Ammonium bromide

Toxicity to birds

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to birds: acute oral toxicity test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

EPA OPP 71-2 (Avian Dietary Toxicity Test)

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Ammonium bromide is an inorganic salt that dissociates to its composite ions in aqueous solutions at environmental pH and temperature. Comparison of the available data on the various bromide salts have shown that the bromide ion is the relevant ion for determination of the toxicological profile with simple cations such as potassium, sodium or ammonium, that are ubiquitous in nature, having little or no influence on the bromide ion properties. It is therefore justified to read-across data from other inorganic bromide salts to ammonium bromide.

Dose method:

capsule

Analytical monitoring:

yes

Vehicle:

yes

Details on preparation and analysis of diet:

no further details

Test organisms (species):

Anas platyrhynchos

Details on test organisms:

Criteria Details
Species/strain Mallard Ducks (Anas platyrhynchos)
Source Whistling Wings Inc., Hanover, IL, USA
Age (in weeks), sex and initial body weight (bw) Age: 16 weeks when received
Bodyweight: 831-1441 g
Equal numbers of males and females
Breeding population Not stated
Amount of food Estimated feed consumption: 57 to 106 g/bird/day
Age at time of first dosing 18-19 weeks
Health condition / medication The ducks had received P.A. bacterin vaccinations at 7 and 14 days of age.

Limit test:

yes

Total exposure duration (if not single dose):

21 d

Post exposure observation period:

no

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

5

Control animals:

yes

Nominal and measured doses / concentrations:

Single dose: 0, 1470 and 2150 mg/kg bw

Details on test conditions:

Criteria Details
Test temperature 48 to 72 °F
Shielding of the animals Not stated
Ventilation Not stated
Relative humidity 81 to 94%
Photoperiod and lighting Daily photoperiod: 8 h
Light source: fluorescent lights

Details on examinations and observations:

Observations were made daily to ascertain the presence or absence of clinical signs indicative of test material effect. Inspections were made daily for mortalities, abundance of food and water, and food spillage

Details on reproductive parameters:

no further details

Reference substance (positive control):

no

Duration (if not single dose):

21 d

Dose descriptor:

LC50

Effect level:

> 2 150 mg/kg bw

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: single oral dose

Repellency factors (if applicable):

N.A

Mortality and sub-lethal effects:

No mortality occurred.

Effects on reproduction:

no further details

Results with reference substance (positive control):

no further details

Further details on results:

no further details

Reported statistics and error estimates:

Analysis of variance was used to assess significant changes in body weights over the course of the observation period.

Test result is equivalent to: LC50 >1668 mg(Br-)/kg bw for the bromide ion

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity test was conducted according to FIFRA guideline 71-2. Mallard ducks were given single oral doses of sodium bromide in capsules and monitored for 21 days afterwards – 10 birds per dose group were tested.
No deaths were recorded during the investigation. No abnormal behavioural reaction or systemic signs of toxicity were noted among the control or dose groups. Statistical analysis of the body weights showed no statistically significant variations. Food consumption depressions were noted in the higher dose group compared to those of the control group at each interval. Gross pathological examinations on selected birds revealed no abnormal tissue alterations.

Reference 2

Endpoint:

short-term toxicity to birds: dietary toxicity test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

EPA OPP 71-2 (Avian Dietary Toxicity Test)

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
no further details

Dose method:

feed

Analytical monitoring:

no

Vehicle:

yes

Details on preparation and analysis of diet:

Carrier / Vehicle Details
Water No
Organic carrier Yes - corn oil
Concentration of the carrier [% v/v] 2% in the feed
Other vehicle N/A
Function of the carrier / vehicle To facilitation of uptake and digestion

Test organisms (species):

Anas platyrhynchos

Details on test organisms:

Criteria Details
Species/strain Mallard ducks (Anas platyrhynchos)
Source Whistling Wings, Hanover, Illinois, USA
Age (in weeks), sex and initial body weight (bw) Age: 10 days at study initiation
Bodyweight: 148-157 g
Sex: birds were too immature to differentiate between the sexes.
Age range within the test All birds were aged 10 days at test initiation
Breeding population All birds were born on the day they were received at the testing laboratory.
Age at time of first dosing 10 days
Health condition / medication No medication was given to the birds during acclimation or the test.

Limit test:

yes

Total exposure duration (if not single dose):

5 d

Post exposure observation period:

3 days

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

10

Control animals:

yes

Nominal and measured doses / concentrations:

nominal test material concentrations of 563, 1002, 1784, 3167 and 5633 ppm a.i.

