Registration Dossier
Registration Dossier
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EC number: 308-415-1 | CAS number: 97953-16-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 June 2017 - 20 July 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- July 29, 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized
- EC Number:
- 308-415-1
- EC Name:
- 9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized
- Cas Number:
- 97953-16-7
- IUPAC Name:
- 9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDerm™ Kit
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 ± 2 mg (39.7 mg/cm2 according to guideline)
- Duration of treatment / exposure:
- 3 min or 1 hour
- Number of replicates:
- Duplicate
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute exposure
- Value:
- 107.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour exposure
- Value:
- 92.3
- 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 acceptance criteria are met:
• the mean OD of the tissue replicates treated with the negative control is ≥ 0.8 and ≤ 2.8 for every exposure time (range: 1.369 to 1.766)
• the mean viability of the tissue replicates treated with the positive control for 1 hour, is <15% compared to the negative control (4.8%)
• the Coefficient of Variation (CV) in the range 20 – 100% viability between tissue replicates is ≤ 30% (range: 2.5% to 9.1%)
Any other information on results incl. tables
Results after treatment with the substance and the controls
| Dose Group |
Exposure Interval |
Mean Absorbance (OD) of 2 Tissues |
CV [%] |
Mean Rel. Absorbance [%]** |
| Negative Control |
3 minutes | 1.388 | ||
| Positive Control |
0.298 | |||
| Test Item | 1.487 | |||
| Negative Control |
60 minutes | 1.683 | ||
| Positive Control |
0.080 | |||
| Test Item | 1.553 |
3 Minutes Treatment Historical Data:
| Positive Control | Negative Control | ||
| Mean Viability [%] | 22.65 | Mean OD | 1.67 |
| Stand. Dev. | 8.84 | Stand. Dev. | 0.13 |
| Range of Viabilities [%] | 4.60 – 39.83 | Range of ODs | 1.34 – 1.93 |
60 Minutes Treatment Historical Data:
| Positive Control | Negative Control | ||
| Mean Viability [%] | 6.72 | Mean OD | 1.64 |
| Stand. Dev. | 3.01 | Stand. Dev. | 0.15 |
| Range of Viabilities [%] | 2.30 – 14.77 | Range of ODs | 1.32 – 1.85 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not considered to be corrosive.
- Executive summary:
An in vitro study was performed to assess the corrosive potential of the substance by means of the Human Skin Model Test with EpiDerm™ tissues models. Exposure to the positive control induced a decrease in the relative absorbance as compared to the negative control, both for the 3 minutes exposure period (21.4%) and for the 1 hour exposure period 4.8%) thus confirming the validity of the test system and the specific batch of tissue models. After 3 minutes exposure to the substance the relative absorbance value was not reduced (107.1%). After 1 hour exposure the relative absorbance value decreased to 92.3%. Both values did not exceed the threshold for corrosivity which is defined to be 50% after the 3 minutes exposure and 15% after the 1 hour exposure. Therefore, the substance is not considered to be corrosive.
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