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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 261-235-4 | CAS number: 58398-71-3
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented and scientifically acceptable.
Data source
Reference
- Reference Type:
- publication
- Title:
- Dynamics of 241Am in the skeleton of the rat: A study of the relationsship betwenn behavior of bone-seeking elements and bone-growth status
- Author:
- Durbin, P.W.; et al.
- Year:
- 1 969
- Bibliographic source:
- In: Mays, C.F.; et al. (Eds.): Delayed Effects of Bone-Seeking Radionuclides, Univ. of Utah Press, 137-156
Materials and methods
- Objective of study:
- distribution
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Behaviour of 241Am and 45Ca in the skeleton and growth and senescence of the skeleton of female rats.
- GLP compliance:
- no
Test material
- Reference substance name:
- Calcium
- EC Number:
- 231-179-5
- EC Name:
- Calcium
- Cas Number:
- 7440-70-2
- IUPAC Name:
- calcium
- Details on test material:
- - Name of test material (as cited in study report): Calcium ion (unspecified)
No further details are given.
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 45Ca
Test animals
- Species:
- rat
- Strain:
- other: CRCD
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: rats free of disease raised by Charles River Breeding Laboratories, North Wilmington, Massachusetts
- Age at study initiation: 11 days
- Individual metabolism cages: yes
No further details are given.
Administration / exposure
- Route of administration:
- intramuscular
- Vehicle:
- other: isotonic sodium citrate
- Details on exposure:
- Isotopes were diluted with isotonic sodium citrate and administered to rats.
- Duration and frequency of treatment / exposure:
- single exposure; effect observations: 180 days after injection
Doses / concentrations
- Remarks:
- Doses / Concentrations:
241Am: 0.1 µCi/rat;
45Ca: 10 µCi/rat
- No. of animals per sex per dose / concentration:
- 45Ca: 8 female rats housed in individual cages
241Am: 4 groups of rats (three rats per cage) - Control animals:
- not specified
- Positive control reference chemical:
- No positive control substance was tested.
- Details on study design:
- - Dose selection rationale: no data
- Rationale for animal assignment (if not random): no data - Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces and other tissues
- Time and frequency of sampling: excreta were collected from Ca-injected rats.
Soluble soft tissue ash was removed from insoluble bone ash by gentle rinsing with alkaline water. Rinse from each rat carcass was analysed as a separate sample designated "soft tissue balance".
- Other: Three radiochemical procedures were used: a) 45Ca and 241Am in ashed excreta were precipitated as oxalates according to the method of Comar. b) Bone and tissue ash were evaporated on glass plates as Ca3(PO4)2, according to the method of Barr. c) When Am levels in excreta were very low, Am was first concentrated by the oxalate method, then redissolved and coprecipitated with LaF3 as described by Scott et al.
Bones were fixed in 80% alcohol, sawed, dehydrated in alcohol and acetone, and embedded in Bioplastic. Autoradiographs were prepared by exposure to X-ray film, NTA plates and spectrographic plates.
METABOLITE CHARACTERISATION STUDIES
not examined - Statistics:
- no data
Results and discussion
- Preliminary studies:
- not performed
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- no data
- Details on distribution in tissues:
- 45Ca kinetics: After 45Ca injection 4 general processes were identified - their rates were sufficiently different to be distinguishable:
- Component A1 (T1/2 = 2 to 4 days) was attributed to early exchange loss of diffuse label;
- Component A2 (T1/2 = 20 to 30 days) was associated with resorption during growth remodeling;
- Component A3 (t1/2 = 150 to 300 days) was related to slow growth remodeling as in rip and mandible and maintenance remodeling in long bones and vertebrae;
- Component A4 (T1/2 = 2600 days) was associated with cortical bone remodeling and structural loss in very old age.
The recirculation of 45Ca is demonstrated by continued deposition in incisors and in metaphysal trabeculae formed during the first 180 days PI. When 45Ca enters bone, it partitions between diffuse deposition in pre-existing bone and concentrated deposition in regions of new bone formations.
- Details on excretion:
- no data
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- not examined
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
Early exchange loss of diffuse label, resorption during growth remodeling,
Redistribution trend of Ca was mainly towards new bone formation in temporary bony structures
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.