Registration Dossier
Registration Dossier
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EC number: 231-665-7 | CAS number: 7681-38-1
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-standard study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
- Objective of study:
- absorption
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium sulphate
- EC Number:
- 231-820-9
- EC Name:
- Sodium sulphate
- Cas Number:
- 7757-82-6
- Molecular formula:
- H2O4S.2Na
- IUPAC Name:
- disodium sulfate
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4
Constituent 1
Test animals
- Species:
- other: homo sapiens
Administration / exposure
- Route of administration:
- oral: unspecified
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Males: 18.1 g Na2SO4 decahydrate (800 g of the anhydrous salt)
- No. of animals per sex per dose / concentration:
- Males: 5 Females: 0
Results and discussion
Toxicokinetic / pharmacokinetic studies
Toxicokinetic parametersopen allclose all
- Toxicokinetic parameters:
- half-life 1st:
- Toxicokinetic parameters:
- half-life 2nd:
- Toxicokinetic parameters:
- half-life 3rd:
Any other information on results incl. tables
RS-Freetext:
Prior to exposure three separate 24-hour periods for
urine volume and baseline sulfate excretion determination
(twice, one -week interval). Subjects received either above
dose in a single dose or in four hourly increments; one week
later the alternative dosing schedule.
72 -hour urine was collected in 24-hour portions. Urinary
free sulfate excretion corrected for baseline was about 53.4
+-16.8 for the single dose and 61.8 +-7.8 for the divided
dose. Single dose causeds severe diarrhoea, divided dose did
not. Excretion of free sulfate is not influenced by urine
flow, but excretion of organicaly bound sulfate is.in a
linear fashion.
Applicant's summary and conclusion
- Conclusions:
- Sodium sulfate is better absorbed from the intestine when given in divided dose than from a single large dose, indicating saturation of the transport system.
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