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EC number: 236-751-8 | CAS number: 13473-90-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Studies of repeated dose toxiicity are available for the oral route of exposure. A modern guideline-compliant study performed with a read-across substance provides comparanle results to older published drinking water stuides performed with aluminium nitrate
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Published study comparable to guidelines but with investigation of more limited parameters and performed in females only
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of tats were exposed to aluminium nitrate via drinking water at three different concentrations for a total of 100 days
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna, Spain
- Weight at study initiation: 70.5 +- 4.4 g
- Housing: individually in metabolism cages
- Diet: ad libitum (perfectly balanced Panlab diet, Barcelona, Spain)
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
no data - Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Solutions were prepared weekly to adjust the dose to achieve a constant intake. Sugar was added to reduce the aversive effect of the aluminum in the
water (taste). Similar quantities of sugar were also added to tbe drinking water of control animals in order to make comparable the results.
The rats were housed individually in metabolism cages throughout the study and food and waterconsumption ,volume of urine excreted and faecal weight eliminated were measured daily. Bodyweights were recorded weekly and protein efficiency coefficients calculated based on nitrogen ingested and weight gain per unit time. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 100 days
- Frequency of treatment:
- continuous via drinking water - nominal dose concentrations were 360, 720 and 3600 mg/kg bw/d as aluminium nitrate nonahydrate
- Remarks:
- Doses / Concentrations:
0, 360, 70, 3600 mg/kg bw/d
Basis:
nominal in water - No. of animals per sex per dose:
- 10 females per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: doses were selected at 1/10, 1/5 and 1/1 of the acute oral LD50 (gavage)
- Positive control:
- no data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes, but not specified
DETAILED CLINICAL OBSERVATIONS: Yes, but not specified
BODY WEIGHT: Yes
- Time schedule for examinations: before the start of the experiment and weekly throughout the 100 days
FOOD CONSUMPTION: Yes, daily
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes, daily
VOLUME OF URINE EXCRETED: Yes, daily
FECES WEIGHT EXCRETED: Yes, daily
CALCULATION OF PROTEIN EFFICIENCY COEFFICIENT: Yes, weekly
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY/CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: blood samples were taken every month and at the end of the experiment
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 5 animals
- Parameters examined: hematocrit measurements and hemoglobin, plasma levels of glutamic-pyruvic and glutamic-oxalacetic transaminases, alkaline phosphatase, urea, creatinine, uric acid, total protein, cholesterol and glucose
URINALYSIS: Yes
- Time schedule for collection of urine: daily
- Metabolism cages used for collection of urine: Yes
- Animals fasted: No data
- Parameters examined: daily urine volume
OTHER: Aluminum concentrations in brain, heart, lungs, kidneys, liver, spleen, abdominal muscle, bone and blood were measured by atomic absorption spectrophotometry. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes: After 100 days of treatment, the animals were killed and the weight of brain, heart, lungs, kidneys, liver and spleen
measured.
HISTOPATHOLOGY: Yes: Histological tissue examination (paraffin slices, hematoxylin-eosin) was made of heart, liver, kidney, spleen, brain and
cerebellum samples in three rats from each group. - Other examinations:
- None detailed
- Statistics:
- Nutritional parameters, hematological data, clinical chemistry and the concentrations of aluminum were evaluated first by analysis of variance. Any
significant effects disclosed were further analyzed by Student's t-test. In all cases a minimum level of significance of P<0.05 was used. - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No mortality was observed, no data on clinical signs
BODY WEIGHT AND WEIGHT GAIN
A significant decrease in weight gain was observed in the animals of the highest dose group. The animals in the low and mid dose group did not show significant differences in body weights.
FOOD CONSUMPTION
The food consumption was significantly decreased in the animals of the highest dose group.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study)
The drinking water intake was significantly decreased in the animals of the highest dose group (urinary excretion volume also reduced in this group).
VOLUME OF URINE EXCRETED
The volume of urine excreted was significantly decreased in the animals of the highest dose group.
