Caramel (color)

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Deviations:

yes

Remarks:

without impact on the study conclusion

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Caramel (color)

EC Number:

232-435-9

EC Name:

Caramel (color)

Cas Number:

8028-89-5

Molecular formula:

C6H12OH

IUPAC Name:

Caramel

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Details on test system:

The reconstituted epidermis (epiCS) measured 0.6 cm². The insert (filter + epidermis) was gently removed from the agarose while avoiding leaving agarose on the polycarbonate filter. The insert was placed in a 6 wells culture plate which had been previously filled with 1 mL of culture medium. The culture dishes were incubated at 37±2°C, 5% CO2 during 21 hours before treatment. Just before the treatment, the culture medium was replaced by a new culture medium.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

The test item was applied as supplied at the dose of 50 μL.

Duration of treatment / exposure:

During 3 minutes at room temperature
During 1 hour at 37°C ± 1°C

Number of replicates:

2 living human skin models.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

mean % viability of the epidermis skins treated with the test item during 3 minutes

Value:

ca. 129.74

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: % tissue viability considered as 100%

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

mean % viability of the epidermis skins treated with the test item during 1 hour

Value:

ca. 96.29

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Deviation to the study plan:

Acceptability criteria: The difference of viability between the 2 tissues treated with the test item during 3 minutes was 52.5% instead of ≤ 30% at the maximum, as defined in O.E.C.D. test guideline.

Considering the results obtained after 1 hour treatment, this deviation is considered as without impact on the conclusion of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item CARAMEL COLOUR E150c does not have to be classified in Category 1 “Corrosive”. The hazard statement “H314: Causes severe skin burns and eye damage” with the signal word “Danger” are not required.