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EC number: 233-382-4 | CAS number: 10138-04-2
- 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
In aqueous solution ammonium iron bis(sulphate) dissociates forming sulfate, ammonium and ferric ions. The genetic toxicity of this substance can therefore be assessed by evaluating the genetic toxicity of substances forming the same ions upon dissolution. In vitro gene mutation studies on ammonium chloride, ammonium hydrogencarbonate, ferric chloride, ferric ammonium citrate and ferrous sulfate reported non-mutagenic properties for all these substances both, with an without metabolic activation. Therefore, ammonium iron bis(sulphate) is expected to be non-mutagenic, as well.
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Reverse mutation assays using S. typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 were carried out according to the method of Ames, McCann & Yamasaki (1975).
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Purity: 99.7 %. Samples were supplied from the Japan Food Additives Association, Tokyo, at the request of the Ministry of Health and Welfare of Japan, where the purity and quality of each sample were checked.
- Target gene:
- his
- Species / strain / cell type:
- S. typhimurium, other: TA92, TA94, TA98, TA100, TA1535, TA1537
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix prepared from the liver of Fischer rats pretreated with polychlorinated biphenyls
- Test concentrations with justification for top dose:
- six different concentrations, maximum dose: 10 mg/plate
- Vehicle / solvent:
- phosphate buffer
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- no
- Details on test system and experimental conditions:
- Cells cultured overnight were pre-incubated with both the test sample and the S-9 mix for 20 min at 37°C before plating. Duplicate plates were used for each of six different concentrations of the sample. The number of revertant (his +) colonies was scored after incubation at 37°C for 2 days.
- Evaluation criteria:
- The scoring result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated).
- Species / strain:
- S. typhimurium, other: TA92, TA94, TA98, TA100, TA1535, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- Ammonium chloride was not mutagenic in an Ames test with and without metabolic activation.
- Executive summary:
In this publication by Ishidate Jr et al. (published in 1984) the mutagenicity of broad variety of substances used as food additives is evaluated. A bacterial reverse mutation assay is used to investigate the mutagenicity of ammonium chloride. Six test strains were used in the experiments and each was conducted with and without metabolic activation. The results of all tests were negative.
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Reverse mutation assays using S. typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 were carried out according to the method of Ames, McCann & Yamasaki (1975).
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Samples were supplied from the Japan Food Additives Association, Tokyo, at the request of the Ministry of Health and Welfare of Japan, where the purity and quality of each sample were checked.
- Target gene:
- his
- Species / strain / cell type:
- S. typhimurium, other: TA92, TA94, TA98, TA100, TA1535, TA1537
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix prepared from the liver of Fischer rats pretreated with polychlorinated biphenyls
- Test concentrations with justification for top dose:
- Six different concentrations, maximum dose: 25 mg/plate
- Vehicle / solvent:
- phosphate buffer
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- no
- Details on test system and experimental conditions:
- Cells cultured overnight were pre-incubated with both the test sample and the S-9 mix for 20 min at 37°C before plating. Duplicate plates were used for each of six different concentrations of the sample. The number of revertant (his +) colonies was scored after incubation at 37°C for 2 days.
- Evaluation criteria:
- The scoring result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated).
- Species / strain:
- S. typhimurium, other: TA92, TA94, TA98, TA100, TA1535, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- Ammonium hydrogencarbonate was not mutagenic in an Ames test with and without metabolic activation.
- Executive summary:
In this publication by Ishidate Jr et al. (published in 1984) the mutagenicity of broad variety of substances used as food additives is evaluated. A bacterial reverse mutation assay is used to investigate the mutagenicity of ammonium hydrogencarbonate. Six test strains were used in the experiments and each was conducted with and without metabolic activation. The results of all tests were negative.
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Reverse mutation assays using S. typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 were carried out according to the method of Ames, McCann & Yamasaki (1975).
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Samples were supplied from the Japan Food Additives Association, Tokyo, at the request of the Ministry of Health and Welfare of Japan, where the purity and quality of each sample were checked.
- Target gene:
- his
- Species / strain / cell type:
- S. typhimurium, other: TA92, TA94, TA98, TA100, TA1535, TA1537
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix prepared from the liver of Fischer rats pretreated with polychlorinated biphenyls
- Test concentrations with justification for top dose:
- six different concentrations, maximum dose: 100 mg/plate
- Vehicle / solvent:
- phosphate buffer
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- no
- Details on test system and experimental conditions:
- Cells cultured overnight were pre-incubated with both the test sample and the S-9 mix for 20 min at 37°C before plating. Duplicate plates were used for each of six different concentrations of the sample. The number of revertant (his +) colonies was scored after incubation at 37°C for 2 days.
- Evaluation criteria:
- The scoring result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated).
- Species / strain:
- S. typhimurium, other: TA92, TA94, TA98, TA100, TA1535, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Conclusions:
- Ferric ammonium citrate was not mutagenic in an Ames test with and without metabolic activation.
- Executive summary:
In this publication by Ishidate Jr et al. (published in 1984) the mutagenicity of broad variety of substances used as food additives is evaluated. A bacterial reverse mutation assay is used to investigate the mutagenicity of ferric ammonium citrate. Six test strains were used in the experiments and each was conducted with and without metabolic activation. The results of all tests were negative.