Details on test conditions:

Criteria Details
Test temperature Brooding compartment: 31 ± 4 °C
Ambient room temperature: 22 ± 2 °C
Shielding of the animals Not stated
Ventilation Not stated
Relative humidity 33 %
Photoperiod and lighting Daily photoperiod: 16 h
Type of light: chroma 50 fluorescent lights
Lighting intensity: 12 foot candles of illumination

Details on examinations and observations:

All birds were observed at least twice daily for mortality, signs of abnormal behaviour or toxicity.

Details on reproductive parameters:

no further details

Reference substance (positive control):

no

Duration (if not single dose):

5 d

Dose descriptor:

LC50

Effect level:

> 5 633 other: ppm

Basis for effect:

mortality

Mortality and sub-lethal effects:

One death was noted in the 1784 ppm dose group on day 8. The mortality occurred during pen maintenance and was not considered treatment related.
All birds in the control, 563, 1002 and 1784 ppm dose groups were normal in appearance and behaviour throughout the study.
At 3167 ppm concentration, signs of toxicity were first noted in all birds on the afternoon of day 4. Two to five birds continued to display signs through the morning of day 8.
At the 5633 ppm concentration, signs of toxicity were first noted on the afternoon of day 4 and continued through the morning of day 7. Recovery was evident in most birds by the morning of day 8, although three birds continued to display signs of toxicity.
Signs of toxicity typical of intoxication with sodium bromide included lethargy, slight to severe ataxia (increasing with external stimuli) and loss of righting reflex.
When compared to controls, there was no effect on body weights or feed consumption at any of the concentrations tested.

Effects on reproduction:

no further details

Results with reference substance (positive control):

no further details

Further details on results:

no further details

Reported statistics and error estimates:

The mortality pattern in this study was not conducive to calculating the LC50 value. Therefore, an estimation of the LC50 value was made by a visual inspection of the mortality data.

Test result is equivalent to: LC50 >4371 ppm for the bromide ion

Validity criteria fulfilled:

no

Conclusions:

The acute toxicity test was conducted according to EPA FIFRA Guideline 71-2 and ASTM Standard E857-81. Mallard ducks were given sodium bromide in their feed (563 to 5633 ppm) daily for 5 days and monitored for 3 additional days afterwards – 10 birds per dose group were tested.
One death occurred during the course of the study, but this was not considered to be substance related. Signs of toxicity typical of intoxication with sodium bromide included lethargy, slight to severe ataxia (increasing with external stimuli) and loss of righting reflex. When compared with the controls there was no effect on body weight or consumption at any of the concentrations tested.
The NOEC was determined to be 1784 ppm based upon signs of toxicity at the 3167 ppm concentration.

Reference 3

Endpoint:

short-term toxicity to birds: acute oral toxicity test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

EPA OPP 71-1 (Avian Acute Oral Toxicity Test)

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Ammonium bromide is an inorganic salt that dissociates to its composite ions in aqueous solutions at environmental pH and temperature. Comparison of the available data on the various bromide salts have shown that the bromide ion is the relevant ion for determination of the toxicological profile with simple cations such as potassium, sodium or ammonium, that are ubiquitous in nature, having little or no influence on the bromide ion properties. It is therefore justified to read-across data from other inorganic bromide salts to ammonium bromide.

Dose method:

gavage

Analytical monitoring:

no

Vehicle:

no

Details on preparation and analysis of diet:

Carrier / Vehicle Details
Water Yes – distilled water
Organic carrier N/A
Concentration of the carrier [% v/v] Various
Other vehicle N/A
Function of the carrier / vehicle Solvent for test substance, facilitation of uptake and digestion)

Test organisms (species):

Colinus virginianus

Details on test organisms:

Criteria Details
Species/strain Bobwhite quail (Colinus virginianus)
Source Fritts Quail Farm, Phillipsburg, New Jersey
Age (in weeks), sex and initial body weight (bw) Age: 18 weeks
Bodyweight: 161-194 g
Equal numbers of males and females
Breeding population Not stated
Amount of food Feed was offered ad libitum. Estimated feed consumption: 19 to 43 g/bird/day
Age at time of first dosing Age 18 weeks at study initiation
Health condition / medication No antibiotic medication was given to the birds during the study. All birds appeared healthy at study initiation.

Limit test:

yes

Total exposure duration (if not single dose):

1

Remarks:

1 oral 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:

Single oral dose: 0, 292, 486, 810, 1350 and 2250 mg a.i./kg bw. Volume of dose/vehicle 6 mL for all birds.

