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EC number: 410-690-9 | CAS number: 103055-07-8 CGA 184699
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- Endpoint summary
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- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to birds
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to birds: reproduction test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Aug 1993 to 4 Mar 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 71-4 (Avian Reproduction Test)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Dose method:
- feed
- Analytical monitoring:
- yes
- Vehicle:
- yes
- Remarks:
- feed
- Details on preparation and analysis of diet:
- It was not necessary to use a vehicle in the incorporation of test substance in the diet. A premix of suitable strength was prepared weekly by mixing the required quantity of test substance with untreated basal diet. Blending of the premix was achieved by mixing in a mixer for a minimum period of 5 minutes. The required concentrations were prepared by direct dilution of the prepared premix. Blending of the inclusion levels for feeding was achieved by mixing in a Gardner double-cone blender for a minimum period of 7 minutes.
Prior to the start of the main study, samples were taken from a trial mix to determine stability and homogeneity of the test substance in SDS layer diet at 200 and 600 ppm. Samples were taken from the top, middle and bottom of the mix for analysis of homogeneity. Additional samples were taken to determine the stability of the test substance in avian diet over 0, 8 and 16 days under animal room conditions. Results from the trial mix indicated that the test substance was stable in avian diet under normal animal room conditions for up to 16 days. A 200 g random sample was taken at the time of mixing from each dietary level prepared for Weeks 1, 12 and 22 for analysis of active ingredient content. All samples were sent for analysis. - Test organisms (species):
- Colinus virginianus
- Details on test organisms:
- TEST ORGANISM
- Common name: Bobwhite quail
- Supplier culture condition: The Supplier had maintained the birds on deep litter under a photoperiod of 7 hours light : 17 hours darkness and reported no health problems. On arrival at the test facility the birds received a routine course of antibiotic.
- Age at test initiation: Approximately 11 months old (were approaching their first reproductive season.)
- Weight at test initiation: 169 - 228 g
- Sexes used / mixed or single sex: mix
- Disease free: Yes (All birds were in apparent good health at the start of the pre—treatment period) - Limit test:
- no
- Total exposure duration (if not single dose):
- 23 wk
- Remarks:
- 11 weeks pre-egg laying period and 12 weeks egg production period
- No. of animals per sex per dose and/or stage:
- 1 male and 1 female / replicate
- Control animals:
- yes, plain diet
- Nominal and measured doses / concentrations:
- - Norminal concentrations: 0 (control), 200, 400 and 600 mg/kg diet
- Details on test conditions:
- PEN SIZE AND CONSTRUCTION MATERIALS
- Description: The birds were housed in 5 batteries of cages, each battery consisting of 4 tiers of 4 cages. Each cage, was constructed of polythene coated steel wire and measured approximately 0.31 x 0.39 x 0.24 m.
- Floor covering: The cages had sloping floors with 0.1 m egg-catchers, and had externally attached food hoppers and automatic drinkers.
- Compliant to good husbandry practices: Yes
- Suitable to avoid crowding stress: Yes
- Caging: Group (1 male and 1 female)
NO. OF BIRDS PER REPLICATES
- For negative control: 1 male and 1 female
- For vehicle control: 1 male and 1 female
- For treated: 1 male and 1 female
NO. OF REPLICATES PER GROUP
- For negative control: 20
- For vehicle control: 20
- For treated: 20
TEST CONDITIONS
- Room temperature: 18 - 21˚C
- Relative humidity (%): 44
- Photoperiod: 7 hours light : 17 hours darkness (from arrival until the beginning of Week 6); The photoperiod was then increased to
16 hours and remained so until the end of egg production.
- Light intensity: 60 to 150 lux (6 to 14 foot candles)
- Feeding: The basal diet used was avian layer diet. The diet was known to contain no added antibiotics or other non-nutritional feed additives.was available ad libitum throughout the study. Domestic quality potable water (Anglian Water) was available ad libitum at all times.
RANGE FINDING STUDY
Dose levels were selected on the basis of known residue levels in crops and on a preliminary study conducted between May and June 1993.
- Test concentrations: 0, 50, 200 and 400 ppm
- Test conditions: Fifteen male and fifteen female adult Bobwhite quail were used, including spare birds for possible
replacements during the pre-treatment period. The birds were housed in in treatment replicate groups of one male and one female bird, in polythene coated steel wire tiered cages measuring approximately 0.31 x 0.39 x 0.24 m. Each cage had an externally attached food hopper and an automatic drinker. The room in which the birds were housed was designed to provide suitable environmental conditions for the species. Ventilation fans were adjusted as required. A photoperiod of 16 hours was adopted. The mean maximum and minimum temperatures of the animal room were 25°C and 21 °C respectively and the mean daily relative humidity value was 67 %. Birds were given basal (untreated) diet during the 14-day pre-treatment period, and basal diet (Control) or treated diet during the treatment period. The test substance was given via the diet for 4 weeks following a 14-day acclimatisation period.
