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EC number: 930-915-9 | CAS number: 1318-02-1
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb. 28, 1976 - Feb. 8, 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- But the results of this study have to be considered with some caution due to chronic pneumonia that affected almost all animals.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
- Reference Type:
- publication
- Title:
- Zeolithe A - A Phosphate Substitute for Detergents: Toxicological Investigation
- Author:
- Gloxhuber et al.
- Year:
- 1 982
- Bibliographic source:
- Fd. Chem Toxic. Vol. 21, No. 2, pp. 209-220
- Report date:
- 1982
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- chronic inhalation study in rats: 1 dose and 1 control group (and one additional dose and one additional control group after 14 months), 3 whole body inhalations per week.
Due to chronic pneumonia that affected almost all animals about the 20th month of the experiment, the final sacrifice was performed after 22 months. - GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- EC Number:
- 930-915-9
- Cas Number:
- 1318-02-1
- Molecular formula:
- M2/nO • Al2O3 • ySiO2 • wH2O (n is the valency of the cation M, predominantly Na, y can range from 0.64 to 8.8, and w is the number of water molecules (general formula) Na: 1.34 - 24.02%, Al: 2.20 - 39.51%, Si: 15.52 - 68.64% (general composition); additionally, depending on the water quality: Ca, Mg and K might be present below 6%
- IUPAC Name:
- Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- Test material form:
- solid: particulate/powder
- Remarks:
- no surface treatment
Constituent 1
- Specific details on test material used for the study:
- SASIL (A Zeolite)
charge F-325, fine white powder, particle size to over 80% between 1 and 6 µm.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - HAN 67 SPF Wistar rats with an average body weight of 139-154 g (main group) and 125-130 g (additional group) at the start of the experiment
- keeping: conventionally under daylight
- feed: ALTROMIN 1324 and water ad libitim. During inhalations food and water were withdrawn from the animals.
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Remarks:
- inhalation chamber
- Vehicle:
- air
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- gravimetric measurements of the amount of dust and dose
- Duration of treatment / exposure:
- main groups: 22 months
additional groups: 8 months - Frequency of treatment:
- on Mondays, Wednesdays and Fridays for 5 hours each
Doses / concentrations
- Dose / conc.:
- 20 mg/m³ air (nominal)
- No. of animals per sex per dose:
- 15 in treatment and control groups (main groups for 22 months)
15 males and 10 females in treatment and control groups (additional groups for 8 months) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- inhalation chambers: 24°C; relative humidity 55%; in wire cages; 5 test animals or 5 control animals per cage.
Examinations
- Observations and examinations performed and frequency:
- daily observation
weighted once per week until week 23, thereafter every fortnight, and beginning with the 32nd week of the experiment once per month - Sacrifice and pathology:
- All rats were dissected at the end of the experiment and the internal organs, especially the target organs, histologically examined. 2 male controls were also microbiologically examined due to infectious disease of airways of all rats.
Due to chronic pneumonia that attacked about the 20th month of the experiment almost all animals, the final sacrifice was performed already after 22 months.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 10 months after the start of the experiment, the first cases of respiratory diseases were observed. The affected rats began to sneeze briefly,
there were convulsions of coughing with whistling sounds in the expirium. The animals lost weight and sat apathetically in a crouching position in the cages. After occurrence of the marked dyspnea some rats developed a reddish discharge from the nose. These observations concerned both the test animals and the controls evenly. Reinforced hygiene measures did not help. The chronic pneumonia attacked about the 20th month of the experiment almost all animals - Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Mortality occured in treated and control animals.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The average body weights of the two groups of animals were more or less parallel during the experiment, and taking the age of the animals into account
it was without any special features. The slight deviations from the 11th month onward were not significant and did not occur substance-specific, but rather due to the moribund state of some rats. - Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- After taking the animals out of the chambers and they were transferred to their stay cages, the feed consumption and water consumption increased for about 2 hours, obsered both in the experimental and control animals.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- After taking the animals out of the chambers and they were transferred to their stay cages, the feed consumption and water consumption increased for about 2 hours, obsered both in the experimental and control animals.
