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EC number: 814-319-5 | CAS number: 110393-28-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-10-10 to 2017-10-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals No. 439: In Vitro Skin Irritation: Reconstructed human Epidermis Test Method, 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 640/2012, L 193, Part B.46. “In vitro Skin Irritation: Reconstructed Human Epidermis Test Method” 06-Jul-2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: L’Oréal Standard Operating Procedure: “EpiSkin™ Skin Irritation Test Method“; - ECVAM Skin Irritation Validation Study - Validation of the EpiSkin™ Test Method15 min - 42 hours for the Prediction of Acute Skin Irritation of Chemicals.
- Version / remarks:
- Version 1.8, Feb-2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM DB-ALM Protocol No. 131 “EpiSkin™ Skin Irritation Test15 min – 42 hours. 09-Jun-2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
Test material
- Reference substance name:
- diethyl({3-[(4-nitrophenyl)formamido]propyl})azanium chloride
- EC Number:
- 814-319-5
- Cas Number:
- 110393-28-7
- Molecular formula:
- C14H22N3O3Cl
- IUPAC Name:
- diethyl({3-[(4-nitrophenyl)formamido]propyl})azanium chloride
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Vehicle:
- water
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 1. Negative control 10 µL Dulbecco's phosphate buffered saline
2. Positive control 10 µL 5% sodium dodecyl sulfate solution
3. Test Item 10 ± 2 mg + 10 µL aqua dest. - Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- 42 ± 1 h
- Number of replicates:
- The test was performed on a total of 3 tissues per dose group.
Test system
- Details on study design:
- The test was performed on EpiSkin, an organotypic reconstructed three-dimensional model of the human epidermis. 3 replicate tissues are dosed with the test item, the negative control (10µL DPBS) and the positive control (10µL 5% SDS), respectively. After 15 minutes treatment period at room temperature the test item and the controls are rinsed off with DPBS and the tissues are post-incubated for 42 +/- 1 h. Then the tissues are stained via MTT for 3 hours. Isopropanol extracts are measured photometrically at 570 nm.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 118.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 116.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 116.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 117.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Result of the Test Item N-[3-(Diethylamino)propyl]-4-nitrobenzamide, hydrochloride
Name |
Negative Control |
Positive Control |
Test Item |
||||||
Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
Absolute OD570 |
1.003 |
0.958 |
0.999 |
0.111 |
0.097 |
0.109 |
1.165 |
1.146 |
1.142 |
0.997 |
0.956 |
1.031 |
0.110 |
0.097 |
0.094 |
1.164 |
1.151 |
1.155 |
|
OD570(Blank-Corrected) |
0.961 |
0.916 |
0.956 |
0.069 |
0.054 |
0.066 |
1.123 |
1.103 |
1.100 |
0.955 |
0.914 |
0.989 |
0.068 |
0.055 |
0.052 |
1.122 |
1.108 |
1.113 |
|
Mean OD570Of The Duplicates (Blank-Corrected) |
0.958 |
0.915 |
0.973 |
0.068 |
0.055 |
0.059 |
1.122 |
1.106 |
1.106 |
Total Mean OD570Of 3 Replicate Tissues (Blank-Corrected) |
0.949* |
0.061 |
1.112 |
||||||
SD OD570 |
0.030 |
0.007 |
0.009 |
||||||
Relative Tissue Viabilities [%] |
101.0 |
96.5 |
102.5 |
7.2 |
5.8 |
6.2 |
118.3 |
116.6 |
116.6 |
Mean Relative Tissue Viability [%] |
100.0 |
6.4** |
117.2 |
||||||
SD Tissue Viability [%]*** |
3.2 |
0.7 |
1.0 |
||||||
CV [% Viability] |
3.2 |
11.4 |
0.8 |
||||||
* Corrected mean OD570of the negative control corresponds to 100% absolute tissue viability.
** Mean relative tissue viability of the three positive control tissues is ≤ 40%.
*** Standard deviation (SD) obtained from the three concurrently tested tissues is ≤ 18%.
Applicant's summary and conclusion
- Interpretation of results:
- other: non-irritant
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The relative mean tissue viability after 15 min of exposure and 42 h post-incubation was > 50%. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
- Executive summary:
In the present study theskin irritant potential of N-[3-(Diethylamino)propyl]-4-nitrobenzamide, hydrochloride was analysed. The EPISKIN-Standard Model™ (EPISKIN-SMTM), a reconstituted three-dimensional human epidermis model, was used as a replacement for the Draize Skin Irritation Test (OECD TG 404[8]) to distinguish between UN GHS “Category 2” skin irritating test substances and not categorized test substances (“No Category”) which may be considered as non-irritant. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 15 min exposure and 42 h post-incubation period and compared to those of the concurrent negative controls.The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (117.2%) after 15 min treatment and 42 h post-incubation
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