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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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test guideline (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Report meets generally accepted scientific standards, well documented and acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- The effects of aluminium ingestion on reproduction and postnatal survival in rats
- Author:
- Domingo JL, Paternain JL, Llobet JM & Corbella J
- Year:
- 1 987
- Bibliographic source:
- Life Sciences 41: 1127-1131
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Principles of method if other than guideline:
- Male rats were treated orally for 60 days prior to mating and female rats were treated for 14 days prior to and throughout the mating period, gestation, delivery, and lactation.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- aluminium nitrate nonahydrate
- IUPAC Name:
- aluminium nitrate nonahydrate
- Test material form:
- not specified
- Details on test material:
- Al(NO3)3*9H2O (source: Merck)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna Iberica, Spain
- Weight at study initiation: (P) Males: 240-280 g; Females: 240-280 g
- Diet: ad libitum, high protein rat diet (Panlab, Barcelona, Spain)
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2 °C
- Humidity (%): 55 +- 5 %
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
no data
Dose levels were selected to approximate to 1/20, 1/10, and 1/5 of the acute oral LD50 value estimated for aluminium nitrate.
Male rats were treated by gavage for 60 days prior to mating and the females were dosed for 14 days prior to mating and then throughout the mating period, gestation, delivery and lactation. - Details on mating procedure:
- Groups of 25 females were used at each dose level. Following pairing with treated males, proof of pregnancywas indicated by sperm in vaginal smears. The day sperm were observed was referred to as day 0 of pregnancy (Gestation day 0)
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- Male rats were dosed for 60 days prior to mating and female rats were treated for 14 days prior to and throughout the mating period, gestation,
delivery, and lactation. - Frequency of treatment:
- Daily
- Details on study schedule:
- Males were treated for 60 days and females for 14 days prior to pairing. The rats were mated within the dose group. Day 0 of gestation was taken as the day sperm were observed in the vaginal smear. Dams were treated throughout the gestation and lactation phases. On Day 13 of gestation half of the dams in each group were terminated and examined to determine the number of corpora lutea, total number of implantations, early and late resorptions and the number of live and dead foetuses. The remaining dams were allowed to litter and nurse the neonates to day 21 of lactation
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 180, 360, 720 mg/kg bw/d
Basis:
actual ingested
aluminium nitrate nonahydrate
- Remarks:
- Doses / Concentrations:
0, 102, 204, 409 mg/kg bw/d
Basis:
actual ingested
equivalent dose anhydrous aluminium nitrate
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: doses were selected based on a prior 100 days study at 1/20, 1/10 and 1/5 of the LD50 (gavage)
- Positive control:
- no data
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Not specified
DETAILED CLINICAL OBSERVATIONS: Not specified
BODY WEIGHT: Not specified
FOOD CONSUMPTION: Not specified
WATER CONSUMPTION: Not specified - Oestrous cyclicity (parental animals):
- Not specified
- Sperm parameters (parental animals):
- Parameters examined in male parental generations: not specified
- Litter observations:
- STANDARDISATION OF LITTERS
Performed on day 4 postpartum: no
PARAMETERS EXAMINED
The following parameters were examined in [F1] offspring: mortality, normal body weight gain, body and tail lengths and general symptomatology after 1, 4, and 21 days of nursing - Postmortem examinations (parental animals):
- On day 13 of gestation, one-half of the dams from each group were killed. The following examinations were made: determination of the number of corpora lutea, total implantations, living and dead fetuses as well as the number of early and late resorptions.
- Postmortem examinations (offspring):
- The offspring were killed after 21 days; heart, lungs, spleen, liver, kidneys, brain, and testicles were removed and weighed. The ratios of organ weight/body weight, were calculated.
- Statistics:
- Statistical analyses were made by means of the distribution-free ranking test according to Wilcoxon in the modified version of Mann-Whitney, and using the chi-square test. The effect of aluminium on relative organ weights of rats pups was evaluated by the Kruskal-Wallis statistical test. In all cases a minimum level of significance of P < 0.05 was used.
- Reproductive indices:
- not specified
- Offspring viability indices:
- not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- general toxicity
- Effect level:
- 720 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects were reported
- Dose descriptor:
- NOAEL
- Remarks:
- fertility
- Effect level:
- 720 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects were reported
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Details on results (F1)
The fresh organ weights of rat pups killed after 21 days of lactation 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.