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The experimental materials, methods, and procedures as explained below are based on those described by Ames et al., 1975, Mutat Res 31:347–364.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Supplier: Mallinckrodt. Purity: 100%. The compound was acquired by FDA, NCI, and the NCI Chemical Carcinogen References Standards Repository (Midwest Research Institute [MRI], Kansas City, MO) and supplied as coded samples to the contract laboratory (Bio Reliance Corp., Rockville, MD).
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA102, TA1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix: 8 mM MgCl2, 33 mM KCl, 5 mM glucose-6-phosphate, 4 mM NADP, 100 mM sodium phosphate (pH 7.4), appropriate S9 homogenate (rat/hamster) at a concentration of 0.1 ml/ml of mix.
- Test concentrations with justification for top dose:
- The doses to be tested in the mutagenicity assay were selected based on the levels of cytotoxicity observed in a preliminary dose range-finding study using strain TA100. Ten dose levels of the chemical, one plate per dose, were tested both in the presence and absence of induced hamster S9. If no toxicity was observed, a total maximum dose of 10 mg of test chemical per plate was used.
- Vehicle / solvent:
- 10% water, 1% dimethyl sulfoxide (DMSO), and 1N HCl
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- Plate Incorporation Methodology. For testing in the absence of S9 mix, 100 ml of the tester strain and 50 ml of solvent or test chemical were added to 2.5 ml of molten selective top agar at 45 °C. When S9 was used, 0.5 ml of S9 mix, 100 ml of tester strain, and 50 ml of solvent or test chemical were added to 2.0 ml of molten selective top agar at 45 °C. The plates were incubated for 48 hr at 37 °C. Preincubation Methodology. In the test with metabolic activation, 500 ml of S9 mix was added to glass culture tubes preheated to 37 °C. To these tubes were added 100 ml of the appropriate tester strain and 50 ml of vehicle or the appropriate concentration of test article. When the chemical was tested without metabolic activation, 500 ml of the cofactor mix without S9 was substituted for the complete S9 mix. After vortexing, the mixture was incubated for 20 min at 37 °C. Top agar (2 ml) was then added to each tube and the mixture was overlaid onto 25 ml of minimal bottom agar. After the overlay had solidified, the plates were inverted and incubated for approximately 48 hr at 37 °C. All plates were counted with a Mini Count automated colony counter (Imaging Products, International, Inc., Chantilly, VA), which was calibrated prior to use.
- Evaluation criteria:
- The criteria used to evaluate a test stipulated that a test article must induce at least a doubling (TA97a, TA98, TA100, TA102, and TA1535) in the mean number of revertant per plate of at least one tester strain for it to be considered positive. This increase in the mean revertants per plate must be accompanied by a dose response to increasing concentrations of the test chemical. If the study shows a dose–response, but with a less than 3-fold increase on TA1537 or TA1538, the response must be confirmed in a repeat experiment.
- Species / strain:
- S. typhimurium, other: TA97a, TA98, TA100, TA102, TA1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- There was no evidence of a mutagenic response with iron (III) chloride in this bacterial reverse mutation assay with and without metabolic activation.
- Executive summary:
In this publication by Dunkel et al. 1999 the genotoxicity of several iron compounds is evaluated. A bacterial reverse mutation assay is used to investigate the mutagenicity of iron (III) chloride. Seven test strains were used in the experiments and each was conducted with and without metabolic activation. The results of all tests were negative. The validity of the experiments was demonstrated by positive reactions induced by reference mutagens.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Reverse mutation assays using S. typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 were carried out according to the method of Ames, McCann & Yamasaki (1975).
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Purity: 85 %. Samples were supplied from the Japan Food Additives Association, Tokyo, at the request of the Ministry of Health and Welfare of Japan, where the purity and quality of each sample were checked.
- Target gene:
- his
- Species / strain / cell type:
- S. typhimurium, other: TA92, TA94, TA98, TA100, TA1535, TA1537
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix prepared from the liver of Fischer rats pretreated with polychlorinated biphenyls
- Test concentrations with justification for top dose:
- six different concentrations, maximum dose: 10 mg/plate
- Vehicle / solvent:
- phosphate buffer
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- no
- Details on test system and experimental conditions:
- Cells cultured overnight were pre-incubated with both the test sample and the S-9 mix for 20 min at 37°C before plating. Duplicate plates were used for each of six different concentrations of the sample. The number of revertant (his +) colonies was scored after incubation at 37°C for 2 days.
- Evaluation criteria:
- The scoring result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated).
- Species / strain:
- S. typhimurium, other: TA92, TA94, TA98, TA100, TA1535, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- Iron(II) sulfate was not mutagenic in an Ames test with and without metabolic activation.
- Executive summary:
In this publication by Ishidate Jr et al. (published in 1984) the mutagenicity of broad variety of substances used as food additives is evaluated. A bacterial reverse mutation assay is used to investigate the mutagenicity of iron(II) sulfate. Six test strains were used in the experiments and each was conducted with and without metabolic activation. The results of all tests were negative.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
In aqueous solution ammonium iron bis(sulphate) dissociates forming sulfate, ammonium and ferric ions. The genetic toxicity of this substance can therefore be assessed by evaluating the genetic toxicity of substances forming the same ions upon dissolution. In vitro gene mutation studies on ammonium chloride, ammonium hydrogencarbonate, ferric chloride, ferric ammonium citrate and ferrous sulfate reported non-mutagenic properties for all these substances both, with an without metabolic activation. Therefore, ammonium iron bis(sulphate) is expected to be non-mutagenic, as well.
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.