Kombucha

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Type of information:

experimental study

Adequacy of study:

key study

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:

Please refer to the Read-across Justification provided in IUCLID section 13

Data source

Reference

Reference Type:

review article or handbook

Title:

Cosmeceutical effect of ethyl acetate fraction of Kombucha tea by intradermal administration in the skin of aged mice

Author:

Pakravan N, Mahmoudi E, Hashemi SA, Kamali J, Hajiaghayi R, Rahimzadeh M, Mahmoodi V.

Year:

2017

Bibliographic source:

J Cosmet Dermatol. 2018 Dec;17(6):1216-1224.

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

A total of 54 female NMRI mice were purchased from Pasteur Institute Experimental Animal Center (Tehran, Iran). All animals were kept under standard conditions of temperature (23 +/- 2°C) and humidity (50% +/- 10%) with an alternating 12-h light/dark cycles at the conventional animal house of Alborz University of Medical Sciences. Given free access to food and water, mice were housed for 1 week before experiments and maintained under standard environmental conditions.
All experiments were done according to Animal Care and Use Protocol of Ethics Committee of Alborz University of Medical Sciences.
According to the age, 5 experimental groups (n = 9) were considered including: Group 1 as control young group (aged 2 months), Group 2 as old group (aged 15 months) treated with KEAf at a dose of 5 mg/mL, Group 3 as old group (aged 15 months) treated with KEAf at a dose of 10 mg/mL, Group 4 as control old group (aged 15 months) treated with saline, and Group 5 as control old group (aged 15 months) without any treatment. Treatments were carried out for 14 days and performed via the intradermal route after the induction of anesthesia and shaving a 2 x 2 cm region behind the animal’s neck.

GLP compliance:

not specified

Remarks:

Not mentioned

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

In vitro test system

Amount/concentration applied:

Group 1 and 2: 5 mg/mL
Group 3 and 4: 10 mg/mL
Group 4 and 5: 0 mg/mL

Test animals

Species:

mouse

Strain:

NMRI

Details on test animals or test system and environmental conditions:

A total of 54 female NMRI mice were purchased from Pasteur Institute Experimental Animal Center (Tehran, Iran). All animals were kept under standard conditions of temperature (23 +/- 2°C) and humidity (50% +/- 10%) with an alternating 12-h light/dark cycles at the conventional animal house of Alborz University of Medical Sciences. Given free access to food and water, mice were housed for 1 week before experiments and maintained under standard environmental conditions.
All experiments were done according to Animal Care and Use Protocol of Ethics Committee of Alborz University of Medical Sciences.

According to the age, 5 experimental groups (n = 9) were considered including: Group 1 as control young group (aged 2 months), Group 2 as old group (aged 15 months) treated with KEAf at a dose of 5 mg/mL, Group 3 as old group (aged 15 months) treated with KEAf at a dose of 10 mg/mL, Group 4 as control old group (aged 15 months) treated with saline, and Group 5 as control old group (aged 15 months) without any treatment. Treatments were carried out for 14 days and performed via the intradermal route after the induction of anesthesia and shaving a 2 x 2 cm region behind the animal’s neck.

Test system

Type of coverage:

other: intradermal injection

Preparation of test site:

shaved

Remarks:

2 x 2 cm region behind the animal’s neck

Number of animals:

54

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Irritant / corrosive response data:

Visual evaluation of skin reaction at 24 and 72 hours after ID injection did not show inflammatory reactions, such as edema and erythema.
The score of irritation in Kombucha tea ethyl acetate fraction (KEAf) and the vehicle (PBS) groups was 0%, and the mean evaluation score was 0.

Other effects:

Also, histological observation of the skin tissue sections did not show pathological damage or accumulation of inflammatory cells in the treated animals suggesting that KEAf is not cytotoxic and does not sensitize the skin.

Any other information on results incl. tables

Groups	Vehicle L (PBS)				Kombucha tea ethyl acetate fraction (KEAf)
Hours	24		72		24		72
Skin reaction	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
Mean score	0	0.1	0	0	0	0	0	0

Applicant's summary and conclusion

Conclusions:

Kombucha tea ethyl acetate fraction (KEAf) is not irritating to the skin.

Executive summary:

Background/purpose: Natural ingredients have been always an interesting approach to prolong youthful appearance of skin. One of the natural compounds is Kombucha tea (KT), which has been mainly used as an energy drink in Asian countries for a long time. Previous reports indicated that it has pharmaceutical and favorable wound repairing effects. The beneficial properties of KT are thought to be mainly due to the presence of fermentation products such as flavonoids and other polyphenols with inhibition of hydrolytic and oxidative enzymes and anti-inflammatory effects. These properties prompted us to study the anti-aging potential of KT and investigate its effective fraction in aged mice.
Methods: Kombucha tea was fractionated into chloroform, butanol, and ethyl acetate, and flavonoid content was determined. Young and old mice were used as control.
KT ethyl acetate fraction (KEAf), which had the highest flavonoid content, was intradermally administered to old mice.
Results: Administration of KEAf significantly increased the collagen content, NAD+/NADH level, and concomitantly improved skin connective tissue abnormalities in the aged skin. No sensitivity or irritation was observed.
Conclusion: This finding suggested that KEAf can be a suitable candidate as a cosmetic product to improve aging-related skin abnormalities and regeneration of aged skin.