:

After arrival, eggs were candled for eggshell cracks and intact eggs placed into an incubator for 24 days. On day 24, eggs were placed into a hatcher and allowed to hatch. When hatched, ducklings were placed into the test cages to get acclimatized to testing conditions. For identification, they were marked by colour-coded leg bands with individual numbers.

Total exposure duration (if not single dose):

5 d

Post exposure observation period:

Exposure was followed by a subsequent 3-day observation period on untreated feed.

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

Young mallard ducks (10-day-old chicks, 10 per diet group; two controls) were exposed for 5 days.

Control animals:

yes

Nominal and measured doses / concentrations:

Nominal: 0, 313, 625, 1250, 2500 and 5000 ppm mg a.i./kg feed
Measured: The analytically determined test concentrations were well within the requested range of 80 to 120 % of the nominal values.

Duration (if not single dose):

5 d

Dose descriptor:

LC50

Effect level:

> 5 000 mg/kg diet

Conc. / dose based on:

act. ingr.

Basis for effect:

mortality

Repellency factors (if applicable):

Exposure to contaminated food also caused chicks to reduce feed consumption in all treatment groups > 625 mg a.i./kg feed. Thus, an aversive response may be exerted by the test substance to birds.

Mortality and sub-lethal effects:

There were no treatment related mortalities at any test concentration. At test concentrations > 625 mg a.i./kg feed, some chicks exhibited signs of intoxication (discoordinated movements, narcotic effects) which, however, were fully reversible within the study period.

Validity criteria fulfilled:

not specified

Conclusions:

Young mallard ducks (10-day-old chicks, 10 per diet group; two controls) were exposed for 5 days to dietary concentrations of 0, 313, 625, 1250, 2500 and 5000 mg a.i./kg feed; exposure was followed by a subsequent 3-day observation period on untreated feed.
There were no treatment related mortalities at any test concentration. At test concentrations >625 mg a.i./kg feed, some chicks exhibited signs of intoxication (discoordinated movements, narcotic effects) which, however, were fully reversible within the study period. Exposure to contaminated food also caused chicks to reduce feed consumption in all treatment groups > 625 mg a.i./kg feed. Thus, an aversive response may be exerted by the test substance to birds.

Reference 6

Endpoint:

long-term toxicity to birds: reproduction test

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

07 Jul - 18 Sep 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 206 (Avian Reproduction Test)

Version / remarks:

Draft version from 08/95

GLP compliance:

yes (incl. QA statement)

Dose method:

feed

Analytical monitoring:

yes

Vehicle:

no

Details on preparation and analysis of diet:

The test compound was added in the respective amounts to a small quantity of the basal diet and premixed by a high-speed homogenizes Subsequently, this premix was transferred into the 125 litre Lödige Mixer "MGT 125", the remaining aliquot of the test diet added and agitated at 3000 UPM for five minutes. No carrier material was used.

Test organisms (species):

Coturnix coturnix japonica

Details on test organisms:

Pen-reared 9 weeks old Japanese quail (Coturnix coturnix japonica), that were apparently healthy and phenotypically indistinguishable from wild birds, were obtained from Geflügelzucht H. u. E. Küberich, Rüdenerstr. 11, D - 97353 Geesdorf. All birds were from the same hatch. They were approaching their first breeding season and had not been used in previous testing. Two weeks prior to the beginning of the egg-laying stabilization period, all birds were examined for physical injuries and general health. Birds that were injured or did not appear healthy were discarded. 160 well-developed birds were selected from the remaining individuals for randomized assignment to the exposure groups.

Total exposure duration (if not single dose):

6 wk

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

Each group consisted of 18-19 breeding pairs and received nominal dietary concentrations of the test substance.

Control animals:

yes

Nominal and measured doses / concentrations:

Nominal: 60, 173 or 500 ppm
Measured: The analytically determined test concentrations were well within the requested range of 80 to 120% of the nominal values.

Duration (if not single dose):

6 wk

Dose descriptor:

NOEC

Effect level:

157 mg/kg diet

Conc. / dose based on:

act. ingr.

Remarks:

measured concentration

Basis for effect:

reproductive parameters

Repellency factors (if applicable):

Feed consumption rates, body mass at study termination, and fresh masses of liver (both sexes) and heart (females only) of the parental birds were statistically significantly lower in the 500 ppm treatment group relative to the control group.

Mortality and sub-lethal effects:

There were no treatment-related mortalities or overt signs of toxicity with either the parental birds or their offsprings.

Effects on reproduction:

None of the examined reproductive parameters was adversely affected in any treatment group compared with the control birds. However, there was a significantly lower average body mass of the 14-day surviving chicks from the 500 ppm treatment group when compared with the controls.

