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EC number: 240-968-3 | CAS number: 16919-19-0
- 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
Sodium hexafluorosilicate did not induce mutations in the bacterial reverse mutation assay, hence using the principles of read across, ammonium hexafluorosilicate was also considered to be not mutagenic.
Link to relevant study records
- 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 chapter 13 for detailed read across justification.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Conclusions:
- Sodium hexafluorosilicate was found to have no mutagenic potential in the bacterial reverse mutation assay.
- Executive summary:
Currently no study is available on Ammonium hexafluorosilicate. However a similar substance Sodium hexafluorosilicate was evaluated for the mutagenic potential in a bacterial reverse mutation assay. This method is similar or equivalent to OECD test guideline 471. 5 tester strains of Salmonella typhimurium designated TA1535, TA100, TA1538, TA98 and TA1537, provided by Dr. B.N. Ames, University of California, Berkeley, CA (U.S.A.); were used. Two 1535 strains with different histories, TA1535 A obtained in 1973 and TA1535 B obtained in 1977, were also used for the testing. Tests were performed using 5 doses, up to 3600 µg/plate, in all 5 strains with and without activation by the S9 liver fraction from Aroclor-pretreated rats. No reverse mutations were observed with any of the tested strains. Hence, sodium hexafluorosilicate can be considered to be not mutagenic in this bacterial reverse mutation assay.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Publication date - 11 May 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- 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:
- Name: Sodium hexafluorosilicate
- Target gene:
- Histidine auxotrophic strains of S. typhimurium
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA100, TA1538, TA98 and TA1537
- Details on mammalian cell type (if applicable):
- provided by Dr. B.N. Ames, University of California, Berkeley, CA (U.S.A.). Two 1535 strains with different histories were used: TA1535 A obtained in 1973 and TA1535 B obtained in 1977.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver fraction from Aroclor-pretreated rats.
- Test concentrations with justification for top dose:
- 5 doses, up to 3600 µg/plate
- Details on test system and experimental conditions:
- The substance was tested on 2 slightly different minimal media: one (in the following named ZLM medium) is a modified minimal medium for E. coli , and the other is the Vogel-Bonner (VB) medium. ZLM medium contained (in g/l): tri-sodium citrate. 2H20 (0.82), K2HPO4-3H20 (4.60), KH2PO 4 (1.50), (NH4)2SO 4 (1.00), MgSO4.7H20 (0.10) and glucose (17.0). The concentration of citrate was 3.5 times higher in VB medium than in ZLM medium. The concentrations of the other ions are up to 2-fold higher in VB medium.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Conclusions:
- Sodium hexafluorosilicate was found to have no mutagenic potential in the bacterial reverse mutation assay.
- Executive summary:
Sodium hexafluorosilicate was evaluated for the mutagenic potential in a bacterial reverse mutation assay. This method is similar or equivalent to OECD test guideline 471.
5 tester strains of Salmonella typhimurium designated TA1535, TA100, TA1538, TA98 and TA1537, provided by Dr. B.N. Ames, University of California, Berkeley, CA (U.S.A.); were used. Two 1535 strains with different histories, TA1535 A obtained in 1973 and TA1535 B obtained in 1977, were also used for the testing.
Tests were performed using 5 doses, up to 3600 µg/plate, in all 5 strains with and without activation by the S9 liver fraction from Aroclor-pretreated rats. No reverse mutations were observed with any of the tested strains. Hence, sodium hexafluorosilicate can be considered to be not mutagenic in this bacterial reverse mutation assay.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Sodium hexafluorosilicate did not induce mutations in the drosophila sex-linked recessive lethal assay nor it lead to micronucleus induction in the polychromatic erythrocytes of mice, hence using the principles of read across, ammonium hexafluorosilicate was also considered to be neither mutagenic nor clastogenic in vivo.
Link to relevant study records
- Endpoint:
- in vivo insect germ cell study: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Publication date - 11 May 1981.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 477 (Genetic Toxicology: Sex-linked Recessive Lethal Test in Drosophila melanogaster)
- GLP compliance:
- not specified
- Type of assay:
- Drosophila SLRL assay
- Specific details on test material used for the study:
- Test material was obtained from Fisher Scientific Co., Fair Lawn, NJ (U.S.A.);
- Species:
- Drosophila melanogaster
- Strain:
- other: The Berlin K (wild-type) and Basc strains were used.
- Route of administration:
- oral: feed
- Vehicle:
- 2 % Tween 80
- Details on exposure:
- In Drosophila one dose close to the LD50 (0.25 mM) was applied by the adult feeding method in 5 % saccharose.
