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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2009-07-27 to 2009-08-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Kolec u Kladna, Czech Republik
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 19.6-22.6 g
- Housing: in groups of max. 6 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 - Vehicle:
- other: DAE 433 (mixture of 40% Diethylacetamid, 30% Acetone and 30% Ethanol)
- Concentration:
- 0.3, 3 and 30% (w/v)
- No. of animals per dose:
- Pilot experiment: 3 female
Exposure experiment: 15 females (5 in 3 groups)
Positive control: 5 females
Negative control: 5 females - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 30% (w/v) was the maximum technically practicable concentration derived from the pilot experiment
- Irritation: When the ear weights are statistically significant increased the subsatnce may cause irritation to the skin. Positive control inducd ear swelling, negative control and test material showed no irritating effects.
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
Incorporation of ³H-methyl-thymidine: When SI ≥ 3 and dose response is recorded, the subsatnce is regared as skin sensitiser
TREATMENT PREPARATION AND ADMINISTRATION:
Day 1: open application of 25 µL of the three test concentrations, the positive and the negative control to the dorsum of the ear
Day2 and 3: repeated application as on day 1
Day 6: Injection of 250 µL of PBS containing 7.8x10^5 Bq (c.21 µCi) of ³H-methyl-thymidine to all animals via the tail vein. Five hours later all animals were sacrificed. - Positive control substance(s):
- other: DNBC (Dinitrochlorobenzene, CAS: 97-00-7)
- Statistics:
- Software Statgraphic centurion (Version XV, USA) was used:
- Non parametric Kruskal-Wallis test
- Non parametric two group Mann-Whitmey rank test - Positive control results:
- 8756 DPM and SI of 12.1
- Parameter:
- SI
- Remarks on result:
- other: 0.3%-group: 2.65, 3%-group: 1.23, 30%-group: 1.61
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: negative control: 711.51, 0.3%-group: 1886.5, 3%-group: 872.74, 30%-group: 1144.06
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
No animals died during the study. No symptomes of toxicity were observed in the treatment and negative control groups. Positive control group animals showed hyperaemia of skin and clonospasm.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A local lymph node assay (LLNA) according to OECD guideline 429 was performed with the read across substance Fluidized Bed Combustion (FBC) Fly Ash in mice (Brabnikova, 2009). 5 animals per dose group were exposed to 0.3, 3 and 30% FBC in DAE 433 (mixture of 40% Diethylacetamid, 30% Acetone and 30% Ethanol) at 3 consecutive days. On day six radiolabled ³H-Methyl-Thymidine was injected and after 5 hours the measurements were performed. The stimulation index (SI) was 2.65 for the 0.3% group, 1.23 for the 3% group, 1.61 for the 30% group and 12.1 for the high control DNBC (Dinitrochlorobenzene). FBC has no sensitising potential because the SI of the treatment groups were < 3 and the positive control was valid.
Migrated from Short description of key information:
LLNA with read across substance Fluidized Bed Combustion (FBC) Fly Ash: not sensitising
Justification for selection of skin sensitisation endpoint:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.
Justification for classification or non-classification
Testing with the read across substance Fluidized Bed Combustion (FBC) Fly Ash revealed no sensitising potential in a LLNA. Therefore the test substance has not to be classified.
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