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EC number: 214-787-5 | CAS number: 1194-65-6
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Endpoint summary
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- Environmental data
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- 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
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- Toxicological Summary
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- Acute Toxicity
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- Specific investigations
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- Additional toxicological data
Toxicity to birds
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to birds: acute oral toxicity test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 November 1993 to 14 November 1994
- 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)
- Deviations:
- no
- GLP compliance:
- yes
- Dose method:
- capsule
- Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- Colinus virginianus
- Details on test organisms:
- TEST ORGANISM
- Common name: Bobwhite Quail
- Age at test initiation (mean and range, SD): at least 16-18 weeks old
- Sexes used: male and female
- Disease free: yes (daily check performed during acclimation period) - Limit test:
- no
- Remarks:
- One dosing
- Post exposure observation period:
- 15 days
- No. of animals per sex per dose and/or stage:
- Five
- Control animals:
- yes
- Nominal and measured doses / concentrations:
- 400, 800, 1086, 1474 and 2000 mg/kg bw
- Details on test conditions:
- ACCLIMATION
- Acclimation period: at least fifteen days
- Feeding: Avian Layer Diet, Special Diet Services, Witham, Essex, UK ad libitum
- Health (any disease or mortality observed): no
FEED WITHHOLDING PERIOD BEFORE DOSING
- No. of days: overnight before dosing
PEN SIZE AND CONSTRUCTION MATERIALS
- Description: stainless steel grid cages
- Caging: individual
NO. OF BIRDS PER REPLICATE
- For treated: five per sex
TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: 18-25 ºC
- Relative humidity (%): 40-70 %
- Photoperiod: eight hours light/16 hours dark
- Ventilation: approximately fifteen air changes per hour
RANGE FINDING STUDY
- Test concentrations: 2000 ppm
- Test conditions: as main test
- Results used to determine the conditions for the definitive study: yes (one male and one female treated at 2000 ppm, both died within 7 days. 2000 ppm used as highest dose in main study). - Details on examinations and observations:
- MORTALITY / CLINICAL SIGNS
- Time schedule for examinations: three times on day 1 and at least once daily from day 2 onwards
BODY WEIGHT
- Time schedule for examinations: day before dosing (day -1), days 1, 8 and 15.
FOOD CONSUMPTION (if feeding study)
- Time schedule for examinations: weekly
PATHOLOGY
- Dose groups that were examined: all
- Remarks: all body cavities were opened, larger organs were sectioned and the intestinal tract was opened at intervals for examination of mucosal surfaces. - Reference substance (positive control):
- no
- Key result
- Dose descriptor:
- LD50
- Effect level:
- 683 mg/kg bw
- Conc. / dose based on:
- test mat.
- Remarks on result:
- other: 95 % CL 549-818 mg/kg bw
- Key result
- Dose descriptor:
- LD50
- Effect level:
- 698 mg/kg bw
- Conc. / dose based on:
- test mat.
- Remarks on result:
- other: males only
- Key result
- Dose descriptor:
- LD50
- Effect level:
- 727 mg/kg bw
- Conc. / dose based on:
- test mat.
- Remarks on result:
- other: females only
- Mortality and sub-lethal effects:
- Ante mortem signs comprised under-activity, resting on hocks, reluctance or inability to stand, staggering gait, unconsciousness, prone position, slow and deep respiration, closed eyes, thin body conformation, cold to touch, ungroomed appearance, plumo-erection, little diet eaten, few faeces and feather loss. Some birds treated at 2000 mg/kg also had pink staining in the under-trays. Signs of reaction to treatment in surviving birds comprised thin body conformation, plumo-erection, little diet eaten and few faeces. All of these birds were overtly normal on day 13.
The food consumption of birds treated at 400 mg/kg was considerably lower than that of control birds during the first week of the study. Thereafter, the food consumption of these birds was similar to that of the controls. Other surviving birds treated with the test material consumed little diet throughout the study.
Birds treated at 400 mg/kg lost considerable body weight during the first week of the study, but made substantial gains during the second week. The remaining surviving birds treated with the test substance lost body weight throughout the study. Necropsy findings were unremarkable. - Validity criteria fulfilled:
- not specified
- Conclusions:
- Under the conditions of the test, the acute oral median LD50 of the test material was 683 mg/kg bw (95 % C.I. 549-818 mg/kg bw).
- Executive summary:
In a GLP compliant acute oral toxicity to birds study conducted in line with standardised guideline EPA 71-1, the acute oral toxicity of the test material to bobwhite quail was determined. The test material was administered by capsule as a single dose, followed by a 15 day observation period, at 0, 400, 800, 1086, 1474 and 2000 mg/kg. Under the conditions of the test the LD50value was determined to be 683 mg/kg bw (95 % C.I. 549-818 mg/kg bw).
