Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2 May 2012 to 11 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:
- in vitro gene mutation study in bacteria
- 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
- Species / strain:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
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 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
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
- Specific details on test material used for the study:
- As the test material is not sufficiently soluble in any acceptable vehicle for use in an Ames test, the supernatant of suspensions were used. The test material was weighed directly for all tested concentrations and suspended in sterile aqua demin. All suspensions were stirred during the test.
As no complete dissolution was possible, undissolved particles were visible on the plates.
Method
- Target gene:
- - Histidine requirement in the Salmonella typhimurium strains (Histidine operon).
Species / strain
- Species / strain / cell type:
- other: S typhimurium TA 97a, TA 98, TA 100, TA 102, and TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- First experiment: 0, 51, 157, 498, 1497 and 5007 µg/plate (without and with activation)
Second experiment: 317, 626, 1255, 2508 and 5011 µg/plate (without and with activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene diamine (20 µg/plate) and 2-Amino-anthracene (1 µg/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and pre-incubation
EXPERIMENT 1- PLATE INCORPORATION METHOD
100 µL test material suspension, vehicle or positive control was added to 100 µL bacteria suspension and 500 µL S9 mix or 500 µL phosphate buffer (for tests with and without metabolic activation, respectively) and 2 000 µL overlay agar. The plates were closed and left to harden for a few minutes, then inverted and placed in the dark incubator at 37 °C.
EXPERIMENT 2- PRE-INCUBATION METHOD
100 µL test material suspension, vehicle or positive control was added to 100 µL bacteria suspension and 500 µL S9 mix or 500 µL phosphate buffer (for tests with and without metabolic activation, respectively) and gently vortexed in a test tube and incubated at 37°C for 20 minutes. After pre-incubation 2 000 µL overlay agar was added, the tube gently vortexed and the mixture poured onto the selective agar plate. The plates were closed and left to harden for a few minutes, then inverted and placed in the dark incubator at 37 °C.
The colonies were counted visually, the numbers were recorded. - Evaluation criteria:
- A test material is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor ≥ 2) in at least one strain can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- EXPERIMENT 1
- Confirmation of the Criteria and Validity: The treatments for the sterility control and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls showed mutagenic effects with and without metabolic activation.
- Toxicity: No signs of toxicity towards tested strains could be observed. The background lawn was visible and the number of revertant colonies was not reduced.
- Mutagenicity: No significant increase in the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
Therefore, the test material was found not to be mutagenic under the sonditions of this experiment. To verify the result, a second experiment was conducted using the pre-incubation method.
EXPERIMENT 2
- Confirmation of the Criteria and Validity: The treatments for the sterility control and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls showed mutagenic effects with and without metabolic activation.
- Toxicity: No signs of toxicity towards tested strains could be observed. The background lawn was visible and the number of revertant colonies was not significantly reduced.
- Mutagenicity: No significant increase in the number of revertant colonies in the treatments with and without metabolic activation was observed. No concentration-related increase over the tested range was found.
The results of the second experiment confirmed the findings of the first experiment.
Any other information on results incl. tables
First Experiment:
The mean revertant values of the four replicates are presented in the following table. Concentrations of the test mateiral are stated as nominal concentrations, as suspensions had to be tested due to the poor solubility of the test material. As no complete dissolution was possible, undissolved particles were visible on the plates.
Strain | TA97a | TA98 | TA100 | TA102 | TA1535 | ||||||
Induction | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
H2O | Mean | 108 | 116 | 15 | 16 | 87 | 89 | 140 | 146 | 13 | 15 |
sd | 13.1 | 5.1 | 3.9 | 1.4 | 10.2 | 3.6 | 7.9 | 7.7 | 1.5 | 2.6 | |
DMSO | Mean | 104 | 108 | 12 | 17 | 88 | 91 | 150 | 149 | 15 | 17 |
sd | 6.5 | 13.1 | 1.7 | 1.2 | 6.8 | 11.4 | 14.7 | 10.2 | 1.7 | 1.0 | |
Positive Controls | Mean | 531 | 583 | 245 | 217 | 516 | 559 | 582 | 632 | 212 | 202 |
sd | 74 | 88 | 15 | 15 | 38 | 28 | 25 | 39 | 21 | 21 | |
f(I) | 5.11 | 5.40 | 20.42 | 12.76 | 5.93 | 6.14 | 3.88 | 4.24 | 16.31 | 11.88 | |
5007 µg/pl. | Mean | 113 | 118 | 17 | 15 | 79 | 77 | 152 | 144 | 15 | 15 |
sd | 6 | 4 | 2 | 1 | 6 | 10 | 6 | 9 | 4 | 1 | |
f(I) | 1.05 | 1.02 | 1.13 | 0.94 | 0.91 | 0.87 | 1.09 | 0.99 | 1.15 | 1.00 | |
1497 µg/pl. | Mean | 117 | 119 | 16 | 15 | 84 | 93 | 145 | 142 | 17 | 15 |
sd | 3 | 5 | 2 | 1 | 11 | 13 | 10 | 9 | 4 | 2 | |
f(I) | 1.08 | 1.03 | 1.07 | 0.94 | 0.97 | 1.04 | 1.04 | 0.97 | 1.31 | 1.00 | |
498 µg/pl. | Mean | 120 | 121 | 16 | 16 | 77 | 96 | 148 | 137 | 16 | 16 |
sd | 2 | 2 | 2 | 1 | 8 | 9 | 5 | 6 | 3 | 2 | |
f(I) | 1.11 | 1.04 | 1.07 | 1.00 | 0.89 | 1.08 | 1.06 | 0.94 | 1.23 | 1.07 | |
157 µg/pl. | Mean | 114 | 116 | 16 | 15 | 76 | 93 | 129 | 147 | 15 | 14 |
sd | 3 | 4 | 2 | 2 | 22 | 16 | 10 | 13 | 4 | 1 | |
f(I) | 1.06 | 1.00 | 1.07 | 0.94 | 0.87 | 1.04 | 0.92 | 1.01 | 1.15 | 0.93 | |
51 µg/pl. | Mean | 120 | 113 | 15 | 16 | 82 | 84 | 144 | 133 | 14 | 14 |
sd | 3 | 5 | 4 | 1 | 5 | 6 | 8 | 12 | 3 | 1 | |
f(I) | 1.11 | 0.97 | 1.00 | 1.00 | 0.94 | 0.94 | 1.03 | 0.91 | 1.08 | 0.93 |
Second Experiment:
The mean revertant values of the four replicates are presented in the following table. Concentrations of the test material are stated as nominal concentrations, as suspensions had to be tested due to the poor solubility of the test material. As no complete dissolution was possible, undissolved particles were visible on the plates.