- Results used to determine the conditions for the definitive study: There were no mortalities and all birds remained in good health throughout the study. Bodyweight changes were similar in all groups and there was no evidence of any treatment-related effect. Food consumption was similar in all groups and there was no evidence of any treatment-related effect. It was concluded that dietary administration of up to 400 ppm the test substance over a period of four weeks had no effect on health, bodyweights or food consumption of adult Bobwhite quail. - Details on examinations and observations:
- MORTALITY / CLINICAL SIGNS
Adult birds and chicks were observed daily for mortalities and clinical signs. Individual adult bodyweights were recorded in Weeks -2, 0 (immediately prior to the introduction of test diets), 2, 4, 6, 8 and at termination, Week 23.
BODY WEIGHT
Individual chick bodyweights were recorded within 24 hours of hatching and again after 14 days.
FOOD CONSUMPTION
Food consumption for each replicate was recorded weekly throughout the pre-treatment and treatment periods of the adult phase.
OTHER: All sporadic mortalities were subjected to a macroscopic external and internal examination. At termination all adult birds were examined following sacrifice by cervical dislocation. Chicks were not examined post mortem at termination of 14 days observation. - Details on reproductive parameters:
- The following parameters were examined per week, except for egg shell thickness which was recorded on alternate weeks.
- Eggs laid : Eggs were collected and the number recorded daily for each pen over the 12-week egg production period from the start of Week 12 to the end of Week 23. Each egg was labelled with the study schedule number, replicate number and treatment group, together with the date of collection. The eggs were then stored on plastic egg trays in a refrigerator which was set to run at 16 ˚C. At the end of each 7-day period the eggs were removed from the refrigerator and allowed to reach room temperature for at least 12 hours prior to incubation.
- Eggs cracked; eggs broken : Each egg was candled and any broken or cracked eggs were recorded and discarded. The remaining eggs (except those for shell thickness measurement) were incubated.
- Eggshell thickness: Eggs laid on the first days of Weeks 12, 14, 16, 18, 20 and 22 in each replicate were removed for shell thickness measurement. The eggs were cracked open at the widest point and the contents washed out with tap water. The shells were then left to dry at room temperature for a minimum of 48 hours. The shell thickness of each egg was measured at 4 points around the circumference using a micrometer calibrated to 0.01 mm.
- Eggs incubation: Eggs were incubated in an incubator for 21 days prior to transferring to a hatcher. The incubator was set to run at 37.7°C and 55% relative humidity. The eggs were turned automatically once every hour through 90° each side of the vertical throughout the incubation period. Eggs were candled for cracks prior to incubation and again on Days 11 and 18 of the incubation period. At Day 11 all infertile eggs and eggs showing early embryonic death were identified, recorded and discarded. On Day 18 all late embryonic mortalities were similarly discarded. Early and late embryonic mortalities were recorded on the basis of candling only and internal examination was carried out only if the candling result was ambiguous.
- Normal hatchlings : After 21 days incubation, the eggs were transferred to a still air hatcher which was set to run at a temperature of 37.5 ˚C. The eggs were placed on wire mesh trays and separated according to replicate. All chicks which hatched were removed and transferred to floor pens within 24 hours of hatching. Any unhatched eggs remaining after 3 days were classed as dead in shell, with a record being made of whether or not the shells had been pipped.
- Chicks : On removal from the hatcher, chicks were individually weighed and identified by coloured plastic leg bands. Each was allocated a separate series of numbers with letter suffix, and each chick had a unique identification comprising colour code, number and letter suffix. The chicks were housed in wooden box floor pens according to the week of hatch. Each box contained a low level feeder and a drinking fount supplied with domestic quality tap water. Bedding consisted of wood shavings from an approved source. A heat lamp was suspended over each box to provide additional heat. Ventilation fans were adjusted as required and a 14-hour photoperiod was adopted. The mean maximum and minimum temperatures in the animal room were 30°C and 24°C respectively and the mean daily relative was 57%. All chicks were fed standard HRC chick diet in meal or crumb form. Food and water were available ad libitum. At the end of the l4-day observation period, chicks were killed by carbon dioxide asphyxiation.
- Reference substance (positive control):
- no
- Key result
- Duration (if not single dose):
- 23 wk
- Dose descriptor:
- NOEC
- Effect level:
- 200 mg/kg diet
- Conc. / dose based on:
- act. ingr.
- Basis for effect:
- reproductive parameters
- Remarks on result:
- other: equivalent to a daily dietary dose of 19.9 mg/kg bw/day
- Mortality and sub-lethal effects:
- An overview of the results is provided in Table 1 – Table 10 in ‘Any other information on results incl. tables’
- Adult clinical observations and mortalities: There was no evidence of any treatment-related signs of toxicity. A small number of mortalities occurred in each group, and there was no evidence of any treatment-related effect. Several birds were observed to have cut heads during the study; this, together with cut feet, was related to the long-term housing of birds in cages.
- Adult body weight: Bodyweights were similar in all groups throughout the study. Statistical analysis revealed no significant treatment-related effects.
