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EC number: 278-601-4 | CAS number: 77061-58-6
- 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
- Study period:
- 08 Sep 2014 to 13 May 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
- Principles of method if other than guideline:
- The objective was to assess the skin sensitizing potential of Vibracolor ruby red. A combination of several in vitro methods addressing key events of the adverse outcome pathway (AOP) for skin sensitization1 as defined by the OECD, were part of this in vitro Skin Sensitization Turnkey Testing Strategy:
*protein reactivity (DPRA),
*activation of keratinocytes (LuSens), and
*activation of dendritic cells (h-CLAT).
There are no official national or international guidelines for In Vitro Sensitization; however, the studies were performed according to the methods described in the following publications:
*Bauch C, Kolle SN, Fabian E, Pachel C, Ramirez T, Wiench B, Wruck CJ, van Ravenzwaay B, Landsiedel R. Intralaboratory validation of four in vitro assays for the prediction of the skin sensitizing potential of chemicals. Toxicology in Vitro 25, 1162 –1168, 2011.
*Maxwell G, Aeby P, Ashikaga T, Bessou-Touya S, Diembeck W, Gerberick F, Kern P, Marrec-Fairley M, Ovigne JM, Sakaguchi H, Schroeder K, Tailhardat M, Teissier S, Winkler P. Skin sensitisation: the Colipa strategy for developing and evaluating nonanimal test methods for risk assessment. ALTEX 28(1): 50-5, 2011.
*Bauch C, Kolle SN, Ramirez T, Eltze T, Fabian E, Mehling A, Teubner W, van Ravenzwaay B, Landsiedel R, (2012), Putting the parts together: Combining in vitro methods to test for skin sensitizing potentials, Regul Toxicol Pharmacol, 63(3):489-504.
*Urbisch D, Mehling A, Guth K, Ramirez T, Honarvar N, Kolle SN, Landsiedel R, Jaworska J, Kern P, Gerberick F, Natsch A, Emter R, Ashikaga T, Miyazawa M, Sakaguchi H. Assessing skin sensitization hazard in mice and men using non-animal test methods. Regulatory Toxicology and Pharmacology 71(2), 135-352. 2015.
For the DPRA test the following publications apply additionally:
The study is conducted based on the following draft test guideline:
*oECD: Draft Proposal for a New Guideline on In Vitro Skin Sensitization: Direct Peptide Reactivity Assay (DPRA), accessed on 13 Nov 2013 at http://www.oecd.org
In addition the study is performed according to the methods described in the following
publications:
*Gerberick GF, Vassallo JD, Bailey RE, Chaney JG, Morrall SW, Lepoittevin JP. Development of a Peptide Reactivity Assay for Screening Contact Allergens. Toxicological Sciences 81,332-343, 2004.
*Gerberick GF, Vassallo JD, Foertsch LM, Price BB, Chaney JG, Lepoittenvin JP. Quantificationn of Chemical Peptide Reactivity for Screening Contact Allergens: A Classification Tree Model Approach. Toxicological Sciences 97(2), 417-427, 2007.
Based on the results of an ECVAM (European Center for Validation of Alternative Methods) led validation study on the DPRA, it was concluded by the EURL (EU Reference Laboratory for Alternatives to Animal Testing) ECVAM Scientific Advisory Committee (ESAC) that the DPRA is suitable to be used in a weight-of-evidence approach or integrated testing strategy for distinguishing between skin sensitizers and non-skin sensitizers (ECVAM: EURL ECVAM Recommendation on the Direct Peptide Reactivity Assay (DPRA) of 12 Dec 2013).
For the LuSens the following publications apply additionally:
The study is conducted based on the following draft test guideline:
*OECD: Draft Proposal for a New Guideline on In Vitro Skin Sensitization: In vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method, accessed on 03 Sep 2014 at http://www.oecd.org
In addition the study is performed according to the methods described in the following publications:
*Ramirez T, Mehling A, Kolle SN, Wruck CJ, Teubner W, Eltze T, Aumann A, Urbisch D, Ravenzwaay BV, Landsiedel R.., LuSens: A keratinocyte based ARE reporter gene assay for use in integrated testing strategies for skin sensitization hazard identification. Toxicol In Vitro. 2014 Dec;28(8).
