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EC number: 215-145-7 | CAS number: 1306-06-5
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test substance is not mutagenic under this test conditions.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Hydroxyapatite with zirconia added (to make it tougher), whitish grey fine powder, aseptic precautions taken when handling the substance
- Species / strain / cell type:
- other: S. typhimurium TA98, TA100, TA1535, TA1537 and E.coli WP2uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- 5000, 2500, 1250, 625 and 313 µg/plate
top dose according to guideline for non-cytotoxic substances, cytotoxicity tested (= not cytotoxic) - Untreated negative controls:
- no
- Remarks:
- water
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3(5-nitro-2-furyl)acrylamide, Sodium azide, 2-d-2-Aminoanthracene, Methoxy-6-chloro-9(3-(2-chloroethyl)-aminopropylamino)acrinidine
- Details on test system and experimental conditions:
- pre-incubation method
negative control: triplicate, positive controls and treatment: duplicate, control for bacterial contamination of the agar plates: once - Rationale for test conditions:
- according to guideline
- Evaluation criteria:
- number of revertant colonies equal or less than negative control, reproducible effects (duplicates),no concentration-dependent effects
- Statistics:
- The colonies were counted with a manual counter or a colony analizer. Each plate was counted 3 times and the mean was given. The average plate count for each dose was calculated as the average of the duplicates.
- Key result
- Species / strain:
- other: S. typhimurium TA98, TA100, TA1535, TA1537 and E.coli WP2 uvrA
- 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:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no mutagenic potential
- Conclusions:
- The test substance is not mutagenic under this test conditions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
The test item is not genotoxic under the conditions of this test.
Link to relevant study records
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- other: Bone Marrow Abberation Test
- Species:
- mouse
- Strain:
- other: Swiss Albino Strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Animal House Unit of the USM Health Campus
adult, healthy mice (10-12 weeks old), body weights: females: 29.51+/-0.22g, males: 36.28+/-0.37g
reared in cages, comercial pellet diet and distilled water ad libitum - Route of administration:
- intraperitoneal
- Vehicle:
- distilled water
- Duration of treatment / exposure:
- 6, 24, 48 hours
- Frequency of treatment:
- once
- Post exposure period:
- 90 min. before sacrifice: intraperitoneally injection of caochicine (4mg/kg)
- Remarks:
- 2000mg/kg body weight (synthetic hydroxyapatite granules, porous form, 100 - 200 microns in size, dispersed in 0.5ml of distilled water)
- No. of animals per sex per dose:
- 5 females + 5 males per dose, 3 doses
+ negative control group + positive control group - Control animals:
- yes
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C (1.5 mg/kg bw), killed 24 hours after treatment
- Tissues and cell types examined:
- bone marrow from both femurs
- Details of tissue and slide preparation:
- The cells were flushed in water, centrifuged, fixed on slides and stained with Leishman's stain in phosphate buffered saline. A total of 100 metaphase cells per animal were scored under a microscope for chomosomal abberations, documented by photographs. Then the mitotic index as mean of 10 animals was calculated.
- Statistics:
- mean values, standard errors and satistical evaluation following ANOVA tset and subsequent comparing with Duncan's newe multiple range test values
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- The teswt subsstance is not genotoxic under the conditions of this test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Nanoparticles of hydroxyapatite have sub-lethal toxic effects on fish cells and fish embryos. The effects of neddles is stronger.
Justification for classification or non-classification
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.
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