- Adult food consumption: Food consumption was similar in all groups and there was no evidence of any treatment-related effect. Statistical analysis revealed no significant differences between control and treated groups.
- Microscopic post mortem examination: Some post mortem observations were related to long-term housing in cages. None of the observations was considered to be related to treatment.
- Chick body weight: Mean chick bodyweights at hatching were slightly reduced in Groups 3 and 4 (400 and 600 ppm test substance) compared with control values. Statistical analysis revealed these reductions to be significant (P <0.01). Mean 14-day bodyweights were similar in all groups and there was no evidence of any treatment- related effects. This was supported by statistical analysis.
- Chick health and mortality: Although a large number of treatment-related mortalities occurred, all chicks appeared normal at hatching and no clinical signs of toxicity were observed during the 14-day observation period. At post mortem examination, a small proportion of chicks was observed to have been peeked by other birds. In addition, two birds from the Week 18 hatch were observed to have swollen eyes. None of these observations was considered to be related to treatment. - Effects on reproduction:
- An overview of the results is provided in Table 1 – Table 10 in ‘Any other information on results incl. tables’
- Number of eggs laid: The number of eggs laid was slightly reduced in Groups 3 and 4 (400 and 600 ppm the test substance) relative to control values. However, statistical analysis revealed no significant treatment-related effects.
- Number of cracked eggs: The proportion of cracked eggs of eggs laid was variable and there was no evidence of any treatment-related effect. This was supported by statistical analysis.
- Egg shell thickness: Egg shell thickness was similar in all groups and there was no evidence of any treatment-related effect. This was supported by statistical analysis.
- Candling: The proportion of viable embryos (fertile eggs) of eggs set initially was slightly reduced in Group 4 (600 ppm test substance) relative to the control. However, statistical analysis revealed no significant treatment-related effects. The proportions of live 3-week embryos of viable embryos were similar in all groups. Statistical analysis revealed no significant differences between control and treated group.
- Hatching: The proportion of normal hatchlings of viable embryos was slightly reduced in all groups relative to control values. The proportion of normal hatchlings of live 3-week embryos was slightly reduced in Groups 3 and 4 (400 and 600 ppm the test substance) relative to control values. However, statistical analysis of these parameters revealed no significant treatment-related effects.
- 14-day survivors: The proportion of 14-day survivors of eggs laid was slightly reduced in all treated groups as compared with the control. However, statistical analysis showed this decrease to be significant only in Group 4 (600 ppm test substance; P <0.01). The proportion of 14-day survivors of normal hatchlings also appeared slightly reduced in all treated groups. Statistical analysis revealed this decrease to be significant in Groups 3 and 4 (400 and 600 ppm test substance; P <0.01) The number of 14-day survivors per adult female also appeared slightly reduced in all treated groups. However, statistical analysis revealed no significant treatment-related effects. - Reported statistics and error estimates:
- Analyses of variance were carried out on the data; factors in the analyses were: (i) treatment (the main component of interest); (ii) position (batteries, and rows by columns within batteries). Williams' test for contrasting increasing dose levels of a compound with a zero dose control was used to compare the treated groups with the control. Significant differences are indicated in the Tables using the conventional asterisk notation: * P < 0.05; ** P < 0.01.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a reproduction toxicity study in birds, performed with Bobwhite quail and in accordance with EPA 71-4 guideline, the 23-wk NOEC was determined to be 200 mg/kg diet, equivalent to a daily dietary dose of 19.9 mg/kg bw/day.
- Executive summary:
The effects of dietary administration of the test substance on reproduction in the Bobwhite quail (Colinus virginianus). The study was performed according to EPA guideline 71-4 and in compliance with GLP criteria. Three treated groups of 20 replicates, each of one male and one female, were offered test diet containing 200, 400 and 600 mg a.s./kg over a period of 23 weeks (for 11 weeks prior to the start of egg production and during 12 weeks of egg production). A similar sized control group was given untreated diet only. The birds (approximately 11 months old) were housed in 5 batteries of cages, each battery consisting of 4 tiers of 4 cages. Each cage had an externally attached food hopper and automatic drinker. The mean temperature and humidity (measured once daily) in the test room were 18 – 21 ˚C and 44%, respectively. An artificial light photoperiod of 7 hours daily was provided until the end of week 6, when the photoperiod was increased to 16 hours daily (light intensity range 60 to 150 lux). The test birds were fed ad libitum with a layer diet (treated or untreated) and water. Eggs were collected and recorded daily for each pen over the 12-week egg production period. The eggs were labelled and then stored on plastic egg trays at 16˚C. At the end of each 7-day period the eggs were removed and allowed to reach room temperature for at least 12 hours before being candled. Any broken or cracked eggs were recorded and discarded; the remaining eggs (except those removed for shell thickness measurement) were incubated. Eggs were incubated for 21 days at nominal 37.7°C and 55% RH. The eggs were automatically turned once every hour through 90˚each side of vertical. After 21 days the eggs were transferred to a hatcher. All eggs laid on the first day of weeks 12, 14, 16, 18, 20 and 22 in each replicate were removed for shell thickness examination. The eggs were cracked open at the widest point and the contents washed out. The shells were then left to dry at room temperature for at least 48 hours. The shell thickness of each egg was measured at four points around the circumference using a micrometre. Eggs were candled for cracks prior to incubation and then on days 11 and 18 of the incubation period. At day 11, all infertile eggs and eggs showing early embryonic death were recorded and removed. At day 18, late embryonic deaths were recorded and removed. After 21 days incubation, the eggs were transferred to a hatcher set at 37.5 ˚C. All chicks that hatched were removed within 24 hours of hatching and transferred to floor pens. Any eggs remaining unhatched after 3 days were classified as “dead in shell”. Adult birds and chicks were observed daily for mortalities and clinical signs. Individual adult bodyweights were recorded on weeks -2, 0 (immediately before introduction of the test diets), 2, 4, 6, 8 and 23 (termination of test). Food consumption for each replicate was recorded weekly during the adult phase. Individual chick bodyweights were recorded within 24 hours of hatching and again after 14 days. All data relating to food consumption, eggs and chicks were collated over weekly intervals, except for eggshell thickness, which was recorded on alternate weeks. All sporadic mortalities were subjected to a macroscopic external and internal examination. At termination, all adult birds were sacrificed and examined. Ducklings were not examined post-mortem.