For the h-CLAT test the following publications apply additionally:
The study is conducted based on the following draft test guideline:
*OECD: Draft Proposal for a New Guideline on In Vitro Skin Sensitization: human Cell Line Activation Test (h-CLAT), accessed on 01 Sep 2014 at http://www.oecd.org
In addition the study is performed according to the methods described in the following publications:
*Ashikaga T, Sakaguchi H, Sono S, Kosaka N, Ishikawa M, Nukada Y, Miyazawa , Ito Y, Nishiyama N, Itagaki H. (2010) A comparative evaluation of in vitro skin sensitisation tests: the human cell-line activation test (h-CLAT) versus the local lymph node assay (LLNA). Altern Lab Anim. 38(4):275-84.
*sakaguchi H, Ryan C, Ovigne JM, Schroeder KR, Ashikaga T. (2010) Predicting skin sensitization potential and inter-laboratory reproducibility of a human Cell Line Activation Test (h-CLAT) in the European Cosmetics Association (COLIPA) ring trials. Toxicol In Vitro. 24(6):1810-20. - GLP compliance:
- yes
- Type of study:
- other: Study investigating: protein reactivity (DPRA), activation of keratinocytes (LuSens), activation of dendritic cells (h-CLAT).
Test material
- Reference substance name:
- 2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- EC Number:
- 278-601-4
- EC Name:
- 2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- Cas Number:
- 77061-58-6
- Molecular formula:
- C13H18N5.Cl
- IUPAC Name:
- 2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Name of test substance: Vibracolor ruby red
Test-substance No.: 10/0383-3
Batch identification: 0009051093
CAS No.: 77061-58-6
Purity: 98% total color (for information see Certificate of Analysis no. 4186 in the appendix)
Homogeneity: The test substance is homogeneous by visual inspection.
Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
ADDITIONAL TEST-SUBSTANCE INFORMATION
Molecular weight: 279.77 g/mol.
Physical state / color: solid / violet
In vitro test system
- Details on the study design:
- DPRA:
Synthetic peptides:
Cysteine- (C-) containing peptide: Ac-RFAACAA-COOH (MW=751.9 g/mol)
Lysine- (K-) containing peptide: Ac-RFAAKAA-COOH (MW=776.2 g/mol)
The peptides are custom material (Supplier: GenScript, Piscataway, NJ, USA and RS Synthesis, Louisville KY, USA) containing phenylalanine to aid in detection and either cysteine or lysine as the reactive centre.
LuSens:
Cell line: LuSens
transgenic keratinocyte cell line derived from HaCaT cells, prepared in collaboration with Christoph J. Wruck, RWTH Aachen
h-CLAT:
Cell line: THP-1 cells
The human monocytic leukemia cell line was obtained from “American Type Culture Collection, Manassas, USA” (ATCC, TIB-202).
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: Direct Peptide Reactivity Assay (DPRA); cysteine peptide depletion
- Parameter:
- other: EC 6.38% (the concentration resulting in a mean peptide depletion of 6.38%)
- Value:
- 4.24
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The EC 6.38% was calculated to be 4.24 mM
- Key result
- Run / experiment:
- other: Direct Peptide Reactivity Assay (DPRA); lysine peptide depletion
- Parameter:
- other: EC 6.38% (the concentration resulting in a mean peptide depletion of 6.38%)
- Value:
- 7.93
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The EC 6.38% was calculated to be 7.93 mM
- Key result
- Run / experiment:
- other: Keratinocyte Activation Assay - LuSens
- Parameter:
- other: EC1.50
- Value:
- 0.24
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- In at least two consecutive concentrations of at least two independent experiments ARE-dependent luciferase activity induction above 1.50-fold of statistic significance at test substance concentrations that did not reduce-cell viability below 70% was observed. EC1.50 was calculated to be 0.24 μg/mL
- Key result
- Run / experiment:
- other: Dendritic Cell Line Activation Assay Human Cell Line Activation Test (h-CLAT)
- Parameter:
- other: EC150 for CD86
- Value:
- 6.04
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The EC150 for CD86 was calculated to be 8.3 μg/mL or 6.04 μg/mL.
- Key result
- Run / experiment:
- other: Dendritic Cell Line Activation Assay Human Cell Line Activation Test (h-CLAT)
- Parameter:
- other: The EC200 for CD54
- Value:
- 5.68
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The EC200 for CD54 was calculated to be 5.68 μg/mL and 5.79 μg/mL, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Vibracolor ruby red is peptide reactive, activates keratinocytes and activates dendritic cells. Applying the evaluation criteria Vibracolor ruby red is predicted to be a skin sensitizer.
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