polymeric zinc propylenebis(dithiocarbamate);propineb (ISO)

Toxicity to birds

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to birds: reproduction test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013/07/22 to 2013/10/21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 206 (Avian Reproduction Test)

Version / remarks:

1984

Deviations:

yes

Remarks:

Exposure to contaminated diet were only 13 weeks and not =20 weeks.

GLP compliance:

yes (incl. QA statement)

Dose method:

feed

Analytical monitoring:

yes

Remarks:

Diet samples were taken from the top, middle and bottom of each batch, and kept deep-frozen at the analytical test site until analysis. Measured concentrations of propineb throughout the whole study ranged 88 to 110% of the nominal concentrations.

Vehicle:

no

Details on preparation and analysis of diet:

First, the control diet (= S5677-S090) that is identical with the standard feed V6120 (Japanese quail, layer) has been produced from a basal layer mixture, vitamin and trace element pre-mixture, wheat and soybean oil. This basal diet (= S5677-S090) has then be used for the preparation of the test compound diets. The test compound diets were always produced in the same sequence, i.e. (i) S5677-P201, (ii) S5677-P203, (iii) S5677-P205. For the preparation of the test compound diets pre-mixtures (1% in the final diet, i.e. 0.54 and 0.42 kg, respectively) were produced by mixing an aliquot of the basal diet with respective amount of the Propineb technical. These pre-mixtures were then mixed with the remaining 99% (53.46 and 41.58 kg, respectively) of the basal diet. Samples were taken for the homogeneity test directly out of the mixer (3 samples each from top, middle and bottom) 1 sample from outlet.
After the mixing and sampling procedure, the diets were immediately packed in 6 kg polyethylene bags. Deviations of the determined concentrations from the nominal concentrations were small (89 - 110% of nominal) for all three concentration levels. Homogeneity was given for all batches (top, middle, bottom and outlet) with a relative standard deviation of <6%.

Test organisms (species):

Coturnix coturnix japonica

Details on test organisms:

each individual was 9 weeks old at the beginning of the treatment.
males 149 – 247 g (mean: 204.6, SD: 18.23) mean bodyweight
females 189 – 315 g (mean: 252.8 g, SD: 26.01) mean bodyweight

Birds were housed indoors by pairs (one male + one female) in pens, using special bedding (made from zeolit) for bath and for comfortable condition for the birds.

Limit test:

no

Total exposure duration (if not single dose):

13 wk

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

20 / sex / dose

Nominal and measured doses / concentrations:

Nominal concentrations: 250, 400 and 550 ppm as propineb, Mean daily consumptions of a.s.: 27.9, 45.5 and 64.7 mg a.s./kg bw/day

Details on test conditions:

Each pen consisted of one male and one female. After 2 weeks of treatment birds were induced, by photoperiod manipulation, to start laying eggs. Eggs were collected over a ten-week period, artificially incubated and hatched, and the young maintained for 14 days.

Throughout the study, all birds were housed indoors by pairs (one male + one female) in pens. Each pen has floor space with 1.2 m2. External walls, ceiling and floors are constructed of stainless steel.

Adult birds were maintained with good ventilation at temperature of 18.99 - 25.01°C and 41.98 to 81.41 per cent relative humidity. The minimum and maximum values of the relative humidity were out of the recommended range (50 - 75%), but this minor deviation did not affect the quality of the study.

Birds were held under short-day conditions (seven to eight hours light per day) for the first 2 weeks under the acclimatization period with untreated diet. Then, treated diet was given over 2 weeks under short-day conditions. Then, light regime was lengthened to 16-18 hours of light in the third week of treatment. The birds were then fed treated diet over 10 weeks of egg laying. Lighting was artificial, minimum 10 lux at the feeder of birds. The light intensity was measured and recorded before the experiment.

The Hatchlings were kept indoors in covered brooder pens, separated by dose levels. Each brooder pen has floor space that measures 1.5 X 1.0 m. External walls, ceiling and floors are constructed of galvanised wire and stainless steel. As litter Lignocel Hygienic Animal Bedding produced by J. Rettenmaier & Söhne GmbH+Co.KG (Holzmühle 1, D-73494 Rosenberg, Germany) were used. Temperature in the brooder pens was between 35.0 – 37.8°C (first week) and between 30.1- 32.9°C (second week) with relative humidity 50 - 66%.

The maximum value of the temperature (second week) was above the recommended value (32°C), but this minor deviation not affected the quality of the study. Photoperiod was 12-14 hours of light per day. The environmental conditions (temperature, humidity) of the animal room were recorded twice daily.

Details on examinations and observations:

In adults: body weight, food consumption, pathological changes were all measured

For egg parameter: eggs laid, eggshell thickness, eggs cracked/broken, egg weight, egg
fertility, viability and embryonic death were all measured

For offspring parameters: number and body weight of hatchlings and of 14-day old
survivors, food consumption and general state of health were all recorded

Reference substance (positive control):

no

Key result

Duration (if not single dose):

13 wk

Dose descriptor:

NOEC

Effect level:

64.7 mg/kg bw/day

Conc. / dose based on:

test mat.

