Registration Dossier

Ecotoxicological information

Toxicity to birds

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to birds: acute oral toxicity test
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EPA OPPTS 850.2100 (Avian Acute Oral Toxicity Test)
Deviations:
no
Qualifier:
according to
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
Limit test:
yes
Remarks:
single encapsulated dose
Post exposure observation period:
14 days
No. of animals per sex per dose and/or stage:
5
Control animals:
yes
Nominal and measured doses / concentrations:
292, 486, 810, 1350, 2250 mg a.s./kg bw
Reference substance (positive control):
no
Key result
Dose descriptor:
LD50
Effect level:
2 109 mg/kg bw
Conc. / dose based on:
act. ingr.
Basis for effect:
mortality
Key result
Dose descriptor:
NOEL
Effect level:
292 mg/kg bw
Conc. / dose based on:
act. ingr.
Basis for effect:
body weight
Validity criteria fulfilled:
yes
Conclusions:
LD50 (Northern Bobwhite): 2109 mg a.s./kg bw (mortality)
NOEL (Northern Bobwhite): 292 mg a.s./kg bw (body weight)
Executive summary:

The test substance was administered to fasted northern bobwhite quail (Colinus virginianus) in an acute oral toxicity study. The study was conducted according to U.S. EPA OCSPP Number 850.2100 and FIFRA Subdivision E Section 71-1. Five bobwhite/sex/dose received single oral nominal doses of 0, 292, 486, 810, 1350 and 2250 mg a.s./kg body weight (bw) delivered in a capsule. Birds were observed for clinical signs of toxicity, body weight effects, and mortality for 14 days after dosing. Three birds from each dosage level were examined for gross pathological changes. The acute oral LD50 value for northern bobwhite exposed to the test substance by single oral dose was determined to be 2109 mg a.s./kg bw, with 95% confidence that it is greater than 1350 mg a.s./kg bw. The no mortality level was 1350 mg a.s./kg bw. The no-observed-effect level was 292 mg a.s./kg bw based on a body weight effect at the 486 mg a.s./kg bw dosage group.

Endpoint:
short-term toxicity to birds: acute oral toxicity test
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 223 (Avian Acute Oral Toxicity Test)
Deviations:
no
GLP compliance:
yes
Dose method:
gavage
Analytical monitoring:
yes
Vehicle:
yes
Remarks:
0.5 % (w/v) Sodium Carboxymethyl cellulose (medium viscosity) with 0.1% (v/v) Tween 80 in Milli-Q water
Test organisms (species):
Colomba livia
Limit test:
yes
Remarks:
single dose
Post exposure observation period:
14 days
No. of animals per sex per dose and/or stage:
5 (female)
Control animals:
yes, concurrent vehicle
Nominal and measured doses / concentrations:
2000 mg a.i./kg body weight
Reference substance (positive control):
no
Key result
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Conc. / dose based on:
act. ingr.
Basis for effect:
mortality
Validity criteria fulfilled:
yes
Conclusions:
LD50 (Pigeon): >2000 mg a.i./kg bw (mortality)
Executive summary:

The acute oral toxicity study with the test substance in pigeon was conducted to assess the toxicological profile of the test item as per a limit dose test. The study was conducted according to OECD Guideline 223.

The test substance was administered as oral gavage to five overnight fasted (12 to 15 hours) female pigeons at the dose of 2000 mg a.i./kg body weight. The birds did not show any clinical signs of toxicity and there were no gross findings at necropsy. The birds decreased bodyweight on days 4 and gained body weight on days 8 and 15 when compared to their initial weight. Except one bird decreased body weight on days 4, 8 and 15 compared to their initial weight. The food consumption of the birds was comparable to the control group during days 1-4, 4-8 and 8-15.

The five birds of control group were administered 10 mL/kg body weight of the vehicle. There were no clinical signs of toxicity observed, food consumption was normal and weight of all birds increased throughout the observation period. There were no gross findings at necropsy.

Based on the above findings, the acute oral LD50 value for Pigeon exposed to the test substance as a single oral dose is determined to be greater than 2000 mg a.i./kg body weight.

