Registration Dossier
Registration Dossier
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EC number: 942-330-6 | CAS number: -
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
- Year:
- 2 013
- Report date:
- 2013
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:
- Reaction products of Fatty acids, tall-oil, compds. with oleylamine and Fatty acids, C18-unsatd., trimers, compds. with oleylamine
- EC Number:
- 942-330-6
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Reaction products of Fatty acids, tall-oil, compds. with oleylamine and Fatty acids, C18-unsatd., trimers, compds. with oleylamine
- Details on test material:
- - Name of test material (as cited in study report): Reaction mass of Fatty acids, tall-oil, compds. with oleylamine and Fatty acids, C18-unsatd., trimers, compds. with oleylamine
- Physical state: liquid
- Analytical purity:
- Purity test date:
- Lot/batch No.: D987-AM-202011
- Expiration date of the lot/batch:
- Storage condition of test material:
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 to ensure homogenous distribution 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
- OD570 values for the test substance had to be corrected because of its ability to directly reduce MTT. For this, a freeze killed tissue sample each was treated with the test substance or the negative control in the same way as all other samples.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- irritation test
- Run / experiment:
- exposure period of 1 hour with about 42 hours post-incubation
- Value:
- 6
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- corrosion test
- Run / experiment:
- exposure period of 3 minutes or 1 hour
- Value:
- 94
Applicant's summary and conclusion
- Interpretation of results:
- irritating
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