Basis for effect:

reproductive parameters

Mortality and sub-lethal effects:

One animal died in the control (6166, female), and two animals died in the highest dose group (6018, male and 6181, female). In the case where one member of a pair died during the treatment period, the other member of the pair was also euthanized.

As the mortality in the controls did not exceed 10 per cent at the end of the test (there was only one dead bird), the validity criterion was met. No mortality or clinical signs considered related to test item exposure were observed during the study.

Effects on reproduction:

Significant differences could not be noted when compared to the control. Exposure to the test item had no effect on egg-laying of the birds.

No treatment related egg weight differences could be noted during the experiment.

No test item related changes were observed in the percentage number of abnormal eggs of test groups compared to the control group. Rate of abnormal eggs per hen in the test groups was similar to the control. There was no concentration related effect.

Significant differences were observed between the exposed and control groups in the test item treatment period regarding percentage of viable embryos of eggs. However these deviations were in positive direction, and therefore not considered as adverse effect from treatment with test item.

Statistically significant differences were observed between the exposed and control groups in the test item treatment period in regards to the percentage hatchlings of eggs. However these deviations were in positive direction, and therefore not considered as adverse effect from treatment with test item.

Further details on results:

Initial hatchling mean body weight in the test groups was similar to the control. There
was no concentration related effect. Mean body weight of the 14-d survivors was below the control value in the mid dose group, while it was above control in the low and in the high dose groups.

No test item related differences were observed in food consumption between the hatchlings of exposed and control groups during observation period.

 

Table one

 

Overall reproduction results after 10 weeks of egg-laying

Overall result after 10 weeks	Experimental group dose (ppm pure a.s)
reproductive parameter	control	250	400	550
Number of hen (cage)	20	19	19	17
Eggs laid per hen	63	64	64	59
Eggs abnormal per hen	3.65	3.42	3.74	3.00
Eggs not abnormal / eggs laid (%)	94.3	94.7	94.1	94.9
Eggs set per hen	56	57	57	53
Eggs set / eggs laid (%)	88.5	89.2	89.0	89.4
Egg Weight (g)	12.82	12.70	12.93	12.67
Viable embryo per hen	52.7	55.1	54.4	50.2
Viable embryos/eggs set (%)	94.3	96.6*	95.7*	94.8*
Live embryos per hen	51.3	54.4	53.9	48.9
Live embryos/viable embryos (%)	97.3	98.9	99.0	97.3
Hatchlings per hen	48.6	52.8*	51.6*	46.2
Initial hatchling body weight (g)	8.96	8.93	9.09	8.93
Survior Hatchling body weight (g)	60.25	62.36*	55.48*	68.13*
Hatchling survivor per hen	37.7	38.0	43.5	37.5
Hatchlings/eggs laid (%)	76.9	82.6	80.8	78.0
Hatchlings/live embryos (%)	94.6	96.9	95.7	94.6
Hatchlings/eggs set (%)	86.9	92.5	90.7	87.2
Hatchlings survival/ no. hatched (%)	77.7	72.0	84.4	81.2
Eggshell thickness (mean) (mm)	0.205	0.203	0.203	0.196

*: statistically significant difference, not considered adverse / treatment related

Validity criteria fulfilled:

yes

Conclusions:

The objective of the study was to investigate the effect of dietary exposure of propineb on Japanese quail's reproduction according to OECD No. 206. Birds were fed a diet containing the test item in concentrations of 0, 250, 400 or 550 ppm, for a period of 13 weeks. In conclusion, under the conditions of this study NOEC of Propineb administered in diet to Japanese quails in 13-weeks exposure is considered to be 550 ppm Propineb pure active substance, corresponding to an achieved daily dietary dose of 64.7 mg a.s./kg bw/d.

Executive summary:

The objective of the study was to investigate the effect of dietary exposure of propineb on Japanese quail's reproduction according to OECD No. 206 (adopted 04 April 1984).

Birds were fed a diet containing the test item in concentrations of 0, 250, 400 or 550 ppm, for a period of 13 weeks.

No mortality or clinical signs considered related to test item was observed during the study. There were no test item related effects on body weight and body weight gain or food consumption. There were no test item related adverse effects in reproduction parameters (eggs laid, viability, hatchability, eggs cracked/broken, egg mass, eggshell thickness and effects on young birds) at any dose level.

NOEC was determined to be 64.7 mg a.s/kg bw/d.

Description of key information

The objective of the study was to investigate the effect of dietary exposure of propineb on Japanese quail's reproduction according to OECD No. 206 (adopted 04 April 1984).

Birds were fed a diet containing the test item in concentrations of 0, 250, 400 or 550 ppm, for a period of 13 weeks.

No mortality or clinical signs considered related to test item was observed during the study. There were no test item related effects on body weight and body weight gain or food consumption. There were no test item related adverse effects in reproduction parameters (eggs laid, viability, hatchability, eggs cracked/broken, egg mass, eggshell thickness and effects on young birds) at any dose level.

The NOEC was determined to be 64.7 mg a.s/kg bw/d.

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for birds:

64.7 mg/kg bw/day