Dietary administration of 200 mg/kg diet test substance to adult Bobwhite quail had no effect on adult birds or their reproductive performance. At 400 mg/kg diet, there was a reduction in the number of chicks surviving to 14 days as a proportion of normal hatchlings (P <0.01). Additionally, chicks were lighter in weight at hatching. At 600 mg/kg diet, there was a reduction in the number of chicks surviving to 14 days both as a proportion of normal hatchlings (P <0.01) and as a proportion of eggs laid (P <0.01). Additionally, chicks were lighter in weight at hatching. Based on this information, the NOEC was determined to be 200 mg/kg diet, equivalent to a daily dietary dose of 19.9 mg/kg bw/day.
Reference
Table 1. Mean bodyweights (g) adult birds
|
|
Week of study |
||||||
Dose (ppm) |
Sex |
-2 |
0 |
2 |
4 |
6 |
8 |
23 |
0 (control) |
M |
193 |
187 |
186 |
187 |
187 |
186 |
193 |
F |
189 |
184 |
184 |
186 |
189 |
201 |
207 |
|
200 |
M |
188 |
185 |
187 |
189 |
192 |
192 |
197 |
F |
188 |
184 |
188 |
187 |
186 |
197 |
204 |
|
400 |
M |
196 |
189 |
191 |
191 |
191 |
191 |
195 |
F |
190 |
187 |
186 |
188 |
186 |
190 |
202 |
|
600 |
M |
192 |
184 |
186 |
187 |
186 |
187 |
187 |
F |
184 |
181 |
184 |
188 |
188 |
194 |
207 |
Table 2. Mean weekly food consumption (g/bird/day)
Dose (ppm) |
Week of study (Pre-egg production) |
||||||||||||
|
-2 |
-1 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
9 |
10 |
11 |
0 (control) |
10 |
13 |
13 |
14 |
|
|
14 |
16 |
16 |
17 |
19 |
19 |
20 |
200 |
10 |
13 |
13 |
14 |
13 |
13 |
13 |
15 |
16 |
16 |
18 |
18 |
19 |
400 |
11 |
12 |
13 |
14 |
13 |
14 |
14 |
15 |
16 |
16 |
17 |
18 |
18 |
600 |
11 |
14 |
14 |
15 |
15 |
15 |
15 |
15 |
16 |
16 |
18 |
19 |
19 |
Dose (ppm) |
Week of study (egg production) |
Mean weeks 1 - 23 |
||||||||||||
|
|
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
22 |
23 |
|
0 (control) |
1 |
21 |
21 |
22 |
22 |
23 |
23 |
23 |
22 |
22 |
22 |
22 |
22 |
19 |
200 |
2 |
20 |
20 |
21 |
22 |
22 |
23 |
23 |
21 |
22 |
22 |
22 |
22 |
19 |
400 |
3 |
19 |
20 |
21 |
22 |
21 |
22 |
22 |
21 |
22 |
22 |
22 |
22 |
18 |
600 |
4 |
20 |
20 |
21 |
23 |
22 |
23 |
23 |
22 |
23 |
23 |
22 |
22 |
19 |
Table 3. Number of eggs laid
Parameter |
Dose (ppm) |
Week of study |
Total |
|||||||||||
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
22 |
23 |
|||
Number of eggs laid
|
0 (control) |
37 |
45 |
57 |
46 |
62 |
77 |
72 |
57 |
57 |
58 |
53 |
46 |
667 |
200 |
27 |
45 |
57 |
53 |
68 |
77 |
87 |
79 |
73 |
64 |
52 |
45 |
727 |
|
400 |
20 |
31 |
38 |
40 |
46 |
49 |
48 |
50 |
49 |
