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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26th April - 12th 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Shale oils
- EC Number:
- 269-646-0
- EC Name:
- Shale oils
- Cas Number:
- 68308-34-9
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
- IUPAC Name:
- Shale oil
- Details on test material:
- Identification: Shale oil, middle fraction
Description :Liquid
Batch number: 1
Purity min.: 99 %
Composition: Complex mixture of hydrocarbons and oxygen compounds
Stability of test item: Stable under storage conditions
Expiry date: 04-MAR-2006
Storage conditions: At room temperature (range of 20 ± 5 °C), light protected.
Safety precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, BP 0109, F-69592, L’Arbresle
- Age at study initiation: 14 weeks (male), 12-13 weeks (females)
- Weight at study initiation: NDA
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: 26th April - 2nd May 2005
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
- Other: Music was played during the daytime light period.
IN-LIFE DATES: From: 26th April 2005 To: 17th May 2005
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml shale oil
- Concentration (if solution): N/A
VEHICLE
N/A - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: NDA
- Type of wrap if used: Shale oil was placed on a surgical gauze patch. This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with luke warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004, approximately 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after the removal of the dressing, gauze patch and test item.
To allow further examination of the test site, one animal was re-clipped on completion of the 10-day examination.
If evident, corrosive or staining properties of the test item were described and recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 28
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 29
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 30
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 28
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 29
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 30
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 2.00, 1.00 and 2.00, respectively and the mean oedema score was 1.00 for all three animals, respectively. (see table 1)
Very slight to well-defined erythema were noted in all animals from the 1- to the 72-hour reading and very slight erythema persisted in two animals up to the 7-day examination.
Very slight swelling was observed in all animals from the 24- to the 72-hour reading and persisted in two animals up to the 7-day examination.
Scaling was noted in all animals from the 72-hour reading to the 10-day examination or to the end of the observation period.
No abnormal findings were observed on the treated skin of any animal 14 days after treatment except scaling, which was present in two animals from the 72-hour reading to the end of the observation time. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
Slight brown staining produced by the test item of the treated skin was observed in all animals from the 1-hour reading up to the 7- or 10-day examination, respectively.
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
The body weights of all rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
COMMISSION DIRECTIVE 2004/73/EC, APRIL 29, 2004
Grading of Skin Reactions
ERYTHEMA AND ESCHAR FORMATION
No erythema.......................................................................................................................0
Very slight erythema............................................................................................................1
Well-defined erythema........................................................................................................2
Moderate to severe erythema.............................................................................................3
Severe erythema (beet redness) or eschar formation (injuries in depth preventing erythema) reading.................................................4
OEDEMA FORMATION
No oedema.........................................................................................................................0
Very slight oedema (barely perceptible)...............................................................................1
Slight oedema (edges of area well-defined by definite raising)...............................................2
Moderate oedema (edges raised approximately 1 mm).........................................................3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure)............4
Applicant's summary and conclusion
- Interpretation of results:
- other: Classified for skin irritation (category 2) according to EU criteria
- Conclusions:
- The mean scores of the three rabbits combined at the mean of the 24, 48 and 72 hour time points was 1.67 for erythema and 1 for oedema. Scaling was present in all three animals at 72 hours, and still present in two at the end of the 14 day observation period.
- Executive summary:
The skin irritation potential of shale oils, middle was examined in an experiment which was conducted in accordance with tha standardised guideline OECD 404 and under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
During the study, Shale oils, middle was applied to the torso of 2 female and 1 male New Zealand white rabbit, and held in place with a semi-occlusive dressing for 4 hours. After the exposure, the test substance was washed off and the rabbits were then observed for 14 days.
The mean scores of the three rabbits combined at the mean of the 24, 48 and 72 hour time points was 1.67 for erythema and 1 for oedema. Scaling was present in all three animals at 72 hours, and still present in two at the end of the 14 day observation period. Based upon EU classification criteria, Shale oil is considered to be “irritating” to rabbit skin with respect to the scaling effects observed.
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