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EC number: 930-690-7 | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5th March - 14th April 2010
- 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:
- 2 010
- Report date:
- 2010
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:
- no
Test material
- Reference substance name:
- Shale oils, heavy
- EC Number:
- 930-690-7
- Molecular formula:
- Not applicable. A generic molecular formula cannot be assigned to this UVCB substance.
- IUPAC Name:
- Shale oils, heavy
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Accredited Breeding Velaz, Prague, Czech Republic
- Age at study initiation: NDA
- Weight at study initiation: Males 145 - 160 g, females 120 - 140 g
- Fasting period before study: overnight prior to study
- Housing: Animals were housed 3 to a cage with wooden grate bedding and in conformity with animal welfare legislation.
- Diet (e.g. ad libitum): A standard certified laboratory diet was served. The diet is routinely analysed by the manufacturer for nutritional components and environmental contaminants.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 ºC
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: NDA
- Lot/batch no. (if required): L 812160
- Purity: NDA
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
DOSAGE PREPARATION (if unusual): Test article was mixed with vehicle shortly before administration. Required amount of test article was weighed out and mixed with precise amount of vehicle shortly before application. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 (3 male/3 female) animals per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 days after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic evaluation - Statistics:
- NDA
Results and discussion
- Preliminary study:
- NDA
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None observed
- Clinical signs:
- other: None observed
- Gross pathology:
- One male had an enlarged spleen with an uneven surface. One female was found with an uneven surface on the spleen. No other effect were found.
- Other findings:
- NDA.
Any other information on results incl. tables
Table 1: Body weight changes
Cage No. |
Sex |
Animal No. |
B.W. initial [g] |
Applied volume [ml] |
Response
|
After 1 week |
After 2 weeks |
||
B.W. [g] |
B.W. change [g] |
B.W. [g] |
B.W. change [g] |
||||||
3 |
Females |
1 |
140 |
1.4 |
0 |
165 |
25 |
185 |
20 |
2 |
120 |
1.2 |
0 |
140 |
20 |
155 |
15 |
||
3 |
135 |
1.35 |
0 |
155 |
20 |
180 |
25 |
||
4 |
Males |
4 |
150 |
1.5 |
0 |
180 |
30 |
230 |
50 |
5 |
145 |
1.45 |
0 |
200 |
55 |
225 |
25 |
||
6 |
160 |
1.6 |
0 |
205 |
45 |
235 |
30 |
Response: 0 - surviving
X - death
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 to male and female rats was > 2000 mg/kg bw, It can be concluded that product Shale oils, heavy is not toxic after single oral administration and belongs to class 5 (unclassified) according to GHS.
- Executive summary:
Shale oils, heavy fraction was dosed orally via gavage to 3 female (120 - 140 g) and 3 male (145 - 160 g) wistar rats at limit dose of 2000 mg/kg, in accordance with OECD 423 and performed to GLP. Neither death nor visible symptoms of toxicity during 14 day observation period were seen. It can be concluded that product Shale oils, heavy is not toxic after single oral administration and belongs to class 5 (unclassified) according to GHS.
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