Details on test conditions:

Criteria Details
Test location Indoor in holding pens
Holding pens Type: batteries of pens
Size: ceiling height ranged from 20 to 25 cm, floor space measured approx 51 x 78 cm.
Material: External walls, ceiling and floor were constructed of galvanised wire, side walls were constructed of galvanised sheeting.
Number of animals 60
Number of animals per pen [cm²/bird] 5 animals per pen, 800 cm2 / bird
Number of animals per dose 5 birds/sex/dose
Pre-treatment / acclimation All test birds were acclimated to the caging and facilities for 3 weeks prior to the initiation of the study. Throughout acclimation and testing all test birds were fed a game bird ration. Water and feed were provided ad libitum during the acclimation.
Diet during test Diet formulation: %
Fine corn meal 37.45
Ground oats 5.00
Alfalfa meal dehydrated 3.00
CDP (phosphate source) 0.70
Dry whey 2.50
Fish meal 6.00
Meat poultry blend 4.00
Wheat midds 5.00
Soy bean meal 34.80
Salt iodized 0.10
Ground limestone 0.60
GL ferm 0.25
Methionine Premix 0.20
Vitamin and mineral premix 0.40
Vitamin mix included: vitamins A, B12, D3, E and K, riboflavin, niacin, pantothenic acid, folic acid, biotin, pyridoxine, thiamine, manganese, zinc, copper, iodine, iron and selenium.
Dosage levels (of test substance) Single oral dose: 0, 292, 486, 810, 1350 and 2250 mg a.i./kg bw. Volume of dose/vehicle 6 mL for all birds.
Replicate/dosage level 5 birds/sex/dose level – no other replicates
Feed dosing method By gavage
Dosing volume per application Dosing quantity varied according to the weight of the bird.
Frequency, duration and method of animal monitoring after dosing Post observation period: 14 days. Animals were observed twice daily for mortality, signs of toxicity or abnormal behaviour.
Time and intervals of body weight determination Body weights were measured at initiation of the test and by group on days 3, 7 and 14 of the test.

Details on examinations and observations:

Animals were observed twice daily for mortality, signs of toxicity or abnormal behaviour.

Details on reproductive parameters:

no further details

Reference substance (positive control):

no

Duration (if not single dose):

14 d

Dose descriptor:

LC50

Effect level:

> 2 250 mg/kg bw

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: single oral dose

Duration (if not single dose):

14 d

Dose descriptor:

NOEC

Effect level:

292 mg/kg bw

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: single oral dose

Repellency factors (if applicable):

N.A

Mortality and sub-lethal effects:

No mortalities occurred in any dose groups
292 mg/kg: all birds were normal in appearance and behaviour.
486 mg/kg: signs of toxicity were first noted in one bird on the morning of day 1. By the morning of day 2, two birds were displaying signs of toxicity. Recovery was evident by the morning of day 3, although one bird displayed a ruffled appearance on day 5. All birds were normal in appearance and behaviour from the morning of day 6 until study termination.
810 mg/kg: signs of toxicity were first noted in three birds on the afternoon of day 1. One bird was noted displaying signs on the morning of day 2 and another on the morning of day 3. From the afternoon of day 3 until study termination, all birds were normal in appearance and behaviour.
1350 mg/kg: signs of toxicity were first observed in two birds on the morning of day 1. Signs continued to be displayed in as many as five birds throughout the afternoon of day 3. All birds were normal in appearance and behaviour from the morning of day 4 until study termination with the exception of one bird which was noted with a slight head injury on the afternoon of day 7.
2250 mg/kg: signs of toxicity were first observed in three birds on the afternoon of day 0. Signs continued to be displayed in as many as ten birds through the afternoon of day 3. All birds normal in appearance and behaviour from the morning of day 4 until study termination.
Signs of toxicity typical of intoxication with sodium bromide included lethargy, wing droop, riffled appearance, and slight to severe intermittent ataxia (increasing with external stimuli).
When compared to controls, there was no effect on body weight or feed consumption at any dosage level.

Effects on reproduction:

no further details

Results with reference substance (positive control):

no further details

Further details on results:

no further details

Reported statistics and error estimates:

The mortality pattern in this study was not conducive to calculating the LD50 value. Therefore, an estimation of the LD¬50¬ value was made by a visual inspection of the mortality data.