- Endpoint:
- short-term toxicity to birds: dietary toxicity test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 June 1987 to 24 March 1988
- 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)
- Deviations:
- no
- GLP compliance:
- yes
- Dose method:
- feed
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and analysis of diet:
- DIET PREPARATION
- Description and nutrient analysis of basal diet provided in study report: no
- Preparation of doses: weighed amount of test material was added to untreated diet to give a premix of 25000 ppm which was mixed by being shaken in a polythene bag for a minimum of three minutes. Aliquots of the premix were used to prepare the final inclusion levels. - Test organisms (species):
- Anas platyrhynchos
- Details on test organisms:
- TEST ORGANISM
- Common name: Mallard duck
- Age at test initiation (mean and range, SD): 10 days old
- Weight at test initiation (mean and range, SD): mean 71 g
- Sexes used: not determined - Limit test:
- no
- Total exposure duration (if not single dose):
- 5 d
- Post exposure observation period:
- Three days
- No. of animals per sex per dose and/or stage:
- Ten animals per dose (sex not identified)
- Control animals:
- yes, plain diet
- Nominal and measured doses / concentrations:
- 0, 650, 1300, 2600 and 5200 ppm
- Details on test conditions:
- PEN SIZE AND CONSTRUCTION MATERIALS
- Description: galvinzed steel tiered brooders
NO. OF BIRDS PER REPLICATE
- For treated: 10
TEST CONDITIONS (range, mean, SD as applicable)
- Room temperature: 26 ± 1 ºC - 29 ± 1 ºC
- Relative humidity: mean 65 ± 10 %
- Photoperiod: continuous illumination
- Ventilation: adjusted as required - Details on examinations and observations:
- MORTALITY / CLINICAL SIGNS
- Time schedule for examinations: daily
BODY WEIGHT
- Time schedule for examinations: group-weighed on days -3, 0 (prior to introduction of diets), 5 and 8
FOOD CONSUMPTION (if feeding study)
- Time schedule for examinations: over the following days: -3 to -1, 1 to 5 (daily) and 6 to 8.
PATHOLOGY
- Dose groups that were examined: eight surviving birds treated at 5200 ppm and two surviving birds treated at 2600 ppm were examined macroscopically at the termination of the study. - Reference substance (positive control):
- no
- Key result
- Duration (if not single dose):
- 5 d
- Dose descriptor:
- LC50
- Effect level:
- > 5 200 mg/kg diet
- Conc. / dose based on:
- test mat.
- Basis for effect:
- mortality
- Mortality and sub-lethal effects:
- Two mortalities occurred in the 5200 ppm treatment period. All birds were in good health during pre-treatment period. During the treatment period birds dosed at 2600 ppm and 5200 ppm became subdued and were huddled together. Birds in all other groups remained in good health throughout the treatment period. All birds appeared to be in good health during the post-treatment period. Body weight changes and an overview of the deaths occurring are given in Table 1.
Birds in the controls and the 650 ppm treatment group comparable body weight increase, birds in the 1300 ppm treatment group showed a reduced increase during the treatment period, birds in the 2600 ppm treatment group showed only a very small increase during the treatment period, while the surviving birds in the 5200 ppm treatment group showed an actual decrease during the treatment period. During pre- and post-treatment period body weights changes were similar in all groups.
There was a treatment related depression of food consumption in the three highest treatment groups during the treatment period, but it increased again during the post-treatment period. The two birds in the 5200 ppm treatment group, which died during the treatment period, were examined microscopically and both birds were found to be thin. At termination of the study a total number of ten birds (two from the 2600 ppm treatment group and eight from the 5200 ppm treatment group) were examined. No abnormalities were detected. - Validity criteria fulfilled:
- not specified
- Conclusions:
- Under the conditions of the test, it was not possible to determine a LC50 value since only two mortalities occurred at the highest dose level tested. The LC50 for the test material in the mallard duck is therefore >5200 mg/kg diet.
- Executive summary:
In a GLP compliant short-term dietary toxicity to birds study conducted in line with standardised guideline EPA 71-2, the short-term dietary toxicity of the test material to mallard ducks was determined. The test material was administered by dietary inclusion at 650 1300, 2500 and 5200 ppm. Under the conditions of the test it was not possible to determine a LC50value because there were only two mortalities at the highest dose level tested. This value must therefore be in excess of 5200 mg/kg diet.