Validity criteria fulfilled:

not specified

Conclusions:

Under laboratory conditions, the test substance was administered in the diet to three groups of sexually mature Japanese quail (17 weeks old at test initiation) which approached their first breeding season. Each group consisted of 18-19 breeding pairs and received nominal dietary concentrations of the test substance of either 60, 173 or 500 ppm over a period of 6 weeks. A control group of 18 breeding pairs was maintained concurrently with the treatment groups.
There were no treatment-related mortalities or overt signs of toxicity with either the parental birds or their offsprings. Feed consumption rates, body mass at study termination, and fresh masses of liver (both sexes) and heart (females only) of the parental birds were statistically significantly lower in the 500 ppm treatment group relative to the control group. None of the examined reproductive parameters was adversely affected in any treatment group compared with the control birds. However, there was a significantly lower average body mass of the 14-day surviving chicks from the 500 ppm treatment group when compared with the controls. Based on statistical analyses, the chronic no-observed-effect concentration of the test substance for Japanese Quail is 157 mg a.i./kg food.

Description of key information

NOEC (21 wk): 47.6 mg/kg diet (Anas platyrhynchos, EPA OPP 71-4)

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for birds:

47.6 mg/kg food

Additional information

Several studies are available assesing the toxicity of 3-(2-chlor-5-pyridyl-methyl)-cyanimino-1,3-thiazolidin on birds.

The key study, which was performed according to FIFRA guideline 71-4, ASTM Standard E 1062-86, determined effects on reproduction to Mallard duck (Anas platyrhynchos).

The test item was administered in the diet to three groups of sexually mature Mallard ducks, which approached their first breeding season. Each group consisted of 15 breeding pairs and received nominal dietary concentrations of either 0, 60, 173 or 500 ppm over a period of 20 weeks (measured concentrations: 47.6, 140 and 418 ppm). Adults were observed daily for mortality, abnormal behavior, and signs of toxicity. Adult body weight was measured at test initiation, on the first day of weeks 3, 5, 7 and 9, and at adult sacrifice. Feed consumption was measured weekly for each pen for a seven day period. Necropsies were performed on all adults at the top dose and at least 4 males and 4 females of the remaining treatment groups including the control. In addition, effects upon egg production and quality, and hatchling health and survivability were examined. No overt signs of intoxication were observed during the study in any test group. Statistical analyses of body mass of females revealed significant differences at the 140 and 418 ppm the treatment groups at adult sacrifice. Additionally, male body weight gain at 140 ppm was statistically significantly lower than the control. Food consumption was not significantly different from the control at any treatment level. There were no statistically significant treatment related effects upon any of the reproductive parameters measured except for 14-d survivor chick weight. Based on these findings the NOEC of parental toxicity was established at 47.6 ppm (3.75 mg a.i./kg bw/d).

In a further GLP and guideline study, following OECD Guideline 205 (Avian Dietary Toxicity Test), 14 days old Japanese Quail (Coturnix coturnix japonica) were used to evaluate the dietary toxicity of the test substance. After exposure of 5 days to dietary concentrations of 625, 1250, 2500, 5000 or 10000 mg a.i./kg feed (ppm) all groups were held for a 3-day observation period on untreated feed. The subacute dietary LC50 (50 d) of the test substance to Japanese Quail was determined to be 2500 mg a.i./kg feed.

In another experimental study, performed according to GLP and OECD Guideline 205 (Avian Dietary Toxicity Test), young mallard ducks (A. platyrhynchos, 10-day-old chicks, 10 per diet group; two controls) were exposed for 5 days to dietary concentrations of 0, 313, 625, 1250, 2500 and 5000 mg a.i./kg feed. The exposure was followed by a subsequent 3-day observation period on untreated feed. There were no treatment related mortalities at any test concentration. At test concentrations > 625 mg a.i./kg feed, some chicks exhibited signs of intoxication (discoordinated movements, narcotic effects) which, however, were fully reversible within the study period.

In a further study performed according to OECD 205, 14 days old Bobwhite Quail (Colinus virginianus) were used to evaluate the dietary toxicity of the test substance after 5 days of exposure. The subacute dietary LC50 of the test substance was determined to be 5459 mg a.i./kg feed. The NOEC was determined to be 1250 mg a.i./kg feed.

In a study performed according to GLP and OECD Guideline 206, birds were exposed to the test substance for 23 weeks. Groups of 20 pairs of sexually mature Northern bobwhite (25 weeks old at test initiation) received the test substance at nominal dietary concentrations of 60, 173 and 500 ppm a.i.. A control group was maintained concurrently with the treatment groups. There were no treatment related mortalities, overt signs of toxicity or treatment related effects in body mass or reproductive parameters at any test concentration. The NOEC (23 w) was determined as 466 ppm a.i..

Additionally a study following GLP and OECD Draft Guideline for Testing of Chemicals: Avian Reproduction Test is available. The test substance was administered in the diet to sexually mature Japanese quail (Coturnix coturnix japonica). Each group received nominal dietary concentrations of the test substance of either 60, 173 or 500 ppm over a period of 6 weeks. There were no treatment-related mortalities or overt signs of toxicity with either the parental birds or their offsprings. The NOEC (6 wk) of the test substance was determined as 157 mg a.i./kg food.