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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
Endpoint summary
Administrative data
Description of key information
Acute Oral Toxicity
In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.
It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested.
- Supporting information on the read-across substance, samarium oxide
- 1990 Study:
Under the conditions of the study the acute oral LD50 to male and female Sprague dawley rats was determined to be in excess of 5 000 mg/kg.
- 1963 Study:
Under the conditions of the study the acute oral LD50 to female rats was determined to be in excess of 1 000 mg/kg.
Since the surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide, it is considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.
Acute Inhalation Toxicity
In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.
It is not possible to generate an atmosphere of test material that would be suitable for testing. The smallest size of substance that can be generated without the risk of fire would be too dense to produce a test atmosphere for testing.
Furthermore, exposure of humans via inhalation will not occur as the substance is not used in powdered form and the powdered form of the substance will not be generated during substance use.
Acute Dermal Toxicity
In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.
It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested.
As the substance is highly insoluble, the study is also omitted on grounds there would be no potential for a significant rate of absorption through the skin.
Furthermmore, information from an acute oral toxicity study conducted with the read across substance, samarium oxide, suggests the substance does not meet the criteria for classification as acute toxicity or STOT SE (acute oral LD50 > 5 000 mg/kg).
Since 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.
- Supporting information on the read-across substance, samarium oxide
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.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.
It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested. - Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not reported
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- 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:
- other: read-across target
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- A Limit Dose of 5.0 g/kg was administered by gavage (50 % w/w solution in distilled water) to 10 fasted Sprague-Dawley rats (200-300 g) using 5/sex. Animals were observed for clinical signs for 14 days following dosing.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- DOSAGE
5.0 g/kg as a 50 % w/w solution in distilled water - Doses:
- 5.0 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 other: mg/kg
- Based on:
- test mat.
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of the study the acute oral LD50 to male and female Sprague dawley rats was determined to be in excess of 5 000 mg/kg.
- Executive summary:
The acute oral toxicity of the test material, samarium oxide, was investigated.
During the study, a Limit Dose of 5.0 g/kg was administered by gavage (50 % w/w solution in distilled water) to 10 fasted Sprague-Dawley rats (200-300 g) using 5/sex. Animals were observed for clinical signs for 14 days following dosing.
Under the conditions of the study the acute oral LD50 to male and female Sprague dawley rats was determined to be in excess of 5 000 mg/kg.
- Endpoint:
- acute toxicity: oral
- 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:
- > 5 000 other: mg/kg
- Based on:
- test mat.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not reported
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- 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:
- other: read-across target
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A single 1 000 mg/kg dose of test material was administered, as a 50 % aqueous solution, by gavage to a group of female rats. The rats were subsequently observed for a period of 30 days.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 190 - 250 g
- Diet: Ad libitum (Rockland Rat Diet)
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
Animals were housed in air-conditioned quarters. - Route of administration:
- oral: gavage
- Details on oral exposure:
- DOSAGE PREPARATION
The samarium oxide dose was prepared as a 50 % suspension by homogenisation in an aqueous 0.2 % solution of carboxymethylcellulose. - Doses:
- 1 000 mg/kg
- Details on study design:
- - Duration of observation period following administration: 30 days
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 other: mg/kg
- Based on:
- test mat.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of the study the acute oral LD50 to female rats was determined to be in excess of 1 000 mg/kg.
- Executive summary:
The acute oral toxicity of the test material, samarium oxide, was investigated.
During the study, a single 1 000 mg/kg dose of test material was administered, as a 50 % aqueous solution, by gavage to a group of female rats. The rats were subsequently observed for a period of 30 days.
Under the conditions of the study the acute oral LD50 to female rats was determined to be in excess of 1 000 mg/kg.
- Endpoint:
- acute toxicity: oral
- 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:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 other: mg/kg
- Based on:
- test mat.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.
It is not possible to generate an atmosphere of test material that would be suitable for testing. The smallest size of substance that can be generated without the risk of fire would be too dense to produce a test atmosphere for testing.
Furthermore, exposure of humans via inhalation will not occur as the substance is not used in powdered form and the powdered form of the substance will not be generated during substance use.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies)
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.
It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested.
As the substance is highly insoluble, the study is also omitted on grounds there would be no potential for a significant rate of absorption through the skin.
Furthermore, information from an acute oral toxicity study conducted with the read across substance, samarium oxide, suggests the substance does not meet the criteria for classification as acute toxicity or STOT SE (acute oral LD50 > 5 000 mg/kg).
Since 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. - 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.
- Reason / purpose for cross-reference:
- other: read-across target
- 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
- 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 - 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 - 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.
- 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.
- 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.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute Oral Toxicity
In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.
It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested.
- Supporting information on the read-across substance, samarium oxide
- 1990 Study:
The acute oral toxicity of the test material, samarium oxide, was investigated.
During the study, a Limit Dose of 5.0 g/kg was administered by gavage (50 % w/w solution in distilled water) to 10 fasted Sprague-Dawley rats (200-300 g) using 5/sex. Animals were observed for clinical signs for 14 days following dosing.
Under the conditions of the study the acute oral LD50 to male and female Sprague dawley rats was determined to be in excess of 5 000 mg/kg.
- 1963 Study:
The acute oral toxicity of the test material, samarium oxide, was investigated.
During the study, a single 1 000 mg/kg dose of test material was administered, as a 50 % aqueous solution, by gavage to a group of female rats. The rats were subsequently observed for a period of 30 days.
Under the conditions of the study the acute oral LD50 to female rats was determined to be in excess of 1 000 mg/kg.
Since the surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide, it is considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.
Acute Inhalation Toxicity
In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.
It is not possible to generate an atmosphere of test material that would be suitable for testing. The smallest size of substance that can be generated without the risk of fire would be too dense to produce a test atmosphere for testing.
Furthermore, exposure of humans via inhalation will not occur as the substance is not used in powdered form and powdered form of the substance will not be generated during substance use.
Acute Dermal Toxicity
In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.
It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested.
As the substance is highly insoluble, the study is also omitted on grounds there would be no potential for a significant rate of absorption through the skin.
Furthermmore, information from an acute oral toxicity study conducted with the read across substance, samarium oxide, suggests the substance does not meet the criteria for classification as acute toxicity or STOT SE (acute oral LD50 > 5 000 mg/kg).
Since 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.
- Supporting information on the read-across substance, samarium oxide
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.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity via the oral or dermal routes.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.