Cinchocaine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: 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

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

Cinchocaine

EC Number:

201-632-1

EC Name:

Cinchocaine

Cas Number:

85-79-0

Molecular formula:

C20H29N3O2

IUPAC Name:

2-butoxy-N-[2-(diethylamino)ethyl]quinoline-4-carboxamide

Test material form:

solid: particulate/powder

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: Adult humanderived epidermal keratinocytes

Details on animal used as source of test system:

EPISKINTM (SM) (Manufacturer: SkinEthic, France, Batch No.: 18-EKIN-010, Expiry Date: 12 March 2018) is a three-dimensional human epidermis model

Justification for test system used:

The EPISKINTM (SM) model has been validated for irritation testing in an international validation study [10] and its use is recommended by the relevant OECD guideline for irritation testing (OECD No. 439); therefore, it was considered to be suitable for this study.

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

First an appropriate amount (10 μL) distilled water was applied to the epidermal surface in order to improve further contact between test item and epidermis and then 10 mg of the powdered test item was applied evenly to the epidermal surface, the test item was spread gently on the skin surface with a pipette tip without damaging the epidermis. The amount was sufficient to cover the epidermal surface.

Duration of treatment / exposure:

15 min

Number of replicates:

3

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Run 1

Value:

73

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Run 2

Value:

71.1

Negative controls validity:

valid

Positive controls validity:

valid

Results 3

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Run 3

Value:

71.3

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, in this in vitro EPISKINTM (SM) model test with BUTOXYAMIDE (Batch number: 02402660053), the results indicate that the test item is non-irritant to skin, UN GHS Classification: No Category (since the test item is known not to be corrosive).

Executive summary:

The skin irritation potential of butoxyamide was performed using the in vitro EPISKINTM (SM) model. The results indicate that the test item is non-irritant to skin, UN GHS Classification: No Category (since the test item is known not to be corrosive).