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Ecotoxicological information

Toxicity to birds

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Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles.
Principles of method if other than guideline:
Birds were fed two levels of dietary acid (sulfuric acid) and dietary aluminum. Effects of aluminum or acid on growth-related hormones were compared in mallard ducklings: growth hormone, insuline-like growth factor, and insulin-like growth factor binding proteins (IGFBPs).
GLP compliance:
no
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: see table under "any other information on materials and methods"

ANALYSIS
- Liver samples were analyzed for aluminum, performed by the US Fish and Wildlife Service at Patuxent Wildlife Research Center. Analyses were performed by the dry ash procedure described by Haseltine et al. (1981, Pestic Monit. Jour. 15: 90-97) and a Perkin Elmer Plasma II sequential inductively coupled plasma emission spectrometer.
- Blood samples were obtained via decapitation. Liver, kidney, testis, and bone (tibia) were dissected, weighed, and stored (frozen -20) for possible future analysis. Plasma samples were maintained frozen (-20 °C) for GH, IGF-I, and IGFBP analysis.
Test organisms (species):
Anas platyrhynchos
Details on test organisms:
TEST ORGANISM
- Common name: mallard duck
- Source: Oakridge Game Farm (Gravette, AK, USA); shipped immediately after hatching
- Age at test initiation (mean and range, SD): mean 45.88 g ± 0.07
- Age at test initiation (mean and range, SD): 3-4 days
- Housing: housed in Petersime batteries. Prior to study initiation, all birds wer given control diet ad libitum for 3 days at a temperature of 21 °C with a 12 hour light/dark cycle.
Limit test:
no
Total exposure duration (if not single dose):
15 d
No. of animals per sex per dose and/or stage:
four replicates á two ducklings, number of males/females not specified
Control animals:
yes, plain diet
Nominal and measured doses / concentrations:
low aluminum diet (1000 mg Al/kg)
high aluminum diet (5000 mg Al/kg)
Details on test conditions:
ACCLIMATION
- Acclimation period: 3 days
- Acclimation conditions (same as test or not): yes



NO. OF BIRDS PER REPLICATE
- For negative control: 2
- For treated: 2


NO. OF REPLICATES PER GROUP
- For negative control: 4
- For treated: 4


TEST CONDITIONS (range, mean, SD as applicable)
- Temperature:
- Brooder temperature: 21 °C
- Photoperiod: 12L:12D
Details on examinations and observations:
- Feed intake was measured daily
- body weights and bone lengths were measured on days 0, 3, 6, 10, 13, and 15 of the study
Reference substance (positive control):
no
Reported statistics and error estimates:
Data were analyzed by one way ANOVA, followed by least significant difference or the unpaired t-test where appropriate using the Macintosh Statview 512 program.

In the high-aluminum dose groups (5000 mg/kg), duckling growth and body weight were reduced. In the low-aluminum dose groups (1,000 mg/kg), no differences were found in the duckling growth and body weight. Also no effects on weights of liver, kidney, or testes were found in either of the aluminum-treated groups in comparison to controls. Aluminum concentrations in the liver were 5.16 ppm for the low-aluminum diet, 15.52 ppm for the high-aluminum diet, and 3.59 ppm for the controls. Plasma concentrations of GH and IGF-I also did not differ between the aluminum treatments and controls. Plasma IGFBP levels were increased compared to the controls in the low-aluminum treatment.

Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles.
Principles of method if other than guideline:
Birds were fed two levels of dietary acid (sulfuric acid) and dietary aluminum. Effects on bone growth, mineralization, and phosphorous/calcium homeostasis in growing birds was followed. Consistent with the principles of a good scientific study, but not according to OECD guidelines: birds tested were younger than recommended, lesser number of doses, LC50 was not determined, no analytical measurement of aluminum.
GLP compliance:
no
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: yes
- Preparation of doses: see table under "any other information on materials and methods"
Test organisms (species):
other: Gallus gallus domesticus
Details on test organisms:
TEST ORGANISM
- Common name: chicken, heavy broiler strain
- Source: Avian Services (Frenchtown, NJ, USA)
- Age at test initiation (mean and range, SD): 4 days
- Sexes used: male
- Maintainance: for 3 days prior to study and during 15 days of study in Petersime brooder batteries at 21 °C on a 12L:12D photoperiod
Limit test:
no
Total exposure duration (if not single dose):
15 d
No. of animals per sex per dose and/or stage:
four replicates á three chikens, all male
Control animals:
yes, plain diet
Nominal and measured doses / concentrations:
low aluminum diet (1000 mg Al/kg)
high aluminum diet (5000 mg Al/kg)
Details on test conditions:
ACCLIMATION
- Acclimation period: 3 days
- Acclimation conditions (same as test or not): yes

NO. OF BIRDS PER REPLICATE
- For negative control: 3
- For treated: 3

NO. OF REPLICATES PER GROUP
- For negative control: 4
- For treated: 4

TEST CONDITIONS (range, mean, SD as applicable)
- Temperature:
- Brooder temperature: 21 °C
- Photoperiod: 12 h light:12 h dark
Details on examinations and observations:
At the end of the study, birds were sacrificed and blood and bone samples (whole tibiae) were collected. Plasma samples and bones were stored at -20 °C prior to analysis.
Bones were dried at 60 °C for 72 h and ashed at 650 °C for 24 h. The ash was dissolved in 12N hydrochloric acid. Samples were diluted with 0.1% LaCl3 for calcium analysis (by Perkin-Elmer 560 atomic absorption spectrophotometer) or distilled water for phosphate analysis (Shimadzu UV-160 spectrophotometer).
Plasma 1,25(OH2)D3 concentrations were determined by radioreceptor assay after isolation of the 1,25(OH2)D3 by liquid chromatography. Plasma phosphorus concentration was determined by calorimetric assay using P-phenylene diamine as a reducing agent.
Reference substance (positive control):
no
Reported statistics and error estimates:
Data were analyzed by one way ANOVA, followed by least significant difference or the unpaired t-test where appropriate using the Macintosh Statview 512 program.

Body growth rate (as measured by average daily gain) and skeletal growth (measured by tibial length) were reduced in chicks on the high aluminum and acid diets compared to chicks on the control diet. Tibiae of chicks on the high aluminum diet were soft, spongy, pliable, and easily broken. The wet and dry bone weights for the high aluminum treatment group (5000 mg/kg) were 48% and 58% less (p < 0.05) than the respective bone weights of the chicks on the control diet. Calcium and phosphate in tibiae and plasma were reduced in chicks compared to ad libitum control. The low-aluminum diet had a less-pronounced effect on bone indices, and on calcium and phosphorus levels, with no significant difference between exposed chicks and the pair-fed control.

Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles.
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
Birds were fed two levels of dietary acid (sulfuric acid) and dietary aluminum. Effects on bone growth, mineralization, and phosphorous/calcium homeostasis in growing birds was followed. Consistent with the principles of a good scientific study, but not according to OECD guidelines: birds tested were younger than recommended, lesser number of doses, LC50 was not determined, no analytical measurement of aluminum.
GLP compliance:
no
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: yes
- Preparation of doses: see table under "any other information on materials and methods"
Test organisms (species):
Anas platyrhynchos
Details on test organisms:
TEST ORGANISM
- Common name: mallard duck
- Source: Oakridge Game Farm (Gravette, AK, USA)
- Age at test initiation (mean and range, SD): 4 days
- Sexes used: male/female
- Maintainance: for 3 days prior to study and during 15 days of study in Petersime brooder batteries at 21 °C on a 12L:12D photoperiod
Limit test:
no
Total exposure duration (if not single dose):
15 d
No. of animals per sex per dose and/or stage:
four replicates á two ducklings, number of males/females not specified
Control animals:
yes, plain diet
Nominal and measured doses / concentrations:
low aluminum diet (1000 mg Al/kg)
high aluminum diet (5000 mg Al/kg)
Details on test conditions:
ACCLIMATION
- Acclimation period: 3 days
- Acclimation conditions (same as test or not): yes