60 |
59 |
45 |
535 |
|
600 |
16 |
31 |
33 |
39 |
45 |
53 |
58 |
62 |
58 |
60 |
51 |
46 |
552 |
|
Number of eggs laid per female |
0 (control) |
1.9 |
2.4 |
3.0 |
2.4 |
3.3 |
4.1 |
3.8 |
3.0 |
3.0 |
3.1 |
2.8 |
2.6 |
35.4 |
200 |
1.4 |
2.3 |
2.9 |
2.7 |
3.4 |
3.9 |
4.4 |
4.0 |
3.8 |
3.4 |
2.7 |
2.4 |
37.3 |
|
400 |
1.2 |
1.8 |
2.2 |
2.4 |
2.7 |
2.9 |
2.8 |
2.9 |
2.9 |
3.5 |
3.5 |
2.6 |
31.4 |
|
600 |
0.8 |
1.6 |
1.7 |
2.1 |
2.4 |
2.8 |
3.1 |
3.3 |
3.1 |
3.2 |
2.8 |
2.7 |
29.6 |
Table 4. Cracked eggs
Parameter |
Dose (ppm) |
Week of study |
Total |
|||||||||||
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
22 |
23 |
|||
Number of eggs cracked |
0 (control) |
1 |
0 |
3 |
2 |
2 |
4 |
1 |
2 |
1 |
0 |
0 |
2 |
18 |
200 |
2 |
7 |
2 |
1 |
3 |
5 |
5 |
5 |
5 |
5 |
4 |
4 |
48 |
|
400 |
1 |
1 |
1 |
0 |
1 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
10 |
|
600 |
1 |
0 |
1 |
1 |
3 |
2 |
1 |
4 |
3 |
6 |
3 |
5 |
30 |
|
% cracked of eggs laid |
0 (control) |
2.7 |
0 |
5.3 |
4.3 |
3.2 |
5.2 |
1.4 |
3.5 |
1.8 |
0 |
0 |
4.3 |
2.7 |
200 |
7.4 |
15.6 |
3.5 |
1.9 |
4.4 |
6.5 |
5.7 |
6.3 |
6.8 |
7.8 |
7.7 |
8.9 |
6.6 |
|
400 |
5.0 |
3.2 |
2.6 |
0 |
2.2 |
0 |
2.1 |
2.0 |
2.0 |
1.7 |
1.7 |
2.2 |
1.9 |
|
600 |
6.3 |
0 |
3.0 |
2.6 |
6.7 |
3.8 |
1.7 |
6.5 |
5.2 |
10.0 |
5.9 |
10.9 |
5.4 |
Table 5. Mean shell thickness (mm)
Dose (ppm) |
Week of study |
Mean |
|||||
12 |
14 |
16 |
18 |
20 |
22 |
||
0 (control) |
0.20 |
0.22 |
0.21 |
0.21 |
0.21 |
0.21 |
0.21 |
200 |
0.20 |
0.21 |
0.21 |
0.20 |
0.20 |
0.20 |
0.20 |
400 |
0.20 |
0.22 |
0.22 |
0.21 |
0.21 |
0.21 |
0.21 |
600 |
(0.21) |
0.21 |
0.21 |
0.21 |
0.20 |
0.20 |
0.21 |
() One value day
Table 6. Candling
Parameter |
Dose (ppm) |
Week of study |
Total |
|||||||||||
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
22 |
23 |
|||
Number of eggs set initially |
0 (control) |
30 |
45 |
45 |
44 |
49 |
72 |
63 |
55 |
46 |
57 |
46 |
44 |
596 |
200 |
22 |
38 |
49 |
52 |
55 |
71 |
70 |
74 |
56 |
59 |
39 |
40 |
625 |
|
400 |
17 |
30 |
34 |
40 |
39 |
49 |
40 |
49 |
42 |
59 |
50 |
44 |
493 |
|
600 |
14 |
31 |
29 |
38 |
36 |
51 |
49 |
58 |
52 |
54 |
39 |
41 |
492 |
|
Number of viable embryos |
0 (control) |
27 |
36 |
38 |
40 |
48 |
63 |
53 |
50 |
40 |
49 |
37 |
33 |
514 |
200 |
12 |
22 |
33 |
42 |
45 |
56 |
58 |
60 |
43 |
46 |
31 |
32 |
480 |
|
400 |
12 |
19 |
29 |
37 |
39 |
46 |
40 |
49 |
38 |
52 |
38 |
34 |
433 |
|
600 |
9 |
18 |
19 |
24 |
18 |
|
38 |
45 |
37 |
42 |
29 |
29 |
344 |
|
Number of live 3-week embryos |
0 (control) |
26 |
34 |
37 |
40 |
48 |
60 |
52 |
47 |
38 |
49 |
