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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 237-424-2 | CAS number: 13780-06-8
- 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:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 4-16 January 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Good-quality study, conducted to GLP. The test material was a 34% solution of hydrated calcium nitrite. The deviation from the current relevant OECD guideline (e.g. inclusion also of TA102 or E.coli) would not impact the overall conclusion.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 26 May 1983 version
- Deviations:
- yes
- Remarks:
- Current Guideline recommends the use of at least 5 tester strains; the study used only 4, omitting a strain for detecting cross-linking mutagens (e.g. TA102 or E. coli WP2 uvrA). Calcium nitrite was only tested at up to 1700 µg/plate (cf. 5000 µg/plate).
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 29/12/1992 version
- Deviations:
- yes
- Remarks:
- Current Guideline recommends the use of at least 5 tester strains; the study used only 4, omitting a strain for detecting cross-linking mutagens (e.g. TA102 or E. coli WP2 uvrA). Calcium nitrite was only tested at up to 1700 µg/plate (cf. 5000 µg/plate).
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Version / remarks:
- 1984 version
- Deviations:
- yes
- Remarks:
- Current Guideline recommends the use of at least 5 tester strains; the study used only 4, omitting a strain for detecting cross-linking mutagens (e.g. TA102 or E. coli WP2 uvrA). Calcium nitrite was only tested at up to 1700 µg/plate (cf. 5000 µg/plate).
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Calcium nitrite
- EC Number:
- 237-424-2
- EC Name:
- Calcium nitrite
- Cas Number:
- 13780-06-8
- Molecular formula:
- Ca.2HNO2
- IUPAC Name:
- calcium nitrite
- Test material form:
- liquid
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced S9 fraction obtained from the livers of male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500 or 5000 µg DCI/plate [top dose level is equivalent to about 1700 µg calcium nitrite/plate]
In a preliminary toxicity test, concentrations of 5, 50, 500 or 5000 µg/plate were tested in strains TA1535, TA1537, TA98 and TA100, with and without metabolic activation. Both the mutagenic and cytotoxic effects of the test material on these strains were analysed. As only slight cytotoxicity was observed at the highest concentration, subsequent mutagenicity testing on the four bacterial strains also used 5000 µg/plate as the top concentration; other concentrations used were 50, 150, 500 and 1500 µg/plate (with and without metabolic activation). - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: The test substance was supplied as an aqueous solution.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: not applicable
- Exposure duration: 3 days
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): not applicable
SELECTION AGENT (mutation assays): no data
NUMBER OF REPLICATIONS: 3
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: not applicable
NUMBER OF CELLS EVALUATED: not applicable
DETERMINATION OF CYTOTOXICITY
- Method: measured by the presence of an incomplete background lawn. - Evaluation criteria:
- A test substance is considered positive (mutagenic) in the test if it induced at least a 2-fold increase (with some evidence of a positive dose-response) in the number of revertants with respect to the number induced by the solvent control in two separate experiments, with any of the tester strains, either with or without metabolic activation.
A test substance is considered to be negative (not mutagenic) if the total number of revertants in any tested strain at any concentration is not greater than 1.5 times the solvent control value, with or without metabolic activation. - Statistics:
- No statistical evaluation was performed.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- Large, dose-related increases in the revertant colony numbers were observed in both mutation experiments
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- Large, dose-related increases in the revertant colony numbers were observed in both mutation experiments
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: no data
RANGE-FINDING/SCREENING STUDIES: The test material caused slight cytotoxicity (incomplete bacterial lawn) at the highest tested concentration (5000 µg DCI/plate) in all four tester strains, both with and without S9.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: no data
- Negative (solvent/vehicle) historical control data: no data - Remarks on result:
- other: Although the test material was applied at up to the recommended limit concentration of 5000 µg/plate, the highest actual tested concentration of calcium nitrite was 1700 µg/plate.
Applicant's summary and conclusion
- Conclusions:
- In an OECD Test Guideline 471 study, to GLP, calcium nitrite (hydrate) showed evidence of mutagenic activity in Salmonella typhimurium strains TA100 and TA1535 (but not in TA98 or TA1537) in the presence and absence of mammalian metabolic activation.
- Executive summary:
The genotoxic potential of calcium nitrite (hydrate) was assessed in an in vitro bacterial reverse mutation (Ames) assay, conducted according to OECD Test Guideline 471 and to GLP.
In a preliminary toxicity test, Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 were exposed to test material concentrations of 0, 5, 50, 500 or 5000 µg/plate (equivalent to up to 1700 µg calcium nitrite/plate), both in the presence and absence of metabolic activation by rat liver fraction S9 (alongside appropriate vehicle controls). Only slight cytotoxicity was observed at the highest concentration only, therefore this was used as the highest test concentration in the mutagenicity assay.
Triplicate cultures of the four bacterial strains were exposed to the test material at concentrations of 50, 150, 500, 1500 or 5000 µg/plate, both with and without S9 (alongside appropriate vehicle and positive controls). These cultures were incubated for 72 hours at 37°C before being inspected for signs of cytotoxicity and for the incidence of revertant colonies. The main mutagenicity experiment was repeated using the same test material concentrations and following an identical procedure.
No signs of cytotoxicity were observed for any of the tested strains, at any of the tested concentrations, in either of the mutagenicity experiments. Large, dose-related increases in the number of revertant colonies were seen for S. typhimurium strains TA100 and TA1535 (with and without S9) in both mutagenicity experiments. No significant, dose-related increase was seen in S. typhimurium strains TA98 or TA1537 (both in the absence and presence of S9). The concurrent positive control substances demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations.
Under the conditions of this assay, calcium nitrite (hydrate) showed evidence of mutagenic activity in bacteria.
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.
Bár az ECHA sok anyagot az ön nyelvén is rendelkezésre bocsát az interneten, az oldal egy része csak angolul érhető el. Bővebben az ECHA többnyelvűségre irányuló gyakorlatáról.
Üdvözöljük az ECHA weboldalán! Az oldal az Internet Explorer 7 (és korábbi verziók) alatt nem teljes mértékben támogatott. Kérjük, frissítse Internet Explorer böngészőjét egy újabb verzióra!
Ez a weboldal cookie-kat használ a legjobb felhasználói élmény biztosítása érdekében.
További információ a cookie-k használatáról.