NO. OF BIRDS PER REPLICATE
- For negative control: 2
- For treated: 2


NO. OF REPLICATES PER GROUP
- For negative control: 4
- For treated: 4


TEST CONDITIONS (range, mean, SD as applicable)
- Temperature:
- Brooder temperature: 21 °C
- Photoperiod: 12L:12D
Details on examinations and observations:
At the end of the study, birds were sacrificed and blood and bone samples (whole tibiae) were collected. Plasma samples and bones were stored at -20 °C prior to analysis.
Bones were dried at 60 °C for 72 h and ashed at 650 °C for 24 h. The ash was dissolved in 12N hydrochloric acid. Samples were diluted with 0.1% LaCl3 for calcium analysis (by Perkin-Elmer 560 atomic absorption spectrophotometer) or distilled water for phosphate analysis (Shimadzu UV-160 spectrophotometer).
Plasma 1,25(OH2)D3 concentrations were determined by radioreceptor assay after isolation of the 1,25(OH2)D3 by liquid chromatography. Plasma phosphorus concentration was determined by calorimetric assay using P-phenylene diamine as a reducing agent.
Reference substance (positive control):
no

Growth as measured by tibial length was reduced (p < 0.05) in ducklings on the high aluminum diet and high acid dite compared to ducklings receiving the control diet ad libitum but not when compared to pairfed controls. Tibial contents of ash (g), and calcium (%) (p < 0.05) were reduced compared to both ducklings receiving the control diet ad libitum and pairfed controls (ash only). No effects on growth, tibia weight, or length were seen in ducklings fed the low aluminum diet.

Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles.
Principles of method if other than guideline:
The study investigates the role of dietary levels of aluminum, calcium, and phosphorus on growth and survival of pen-reared black ducks and mallards.
Birds were exposed to different regimes of calcium and phosphorus with each regimen divided into different levels of aluminum exposure. Mortality, growth rates for body weight, culmens, wings, and tarsi, as well as food consumption was examined.
Consistent with the principles of a good scientific study, but not according to OECD guidelines: birds tested were younger than recommended, lesser number of doses, LC50 was not determined, no analytical measurement of aluminum.
GLP compliance:
no
Dose method:
feed
Analytical monitoring:
no
Vehicle:
no
Details on preparation and analysis of diet:
DIET PREPARATION
- base diet consisted of commercial turkey starter (28% protein, 3.5% fat, 4.5% fiber, 4-7% ash, 10% moisture, and 45% nitrogen-free extract
Test organisms (species):
other: Anas rubripes
Details on test organisms:
TEST ORGANISM
- Common name: North American black duck
- Source: obtained as eggs from a colony housed at the Patuxent Wildlife Research Center. Original stock for this colony came from the maritime provinces of Canada in areas considered free of mallards and several generations seperated original and current stocks.
- Housing: Eggs were incubated in a Petersime forced-air incubator. Day-old ducklings were randomly assigned to pens. Pens measured 1.5m x 3m. Ducklings were exposed to natural daylight
Limit test:
no
Total exposure duration (if not single dose):
10 wk
No. of animals per sex per dose and/or stage:
at least six per treatment
Control animals:
yes, plain diet
Nominal and measured doses / concentrations:
200, 1000, and 5000 mg Al/kg
Details on test conditions:
PEN SIZE AND CONSTRUCTION MATERIALS
- Description: 1.5m x 3m
- Floor covering: Spillage and soaking were reduced by including clean floor sweepings in weights and by using a partially covered through
- Caging: group

TEST CONDITIONS (range, mean, SD as applicable)
- Photoperiod: natural light
Details on examinations and observations:
- checked daily for mortality and general condition
- weighed and measured weekly (nearest mm) for wing (manus), culmen, and tarsus (tarsometatarsus) length
- bofy weight was initially measured to the nearest g but resolution decreased to the nearest 10g by the end of the study due to sensitivety of spring scales used
- average daily food consumption per duckling measured weekly as the amount of food removed from the through between two consecutive days dived by the number of ducklings alive during that period. If a duckling died during a 24-h period, it was accorded one half-day of consumption
Reference substance (positive control):
yes
Remarks:
high dose Al positive control (10000 mg/kg)
Reported statistics and error estimates:
Analysis of variance and Tukey’s HSD test for pairwise comparisons after log transformation.

