5-(Methylsulfonyl)pyridine-2-carbonitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1 March 2018 - 25 April 2018

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

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-(Methylsulfonyl)pyridine-2-carbonitrile

EC Number:

682-451-9

Cas Number:

848141-13-9

Molecular formula:

C7 H6 N2 O2 S

IUPAC Name:

5-(Methylsulfonyl)pyridine-2-carbonitrile

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.
The test was performed on a total of three tissues per test article, negative and positive
control. At treatment initiation, the media under the tissues was replaced with 0.9 mL of
assay medium (supplied with the EpiDermTM SIT (EPI-200) tissues).
25 mg of the test article was added topically to the tissues. The tissues were moistened with
25 μL of PBS, prior to application. A volume of 30 μL of the positive and negative control
solutions was used.

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

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.

Duration of post-treatment incubation (if applicable):

Following treatment, substances were
removed by washing the tissues. The tissues were then placed on the appropriate medium and
incubated for 42 hours.

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

ca. 101.5

Negative controls validity:

valid

Remarks:

100.0%

Positive controls validity:

valid

Remarks:

4.4%

Remarks on result:

no indication of irritation

Any other information on results incl. tables

The test article, BI 730357 Nitril, 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 with BI 730357 Nitril, 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 101.5 %, for the negative control was 100.0%
and for the positive control was 4.4%.
The test article, BI 730357 Nitril, was not considered to be irritant in the in vitro skin model
EpiDermTM SIT (EPI-200).