Registration Dossier
Registration Dossier
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EC number: 617-694-1 | CAS number: 85261-19-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23-02-2017 to 12-05-2017
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- Adopted 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-methyl-N-[(2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl]nonanamide
- EC Number:
- 617-694-1
- Cas Number:
- 85261-19-4
- Molecular formula:
- C16H33NO6
- IUPAC Name:
- N-methyl-N-[(2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl]nonanamide
- Test material form:
- solid
- Details on test material:
- sample no. MTDID 48740
MEGA 9: 98.1 % (GC)
Water content: 0.3%
pH (aqueous solution 1%): 7.5
Expiry Date: 2017-12
Product Nr: MTDID 48740
Batch: 549612
Constituent 1
- Specific details on test material used for the study:
- Storage: room temperature
Description: White powder
Expiry date: 2017-12
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Vehicle:
- water
- Details on test system:
- This study is designed based on MatTek protocol "in vitro EpidDerm skin corrosion test". EpiDerm TM tissue, Lot 25700 Kit P, were received from MatTek Corporation (Ashland, MA) on 28 Feb 2017 and refrigerated at 2-8 °C. Before use, tissue were incubated (37°C +/- 1 °C, 5% +/- 1% CO2) with assay medium (Mat Tek) for a one-hour equilibration. Equilibration medium was replaced with fresh medium before dosing.
25 mg of the test item, plus 25 µl H2O were applied to the top of each EpiDerm tissue. The test article remained in contact with the EpiDerm tissue for 3 and 60 minutes. A negative control (H2O) and a positive control (50 µl of KOH) were tested in the same manner (all treatments were conducted in duplicates).
At the end of the exposure period, each EpiDerm tissue was rinsed with PBS and transferd to a 24-well microplate containing 300 µl MTT solution (1 mg/ml MTT in DMEM). The tissues were then returned to the incubator for a 3-hour MTT incubation period. Following the MTT incubation period, each Epiderm tissue was rinsed with PBS and then treated overnight with 2.0 ml of extractant solution (isopropanol) per well. The absorbency of an aliquot of the extracted MTT formazan was measured in triplicate at 540 nm usin a microplate reader (µQuant Plate Reader, bio-Tek Instruments, Winooski, VT).
The direct reduction of MTT by the test item was investigated in advance and revealed that the test item did not reduce MTT. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg of the test Item, plus 25 µl of TCh2O, were applied to the top of each EpiDerm tissue.
- Duration of treatment / exposure:
- 3 and 60 minutes
- Number of replicates:
- each group in duplicate (test item positive and negative control)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 min
- Run / experiment:
- mean (Test item)
- Value:
- 90.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 min
- Run / experiment:
- mean (test item)
- Value:
- 30.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 min
- Run / experiment:
- mean (negative control)
- Value:
- 100
- Vehicle controls validity:
- valid
- Remarks:
- Water
- Negative controls validity:
- valid
- Remarks:
- Water
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 min
- Run / experiment:
- mean (negative control)
- Value:
- 100
- Vehicle controls validity:
- valid
- Remarks:
- Water
- Negative controls validity:
- valid
- Remarks:
- Water
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 min
- Run / experiment:
- mean (positive control)
- Value:
- 31
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Potassium Hydroxide Solution
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean (positive control)
- Value:
- 1.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Potassium Hydroxide Solution
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
| Test and Control article | Mean Viability (3 min) | Mean viability (60 min) | Predicted corrosivity |
| test item | 90.2% | 30.1% | Non-Corrosive |
| Tissue culture water (negative control) | 100.0% | 100.0% | Non-Corrosive |
| Potassium hydroxide Solution, 8.0N (positive control) | 31.0% | 1.7% | Corrosive |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- non-corrosive
- Executive summary:
To predict the skin corrosivity potential of the test item In vitro skin corrosion: reconstructed human epidermis (RHE) test method was used according to OECD test guidline 431. This study is designed based on MatTek protocol "in vitro EpidDerm skin corrosion test". 25 mg of the test item, plus 25 µl H2O were applied to the top of each EpiDerm tissue. The test article remained in contact with the EpiDerm tissue for 3 and 60 minutes. A negative control (H2O) and a positive control (50 µl of KOH) were tested in the same manner (all treatments were conducted in duplicates). The viability of the tiseues after the incubation period were measured by using MTT. The light absorption of the extracted MTT from each sample was measured at 54 nm using a microplate reader. Th emean absorbance value for each time point was calculated from the optical density (OD) of the duplicate tissues and expressed as precent viability for each sample using following formula:
% viability= 100 x (ODsample/OD negative)
Based on following results and according the prediction model for EpiDerm (OECD TG 431) the test item is considered to be non-corrosive.
Test and Control Article Identity Mean viability (3 min.) Mean viability (60 min.) Predicted Corrosivity Test Item 90.2 % 30.1 % Non-Corrosive Negative control (H2O) 100 % 100 % Non-Corrosive Positive Control (KOH) 31.0 % 1.7 % Corrosive
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