Kombucha

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:

2000

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

Test material information

1

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

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.