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EC number: 232-000-3 | CAS number: 7783-48-4
- 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 cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study started on 15 December 2009 and was completed on 11 February 2010.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD (2008) ‘Genetic Toxicology: OECD Guideline for the testing of chemicals. Draft proposal for a new Guideline 487: In vitro micronucleus test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed by The Department of Health of the Government of the United Kingdom (2010-06-23)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 10042-76-9
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Strontium nitrate
- Molecular formula (if other than submission substance): Sr(NO3)2
- Molecular weight (if other than submission substance): 211.63 g/mol
- Physical state: solid, white powder
- Storage condition of test material: stored at 15 - 25°C in the dark
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- lymphocytes: from female volunteers
- Details on mammalian cell type (if applicable):
- Blood from two healthy, non-smoking female volunteers was used for each experiment in this study. The measured cell cycle time of the donors used at Covance falls within the range 13 +/- 1.5 hours.
- Type and identity of media: Whole blood cultures were established in sterile disposable centrifuge tubes by placing 0.4 mL of pooled heparinised blood into 8.1 mL HEPES-buffered RPMI medium containing 20% (v/v) heat inactivated foetal calf serum and 50 µg/mL gentamycin, so that the final volume following addition of S9 mix/KCl and the test article in its chosen vehicle is 10 mL. The mitogen Phytohaemagglutinin (PHA) was included in the culture medium at a concentration of approximately 2% of culture to stimulate the lymphocytes to divide. Blood cultures were incubated at 37°C +/- 1°C for 48 hours and rocked continuously.
No further details are given. - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Concentrations selected for the Main Experiment were based on the results of this cytotoxicity Range-Finder Experiment.
Range-Finder:
- 3+21 hours, without and with metabolic activation; as well as 24+0 hours, without metabolic activation: 7.677, 12.79, 21.32, 35.54, 59.23, 98.72, 164.5, 274.2, 457.1, 761.8, 1270 and 2116 µg/mL
Main Experiment:
- 3+21 hours, without metabolic activation: 200, 400, 800, 1200*, 1500*, 1800* and 2116 µg/mL
- 3+21 hours, with metabolic activation: 200, 400, 800*, 1200*, 1500*, 1800 and 2116 µg/mL
- 24+0 hours, without metabolic activation: 200, 400, 800, 1200, 1500*, 1800* and 2116* µg/mL
* = Concentrations selected for analysis. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: purified water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile purified water was added to cultures.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without metabolic activation Migrated to IUCLID6: 0.8 and 0.8 µg/mL
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile purified water was added to cultures.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation Migrated to IUCLID6: 6.25 and 15.5 µg/mL
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile purified water was added to cultures.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: vinblastine; 0.02, 0.03 and 0.04 µg/mL
- Remarks:
- without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 3 hours (+ 21 hours recovery) or 24 hours
Cytochalasin B, formulated in DMSO, was added directly (0.1 mL/culture) to all 24-hour cultures at the time of treatment. Cultures were incubated at 37°C +/- 1°C for the designated exposure time.
- Addition of Cytochalasin B: Cytochalasin B (formulated in DMSO) was added to post wash-off culture medium after approximately 51 hours for the cultures exposed 3 hours to the test substance or after 48 hours for cultures exposed continuously (test substance was removed at time of harvest).
- Fixation time (start of exposure up to fixation or harvest of cells): Cells were harvested after 72 hours. Cells were fixed by dropping the suspension into fresh, cold methanol/glacial acetic acid (3:1, v/v). The fixative was changed by centrifugation and resuspension. This procedure was repeated until the cell pellets were clean.
SLIDE PREPARATION: Several drops of fixed cell suspension were gently spread onto multiple clean, dry microscope slides.
STAIN (for cytogenetic assays): After the slides had dried the cells were stained for 5 minutes in filtered 4% (v/v) Giemsa in pH 6.8 buffer. The slides were rinsed, dried and mounted with coverslips.
NUMBER OF REPLICATIONS: Cultures exposed to the test article and the positive controls were tested in duplicate; for the negative controls 4 cultures were tested for each exposure.
NUMBER OF CELLS EVALUATED: Where possible, a minimum of 1000 binucleate cells from each culture (at least 2000 per concentration) were analysed for micronuclei. The number of cells containing micronuclei and the number of micronuclei per cell on each slide was noted.
DETERMINATION OF CYTOTOXICITY
- Method: other:
Single cultures were treated with the test article for 3 hours (+ 21 hours recovery; in the absence and presence of metabolic activation) or continuously for 24 hours (without S9 mix). Vehicle controls (1 mL/culture) were tested in duplicates. Positive control treatments were not included.
Cytochalasin B, formulated in DMSO was added directly (0.1 mL/culture) to all continuous cultures at the time of treatment. Cultures were incubated at 37°C +/- 1°C for the designated exposure time.