Growth was inversely related to aluminum concentration within each treatment regime.

Most of the ducks that died displayed broken or dislocated limbs, rickets, and an inverse relationship between food consumption and Al in the diet. Diets with 10000 mg Al/kg caused stunted growth and mortality. Food consumption significantly decreased in the 5000 and 10000 mg/kg treatment groups.

Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles.
Principles of method if other than guideline:
The study investigates the role of dietary levels of aluminum, calcium, and phosphorus on growth and survival of pen-reared black ducks and mallards. Birds were exposed to different regimes of calcium and phosphorus with each regimen divided into different levels of aluminum exposure. Mortality, growth rates for body weight, culmens, wings, and tarsi, as well as food consumption was examined. Consistent with the principles of a good scientific study, but not according to OECD guidelines: birds tested were younger than recommended, lesser number of doses, LC50 was not determined, no analytical measurement of aluminum.
GLP compliance:
no
Dose method:
feed
Analytical monitoring:
no
Vehicle:
no
Details on preparation and analysis of diet:
DIET PREPARATION
- base diet consisted of commercial turkey starter (28% protein, 3.5% fat, 4.5% fiber, 4-7% ash, 10% moisture, and 45% nitrogen-free extract
Test organisms (species):
Anas platyrhynchos
Details on test organisms:
TEST ORGANISM
- Common name: mallard
- Source: day-old ducklings obtained from a game farm (Frost Game Farms, Coloma, WS, USA)
- Housing: Day-old ducklings were randomly assigned to pens. Pens measured 1.5m x 3m. Ducklings were exposed to natural daylight
Limit test:
no
Total exposure duration (if not single dose):
10 wk
No. of animals per sex per dose and/or stage:
at least six per treatment
Control animals:
yes, plain diet
Nominal and measured doses / concentrations:
200, 1000, and 5000 mg Al/kg
Details on test conditions:
PEN SIZE AND CONSTRUCTION MATERIALS
- Description: 1.5m x 3m
- Floor covering: Spillage and soaking were reduced by including clean floor sweepings in weights and by using a partially covered through
- Caging: group

TEST CONDITIONS (range, mean, SD as applicable)
- Photoperiod: natural light
Details on examinations and observations:
- checked daily for mortality and general condition
- weighed and measured weekly (nearest mm) for wing (manus), culmen, and tarsus (tarsometatarsus) length
- bofy weight was initially measured to the nearest g but resolution decreased to the nearest 10g by the end of the study due to sensitivety of spring scales used
- average daily food consumption per duckling measured weekly as the amount of food removed from the through between two consecutive days dived by the number of ducklings alive during that period. If a duckling died during a 24-h period, it was accorded one half-day of consumption
Reference substance (positive control):
yes
Remarks:
high dose Al positive control (10000 mg/kg)
Reported statistics and error estimates:
Analysis of variance and Tukey’s HSD test for pairwise comparisons after log transformation

Growth was inversely related to aluminum concentration within each treatment regime.

Most of the ducks that died displayed broken or dislocated limbs, rickets, and an inverse relationship between food consumption and Al in the diet. Diets with 10000 mg Al/kg caused stunted growth and mortality. Food consumption significantly decreased in the 5000 and 10000 mg/kg treatment groups.

Endpoint:
long-term toxicity to birds
Data waiving:
other justification
Justification for data waiving:
other:

Description of key information

Key value for chemical safety assessment

Additional information

There are no studies available on birds for the registered substance reaction mass of aluminium hydroxide and aluminium nitrate and aluminium sulphate.