- Dose / conc.:
- 0.25 other: mM
- Dose / conc.:
- 42.02 other: mg
- Remarks:
- Dose was not specified in terms of 'per kg'
- Key result
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Of the tested chromosomes, only a small portion (brood 1: 3 out of 1226, brood 2: 1 out of 1212 and brood 3: 2 out of 1236) were confirmed as sex-linked recessive lethals.
- Conclusions:
- Sodium hexafluorosilicate did not induce mutations/was not mutagenic in the Drosophila sex-linked recessive lethal assay.
- Executive summary:
Sodium hexafluorosilicate was evaluated for the potential to induce mutations in a Drosophila melanogaster sex linked recessive lethal assay. Drosophila melanogaster strains: Berlin K (wild-type) and Basc, were used. In the tested Drosophila, one dose close to the LD50 (0.25 mM or 42.02 mg) was applied by the adult feeding method in 5 % saccharose. About 1200 X-chromosomes (brood 1: 1226, brood 2: 1212 and brood 3: 1236) were tested per experiment in each of 3 successive broods (3-3-4 days). In repeat experiments, sometimes only single broods were tested. F: progeny cultures with 2 or fewer wild-type males were routinely retested in the F3 generation to confirm X-linked recessive lethal mutations (RLs). Mosaics were not counted. "Clusters" of 2 were included because their occurrence was compatible with statistical expectation of independent origin. Of the tested chromosomes, only a small portion (brood 1: 3 out of 1226, brood 2: 1 out of 1212 and brood 3: 2 out of 1236) were confirmed as sex-linked recessive lethals. Hence based on the above findings, it can be concluded that sodium hexafluorosilicate did not induce mutations/was not mutagenic in the Drosophila sex-linked recessive lethal assay.
- Endpoint:
- in vivo insect germ cell study: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer chapter 13 for detailed read across justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- Sodium hexafluorosilicate did not induce mutations/was not mutagenic in the Drosophila sex-linked recessive lethal assay.
- Executive summary:
Currently no study is available on Ammonium hexafluorosilicate. However a similar substance Sodium hexafluorosilicate was evaluated for the potential to induce mutations in a Drosophila melanogaster sex linked recessive lethal assay. Drosophila melanogaster strains: Berlin K (wild-type) and Basc, were used. In the tested Drosophila, one dose close to the LD50 (0.25 mM or 42.02 mg) was applied by the adult feeding method in 5% saccharose. About 1200 X-chromosomes (brood 1: 1226, brood 2: 1212 and brood 3: 1236) were tested per experiment in each of 3 successive broods (3-3-4 days). In repeated experiments, sometimes only single broods were tested. F: progeny cultures with 2 or fewer wild-type males were routinely retested in the F3 generation to confirm X-linked recessive lethal mutations (RLs). Mosaics were not counted. "Clusters" of 2 were included because their occurrence was compatible with statistical expectation of independent origin. Of the tested chromosomes, only a small portion (brood 1: 3 out of 1226, brood 2: 1 out of 1212 and brood 3: 2 out of 1236) were confirmed as sex-linked recessive lethals. Hence, based on the above findings, it can be concluded that sodium hexafluorosilicate did not induce mutations/was not mutagenic in the Drosophila sex-linked recessive lethal assay.
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study completion date - 11 May 1981.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- other: in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Specific details on test material used for the study:
- Test material was obtained from Fisher Scientific Co., Fair Lawn, NJ (U.S.A.);
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female mice (NMRI) and were obtained from S. Ivanovas GmbH and Co., Kisslegg/Allgau (Germany), and given standard chow (Altromin GmbH, Lage, Germany) and water ad libitum.
- Route of administration:
- intraperitoneal
- Vehicle:
- 2 % Tween 80
- Details on exposure:
- The animals were treated at 0 and 24 h
- Dose / conc.:
- 37.6 mg/kg bw/day
- No. of animals per sex per dose:
- 4 mice (2 male, 2 female) per dose
- Control animals:
- yes, concurrent vehicle
- Tissues and cell types examined:
- micronucleated polychromatic erythrocytes
- Details of tissue and slide preparation:
- Slides were coded, and 1000 polychromatic erythrocytes were scored per mouse.
- Statistics:
- Significance was calculated according to the Kastenbaum-Bowman tables.
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
- Additional information on results:
- In the only group treated with sodium hexafluorosilicate (37.6 mg/kg bw/day), the micronuleated polychromatic erythrocytes were found to be at 2 %, while in the group treated with vehicle (2 % Tween 80), the micronucleated polychromatic erythrocytes were found at 2.2 %.
- Conclusions:
- Sodium hexafluorosilicate did not induce micronuclei when administered to the mice intraperitoneally. Hence, it is devoid of clastogenic potential.