FECES EXCRETED
The faeces excreted was significantly decreased in the animals of the highest dose group.
HAEMATOLOGY/CLINICAL CHEMISTRY
Only slight variations in some determinations occurred randomly in treated animals (GPT and alkaline phosphatase for the high dose group and urea
for the mid dose group).
URINALYSIS
The volume of excreted urine was significantly decreased in the animals of the highest dose group.
ORGAN WEIGHTS
At the end of the treatment, tbe fresh weight of the organs were measured in ten animals from each group. There were no significant differences between the control and treated groups when expressed relative to body weight.
HISTOPATHOLOGY: NON-NEOPLASTIC
Histological examinations of the various organs showed no anomalies either in the treated animals or in the cantrols. With regard to the bone tissue, it showed a mild hypotrophy upon tbe calcifying cartilage bands of the epiphyseal disk.
OTHER FINDINGS
The concentrations of aluminum in tissues of rats given aluminum nitrate were higher for the treated animals than for the controls. However, no significant relationship between dose and accumulation could be observed. - Dose descriptor:
- NOAEL
- Effect level:
- 720 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Reduced body weight (gain), food consumption, water consumption, volume of urine excreted and feces excreted
- Dose descriptor:
- NOAEL
- Effect level:
- 409 mg/kg bw/day (nominal)
- Based on:
- other: anhydrous aluminium nitrate
- Sex:
- female
- Critical effects observed:
- not specified
- Conclusions:
- A NOAEL of 720 mg/kg bw/d (equivalent to 409 mg/kg bw/d anhydrous aluminium nitrate) can be calculated for this study based on bodyweight changes, reduced water consumption and urinary excretion, and effects on nutritional parameters noted at the highest dose level.
- Executive summary:
Aluminium nitrate was administered by inclusion in drinking water. Four groups of female Sprague-Dawley rats were treated at 0, 360, 720 or 3600 mg/kg bw/d over a period of one hundred days. Weight gain, food intake, water consumption, haematology and serum chemistry parameters were checked regularly through out the study. Ingestion of aluminium nitrate by rats resulted in significant growth retardation and significantly lower nutritional parameters. Aluminium did not show any dose-related accumulation in any of the organs or tissues examined. No histopathological changes of note were observed and organ weights showed no significant treatment-related changes. A NOAEL of 720 mg/kg bw/d (equivalent to 409 mg/kg bw/d anhydrous aluminium nitrate) can be calculated for this study based on bodyweight changes, reduced water consumption and urinary excretion, and effects on nutritional parameters noted at the highest dose level.
Reference
Nutritional effects in rats treated with aluminium nitrate in drinking water for 100 days
Dose 0, 360, 720 or 3600 mg/kg bw/d - Al (NO3)3.9H20
|
Study time |
|||||||
Week 1/2 |
Week 3/4 |
Week 5/6 |
Week 7/8 |
Week 9/10 |
Week 11/12 |
Week 13/14 |
Week 15/16 |
|
Drinking water (mL) |
|
|||||||
Control |
365.0 |
350.2 |
355.5 |
416.7 |
422.2 |
477.5 |
466.7 |
2853.8 |
360 |
325.8* |
344.8 |
357.5 |
