Basic toxicokinetics.005
Administrative data
- Purpose flag:
- key study
- Study result type:
- read-across from supporting substance (structural analogue or surrogate)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- non-standard study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1979
Materials and methods
Objective of study
- Objective of study:
- absorption
Test materials
- Identity of test material same as for substance defined in section 1 (if not read-across):
- no
Test material identityopen allclose all
Test animals
- Species:
- rat
Results and discussion
Pharmacokinetic studies
Toxicokinetic parametersopen allclose all
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- not relevant
Bioaccessibility
- Any other information on results incl. tables:
- RS-Freetext:
Absorption of inorganic sulfate after ingestion in rats
(male, Wistar (30-330 g body weight) was investigated. A
inorganic sulfate concentration was measured in the serum
after 2 hours of oral administration of 5 mmol Na2SO4. A
threefold increase in serum sulfate concentration was
measured. Complete absorption from the gastrointestinal tract
was measured using 35S labelled sulfate.
Applicant's summary and conclusion
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Basic toxicokinetics.004
Administrative data
- Purpose flag:
- key study
- Study result type:
- read-across from supporting substance (structural analogue or surrogate)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- non-standard study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1981
Materials and methods
- Methods:
- in vivo
- GLP compliance:
- no
Objective of study
- Objective of study:
- absorption
Test materials
- Identity of test material same as for substance defined in section 1 (if not read-across):
- no
Test material identityopen allclose all
- Identifier:
- EC name
- Identity:
- sodium sulphate
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4
Test animals
- Species:
- other: homo sapiens
Administration / exposure
- Route of administration:
- oral: unspecified
- Doses / concentrations:
- Males: 18.1 g Na2SO4 decahydrate (800 g of the anhydrous salt)
- No. of animals per sex per dose:
- Males: 5 Females: 0
Results and discussion
Pharmacokinetic studies
Toxicokinetic parametersopen allclose all
- Toxicokinetic parameters:
- Half-life 1st:
- Toxicokinetic parameters:
- Half-life 2nd:
- Toxicokinetic parameters:
- Half-life 3rd:
Bioaccessibility
- 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.
*************************************************
Basic toxicokinetics.001
Administrative data
- Purpose flag:
- key study
- Study result type:
- read-across from supporting substance (structural analogue or surrogate)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- non-standard study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1976
Materials and methods
- Methods:
- in vivo
- GLP compliance:
- no
Objective of study
- Objective of study:
- distribution
Test materials
- Details on test material:
- IUCLID4 Test substance: other TS: Na2SO4 (35S-labeled)
Test animals
- Species:
- other: homo sapiens
Administration / exposure
- Route of administration:
- other: intravenously and oral
- Doses / concentrations:
- Males: 60-80 microCurie
- No. of animals per sex per dose:
- Males: 8 Females: 0
Results and discussion
Pharmacokinetic studies
Toxicokinetic parametersopen allclose all
- Toxicokinetic parameters:
- Half-life 1st:
- Toxicokinetic parameters:
- Half-life 2nd:
- Toxicokinetic parameters:
- Half-life 3rd:
Bioaccessibility
- Any other information on results incl. tables:
- RS-Freetext:
Volunteers received above dose IV, followed by 24-hours
fluid restriction and blood and urine collection to
determine radio-activity and creatinine concentration
Same volunteers received same amount orally 14 days later,
followed by same regimen.
Plasma equilibrium iwas reached within 90 and 105 minutes
respectively.
Calculated mean extracelluar fluid space was 16.8 +- 1.1 and
15.3 +- 1.2 respectively or only 9%.
Conclusion: 35S-labeled sulfate is absorbed completely and
rapidly.
Applicant's summary and conclusion
- Conclusions:
- 35S-labeled sulfate is absorbed completely and rapidly.
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