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EC number: 219-291-2 | CAS number: 2403-88-5
- 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
skin: erythema score: 2.7 (not fully reversible within 14 days), edema score: 1.2; CIBA, 1992, GLP-OECD Guideline Study
eye: not tested because corrosive to skin
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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: Guideline Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hüls AG, Marl, Germany
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.1-2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
according to guideline - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g with 0.5 mL water to 6cm2
- Duration of treatment / exposure:
- animal 1: 4 hours, thereafter the bandage was removed and the site washed with water
animal 2: 3 min: open patch
animal 3: 1 hour: semiocculsive, observation up to 6 days - Observation period:
- animal 1: up to 72 hours post application. Due to the high corrosvitiy, the animal was killed after 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gatze fixed with non irritating adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to Guideline - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: animal was killed after 3 days
- Remarks on result:
- other: 4 hour test
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: animal was killed after 3 days
- Remarks on result:
- other: 4 hour test
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 3 min test
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 1 hour test
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 1 hour test
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- Under conditions tested, the test item is regarded to be corrosive.
Reference
1 hour exposure time: After 30 to 60 min and after 24 hours clear erythema and very slight edema were seen. After 48 and 72 hours only dry skin and very slight desquamation were observed. Irritation scores: Erythema: 0.67, Edema: 0.33 After 6 days the effects were reversible. 4 hours exposure time: Direct after patch removal and 30 to 60 min strong subcutaneous bleeding and redbroun discoloration of the skin were observed. The skin was hardened and the animal showed a very strong erythema and edema Necrosis appeared 24 hours p.a. The animal was killed three days p.a..
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Additional information
Skin: There was one report from a study on acute dermal irritation/corrosion [OECD TG 404] in the rabbit (Ciba GmbH Lampertheim, 1992). This study was identified as the key study because it was well conducted and used a current protocol. A 4-hour occlusive exposure to 0.5 g of the unchanged 2,2,6,6 -tetramethylpiperidin-4 -ol, produced moderate to severe skin irritations. The mean score for the 24, 48 and 72 h reading for erythema and edema, respectively was 2.7 and 1.2. In one of three animals the erythema were not reversible within 14 days after patch removal whereas the edema were fully reversible within 10 days.
Conclusion: Since the effects are not reversible 2,2,6,6 -tetramethylpiperidin-4 -ol is corrosive to skin.
Eye: There is no study done to determine eye irritation because 2,2,6,6 -tetramethylpiperidin-4 -ol is corrosive to skin already.
Respiratory irritation: no data available
Effects on skin irritation/corrosion: corrosive
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008.
As severe irritation effects were observed for skin, 2,2,6,6 -tetramethylpiperidin-4 -ol has to be classified as Category 1C.
Respiratory system
Actually, there are no data available for a classification regarding to this endpoint.
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