Test result is equivalent to: LC50 >1746 mg(Br-)/kg bw for the bromide ion

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity test was conducted according to FIFRA guideline 71-1. Bobwhite quail were given single oral doses of sodium bromide by gavage and monitored for 14 days afterwards – 10 birds per dose group were tested.
No mortalities occurred in any dose groups. When compared to controls, there was no effect on body weight or feed consumption at any dosage level. Various signs of toxicity were observed in each dose groups at some point during the first week except the lowest dose and control groups. No signs persisted into the second week of observation.
Validity criteria can be considered as fulfilled. See validity criteria summarized in table A7_5_3_1_1(1)-6.

Reference 4

Endpoint:

short-term toxicity to birds: dietary toxicity test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

EPA OPP 71-2 (Avian Dietary Toxicity Test)

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Ammonium bromide is an inorganic salt that dissociates to its composite ions in aqueous solutions at environmental pH and temperature. Comparison of the available data on the various bromide salts have shown that the bromide ion is the relevant ion for determination of the toxicological profile with simple cations such as potassium, sodium or ammonium, that are ubiquitous in nature, having little or no influence on the bromide ion properties. It is therefore justified to read-across data from other inorganic bromide salts to ammonium bromide.

Dose method:

feed

Analytical monitoring:

no

Vehicle:

yes

Details on preparation and analysis of diet:

Carrier / Vehicle Details
Water No
Organic carrier Yes - corn oil
Concentration of the carrier [% v/v] 2% in the feed
Other vehicle N/A
Function of the carrier / vehicle To facilitation of uptake and digestion

Test organisms (species):

Colinus virginianus

Details on test organisms:

Criteria Details
Species/strain Bobwhite quail (Colinus virginianus)
Source Fritt’s Quail Farm, Phillipsburg, New Jersey
Age (in weeks), sex and initial body weight (bw) Age: 10 days at study initiation
Bodyweight: 18-20 g
Sex: birds were too immature to differentiate between the sexes.
Age range within the test All birds were aged 10 days at test initiation
Breeding population All birds were born on the day they were received at the testing laboratory.
Age at time of first dosing 10 days
Health condition / medication No medication was given to the birds during acclimation or the test.

Limit test:

yes

Total exposure duration (if not single dose):

5 d

Post exposure observation period:

3 days

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

10

Control animals:

yes

Nominal and measured doses / concentrations:

nominal test material concentrations of 563, 1002, 1784, 3167 and 5633 ppm a.i.

Details on test conditions:

Criteria Details
Test temperature Brooding compartment: 38 ± 3 °C
Ambient room temperature: 21 ± 2 °C
Shielding of the animals Not stated
Ventilation Not stated
Relative humidity 24 %
Photoperiod and lighting Daily photoperiod: 16 h
Type of light: chroma 50 fluorescent lights
Lighting intensity: 12 foot candles of illumination
Criteria Details
Test location Indoor in holding pens
Holding pens Floor space: 72 x 90 cm
Ceiling height: 23 cm.
The external walls, ceilings and floors of the thermostatically controlled brooding pens were made of galvanised steel wire and sheeting.
Number of animals 100
Number of animals per pen [cm²/bird] 10 animals per pen, 648 cm2 per bird
Number of animals per dose 10 animals per dose group
Pre-treatment / acclimation Birds were acclimated to the caging and facilities for 10 days.
Throughout acclimation and testing all birds were fed a game bird ration. Water and feed were provided ad libitum during acclimation and the test. The chicks were given a vitamin supplement in their water from the day they were received until the initiation of the study.
Diet during test Throughout acclimation and testing all birds were fed a game bird ration. Water and feed were provided ad libitum during acclimation and the test. The chicks were given a vitamin supplement in their water from the day they were received until the initiation of the study.
Diet formulation: %
Fine corn meal 37.45
Ground oats 5.00
Alfalfa meal dehydrated 3.00
CDP (phosphate source) 0.70
Dry whey 2.50
Fish meal 6.00
Meat poultry blend 4.00
Wheat midds 5.00
Soy bean meal 34.80
Salt iodized 0.10
Ground limestone 0.60
GL ferm 0.25
Methionine Premix 0.20
Vitamin and mineral premix 0.40
Vitamin mix included: vitamins A, B12, D3, E and K, riboflavin, niacin, pantothenic acid, folic acid, biotin, pyridoxine, thiamine, manganese, zinc, copper, iodine, iron and selenium.
Dosage levels (of test substance) Diet (offered ad libitum) contained nominal test material concentrations of 563, 1002, 1784, 3167 and 5633 ppm a.i.
Replicate/dosage level 10 birds per dose group, 5 control groups.
Dosing method Orally – test material in diet
Dosing volume per application Feed offered ad libitum
Frequency, duration and method of animal monitoring after dosing All birds were observed at least twice daily for mortality, signs of abnormal behaviour or toxicity.
Time and intervals of body weight determination Body weights by group were measured at initiation of the study, on day 5, and at termination of the test on day 8.

