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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
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- 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
- 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
- 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 % - 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
- 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
- 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
- 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: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- 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
- 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
- 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
- Reproductive effects observed:
- not specified
- 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.
Reference
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.
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) |
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 102 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- A number of studies are available for this endpoint, including a screening study and one-generation study.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No effects on fertility were observed in an OECD 422 screening study (Beekhuijzen, 2007) performed with aluminium chloride at dose levels of up to 1000 mg/kg bw/d (equivalent to 90 mg/kg bw/d Al3+). In a one-year developmental / neurotoxicity performed with aluminium citrate (ToxTest, 2010), no effects on fertility were observed at dose levels of up to 3225 mg/kg bw/d (300 mg/kg bw/d (Al3+); however reduced post-natal survival was seen at this dose level. A one generation study performed with aluminium nitrate (Domingo et al, 1987) similarly demonstrates an absence of effects on fertility but indicates effects on pup growth and survival at all dose levels (≥180 mg/kg bw/d) although a dose-response relationship is not always apparent. Llobet et al (1995) demonstrate that the administration of aluminium nitrate by intraperitoneal injection at dose levels of 50, 100 or 200 mg/kg bw/d resulted in systemic toxicity; effects on the male reproductive tract and fertility were seen at 100 and 2000 mg/kg bw/d. The results of this study are not considered to be of direct relevance to the human risk assessment due to the non-physiological route of administration and the known low bioavailability of aluminium nitrate.
The findings of reduced offspring growth and survival from the reproductive study with aluminium nitrate are not consistent with those of the longer term study with aluminium citrate, in which effects were observed only at a much higher dose level. Additionally the oral bioavailability of aluminium is known to be significantly enhanced by the presence of citrate.
Short description of key information:
A screening study (OECD 422) is available for the read-across substance aluminium chloride; a one-generation study study is available for aluminium nitrate and a chronic study is available for aluminium citrate. A study of male fertility using aluminium nitrate is considered to be of limited relevance due to the use of intraperitoneal dosing.
Justification for selection of Effect on fertility via oral route:
One-generation study showing adverse effects
Effects on developmental toxicity
Description of key information
A guideline-comparable developmental toxicity study in the rat is available for aluminum nitrate
Link to relevant study records
- Endpoint:
- developmental toxicity
- 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.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Three groups of ten pregnant rats were exposed to the test substance from day 6-14 of gestation at three different dose levels.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna Iberica, Spain
- Weight at study initiation: 240-280 g
- Housing: 1 male was cohoused with 2 females until copulation was detected
- Diet: ad libitum, Panlab diet, Barcelona, Spain
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23 °C
- Humidity (%): 50 +- 5 %
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The aluminum nitrate solutions were prepared to give a dose in a volume of 1 ml/250 g body weight.
Dose levels of aluminium nitrate nonahydrate were 180, 360 and 720 mg/kg bw/day - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1 male / 2 females
- Length of cohabitation: until copulation was detected
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: sperm in vaginal smear referred to as day 1 of pregnancy - Duration of treatment / exposure:
- from day 6 to day 14 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- continuous dosing until day 20 of gestation
- Remarks:
- Doses / Concentrations:
0, 180, 360, 720 mg/kg bw/d
Basis:
actual ingested
test material - Remarks:
- Doses / Concentrations:
0, 102, 204, 409 mg/kg bw/d
Basis:
actual ingested
anhydrous aluminium nitrate - No. of animals per sex per dose:
- four groups of ten pregnant rats (incl. control group)
- Control animals:
- yes, concurrent vehicle
- 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)
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Not specified
DETAILED CLINICAL OBSERVATIONS: Not specified
BODY WEIGHT: Not specified, weight gain during gestation was determined
POST-MORTEM EXAMINATIONS: Not specified - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included: number of corpora lutea, total implantations, number of live and dead fetuses, number of resorptions, average fetal body weights, number of stunted fetuses (under 2/3 average body weigth), placental weights per litter, fetal body lengths and fetal tails lengths per litter. - Fetal examinations:
- - External examinations: Yes: [all per litter]
- Skeletal examinations: Yes: [more than half per litter]
- Soft tissue examinations: Yes: [the remainder of the litter]
- Head examinations: No data - Statistics:
- All statistical analyses compared the treatment groups to the control group with the level of significance at P<0.05. Maternal body weights, fetal body weights, fetal body lengths, fetal tail lengths, corpora lutea, implantations, resorptions, and live and dead fetuses were analyzed statistically using a one-way analysis of variance and Mann-Whitney U test. Fetal abnormalities were analyzed using the chi-square test criterion with Yates' correction for 2 x 2 contingency tables and/or Fisher's exact probability test to judge significance of differences.