- Endpoint:
- long-term toxicity to birds: reproduction test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 November 1999 to 07 September 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 206 (Avian Reproduction Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 71-4 (Avian Reproduction Test)
- Deviations:
- no
- GLP compliance:
- yes
- Dose method:
- feed
- Analytical monitoring:
- yes
- Vehicle:
- no
- Details on preparation and analysis of diet:
- DIET PREPARATION
- Description and nutrient analysis of basal diet provided in study report: yes
- Preparation of doses: test substance was mixed into a premix that was used for weekly preparation of the final diet.
HOMOGENEITY AND STABILITY OF TEST MATERIAL IN DIET
- How often was homogeneity and stability tested: on day 0 of week 1 and then during weeks 2, 3, 4, 8, 12, 16 and 20.
- When and at what dose levels were samples of treated food analysed for stability and concentration during the study: all dose levels.
- % of nominal: 91.0-98.7 % - Test organisms (species):
- Colinus virginianus
- Details on test organisms:
- TEST ORGANISM
- Common name: Northern bobwhite quail
- Age at test initiation (mean and range, SD): 20 weeks
- Weight at test initiation (mean and range, SD): 180-223 g
- Sexes used: male/female - Limit test:
- no
- Total exposure duration (if not single dose):
- 22 wk
- No. of animals per sex per dose and/or stage:
- Sixteen
- Control animals:
- yes, plain diet
- Nominal and measured doses / concentrations:
- 0, 150, 300 and 600 ppm (nominal)
- Details on test conditions:
- ACCLIMATION
- Acclimation period: 6 weeks
PEN SIZE AND CONSTRUCTION MATERIALS
- Description: 27 x 51 cm galvanised wire mesh/galvanised sheeting pens with ceiling height of 20-25 cm
- Compliant to good husbandry practices: yes
- Caging: one male and one female per pen
NO. OF BIRDS PER REPLICATE
- For treated: 16
TEST CONDITIONS (range, mean, SD as applicable)
- Room temperature: 19.4 ± 1.6 ºC
- Relative humidity (%): 37 ± 12 %
- Photoperiod: 8 hours light per day in the first seven weeks and then 17 hours per day to induce egg laying
- Ventilation: vent up to 15 room air volumes every hour and replace with fresh air - Details on examinations and observations:
- MORTALITY / CLINICAL SIGNS
- Time schedule for examinations: daily
BODY WEIGHT
- Time schedule for examinations: at test initiation, weeks 2, 4, 6, 8 and at termination but not during egg laying to prevent adverse effects on egg production.
FOOD CONSUMPTION (if feeding study)
- Time schedule for examinations: weekly
- Remarks: presented as an estimate because it was not possible to measure wasted feed.
PATHOLOGY
- Dose groups that were examined: all
- Remarks: all animals that died or euthanised during the course of study and all surviving animals at termination. - Details on reproductive parameters:
- The following parameters were examined per parental pen per week:
- Eggs laid
- Eggs cracked; eggs broken
- Egg abnormalities
- Eggshell thickness or eggshell strength
- Eggs fertile
- Embryos viable
- Normal hatchlings
- 14-day old surviving chicks
- Chick body weight at hatching and 14 days after hatching - Reference substance (positive control):
- no
- Key result
- Duration (if not single dose):
- 22 wk
- Dose descriptor:
- NOEC
- Effect level:
- 150 other: ppm
- Conc. / dose based on:
- test mat.
- Basis for effect:
- reproductive parameters
- Remarks:
- egg production, hatchability and offspring survival
- Mortality and sub-lethal effects:
- No mortalities occurred in the 300 ppm treatment group, two incidental mortalities occurred in the control group and one incidental mortality occurred in both the 150 and 600 ppm treatment groups; none of these are considered to be treatment-related.
No overt signs of toxicity were observed at any of the concentrations tested. Except for incidental findings (including foot, leg, back, wing and head lesions, feather loss, bruising, lameness, lower limb weakness, reduced reaction to external stimuli, ruffled appearance), all birds appeared normal throughout the study.
All surviving adults were subjected to gross necropsy following adult termination (see Table 1). All findings were considered unrelated to treatment.
There were no apparent treatment-related effects upon adult body weight at any of the concentrations tested (see Table 2).
There were slight, but statistically significant, differences in the mean body weights of cocks in all treatment groups. They were primarily the result of the presence of two heavier males in the control group and very tight standard deviations for all groups. The slight differences observed were not considered biologically meaningful or related to treatment.
There were no apparent treatment-related effects upon feed consumption. No statistically significant differences were observed at any of the feed consumption intervals. - Effects on reproduction:
- There were no treatment-related effects upon any of the reproductive parameters measured at the 150 ppm test concentration.
