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EC number: 204-886-1 | CAS number: 128-44-9
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Scientific publication, no GLP.
- Objective of study:
- metabolism
- Principles of method if other than guideline:
- Saccharin labelled with t4C in the carbonyl group was administered orally to albino rats and the amounts excreted and retained in the body were determined by radioassay A method was developed for the separation and quantitative determination of saccharin and its hydrolytic products, o-sulphamoylbenzoic acid and ammonium o-carboxybenzenesulphonate.
- GLP compliance:
- no
- Specific details on test material used for the study:
- Saccharin sodium salt, saccharin labelled with 1+C in the carbonyl group and having a specific activity of 1.15 mc/g, o-sulphamoylbenzoic acid (CompoundI) and ammonium o-carboxybenzenesulphonate (Compound II) were obtained from Monsanto Co., St. Louis. Mo.
- Radiolabelling:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Two male and two female young adult Charles River albino rats, obtained from the Charles River Breeding Laboratories, North Wilmington, Mass. and weighing about 200 g.
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Duration and frequency of treatment / exposure:
- On the morning of the first test day, after a 16-hr fast (water permitted), each rat was intubated with a solution of labelled saccharin in 1 70 aqueous methylcellulose. One male and one female each received 1-0 ml, containing 10 t~c of 14C activity, and one male and one female received 2-0 ml each (20 tzc). Similar doses of non-radioactive material have been well tolerated by animals. The solutions were administered using a hypodermic syringe
equipped with a ball-pointed intubation needle. The exact amount received by each animal was determined by weighing the syringe and needle before and after dosing. - Dose / conc.:
- 8.21 other: microC/rat
- Dose / conc.:
- 17.54 other: microC/rat
- Dose / conc.:
- 8.12 other: microC/rat
- Dose / conc.:
- 18.27 other: microC/rat
- No. of animals per sex per dose / concentration:
- Two male and two female
- Metabolites identified:
- yes
- Conclusions:
- The rats used in the radiotracer study showed no signs of toxicity during the study. Food and water consumption and excretory patterns were normal and there were no significant
changes in body weight during the test period. - Executive summary:
The study of metabolic fate of sodium sacchrin in rats was performed. Radiolabelled sodium saccharin was administrated orally to rats (2 male and 2 female).
It was found that almost all the saccharin was eliminated unchanged within 48 h, only traces of the other two compounds being found. The study conclusion is sodium saccharin, when administered orally to the albino rat, is neither stored nor metabolized.
Reference
Table 1.Recovery of 14 C activity from TLC plates following chromatography of whole urine samples from rats given an oral dose of[14C]saccharin
|
| Radioactivity | ||
Animal no | Sample time interval (h) | Total urine (counts/min) | Saccharin (counts /min) | Saccharin (% of total) |
1 | 12 | 5839 | 5149 | 99.7 |
24 | 5717 | 5676 | 99.3 | |
2 | 12 | 7314 | 7276 | 99.5 |
24 | 5311 | 5280 | 99.4 | |
48 | 5335 | 5288 | 99.1 | |
72 | 2181 | 2178 | 99.9 | |
3 | 12 | 5192 | 5171 | 99.6 |
24 | 2673 | 2671 | 99.9 | |
4 | 12 | 6032 | 6024 | 99.8 |
24 | 3116 | 3098 | 994 |
The rats used in the radiotracer study showed no signs of toxicity during the study. Food and water consumption and excretory patterns were normal and there were no significant changes in body weight during the test period.
Description of key information
Weight of evidence:
The study of metabolic fate of sodium sacchrin in rats was performed. Radiolabelled sodium saccharin was administrated orally to rats (2 male and 2 female).
It was found that almost all the saccharin was eliminated unchanged within 48 h, only traces of the other two compounds being found. The study conclusion is sodium saccharin, when administered orally to the albino rat, is neither stored nor metabolized.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
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.
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