Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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Diss Factsheets
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EC number: 218-760-9 | CAS number: 2226-96-2
- 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
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Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a skin sensitisation assay (Bühler test: 95-0258-DGT), 20 female Guinea pigs received three dermal doses (day 0, 7 and 14) of 0.5 g 4-Hydroxy-TEMPO as a paste in petrolatum at a 50 % (w/w) concentration onto their left caudal flank, while nine female negative control animals received the vehicle alone. The maximum concentration feasible was determined in a pre-test. The animals were challenged on day 28, using the same vehicle and test item concentration, applied onto the right flank. No signs of skin sensitisation where detected. The latest positive control using 2-Mercaptobenzothiazol was positive. The study was performed according to GLP and it satisfies the requirements of OECD test guideline 406. The study is considered acceptable (key study).
Short description of key information:
The test substance 4-Hydroxy TEMPO did not induce delayed contact hypersensitivity in the Bühler test and is thus not regarded as a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
Adequate assay to address endpoint
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
The test item has no structural alert indicative for respiratory sensitisation. In addition, no human data on respiratory sensitisation have been reported. The test item is considered not to induce respiratory sensitisation.
Short description of key information:
Considered not to induce respiratory sensitisation.
Justification for classification or non-classification
Skin sensitisation
Based on the results of an in vivo skin sensitisation test, the test item should not be classified with regard to skin sensitisation according to Directive 67/548/EEC and Regulation (EC) No 1272/2008 (GHS, CLP).
Respiratory sensitisation
Considered not to induce respiratory sensitisation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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