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Diss Factsheets
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EC number: 944-886-5 | CAS number: -
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: study well documented with acceptable restrictions
- Justification for type of information:
- Justification for Read Across is given in Section 13 of IUCLID
Data source
Reference
- Reference Type:
- publication
- Title:
- In vitro effect of fluor-hydroxyapatite, fluorapatite and hydroxyapatite on colony formation, DNA damage and mutagenicity
- Author:
- Jantová Sona, Theiszová M., Letašiová Silvia, Birošová L., Palou Tchingnabe Palou
- Year:
- 2 008
- Bibliographic source:
- Mutat Res. 2008 Apr 30;652(2):139-44
Materials and methods
- Principles of method if other than guideline:
- The bacterial mutagenicity test of the substance is evaluated by using Salmonella typhimurium TA100 according to Maron and Ames.
D.M. Maron, B.N. Ames. Revised methods for Salmonella mutagenicity test, Mutat. Res. 113 (3-4) (1983) 173-215 - GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fluorohydroxyapatite
- Molecular formula:
- Ca10(PO4)6(OH)F
- IUPAC Name:
- Fluorohydroxyapatite
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 1-5-10-25-50-75-100 %
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-Methyl-N′-nitro-N-nitrosoguanidine (ΜΜΝG) - stock solution was 1 μg/ml
- Details on test system and experimental conditions:
- PREPARATION OF BIOMATERIAL ELUATES
The test material powders (porous size was less than 125 μm, shot 100 mg/ml) were used for preparation of 5-day´s concentrated eluates (non-diluted). Culture medium supplemented with penicillin and streptomycin was used. Biomaterial powders was sterilized for 30 min at 130 °C, then the cultivation medium was added and samples were shaken on reciprocal shaker for 5 days at 37 °C. After 5 day eluation the concentrated samples were centrifugated (10 min, 1100 g), the culture medium was aspirated by syringe and filtered (Ø 0.22 μm). This procedure led to preparation of 100 % (concentrated, non-diluted) of biomaterial eluates which pH was in the range 6.8 – 7.1. Eluates were stored at -20 °C. Before experiment these concentrated eluates were diluted by culture medium to concentrations tested (75, 50, 25, 10, 5 and 1 %).
TEST SYSTEM
TA100 was received from the Collection of Microorganisms, Masaryk University, Brno (Czech Republic). It was stored at -80 °C and regularly checked for their genetic markers.
PERFORMANCE OF THE TEST
Bacterial strain Salmonella typhimurium TA100 was cultivated on nutrient agar and 16 h before experiment overnight culture was prepared in nutrient broth. The strain was used for its sensitivity for a broad spectrum of chemical compounds. The plate- incorporation method was used. To 2 ml of melted top agar containing 50 μM of L-histidine-biotin, 0.1 ml of a cell suspension (overnight cultivation at 37 °C, approximate cell density 2-5 x 10^8 cells/ml) and 0.1 ml of a solution of the tested compound were added. The mixture was poured onto a minimal glucose agar plate and incubated for 48 h at 37 °C and then the number of histidine- independent revertants was counted. Data points represents at least three separate experiments, each run in triplicate. - Evaluation criteria:
- A positive response was defined as a reproducible, two-fold increase of revertants with dose-response relationship.
- Statistics:
- Student´s t-test
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- - The highest tested concentration (100 %) of tge test material did not induce growth of revertants. No mutagenic activity was observed.
- Positive control MNNG induced mutagenic activity in Salmonella typhimurium TA100.
Applicant's summary and conclusion
- Conclusions:
- No mutagenic activity was observed
- Executive summary:
Τhe bacterial mutagenic potential of the substance on Salmonella typhimurium TA100 was evaluated in the plate-incorporation method.
S. Typhimurium TA100 was exposed to 1-5-10-25-50-75-100 % of the test material, Positive control (MMNG) run in parallel. A positive response was defined as a reproducible, two-fold increase of revertants with dose-response relationship and statistical evaluation using Student´s t-test.
No mutagenic activity was observed.
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