Ethyl [(4-methylphenyl)sulphonyl]carbamate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

other: In vitro

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP. Guideline study

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 439: In vitro skin irritation

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

The test is based on the experience that irritant chemical show cytotoxic effects following short term exposure to the stratum corneum of the epidermis. The test is designed to predict and classify the skin irritation potencial of a test substance by assessment of its effect on a three dimensional human epidermis model.
The test consists of topical application of Tolfamato on the skin tissue for 15 minutes. After exposure the skin tissue is thoroughly rinsed to remove the test substance and transferred to fresh medium. After a 42 hour incubation period, determination of the cytotoxic (irritancy) effect is performed.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl [(4-methylphenyl)sulphonyl]carbamate

EC Number:

226-952-9

EC Name:

Ethyl [(4-methylphenyl)sulphonyl]carbamate

Cas Number:

5577-13-9

Molecular formula:

C10H13NO4S

IUPAC Name:

ethyl [(4-methylphenyl)sulfonyl]carbamate

Details on test material:

Tolfamato was topically applied on a human three dimensional epidermal model.

Test animals

Species:

other: human skin model

Test system

Type of coverage:

other: Its an in vitro test with no occlusive bandage as for in vivo test.

Controls:

yes

Duration of treatment / exposure:

15 min

Observation period:

After exposure the skin tissue is thoroughly rinsed to remove the test substance and transferred to fresh medium.
After a 45 hour post-incubation period, determination of the cytotoxic (irritancy) effect is performed via MTT test.

Number of animals:

No animals in this study but 3 tissue samples with control samples in parallel.

Results and discussion

In vivo

Results

Irritation parameter:

other: OD570

Basis:

other: OD570

Time point:

other: 15 min

Score:

>= 0.818 - <= 0.863

Max. score:

0.863

Reversibility:

no data

Irritant / corrosive response data:

Tolfamato was checked for possible direct MTT reduction by adding the test substance to MTT
medium. Because no colour change was observed it was concluded that Tolfamato did not interact
with MTT.
The mean absorption at 570 nm measured after treatment with Tolfamato and controls are presented
in Table 1. The individual OD570 measurements are presented in
Table 2 shows the mean tissue viability obtained after 15 minutes treatment with Tolfamato compared
to the negative control tissues. Skin irritation is expressed as the remaining cell viability after exposure
to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with
Tolfamato compared to the negative control tissues was 101%. Since the mean relative tissue viability
for Tolfamato was above 50% Tolfamato is considered to be non-irritant.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Tolfamato is non-irritant in the in vitro skin irritation test under the experimental conditions described.