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EC number: - | CAS number: -
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Please refer to the Read-across Justification provided in IUCLID section 13
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Subacute (90 Days) Oral Toxicity Studies of Kombucha Tea
- Author:
- Vijayaraghavan R, Singh M, Rao PV, Bhattacharya R, Kumar P, Sugendran K, Kumar O, Pant SC, Singh R.
- Year:
- 2 000
- Bibliographic source:
- Biomed Environ Sci. 2000 Dec;13(4):293-9.
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No data available
- GLP compliance:
- not specified
- Test type:
- other: 90d toxicity study (oral route)
Test material
- Reference substance name:
- Fermentation product of sucrose and Theaceae Camellia Camellia sinensis leaves with a variable symbiosis of bacteria and yeast, of including bacteria of Acetoacteraceæ Acetobacter and Gluconobacter genus, and yeasts of Saccharomycetaceae family
- Molecular formula:
- Not applicable
- IUPAC Name:
- Fermentation product of sucrose and Theaceae Camellia Camellia sinensis leaves with a variable symbiosis of bacteria and yeast, of including bacteria of Acetoacteraceæ Acetobacter and Gluconobacter genus, and yeasts of Saccharomycetaceae family
1
- Specific details on test material used for the study:
- Kombucha tea
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Randomly bred Wistar female rats (110-170 g body weight) maintained in the Establishment animal house were used for the study. The animals were housed in polypropylene cages, 5 per cage on dust free rice husk as the bedding material. The bedding material was changed every day. The animals were provided with pellet diet and water ad libitum. This study was approved by the ethical committee of the Establishment.
Administration / exposure
- Route of administration:
- other: oral (gavage) and drinking water
- Doses:
- 2 ml/kg orally and through drinking water at 1% v/v ad libitum
- No. of animals per sex per dose:
- 10 animals/group
- Details on study design:
- The rats were divided into five groups: (a) control group given tap water orally, (b) Kombucha tea (KT) given 2 ml/kg orally, (c) Plain tea without Kombucha culture (PT) given 2 ml/kg orally, (d) KT given through drinking water, 1% v/v ad libitum and (e) PT given in drinking water 1% v/v ad libitum. The quantity of KT and PT given by the 2 ml/kg oral administration and the 1% ad libitum were approximately same. The oral feeding was done using an 18 gauge stainless steel oral feeding cannula. Each treatment group consisted of 10 rats, housing 5 rats per cage. The rats were given this treatment daily for a period of 90 days. The feed intake, water intake, general behaviour and weekly weight were recorded. Five rats from each treatment group were sacrificed on the 91st day. The remaining animals were maintained on control conditions for a further period of one month with tap water.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- other: 2 ml/kg orally and through drinking water at 1% v/v ad libitum
- Remarks on result:
- other: NoLD50 can be determnied. The present study indicated that rats fed Kombucha tea for 90 days showed no toxic effects.
Any other information on results incl. tables
There was no significant difference in the growth of the animals as evidenced by the progressive body weight gain. There was no change in the feed intake, water intake or the general behaviour of the animals. The organ body weight ratio also did not show any toxic signs.
Histological and biochemical parameters showed isolated significant changes but were within clinical limits. Histological examination of the organs also did not reveal any toxic effect. The animals which were maintained on control condition for a further period of one month did not show any toxic symptoms. The feed intake, water intake and growth were normal.
In conclusion, the study indicated that rats fed with Kombucha tea for 90 days showed no toxic effects.
Applicant's summary and conclusion
- Conclusions:
- The present study indicated that rats fed Kombucha tea for 90 days showed no toxic effects.
- Executive summary:
Kombucha tea (KT) is a popular health beverage and is used as an alternative therapy. KT is prepared by placing the kombucha culture in solution of tea and sugar and allowing to ferment. Tje inoculum is a fingus consisting of symbiotic colony of yeast and bacteria. KT is consumed in several countries and is believed to have prophylactic and therapeutic benefits in a wide variety of ailments, viz., intestinal disorders, arthritis, ageing and stimulation of immunological system. Though KT is use din several parts of the world its benefical effects and adverse effects have not been scientifically evaluated. Since there are no animal toxicological data on KT, subacute oral toxicity study was carried out. Five groups of rats were maintained: (a) control group given tap water orally, (b) KT given 2 ml/kg orally, (c) Plain tea (PT) given 2 ml/kg orally, (d) KT given through drinking water, 1% v/v ad libitum and (e) PT given in drinking water 1% v/v ad libitum. The rats were given this treatment daily for a period of 90 days. Weekly records of weight, feed intake, water intake and general behaviour were monitored. There was no significant difference in the growth of the animals as evidenced by the progressive body weight gain. The organ body weight ratio and histological evaluation did not show any toxic signs. The haematological and biochemical variables were within the clinical limits.
The study indicates that rats fed KT for 90 days showed no toxic effects.
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