Details on examinations and observations:

All birds were observed at least twice daily for mortality, signs of abnormal behaviour or toxicity.

Details on reproductive parameters:

no further details

Reference substance (positive control):

no

Duration (if not single dose):

5 d

Dose descriptor:

LC50

Effect level:

> 5 633 mg/kg diet

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Repellency factors (if applicable):

N.A.

Mortality and sub-lethal effects:

No mortality occurred.
At the 563, 1002 and 1784 ppm concentrations, there were no overt signs of toxicity and all birds were normal in appearance and behaviour throughout the study.
At the 3167 ppm concentration, signs of toxicity were first observed on the afternoon of day 5 in two birds. One to two birds continued to display signs of toxicity through the afternoon of day 7. All other birds at this concentration were normal in appearance and behaviour throughout the test period.
At the 5633 pm concentration, signs of toxicity were first observed on the morning of day 5 in five birds. Two to five birds continued to display signs through the morning of day 8. One bird was noted with lesions from toe-picking, a cannibalistic form of aggression from the afternoon of day 3 through the morning of day 8. All other birds at this concentration were normal in appearance and behaviour throughout the study.

Effects on reproduction:

no further details

Results with reference substance (positive control):

no further details

Further details on results:

no further details

Reported statistics and error estimates:

The mortality pattern in this study was not conducive to calculating the LC50 value. Therefore, an estimation of the LC50 value was made by a visual inspection of the mortality data.

Test result is equivalent to: LC50 >4371 ppm for the bromide ion

Validity criteria fulfilled:

no

Conclusions:

The acute toxicity test was conducted according to EPA FIFRA Guideline 71-2 and ASTM Standard E857-81. Bobwhite quail were given sodium bromide in their feed (563 to 5633 ppm) daily for 5 days and monitored for 3 additional days afterwards – 10 birds per dose group were tested.
No mortalities occurred during the course of the study. Signs of toxicity typical of intoxication with sodium bromide included slight to severe ataxia (increasing with external stimuli), wing droop, lethargy, ventral head curl, and loss of righting reflex. When compared with the controls there was no effect on body weight or consumption at any of the concentrations tested.
The NOEC was determined to be 1784 ppm based upon signs of toxicity at the 3167 ppm concentration.

Description of key information

Acute toxicity tests on Bobwhite quail (Colinus virginianus) and mallard duck (Anas platyrhynchos) were conducted with sodium bromide according to FIFRA guideline 71-1 and ASTM Standard E857-81. No mortalities occurred during the course of the study for mallard duck. Signs of toxicity typical of intoxication with sodium bromide included slight to severe ataxia (increasing with external stimuli), wing droop, lethargy, ventral head curl, and loss of righting reflex. When compared with the controls there was no effect on body weight or consumption at any of the concentrations tested. The 5-d LC50 > 5633 mg/kg for both species.

Key value for chemical safety assessment

Short-term EC50 or LC50 for birds:

5 633 mg/kg food

Additional information

Ammonium bromide is an inorganic salt that dissociates to its composite ions in aqueous solutions at environmental pH and temperature. Comparison of the available data on the various bromide salts have shown that the bromide ion is the relevant ion for determination of the toxicological profile with simple cations such as potassium, sodium or ammonium, that are ubiquitous in nature, having little or no influence on the bromide ion properties. It is therefore justified to read-across data from other inorganic bromide salts to ammonium bromide.

An acute toxicity test was conducted according to FIFRA guideline 71-1 and ASTM Standard E857-81. Bobwhite quail (Colinus virginianus) and mallard duck (Anas platyrhynchos) were given single oral doses of sodium bromide by gavage and monitored for 14 days afterwards – 10 birds per dose group were tested. No mortalities occurred in any dose groups of bobwhite quail. When compared to controls, there was no effect on body weight or feed consumption at any dosage level. Various signs of toxicity were observed in each dose groups at some point during the first week except the lowest dose and control groups. No signs persisted into the second week of observation. No mortalities occurred during the course of the study for mallard duck. Signs of toxicity typical of intoxication with sodium bromide included slight to severe ataxia (increasing with external stimuli), wing droop, lethargy, ventral head curl, and loss of righting reflex. When compared with the controls there was no effect on body weight or consumption at any of the concentrations tested. The 5-d LC50 > 5633 mg/kg for both species.