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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:
2013
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

Constituent 1
Chemical structure
Reference substance name:
Reaction products of fatty acids, tall oil and fatty acids, C18 unsaturated, trimers and fatty acids, C18 unsaturated, dimers with (9Z)-octadec-9-en-1-amine
EC Number:
942-330-6
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Reaction products of fatty acids, tall oil and fatty acids, C18 unsaturated, trimers and fatty acids, C18 unsaturated, dimers with (9Z)-octadec-9-en-1-amine
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:

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