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- The animals calmed down quickly after onset of inhalation and lay isolated, rarely in small groups, with normal breathing frequency, in the cages. The rats did not show aggressiveness. There were no abnormalities with regard to excrement or urine output. The experimental animals cleaned themselves more often than the controls and closed their eyes during the inhalation time and also in the in the activity phase more often (avoidance of conjunctival foreign body reactions due to SASIL).
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The rats showed macroscopically almost without exception bronchiectasis, purulent slimy exudates in the trachea and in the large
bronchial branches. Some of the lungs were atelectatic bloated, the individual gray-red lung lobes partially to completely hepatized. The mediastinal lymph nodes were mostly enlarged and dark to black. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- All animals examined, i.e. controls and experimental animals showed bronchopneumonia in various stages corresponding to the picture of chronic murine pneumonia.
But there were no histological indications either for fibrogenic, silicogenic or carcinogenic effects provoked by SASIL. - Histopathological findings: neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Different kinds of tumors were observed in five treated and in five control animals.
There were no histological indications either for fibrogenic, silicogenic or carcinogenic effects provoked by SASIL. - Description (incidence and severity):
- The test substance ws deposited in alveolar epihelias near the alveolar septum, in alveolar macrophages or alveolar epithelia in the alveoli, or in macrophages in the perivascular or peribronchial lymph sheaths. In the further consequence the substance was also deposited in the paracortical area
of the mediastinal lymph node. - Details on results:
- A histopathological examination of some rats came to the following conclusion:
"The findings suggest a soluble dust, the initially clear fibrotic reaction of which was in regression.
In the periportal and mediastinal lymph nodes, individual and groups of macrophages were found that contained the material (SASIL). The dust centers showed no fibrotic tendency after the test period. They were fitted into the local network of reticular fibers. An increase in reticular and collagen fibers could certainly be ruled out. Thus, the material behaved like inert dust in the lymph nodes.
Another histopathological examination of 6 Sasil-treated and 4 control rats concluded that after 22 months of administration the inhaled Sasil did not cause tumors in the six experimental animals of the treated group and did not produce fibrosis in the lungs and regional mediastinal lymph nodes.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 20 mg/m³ air (nominal)
- Sex:
- male/female
- Basis for effect level:
- histopathology: neoplastic
- histopathology: non-neoplastic
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 20 mg/m³ air (nominal)
- System:
- respiratory system: lower respiratory tract
- Organ:
- lungs
- Treatment related:
- no
- Dose response relationship:
- no
- Relevant for humans:
- no
Any other information on results incl. tables
The results of this inhalation experiment allowed to conclude that the test substance after chronic inhalation in the lungs was neither silicogenic nor fibrogenic. No tumorous changes were found pathologically or histologically in the respiratory tract or in other associated locations observed. The quality of those tumors observed and their temporal occurrence gave no indications of a carcinogenic activity of the test substance.
Applicant's summary and conclusion
- Conclusions:
- The experiment had to be interrupted after 22 months of inhalation, since the rats developed chronic murine pneumonia.
But the findings suggested that SASIL neither produces fibrogenic nor carcinogenic effects. - Executive summary:
The aim of this investigation was to determine whether SASIL produces fibrotic or silicotic changes after repeated inhalation, and if it might produce tumors. For this purpose main groups of 15 male and 15 female Wistar rats were exposed to an aerosol of zeolite A at an average concentration of 20 mg/m³ for five hours a day, three days a week for a schedulded time period of 24 months. The control group received pure air. One additional dose group was dosed beginning after the 14th month of the experiment. Due to chronic pneumonia that affected almost all animals about the 20th month of the experiment, the final sacrifice was performed already after 22 months for the main groups (i.e. 8 months of administration for the additional group).
The results of this inhalation experiment allowed to conclude that the test substance after chronic inhalation in the lungs was neither silicogenic nor fibrogenic. No tumorous changes were found pathologically or histologically in the respiratory tract or in other associated locations observed.
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