OTHER EXAMINATIONS:
Slides from the cytotoxicity Range-Finder Experiment were examined, for proportions of mono-, bi- and multinucleate cells, to a minimum of 200 cells per concentration. From these data the replication index (RI) and the relative RI were determined. Cytotoxicity (%) is expressed as (100 – Relative RI). - Evaluation criteria:
- For valid data, the test article was considered to induce clastogenic and/or aneugenic events if:
1. A statistically significant increase in the frequency of MNBN cells at one or more concentrations was observed.
2. An incidence of MNBN cells at such a concentration that exceeded the normal range in both replicates was observed.
3. A concentration-related increase in the proportion of MNBN cells was observed.
The test article was considered as positive in this assay if all of the above criteria were met.
The test article was considered as negative in this assay if none of the above criteria were met.
Results which only partially satisfied the above criteria were dealt with on a case by case basis. Evidence of a concentration-related effect was considered useful but not essential in the evaluation of a positive result. - Statistics:
- The proportion of MNBN cells for each treatment condition were compared with the proportion in negative controls by using Fisher's exact test. Probability values of p < 0.05 were accepted as significant. Additionally, the number of micronuclei per binucleate cell were obtained and recorded.
Results and discussion
Test results
- Species / strain:
- lymphocytes: from humans
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Treatment of cells with Strontium nitrate (+/- S9) resulted in frequencies of MNBN cells that were similar to (and not significantly different from) those observed in concurrent vehicle controls at all concentrations analysed. For details see table below.
- 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 examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH and osmolality: No marked changes in osmolality or pH were observed at the highest concentration tested in the cytotoxicity Range-Finder (2116 µg/mL), compared to the concurrent vehicle controls (individual data not reported).
- Water solubility: Preliminary solubility data indicated that Strontium nitrate was soluble in purified water at concentrations up to at least 58.53 mg/mL. The solubility limit in culture medium was in excess of 5853 µg/mL.
RANGE-FINDING/SCREENING STUDIES: The results of the cytotoxicity Range-Finder Experiment were used to select suitable maximum concentrations for the Main Experiment.
COMPARISON WITH HISTORICAL CONTROL DATA: yes; The MNBN cell frequency of all Strontium nitrate treated cultures fell within normal ranges.
ADDITIONAL INFORMATION ON CYTOTOXICITY: no further data - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Main experiment (48 hours PHA) - Summary of results
Treatment |
Concentration (mg/mL) |
Cytotoxicity (%) |
Mean MNBN cell frequency (%) |
Historical(%) # |
Statistical significance |
3+21 hour -S-9 |
Vehiclea |
- |
0.62 |
0.1-1.2 |
- |
Trial 2 |
1200 |
0 |
0.32 |
|
NS |
|
1500 |
0 |
0.34 |
|
NS |
|
1800 |
0 |
0.79 |
|
NS |
|
*MMC, 0.80 |
ND |
11.02 |
|
p<0.001 |
|
*VIN, 0.02♦ |
ND |
4.86 |
|
p<0.001 |
3+21 hour +S-9 |
Vehiclea |
- |
0.32 |
0.0-1.2 |
- |
Trial 2 |
800.0 |
0 |
0.39 |
|
NS |
|
1200 |
0 |
0.42 |
|
NS |
|
1500 |
0 |
0.34 |
|
NS |
|
*CPA, 12.5 |
ND |
2.03 |
|
p<0.001 |
24+0 hour -S-9 |
Vehiclea |
- |
0.25 |
0.1-1.2 |
- |
Trial 1 |
1500 |
5 |
0.20 |
|
NS |
|
1800 |
19 |
0.20 |
|
NS |
|
2116 |
10 |
0.25 |
|
NS |
|
*VIN, 0.02 |
ND |
4.40 |
|
p<0.001 |
|
*MMC, 0.80♥ |
ND |
8.45 |
|
p<0.001 |
♦ 24+0 hour –S-9 treatment ♥ 3+21 hour –S-9 treatment aVehicle control waspurified water * Positive control #95thpercentile of the observed range NS = Not significant ND = Not determined |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It is concluded that Strontium nitrate did not induce micronuclei in cultured human peripheral blood lymphocytes when tested in excess of the limit of solubility in both the absence and presence of S-9. - Executive summary:
Strontium nitrate was tested in an in vitro micronucleus assay using human lymphocytes, both in the absence and presence of metabolic activation.
Treatments covering a broad range of concentrations, the highest concentration used in the Main Experiment, 2116 mg/mL, (equivalent to 10 mM) was determined following a preliminary cytotoxicity Range-Finder Experiment.
Treatments were conducted 48 hours following mitogen stimulation by Phytohaemagglutinin (PHA). In the Main Experiment, micronuclei were analysed at 3 concentrations. Appropriate vehicle control cultures were included in the test system under each treatment condition.
Treatment of cells with Strontium nitrate in the absence and presence of S9 mix resulted in frequencies of MNBN cells that were similar to (and not significantly different from) those observed in concurrent vehicle controls at all concentrations analysed under all treatment conditions. The MNBN cell frequency of all Strontium nitrate treated cultures fell within normal ranges.
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