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EC number: 909-586-0 | CAS number: -
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the maternal and developmental toxicity of aluminium from high doses of aluminium hydroxide in rats.
- Author:
- Gomez et al.
- Year:
- 1 990
- Bibliographic source:
- Vet. Hum. Toxicol. , 32: 545-548.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- : lack of details on test substance
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Aluminium hydroxide
- EC Number:
- 244-492-7
- EC Name:
- Aluminium hydroxide
- Cas Number:
- 21645-51-2
- IUPAC Name:
- aluminum trihydroxide
- Details on test material:
- - Name of test material (as cited in study report): Aluminium hydroxide
- Analytical purity: analytical grade was obtained from E. Merck (Darmstadt, FRG). No further information.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna Iberica (Barcelona, Spain)
- Weight at study initiation: 225-240 g
- Diet: Food (commercial chow, Panlab , Barcelona, Spain), ad libitum
- Water: tap water: ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23 °C
- Humidity (%): 45±5%
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Details on the preparation of dosing solutions and on administration of the test substance are not provided.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data.
- Details on mating procedure:
- Females were housed with males (2:1) until copulation was detected.
Finding of sperm indicated copulation and the day of detection was designated day 0 of gestation. - Duration of treatment / exposure:
- 10 days (GD 6-15).
- Frequency of treatment:
- Daily (twice).
- Duration of test:
- 20 days (GD 0-20).
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 192, 384, 768 mg/kg/bw/day equivalent to 66.5, 133.0, 266.0 mg Al/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Twenty females for each dose group, 18-19 pregnant rats at termination.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Animals were randomly assigned to each experimental/control group.
Maternal-placental-fetal Al contents following gestational exposure have been examined. Al concentrations (µg/g wet weight) in maternal liver, brain, bone, placenta; and whole fetus (detection limit 0.05 µg/g).
Examinations
- Maternal examinations:
- Clinical signs of toxicity, appearance, behavior changes were observed daily within 3 day intervals during pre-treatment, treatment and post-treatment period.
Hematological and serum biochemical analyses were performed on day 20 of gestation after euthanazy; blood was obtained by cardiac puncture.
Maternal body weight and food consumption:
Food consumption, maternal body weight and absolute/relative organ weight (kidney, liver, gravid uterine weight).
Post-mortem examination:
Animals sacrificed of GD 20. - Ovaries and uterine content:
- Uterine content:
• Number of litters;
• corpora lutea;
• implantations/litter;
• preimplantation loss/litter;
• viable implants/litter;
• early resorption;
• late resorption;
• dead fetuses;
• postimplantation loss/litter. - Fetal examinations:
- • Sex ratio;
• fetal body weight.
• Fetal examination for external and visceral abnormalities and skeletal malformations and variations performed. - Statistics:
- • The unit of comparison was the pregnant female or the litter.
• Results of the quantitative continuous variables (e.g., maternal body weights, organ weights, fetal weights, etc.) were compared using analysis of variance (ANOVA) with significant F values further analyzed using Student’s t-test or Mann-Whitney U-test.
• Nonparametric data were statistically evaluated using the Kruskal-Wallis test when appropriate. The incidence of developmental abnormalities was not analyzed statistically because no differences were evident between treated and control groups. - Indices:
- No data.
- Historical control data:
- No data.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No signs of toxicity, changes in body weight gain, absolute and relative internal organ weights (liver, kidney, gravid uterine) were observed in any group during the test (GD 0-20).
Group I
•• increased number of early resorption (statistically non-significant).
Group II:
•• • >number of post-implantation loss (2.2 times);
• increased number of early resorption(not statistically significant).
Group III:
•• • increased number of early resorption (statistically non-significant).
Statistically significant dose- and time-dependent decreased maternal food consumption during the treatment periods (6-15) was observed in Al treated animals compared to control group rats. However, food consumption recovered during the post-treatment period on GD 15-20.
No significant treatment-related differences were observed after exposure to Al hydroxide at any dose levels in:
• the number of corpora lutea;
• in percentage of pre-implantation loss ;
• in the number of total implants and viable; or nonviable implants per litter.
• > percentage of post-implantation loss – at 133 mg Al/kg bw/day (12.48± 11.56 vs 0.55 ± 0.90 in control group).
No dose-response observed for post-implantation losses. High variability was evident in all Al treated and control groups.
No Al related treatment effects were observed on maternal hematology and biochemical parameters at termination (GD 20) (data not shown).
No increased Al levels in maternal liver, bone, brain and placenta in Al treated animals compared to the control group was detected.
The maternal/placental Al concentrations were not statistically different between control and treated rats (high variability is evident in all groups).
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 266 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: other:
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No differences were observed between control and Al treated groups in the incidence of individual malformations (external, visceral, or skeletal), or in the number of total malformations.
No significant changes in the incidence of any developmental variations were reported.
No increased Al levels in whole fetuses in any Al treated group (limit of detection – 0.05 μg/g.
Embryotoxic /teratogenic effects:
No Al treatment-related differences in number of live fetuses per litter, gender ratio, fetal body weight were detected.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
The goal of study is to assess the developmental toxicity and embryotoxic/teratogenic potential of high doses of target compound - AI(OH)3orally administered to rats during the period of active organogenesis.
No significant general/maternal toxicity was observed in any Al treated groups that were orally exposed to Al hydroxide at doses 66.5, 133 and 266 mg Al/kg bw/day.
The results have contributed to the weight of evidence on the lack of pre-natal developmental toxicity of Al hydroxide administered orally to rats at high doses (66.6; 133 and 266 mg Al/kg bw/day). Toxicokinetic studies support the reported negative developmental outcomes.
Well designed and conducted study with many studied endpoints comparable to guideline OECD TG 414 with acceptable deviations.
However, particular test data/relevant information are absent (physiochemical properties, identification including CAS number, details on food and water quality (Al content in diet, water); details on test substance formulations (preparation, pH, stability and homogeneity of the preparation), details on reported negative teratogenic effects are not provided.
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