Piperidine-4-carbothioamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 - 31 May 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in 2016

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Version / remarks:

adopted in 2019

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Version / remarks:

adopted in 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany

Test material

Test material information

Constituent 1

Reference substance name:

piperidine-4-carbothioamide

EC Number:

808-281-9

Cas Number:

112401-09-9

Molecular formula:

C6H12N2S

IUPAC Name:

piperidine-4-carbothioamide

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: MatTek In Vitro Lifescience Laboratories, Bratislava, Slovakia

Source strain:

other: EpiDerm™ Skin Model (EPI-200)

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount applied: 25 mg, skin was moistened with 25 µL sterile deionised water

POSITIVE CONTROL
- Amount applied: 50 μL
- Concentration: 8 N

NEGATIVE CONTROL
- Amount applied: 50 μL

Duration of treatment / exposure:

3 min and 60 min

Duration of post-treatment incubation (if applicable):

not applicable

Number of replicates:

duplicates for each treatment and control group

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Remarks:

mean values of 2 tissues

Run / experiment:

3 min exposure

Value:

77

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Remarks:

mean value of 2 tissues

Run / experiment:

60 min exposure

Value:

58.7

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Conclusions:

In this in vitro skin corrosion test in EpiDerm™ tissue, the mean cell viability compared to the negative control was 77.0% after 3 min exposure and 58.7% after 60 min exposure with the test substance. All validity criteria were within acceptable limits. In conclusion, the test substance was not corrosive to human epidermis tissue. There is regulatory acceptance in the EU that a substance can be considered corrosive based on a positive result in the reconstructed human epidermis test method (in vitro skin corrosion). A negative in vitro corrosivity response is not conclusive with respect to non-classification or classification as a skin irritant and therefore requires further evaluation and/or data generation.