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EC number: 219-210-0 | CAS number: 2387-03-3
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data is from BASF study reports
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The objective was to assess the potential for skin irritation of the test material upon first contact with skin. The assessment of the skin irritation potential is included in international regulatory requirements for the testing of chemicals. Due to animal welfare reasons skin irritation was determined using the reconstructed human epidermal model EpiDermTM.The present test is based on the experience that irritant chemicals produce cytotoxicity in human reconstructed epidermis after a 1-hour topical exposure and about 42 hours postincubation.The test is designed to predict skin irritation potential of a chemical by using the three dimensional human epidermis model EpiDermTM. After application of the test material to the stratum corneum surface of the EpiDermTM tissue the induced cytotoxicity (=loss of viability) is measured by a colorimetric assay. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity. The mitochondrial dehydrogenase reduces the yellow colored water-soluble 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) to the insoluble blue colored formazan. After isopropanol extraction of the formazan from the tissue the optical density of the extract is determined spectrophotometrically. Optical density of the extracts of test-item treated tissues is compared to negative control values from tissue treated with PBS and expressed as relative tissue viability.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-hydroxynaphthalene-1-carbaldehyde [(2-hydroxy-1-naphthyl)methylene]hydrazone
- EC Number:
- 219-210-0
- EC Name:
- 2-hydroxynaphthalene-1-carbaldehyde [(2-hydroxy-1-naphthyl)methylene]hydrazone
- Cas Number:
- 2387-03-3
- Molecular formula:
- C22H16N2O2
- IUPAC Name:
- 1,1'-(hydrazine-1,2-diylidenedimethylylidene)di(2-naphthol)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):Pigment Yellow 101 (Chemical Name: 2-hydroxynaphthalene-1-carbaldehyde [(2-hydroxy-1-naphthyl)methylene]hydrazone)- Molecular formula (if other than submission substance):C22H16N202- Molecular weight (if other than submission substance):340,385g/mol- Smiles notation (if other than submission substance):Oc1c(c2c(cccc2)cc1)\C=N\N=C\c1c2c(cccc2)ccc1O- InChl (if other than submission substance):1S/C22H16N2O2/c25-21-11-9-15-5-1-3-7-17(15)19(21)13-23-24-14-20-18-8-4-2-6-16(18)10-12-22(20)26/h1-14,25-26H/b23-13+,24-14+- Substance type:Organic- Physical state:Solid- Lot/batch No.:29010809T0- Analytical purity:100%- Storage condition of test material:The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: not applicable
Test system
- Type of coverage:
- other: reconstructed three dimensional human epidermis model (EpiDerm™)
- Preparation of test site:
- other: incubation
- Vehicle:
- other: sterile PBS
- Controls:
- yes
- Amount / concentration applied:
- 25 μL bulk volume (about 8 mg) CONTROLS:Negative control (NC): PBS, sterilePositive control (PC): 5% (w/v) sodium dodecyl sulfate (SDS, Sigma, Germany) in highly de-ionized water, sterile
- Duration of treatment / exposure:
- 1 hour
- Observation period:
- 42 hours
- Number of animals:
- Three dimensional human epidermis model
- Details on study design:
- EXPERIMENTAL PROCEDURE:Mesh compatibility:For liquid test items a nylon mesh can be used as a spreading support. However, this was not necessary for the solid test item.Thus no pretest for mesh compatibility was performed.Direct MTT reduction:To assess the ability of the test material to directly reduce MTT a pretest was performed as described below.Approximately 25 μL bulk volume of the test item was added to 0.9 mL of the MTT solution.The mixture was incubated in the dark at about 37 °C for 55 to 65 minutes. A negative control (50 μL of highly de-ionized water) was tested concurrently. If the MTT solution color or, in case of water-insoluble test items the border to the waterphase,turned blue / purple, the test item was presumed to directly reduce MTT.The direct reduction of MTT by a test item interferes with the color density produced by metabolic capacity of the tissue and would falsify the test results.In case that direct MTT reduction occurred and visible residues of the test item remained on the tissues after washing, subsequent testing of killed controls (one freeze-killed control tissue (KC)) was considered. Killed controls are treated with, each, the test article and the negative control, in the same way as described in section “Basic procedure” (3.6.3),additionally.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Mean tissue viability(% of negative control)
- Basis:
- mean
- Time point:
- other: 42 hrs.
- Reversibility:
- no data
- Remarks on result:
- other: > 50 % -non-irritant
Any other information on results incl. tables
FINDINGS:
Test article |
| tissue 1 | tissue 2 | tissue 3 | mean | SD |
NC | mean OD570 | 1.9402 | 1.8402 | 1.8907 | 1.8903 |
|
| viability [% of NC] | 102.6 | 97.3 | 100.0 | 100 | 2.65 |
01/0031-2 | mean OD570 | 2.0252 | 1.5387 | 1.6927 | 1.7522 |
|
| viability [% of NC] | 107.1 | 81.4 | 89.5 | 93 | 13.15 |
PC | mean OD570 | 0.1067 | 0.1237 | 0.1212 | 0.1172 |
|
| viability [% of NC] | 5.6 | 6.5 | 6.4 | 6 | 0.49 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Based on the observed results and applying the evaluation criteria it was concluded, that Pigment Yellow 101 (chemical name: 2-hydroxynaphthalene-1-carbaldehyde [(2-hydroxy-1-naphthyl)methylene]hydrazone, CAS No 2387-03-3) does not show a skin irritation potential in the EpiDermTM skin irritation test under the test conditions chosen.
- Executive summary:
The potential of Pigment Yellow 101 to cause dermal irritation was assessed by a single topical application of 25 μL bulk volume (about 8 mg) of the test item to a reconstructed three dimensional human epidermis model (EpiDerm™).
Three EpiDerm™ tissue samples were incubated with the test item for 1 hour followed by a 42-hours post-incubation period.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/ post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as suitable endpoint. The formazan production of the test item treated epidermal tissues is compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability.
The EpiDerm skin irritation test showed the following results:
The test item is not able to reduce MTT directly.
The mean viability of the test-item treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 93%.
Based on the observed results it was concluded, that Pigment Yellow 101 does not show a skin irritation potential in the EpiDerm™ skin irritation test under the test conditions chosen.
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