Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Inlife Februaty 12 - March 20, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, acceptable study according to GLP principles. No details about test substance purity.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 422 and OPPTS 870.3650
- Deviations:
- yes
- Remarks:
- But not which have a negative impact on the outcome of the study. 1) The protocol stated that the vehicle (distilled water) was to be analyzed with the prepared test mixture for the pressence of Potassium Sulfate. Although the test mixtures were analyzed,
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium sulphate
- IUPAC Name:
- Potassium sulphate
- Reference substance name:
- Potassium sulfate
- EC Number:
- 231-915-5
- EC Name:
- Potassium sulfate
- Cas Number:
- 7778-80-5
- IUPAC Name:
- dipotassium sulfate
- Details on test material:
- Due to a storage of test substance, additional substance with equivalent composition was obtained and used in the latter phase of the study.
Potassium sulphate (K2-S-O4)
Physical Description: White crystals
Composition: > 97% Potassium Sulfate / < 3% impurities
Lot/batch No.: and (Due to shortage of test substance, both test substance batches (which both meet the above definition) were mixed together at a 2:1 ratio and used from day 4 till the end of the study.
- Expiration date of the lot/batch: Not applicable
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, NC
- Age at study initiation: males: 64 days old on arrival and females 61 days old on arrival
- Weight at study initiation: males: 239 – 375 grams on arrival; females: 162 – 220 grams on arrival
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum): Purina Certified Rodent Diet #5002; ad libitum
- Water (e.g. ad libitum): filtered tap water; ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 – 23C
- Humidity (%): 45 – 69%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hr light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on exposure:
- Doses: 0, 50, 750, 1500 mg/kg/day
Doses were selected based on parameters assessed in a range-finding study at concentrations up to 1000 mg/kg/day
Frequency of treatment: daily
Details on oral exposure: gavage (oral intubation)
PREPARATION OF DOSING SOLUTIONS: Individual doses were calculated based on the most recent weekly body weights and were adjusted each week to maintain the targeted dose level for all rats in the general toxicity group (mg/kg/day). For female rats in the reproduction groups, individual doses were calculated based on the most recent body weights and were adjusted to maintain the targeted dose level (mg/kg/day). All doses were administered volumetrically after correcting for concentration of the test mixture. Control animals received the vehicle only at the same volume as the test groups.
DIET PREPARATION
- Rate of preparation of diet (frequency):
- Mixing appropriate amounts with (Type of food):
- Storage temperature of food:
VEHICLE
- Justification for use and choice of vehicle (if other than water): distilled water
- Concentration in vehicle:
- Amount of vehicle (if gavage): - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- See 7.6.1
- Details on mating procedure:
- no data
- 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 28days. The exposure period for the reproductive subgroup males was at most 28 days. The exposure period for reproductive subgroup females was at most 53 days (14 days mating and gestatioale and lactational periods up to lactation day 4)
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 750, 1500 mg/kg bw/day
Basis:
nominal conc.
Control animals: Received the vehicle (distilled water) only at the same volume as the test groups.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Reproductive subgroup: male (5 males) in the reproductive subgroup were administrated K2SO4 for 28 days via oral gavage. Female rats (10 females) in the reproductive subgroup were administrated K2SO4 for a period encompassing approximately 53 continous 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).
Examinations
- Maternal examinations:
- no data
- Ovaries and uterine content:
- no data
- Fetal examinations:
- no data
- Statistics:
- Mean and standard deviations were calculated for all quantitative data. Except for clinical data where the contract laboratory, Huntingdon Life Sciences, elected to use statistics to aid in data interpretation; no further statistical treatment of the study data was conducted due generally to small group sizes.
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Reproductive subgoup: there were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weigth, food consumption, or food efficiency. Mating performance and fertility were unaffected by treatment. All animals mated within 4 days.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: other:
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There were no treatment related effects on gestation length, gestation index, litter size, offspring survival indices, sex ratio, offspring bodyweight, or macropathology for offspring.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No adverse effects were seen on reproduction/developmental toxicity endpoints
NOAEL = 1500 mg/kg/day (reproduction and developmental)
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.