Nevertheless, aluminium is the most abundant metallic element in the Earth's crust. Based on its ubiquitous occurrence the present natural background concentration far outweighs anthropogenic contributions of aluminium to the terrestrial environment. Thus, secondary poisoning is also not considered a relevant route of contribution to the toxicity of aluminium to birds. Furthermore, the existence of a large mammalian dataset demonstrates little toxicity to higher organism. As detailed in the endpoint summary on terrestrial toxicity in general further toxicity testing on terrestrial organisms is thus considered unjustified and waiving based on exposure consideration is applied.

 

Existing data on the toxicity of aluminium to birds is considered to overestimate effects of aluminium. However, for reasons of completeness data are provided in addition and summerised here. Data provided are read-across based on an analogue-approach from three short-term dietary toxicity studies with aluminum applied as aluminum sulphate (Capdevielle et al. 1998, Capdevielle and Scanes 1995, and Sparling 1990).

 

Capdevielle et al. (1998) examined the effects of two levels of dietary aluminum, 1000 and 5000 mg Al/kg, on bone growth, mineralization, and phosphorous/calcium homeostasis in growing mallard ducklings and chicks. Generally, a reduction in bone mineralization was observed in both species. Body growth rate and skeletal growth were reduced in both chicks and ducklings in the high aluminum diet. It was observed that the tibiae of chicks on this diet were soft, spongy, pliable, and easily broken. The levels of calcium and phosphate in tibiae and plasma were reduced in chicks compared to the controls. The low-aluminum diet had a less-pronounced effect with no significant difference between exposed chicks and the pair-fed controls. No effects on growth, tibia weight, or length were seen in ducklings fed the low aluminum diet. Calcium and phosphorus levels in ducklings, though slightly lower than the control, were consistent with or better than those measured in the pair-fed control.

 

In another study by Capdevielle and Scanes (1995) mallards were fed two levels of dietary aluminum. There, effects of aluminum on growth-related hormones were compared, i.e. growth hormone, insuline-like growth factor, and insulin-like growth factor binding proteins (IGFBPs). In the treatment with a high aluminum dose at 5000 mg Al/kg diet, the growth and also body weight were reduced in the mallard ducklings as a consequence of exposure to aluminum. In the treatment with the lower aluminum dose at 1000 mg Al/kg diet, there were no differences found in the ducklings growth rate and body weight. Furthermore, no effects on the weights of organs, i.e. liver, kidney, or testes, were observed in any of the aluminum treated groups when compared to the controls. Aluminum concentrations in the liver were 5.16 ppm for the low-aluminum diet and 15.52 ppm for the high-aluminum diet. In the controls aluminum concentration was 3.59 ppm. Also the plasma concentrations of GH and IGF-I did not differ between the treated animals and controls. However, plasma IGFBP levels were increased in comparison to the controls in the low-aluminum treatment. In conclusion, the results of this study demonstrate that the aluminum diets had no effect on the plasma concentrations of growth hormones and that aluminum influences growth in ducks directly and by reducing feed consumption.

 

Sparling (1990) investigated the role of dietary levels of aluminum, calcium, and phosphorus on growth and survival of black ducks and mallards. The birds were exposed to different regimes of calcium and phosphorus (low Ca and low P, normal Ca and normal P, low Ca and high P) with each regimen further divided into three levels of aluminum exposure (200, 1000, and 5000 mg Al/kg diet). Mortality, growth rates for body weight, culmens, wings, and tarsi, as well as food consumption was studied. This study demonstrated for all growth parameter that growth is inversely related to aluminum concentration regardless of the Ca and P treatment regime in both species of ducks. Most of the ducks that died displayed broken or dislocated limbs, rickets, and an inverse relationship between food consumption and Al in the diet. Diets with 10000 mg Al/kg caused stunted growth and mortality in black ducks and mallards. Food consumption significantly decreased in the 5000 and the 10000 mg Al/kg positive control treatment groups for both black ducks and mallards.