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EC number: 215-724-4 | CAS number: 1390-65-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- The LuSens cell line was specially designed for this test system by the BASF SE (Lud-wigshafen, Germany). It employs the use of a luciferase reporter gene placed under the control of the antioxidant response element (ARE) and hence monitors Nrf-2 transcription factor activity. For designing this cell line, a human keratinocyte cell line (provided by RWTH, Aachen, Germany) was transfected with the pGL4.20 [luc2/Puro] vector (Promega, Germany) carrying the regulatory antioxidant response element (ARE) upstream of the luciferase gene (Luc2, Promega, Germany) at the Institute of Anatomy and Cell Biology of the RWTH, Aachen (laboratory of PD Dr. Wruck).
Test material
- Reference substance name:
- Carmine
- EC Number:
- 215-724-4
- EC Name:
- Carmine
- Cas Number:
- 1390-65-4
- Molecular formula:
- C22H20O13
- IUPAC Name:
- Carmine
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- In accordance with the OECD guideline 442D (draft version 21. Dec. 2017), the maximum final test item concentration should be 2000 µM. For a test chemical which has no de-fined molecular weight, the final test item concentration 2000 µg/mL can also be used. Alternative concentrations may be used upon justification (e.g. in case of cytotoxicity or poor solubility).
In the case of a cytotoxic result, the concentrations for experiment III and IV should be determined so that at least one of them is in the cytotoxic range.
Since a cytotoxic reaction was observed in the CRFT the following 12 nominal concentra-tions were chosen for experiment III and VI:
7.81 µM, 9.37 µM, 11.25 µM, 13.50 µM, 16.19 µM, 19.43 µM, 23.32 µM, 27.98 µM, 33.58 µM, 40.30 µM, 48.36 µM, 58.03 µM
Results and discussion
- Positive control results:
- Name: EGDMA (Ethylene glycol dimethylacrylate)
CAS no.: 97-90-5
Solvent: DMSO
Supplier: Sigma-Aldrich
Purity: 98 %
Lot no.: SHBG0572V
Expiry Date: 27. Jan. 2021
Final concentration: 120 µM
Storage: Fridge
Stability: Stable under specified storage conditions
The solution was freshly prepared on the day of the experiment.
All control substances indicated the expected effect. No considerable reduction of the viability was detected (all values ≥ 86 %). Regarding the Luciferase induction, the growth control and the negative control did not exceed the threshold of 1.5 fold in comparison to the solvent control (growth control: 1.3 fold, negative control: 1.0 fold). However, the posi-tive control induced a clear effect with an induction value of 4.8 fold in comparison to the solvent control.
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: 2000 µM
- Parameter:
- other: Relative viability
- Value:
- 65.1 %
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 500 µM
- Parameter:
- other: Relative Viability
- Value:
- 73.7 %
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 125 µM
- Parameter:
- other: Relative Viability
- Value:
- 58.8 %
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 31.25 µM
- Parameter:
- other: Relative Viability
- Value:
- 55.2 %
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 1.95 µM
- Parameter:
- other: Relative Viability
- Value:
- 83 %
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Prior to routine use, the validity of the LuSens test at LAUS GmbH was demonstrated in a proficiency study. In this study, 22 proficiency chemicals (indicated by the OECD 442D guideline as well as the OECD PERFORMANCE STANDARDS FOR ASSESSMENT OF PROPOSED SIMILAR OR MODIFIED IN VITRO SKIN SENSITISATION ARE-NRF2 LU-CIFERASE TEST METHODS) were tested. As prescribed by the guidelines, more than 80 % (96 %) of the results were correctly categorized. Therefore, the proficiency of the LuSens test was demonstrated
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The induction triggered by the negative control and growth control should be < 1.5 fold as compared to the induction of the solvent control and the viability should be above 70%.
- Acceptance criteria met for positive control: The average induction for the positive control should be ≥ 2.5 fold and it should have a rela-tive viability of at least 70 %.
- Acceptance criteria met for variability between replicate measurements: The average percentage standard deviation (luciferase induction) of the variability in at least 21 solvent control wells should be below 20 %.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, it can be stated that under the experimental conditions of this study, the test item, CARMINE LAKE, was negative in the LuSens assay and is therefore considered not to have the potential to activate the Nrf2 transcription factor (no sensitizing po-tential).
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