35 |
33 |
499 |
200 |
11 |
21 |
32 |
41 |
43 |
52 |
55 |
58 |
40 |
43 |
30 |
27 |
453 |
|
400 |
12 |
19 |
28 |
37 |
39 |
40 |
36 |
49 |
37 |
50 |
33 |
34 |
414 |
|
600 |
9 |
17 |
18 |
24 |
17 |
33 |
34 |
42 |
35 |
41 |
29 |
28 |
327 |
|
% viable embryos of eggs set initially |
0 (control) |
90 |
80 |
84 |
91 |
98 |
88 |
84 |
91 |
87 |
86 |
80 |
75 |
86 |
200 |
55 |
58 |
67 |
81 |
79 |
83 |
81 |
77 |
78 |
79 |
80 |
77 |
55 |
|
400 |
71 |
63 |
85 |
93 |
100 |
94 |
100 |
100 |
90 |
88 |
76 |
77 |
88 |
|
600 |
64 |
58 |
66 |
63 |
50 |
71 |
78 |
78 |
71 |
78 |
74 |
71 |
70 |
|
% live 3-week embryos of viable embryos |
0 (control) |
96 |
94 |
97 |
100 |
100 |
95 |
98 |
94 |
95 |
100 |
95 |
100 |
97 |
200 |
92 |
95 |
97 |
98 |
96 |
93 |
95 |
97 |
93 |
93 |
97 |
84 |
94 |
|
400 |
100 |
100 |
97 |
100 |
100 |
87 |
90 |
100 |
97 |
96 |
87 |
100 |
96 |
|
600 |
100 |
94 |
95 |
100 |
94 |
92 |
89 |
93 |
95 |
98 |
100 |
97 |
95 |
Table 7. Hatching results
Parameter |
Dose (ppm) |
Week of study |
Total |
|||||||||||
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
22 |
23 |
|||
Number of normal hatching |
0 (control) |
22 |
29 |
35 |
36 |
46 |
53 |
48 |
42 |
37 |
48 |
33 |
32 |
461 |
200 |
11 |
20 |
30 |
36 |
36 |
50 |
51 |
51 |
38 |
35 |
25 |
25 |
403 |
|
400 |
10 |
19 |
25 |
26 |
35 |
39 |
29 |
42 |
31 |
41 |
27 |
30 |
354 |
|
600 |
8 |
14 |
15 |
18 |
15 |
32 |
27 |
38 |
30 |
35 |
26 |
27 |
285 |
|
Number of dead in shell |
0 (control) |
4 |
5 |
2 |
4 |
2 |
7 |
4 |
5 |
1 |
1 |
2 |
1 |
38 |
200 |
0 |
1 |
2 |
5 |
6 |
2 |
4 |
7 |
2 |
8 |
5 |
2 |
44 |
|
400 |
2 |
0 |
3 |
10 |
4 |
1 |
7 |
7 |
6 |
9 |
6 |
4 |
59 |
|
600 |
1 |
3 |
3 |
6 |
2 |
1 |
6 |
4 |
5 |
6 |
3 |
1 |
41 |
|
% normal hatchings of viable embryos |
0 (control) |
81 |
81 |
92 |
90 |
96 |
84 |
91 |
84 |
93 |
98 |
89 |
97 |
90 |
200 |
92 |
91 |
91 |
86 |
80 |
89 |
88 |
85 |
88 |
76 |
81 |
78 |
85 |
|
400 |
83 |
100 |
86 |
70 |
90 |
85 |
73 |
86 |
82 |
79 |
71 |
88 |
82 |
|
600 |
89 |
78 |
79 |
75 |
83 |
89 |
71 |
84 |
81 |
83 |
90 |
93 |
83 |
|
% normal hatchings of live 3-week embryos |
0 (control) |
85 |
85 |
95 |
90 |
96 |
88 |
92 |
89 |
97 |
98 |
94 |
97 |
92 |
200 |
100 |
95 |
94 |
88 |
84 |
96 |
93 |
88 |
95 |
81 |
83 |
93 |
90 |
|
400 |
83 |
100 |
89 |
70 |
90 |
98 |
81 |
86 |
84 |
82 |
82 |
88 |
86 |
|
600 |
89 |
82 |
83 |
75 |
88 |
97 |
79 |
90 |
86 |
85 |
90 |
96 |
87 |
Table 8. 14-day survivors
Parameter |
Dose (ppm) |
Week of study |
Total |
|||||||||||
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
22 |
23 |
|||
Number of 14-day survivor |
