Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 205-739-4 | CAS number: 149-44-0
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1936
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 936
- Report date:
- 1936
Materials and methods
- Objective of study:
- distribution
- other: Absorption after oral uptake... (see attached file)
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Evaluation of a toxikokinetic study: Hug, E.: Absorption and disappearance of the test substance from the blood after administration intravenously or by stomach tube.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium hydroxymethanesulphinate
- EC Number:
- 205-739-4
- EC Name:
- Sodium hydroxymethanesulphinate
- Cas Number:
- 149-44-0
- Molecular formula:
- CH4O3S.Na
- IUPAC Name:
- sodium hydroxymethanesulphinate
- Details on test material:
- no data given in the toxicokinetic study
Constituent 1
- Radiolabelling:
- not specified
Test animals
- Species:
- dog
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data given in the toxicokinetic study
Administration / exposure
- Route of administration:
- other: oral application by stomach tube, intravenous injection
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
see table 1
PREPARATION OF DOSING SOLUTIONS:
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):
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Lot/batch no. (if required):
- Purity:
HOMOGENEITY AND STABILITY OF TEST MATERIAL: - Duration and frequency of treatment / exposure:
- 8 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
intravenous injection (dosing volume): 10 c.c/kg, gavage via digestive tract (volume): 20 c.c/kg
- No. of animals per sex per dose / concentration:
- intravenous injection (6 animals): animals #1 and #2: 0.1 g/kg;
animals # 3and # 4: 0.2 g/kg;
animals # 5 and # 6: 0.5 g/kg
application by stomach tube :
animals #7 and #8: 0.2 g/kg;
animals #9 and # 10: 0.5 g/kg;
animals # 11 and # 12: 1g/kg(see table 2) - Control animals:
- no
- Positive control reference chemical:
- no
- Details on study design:
- no data given in the toxicokinetic study given
- Details on dosing and sampling:
- no data given in the toxicokinetic study given
- Statistics:
- no data given in the toxicokinetic study given
Results and discussion
- Preliminary studies:
- no preliminary study was conducted.
Main ADME resultsopen allclose all
- Type:
- other: Absorption after oral uptake:
- Results:
- most of injected substance disappeared from blood within < 2 h & practically all disappeared within 5 h.
- Type:
- other: Absorption after dermal exposure:
- Results:
- no relevant dermal absorption
- Type:
- other: Absorption after inhalation:
- Results:
- uptake by inhalation may be only relevant after exposure to dusts of the substance (systemic absorption)
- Type:
- distribution
- Results:
- fast distribution into blood, plasma & water based body fluids is expected after systemic absorption
- Type:
- distribution
- Results:
- transfer to lipophilic body parts is highly unlikely
- Type:
- metabolism
- Results:
- no metabolites identified
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Absorption after oral uptake:t ests revealed very slow resorption from the digestive tract after application by stomach tube such that its bioavailability was too low for antidote effectiveness
Absorption after dermal exposure: dermal absorption of this substance is not expected
Absorption after inhalation: The uptake by inhalation may be only relevant after exposure to dusts of the substance when particles are small enough to pass the tracheal airways down to the alveoli.
Solubilisation of solid Sodium formaldehyde sulfoxylate in surfactant fluid may then be expected together with systemic absorption. - Details on distribution in tissues:
- Due to its strong hydrophilicity, a fast distribution after systemic absorption into blood, plasma and further water based body fluids is to be expected as long as biological membranes do not inhibit such distribution.
A transfer to any lipophilic compartments of the human body is highly unlikely, the fact of which clearly indicates a very low potency for bioaccumulation.
After parenteral application to dogs the substance disappeared from the blood in less than 2 hours and practically all disappeared within 5 hours (see above).
- Details on excretion:
- most of the substance was excreted renally (up to 68 % within 8 hours after intravenous application).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
after intravenous injection the concentration of the test item in the blood plasm decreased rapidly. The main elimination took place via renal way in the first two hours. The total elimination was stated to be between 48.9 and 67.9 %.
After gavage via digestive tract the concentration in the blood plasm can be stated as proportional to the given doses.The total elimination was stated to be between 7.4 and 33.1 % - Executive summary:
Absorption:
Absorption after oral uptake:
Hug, E. performed tests with dogs for sodium formaldehyde sulfoxylate`s afficacy to be used as an antidote against Mercury poisoning.
These tests revealed very slow resorption from the digestive tract after application by stomach tube such that its bioavailability was too low for antidote effectiveness.
After intravenous injection of sodium formaldehyde sulfoxylate most of it disappeared from the blood in less than 2 hours and practically all disappeared within 5 hours.
Absorption after dermal exposure:
Sodium formaldehyde sulfoxylate is an organic salt which is highly soluble in water.
On the other hand human epidermis is an excellent barrier for salts, in particular since highly water soluble and charged molecules can not (easily) penetrate such barrier.
Therefore any relevant dermal absorption of this substance is not expected.
Absorption after inhalation:
Sodium formaldehyde sulfoxylate is a solid with a melting point of 64 °C; its boiling point cannot be determined, because the substance decomposes at the melting point.
The uptake by inhalation may be only relevant after exposure to dusts of the substance when particles are small enough to pass the tracheal airways down to the alveoli.
Solubilisation of solid Sodium formaldehyde sulfoxylate in surfactant fluid may then be expected together with systemic absorption.
Distribution:
This substance is highly soluble in water (> 1,000 g/L).
Due to its strong hydrophilicity, a fast distribution after systemic absorption into blood, plasma and further water based body fluids is to be expected as long as biological membranes do not inhibit such distribution.
A transfer to any lipophilic compartments of the human body is highly unlikely, the fact of which clearly indicates a very low potency for bioaccumulation.
After parenteral application to dogs the substance disappeared from the blood in less than 2 hours and practically all disappeared within 5 hours (see above).
Metabolism:
Metabolites of Sodium formaldehyde sulfoxylate were not identified in the experiments with dogs (see above), but most of the substance was excreted renally (up to 68 % within 8 hours after intravenous application).
This simple excretion pattern is plausible, since very hydrophilic substance do not need metabolic conversion for excretion, i.e. Sodium formaldehyde sulfoxylate can be directly renally eliminated.
Excretion:
Excretion of (unchanged) Sodium formaldehyde sulfoxylate from the body is fast and obviously does not need any metabolic conversion due to its high water solubility.
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.
