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EC number: 212-554-2 | CAS number: 826-36-8
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline study under GLP . Deficiency: One animal removed the patch itself before the end of the treatment period; the skin irritation values obtained for this animal are therefore considered to be too low. However, the outcome of the study is not affected.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (occlusive dressing)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2,6,6-tetramethyl-4-piperidone
- EC Number:
- 212-554-2
- EC Name:
- 2,2,6,6-tetramethyl-4-piperidone
- Cas Number:
- 826-36-8
- Molecular formula:
- C9H17NO
- IUPAC Name:
- 2,2,6,6-tetramethylpiperidin-4-one
- Details on test material:
- - Physical state: melt, yellow to dark yellow
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, 7 950 Biberach/Riss
- Weight at study initiation: 2470 - 2610 g
- Housing: single
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland (ad libitum)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: distilled water
- Controls:
- other: a control gauze patch was applied to the contralateral flank
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (patches were moistened before application with distilled water) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1 and 24 hours after removing the gauze patches
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 12 - 16 cm2
- Type of wrap if used: The patches were loosely covered with an aluminum foil (approx. 36 cm2) and held in place for 4 hours by an adhesive tape
(Isoplast, Isoplast AG, CH-5200 Brugg).
SCORING SYSTEM: according to the OECD scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (animal 1 / animal 3)
- Time point:
- other: 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: TK 11831 induced maximum irritant effects which were expected not to be reversible within 14 days. The animals were killed for animal protective reasons 24 hours after removing the bandage.
- Remarks on result:
- other: One animal removed the patch itself before the end of the treatment period. Therefore the skin irritation values obtained for this animal are considered to be too low and are not included in the calculation of the mean.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (animal 1 / animal 3)
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- other: TK 11831 induced maximum irritant effects which were expected not to be reversible within 14 days. The animals were killed for animal protective reasons 24 hours after removing the bandage.
- Remarks on result:
- other: One animal removed the patch itself before the end of the treatment period. Therefore the skin irritation values obtained for this animal are considered to be too low and are not included in the calculation of the mean.
Any other information on results incl. tables
erythema | edema | |||||
animal no. | 633 | 565 | 625 | 633 | 565 | 625 |
after 1 hr | 4 | 2 | 4 | 2 | 1 | 2 |
after 24 hrs | 4 | 3 | 4 | 3 | 2 | 3 |
One animal (No. 565) removed the patch itself before the end of the treatment period period. Therefore the skin irritation values obtained for this animal are considered to be too low.
At the 1 hr-reading a necrotic area (diameter: 1 cm) was observed at the treated skin site of animal No. 565. 24 hours after patch removal the treated skin of animals No. 633 and 625 appeared strongly necrotic and showed black discoloration at a size of approximately 8 x 8 cm (animal No. 633) and 3 x 3 cm (animal No. 625). In animal No. 565 a yellowish discoloration of the skin was seen. Furthermore, at the 24 hours evaluation a slight loss of weight was observed in animals No. 633 and 625.
TK 11831 induced maximum irritant effects which were expected not to be reversible within 14 days. The animals were killed for animal protective reasons 24 hours after removing the bandage.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- According to OECD Guideline No. 404 it has to be concluded that the test substance has corrosive effects in albino rabbits under these test conditions. The test substance has therefore to be classified according to EU (C, R34) and GHS (cat. 1B).
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