[5-(methanesulfonyl)pyridin-2-yl]methanaminium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 October 2016 - 30 Nov 2016

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes

Remarks:

including compliance statement and signature page

Test material

Test material information

Constituent 1

Reference substance name:

(5-methanesulfonylpyridin-2-yl)methanaminium chloride

EC Number:

946-348-5

Cas Number:

848141-14-0

Molecular formula:

C7H10N2O2S x HCl

IUPAC Name:

(5-methanesulfonylpyridin-2-yl)methanaminium chloride

Test material form:

solid

In vitro test system

Test system:

human skin model

Remarks:

EpiDermTM SIT (EPI-200) three-dimensional human skin model

Cell type:

non-transformed keratinocytes

Vehicle:

other: deionised water and isopropanol

Details on test system:

EpiDermTM SIT (EPI-200) tissues were kept in their packaging until the next step. The tissues
were set up the day prior to treatment by placing each tissue onto 0.9 mL maintenance
medium (supplied with the EpiDermTM SIT (EPI-200) tissues) in 6-well plates and incubating
at 37°C.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

yes, concurrent MTT non-specific colour control

Amount/concentration applied:

25 mg of test article was added to 1 mL of MTT
25 mg of the test article was added to 0.3 mL deionised water and 0.3 mL isopropanol in a suitable glass container

A volume of 30 μL of the positive and negative control solutions was used.

Duration of treatment / exposure:

The treated tissues were paced into an incubator at 37±1ºC, 5±1% CO2 for 35 minutes. The
plates were removed from the incubator and placed into a sterile hood until the 60 minute
treatment period was complete for each tissue. Following treatment, substances were
removed by washing the tissues.

Duration of post-treatment incubation (if applicable):

The tissues were then placed on the appropriate medium and
incubated for 41 hours and 20 minutes.

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

ca. 96.4

Negative controls validity:

valid

Remarks:

100.0%

Positive controls validity:

valid

Remarks:

2.2%

Remarks on result:

no indication of irritation

Any other information on results incl. tables

The test article, BI 730357 Sulfon CL, was not considered to be irritant in the in vitro skin model

EpiDermTM SIT (EPI-200).

Applicant's summary and conclusion

Interpretation of results:

other: not classified acc. CLP

Conclusions:

This study was conducted to determine whether the test article causes irritation in the in vitro
skin model EpiDermTM SIT (EPI-200).
EpiDermTM SIT (EPI-200) inserts were treated withI BI 730357 Sulfon CL, negative control (phosphate
buffered saline (PBS)) and positive control (5% w/v sodium dodecyl sulphate (SDS)) for
60 minutes. At the end of the treatment period, the tissues were washed with PBS and cell
viability was assessed using the MTT assay. The skin irritation potential was classified
according to the remaining cell viability obtained after test article treatment.
The group mean viability for the test article was 96.4 %, for the negative control was 100% and
for the positive control was 2.2%.
The test article, BI 730357 Sulfon CL, was not considered to be irritant in the in vitro skin model
EpiDermTM SIT (EPI-200).