- Indices:
- no data
- Historical control data:
- no data
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Dams given aluminium nitrate gained significantly (P< 0.01) less body weight than the control dams throughout the gestation period. - Dose descriptor:
- LOAEL
- Effect level:
- 180 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 180 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Aluminium-nitrate intubation had no significant adverse effects on the following parameters: number of corpora lutea, number of implantations, number of resorptions, and number of live and dead fetuses. These values were similar for the treated and the control groups. Nevertheless, the number of runt fetuses as well as the number of litters with runt fetuses showed recognizable dose-dependent increases in the aluminium-treated groups.
Body weight and tail length of fetuses from the treated groups showed significant decreases (P< 0.001) compared with the control values. Also, body length was significantly lower in the fetuses from the high dose group. The average weight of placentas decreased significantly in the mid and high dose groups.
The most common statistically significant increased variations and visceral malformations were hematomas (especially in abdominal cavity and thorax), renal hypoplasia, and dextrocardia in the high dose group. Furthermore, fetal examinations revealed effects on skull (decreased ossifications of supraoccipital bone), ribs (hypoplastic deformations; vertebral alterations), and sternebrae (partial ossification; bilobed appearance; other variations) in all treatment groups. - Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- Teratogenic effects were evident at maternally toxic dose levels in rats administered aluminium nitrate during the period of organogenesis. While the numbers of copora lutea, total implants, resorptions and live/dead ratios were not significantly affected in the treated groups, there were significant increases in the number of runts per litter in the treated groups, and treatment related malformations and variations were identified in all dose groups.
- Executive summary:
The embryotoxic and teratogenic potential of aluminium was investigated in pregnant Sprague-Dawley rats. Daily doses of 0, 180, 360 or 720 mg/kg bw/d, were administered by oral gavage from the sixth to fourteenth day of gestation. Foetal examinations were completed on Gestation Day 20, including determination of numbers of corpora lutea, total implants, resorptions, live and dead foetuses. None of these parameters showed any significant changes in treated groups compared with controls. It was concluded from these data that embryolethality could not be induced, but exposure of rats to aluminium nitrate did result in decreased foetal bodyweight and an increase in the incidence, and type, of external, visceral and skeletal malformations and variations in all treated groups. High doses of orally administered aluminium nitrate results in teratogenic effects in rats at levels that induce concommitant maternal toxicity.
Reference
Effects of aluminium nitrate administered by gavage to rats during gestation day 6-14
|
Dose level mg/kg bw/d |
|||
0 |
180 |
360 |
720 |
|
Number of litters |
10 |
8 |
7 |
8 |
No. of corpora lutea |
14.5 |
13.9 |
15.6 |
15.4 |
No. of total implants |
12.5 |
10.3 |
13.2 |
13.4 |
No. of live foetuses |
12.3 |
9.3 |
12.5 |
12.8 |
No. of resorptions |
0.2 |
0.3 |
0.5 |
0.5 |
No. of dead foetuses |
0.0 |
0.7 |
0.2 |
0.1 |
No. of total foetuses |
126 |
83 |
88 |
101 |
No. of runt foetuses |
0 |
4 |
6 |
20 |
No. of litters with runt foetuses |
0 |
2 |
3 |
5 |
Weight gain during gestation (g) |
122 |
99.4 |
97.9 |
98.8 |
Placental weight (g) |
1.05 |
1.06 |
0.82 |
0.89 |
Mean foetal bodyweight (g) |
3.29 |
2.82 |
2.75 |
2.19 |
Mean foetal body length (mm) |
