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Diss Factsheets
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EC number: 231-298-2 | CAS number: 7487-88-9
- 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: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented, acceptable study according to GLP principles.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium Sulphate
- IUPAC Name:
- Potassium Sulphate
- Details on test material:
- Potassium Sulphate (K2SO4)
No details about test substance purity.
Due to a shortage of test substance, additional substance with equivalent composition was obtained and used in the latter phase of the study.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- Animals in the study were divided between two subgroups (toxicity and reproductive subgroups). The exposure period for males and females in the toxicity subgroup was 28 days. The exposure period for reproductive subgroup males was at most 28 days. The exposure period for reproductive subgroup females was at most 53 days (14 days pre-mating, 14 days mating, and gestational and lactational periods up to lactation day 4).
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Animals in the study were divided between two subgroups (toxicity and reproductive subgroups). The exposure period for males and females in the toxicity subgroup was 28 days. The exposure period for reproductive subgroup males was at most 28 days. The exposure period for reproductive subgroup females was at most 53 days (14 days pre-mating, 14 days mating, and gestational and lactational periods up to lactation day 4).
- Frequency of treatment:
- 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 750, and 1,500 mg/kg/day (Doses were selected based on parameters assessed in a range-finding study at concentrations up to 1,000 mg/kg/day)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Toxicity subgroup: Animals comprising the toxicity subgroup (5 males and 5 females per dose group) were administered K2SO4 for 28 days (7 days/week) via gavage administration. Among toxicity subgroup animals, functional observations (sensory reactivity, grip strength, motor activity) were conducted during the final days of treatment. Bleeds for hematology and blood chemistry were conducted on Day 28 of treatment. Organ weights were recorded at termination and major organs and tissues (and any other abnormalities observed at necropsy) were processed for microscopic examination.
Reproductive subgroup: Male rats (5 males) in the reproductive subgroup were administered K2SO4 for 28 days via oral gavage. Female rats (10 females) in the reproductive subgroup were administered K2SO4 for a period encompassing approximately 53 continuous days via oral gavage: 14 days of initial treatment, plus a maximum of 14 days of cohabitation to ensure mating, and 25 days to litter and rear their young until Day 4 of age. Histology for reproductive subgroup animals was restricted to retained reproductive organs (and any other abnormalities observed at necropsy). - Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- Among toxicity subgroup animals, functional observations (sensory reactivity, grip strength, motor activity) were conducted during the final days of treatment. Bleeds for hematology and blood chemistry were conducted on Day 28 of treatment.
- Sacrifice and pathology:
- Organ weights were recorded at termination and major organs and tissues (and any other abnormalities observed at necropsy) were processed for microscopic examination.
- Other examinations:
- Reproductive subgroup: Male rats (5 males) in the reproductive subgroup were administered K2SO4 for 28 days via oral gavage. Female rats (10 females) in the reproductive subgroup were administered K2SO4 for a period encompassing approximately 53 continuous days via oral gavage: 14 days of initial treatment, plus a maximum of 14 days of cohabitation to ensure mating, and 25 days to litter and rear their young until Day 4 of age. Histology for reproductive subgroup animals was restricted to retained reproductive organs (and any other abnormalities observed at necropsy).
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Toxicity subgroup: There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Functional observational battery (FOB) and motor activity tests identified no treatment-related changes in behavior, function, or motor activity. Dams at 1,500 mg/kg/day experienced slightly lower food consumption and body weight than the controls during the gestation period only. Because of their moderate and transient nature, these observable effects were considered a LOEL rather than a LOAEL. No treatment-related histopathological changes were reported.
Reproductive subgroup: There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Mating performance and fertility were unaffected by treatment. All animals mated within 4 days. There were no treatment-related effects on gestation length, gestation index, litter size, offspring survival indices, sex ratio, offspring bodyweight, or macropathology for offspring.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: General toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: reproduction/developmental toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- > 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: No adverse effects were seen on general toxicity endpoints. No adverse effects were seen on reproduction/developmental toxicity endpoints
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- NOAEL: 1,500 mg/kg/day (general toxicity)
1,500 mg/kg/day (reproduction/developmental toxicity)
LOAEL: No adverse effects were seen on general toxicity endpoints. No adverse effects were seen on reproduction/developmental toxicity endpoints.
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.
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