N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Principles of method if other than guideline:

The HCE model is currently involved in the eye irritation validation conducted by the COLIPA following ECVAM guidelines. This study is expected to end late this year and results published early 2012. The HCE is produced and commercialized by SkinEthic since 2000- more than 11 years-, and is the only model made from human corneal cells. The model is routinely used by the major Cosmetic and Pharmaceutical companies, and has already been prevalidated in 2004 (4). Furthermore, this model is recognized as the model of choice and scientifically relevant as documented by several publications (5, 6, 7). These tests are also related to OECD 405, Attachment March 2000.

The purpose of this protocol is to evaluate the potential ocular irritation of the test substance by measuring cell viability in the human corneal epithelial cell (HCE) construct, available from SkinEthic Laboratories, following topical exposure to the test substance via MTT [3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide] dye conversion.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide

EC Number:

218-915-0

EC Name:

N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide

Cas Number:

2280-49-1

Molecular formula:

C13H10Cl3NO2S2

IUPAC Name:

N-phenyl-N-[(trichloromethyl)sulfanyl]benzenesulfonamide

Test material form:

other: solid

Details on test material:

N-Phenyi-N[( trichloromethyl)thio]benzenesulphonamide
Content: 99,8%

Test animals / tissue source

Species:

other: in vitro

Strain:

other: human corneal epithelial cell (HCE)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The results of the concurrent negative (NC, PBS) and positive control (PC, 1 H-1 ,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the test model.

Duration of treatment / exposure:

After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 93% (rounded) as measured by a MTT conversion assay.

Observation period (in vivo):

After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 93% (rounded) as measured by a MTT conversion assay.

Number of animals or in vitro replicates:

in vitro; triplicates

Results and discussion

In vitro

Results

Irritation parameter:

other: % cell viability

Run / experiment:

Cell viability [%]

Value:

93.17

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Non-Irritant

Any other information on results incl. tables

After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 93% (rounded) as measured by a MTT conversion assay.

The results of the concurrent negative (NC, PBS) and positive control (PC, 1 H-1 ,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the

test model.

The results show that N-Phenyi-N-[(trichloromethyl)thio]benzenesulphonamide is predicted as non-irritant under the conditions of this test method.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The results show that N-Phenyl-N-[(trichloromethyl)thio]benzenesulphonamide is predicted as non-irritant under the conditions of this test method.