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EC number: 269-646-0 | CAS number: 68308-34-9 The complex combination of hydrocarbons obtained by the thermal decomposition (at 399°C (750°F) or higher) of kerogen. It consists of hydrocarbons and heterocyclic compounds containing nitrogen, sulfur or oxygen.
- 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
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Endpoint summary
Administrative data
Description of key information
Stimulation indices of 15.3, 12.7 and 10.7 were determined with the test item at concentrations of 25 %, 50 % in acetone/olive oil (4/1, v/v) and 100 % (undiluted), respectively. Shale Oil was therefore found to be a skin sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20th April - 16th August 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/CaHsdRcc (SPF)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, CH-4414, Füllinsdorf / Switzerland
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 16 - 24 g
- Housing: Individually housed in Makrolon type-2 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted diet available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum.
- Acclimation period: 20th - 26th April 2005
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hour fluorescent light / 12 hour dark cycle with at least 8 hours music during the light period.
IN-LIFE DATES: From: To: 20th April - 3rd May 2005 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 25, 50 and 100 % in vehicle.
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 10, 25, 50 and 100 % solutions in vehicle.
- Irritation: No irritation effects
- Lymph node proliferation response: NDA
MAIN STUDY
The test item was placed into a volumetric flask on a tared Mettler balance and the vehicle acetone/olive oil (4/1, v/v) was quantitatively added. The weight/volume (w/v) dilutions were prepared individually using a magnetic stirrer as homogenizer.
Test item formulations were made freshly before each dosing occasion and no more than 4 hours prior to application to the ears.
Homogeneity of the test item in the vehicle was maintained during treatment with the magnetic stirrer.
To determine the highest non-irritant and technically applicable test item concentration, a non-GLP pretest was performed in two mice with concentrations of 10 %, 25 %, 50 % in acetone/olive oil (4/1, v/v) and 100 % (undiluted).
The test item in the main study was assayed at three consecutive concentrations. The top dose is the highest technically applicable concentration while avoiding systemic toxicity and excessive local irritation. No severe irritant effects were tolerated choosing the test concentrations.
Concentrations were in terms of material as supplied. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mean and standard deviations of body weights were calculated.
- Positive control results:
- Stimulation indices of 2.4, 3.6 and 11.2 were obtained at concentrations of 5, 10 and 25 % alpha-hexylcinnamaldehyde in the vehicle. The test subsatnce was therefore found to be a skin sensitizer.
The EC3 value is the concentration of test substance at which a score of 3 on the S.I. index is achieved. In the case of alpha-hexylcinnamaldehyde, this was achieved at 7.5 %. - Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 25 % test substance in vehicle gave a measurement of 68765 50 % test substance in vehicle gave a measurement of 57268 100 % test substance gave a measurement of 48048
- Key result
- Parameter:
- SI
- Value:
- 15.3
- Variability:
- Test item concentration: 25%
- Test group / Remarks:
- Group 2: 4 animals
- Key result
- Parameter:
- SI
- Value:
- 12.7
- Variability:
- Test item concentration: 50%
- Test group / Remarks:
- Group 3: 4 animals
- Key result
- Parameter:
- SI
- Value:
- 10.7
- Variability:
- Test item concentration: 100%
- Test group / Remarks:
- Group 4: 4 animals
- Interpretation of results:
- other: Sensitising according to EU criteria
- Conclusions:
- Stimulation indices of 15.3, 12.7 and 10.7 were determined with the test item at concentrations of 25 %, 50 % in acetone/olive oil (4/1, v/v) and 100 % (undiluted), respectively. Shale Oil was therefore found to be a skin sensitiser.
- Executive summary:
A test item is regarded as a sensitizer in the LLNA if the exposure to one or more test concentrations resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.).
In order to study a possible contact allergenic potential of Shale Oil, three groups each of four female mice were treated daily with the test item at concentrations of 25 %, 50 % in acetone/olive oil (4/1, v/v) and 100 % (undiluted) by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. The study was conducted in accordance with the standardised guideline OECD 429 and under GLP conditions. During the study, a control group of four mice was treated with the vehicle acetone/olive oil (4/1, v/v) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a β-scintillation counter.
Stimulation indices of 15.3, 12.7 and 10.7 were determined with the test item at concentrations of 25 %, 50 % in acetone/olive oil (4/1, v/v) and 100 % (undiluted), respectively. Shale Oil was therefore found to be a skin sensitiser.
Referenceopen allclose all
No deaths occurred during the study period.
No clinical signs were observed in any animals of the control group. On the second and the third application days, a slight ear erythema was observed at both dosing sites in all mice of Group 3 (50 %) and Group 2 (25 %), persisting for a total of four or three days. Since the second application day, a slight to moderate ear erythema was observed at both dosing sites in all mice of Group 4 (100 %, undiluted), persisting for the remainder of the in-life phase of the study.
The body weight of the animals, recorded prior to the first application and prior to necropsy, was within the range commonly recorded for animals of the strain and age.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A test item is regarded as a sensitizer in the LLNA if the exposure to one or more test concentrations resulted in 3-fold or greater increase in incorporation of3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.).
In order to study a possible contact allergenic potential of Shale Oil, three groups each of four female mice were treated daily with the test item at concentrations of 25 %, 50 % in acetone/olive oil (4/1, v/v) and 100 % (undiluted) by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. The study was conducted in accordance with the standardised guideline OECD 429 and under GLP conditions. During the study, a control group of four mice was treated with the vehicle acetone/olive oil (4/1, v/v) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of3H-methyl thymidine measured in a β-scintillation counter.
Stimulation indices of 15.3, 12.7 and 10.7 were determined with the test item at concentrations of 25 %, 50 % in acetone/olive oil (4/1, v/v) and 100 % (undiluted), respectively. Shale Oil was therefore found to be a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance should be classified as a Category 1 skin sensitiser with associated hazard phrase H317 in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No.1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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