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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 June 2020 to 23 September 2020
Reliability:
1 (reliable without restriction)

Data source

Reference
Title:
Unnamed
Year:
2020
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)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[(4-{5-AMINO-4-CYANO-1-[(2S)-1,1,1-TRIFLUOROPROPAN-2-YL]-1H-PYRAZOL-3-YL}PHENYL)METHYL]-5-FLUORO-2-METHOXYBENZAMIDE
EC Number:
953-182-7
Cas Number:
2101703-40-4
Molecular formula:
C22H19F4N5O2
IUPAC Name:
N-[(4-{5-AMINO-4-CYANO-1-[(2S)-1,1,1-TRIFLUOROPROPAN-2-YL]-1H-PYRAZOL-3-YL}PHENYL)METHYL]-5-FLUORO-2-METHOXYBENZAMIDE
Specific details on test material used for the study:
Lot no: 60394-18-001

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Details on animal used as source of test system:
EpiDerm Skin Kit (MatTek Corporation) was used for the test.
Vehicle:
unchanged (no vehicle)
Details on test system:
EpiDerm Skin Model
The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
25mg neat test article
Duration of treatment / exposure:
60 minutes
Duration of post-treatment incubation (if applicable):
42 +/- 2 hour post exposure incubation period
Number of replicates:
Done in triplicate

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean of three runs
Value:
ca. 116.5
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Non irritant

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Non irritant
Executive summary:

The test article was tested in EpiDerm TM Skin Model for the Skin Irritation Test. Three tissues were used to assess viability after 60minute exposure. Negative and positive controls were tested in parallel. The test articles were not observed to directly reduce MTT in the absence of viable cells. The test material is deemed to be non-irritating to skin (GHS "No category)