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EC number: 233-899-5 | CAS number: 10421-48-4
- 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
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- short-term repeated dose toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: 4e The study did not meet current guideline requirements for repeated dose toxicity. It does, however, add weight of evidence for subacute toxicity.
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative toxicology of iron compounds.
- Author:
- Weaver L C, Gardier R W, Robinson V B, Bunde C A
- Year:
- 1 961
- Bibliographic source:
- American Journal of Medical Sciences, 241(3): 296-302
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Deviations:
- yes
- Remarks:
- Documentation is insufficient for assessment, no individual animal data or statistical analysis reported, no control group. Single dose level only for ferrous sulphate.
- Principles of method if other than guideline:
- This subacute study is part of a series of investigations carried out to investigate the comparative toxicity of a series of iron compounds which include ferrous sulphate. The emetic dose for dogs was also determined.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Iron sulphate
- EC Number:
- 231-753-5
- EC Name:
- Iron sulphate
- Cas Number:
- 7720-78-7
- IUPAC Name:
- iron(2+) sulfate
- Details on test material:
- - Name of test material (as cited in study report): Ferrous sulfate
Constituent 1
Test animals
- Species:
- dog
- Strain:
- other: mongrel
- Sex:
- not specified
Administration / exposure
- Route of administration:
- other: oral
- Vehicle:
- other: gelatin capsule
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Approximately one month
- Frequency of treatment:
- Twice daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Total daily dose of 0.5 g
- No. of animals per sex per dose:
- Five in total (sex not recorded)
- Control animals:
- no
- Details on study design:
- Post-exposure period: none
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Average bodyweights of dogs given ferrous sulphate and the iron carbohydrate complex at the two higher doses levels were reduced during the first
week of dosing, after this bodyweights remained constant or increased. Changes ranged from 0.6 to 0.8 kg for the 3 affected groups. There were no
other clinical signs of toxicity. Emesis was not reported. There were no gross or histopathological changes indicative of iron toxicity in any of the test
groups. The authors state that no significant differences were observed in iron staining in the liver, spleen or bone marrow in any test group. Total red
blood cell count and haemoglobin were within the normal range for each dog.
Effect levels
- Dose descriptor:
- other: emesis induction level
- Effect level:
- 62 mg/kg bw (total dose)
- Based on:
- other: capsule administration
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Average bodyweights of dogs given ferrous sulphate and the iron carbohydrate complex at the two higher doses levels were reduced during the first
week of dosing, after this bodyweights remained constant or increased. Changes ranged from 0.6 to 0.8 kg for the 3 affected groups. There were no
other clinical signs of toxicity. Emesis was not reported. There were no gross or histopathological changes indicative of iron toxicity in any of the test
groups. The authors state that no significant differences were observed in iron staining in the liver, spleen or bone marrow in any test group. Total red
blood cell count and haemoglobin were within the normal range for each dog.
Applicant's summary and conclusion
- Conclusions:
- In a limited subacute toxicity study (reliability score 4) conducted prior to the adoption of OECD test guidelines and GLP, it appears that a dose of 0.5 g/day ferrous sulphate (salt) was tolerated by dogs the principle effect being a reduction in bodyweight, the limited toxicological assessment does not suggest overt iron toxicity.
- Executive summary:
In a limited subacute toxicity study (reliability score 4) conducted prior to the adoption of OECD test guidelines and GLP, it appears that a dose of 0.5 g/day ferrous sulphate (salt) was tolerated by dogs the principle effect being a reduction in bodyweight, the limited toxicological assessment does not suggest overt iron toxicity.
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