Endpoint:
short-term toxicity to birds: acute oral toxicity test
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 223 (Avian Acute Oral Toxicity Test)
Deviations:
no
GLP compliance:
yes
Dose method:
gavage
Analytical monitoring:
yes
Vehicle:
yes
Remarks:
0.5% Sodium Caboxymethyl cellulose with 0.1% Tween 80 in Milli-Q-water
Test organisms (species):
other: Gallus gallus domesticus
Limit test:
yes
Remarks:
Single dose
No. of animals per sex per dose and/or stage:
5
Control animals:
yes, concurrent vehicle
Nominal and measured doses / concentrations:
2000 mg a.i./kg bw
Reference substance (positive control):
no
Key result
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Conc. / dose based on:
act. ingr.
Basis for effect:
mortality
Validity criteria fulfilled:
yes
Conclusions:
LD50 (Chicken): >2000 mg a.i./kg bw (mortality)
Executive summary:

The acute oral toxicity study with the test substance in Chicken was conducted to assess the toxicological profile of the test item as per the limit dose test. The study was conducted following OECD Guideline 223.

The test substance was administered as oral gavage to overnight fasted (12 to 15 hours) 5 female chicken at the dose of 2000 mg a.i./kg bw. The birds did not show any clinical signs of toxicity and there were no mortality or gross findings at necropsy. The birds had lost bodyweight on days 4, 8 and 15 when compared to their initial weight. The food consumption of the birds was lower during days 1-4, 4-8 and 8-15.

The five birds of control group were administered 10 mL/kg body weight of the vehicle. There were no clinical signs of toxicity observed; food consumption was normal and weight of all birds increased throughout the observation period. There were no gross findings at necropsy.

Based on the above findings, the acute oral LD50 value for Chicken exposed to the test substance as a single oral dose was determined to be greater than 2000 mg a.i./kg body weight.

Endpoint:
long-term toxicity to birds: reproduction test
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 206 (Avian Reproduction Test)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 850.2300 (Avian Reproduction Test)
Deviations:
no
GLP compliance:
yes
Dose method:
feed
Analytical monitoring:
yes
Vehicle:
yes
Remarks:
Laboratory diet
Test organisms (species):
Colinus virginianus
Limit test:
yes
Total exposure duration (if not bolus):
21 wk
Post exposure observation period:
6 weeks
No. of animals per sex per dose and/or stage:
18 pairs of birds/group
Control animals:
yes
Nominal and measured doses / concentrations:
0, 312.5, 625, and 1250 ppm a.s.
Reference substance (positive control):
no
Key result
Duration (if not bolus):
21 wk
Dose descriptor:
NOEC
Effect level:
625 other: ppm
Conc. / dose based on:
act. ingr.
Basis for effect:
other: clinical observations and reproductive effects
Remarks on result:
other: equivalent to 50.7 mg a.s./kg bw/day
Key result
Duration (if not bolus):
21 wk
Dose descriptor:
LOEC
Effect level:
1 250 other: ppm
Conc. / dose based on:
act. ingr.
Basis for effect:
other: clinical observations and reproductive effects
Remarks on result:
other: equivalent to 99.2 mg a.s./kg bw/day
Validity criteria fulfilled:
yes
Conclusions:
21 weeks NOEC (Northern Bobwhite): 625 ppm a.s. (equivalent to 50.7 mg a.s./kg/day) (clinical observations and reproductive effects)
Executive summary:

A one-generation northern bobwhite (Colinus virginianus) reproduction study was conducted with the test substance. The study was conducted according to OECD Guideline 206, U.S. EPA OCSPP 850.2300. Eighteen pairs of northern bobwhite received test substance in the feed at concentrations of 0, 312.5, 625, and 1250 ppm a.s. for 21 weeks. Reproductive parameters were measured beginning at the onset of egg laying. Adult birds were observed for abnormal behavior, mortality, signs of toxicity, and changes in body weight and food intake. All birds were examined for gross pathological changes.

There were no treatment-related mortalities or treatment-related effects upon body weight or feed consumption at any of the concentrations tested. In addition, there were no overt signs of toxicity and no treatment-related effects upon reproductive performance parameters measured at the 312.5 or 625 ppm a.s. test concentrations. However, at the 1250 ppm a.s. test concentration signs of toxicity were observed, as were slight reductions in viability, hatchability and offspring survival. The reductions in reproductive performance observed resulted in reductions in the number of hatchlings and 14-day old survivors of eggs set. A treatment related effect could not be precluded.

The NOEC for northern bobwhite exposed to the test substance in the diet for 21 weeks was 625 ppm a.s. (equivalent to 50.7 mg a.s./kg/day).

