Registration Dossier
Registration Dossier
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EC number: 212-141-7 | CAS number: 765-14-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-11-03 to 2015-11-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Experimental study according to guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
Test material
- Reference substance name:
- 1-(vinyloxy)dodecane
- EC Number:
- 212-141-7
- EC Name:
- 1-(vinyloxy)dodecane
- Cas Number:
- 765-14-0
- Molecular formula:
- C14H28O
- IUPAC Name:
- 1-(ethenyloxy)dodecane
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- Kits used:
- EpiDerm™ 200 kit (Lot: 23301)
- Source: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia,
- containing: 24 Epi-200 tissues (reconstructed epidermis): surface 0.6 cm² cultured in Millicells® ∅ 1 cm
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 30 µL
- Concentration: undiluted - Duration of treatment / exposure:
- 1 h
- Details on study design:
- Please refer to "Any other information on materials and methods".
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 95.7
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 1 h exposure . Reversibility: other: not applicable. Remarks: %, test substance. (migrated information)
- Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 1 h exposure. Reversibility: other: not applicable. Remarks: %, negative control. (migrated information)
- Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 3
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 1 h exposure. Reversibility: other: not applicable. Remarks: %, positive control. (migrated information)
Any other information on results incl. tables
Test substance |
|
Tissue 1 |
Tissue 2 |
Tissue 3 |
Mean |
SD |
CV [%] |
Negative control |
Mean OD570 |
2.33 |
2.267 |
5.599 |
2.399 |
|
|
Viability [% of NC] |
97.1 |
94.5 |
108.3 |
100.0 |
7.3 |
7.3 |
|
Test substance |
Mean OD570 |
2.208 |
2.285 |
2.394 |
2.295 |
|
|
Viability [% of NC] |
92.0 |
95.2 |
99.8 |
95.7 |
3.9 |
4.1 |
|
Positive control |
Mean OD570 |
0.074 |
0.072 |
0.072 |
0.072 |
|
|
Viability [% of NC] |
3.1 |
3.0 |
3.0 |
3.0 |
0.0 |
1.6 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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