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EC number: 297-648-1 | CAS number: 93685-99-5 Oil shale waste is produced by thermal processing in a fluidized bed process at 800°C from mining exhausted oil shale. Oil shale waste consists essentially of Al2O3, CaO, CaSO4, Fe2O3 and SiO2.
- 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: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- publication
- Title:
- Characterization and toxicological behavior of synthetic amorphous hydrophobic silica
- Author:
- Lewinson, J. et al.
- Year:
- 1 994
- Bibliographic source:
- Regul Toxicol Pharmacol. 20(1 Pt 1):37-57
Materials and methods
- Principles of method if other than guideline:
- Repeated dose 35- and 56-day oral toxicity in rodents
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Silane, dichlorodimethyl-, reaction products with silica
- EC Number:
- 271-893-4
- EC Name:
- Silane, dichlorodimethyl-, reaction products with silica
- Cas Number:
- 68611-44-9
- IUPAC Name:
- 68611-44-9
- Details on test material:
- - Name of test material (as cited in study report): Aerosil R 972 (Fumed Hydrophobic Silica)
- Analytical purity: >99.8%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 120 +/- 5 g and 130 +/-5 g (group identity unspecified)
- Diet (e.g. ad libitum): powder diet Altromin (Altromin GmbH, Germany)
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): The test substance was mixed with the powder diet Altromin, supplied by Fa. Altromin GmbH, taking into account the increasing body weight and the decreasing food intake of the animals. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 5 weeks in the low- and mid-dose groups and 8 weeks in the high-dose group
- Frequency of treatment:
- continuous
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 500, 1000, 2000 mg/kg bw
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
4000 mg/kg bw
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
8000 mg/kg bw
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
16000 mg/kg bw
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: The administered doses were 0, 500,1000, and 2000 mg/kg bw. Because the animals tolerated 2000 mg/kg bw, the high dose was elevated to 4000 mg/kg bw after 14 days, to 8000 mg/kg bw after another 14 days, and finally to 16000 mg/kg bw.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Time schedule for examinations: daily and weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At the beginning and at the end of the experiment
- Anaesthetic used for blood collection: Yes (ether)
- How many animals: 5 animals from each group
- Parameters examined: hemoglobin, erythrocytes, leukocytes, and blood smear - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes. Kidney and liver samples were fixed in 10% formalin and stained with hematoxylin/eosin after Hotchkiss (PAS staining).
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Only after the stepwise increase of the high dose to 16000 mg/kg bw (corresponding to approximately 25% of the daily food intake) were treatment-related effects observed. These included shyness, dirty fur, reduced activity, cachexia, and hemorrhage in the mucous membranes of the eyes and nose. Two males and two females died with severe cachexia in week 8 (days 9 and 13 after administration of 16000 mg/kr bw).
BODY WEIGHT AND WEIGHT GAIN
The administration of 16000 mg/kg bw caused a pronounced reduction of the body weight. After a dose of 8000 mg/kg bw, the body weight was only slightly influenced.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
The administration of 16000 mg/kg bw caused decreased food intake.
HAEMATOLOGY
No significant changes were observed in the examined hematological parameters.
GROSS PATHOLOGY
No significant changes were observed after macroscopic evaluation of the treated animals.
HISTOPATHOLOGY: NON-NEOPLASTIC
Microscopic examinations of the liver of rats consuming the highest doses (2000-16000 mg/kg bw) revealed severe atrophy in the epithelium of the liver. Condensation of the cytoplasm, loss of the basophilic structure and hyperchromatic and contracted nuclei occurred in the liver cells. Glycogen could not be detected with PAS staining. To a lesser degree these changes were sporadically seen in two females of the mid-dose group (1000 mg/kg bw). No treatment-related changes were found in the kidneys of any animal. No treatment-related effects were observed in the low-dose group (500 mg/kg bw).
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Sex:
- male/female
- Dose descriptor:
- LOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: sporadical histopathological changes in the liver (atrophy of the epithelium, decrease of the basophilic nuclei and of the glycogen content)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The results of this study demonstrate that the lethal dose range begins at approximately 16000 mg/kg bw for hydrophobic silicas. It should be noted that the acceptance of the treated diet was strongly reduced and that the fraction of the test substance in the diet amounted to approximately 25% by weight. Malnutrition can also cause changes similar to those found, such as weight loss, cachexia, and decrease of the glycogen content in the liver cells. Therefore, it is not clear wether the test substance in a very high dose, the reduced food intake, or the two combined caused the described effects. At a dose of 1000 mg/kg bw in two female rats, similar histopathological changes in the liver (atrophy of the epithelium, decrease of the basophilic nuclei and of the glycogen content) were sporadically found in a slighter degree than in the high-dose group animals. Therefore, the lowest-observed effect level (LOEL) in this study was 1000 mg/kg bw and the no-observed effect level (NOEL) was 500 mg/kg bw.
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