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Diss Factsheets
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EC number: 942-217-1 | CAS number: -
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04.09.2012 - 07.09.2012
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,4,6(1H,3H,5H)-Pyrimidinetrione, 5,5'-(1,2-diazenediyl)bis-
- Cas Number:
- 25157-64-6
- Molecular formula:
- C8H6N6O6
- IUPAC Name:
- 2,4,6(1H,3H,5H)-Pyrimidinetrione, 5,5'-(1,2-diazenediyl)bis-
- Test material form:
- solid: crystalline
- Details on test material:
- Red solid powder
Constituent 1
Test animals
- Species:
- other: in vitro - tissues
Test system
- Details on study design:
- Principle:The test consists of a topical exposure of the neat test chemical to a reconstructed human epidermis (RhE) model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT [(3-4,5-dimethyl thiazole 2-yl) 2,5-diphenyltetrazoliumbromide], present in cell mitochondria, into a blue formazal salt that is quantitatively measured after extraction from tissues. The reduction of the viability of tissues exposed tochemicals in comparison to negative controls (treated with PBS) is used to predict the skin irritation potential. Evaluation is determined by measuring of optical density (OD) of the formazan, extracts using a spectrophotometer at 570 nm. Relative cell viability is calculated for each tissue as % of the mean OD value of the negative control tissues. Skin irritation potential of the test material is predicted if the remaining relative cell viability is below 50 %.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: average viability
- Run / experiment:
- MTT OD570
- Value:
- > 1.689 - < 1.727
- Remarks on result:
- other:
- Remarks:
- Time point: 45 h. Reversibility: other: not relevant. Remarks: average viability = 88.8%. (migrated information)
Any other information on results incl. tables
MTT test
The test substance (25 mg) was placed directly atop to the tissue previously moistened with 25 pl of PBS. The material was then spread on the tissue surface. Tissues were exposed to the test chemical for 1 hour. After exposition, tissues were thoroughly rinsed and blotted to remove the test substance. Then, tissues were let to post-incubate for 24 (medium exchange) + 18 hours (37+1oC,1LIYI CO2, moistened).
After exposition, tissues were slightly coloured yellow; the yeliow colour was not observed after post-incubation.
Afterwards, the MTT assay was performed by transferring the tissues to 24-well plates containing MTT medium (1 mg/ml). After 3 hour MTT incubation, the blue formazan salt formed by cellular mitochondria was extracted with 2.0 ml/tissue of isopropanol and the optical density of the extracted formazan was determined using a spectrophotometer at 570 nm. ODszo measuring was performed after 2-hour extraction with shaking. Results are given in the Table.
treatment | parameter | OD570 | mean | SD | average viability (% NC) | ||
1 | 2 | 3 | |||||
NC (PBS) | OD570 | 1.946 | 1.975 | 2.036 | 1.986 | 0.038 | |
viability | 98.00 | 99.46 | 102.53 | 100.0 | 1.89 | 100.0 | |
C1 (178/12) | OD570 | 1.689 | 1.874 | 1.727 | 1.763 | 0.080 | |
viability | 85.06 | 94.38 | 86.97 | 88.8 | 4.2 | 88.8 | |
PC (5% SDS) | OD570 | 0.217 | 0.13 | 0.188 | 0.178 | 0.036 | |
viability | 10.93 | 6.55 | 9.47 | 8.98 | 1.82 | 8.98 | |
Notes: | |||||||
NC | negative control | ||||||
PC | positive control | ||||||
Cl | test substance | ||||||
mean | arithmetic mean | ||||||
SD | standard deviation calculated from individualyo tissue viabilities | ||||||
viability (%) | viability of single tissues compared with negative control |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the above-described experimental design, average viability of tissues treated by the test substance was 88.8 % of negative control average value, i.e. viability was >50 %.The effect of test substance was negative in EpiDerm'* model.
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