While not statistically significant, there were slight, but treatment-related, reductions in egg production and offspring survival in the 300 ppm treatment group. The reductions in egg production and offspring survival also were reflected as non-statistically significant reductions in 14-day old survivors as a percentage of eggs set, and hatchlings as a percentage of the maximum number of eggs set, and as a statistically significant (p <0.01) reduction in 14-day old survivors as a percentage of the maximum number of eggs set.
There were marked, treatment related, effects on reproductive performance at the 600 ppm test concentration. When compared to the control group, the observed reductions in egg production, hatchability and offspring survival were statistically significant at p <0.01. The reductions were further reflected as statistically significant (p <0.05 and p <0.01) reductions in hatchlings and 14-day old survivors as percentages of both eggs set and the maximum number of eggs set. Summaries of the reproductive data can be found in Table 3.
There were no apparent treatment related effects upon eggshell thickness. There were no apparent treatment related effects upon offspring body weights at the 150 or 300 ppm test concentrations and any differences from the control group were not statistically significant for either the hatchlings or the 14-day old survivors. However, there were treatment related reductions in the mean body weights of hatchlings and 14-day old survivors in the 600 ppm treatment group. Offspring body weight data can be found in Table 4. - Validity criteria fulfilled:
- not specified
- Conclusions:
- Under the conditions of the test, the NOEC for Northern bobwhite exposed to the test material was determined to be 150 ppm based upon the effects seen in the 300 ppm treatment group.
- Executive summary:
In a GLP compliant reproductive toxicity to birds study conducted in line with standardised guidelines OECD 206 and EPA 71-4, the reproductive toxicity of the test material to Northern bobwhite quail was determined. The test material was administered by dietary inclusion at 0, 150, 300 and 600 ppm. Under the conditions of the test the NOEC was determined to be 150 ppm based on the effects seen at the 300 ppm treatment level.
- Endpoint:
- long-term toxicity to birds: reproduction test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 November 1999 to 25 September 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 206 (Avian Reproduction Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 71-4 (Avian Reproduction Test)
- Deviations:
- no
- GLP compliance:
- yes
- Dose method:
- feed
- Analytical monitoring:
- yes
- Vehicle:
- no
- Details on preparation and analysis of diet:
- DIET PREPARATION
- Description and nutrient analysis of basal diet provided in study report: yes
- Preparation of doses: test substance was mixed into a premix that was used for weekly preparation of the final diet.
HOMOGENEITY AND STABILITY OF TEST MATERIAL IN DIET
- How often was homogeneity and stability tested: on day 0 of week 1 and then during weeks 2, 3, 4, 8, 12, 16 and 20.
- When and at what dose levels were samples of treated food analysed for stability and concentration during the study: all dose levels.
- % of nominal: 91.0-98.7 % - Test organisms (species):
- Anas platyrhynchos
- Details on test organisms:
- TEST ORGANISM
- Common name: Mallard
- Age at test initiation (mean and range, SD): 27 weeks
- Weight at test initiation (mean and range, SD): 905-1373 g
- Sexes used: male/female - Limit test:
- no
- Total exposure duration (if not single dose):
- 21 wk
- No. of animals per sex per dose and/or stage:
- Sixteen
- Control animals:
- yes, plain diet
- Nominal and measured doses / concentrations:
- 0, 150, 300 and 600 ppm (nominal)
- Details on test conditions:
- ACCLIMATION
- Acclimation period: 13 weeks
PEN SIZE AND CONSTRUCTION MATERIALS
- Description: 75 x 90 x 45 cm pens
- Compliant to good husbandry practices: yes
- Caging: one male and one female per pen
NO. OF BIRDS PER REPLICATE
- For treated: 16
TEST CONDITIONS (range, mean, SD as applicable)
- Room temperature: 19.3 ± 1.0 ºC
- Relative humidity (%): 40 ± 15 %
- Photoperiod: 8 hours light per day in the first ten weeks and then 17 hours per day to induce egg laying
- Ventilation: vent up to 15 room air volumes every hour and replace with fresh air - Details on examinations and observations:
- MORTALITY / CLINICAL SIGNS
- Time schedule for examinations: daily
BODY WEIGHT
- Time schedule for examinations: at test initiation, weeks 2, 4, 6, 8 and at termination but not during egg laying to prevent adverse effects on egg production.
FOOD CONSUMPTION (if feeding study)
- Time schedule for examinations: weekly
- Remarks: presented as an estimate because it was not possible to measure wasted feed.
