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EC number: 201-321-0 | CAS number: 81-07-2
- 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
Carcinogenicity
Administrative data
Description of key information
NOAEL and non-carcinogenic effect level was considered to be 1000 mg/kg/day when Nctr:SI I(SD)BR Sprague-Dawley female rats treated with Sodium saccharin.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data is of K2 level from peer reviewed publication
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
On the basis of available data, the substance is not classified as a carcinogen.
Additional information
Also from the other repeated dose and carcinogenicity study by Uwagawa et al (1994), NCI-Black-Reiter (NBR) male rats treated with Sodium Saccharin in the concentration of 0 and 5000 mg/kg/day orally in feed. No effect was observed on survival of treated rats as compared to control. Soft feces and decrease body weight were observed in treated male rats. Similarly, moderate decreased in food consumption, Slight increase in water consumption and significantly increased urinary pH and Na ion concentrations were observed in treated rats as compared to control. In addition, No effect was observed on BrdU labeling indices and No calculus formation, hyperplasia, papillomatosis and diffuses epithelial hyperplasia of the bladder epithelium and no cells having ropy or leafy microridges and pleomorphic microvilli and necrotic epithelial cells with silicate crystals were observed in treated rats as compared to control. Therefore, LOAEL and non-carcinogenic effect level was considered to be 5000 mg/kg/day (5%) when NCI-Black-Reiter (NBR) male rats were treated with Sodium Saccharin orally in diet for 8 weeks.
In a study by Clay et al (1989), BALB/cStCrlfC3H/Nctr female mice treated with Sodium saccharin in the concentration of 0, 143, 714, 1428.5 and 7143 mg/kg/day orally in diet initiated with dose of 200 ppm
2-Acetylaminofluorene (2-AAF) for 13 weeks, followed by 2 weeks of control diet. No effect was observed on survival and food consumption of treated mice as compared to control and 2-AAF pre-treated dose groups. Slight decrease in body weight was observed in 7143 mg/kg/day treated mice as compared to control and 2-AAF pretreated dose groups. In addition, Harderian neoplasm was observed in 7143 mg/kg/day dose group as compared to control and 2-AAF pretreated dose groups. Therefore, NOAEL and non-carcinogenic effect level was considered to be 1428.5 mg/kg/day (1%) when BALB / cStCrlfC3H / Nctr female mice were treated with Sodium saccharin orally for 116 weeks.
Thus based on the above studies it can be concluded that sodium saccharin is not considered to be carcinogenic which is further adapted by USEPA in their report confirm sodium saccharin as non-carcinogenic substance.
The EPA has officially removed saccharin and its salts from their list of hazardous constituents and commercial chemical products. In a December 14, 2010 release, the EPA stated that saccharin is no longer considered a potential hazard to human health.
Justification for selection of carcinogenicity via oral route endpoint:
NOAEL and non-carcinogenic effect level was considered to be 1000 mg/kg/day when Nctr:SI I(SD)BR Sprague-Dawley female rats treated with Sodium saccharin.
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