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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 231-826-1 | CAS number: 7757-93-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No reliable data is available with calcium hydrogenorthophosphate. Reliable data is available with the read across substance pentacalcium hydroxide tris(orthophosphate).
In vitro (RA-A 12167 -74 -7):
Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. Coli WP2 uvrA were all negative with and without metabolic activation (OECD 471, RL1)
Cytogenicity (micronucleus assay): negative (OECD 487, RL2)
Gene mutation (mammalian cells / TK test): negative (OECD 476, RL1)
In vivo:
no data available and no further data needed
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 3750 µg/mL onward for 4h treatment + S9 and 24h treatment -S9; at 5000 µg/mL for 4 hour treatment - S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- Since no toxicologically significant increases in the mutant frequency at the TK +/- locus in L5178Y cells are observed, the test material is considered to be non-mutagenic under the conditions of the test.
- Executive summary:
The source substance (pentacalcium hydroxide tris(orthophosphate) is considered to be non-mutagnic as shown in the HPRT test. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in genetic toxicity.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- 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:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- The constituent indicated in the test material information is considered to be non-mutagenic under the conditions of this test.
- Executive summary:
The source substance (pentacalcium hydroxide tris(orthophosphate) is considered to be non-mutagnic as shown in the Ames test. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in genetic toxicity.
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- Since no toxicologically significant increases in the number of cells with micronuclei were found, it is considered that the test material is non-clastogenic and non-aneugenic under the conditions of the test.
- Executive summary:
The source substance (pentacalcium hydroxide tris(orthophosphate) is considered to be non-mutagnic as shown in the in vitro micronucleus test. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in genetic toxicity.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Since all in vitro genetic toxicity test were negative no further in vivo testing is required according to Annex VIII (8.4) of the REACh regulation.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
One gene mutation test in bacteria is available (Fujita, 1987) with calcium hydrogenorthophosphate which is not sufficient for assessment because only the abstract is available in English and only two strains were tested. The test substance was tested for mutagenic activity in Salmonella typhimurium strains TA97 and TA102 at concentrations ranging from 100 to 10000 µg/plate. The tests were conducted with and without metabolic activation. No significant increase in the number of revertants was observed in any of the two bacterial strains, in either activation condition. Under these test conditions calcium hydrogenorthophosphate is not mutagenic.
One chromosome aberration study is available (Ishidate, 1988) with calcium hydrogenorthophosphate which is not sufficient for assessment because the study is missing testing with metabolic activation and a positive control. Apart from that the study was performed similar to OECD 473 with chinese hamster lung fibroblasts. The cells were treated with 0.125, 0.25, and 0.5 mg/mL calcium hydrogenorthophosphate for 24 and 48 hours. After 24 and 48 hours no structural chromosome aberrations and no increase in polyploidy were induced by calcium hydrogenorthophosphate. Under these test conditions calcium hydrogenorthophosphate is neither clastogenic nor aneugenic.
No further data is available with calcium hydrogenorthophosphate.
Genetic toxicity with the read across substance pentacalcium tris(ortho)phosphate was evaluated in three different in vitro tests.
Genetic toxicity (mutagenicity) in bacteria in vitro with pentacalcium tris(orthophosphate):
The gene mutation test in bacteria was performed according to OECD 471. The test substance was tested for mutagenic activity in Salmonella typhimurium strains TA98, TA100, TA 1535 and TA1537 and E. coli WP2 uvrA at concentrations ranging from 313 to 5000 µg/plate. The tests were conducted, using the preincubation method, on agar plates in the presence and absence of an Aroclor 1254 induced rat liver preparation and co-factors (S9 mix). Positive control compounds demonstrated the sensisitivty of the assay and the metabolising potential of the S9 mix. No significant increase in the number of revertants was observed in any of the 5 bacterial strains, in either activation condition, in the main and the confirmatory test. Slight precipitation was observed in all test material concentrations which did not influence the results of the assay. No cytotoxicity was observed up to highest concentration tested. Therefore, the test material was considered to be non-mutagenic under the conditions of the test.
Genetic toxicity (cytogenicity) in mammalian cells in vitro pentacalcium tris(orthophosphate):
An in vitro Micronucleus Test according to OECD 487 and in compliance with GLP was performed with pentacalcium hydroxide tris(orthophosphate). Chinese hamster lung fibroblasts (V79) were treated in duplicate cultures with the test material or vehicle (RPMI 1640 medium supplemented with 10% (v/v) FBS) in the absence or presence of a metabolic activation system (Aroclor 1254-induced rat liver S9-mix ). Short-term (4 hours with and without S9 mix) and long-term (1.5 to 2 normal cell cycles without S9 mix; duration not given in the report) experiments were conducted at concentrations of 0.48, 0.80 and 2.4 µg/mL. Fixation of the cells was performed 24 hours (approx. 1.5 to 2.0 normal cell cycles) after start of exposure with the test material. Appropriate solvent and positive controls were included in the test and gave the expected results. The number of micronucleated cells found after treatment with the test item was within the normal range of the negative control and thus no genotoxic effects were recorded either in the presence or in the absence of metabolic activation. Slight precipitation was observed at 2.4 µg/mL. The cytotoxicity was estimated to be 13.2% at the highest concentration of 2.4 µg/mL. Based on the results of the study the test material is considered not to be clastogenic or aneugenic under the conditions of this in vitro study.
Genetic toxicity (mutagenicity) in mammalian cells in vitro pentacalcium tris(orthophosphate):
An in vitro Mammalian Cell Gene Mutation Test was performed with pentacalcium hydroxide tris(orthophosphate) in mouse lymphoma L5178Y cells (heterozygous at the thymidine kinase locus) according to OECD 476 and under GLP. The cells were treated with the test substance in duplicate cultures, together with vehicle (RPMI 1640 medium without serum) and positive controls (single cultures). The cells were exposed to the test substance for 4 hours in the absence and presence of metabolic activation (phenobarbital and beta-naphthoflavone-induced rat liver S9-mix) in the main and the confirmatory test. The concentration range of the test material in both experiments was 312.5 to 5000 µg/mL following the results of a preliminary toxicity test. Precipitations were seen at and above 312.5 µg/mL. The vehicle controls were within the normal range for the L5178Y cell line at the TK locus. The positive controls induced marked increases in the mutant frequency indicating the satisfactory performance of the test and of the activity of the metabolising system. Cytotoxicity was observed from 3750 µg/mL onward for 4h treatment + S9 mix and 24h treatment without S9 mix and at 5000 µg/mL for 4 hour treatment without S9 mix. Thus, since the test material did not induce any toxicological significant increases in mutant frequencies up to the highest concentration of 5000 µg/mL it was considered to be non-mutagenic to L5178Y cells under the conditions of the test.
Endpoint Conclusion: All in vitro tests showed negative
results with the read across substance pentacalcium tris(orhtophosphate)
which indicate no genotoxic potential for that substance and calcium
hydrogenorthophosphate. A negative gene mutation test in bacteria and a
chromosome aberration test with calcium hydrogenorthophosphate, although
not sufficient for assessment, indicate a non-genotoxic property of
calcium hydrogenorthophosphate.
Since all in vitro test showed clear negative results it is considered scientifically unjustified to do any further testing to assess the genotoxicity and mutagenicity of calcium bis(dihydrogenorthophosphate) in vivo. This is in line with Annex VIII (8.4) of the REACh regulation as only if there are positive results in any of the in vitro genotoxicity studies an appropriate in vivo mutagenicity study shall be considered.
Justification for classification or non-classification
The available data on genetic toxicity do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for 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.
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.