PATHOLOGY
- Dose groups that were examined: all
- Remarks: all animals that died or euthanised during the course of study and all surviving animals at termination. - Details on reproductive parameters:
- The following parameters were examined per parental pen per week:
- Eggs laid
- Eggs cracked; eggs broken
- Egg abnormalities
- Eggshell thickness or eggshell strength
- Eggs fertile
- Embryos viable
- Normal hatchlings
- 14-day old surviving chicks
- Chick body weight at hatching and 14 days after hatching - Reference substance (positive control):
- no
- Key result
- Duration (if not single dose):
- 21 wk
- Dose descriptor:
- NOEC
- Effect level:
- 300 other: ppm
- Conc. / dose based on:
- test mat.
- Basis for effect:
- reproductive parameters
- Mortality and sub-lethal effects:
- No mortalities occurred in the study. Incidental clinical observations were noted, including foot and ankle lesions, feather loss, bill abrasions and lameness. Except for incidental findings, all birds were normal in appearance and behaviour throughout the study. All surviving adults were subjected to gross necropsy following adult termination, findings are reported in Table 1.
There were no apparent treatment-related effects upon adult body weight at any of the concentrations tested (see Table 2).
There were no statistically significant differences between the control group and any treatment group of drakes or between the control group and the 150 ppm and 600 ppm treatment groups of hens. However, the mean body weights of hens in the 300 ppm treatment group were slightly, but significantly greater than the control at week 4, 6 and 8. Since the differences were slight, not concentration responsive, and represented an increase in body weight, the observed differences were not considered biologically meaningful or related to treatment.
Mean food consumption measurements are presented in Table 3. There were no treatment-related effects upon feed consumption at the 150 or 300 ppm test concentrations. However, at the 600 ppm test concentration, there was an increase in feed consumption during the first ten weeks of the study that was statistically significant at each of the ten intervals. As an impact upon energy conversion could not be precluded, the observed increases may have been treatment related. - Effects on reproduction:
- There were no treatment-related effects upon reproductive performance at the 150 or 300 ppm test concentrations. Although there were statistically significant reductions in cracked eggs as percentages of eggs laid at all test concentrations, the observed differences were slight. Since the reductions represented improvements in performance, and all treatment group values were comparable to the historical control, they were not considered related to treatment. For any of the other reproductive parameters measured no statistically significant differences between the control and either the 150 or 300 ppm treatment groups. At the 600 ppm test concentration, there were marked, treatment-related, effects upon reproductive performance, including effects upon egg production, fertility and hatchability. When compared to the control group, the observed reduction in egg production was statistically significant. While not statistically significant, there were slight, but treatment-related, reductions in viable embryos as a percentage of eggs set and hatchlings as a percentage of live 3-week embryos. The reductions were further reflected as reductions in both hatchlings and 14-day old survivors as percentages of both eggs set and as statistically significant reductions in both hatchlings as 14-day old survivors as percentages of the maximum number of eggs set (see Table 4).
There were no apparent treatment related effects upon eggshell thickness. There were no apparent treatment related effects upon offspring body weights at the 150, 300 or 600 ppm test concentrations and any differences from the control group were not statistically significant for either the hatchlings or the 14-day old survivors (see Table 5). - Validity criteria fulfilled:
- not specified
- Conclusions:
- Under the conditions of the test, the NOEC for mallard ducks exposed to the test material was determined to be 300 ppm based upon the effects seen in the 600 ppm treatment group.
- Executive summary:
In a GLP compliant reproductive toxicity to birds study conducted in line with standardised guidelines OECD 206 and EPA 71-4, the reproductive toxicity of the test material to mallard ducks was determined. The test material was administered by dietary inclusion at 0, 150, 300 and 600 ppm. Under the conditions of the test the NOEC was determined to be 300 ppm based on the effects seen at the 600 ppm treatment level.
