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EC number: 212-506-0 | CAS number: 822-89-9
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-03-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Remarks:
- No controls are used
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: The diffusion of the test substance through human epidermis was measured via quantitation of the substance in the receptor solution.
- Short description of test conditions: Samples of human epidermis were mounted in glass diffusion cellls over chambers filled with receptor fluid. Test material was applied to the epidermis as a 2% solution in either water or diluted shampoo solution. Half of the cells were occluded for the 30 h exposure, half were occluded for only half an hour. Samples of the receptor solution were taken periodically and analyzed for the test substance.
- Parameters analysed / observed: Samples taken at intervals to measure the amount of test substance in the receptor fluid. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hydroxyl-2-pyridone
- EC Number:
- 212-506-0
- EC Name:
- Hydroxyl-2-pyridone
- Cas Number:
- 822-89-9
- Molecular formula:
- C5H5NO2
- IUPAC Name:
- 1-hydroxy-1,2-dihydropyridin-2-one
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Certificate of Analysis Reference: 9173
- Analytical purity: 99.6% w/w
- Expiration date: not reported
- Storage condition: not reported
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not reported
- Stability under test conditions: not reported
- Solubility and stability of the test substance in the solvent/vehicle: not reported
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not reported - Radiolabelling:
- no
Test animals
- Species:
- other: Human
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No details on source
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: Water or 5% v/v Commercially available shampoo
- Remarks:
- The shampoo is a straw coloured liquid (Pears Deep Cleansing Shampoo).
- Duration of exposure:
- 1 application, 30 hour exposure. Half of the cells exposed to 2% w/v Oxypyrion in Water and 2% w/v Oxypyrion in Diluted Shampoo were rinsed after 0.5h. After decontamination these membranes were re-occluded for the remainder of the 30h exposure.
- Doses:
- Nominal doses, for both Continuous Exposure and Rinsed Application:
- 2% w/v Oxypyrion in Water
- 2% w/v Oxypyrion in Diluted Shampoo (consisting of 5% v/v shampoo in distilled water) - No. of animals per group:
- 12 epidermis cells per vehicle
- Control animals:
- no
- Details on study design:
- DOSE PREPARATION
- Method for preparation of dose suspensions: Not described
- Method of storage: Not described
APPLICATION OF DOSE: The test material was applied to the epidermal membranes as 2% w/v solutions in water or diluted shampoo at a rate of 200 µL/cm², using 12 cells for each dosing solution.
REMOVAL OF TEST SUBSTANCE
For half of the cells for each application:
- Washing procedures and type of cleansing agent: decontamination by rinsing with 3 x 5 mL distilled water
- Time after start of exposure: 0.5h after start of exposure
ANALYSIS
- Method type(s) for identification: HPLC
- Limits of detection and quantification: 1 µg/mL
- Column: µBondapak phenyl 10 µm; 300 x 3.9 mm id
- Solvent: Methanol:water (5:95 v/v) containing copper (II) nitrate (0.1 % w/v) and citric acid (0.1 % w/v)
- Flow rate: 1 mL/min
- Detector Wavelenght: 300 nm
- Injection volume: 50 µL - Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: Not provided
- Ethical approval if human skin: Not provided
- Type of skin: Not provided
- Preparative technique: Extraneous tissue was removed from human whole skin samples. The skin samples were immersed in water at 60°C for 40-45 seconds and the epidermis teased off the dermis.
- Thickness of skin (in mm): Not provided
- Membrane integrity check: Samples of epidermis were mounted in glass diffusion cells and their integrity determined by measurment of their permeability to tritiated water (Dugard et al., 1984). Membranes with a calculated permeability coefficient of <1.5 x 10^-3 cm/h were regarded as being undamaged and used for exposure to the test material.
- Storage conditions: Deep frozen until required for use.
- Justification of species, anatomical site and preparative technique: Not provided
PRINCIPLES OF ASSAY
- Diffusion cell: Not described
- Receptor fluid: distilled water
- Solubility of test substance in receptor fluid: Not described
- Static system: Not described
- Flow-through system: Not described
- Test temperature: Not described
- Humidity: Not described
- Occlusion: Not described
- Reference substance(s): Not described
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- - from the 2% w/v in water continuous experiment, one cell was rejected as contamination was suspected to be present
Percutaneous absorptionopen allclose all
- Time point:
- 10 h
- Dose:
- mean absorption rate in water, (2.25-10 hr) continuous exposure
- Parameter:
- rate
- Absorption:
- 5.79 other: µg/cm²/h
- Remarks on result:
- other: Mean absorption rate between 2.25 and 10 h
- Time point:
- 30 h
- Dose:
- mean absorption rate in water, (10-30 hr) continuous exposure
- Parameter:
- rate
- Absorption:
- 7.88 other: µg/cm²/h
- Remarks on result:
- other: Mean absorption rate between 10 and 30 h
- Time point:
- 10 h
- Dose:
- mean absorption rate in diluted shampoo, (2.25-10 hr) continuous exposure
- Parameter:
- rate
- Absorption:
- 5.23 other: µg/cm²/h
- Remarks on result:
- other: Mean absorption rate between 2.25 and 10 h
- Time point:
- 30 h
- Dose:
- mean absorption rate in diluted shampoo, (10-30 hr) continuous exposure
- Parameter:
- rate
- Absorption:
- 11.1 other: µg/cm²/h
- Remarks on result:
- other: Mean absorption rate between 10 and 30 h
- Time point:
- 6 h
- Dose:
- mean absorption rate in water, (1-6 hr) rinsed application
- Parameter:
- rate
- Absorption:
- 0.586 other: µg/cm²/h
- Remarks on result:
- other: Mean absorption rate between 1 and 6 h
- Remarks:
- Since the absorption process reached a pleateau by 10h, no steady-state rates of absorption could be calculated for oxypyrion from the rinsed exposures.
- Time point:
- 6 h
- Dose:
- mean absorption rate in water, (1-6 hr) rinsed application
- Parameter:
- rate
- Absorption:
- 0.549 other: µg/cm²/h
- Remarks on result:
- other: Mean absorption rate between 1 and 6 h
- Remarks:
- Since the absorption process reached a pleateau by 10h, no steady-state rates of absorption could be calculated for oxypyrion from the rinsed exposures.
Applicant's summary and conclusion
- Conclusions:
- The data obtained in this study predict that during normal use, dermal absorption of oxypyrion through human epidermis would be minimal.
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