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EC number: 611-575-8 | CAS number: 577953-88-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 20th to January 26th 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-cyclohexylcyclohexanamine 2-[1-[[[(1R)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate
- EC Number:
- 611-575-8
- Cas Number:
- 577953-88-9
- Molecular formula:
- C47H59ClN2O3S
- IUPAC Name:
- N-cyclohexylcyclohexanamine 2-[1-[[[(1R)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- White powder with lumps
Stored at room temperature
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not defined
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EPISKIN Small Model TM (EPISKIN-SM TM, 0.38 cm2, Lot no.: 14-EKIN-003, See APPENDIX 4).
This model is a three-dimensional human epidermis model, which consists of adult human-derived
epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type
I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a
highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous
and granular layers and a functional stratum corneum. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- No correction was made for the purity/composition of the test compound.
The solid test substance (14.2 to 15.8 mg) was applied directly on top of the skin tissue.
Montelukast dicyclohexylamine salt was spread to match the size of the tissue.
- Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3 per test substance
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 104
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The mean absorption at 570 nm measured after treatment with Montelukast dicyclohexylamine salt
and controls are presented in APPENDIX 1,Table 1. The individual OD
measurements are
presented in APPENDIX 2.
Table 2 shows the mean tissue viability obtained after 15 minutes treatment with Montelukast
dicyclohexylamine salt compared to the negative control tissues. Skin irritation is expressed as the
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remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained
after 15 minutes treatment with Montelukast dicyclohexylamine salt compared to the negative control
tissues was 104%. Since the mean relative tissue viability for Montelukast dicyclohexylamine salt was
above 50% Montelukast dicyclohexylamine salt is considered to be non-irritant.
The positive control had a mean cell viability after 15 minutes exposure of 9%. The absolute mean
OD
of the negative control tissues was within the laboratory historical control data range
(See APPENDIX 3). The standard deviation value of the percentage viability of three tissues treated
identically was less than 13%, indicating that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- It is concluded that this test is valid and that Montelukast dicyclohexylamine salt is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
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