Referenceopen allclose all
Table 1: Mortality distribution
Mortality | ||
Dose (mg/kg) | Males | Females |
0 | 0/5 | 0/5 |
400 | 0/5 | 0/5 |
800 | 5/5 | 4/5 |
1086 | 3/5 | 5/5 |
1474 | 5/5 | 5/5 |
2000 | 5/5 | 5/5 |
Table 1: Avian dietary toxicity to the mallard duck (deaths and group mean body weight changes)
Dose units (mg/kg) | 0 | 0 | 0 | 650 | 1300 | 2600 | 5200 |
Mortality | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 2/10 |
Days of study | Group mean body weight change in g/bird | ||||||
-3 to 0 | +36 | +41 | +44 | +37 | +41 | +40 | +36 |
0 to 5 | +102 | +95 | +99 | +97 | +64 | +7 | -15 |
5 to 8 | +44 | +47 | +49 | +52 | +47 | +59 | +53 |
Table 1: Gross pathological observations (adult birds euthanised at test termination)
Males (ppm) | Females (ppm) | |||||||
0 | 150 | 300 | 600 | 0 | 150 | 300 | 600 | |
Number of birds | 14 | 15 | 16 | 16 | 14 | 15 | 16 | 16 |
Foot/leg lesions | 0 | 1 | 2 | 0 | 0 | 0 | 1 | 0 |
Feather loss | 2 | 6 | 8 | 4 | 9 | 10 | 11 | 10 |
Breast muscle - pale | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Spleen - pale | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Small intestines - areas of hyperemia | 1 | 0 | 4 | 0 | 0 | 0 | 0 | 0 |
Testes - small (one or both) | 6 | 3 | 3 | 4 | - | - | - | - |
Ovary - regressing | - | - | - | - | 0 | 0 | 0 | 1 |
Not remarkable | 7 | 6 | 6 | 8 | 5 | 5 | 5 | 6 |
Table 2: Mean adult body weight (g) and weight change (g)
Males (ppm) | Females (ppm) | |||||||
0 | 150 | 300 | 600 | 0 | 150 | 300 | 600 | |
Week 0 | 203 | 194* | 196 | 192* | 197 | 195 | 197 | 193 |
Change week 0-2 | 2 | 1 | 2 | 0 | 0 | 1 | 2 | 1 |
Week 2 | 205 | 195* | 198 | 192** | 198 | 196 | 199 | 194 |
Change week 2-4 | 7 | 5 | 5 | 5 | 4 | 4 | 5 | 3 |
Week 4 | 212 | 200** | 203 | 197** | 202 | 200 | 204 | 197 |
Change week 4-6 | 5 | 4 | 4 | 5 | 2 | 3 | 4 | 3 |
Week 6 | 216 | 203* | 207 | 202** | 204 | 203 | 209 | 200 |
Change week 6-8 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 2 |
Week 8 | 218 | 204** | 207* | 203** | 204 | 205 | 208 | 202 |
Change week 8-Term | 8 | 3 | 7 | 0 | 42 | 44 | 36 | 34 |
Term | 225 | 206** | 214 | 204** | 245 | 249 | 244 | 236 |
Total change | 23 | 13 | 17 | 12 | 47 | 54 | 57 | 44 |
The means for body weights and body weight changes are calculated and rounded separately
*significantly different from control at p <0.05
**significantly different from the control at p <0.01
Table 3: Reproductive performance (normalised as percentage1)
Experimental group (ppm) | ||||
Reproductive parameter | 0 | 150 | 300 | 600 |
Number of replicates | 14 | 15 | 16 | 16 |
Total eggs laid2 | 765 | 734 | 669 | 419 |
Eggs laid/Maximum laid (%) | 76 | 68 | 58 | 36** |
Eggs cracked/Eggs laid (%) | 0 | 2 | 1 | 0 |
Viable embryos/Eggs set (%) | 94 | 94 | 95 | 89 |
Live 3 week embryos/Viable embryos (%) | 100 | 100 | 100 | 100 |
Hatchlings/Live 3 week embryos (%) | 95 | 97 | 92 | 79** |
14 day old survivors/Hatchling (%) | 97 | 93 | 89 | 73** |
Hatchlings/Eggs set (%) | 89 | 90 | 87 | 71* |
14 day old survivors/Eggs set (%) | 85 | 83 | 79 | 52** |
Hatchlings/Maximum set (%) | 64 | 58 | 48 | 24** |
14 day old survivors/Maximum set (%) | 62 | 54 | 45* | 18** |
*significantly different from the control p <0.05
**significantly different from the control p <0.01
1Values represent pen means for experimental group
2Represents the total number of eggs laid in each group
Table 4: Mean body weight (g) of hatchlings and 14 day old survivors
0 ppm | 150 ppm | 300 ppm | 600 ppm | |
Hatchlings | ||||
Number | 602 | 586 | 518 | 260 |
Mean (± SD) | 6 ± 0 | 6 ± 0 | 6 ± 0 | 5** ± 0 |
14 day old survivors | ||||
Number | 580 | 542 | 478 | 194 |
Mean (± SD) | 26 ± 3 | 25 ± 2 | 25 ± 2 | 19** ± 3 |
The total number of hatchlings weighed may differ from the total number of hatchlings since those found dead were not weighed.