347.7** |
317.2*** |
386.5*** |
374.7 |
2454.2 |
720 |
301.5** |
294.8* |
324.2 |
272.7*** |
266.2*** |
271.8*** |
347.1** |
2078.3 |
3600 |
155.7*** |
182.2*** |
180.3*** |
223.5*** |
221.3*** |
209.0*** |
184.3*** |
1356.3 |
Nitrogen ingested |
|
|||||||
Control |
7.73 |
8.63 |
9.33 |
8.95 |
8.36 |
8.87 |
8.50 |
60.37 |
360 |
6.71* |
8.33 |
8.55 |
8.54 |
7.75 |
7.28 |
7.89 |
55.05 |
720 |
7.22 |
8.27 |
8.28 |
7.09** |
7.29 |
5.95** |
7.41 |
51.51 |
3600 |
5.70*** |
6.43*** |
4.74*** |
6.05*** |
4.76*** |
4.22*** |
4.52*** |
36.12 |
Weight gain (g) |
|
|||||||
Control |
71.5 |
26.9 |
53.9 |
6.8 |
19.4 |
19.7 |
8.6 |
192.2 |
360 |
65.9 |
42.6 |
44.2 |
2.7 |
33.0 |
18.7 |
-9.5* |
197.6 |
720 |
67.8 |
25.6 |
42.8* |
0.0 |
20.0 |
16.0 |
13.9 |
186.1 |
3600 |
35.3*** |
26.0 |
40.4** |
3.0 |
16.3 |
-13.7*** |
-7.1** |
100.2 |
PEC |
|
|||||||
Control |
9.2 |
3.1 |
5.8 |
0.8 |
2.3 |
2.2 |
1.0 |
3.3 |
360 |
9.8 |
5.1 |
5.2 |
0.3 |
4.3 |
26 |
-1.2 |
3.6 |
720 |
9.4 |
3.1 |
5.2 |
0.0 |
2.8 |
2.7 |
1.9 |
3.6 |
3600 |
6.2* |
4.0 |
8.5 |
0.5 |
3.4 |
-3.2 |
-1.6 |
2.8 |
Urine excreted (mL) |
|
|||||||
Control |
65.0 |
99.5 |
95.8 |
123.6 |
153.5 |
140.8 |
98.1 |
776.3 |
360 |
50.3 |
78.3 |
95.5 |
92.3* |
96.2*** |
83.3*** |
88.5 |
584.4 |
720 |
45.0* |
65.2* |
75.7* |
79.8** |
76.3*** |
66.5*** |
73.8** |
482.3 |
3600 |
25.3*** |
30.1*** |
33.8*** |
53.3*** |
47.5*** |
34.1*** |
37.0*** |
262.1 |
Faeces (g) |
|
|
|
|
|
|
|
|
Control |
64.3 |
82.0 |
87.5 |
81.1 |
80.3 |
87.5 |
84.8 |
567.5 |
360 |
55.3* |
78.5 |
83.1 |
76.3 |
81.8 |
85.2 |
75.7 |
535.9 |
720 |
54.4** |
73.2* |
75.8* |
72.3 |
73.5 |
85.5** |
64.7** |
489.4 |
3600 |
36.8*** |
53.0*** |
55.2*** |
53.4*** |
50.5*** |
54.5*** |
51.2*** |
354.6 |
*p<0.05; **p<0.01; ***p<0.001 PEC = protein efficiency coefficient = weight gain/nitrogen divided |
Blood investigations for control and aluminium treated rats exposed over 100 days
Blood parameter |
Dose (mg/kg bw/d) Al (NO3)3.9H20 |
|||
0 |
360 |
720 |
3600 |
|
Haematocrit (%) |
37 |
40 |
35 |
26 |
Haemoglobin (g/100 mL) |
13.8 |
15.2 |
13.0 |
10.0 |
GOT (U/l) |
158 |
110 |
147 |
163 |
GPT (U/l) |
71 |
76 |
80 |
53* |
ALP |
145 |
112 |
113 |
231* |
Urea (mg/100 mL) |
45.8 |
44.9 |
62.5* |
57.6 |
Creatinine (mg/100 mL) |
1.0 |
1.1 |
1.1 |
1.0 |
Uric acid (mg/100 mL) |
2.4 |
2.3 |
2.6 |
2.1 |
Total protein (g/100 mL) |
9.2 |
8.2 |
8.8 |
7.7 |
Cholesterol (mg/100 mL) |
105 |
113 |
102 |
130 |
Glucose (mg/100 mL) |
106 |
127 |
107 |
109 |
Relative organ weights (g/100g BW) for control and aluminium treated rats exposed to aluminium nitrate in drinking water over 100 days
Organ weight |
Dose (mg/kg bw/d) Al (NO3)3.9H20 |
|||
0 |
360 |
720 |
3600 |
|
Brain |
0.65 |
0.62 |
0.64 |
0.92 |
Heart |
0.32 |
0.31 |
0.33 |
0.35 |
Lungs |
0.60 |
0.54 |
0.58 |
0.68 |
Kidneys |
0.61 |
0.64 |
0.66 |
0.79 |
Liver |
2.89 |
2.73 |
2.94 |
2.70 |
Spleen |
0.16 |
0.15 |
0.15 |
0.21 |
Tissue concentrations of aluminium following 100 days administration of aluminium nitrate
|
Dose (mg/kg bw/d) Al (NO3)3.9H20 |
|||
0 |
360 |
720 |
3600 |
|
Brain |
ND |
4.93 |
2.09 |
4.28 |
Heart |
1.31 |
2.19 |
2.58 |
4.29 |
Lungs |
ND |
28.9 |
11.5 |
17.2 |
Kidneys |
0.78 |
5.20 |
2.30 |