0 (control) |
19 |
27 |
32 |
30 |
46 |
50 |
43 |
41 |
31 |
46 |
28 |
31 |
424 |
200 |
9 |
19 |
27 |
23 |
30 |
37 |
43 |
45 |
33 |
27 |
16 |
22 |
331 |
|
400 |
8 |
17 |
22 |
13 |
27 |
32 |
25 |
37 |
21 |
16 |
9 |
22 |
249 |
|
600 |
4 |
9 |
9 |
5 |
10 |
21 |
23 |
27 |
14 |
16 |
10 |
9 |
157 |
|
% surviving of eggs laid |
0 (control) |
51 |
60 |
56 |
65 |
74 |
65 |
60 |
72 |
54 |
79 |
53 |
67 |
64 |
200 |
33 |
42 |
47 |
43 |
44 |
48 |
49 |
57 |
45 |
42 |
31 |
49 |
46 |
|
400 |
40 |
55 |
58 |
33 |
59 |
65 |
52 |
74 |
43 |
27 |
15 |
49 |
47 |
|
600 |
25 |
29 |
27 |
13 |
22 |
40 |
40 |
44 |
24 |
27 |
20 |
20 |
28 |
|
% surviving of normal hatchings |
0 (control) |
86 |
93 |
91 |
83 |
100 |
94 |
90 |
98 |
84 |
96 |
85 |
97 |
92 |
200 |
82 |
95 |
90 |
64 |
83 |
74 |
84 |
88 |
87 |
77 |
64 |
88 |
81 |
|
400 |
80 |
89 |
88 |
50 |
77 |
82 |
86 |
88 |
68 |
39 |
33 |
73 |
70 |
|
600 |
50 |
64 |
60 |
28 |
67 |
66 |
85 |
71 |
47 |
46 |
38 |
33 |
55 |
|
Number of 14-day survivor per female |
0 (control) |
1.0 |
1.4 |
1.7 |
1.6 |
2.4 |
2.6 |
2.3 |
2.2 |
1.6 |
2.4 |
1.5 |
1.7 |
22.4 |
200 |
0.5 |
1.0 |
1.4 |
1.2 |
1.5 |
1,9 |
2.2 |
2.3 |
1.7 |
1.4 |
0.8 |
1.2 |
17.1 |
|
400 |
0.5 |
1.0 |
1.3 |
0.8 |
1.6 |
1.9 |
1.5 |
2.2 |
1.2 |
0.9 |
0.5 |
1.3 |
14.7 |
|
600 |
0.2 |
0.5 |
0.5 |
0.3 |
0.5 |
1.1 |
1.2 |
1.4 |
0.7 |
0.8 |
0.6 |
0.5 |
8.3 |
Table 9. Mean initial and 14-day body weight (g)
Parameter |
Dose (ppm) |
Week of study |
Mean |
|||||||||||
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
22 |
23 |
|||
Mean initial bodyweight |
0 (control) |
6.8 |
7.1 |
6.8 |
6.8 |
7.2 |
7.1 |
6.6 |
7.3 |
7.2 |
6.8 |
7.0 |
6.9 |
7.0 |
200 |
6.8 |
6.9 |
7.0 |
6.8 |
7.5 |
7.1 |
6.7 |
7.2 |
7.2 |
6.8 |
6.8 |
7.4 |
7.0 |
|
400 |
6.9 |
6.9 |
6.8 |
6.3 |
6.9 |
6.6 |
6.4 |
6.5 |
6.7 |
6.6 |
6.5 |
6.7 |
6.6 |
|
600 |
6.2 |
6.1 |
6.1 |
6.0 |
6.4 |
6.4 |
6.4 |
6.4 |
6.8 |
6.4 |
6.6 |
6.4 |
6.4 |
|
Mean 14-day bodyweight |
0 (control) |
20 |
24 |
23 |
23 |
25 |
24 |
26 |
25 |
24 |
24 |
22 |
25 |
24 |
200 |
21 |
23 |
25 |
22 |
26 |
25 |
26 |
26 |
24 |
24 |
23 |
28 |
25 |
|
400 |
24 |
24 |
24 |
23 |
26 |
26 |
26 |
23 |
25 |
26 |
21 |
25 |
24 |
|
600 |
19 |
21 |
27 |
22 |
26 |
25 |
26 |
26 |
25 |
22 |
21 |
25 |
24 |
Table 10.Summary of reproductive data for effects of the test substance technical on bobwhite quail
Observation |
Control |
Test substance |
||
200 mg/kg |
400 mg/kg |
600 mg/kg |
||
Adult mean daily food consumption over treatment period (g) Adult mean bodyweight over treatment period (g) Treatment as Daily Dietary Dose a (mg/kg bw/day) |