**significantly different from the control p <0.01
Table 1: Gross pathological observations (adult birds euthanised at test termination)
Males (ppm) | Females (ppm) | |||||||
0 | 150 | 300 | 600 | 0 | 150 | 300 | 600 | |
Number of birds | 16 | 16 | 16 | 16 | 16 | 16 | 16 | 16 |
Foot/leg lesions | 5 | 11 | 10 | 7 | 14 | 14 | 16 | 12 |
Air sacculitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Spleen - enlarged | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
Spleen - mottled | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
Small intestines - areas of hyperemia | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 |
Testes - small (one or both) | 2 | 0 | 1 | 1 | - | - | - | - |
Abdominal cavity - egg remnants | - | - | - | - | 0 | 0 | 0 | 1 |
Abdominal cavity - slight egg yolk peritonitis | - | - | - | - | 1 | 1 | 1 | 1 |
Abdominal cavity - egg yolk peritonitis | - | - | - | - | 1 | 1 | 1 | 3 |
Abdominal cavity - slight old egg yolk peritonitis | - | - | - | - | 0 | 1 | 0 | 0 |
Ovary - regressing | - | - | - | - | 1 | 2 | 1 | 3 |
Ovary - cystic follicles | - | - | - | - | 1 | 0 | 0 | 2 |
Ovary - cyst | - | - | - | - | 1 | 0 | 0 | 0 |
Not remarkable | 10 | 4 | 6 | 9 | 2 | 2 | 0 | 3 |
Table 2: Mean adult body weight (g) and weight change (g)
Males (ppm) | Females (ppm) | |||||||
0 | 150 | 300 | 600 | 0 | 150 | 300 | 600 | |
Week 0 | 1163 | 1204 | 1129 | 1202 | 1033 | 1060 | 1074 | 1018 |
Change week 0-2 | -42 | -48 | -7 | -120 | -57 | -34 | -31 | -12 |
Week 2 | 1121 | 1156 | 1121 | 1190 | 976 | 1027 | 1043 | 1006 |
Change week 2-4 | 5 | 27 | 9 | 8 | 3 | 3 | 14 | 16 |
Week 4 | 1126 | 1183 | 1130 | 1198 | 979 | 1030 | 1057* | 1023 |
Change week 4-6 | 22 | -7 | 39 | 18 | 24 | -1 | -3 | 17 |
Week 6 | 1149 | 1176 | 1169 | 1216 | 1003 | 1028 | 1091** | 1043 |
Change week 6-8 | -11 | -3 | 1 | 4 | 4 | -1 | -3 | -17 |
Week 8 | 1138 | 1174 | 1171 | 1221 | 1006 | 1027 | 1088* | 1060 |
Change week 8-Term | 17 | 12 | 33 | -3 | 126 | 151 | 95 | 32 |
Term | 1155 | 1185 | 1204 | 1218 | 1132 | 1178 | 1182 | 1092 |
Total change | -9 | -19 | 75 | 16 | 99 | 118 | 108 | 73 |
The means for body weights and body weight changes are calculated and rounded separately
*significantly different from control at p <0.05
**significantly different from the control at p <0.01
Table 3: Mean feed consumption (g/bird/day)
Weeks | 0 ppm | 150 ppm | 300 ppm | 600 ppm |
1 | 60 | 65 | 71 | 83** |
2 | 96 | 102 | 99 | 120** |
3 | 96 | 112 | 104 | 122** |
4 | 101 | 113 | 103 | 128** |
5 | 108 | 115 | 114 | 134** |
6 | 105 | 126 | 117 | 142** |
7 | 105 | 123 | 111 | 143** |
8 | 122 | 132 | 121 | 160** |
9 | 112 | 127 | 114 | 152** |
10 | 120 | 135 | 115 | 152** |
11 | 118 | 130 | 113 | 140 |
12 | 151 | 163 | 158 | 166 |
13 | 168 | 187 | 163 | 176 |
14 | 146 | 166 | 140 | 163 |
15 | 166 | 175 | 172 | 173 |
16 | 172 | 177 | 158 | 191 |
17 | 171 | 189 | 172 | 192 |
18 | 188 | 200 | 190 | 203 |
19 | 190 | 199 | 183 | 204 |
20 | 184 | 191 | 189 | 204 |
21 | 189 | 191 | 198 | 201 |
**significantly different from the control p <0.01
Table 4: Reproductive performance (normalised as percentage1)
Experimental group (ppm) | ||||
Reproductive parameter | 0 | 150 | 300 | 600 |
Number of replicates | 16 | 16 | 16 | 16 |
Total eggs laid2 | 852 | 750 | 745 | 561 |
Eggs laid/Maximum laid (%) | 73 | 64 | 64 | 48** |
Eggs cracked/Eggs laid (%) | 4 | 2* | 1** | 1** |
Viable embryos/Eggs set (%) | 88 | 87 | 81 | 76 |
Live 3 week embryos/Viable embryos (%) | 99 | 100 | 97 | 98 |
Hatchlings/Live 3 week embryos (%) | 90 | 92 | 92 | 81 |
14 day old survivors/Hatchling (%) | 99 | 100 | 99 | 100 |
Hatchlings/Eggs set (%) | 78 | 80 | 72 | 59 |
14 day old survivors/Eggs set (%) | 77 | 80 | 72 | 59 |
Hatchlings/Maximum set (%) | 53 | 50 | 46 | 24** |
14 day old survivors/Maximum set (%) | 53 | 50 | 46 | 24** |