Endpoint:
short-term toxicity to birds: acute oral toxicity test
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EPA OPPTS 850.2200 (Avian Dietary Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 205 (Avian Dietary Toxicity Test)
Deviations:
no
GLP compliance:
yes
Dose method:
feed
Analytical monitoring:
yes
Vehicle:
yes
Remarks:
Diet
Test organisms (species):
Colinus virginianus
Limit test:
yes
Total exposure duration (if not bolus):
5 d
Post exposure observation period:
3 days
No. of animals per sex per dose and/or stage:
Treatment group: 10 chicks
Control group: 30 chicks
Control animals:
yes
Nominal and measured doses / concentrations:
562, 1000, 1780, 3160 and 5620 ppm a.s.
Reference substance (positive control):
no
Key result
Dose descriptor:
LC50
Effect level:
> 5 620 other: ppm
Conc. / dose based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: equivalent to 935 mg a.s./kg body weight/day, the highest concentration tested
Key result
Dose descriptor:
NOEC
Effect level:
1 000 other: ppm
Conc. / dose based on:
act. ingr.
Basis for effect:
body weight
Remarks:
body weight effect observed at the 1780 ppm a.s. (379 mg a.s./kg bw/day)
Remarks on result:
other: equivalent to 189 mg a.s./kg bw/day
Validity criteria fulfilled:
yes
Conclusions:
LC50 (Northern Bobwhite): >5620 ppm a.s. (935 mg a.s./kg bw/day) (mortality) (highest concentration tested)
NOEC (Northern Bobwhite): 1000 ppm a.s. (189 mg a.s./kg bw/day) (body weight)
Executive summary:

The test substance was administered to juvenile northern bobwhite quail (Colinus virginianus) in a dietary LC50 study. The study was conducted according to the U.S. EPA OCSPP Number 850.2200 and OECD Guideline 205.

Thirty northern bobwhite chicks (five per pen) were assigned to the control group and ten northern bobwhite chicks (five per pen) were assigned to each of the treatment groups 562, 1000, 1780, 3160 and 5620 parts per million of active substance of the test substance (ppm a.s.). Birds were observed for clinical signs of toxicity, body weight effects, and mortality for 8 days. Since there were no treatment related mortalities or signs of toxicity, only three birds from each test concentration were examined for gross pathological changes. The LC50 value for northern bobwhite exposed to the test substance in diet was >5620 ppm a.s. (equivalent to 935 mg a.s./kg body weight/day), the highest concentration tested. The no mortality concentration was 5620 ppm a.s. and the no-observed effect concentration was 1000 ppm a.s.

Endpoint:
long-term toxicity to birds: reproduction test
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EPA OPP 71-4 (Avian Reproduction Test)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 850.2300 (Avian Reproduction Test)
Deviations:
no
Qualifier:
according to
Guideline:
other: ASTM Standard E1062-86
Deviations:
no
GLP compliance:
no
Dose method:
feed
Analytical monitoring:
yes
Vehicle:
yes
Remarks:
Diet
Test organisms (species):
Colinus virginianus
Limit test:
yes
Total exposure duration (if not bolus):
6 wk
No. of animals per sex per dose and/or stage:
5
Control animals:
yes
Nominal and measured doses / concentrations:
200, 1000 and 5000 ppm a.s.
Reference substance (positive control):
no
Key result
Duration (if not bolus):
6 wk
Remarks on result:
other: There were no treatment-related mortalities or overt signs of toxicity at any concentration tested. There were no treatment-related effects upon body weight or feed consumption at the 200 or 1000 ppm a.s. test concentrations.
Key result
Duration (if not bolus):
6 wk
Remarks on result:
other: While there was no impact upon egg production at the 200 ppm a.s. test concentration, there may have been a slight delay in the onset of egg production at the 1000 ppm a.s. test concentration.
Remarks:
At the 5000 ppm a.s. test concentration there was a transient, treatment-related effect upon body weight and feed consumption and a marked, treatment-related effect on egg production.
Validity criteria fulfilled:
yes
Conclusions:
There were no treatment-related mortalities or overt signs of toxicity at any concentration tested. While there was no impact upon egg production at the 200 ppm a.s. test concentration, there may have been a slight delay in the onset of egg production at the 1000 ppm a.s. test concentration. At the 5000 ppm a.s. test concentration there was a transient, treatment-related effect upon body weight and feed consumption and a marked, treatment-related effect on egg production.
Executive summary:

The objective of this study was to evaluate the effects upon adult northern bobwhite of dietary exposure to the test substance over a six-week period. The study was conducted following guidelines U.S. EPA OPPTS Number 850.2300, FIFRA Subdivision E Section 71-4, ASTM Standard E1062-86.