Strain | TA97a | TA98 | TA100 | TA102 | TA1535 | ||||||
Induction | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
H2O | Mean | 116 | 106 | 21 | 20 | 66 | 83 | 135 | 137 | 14 | 14 |
sd | 15.9 | 7.5 | 2.5 | 2.3 | 4.3 | 12.0 | 18.3 | 18.2 | 1.3 | 3.0 | |
DMSO | Mean | 112 | 109 | 15 | 18 | 70 | 84 | 138 | 146 | 14 | 13 |
sd | 3.0 | 6.7 | 2.6 | 2.9 | 9.7 | 5.7 | 9.2 | 4.5 | 2.2 | 3.4 | |
Positive Controls | Mean | 449 | 301 | 885 | 824 | 683 | 617 | 593 | 692 | 343 | 232 |
sd | 75 | 38 | 47 | 53 | 82 | 98 | 36 | 67 | 80 | 8 | |
f(I) | 4.01 | 2.76 | 59.00 | 45.78 | 10.35 | 7.35 | 4.30 | 4.74 | 24.50 | 17.85 | |
5011 µg/pl. | Mean | 101 | 103 | 16 | 17 | 114 | 102 | 138 | 134 | 15 | 16 |
sd | 7 | 7 | 2 | 4 | 6 | 7 | 3 | 15 | 2 | 2 | |
f(I) | 0.87 | 0.97 | 0.76 | 0.85 | 1.73 | 1.23 | 1.02 | 0.98 | 1.07 | 1.14 | |
2508 µg/pl. | Mean | 102 | 101 | 15 | 19 | 92 | 100 | 132 | 141 | 15 | 16 |
sd | 5 | 12 | 2 | 2 | 19 | 4 | 5 | 2 | 1 | 3 | |
f(I) | 0.88 | 0.95 | 0.71 | 0.95 | 1.39 | 1.20 | 0.98 | 1.03 | 1.07 | 1.14 | |
1255 µg/pl. | Mean | 112 | 96 | 13 | 18 | 85 | 100 | 151 | 146 | 14 | 14 |
sd | 8 | 4 | 3 | 2 | 10 | 7 | 7 | 9 | 1 | 3 | |
f(I) | 0.97 | 0.91 | 0.62 | 0.90 | 1.29 | 1.20 | 1.12 | 1.07 | 1.00 | 1.00 | |
626 µg/pl. | Mean | 93 | 98 | 15 | 14 | 87 | 96 | 151 | 129 | 16 | 14 |
sd | 3 | 6 | 1 | 2 | 6 | 8 | 8 | 4 | 2 | 3 | |
f(I) | 0.80 | 0.92 | 0.71 | 0.70 | 1.32 | 1.16 | 1.12 | 0.94 | 1.14 | 1.00 | |
317 µg/pl. | Mean | 97 | 93 | 15 | 14 | 84 | 105 | 136 | 145 | 16 | 14 |
sd | 4 | 3 | 2 | 3 | 11 | 9 | 6 | 10 | 2 | 1 | |
f(I) | 0.84 | 0.88 | 0.71 | 0.70 | 1.27 | 1.27 | 1.01 | 1.06 | 1.14 | 1.00 |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test material was considered to be non-mutagenic.
- Executive summary:
The mutagenic potential of the test material was investiagted in accordance with the standardised guidelines OECD 471 and EU Method B.13/14, under GLP conditions using the Bacterial Reverse Mutation Assay.
Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 were treated with the test material using both the Ames plate incorporation and pre-incubation methods at five dose levels both with and without the addition of a rat liver homogenate metabolising system.
Under the conditions of the study, the test material was considered not mutagenic. Also, the test material did not show any cytotoxicity towards the bacteria.
As no complete dissolution was possible, undissolved particles were visible on the plates. The confirmation tests of the genotype did not show any irregularities. The control of the titre was above the demanded value. The numbers of revertant colonies of the positive controls were within the range of the historical data of the laboratory and were definitely increased in comparison with the negative controls, as well as showing mutagenic potential of the diagnostic mutagens.
The findings of the study are therefore considered to be valid.
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.