*significantly different from the control p <0.05
**significantly different from the control p <0.01
1Values represent pen means for experimental group
2Represents the total number of eggs laid in each group
Table 5: Mean body weight (g) of hatchlings and 14 day old survivors
0 ppm | 150 ppm | 300 ppm | 600 ppm | |
Hatchlings | ||||
Number | 572 | 538 | 495 | 263 |
Mean (± SD) | 37 ± 3 | 38 ± 2 | 37 ± 3 | 38 ± 2 |
14 day old survivors | ||||
Number | 568 | 533 | 482 | 261 |
Mean (± SD) | 260 ± 19 | 278 ± 20 | 276 ± 20 | 256 ± 21 |
The total number of hatchlings weighed may differ from the total number of hatchlings since those found dead were not weighed.
Description of key information
Acute oral toxicity study in the Bobwhite Quail conducted in line with GLP and standardised guideline EPA 71-1; the LD50 value was determined to be 683 mg/kg bw (95 % C.I. 549-818 mg/kg bw).
The dietary toxicity (LC50) of the test material to the mallard duck conducted in line with GLP and standardised guideline EPA 71-2; the LC50 was determined to be >5200 mg/kg diet.
A reproduction study with the Northern bobwhite conducted in line with GLP and standardised guidelines OECD 206 and EPA 71-4; the NOEC was determined to be 150 ppm.
A reproduction study with the Mallard conducted in line with GLP and standardised guidelines OECD 206 and EPA 71-4; the NOEC was determined to be 300 ppm.
Key value for chemical safety assessment
- Short-term EC50 or LC50 for birds:
- 5 200 mg/kg food
- Long-term EC10, LC10 or NOEC for birds:
- 150 mg/kg food
Additional information
In the key GLP compliant acute oral toxicity to birds study conducted in line with standardised guideline EPA 71-1, the acute oral toxicity of the test material to bobwhite quail was determined. The test material was administered by capsule as a single dose, followed by a 15 day observation period, at 0, 400, 800, 1086, 1474 and 2000 mg/kg. Under the conditions of the test the LD50 value was determined to be 683 mg/kg bw (95 % C.I. 549-818 mg/kg bw).
In a supporting GLP compliant acute oral toxicity to birds study conducted in line with standardised guideline EPA 71-1, the acute oral toxicity of the test material to mallard ducks was determined. Under the conditions of the test it was not possible to determine a LD50value because there were no mortalities; the value must be in excess of 50 mg/kg bw, the maximum dose-level at which there were no emetic effects.
In the key GLP compliant short-term dietary toxicity to birds study conducted in line with standardised guideline EPA 71-2, the short-term dietary toxicity of the test material to mallard ducks was determined. The test material was administered by dietary inclusion at 650 1300, 2500 and 5200 ppm. Under the conditions of the test it was not possible to determine a LC50 value because there were only two mortalities at the highest dose level tested. This value must therefore be in excess of 5200 mg/kg diet.
In a supporting GLP compliant short-term dietary toxicity to birds study conducted in line with standardised guideline EPA 71-2, the short-term dietary toxicity of the test material to bobwhite quail was determined. Under the conditions of the test it was not possible to determine a LC50value because of the distribution of the mortalities that occurred; the value appears to be in the region of 5200 ppm, the maximum dose used.
In key GLP compliant reproductive toxicity studies conducted in line with standardised guidelines OECD 206 and EPA 71-4, the reproductive toxicity of the test material to Northern bobwhite quail and mallard duck was determined. The test material was administered by dietary inclusion at 0, 150, 300 and 600 ppm. Under the conditions of the tests the NOEC was determined to be 150 ppm (Northern bobwhite quail) and 300 ppm (mallard).
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