Registration Dossier
Registration Dossier
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EC number: 614-682-8 | CAS number: 68647-95-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- 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
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted April 2004
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted July 2010
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- adopted May 2008
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- adopted July 2009
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines
- EC Number:
- 614-682-8
- Cas Number:
- 68647-95-0
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines
- Details on test material:
- - Name of test material (as cited in study report): Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines
- Physical state: highly viscous liquid
- Analytical purity: The test item is a complex mixture of isomers and homologues components, so no purity can be stated. (For details see analytical report BASF study-No.: 11S05363)
- Purity test date: 2012-08-08
- Lot/batch No.: BI514173
- Expiration date of the lot/batch: 2013-04-18
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- other: human-derived keratinocyte cell line
- Details on test animals or test system and environmental conditions:
- Three dimensional human epidermis model Epi-200
- Source: MatTek in vitro Life Science Laboratories, Bratislava, Slovakia
- Culture Medium: DMEM
- Cell death detection agent: 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) (MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia / Sigma,Germany)
- duplicate cultures (corrosion test), triplicate cultures (irritation test)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative controls: De-ionized water (corrosion test), PBS (irritation test); Positive controls: 8-n potassium hydroxide solution (corrosion test), 5% (w/v) sodium dodecyl sulfate (irritation test)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50µl (corrosion test), 30µl (irritation test)
- A nylon mesh was used to ensure homogenous distribution of positive and negative control substances, but was not required for the test substance - Duration of treatment / exposure:
- Corrosion test: 3min (room temperature), 1h (incubator)
Irritation test: 25 min (room temperature) + 35 min (incubator) = 1h overall exposure - Details on study design:
- Washing
- with PBS at the end of exposure
Post-incubation period: app. 42h, only irritation test
MTT incubation
- Time: after removal of the test substance (corrosion test) or after the post-incubation period (irritation test) for 3h
- Formazan detection: extraction using isopropanol, measurement of optical density at 570nm
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: cell survival
- Time point:
- other: 3min
- Remarks on result:
- other: 86% (not corrosive)
- Irritation parameter:
- other: cell survival
- Time point:
- other: 1h
- Remarks on result:
- other: 88% (not corrosive)
- Irritation parameter:
- other: cell survival irritation
- Basis:
- mean
- Time point:
- other: 1h
- Remarks on result:
- other: 5% (irritating)
Any other information on results incl. tables
The test substance is not able to reduce MTT directly.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
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