Registration Dossier
Registration Dossier
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EC number: 800-003-4 | CAS number: 1415316-96-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Version / remarks:
- Feb. 2015
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EU) 2017/735, B.60
- Version / remarks:
- Feb. 2017
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
Test material
- Reference substance name:
- Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine
- EC Number:
- 800-003-4
- Cas Number:
- 1415316-96-9
- IUPAC Name:
- Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0012652167 (BASF SE)
- Expiration date of the lot/batch: September 24, 2017
- Purity test date: 2016-09-13
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: guaranteed by sponsor
- Solubility and stability of the test substance in the solvent/vehicle: no vehicle used
In vitro test system
- Details on the study design:
- Skin sensitisation (In vitro test system) - Details on study design:
Dose selection: In a pre-test, the concentration of the substance was determined, which leads to a reduction in viability to 75% (measured via MTT reduction). The highest tested concentration in the 1st main experiment was chosen to be 1.2² fold of this concentration. The additional concentrations were obtained by a 1:1.2 serial dilution series of the maximum concentration.
The following concentrations of the test substance as provided (i.e., containing 45.5% water) were tested: 27, 32, 39, 46, 56, 67, 80, 96µg/mL
Cell line: Human transgenic keratinocyte cell line derived from HaCaT cells
number of passages prior to testing: >= 5 < 15
negative control: DL-Lactic acid (LA, CAS no.: 50-21-5), 450 μg/mL in 1% DMSO in culture medium
vehicle control: 1% DMSO in culture medium
positive control: Ethylene glycol dimethacrylate (EGDMA, CAS no. 97-90-5), 18 μg/mL in 1% DMSO in culture medium
number of replicates: 3
number of independent experiments: 2
Incubation: 48h in incubator under standard culture conditions
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Run / experiment:
- other: 1, all concentrations
- Parameter:
- other: luciferase induction
- Value:
- 0.95
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Run / experiment:
- other: 2, all concentrations
- Parameter:
- other: luciferase induction
- Value:
- 0.66
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Result: negative. The study alone is insufficient for classification.
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