- Executive summary:
The clastogenic potential of sodium hexafluorosilicate was evaluated in a micronucleus assay conducted with NMRI mice. This study was conducted according to method equivalent or similar to OECD test guideline 474. In this assay, two groups of 2 males and 2 females received the test substance at 0 and 37.6 mg/kg bw/day via intraperitoneal administration. The animals were treated at 0 and 24 h, and bone-marrow smears were prepared at 30 h. Slides were coded, and 1000 polychromatic erythrocytes were scored per mouse. Significance was calculated according to the Kastenbaum-Bowman tables. In the only group treated with sodium hexafluorosilicate (37.6 mg/kg bw/day), the micronuleated polychromatic erythrocytes were found to be at 2 %, while in the group treated with vehicle (2 % Tween 80), the micronucleated polychromatic erythrocytes were found at 2.2 %. Hence based on the above findings, it was concluded that sodium hexafluorosilicate did not induce micronuclei when administered to the mice intraperitoneally. Hence, it is devoid of clastogenic potential.
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer chapter 13 for detailed read across justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
- Conclusions:
- Sodium hexafluorosilicate did not induce micronuclei when administered to the mice intraperitoneally. Hence, it is devoid of clastogenic potential.
- Executive summary:
The clastogenic potential of sodium hexafluorosilicate was evaluated in a micronucleus assay conducted with NMRI mice. In this assay, two groups of 2 males and 2 females received the test substance at 0 and 37.6 mg/kg bw/day via intraperitoneal administration. The animals were treated at 0 and 24 h, and bone-marrow smears were prepared at 30 h. Slides were coded, and 1000 polychromatic erythrocytes were scored per mouse. Significance was calculated according to the Kastenbaum-Bowman tables. In the only group treated with sodium hexafluorosilicate (37.6 mg/kg bw/day), the micronuleated polychromatic erythrocytes were found to be at 2 %, while in the group treated with vehicle (2 % Tween 80), the micronucleated polychromatic erythrocytes were found at 2.2 %. Hence based on the above findings, it was concluded that sodium hexafluorosilicate did not induce micronuclei when administered to the mice intraperitoneally. Hence, it is devoid of clastogenic potential.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Currently, no studies evaluating genetic toxicity potential of the ammonium hexafluorosilicate are available. The hexafluorosilicates disassociate into hexafluorosilicate ion and corresponding cation when in water (NTP, 2001; NICNAS, 2017). Hence, the genotoxicity of ammonium hexafluorosilicate has been discussed in terms of data available with hexafluorosilicates (i.e. sodium hexafluorosilicate) and ammonium ion.
Genotoxicity of hexafluorosilicates:
Sodium hexafluorosilicate has been evaluated in a bacterial reverse mutation assay, a drosophila sex linked recessive lethal assay and a micronucleus assay by Gocke et al. in 1981.
Bacterial reverse mutation assay:
A read across substance, Sodium hexafluorosilicate was evaluated for the mutagenic potential in a bacterial reverse mutation assay using S. typhimurium. 5 tester strains of Salmonella typhimurium designated TA1535, TA100, TA1538, TA98 and TA1537, provided by Dr. B.N. Ames, University of California, Berkeley, CA (U.S.A.); were used. Two 1535 strains with different histories, TA1535 A obtained in 1973 and TA1535 B obtained in 1977, were also used for the testing. Tests were performed using 5 doses, up to 3600 µg/plate, in all 5 strains with and without activation by the S9 liver fraction from Aroclor-pretreated rats. No reverse mutations were observed with any of the tested strains. Hence, sodium hexafluorosilicate can be considered to be not mutagenic in this bacterial reverse mutation assay.
Drosophila sex linked recessive lethal assay:
Sodium hexafluorosilicate was evaluated for the potential to induce mutations in a Drosophila melanogaster sex linked recessive lethal assay. Drosophila melanogaster strains: Berlin K (wild-type) and Basc, were used. In the tested Drosophila, one dose close to the LD50 (0.25 mM or 42.02 mg) was applied by the adult feeding method in 5 % saccharose. About 1200 X-chromosomes (brood 1: 1226, brood 2: 1212 and brood 3: 1236) were tested per experiment in each of 3 successive broods (3-3-4 days). In repeat experiments, sometimes only single broods were tested. F: progeny cultures with 2 or fewer wild-type males were routinely retested in the F3 generation to confirm X-linked recessive lethal mutations (RLs). Mosaics were not counted. "Clusters" of 2 were included because their occurrence was compatible with statistical expectation of independent origin. Of the tested chromosomes, only a small portion (brood 1: 3 out of 1226, brood 2: 1 out of 1212 and brood 3: 2 out of 1236) were confirmed as sex-linked recessive lethals. Hence based on the above findings, it can be concluded that sodium hexafluorosilicate did not induce mutations/was not mutagenic in the Drosophila sex linked recessive lethal assay.
