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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
Description of key information
Since ammonium iron bis(sulphate) dissociates upon dissolution in aqueous media, the toxicity of this substance can be assessed by regarding the toxicity of ions formed. In studies regarding the acute oral toxicity of ammonium sulfate, ferric chloride and ferric ammonium citrate LD50 values between 1300 mg/kg bw and 5000 mg/kg bw were found. All the reported values correspond to doses of ammonium iron bis(sulphate) > 2000 mg/kg bw (2093 - 15400 mg/kg bw). Therefore, ammonium iron bis(sulphate) is not classified.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The authors propose a simple method for screening assessment of acute oral and dermal toxicity using only three rats and mice of each sex at each dose level. Animals were first treated with chemicals at a dose of 2000 mg/kg and were carefully observed for compound-related morbidity and mortality. If none of the animals died, the following toxicity tests were suspended. If some of the animals died, toxicity tests at doses of 200 and 20 mg/kg were performed.
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age: 5 - 6 weeks
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- Animals were treated with the substances after at least 5 days of adaptation. The substance dissolved in water was administered orally in a single dose after fasting for 16 h.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- All animals were individually housed in stainless-steel cages. Careful observations of animals, including body weight changes, mortality figures, gross lesion and behavioural and clinical abnormality, were performed for 14 days in the oral toxicity tests, and necropsy of all animals was carried out at the end of the test. Animal experiments were performed simultaneously in two different laboratories.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: laboratory A
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: laboratory B
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: laboratory A
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: laboratory B
- Mortality:
- Laboratory A: no dead animalsLaboratory B: 1 or 2 dead animals per sex
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to laboratory A, LD50 (oral, rat) of ammonium sulfate is >2000 mg/kg body weight for both male and female rats. According to laboratory B, LD50 (oral, rat) of ammonium sulfate is ca. 2000 mg/kg body weight for both male and female rats.
- Executive summary:
In this publication by Yamanaka et al. (published in 1990) a method for assessing the acute toxicity of chemicals is described. In a screening test, fixed doses of ammonium sulfate were administered orally to male and female rats with a maximum dose of 2000 mg/kg body weight. Experiments were performed simultaneously in two different laboratories. Laboratory A reported a LD50 of >2000 mg/kg bw for both male and female rats. Laboratory B reported a LD50 of ca. 2000 mg/kg bw for both male and female rat. The GHS criteria are not met by these results.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The toxicity of iron salts is investigated by administering aqueous solutions of test material with various concentrations to mice. The study was cited in the OECD SIDS for iron salts.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- other: Queckenbusch
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animals were fasted for 19 hours before dosing.
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Volume administered: 0.01 ml/g
- Doses:
- doses / mg Fe/kg body weight: 186, 335, 604, 1087doses / mg Ferric chloride/kg body weight: 540, 974, 1756, 3160
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- The animals were observed for at least 30 days after administration of the test material.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 440 mg/kg bw
- Based on:
- element
- Remarks:
- Fe
- 95% CL:
- >= 300 - <= 630
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 300 mg/kg bw
- Based on:
- test mat.
- Remarks:
- FeCl3
- 95% CL:
- >= 872 - <= 1 830
- Mortality:
- 540 mg/kg bw FeCl3 - 1/10 deaths; 974 mg/kg bw FeCl3 - 2/10 deaths; 1756 mg/kg bw FeCl3 - 8/10 deaths; 3160 mg/kg bw FeCl3 - 10/10 deaths
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 (oral, mouse) for ferric chloride is 1300 mg/kg body weight (440 mg Fe/kg body weight). This value corresponds to 2093 mg ammonium iron bis(sulphate) per kg body weight. Since the GHS criteria are not met and ammonium iron bis(sulphate) is not classified.
- Executive summary:
In this publication by Hosking (published in 1970) the oral toxicity of ferric chloride is assessed. Differently concentrated aqueous solutions of the test material was administered orally to female mice. From the mortality of the test animals LD50 can be developed. The LD50 (oral, mouse) for ferric chloride is 1300 mg/kg body weight (440 mg Fe/kg body weight). This value corresponds to 2093 mg ammonium iron bis(sulphate) per kg body weight. Since the GHS criteria are not met and ammonium iron bis(sulphate) is not classified.
This study was cited by OECD in their SIDS Initial Assessment Report for SIAM 24.
- Endpoint:
- acute toxicity: oral
- 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 acute oral toxicity of some iron salts was investigated by administering the substances to test animals (mouse).
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Doses:
- not specified
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Statistics:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 (oral, mouse) for ferric ammonium citrate is 5000 mg/kg body weight. This value corresponds to ca. 5020 mg ammonium iron bis(sulphate) per kg body weight. Since the GHS criteria are not met by this value, ammonium iron bis(sulphate) is not classified.
- Executive summary:
In this article by Somers (published in 1947) experiments regarding the toxicity of some iron compounds are described. The test materials were administered orally to mice. LD50 (oral, mouse) of 5000 mg/kg bodyweight ferric ammonium citrate is reported. This value corresponds to ca. 5020 mg ammonium iron bis(sulphate) per kg body weight. Since the GHS criteria are not met by this value, ammonium iron bis(sulphate) is not classified.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 093 mg/kg bw
Additional information
Justification for classification or non-classification
LD50, oral for ammonium iron bis(sulphate) is expected to be > 2000 mg/kg bw. Therefore, ammonium iron bis(sulphate) is not classified.
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