Registration Dossier
Registration Dossier
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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.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2009-07-22 to 2009-08-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Fluidized Bed Combustion (FBC) Fly Ash
- IUPAC Name:
- Fluidized Bed Combustion (FBC) Fly Ash
- Details on test material:
- - Name of test material (as cited in study report): Fluidized Bed Combustion (FBC) Fly Ash
- Physical state: Light grey solid powder
- Lot/batch No.: FBC/230309/T1
- Expiration date of the lot/batch: 15 years/ 03/2024
- Storage condition of test material: The substance will be stored in PE container at room temperature.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Kolec u Kladna, Czech Republik
- Age at study initiation: 8-10 weeks
- Fasting period before study: 24 hours
- Housing: in groups of 3 animals
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 1 mL/100 g bw
- Justification for choice of vehicle: solubility, gavage
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: OECD guideline 423 - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- first experiment: 3 animals
second experiment: 3 animals - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations on day 1 and 2 twice and once daily upon study end; weighing before application, on day 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: changes in skin and fur, eyes, visible mucous membranes, behavior, somatomotor activity, reactions to stimuli, presence of lacrimation, discharge and salivation from nostrils, function of respiratory, digestive and urogenital system
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occured
- Clinical signs:
- other: No clinical signs of intoxication were observed.
- Gross pathology:
- No pathologic changes were observed.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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