Registration Dossier
Registration Dossier
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EC number: 244-169-0 | CAS number: 21049-70-7
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- publication
- Title:
- Metabolism and Elimination of Sulphite by rats, Mice and Monkeys
- Author:
- Gibson W.B.; Strong, F.M.
- Year:
- 1 973
- Bibliographic source:
- Fd Cosmet. Toxicol., 11, 185-198.
Materials and methods
- Objective of study:
- absorption
- excretion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The fate of ingested sulfite was investigated in monkeys using dose levels of 50 mg SO2/kg administered as NaHSO3 mixed with Na2[35]SO3.
- GLP compliance:
- no
Test material
- Reference substance name:
- sodium sulfite
- IUPAC Name:
- sodium sulfite
- Reference substance name:
- Sodium sulphite
- EC Number:
- 231-821-4
- EC Name:
- Sodium sulphite
- Cas Number:
- 7757-83-7
- IUPAC Name:
- disodium sulfite
- Details on test material:
- - Name of test material (as cited in study report): Sodium sulfite
- Molecular formula (if other than submission substance): Na2SO3
- Physical state: solid
No further details are given.
Constituent 1
Constituent 2
- Radiolabelling:
- yes
- Remarks:
- [35]SO3
Test animals
- Species:
- monkey
- Strain:
- other: Rhesus
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Primate Research Center, Madison, Wisc.
- Weight at study initiation: approximately 6 kg
- Housing: Animals were housed in stainless-stell metabolism cages, which permitted separation of urine and faeces.
- Individual metabolism cages: yes
- Diet: ad libitum
- Water: ad libitum
No further details are given.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: glucose
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: 15 mL of a Na2[35]SO3-NaHSO3 solution (3.3 x 10^8 counts/minute) in 0.5% glucose.
DIET PREPARATION
no details
VEHICLE
no details - Duration and frequency of treatment / exposure:
- 5 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50 mg SO2/kg
- No. of animals per sex per dose / concentration:
- 5 females and 1 male
- Control animals:
- no
- Positive control reference chemical:
- No positive control substance was tested.
- Details on study design:
- no data
- Details on dosing and sampling:
- Sulfite in aqueous solution was assayed either by colorimetric method based on pararosaniline, or by iodometric titration. A third method of sulfite analysis, using radioactive N-[1-[14C]]ethylmaleimide was used for urine samples.
Urine and faeces were colleceted at 24-hour intervals for 5 days and analysed for radioactivity. The collection funnel was rinsed with water after each daily collection and the rinsings were added to the urine samples. At the end of the experiment, each cage was washed thoroughly, the washings were separated into a solid and liquid fraction by filtration, and the solid and liquid fractions were tabulated respectively as part of the faeces and urine collected on day 5. - Statistics:
- no data
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Most (70-95%) of the ingested [35S]sulfite was absorbed from the intestine and voided in the urine within 24 hours.
- Type:
- excretion
- Results:
- All of the [35]S was eliminated from the body in 3 days. An efficient voidance of the dose via the urinary tract was demonstrated in the first 24 hours.
- Type:
- excretion
- Results:
- The greatest cumulative amount found in the faeces of the 6 monkeys was 6%, the remainder being recovered in the urine.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- no data
- Details on distribution in tissues:
- no data
- Details on excretion:
- no data
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- no data
Applicant's summary and conclusion
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.
