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Diss Factsheets
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EC number: 231-128-7 | CAS number: 7440-19-9
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 16 May 2012 to 30 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.
Cross-reference
- Reason / purpose for cross-reference:
- other: read-across target
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- The surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Samarium (III) oxide
- EC Number:
- 235-043-6
- EC Name:
- Samarium (III) oxide
- Cas Number:
- 12060-58-1
- Molecular formula:
- O3Sm2
- IUPAC Name:
- Samarium (III) oxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: yellowish powder
- Storage conditions: room temperature (20 ± 5°C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 weeks (males); 8 weeks (females)
- Weight at study initiation: 231 - 243 g (males), 196 - 216 g (females)
- Housing: Animals were housed individually in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): ca. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- (distilled)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approximately 24 hours before treatment, fur was removed from the dorsal area of the trunk of the test area by clipping.
- % coverage: at least 10 %
- Type of wrap if used: Test material applications were held in place under gauze dressings.
REMOVAL OF TEST SUBSTANCE
Following the 24 hour exposure period the gauze dressings were removed and the treated areas were rinsed with distilled water.
TEST MATERIAL
- Amount(s) applied: 1 g or 4 g of test material was weighed and 5 or 20 mL of distilled water was added. The preparation was magnetically stirred to obtain a white solution just before administration. The preparation was administered under a volume of 10 mL/kg bw. - Duration of exposure:
- 24 hours
- Doses:
- 2 000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A check for mortality was conducted daily together with systematic examinations to identify any behavioural or toxic effects on the major physiological functions. Body weights were taken just before test material application (day 0) and again on days 2, 7 and 14.
- Necropsy of survivors performed: Yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the study.
- Clinical signs:
- other: No clinical signs that were related to treatment with the test material were observed.
- Gross pathology:
- No treatment-related effects were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of the study the acute dermal LD50 to male and female Sprague Dawley rats was determined to be in excess of 2 000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of the test material was investigated in a study which was conducted in accordance with the standardised guidelines OECD 402 and EU Method B.3, under GLP conditions.
During the study a group of 5 male and 5 female Sprague Dawley rats were exposed to a single dermal application of test material at the limit dose of 2 000 mg/kg bw under semi-occlusive conditions for 24 hours after which the test material was removed with distilled water. The rats were observed for 14 days.
None of the animals died during the study, no clinical signs that could be related to treatment with the test material were noted and all animals gained weight during the study. The macroscopic examination of the animals at necropsy revealed no treatment-related effects.
Therefore, under the conditions of the study, the acute dermal LD50 to male and female Sprague Dawley rats was determined to be in excess of 2 000 mg/kg bw.
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