The number of litters was decreasing with time, and the dead/living ratio and the number of dead young per litter were increasing during the lactation. Dose-response relationships could be induced.
With regard to the growth of the offspring as a measure of body weight, body length and tail length, it was always significantly lower for the treated groups. These decreases must be imputed to the treatment and an important dose response relationship can be remarked. However, the significance of the differences was decreasing with time.
On the other hand, no hypertrophy or hypotrophy in the organs removed after the treatment could be detected.
Effect levels (F1)
- Dose descriptor:
- LOAEL
- Remarks:
- developmental toxicity
- Generation:
- F1
- Effect level:
- 180 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Reduced litter numbers, litter size and offspring viability
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The effect of oral administration of aluminium in Sprague-Dawley rats on gestation day 13
|
Dose level mg/kg bw/d |
|||
0 |
180 |
360 |
720 |
|
Litters |
9 |
7 |
10 |
10 |
Corpora lutea |
18.2 |
16.9 |
15.9 |
14.5a |
Total implants |
13.7 |
13.1 |
12.5 |
14.0 |
Early resorptions |
0.1 |
0.7 |
0.1 |
0.8 |
Late resorptions |
1.5 |
0.9 |
1.4 |
1.1 |
Live foetus |
12.1 |
11.1 |
10.8 |
10.8 |
Dead foetus |
0.1 |
0.4 |
0.2 |
0.3 |
asignificantly different from controls P<0.05 |
Summary of data for pups nursed by aluminium treated mothers
|
Day |
Dose level mg/kg bw/d |
|||
0 |
180 |
360 |
720 |
||
No. of litters |
1 |
9 |
10 |
7 |
7 |
No. of living young |
1 |
108 |
115 |
91 |
66 |
No. of dead young |
1 |
0 |
2 |
2 |
12 |
Dead/living ratio (x100) |
1 |
0.0 |
1.7 |
2.2 |
18.1 |
Male/female ratio |
1 |
1.00 |
0.90 |
0.65 |
0.94 |
Living young/litter |
1 |
12.0 |
11.5 |
13.0 |
9.4 |
Dead young/litter |
1 |
0.0 |
0.2 |
0.3 |
1.7 |
asignificantly different from controls P<0.05 |
Effects of aluminium nitrate on rat pups nursed by aluminium treated mothers
|
Sex |
Day |
Dose level mg/kg bw/d |
|||
0 |
180 |
360 |
720 |
|||
Bodyweight (g) |
M |
1 |
7.2 (54) |
6.9 (55) |
6.7 (36)a |
6.2 (32)c |
F |
1 |
6.9 (54) |
6.3 (60)a |
6.3 (55)a |
6.1 (34)c |
|
Body length (mm) |
M |
1 |
55.4 |
54.8 |
53.3b |
51.8c |
F |
1 |
55.3 |
52.6b |
52.6b |
52.0c |
|
Tail length (mm) |
M |
1 |
20.4 |
19.8 |
18.7 |
17.2b |
F |
1 |
20.2 |
18.7a |
17.9b |
17.7c |
|
a,b,csignificantly different from controls P<0.05; <0.01 or <0.001 (number of animals studied) |
Applicant's summary and conclusion
- Conclusions:
- Fertility rates and reproductive indices were unaffected in the parents but numbers of litters reduced in aluminium treated rats and the ratio of dead to living pups and the number of dead pups showed an increase duration lactation. Pup growth as measured by bodyweight, body length and tail length indices was inhibited in treated groups. The lowest dose level, 180 mg/kg bw/d, resulted in some adverse effects in the offspring in this study although no effects were apparent in the parents.
- Executive summary:
Aluminium nitrate was tested for its effects on reproduction, gestation, and lactation in Sprague-Dawley rats, at dosages of 0, 180, 360 and 720 mg/kg bw/d. Mature male rats were treated orally for 60 days prior to mating with mature virgin female rats treated for 14 days prior to mating with treatment continuing throughout mating, gestation, parturition, and weaning of the litters. One-half of the dams in each group were killed on Day 13 of gestation and the remaining dams were allowed to deliver and wean their offspring. Postnatal development was monitored. No adverse effects on fertility or general reproductive parameters were evident at doses employed in these studies, however effects on post-natal pup growth and survival were apparent in all treated groups.
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