Registration Dossier
Registration Dossier
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EC number: 272-379-2 | CAS number: 68815-51-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
- EC Number:
- 272-379-2
- EC Name:
- 9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
- Cas Number:
- 68815-51-0
- Molecular formula:
- C18 H34 O2 . C4 H12 N2 O
- IUPAC Name:
- 2-(2-aminoethylamino)ethanol; (Z)-octadec-9-enoic acid
- Details on test material:
- - Name of test material (as cited in study report): Kerocom F 100 Test-substance No.: 07/0395-1
- Analytical purity: 100%
- Purity test date: 18.06.07
- Lot/batch No.: GV33754-L2927
- Stability under storage conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: room temperature
- Homogeneity: The test substance was homogeneous by visual inspection.
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- 93
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h exposure
- Value:
- 95
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Findings:
Exposure: 3 min |
||||||
Test-article |
OD570 tissue 1 |
OD570 tissue 2 |
OD570 kc |
mean OD570 |
mean OD570 kc-corrected |
viability [% of negative ctrl] |
negative ctrl |
1.950 |
1.688 |
0.136 |
1.819 |
- |
100 |
07/0395-1 |
1.623 |
1.761 |
0.158 |
1.692 |
- |
93 |
positive ctrl |
0.289 |
0.444 |
- |
0.366 |
- |
20 |
kc: killed control for MTT reduction control
OD: optical density
Exposure: 1 h |
||||||
Test-article |
OD570 tissue 1 |
OD570 tissue 2 |
OD570 kc |
mean OD570 |
mean OD570 kc-corrected |
viability [% of negative ctrl] |
negative ctrl |
1.850 |
1.839 |
0.191 |
1.844 |
- |
100 |
07/0395-1 |
1.788 |
1.700 |
0.181 |
1.744 |
- |
95 |
positive ctrl |
0.122 |
0.174 |
- |
0.148 |
- |
8 |
kc: killed control for MTT reduction control
OD: optical density
Due to the ability of the test substance to reduce MTT directly, a KC was introduced. However, the result of the KC did not indicate an increased MTT reduction; therefore the KC was not used for viability calculation.
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
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