19 190 0 |
19 191 19.9 |
18 191 37.7 |
19 188 60.6 |
Female mortality |
1 |
1 |
2 |
1 |
Eggs laid per female |
35.4 |
37.3 |
31.4 |
29.6 |
Eggs damaged |
18 |
48 |
10 |
30 |
Eggs damaged of eggs laid (%) |
2.7 |
6.6 |
1.9 |
5.4 |
Mean egg shell thickness (mm) |
0.21 |
0.20 |
0.21 |
0.21 |
Eggs set |
596 |
625 |
493 |
492 |
Viable embryos |
514 |
480 |
433 |
344 |
Viable embryos of eggs set (%) |
86 |
77 |
88 |
70 |
Live 3-week embryos |
499 |
453 |
414 |
327 |
Live 3-week embryos of viable embryos (%) |
97 |
94 |
96 |
95 |
Normal hatchlings |
461 |
408 |
354 |
285 |
Normal hatchlings of viable embryos (%) |
90 |
85 |
82 |
83 |
Normal hatchlings of live 3-week embryos (%) |
92 |
90 |
86 |
87 |
14-day old survivors |
424 |
331 |
249 |
157 |
14-day old survivors of eggs laid (%) |
64 |
46 |
47 |
28 ** |
14-day old survivors of normal hatchlings (%) |
92 |
81 |
70 ** |
55 ** |
14-day old survivors per female |
22.4 |
17.1 |
14.7 |
8.3 |
Chick bodyweights at hatching (g) |
7.0 |
7.0 |
6.6 |
6.4 |
Chick bodyweights at 14 days (g) |
24 |
25 |
24 |
24 |
** Statistically significant difference from control (P<0.01; William’s test).
Description of key information
All available data was assessed and the study representing the worst-case effect was included as key study. Other studies are included as supporting information. The effect value from the key study was selected for the CSA.
23-wk, NOEC = 200 mg/kg diet (equivalent to 19.9 mg/kg bw/day), Colinus virginianus, reproduction, EPA 71 -4, Johnson 1994
Key value for chemical safety assessment
- Long-term EC10, LC10 or NOEC for birds:
- 200 mg/kg food
Additional information
Three acute and three chronic toxicity studies of the test substance are available. They all followed standard test guidelines and complied with GLP. One of the chronic studies (Johnson 1994; EPA 71 – 4; Reliability 1) on Bobwhite quail (Colinus virginianus) was selected as key study and its effect value was used as key value. This study was selected as the key study because a long-term toxicity test is preferred for this endpoint, according to ECHA guidance R7c (Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7c: Endpoint specific guidance).It represents the worst-case effect (i.e. shows the lowest NOEC value in daily dietary dose). Three treated groups of 20 replicates, each of one male and one female, were offered test diet containing 200, 400 and 600 mg a.s./kg over a period of 23 weeks (for 11 weeks prior to the start of egg production and during 12 weeks of egg production). A similar sized control group was given untreated diet only. The birds (approximately 11 months old) were housed in 5 batteries of cages, each battery consisting of 4 tiers of 4 cages. Each cage had an externally attached food hopper and automatic drinker. The mean temperature and humidity in the test room were 18 – 21 ˚C and 44%, respectively. An artificial light photoperiod of 7 hours daily was provided until the end of week 6, when the photoperiod was increased to 16 hours daily (light intensity range 60 to 150 lux). The test birds were fed ad libitum with a layer diet (treated or untreated) and water. The result show that the 200 mg/kg diet treatment had no adverse effect on adult birds or their reproductive performance. Higher than this dose, significant effects were observed. Therefore, the 23-week NOEC is 200 mg/kg diet (equivalent to 19.9 mg/kg bw/day) for reproduction parameters.
The other two chronic studies are a 23-wk reproduction test (Redgrave 1995; EPA guideline 71-4; Reliability 1) and a 90-day growth (body weight) test (Gallagher 2003; OECD TG 205 and EPA guideline 71-2; Reliability 1). They have been included as supporting information. In the study from Redgrave (1995), Mallard duck (Anas platyrhynchos) was offered the same dosages of the test substance in the diet as in the key study. The study concluded that the 23-wk NOEC for reproduction is 200 mg/kg diet, equivalent to a daily dietary dose of 32.2 mg/kg bw/day. In the 90 days growth test (Gallagher 2003), the test organisms were fed on 0, 2, 20, 200, 2000 or 20,000 mg/kg test substance in the diet. The NOEC was determined to be 20,000 ppm, the highest concentration tested.
Three supporting acute toxicity studies are available. Two EPA 71-1 guideline followed acute toxicity studies were carried out on mallard duck, Anas platyrhynchos. In one of the studies (Hakin 1990a; Reliability 1), the test organisms (approximately 5 months old) were exposed to control (corn oil), 500, 1000 or 2000 mg/kg feed treatment. Ten birds (5 male and 5 female) were tested for each treatment. After 14-d exposure, no mortalities occurred, no abnormalities were noted in any bird at any dose level. Thus, the LD50 was determined to be > 2000 mg/kg diet, the highest dose tested. In another study (Hakin 1990c ; Reliability 1), higher dosages were used: control, 163, 325, 650, 1300, 2600 and 5200 mg/kg diet. Ten mallard duck (8 days old; unsexed) were tested for each treatment (3 groups of 10 in the control). After 8-d exposure, the results indicate that the LC50 was higher than the highest dose tested (> 5200 mg/kg). The third acute toxicity study was performed on bobwhite quail (Colinus virginianus). The test organisms (12 days old) were exposed to control, 163, 325, 650, 1300, 2600 or 5200 mg/kg diet. Similar result to the other acute studies was found. The LC50 was higher than the highest dose tested (> 5200 mg/kg).
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