37.9 |
38.5 |
37.3 |
34.7 |
Mean foetal tail length (mm) |
13.0 |
11.5 |
11.7 |
11.1 |
*significantly different from controls P<0.05 |
summary of malformations and variations in rats given aluminium nitrate during organogenesis
Malformations |
Dose level mg/kg bw/day |
|||
0 |
180 |
360 |
720 |
|
External |
|
|
|
|
No. of foetuses observed |
126 |
83 |
88 |
101 |
Oedema |
0 (0.0) |
0 (0.0) |
2 (2.27) |
3 (2.97) |
Micrognathia |
0 (0.0) |
0 (0.0) |
7 (7.95)** |
2 (1.98) |
Oligodactyly |
0 (0.0) |
0 (0.0) |
0 (0.0) |
2 (1.98) |
Visceral |
|
|
|
|
No. of foetuses observed |
42 |
27 |
29 |
33 |
Microphthalmia |
0 (0.0) |
0 (0.0) |
2 (6.89) |
0 (0.0) |
Anophthalmia |
0 (0.0) |
0 (0.0) |
4 (3.79) |
3 (9.09) |
Telencephalaic hypoplasia |
0 (0.0) |
0 (0.0) |
1 (3.44) |
0 (0.0) |
Renal hypoplasia |
0 (0.0) |
0 (0.0) |
0 (0.0) |
4 (12.12) |
Hydrocephaly |
0 (0.0) |
0 (0.0) |
1 (3.44) |
2 (6.06) |
Dextrocardia |
0 (0.0) |
0 (0.0) |
0 (0.0) |
4 (12.12) |
|
|
|
|
|
Skeletal |
|
|
|
|
No. of foetuses observed |
84 |
56 |
59 |
68 |
Skull |
|
|
|
|
Decreased ossification of supraoccipital bone |
0 (0.0) |
5 (8.92)* |
6 (10.16)* |
38 (68.0)*** |
Ribs |
|
|
|
|
Hyoplastic deformed |
2 (2.38) |
27 (48.21)*** |
14 (23.72)** |
14 (20.58)** |
Total vertebral alterations |
5 (5.95) |
25 (44.64)*** |
14 (23.72)* |
15 (22.05)* |
Sternebral variations |
|
|
|
|
Partial ossification |
10 (11.90) |
12 (21.42) |
27 (45.76)** |
47 (69.11)*** |
Bilobed appearance |
8 (9.52) |
10 (17.86) |
27 (45.76)** |
47 (69.11)*** |
other |
2 (2.38) |
11 (19.64)** |
11 (18.64)** |
49 (72.05)*** |
Variations |
|
|
|
|
No. of foetuses observed |
126 |
83 |
88 |
101 |
Haematomas |
|
|
|
|
In facial area |
1 (0.79) |
2 (2.40) |
2 (2.27) |
1 (0.99) |
In abdominal cavity |
2 (1.58) |
2 (2.40) |
4 (4.54) |
13 (12.87) |
In thorax |
1 (0.79) |
1 (1.20) |
4 (4.54) |
11 (10.89) |
In limbs |
1 (0.79) |
1 (1.20) |
2 (2.27) |
7 (6.93) |
*significantly different from controls P<0.05 |
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 102 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- A guideline-comparable developmental toxicity study is available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The embryotoxic and teratogenic potential of aluminium was investigated in pregnant Sprague-Dawley rats. Daily doses of 0, 180, 360 or 720 mg/kg bw/d, were administered by oral gavage from the sixth to fourteenth day of gestation. Foetal examinations were completed on Gestation Day 20, including determination of numbers of corpora lutea, total implants, resorptions, live and dead foetuses. None of these parameters showed any significant changes in treated groups compared with controls. It was concluded from these data that embryolethality could not be induced, but exposure of rats to aluminium nitrate did result in decreased foetal bodyweight and an increase in the incidence, and type, of external, visceral and skeletal malformations and variations in all treated groups. High doses of orally administered aluminium nitrate results in teratogenic effects in rats at levels that induce concommitant maternal toxicity.
The findings from the developmental toxicity study with aluminium nitrate are not consistent with those of the longer term study with aluminium citrate, in which effects were observed only at a much higher dose level. Additionally the oral bioavailability of aluminium is known to be significantly enhanced by the presence of citrate.
Justification for selection of Effect on developmental toxicity: via oral route:
Standard study design, reporting adverse effects
Justification for classification or non-classification
No classification proposed for aluminium nitrate based on the results of reproductive and developmental toxicity studies
Additional information
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