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EC number: 611-696-6 | CAS number: 58543-16-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 02, 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- (2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl (1R,4S,5R,9S,10R,13S)-13-{[(2S,3R,4S,5R,6R)-5-hydroxy-6-(hydroxymethyl)-3,4-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxan-2-yl]oxy}-5,9-dimethyl-14-methylidenetetracyclo[11.2.1.0¹,¹⁰.0⁴,⁹]hexadecane-5-carboxylate
- EC Number:
- 611-696-6
- Cas Number:
- 58543-16-1
- Molecular formula:
- C44H70O23
- IUPAC Name:
- (2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl (1R,4S,5R,9S,10R,13S)-13-{[(2S,3R,4S,5R,6R)-5-hydroxy-6-(hydroxymethyl)-3,4-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxan-2-yl]oxy}-5,9-dimethyl-14-methylidenetetracyclo[11.2.1.0¹,¹⁰.0⁴,⁹]hexadecane-5-carboxylate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Purified water (Fresh prepared)
- Doses:
- 300 mg/kg b.w.
2000 mg/kg b.w. - No. of animals per sex per dose:
- The dose level of 300 mg/kg b.w. was selected as the starting dose from one of four fixed dose levels (5, 50, 300, 2000 mg/kg b.w.), and 3 animals were used in each step. The first step dosing was 300 mg/kg b.w. and no animals died. According to this result, 300 mg/kg b.w was selected as the second step dosing, and no animals died. According to this result, 2000 mg/kg b.w. was selected as the third step dosing, and no animals died. According to this result, 2000 mg/kg b.w. was selected as the fourth step dosing, and no animals died.
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
Mortality
Dose Level-The first dosing (300 mg/kg b.w.): All animals showed no deaths or moribund status during the test.
Dose Level-The second dosing (300 mg/kg b.w.): All animals showed no deaths or moribund status during the test.
Dose Level-The third dosing (2000 mg/kg b.w.): All animals showed no deaths or moribund status during the test.
Dose Level-The fourth dosing (2000 mg/kg b.w.): All animals showed no deaths or moribund status during the test.
Clinical Observations
Dose Level-The first dosing (300 mg/kg b.w.): All animals showed no abnormal symptoms during the test.
Dose Level-The second dosing (300 mg/kg b.w.): All animals showed no abnormal symptoms during the test.
Dose Level-The third dosing (2000 mg/kg b.w.): All animals showed no abnormal symptoms during the test.
Dose Level-The fourth dosing (2000 mg/kg b.w.): All animals showed no abnormal symptoms during the test.
Body Weights
All of the surviving animals gained body weights during the test.
Necropsy
All animals under test showed no abnormalities at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results, the acute oral LD50 in rats for Rebaudioside A was estimated to be more than 2000 mg/kg b.w., and the cut-off value of LD50 was estimated to be 5000 or ∞ mg/kg b.w.. According to the GHS’s classification criteria for acute oral toxicity, the test item was classified as “Category 5” or “Unclassified”.
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