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Diss Factsheets
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EC number: 930-986-6 | 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
- Study period:
- 1976-05-12 to 1976-06-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): Sodium Aluminosilicate (Type A Zeolite)
- Framework: cuboidal
- Related CAS number: 1318-02-1
- Analytical purity: no data
- Composition of test material, percentage of components: 16.0% sodium, 40.6% silicone dioxide, 20.1% aluminum and 21% moisture
- Lot/batch No.: UDX-8709
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- 20 female rats/ treatment groups were administered 0.0 (solvent control = water), 74.0, or 1600 mg/kg bw test substance from gestation day 6 till day 15. The total volume applied was 10 ml/kg bw for each treatment group.
- Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- Females were maintained for two weeks before exposure to males, to allow any pseudo-pregnant animals to become sexually receptive. At the end of the two-week period, the females were paired with the males and vaginal smears and observation for plugs were commenced.
- Duration of treatment / exposure:
- on gestation days 6 - 15
- Frequency of treatment:
- daily
- Duration of test:
- Sacrifice of dams: day 20
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 (distilled water), 74, or 1600 mg/kg
Basis:
nominal in water
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- A positive control was run in parallel (aspirin, 250 mg/kg).
Examinations
- Maternal examinations:
- The day the vaginal smear showed the presence of sperm was designated day 0 of pregnancy and the male was removed. The females were weighed on days 0, 6, 9, 12, 15, 18 and 20 of gestation.
PARAMETERS ASSESSED DURING STUDY:
- Maternal weight gains: yes
- Mortality: yes - Ovaries and uterine content:
- PARAMETERS ASSESSED DURING STUDY:
- Fetal weight gains: yes
- Number of Corpora Lutea: yes
- Number of Implantations: yes
- Number of Resorptions: yes - Fetal examinations:
- PARAMETERS ASSESSED DURING STUDY:
- Fetal weight gains: yes
- Examination of fetuses: yes
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
The conception rate ranged from 80 to 90% thus assuring a sufficient number of fetuses to assess the teratogenic potential of sodium aluminiumsilicate.
There were no maternal deaths in zeolite treated group, although there were three deaths in the positive control group. Two of those deaths were attributed to the pulmonary aspiration of the aspirin. There were no statistically significant differences in maternal weight gain, which further indicates the lack of maternal toxicity or mortality from zeolite.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 600 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Statistical examination of the numbers of corpora lutea, implantations and resorptions revealed no significant differences in the numbers of live or dead fetuses or in the weights of the fetuses. These data show that no embryo or fetal toxicity resulted from the zeolite treatment.
There were no significant differences seen in the incidence of gross or soft-tissue malformations. One fetus in the 74 mg/kg dose group had multi-malformations. Hydronephrosis, often times classified as a variation, occurred in a low percentage in the zeolite treated group. No statistical differences were noted in the incidence of skeletal defects in treated groups, although a significant increase in the overall incidence of skeletal abnormalities occurred in the positive control (aspirin) group.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 600 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
The test substance was not teratogenic in rats at these levels tested.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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