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.
Skin sensitisation
Administrative data
- 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
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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
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
- Impurities (identity and concentrations): Metals: As, Be, Cd, Co, Cr, Cu, Hg, Mo, Ni, Pb, Sb, Se, Tl, V, Zn, sum < 0.1%
- 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
In vivo test system
Test animals
- 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
Study design: in vivo (LLNA)
- 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
Results and discussion
- Positive control results:
- 8756 DPM and SI of 12.1
In vivo (LLNA)
Resultsopen allclose all
- 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
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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