Micronucleus assay:
The clastogenic potential of sodium hexafluorosilicate was evaluated in a micronucleus assay conducted with NMRI mice. In this assay, two groups of 2 males and 2 females received the test substance at 0 and 37.6 mg/kg bw/day via intraperitoneal administration. The animals were treated at 0 and 24 h, and bone-marrow smears were prepared at 30 h. Slides were coded, and 1000 polychromatic erythrocytes were scored per mouse. Significance was calculated according to the Kastenbaum-Bowman tables. In the only group treated with sodium hexafluorosilicate (37.6 mg/kg bw/day), the micronucleated polychromatic erythrocytes were found to be at 2 %, while in the group treated with vehicle (2 % Tween 80), the micronucleated polychromatic erythrocytes were found at 2.2 %. Hence based on the above findings, it was concluded that sodium hexafluorosilicate did not induce micronuclei when administered to the mice intraperitoneally. Hence, it is devoid of clastogenic potential. Based on the above information, it can be concluded that sodium hexafluorosilicate is neither mutagenic nor clastogenic, and hence not genotoxic.
Ammonium ion and genotoxicity:
Ammonium ion and several ammonium salts (ammonium ion once in an aqueous solution, can exist in combination with a variety of anions as ammonium salts) are essential for proper physiological functioning in mammals (and humans). The ammonium ion is required in acid-base balance and in intermediary metabolic cycles. Ammonia is produced in the human body by the deamination of amino acids as well as amides. Ammonia is also normally produced in the brain and muscles (SCOGS-34, FDA, 1974). The genotoxicity of ammonium chloride has been discussed in a SIDS Initial Assessment Report for SIAM 17 (OECD SIDS-ammonium chloride, 2003). It was reported to have a negative outcome in a reverse mutation study in bacteria [OECD TG 471, GLP, Hoechst AG, 1987]. Ammonium chloride was found to be clastogenic in an in vitro chromosomal aberration test with Chinese hamster lung cells (CHL/IU) without metabolic activation, however the result is ascribed to the acidity of the substance (osmotic effects rather than a direct interaction with DNA) (Ishidate et al.,1984). However, it did not lead to clastogenic effects in an in vivo micronucleus assay up to the maximum tolerance dose. Based on the above information, the assessment concluded that ammonium chloride should be considered to be not genotoxic [Hayashi et al., 1988]. In addition to these studies, the currently registered dossier for ammonium chloride with ECHA, also lists ammonium chloride to be negative in a bacterial reverse mutation assay (Ishidate et al., 1984) and supports the conclusion that ammonium chloride is not genotoxic. The SIDS Initial Assessment Report for SIAM 24, (OECD SIDS- ammonia, 2007) reports that ammonia, ammonium thiosulfate and the analogues ammonium sulfate and diammonium phosphate (DAP) did not induce effects in tests on gene mutations and chromosomal aberrations. Considering, the negative results obtained in the micronucleus assay with ammonium chloride [Hayashi et al., 1988], the assessment report concludes ammonia and the salts assessed to be not genotoxic. Similarly, currently available dossiers for ammonia anhydrous, ammonium fluoride and ammonium nitrate with ECHA also conclude the substances being not genotoxic. The scientific opinion by EFSA [Opinion Flavouring Group Evaluation 46 (FGE.46)1: Ammonia and two ammonium salts from chemical group 30, EFSA-Q-2008-050, 2008], in addition to the results mentioned above, also discusses a micronucleus assay where a single intraperitoneal dose of ammonium at 12, 25 or 50 mg/kg bw lead to dose-dependent increases in the frequencies of micronuclei when compared to controls (Yadav & Kaushik, 1997). However, in absence of details concluded that no conclusions can be drawn. This assessment also discusses slight mutagenic activity being reported in Drosophila following exposure to ammonia gas, but only at very toxic levels (US ATSDR, 2004). However, taking into account the negative results as discussed above, the ammonia and salts were considered to be devoid of genotoxic potential.
Conclusion:
As discussed above neither the ammonium ion and its salts nor the sodium hexafluorosilicate can be considered genotoxic. Thereby supporting the conclusion that ammonium hexafluorosilicate is not genotoxic.
Justification for classification or non-classification
Based on the above discussion, ammonium hexafluorosilicate was not considered genotoxic and hence does not require classification as per the CLP (Regulation EC No.1272/2008) criteria.
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