Northern bobwhites were exposed to the test substance at dietary concentrations of 0, 200, 1000 and 5000 ppm a.s. There were no treatment-related mortalities or overt signs of toxicity at any concentration tested. There were no treatment-related effects upon body weight or feed consumption at the 200 or 1000 ppm a.s. test concentrations. While there was no impact upon egg production at the 200 ppm a.s. test concentration, there may have been a slight delay in the onset of egg production at the 1000 ppm a.s. test concentration. At the 5000 ppm a.s. test concentration there was a transient, treatment-related effect upon body weight and feed consumption and a marked, treatment-related effect on egg production. While the control group averaged 0.52 eggs/hen/day, the hens in the 5000 ppm a.s. treatment group produced only 0.13 eggs/hen/day.

Endpoint:
short-term toxicity to birds: acute oral toxicity test
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 205 (Avian Dietary Toxicity Test)
Deviations:
no
GLP compliance:
yes
Dose method:
feed
Analytical monitoring:
yes
Vehicle:
yes
Remarks:
diet
Test organisms (species):
Coturnix coturnix japonica
Limit test:
yes
Total exposure duration (if not bolus):
5 d
Post exposure observation period:
3 days
No. of animals per sex per dose and/or stage:
10
Control animals:
yes, plain diet
Nominal and measured doses / concentrations:
5000 ppm
Reference substance (positive control):
no
Key result
Duration (if not bolus):
5 d
Dose descriptor:
other: minimum lethal concentration
Effect level:
> 5 000 other: ppm
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: equivalent to 957.67 mg/kg body weight, highest dose tested
Validity criteria fulfilled:
yes
Conclusions:
Minimum lethal concentration (Japanese quails): >5000 ppm (equivalent to 957.67 mg/kg bw)
Executive summary:

The avian dietary toxicity study with the test substance on Japanese Quails was conducted to assess the toxicological profile of the test substance on repeated exposure to avian species, following OECD Guideline 205.

The study was conducted with 2 control groups and 1 treatment group (limit dose) at the dose of 5000 ppm. The test substance was mixed with feed at the dose of 5000 ppm in diet and fed to quails for 5 days followed by normal feed for 3 days and concurrent control groups were also maintained.

In the treatment group, body weight was lower on days 6 and 9 when compared to the control group. Feed consumption was lower during days 1-6 (treatment period) and was comparable to the control groups during days 6-9 (when fed normal feed). There were no mortality or gross findings at necropsy.

Based on the above results, the acute dietary minimum lethal concentration of the test substance in Japanese quails was greater than 5000 ppm of diet, which was equivalent to 957.67 mg/kg body weight.

Description of key information

5-day LC50 (Northern Bobwhite) > 5620 ppm a.s. (935 mg a.s./kg/day); OECD 205; Reliability = 1

5-day NOEC (Northern Bobwhite) = 1000 ppm a.s. (189 mg a.s./kg/day); OECD 205; Reliability = 1

14-day LD50 (Northern Bobwhite) = 2109 mg a.s./kg; OPPTS 850.2100; Reliability = 1

14-day NOEL (Northern Bobwhite) = 292 mg a.s./kg; OPPTS 850.2100; Reliability = 1

6-week LOEC (Northern Bobwhite) = 1000 ppm a.s.; OPPTS 850.2300; Reliability = 1

21-week NOEC (Northern Bobwhite) = 625 ppm a.s. (50.7 mg a.s./kg/day); OECD 206; Reliability = 1

14-day LD50 (Pigeon) > 2000 mg a.i./kg: OECD 223; Reliability = 1

9-day Minimum lethal concentration (Japanese quails) >5000 ppm (957.67 mg/kg); OECD 205; Reliability = 1

15-day LD50 (Chicken) > 2000 mg a.i./kg; OECD 223; Reliability = 1

Key value for chemical safety assessment

Short-term EC50 or LC50 for birds:
935 mg/kg food
Long-term EC10, LC10 or NOEC for birds:
50.7 mg/kg food

Additional information