Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 219-888-8 | CAS number: 2564-83-2
- 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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Study was not conducted under GLP and reporting of results is limited.
Data source
Reference
- Reference Type:
- publication
- Title:
- Cutaneous tolerance to nitroxide free radicals and nitrone spin traps in the guinea pig
- Author:
- Fuchs J., Groth N., Herrling T.
- Year:
- 1 998
- Bibliographic source:
- Toxicology 126, 33–40
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Standardized performance according to Magnusson and Kligman (1969, J. Invest. Dermatol. 52, 268–76) and Schlede and Eppler (1995,Contact Dermatitis 32,1–4)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study is publicly available, thererfore a new study was not conducted for animal welfare reasons.
Test material
- Reference substance name:
- 2,2,6,6-tetramethylpiperidinooxy
- EC Number:
- 219-888-8
- EC Name:
- 2,2,6,6-tetramethylpiperidinooxy
- Cas Number:
- 2564-83-2
- Molecular formula:
- C9H18NO
- IUPAC Name:
- 2,2,6,6-tetramethylpiperidin-1-ol
- Test material form:
- solid
- Details on test material:
- Handbok data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species/Strain: Guinea pig
- Source: Charles River Wiga, Sulzfeld, Germany
- Body weigth: 300 to 400 g
- Housing: single housing in stainless steel cages
- Diet: Food pellets ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 60 %
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 100 or 10 mM
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- not disclosed
- Day(s)/duration:
- Day 8, 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- not disclosed
- Day(s)/duration:
- Day 24, 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- not disclosed
- Day(s)/duration:
- Day 24, 48 h
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #3
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- not disclosed
- Day(s)/duration:
- Day 24, 72 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- Intradermal induction:
In the intradermal induction treatment, the animals are given the following injections at the beginning of the first week in the shoulder region on both the right and left sides. (1) Cranial injections: 0.1 ml Freunds complete adjuvans (1:1 with physiological saline); (2) medial injections: 0.1 ml of the test substance at a locally and systemically well tolerated concentration (10–100 mM in physiological saline; (3) caudal injections: 0.1 ml Freunds complete adjuvant plus test substance (1:1), final concentration of the test substance as for the medial injection.
Dermal induction:
In the dermal induction experiment on day 8, the test substance was applied at a concentration causing slight to moderate irritation in petrolatum to a filter paper and fixed to the site of application for 48 h. The animals were then left to rest until the challenge test. The negative controls are treated in the same way as the test animals, except that during the induction experiments, application of the test material is omitted. The positive controls were exposed to the skin sensitizer DNCB (0.01%).
Challenge:
In the challenge experiment on day 24, the test substance in the vehicle (petrolatum) was applied at a non-irritant concentration to the sheared flank on a filter paper (2x2 cm), fixed to the skin for 24 h under an occlusive covering.
Evaluation:
The treated area of the skin was cleaned and inspected 24, 48 and 72 h after removal of the occlusive patch. The skin reaction after challenge were assessed according to the Draize scale. Evaluation of the sensitizing potential of the substances is based on the number of the guinea pigs showing a positive degree of sensitization (score > 1) in comparison to the total numbers of animals tested. - Challenge controls:
- negative control group with petrolatum
- Positive control substance(s):
- yes
- Remarks:
- DNCB (0.01%)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.01%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 mM, 100 mM
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item does not have skin sensitizing properties according to the standardized performance of the Magnuson and Kligman test. Thus, the available data on skin sensitivity of 2,2,6,6-tetramethylpiperidinooxy do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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.
