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EC number: 850-929-8 | CAS number: 1584-79-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 February 2020 to 14 April 2020
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- (2019)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-Methyl-N-[[[3-(trifluoromethyl)phenyl]amino]carbonyl] benzenesulfonamide
- EC Number:
- 850-929-8
- Cas Number:
- 1584-79-8
- Molecular formula:
- C15H13F3N2O3S
- IUPAC Name:
- 4-Methyl-N-[[[3-(trifluoromethyl)phenyl]amino]carbonyl] benzenesulfonamide
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: The EPSKIN TM model is a three dimensional reconstructed human epidermis model consisting of adult human derived epdermal keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDermTm SIT kit:
Manufacturer MatTek Corporation
receipt date: 2 March 2020
Components: EpiDerm tissue (Lot Number 32183), assay medium (Lot Number: 022620TVKD), Nylon mesh (Lot Number: 0551428-00), Phosphate buffered saline without Ca2+ and MG2+, 5% SDS solution
The tissue insert and the medium were stored in a cold place. Nylon mesh and phosphate buffered saline without Ca2+ and Mg2+ were stored at room temperature. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg test substance or 30µL of the control substances respectively per tissue
- Duration of treatment / exposure:
- Incubation of all plates for 35 +/- 1 minute and until 60 minutes at room temperature afterwards.
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3 per control group (Test substance, negative control and positive control)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- positive control
- Value:
- 2.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean Negative Control
- Value:
- 100
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean test item
- Value:
- 100
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Acceptable criteria of the test were met:
Mean OD in the negative control substance group is >= 0.8 and =< 2.8
Mean cell viability in the positive control substance group is <10%
SDs of cell viablities in each treatment group used three tissue inserts are 0< 18%.
In a preliminary test it was confirmed that the test item has no reactivity with MTT. Therefore the interference of the test substance with MTT was not evaluated in the skin irritation test.
As a result of tissue-binding test, the staining ratio was 02% whic is く 5%. Therefore, correction of OD was not conducted.
The mean OD in the negative control was l.809. The mean cell viability in the
positive control substance was 2.2%. The SDs of cell viabilities in the negative and the positive control substances, and the test substances were 4.9% , 0.1% and 3.4 %, respectively. These results indicated thatt the present study was appropriately performed. As a result of skin irritation test, the cell viability treated by the test item was 100.0%, exceeding 50%, which is the judgement criteria of skin irritation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It was concluded that the test item was "Non-irritant" (UN GHS Category: not classified (including UN GHS Category 3).
- Executive summary:
The ability of the test item to induce skin irritation was investigated using EpiDermTM SIT (EPI-200). As a result of the skin irritation test, the cell viability treated with the test item was 100.0% exceeding 50% which is the judgement criteria of skin irritation. Consequently, it was concluded that the test item was "Non-irritant" (UN GHS Category: not classified (including UN GHS Category 3).
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