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EC number: 220-778-7 | CAS number: 2896-70-0
- 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
Endpoint summary
Administrative data
Description of key information
In vivo data reports mild-moderate irritation after extended exposure periods which appear to be reversible. Comparisons with similar molecules reported in the literature conclude the substance to be non-irritating.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Executive summary:
The cutaneous reaction to various nitroxides has been reviewed by Fuchs (2000) in Toxicology of the Human Environment, the Critical Role of Free Radicals, Ed. Christopher J Rhodes, Taylor & Francis London pages 139-152
This includes the reaction of Tempo and similar molecules to both animal and human skin. Uniformly slight or non-irritant properties have been described. In addition, for Butoxy Tempo the skin irritation potential (Mullaney T, 2006, Report No 1156/038 ) has been shown to be slight (or non-irritant).
The introduction of an additional substituent at the 4-position was therefore shown not to influence the irritation overall and thus on structure/function grounds Oxo-Tempo is considered to be non-irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- In vivo study available.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-04-07 to 1997-04-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A well conducted study according to guidelines and done in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Chesire, UK
- Age at study initiation:12-16 weeks
- Weight at study initiation: 2.6-3.04 kg
- Housing:Suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22
- Humidity (%): 43-56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml - Duration of treatment / exposure:
- The upper and lower eyelids were held together for about one second immediately after instillation, to prevent loss of
the test material, and then released. - Observation period (in vivo):
- 1, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- group
- Time point:
- other: 1 hour
- Score:
- 8.7
- Max. score:
- 18
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Kay and Calandra Classifiation System
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- 2,2,6,6-Tetramethyl-4-oxopiperidinooxy instilled into the eyes of three rabbits resulted in mild to moderate conjunctival irritation, diffuse corneal
opacity and iridial inflammation. All effects cleared by 48 or 72 hours. The test material was mildly irritating according to the Kay and Calandra
classification system. It was not classified as irritating by OECD GHS standards. - Executive summary:
A GLP study was performed in accordance with OECD guideline 405, to assess the effect of 2,2,6,6,-tetramethyl-4 -oxopiperindinooxy when administered to the eye.
A single dose of 0.1 ml of test material was applied to the right eye of three New Zealand white rabbits. Assessment of the animals was made at 1 hour, 24, 48 and 72 hours after treatment.
The test material produced a maximum group mean score of 8.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye using a modified Kay and Calandra classification system.
No classification with respect to eye irritancy is required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The cutaneous reaction of various nitroxides was reviewed by Fuchs (2000) and concluded, based on comparison with similar molecules and structural information, that 2,2,6,6-tetramethyl-4-oxopiperidinooxy was not irritating.
Dermal effects were reported in the acute dermal toxicity study (Cerven, D.R 1995). After 24 hours, exposure to a single dose of 2000mg/kg bw two New Zealand white rabbits showed an average score of 2 for erythema and 1.5 for oedema using the Draize Dermal Scoring codes. Although not fully reversible in the 14 day observation period, significant reversal was observed.
Topical sighting tests performed with guinea pigs during a skin sensitisation study (Allen, D.J, 1997), reported mild – moderate irritation after 24 and 48 hours exposure periods with, amongst other concentrations, undiluted test substance. The effects observed were fully reversible within the 48 hour observation period.
Although mild- moderate irritation was observed in the studies, the exposure periods were far in excess of the 4 hours cited in OECD 404, Acute Dermal Irritation/Corrosion. It is reasonable to expect that should a skin irritation study be performed in accordance with OECD 404, the effects to the skin would be milder than observed in the dermal acute and skin sensitisation studies reported.
A single study is available to determine the effects on the eye.A GLP study in accordance with OECD guideline 405, applied a single dose of 0.1 ml of test material to the right eye of three New Zealand white rabbits. Assessment of the animals was made at 1 hour, 24, 48 and 72 hours after treatment. The test material produced a maximum group mean score of 8.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye using a modified Kay and Calandra classification system.
In conclusion mild irritation to the eye was observed but was not sufficiently severe to trigger classification.
Justification for selection of skin irritation / corrosion endpoint:
Weight of evidence demonstrates that the criteria for irritating to skin are not met.
Justification for selection of eye irritation endpoint:
A single study was available which was considered to be of adequate quality to fulfil the data requirement.
Justification for classification or non-classification
The criteria for skin irritation/corrosion and eye irritation according to Regulation (EC) No 1272/2008 are not met. No classification with respect to skin irritation/corrosion or eye irritation is required.
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.
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