3.36 |
Liver |
ND |
7.05 |
3.58 |
4.66 |
Spleen |
ND |
1.67 |
4.89 |
4.21 |
Muscle |
ND |
1.34 |
6.58 |
3.33 |
Bone |
17.15 |
75.08** |
79.18** |
56.39** |
Blood |
ND |
ND |
ND |
ND |
*p<0.05; **p<0.01 Limit of detection 0.5 µg/g |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 409 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- A modern guideline-compliant screening study with a read-across substance and two drinking water studies perfomred with aluminium nitrate are available.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a combined repeated dose / reproductive screening study (OECD 422), administration of the read-across substance aluminium chloride by oral gavage to male and female rats at dose levels of 20, 200 or 1000 mg /kg/d (equivalent to 3.6, 18 and 90 mg/kg bw/d Al) was studied. No toxic effects were observed in females at any dose level. Therefore, the overall NOAEL for female rats was established to be 1000 mg/kg bw/d (equivalent to 90 mg/kg bw/d Al). For males the NOAEL for local effects was established to be 200 mg/kg bw/d (equivalent to 18 mg/kg bw/d Al) based on effects on the stomach and for systemic toxicity 1000 mg/kg bw/d (equivalent to 90 mg/kg bw/d Al; 710 mg/kg bw/d anhydrous aluminium nitrate).
Aluminium nitrate was administered in the drinking water to four groups of ten female rats for one month at dose levels of 0, 375, 750 or 1500 mg/kg bw/d. Appearance, behaviour, food and water consumption and growth were not affected by treatment. Bioaccumulation of aluminium occurred dose-dependently in spleen, heart and gastrointestinal tract. Plasma concentrations showed no effects or signs of toxicity. Mild histological changes were observed in the spleen and liver in the high dose group.
The subacute oral NOAEL was determined to be 750 mg/kg bw/d aluminium nitrate nonahydrate; equivalent to 426 mg/kg bw/d as the anhydrous form.
In a 100 -day drinking water study, four groups of female Sprague-Dawley rats were treated at 0, 360, 720 or 3600 mg/kg bw/d over a period of one hundred days. Weight gain, food intake, water consumption, haematology and serum chemistry parameters were checked regularly through out the study. Ingestion of aluminium nitrate by rats resulted in significant growth retardation and significantly lower nutritional parameters. Aluminium did not show any dose-related accumulation in any of the organs or tissues examined. No histopathological changes of note were observed and organ weights showed no significant treatment-related changes. A NOAEL of 720 mg/kg bw/d (equivalent to 409 mg/kg bw/d anhydrous aluminium nitrate) can be calculated for this study based on bodyweight changes, reduced water consumption and urinary excretion, and effects on nutritional parameters noted at the highest dose level.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Study reporting the lowest endpoint and of the longest duration
Justification for classification or non-classification
The results of the available repeated dose toxicity studies do not indicate any effects sufficient to trigger classification for STOT-RE according to the CLP Regulation.
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