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EC number: 231-820-9 | CAS number: 7757-82-6
- 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
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Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Literature data
Data source
Reference
- Reference Type:
- publication
- Title:
- Absorption of Orally Administered Sodium Sulfate in Humans.
- Author:
- Cocchetto David M. and Levy Gerhard
- Year:
- 1 981
- Bibliographic source:
- Journal of Pharmaceutical Sciences / 331 Vol. 70, No. 3, March 1981
Materials and methods
- Objective of study:
- absorption
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium sulphate
- EC Number:
- 231-820-9
- EC Name:
- Sodium sulphate
- Cas Number:
- 7757-82-6
- Molecular formula:
- Na2SO4
- IUPAC Name:
- disodium sulfate
Constituent 1
Test animals
- Species:
- human
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- No of organisms: 5 healthy men.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTION
Sodium sulfate was dissolved in 50 ml of warm water - Duration and frequency of treatment / exposure:
- Test solution was administrate, either as a single dose or in four equally divided hourly doses.
Men received sodium sulfate orally on two occasions, at least 1 week apart.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Men received 18.1 g of sodium sulfate USP, the decahydrate, equivalent to 8.00 g of anhydrous sodium sulfate.
- No. of animals per sex per dose / concentration:
- 5
- Details on study design:
- AFTER DOSE ADMINISTRATION
When men received sodium sulphate, the subjects fasted overnight and consumed a low fat breakfast in the morning.
They emptied their bladder before ingesting the test solution.
BEFORE DOSE ADMINISTRATION
Men ate lunch and their subsequent meals and fluid intake were not restricted or controlled. - Details on dosing and sampling:
- - Tissues and body fluids sampled: all urine, for determination of baseline free sulfate output.
- Time and frequency of sampling: urine sample were collected for three separate 24-hr periods; over 0-24, 24-48 and 48-72 hr.
- Collection vessel: all urine was collected in sterile plastic bags.
- Sample storage: the urines were frozen immediately after collection, pending assay.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- The baseline individual average excretion rate of inorganic sulfate ranged from 13 to 25 mmoles/24 hr and was relatively constant (coefficient of variation of 747%).The individuals with the lowest body weight (DC and SR) exhibited the lowest baseline values. Compared with the amount of sodium sulfate taken by the subjects (56.3 mmoles), the baseline excretion rate of inorganic sulfate was substantial.
The baseline excretion rate of free sulfate was not affected by relatively large changes in urine flow rate, but the baseline excretion rate of total sulfate (and therefore, of organically bound sulfate) increased essentially linearly with increasing urine flow rate. This differential effect of the urine flow rate also was observed after sodium sulfate administration.
The cumulative amounts of free sulfate excreted in the urine 24, 48 and 72 hr after sodium sulfate administration were significantly larger than the amounts of free sulfate excreted during the same lengths of time in control experiments (p < 0.01 by paired t test).
The average urinary recovery of administered sulfate, calculated as the 72-hr excretion of free sulfate minus the baseline excretion, averaged 53.4% from the single dose and 61.8% from the divided doses.
There was considerably less interindividual variation in urinary recovery of free sulfate from the divided doses.
Any other information on results incl. tables
Urinary Excretion of Free Sulfate by Normal Men after Oral Administration of 18 g of Sodium Sulfate Decahydrate (= 8 g sodium sulphate anhydrous) in Single and Divided Doses.
Subject | Age (y) | Bodi weight (kg) | Baseline Excretion rate (mmoles/24hr*) |
Cumulative Percent of dose excreted |
|||||
Single dose | Divided Dose** | ||||||||
24 hr | 48 hr | 72 hr | 24 hr | 48 hr | 72 hr | ||||
PM | 25 | 79 | 22.9 ± 2.9 | 24.5 | 27.1 | 38.8 | 37.2 | 49.7 | 57.2 |
DC | 25 | 66 | 16.7 ± 1.2 | 40.7 | 62.9 | 71.5 | 44.6 | 52.8 | 63.2 |
DS | 34 | 77 | 24.3 ± 6.5 | 55.2 |
65.3 |
68.9 |
48.3 |
60.0 |
69.3 |
UW |
36 |
74 |
25.0 ± 6.4 |
44.4 |
49.0 |
39.4 |
59.8 |
60.4 |
68.4 |
SR |
28 |
66 |
13.0 ± 2.1 |
17.3 |
43.0 |
48.5 |
27.9 |
42.5 |
50.8 |
Mean |
|
|
|
36.4 |
49.5 |
53.4 |
43.5*** |
53.1*** |
61.8*** |
SD |
|
|
|
15.4 |
15.6 |
15.8 |
12.0 |
7.5 |
7.8 |
*Mean f SD, n = 3 consecutive days.
**Four equally divided doses administered at hourly intervals.
***Not significantly different ( p > 0.1) from corresponding value after single dose.
All subjects experienced severe diarrhea after the single dose of sodium sulfate, starting typically after 2 hr and lasting up to 24 hr. The same amount of sodium sulfate taken in four equal hourly doses produced either no diarrhea or mild diarrhea of short duration. No other adverse effects were reported.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
The cumulative amounts of free sulphate excreted in the urine 24, 48 and 72 hr after sodium sulphate administration were significantly larger than the amounts of free sulfate excreted during the same lengths of time in control experiments. The average urinary recovery of administered sulphate averaged 53.4% from the single dose and 61.8% from the divided doses.
The single dose produced severe diarrhea while the divided doses caused only mild or no diarrhea. - Executive summary:
The purposes of this investigation were to determine the absorption of a large amount of sodium sulfate (18.l g as the decahydrate, equivalent to 8.0 g of the anhydrous salt) and to compare the bioavailability when this amount is administered orally to normal subjects as a single dose and as four equally divided hourly doses.
Result
The cumulative amounts of free sulphate excreted in the urine 24, 48 and 72 hr after sodium sulphate administration were significantly larger than the amounts of free sulphate excreted during the same lengths of time in control experiments. The average urinary recovery of administered sulphate, calculated as the 72-hr excretion of free sulphate minus the baseline excretion, averaged 53.4% from the single dose and 61.8% from the divided doses.
The single dose produced severe diarrhea while the divided doses caused only mild or no diarrhea. Thus,a large amount of sodium sulphate, when administered orally in divided doses over 3 hr, is well tolerated and is absorbed to a significant extent.
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