Kombucha

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Justification for type of information:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Guideline:

other: HET-CAM (Hen's Egg Test Chorio-Allantoic Membrane) Test Method

GLP compliance:

not specified

Test material

Test material information

Constituent 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

Test material form:

liquid

Test animals / tissue source

Species:

other: Hen's egg

Details on test animals or tissues and environmental conditions:

Fresh, intact White Leghorn fertilized eggs of about 60g, incubated at 37.5°C for 10 days, with the large end up.

Test system

Amount / concentration applied:

300 µl of pure tested compound

Duration of treatment / exposure:

20 seconds

Number of animals or in vitro replicates:

Four eggs were treated for each compound

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Remarks:

mean score

Value:

3.5

Remarks on result:

other: slightly irritant

Other effects / acceptance of results:

Injection, haemorrhage and coagulation parameter are scored during 5 minutes after treatment. For each egg, the numerical scores are summed to give a single numerical value. The mean score value obtained with 4 eggs allows to class the product to one of four classes described below:
0 to 0.9: practically non-irritant
1 to 4.9: slightly irritant
5 to 8.9: moderately irritant
>= 9: irritant

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

The Hen's Egg Test on Chorioallantoic Membrane (HET-CAM) test is one of the in-vitro test recommended for use as part of a tiered testing strategy for regulatory classification and labelling (e.g. Top-Down Approach). A substance can be considered as causing serious eye damage (Category 1) based on positive results in the HET CAM test. Therefore, the product KOM 02180 is not classified as Serious eye damage (Category 1).

Conclusions:

The HET-CAM assay used in this study classified the compound "KOM 02180" as slightly irritant.