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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-238-0 | CAS number: 10099-59-9
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This publication reports the results of mutagenic and teratogenic tests from rare earth compounds in general. The material and methods section is substantially incomplete, main part of the results are not reported and discussion/conclusion/references parts are inexistant.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- The investigation of mutagenicity and teratogenicity from rare earth compounds
- Author:
- Mu C & Shi W
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Wistar rats and Kunming species mice were administrated orally with 1, 10 and 100 mg/kg mixed rare earth nitrate each day during 5 days. Chromosome aberration and micronucleus rates were measured in the rats and mice marrow cells after the period of administration. The filial generation marrow cells were also investigated at the 3rd month after birth.
- GLP compliance:
- no
- Type of assay:
- other: in vivo chromosome aberration and micronucleus
Test material
- Reference substance name:
- mixed rare earth nitrate
- IUPAC Name:
- mixed rare earth nitrate
- Details on test material:
- The following paragraph has been directly taken from the publication, and contains uncertainties and inaccurate information:
"The mixed rare earth nitrate is provided by Shangqiu Chemical Smeltery in Henan Province. The RexOy content is 38.71%, specific activities of α and β are 1.43E-08 and 1.67E-09 Ci/kg respectively. The main components are Ce 38.7%, La 39.16%, Nd 15.52%, Pr 5.3% and Sm 1.88%. The sole rare-earth compounds include La2O3, Sm2O3, Eu2O3, YCL3, ScCl3, NdCl3, Cd2O3, Pr6O13 and NiCl2 as positive control substance. Their purity is all over 99.9%".
Constituent 1
Test animals
- Species:
- other: rats and mice
- Strain:
- other: Wistar rats and Kunming mice
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- Two periods of exposure were investigated:
(1) daily oral administration during 5 days
(2) feeding with the forage containing rare earth nitrate for 3-6 months - Duration of treatment / exposure:
- (1) 5 days
(2) 3-6 months - Frequency of treatment:
- (1) daily (no data about the frequency per day)
(2) no data, assumed to be daily - Post exposure period:
- no data
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1, 10, 100 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
100, 1000 and 10000 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 animals per dose (no data about species nor sex)
Apparently, the filial generation was also subjected to examination. - Control animals:
- yes, concurrent no treatment
- Positive control(s):
- none
Examinations
- Tissues and cell types examined:
- marrow cells
- Details of tissue and slide preparation:
- no data
- Evaluation criteria:
- none
- Statistics:
- no data
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- not specified
- Negative controls validity:
- other: rates near the results of two other unknown authors
- Positive controls validity:
- not applicable
- Additional information on results:
- (1) After a 5-day exposure to mixed rare earth nitrate, no increase of aberration rate of marrow cells was observed. There was no significant difference in comparison with the control group. The micronucleus rate was also within the normal range (Table 1).
(2) During the third month, there was an increasing tendency with dosage in the aberration rate of marrow cells from experimental mice, but there was no significant difference between each group and the control. In the 6th month and 3rd month of the filial generation, the marrow cell-aberration rate had no change (Table 2).
Any other information on results incl. tables
Table 1: Changes of aberration rate and micronucleus rate of marrow cells in rats after administration RE (first exposure)
Group | Number of animals | Aberration rate % | Micronucleus rate % |
Control | 5 | 0.33±0.45 | 0.23±0.06 |
1 mg/kg | 5 | 0.33±0.28 | 0.32±0.05 |
10 mg/kg | 5 | 0.24±0.45 | 0.27±0.08 |
100 mg/kg | 5 | 0.33±0.48 | 0.23±0.06 |
Table 2: Changes of Aberration rate of marrow cell of mice
Group | Num. Anim. | Parent. 3rd % | Paren. 6th % | Filial 3rd % |
Control | 6 | 0.66±0.24 | - | 0.68 ± 0.31 |
100 ppm | 6 | 0.79 ±0.51 | 0.68 ±0.22 | 0.67±0.51 |
1000 ppm | 6 | 0.84 ±0.53 | 0.45 ±0.44 | 0.70 ±0.25 |
10000 ppm | 6 | 0.94 ±0.35 | - | - |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of these tests, mixed rare earth nitrate does not have mutagenic effect on marrow cells.
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.