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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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Nanomaterial surface chemistry
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- Nanomaterial pour density
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- 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
Based on the irritation parameters and the histopathological evaluation following 4-hour occlusive test item application in an in vivo skin irritation/corrosion study in male and female rabbits, 2,2,6,6-tetramethylpiperidinooxy was considered to be corrosive to the skin. In a supporting study according to a modified Draize protocol, the test item appeared to be slightly irritant to skin.
As a consequence of the instillation of 2,2,6,6-tetramethylpiperidinooxy into the rabbit eye, effects were noted on cornea, iris and conjunctiva in all animals. In half of the animals effects deteriorated after an initial improvement and became so severe that the animals needed to be sacrificed on day 7. Thus, the effects were not expected to reverse within the observation period of 21 days.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
- Study period:
- 20-May to 10-June 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Study was not conducted in compliance with GLP, but is well documented and sufficient to cover this endpoint (conduction close to OECD 404). 3 male and 3 females animals were used, observation period was 21 days.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 3 male and 3 female amimals were used and observation period was 21 days after removal of patches.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Species/Strain: Rabbit (New Zealand albino)
- Source: R and B Enterprise, Hamilton OH
- Body weigth: 2.7 to 3.1 kg
- Housing: single housing in stainless steel cages
- Diet: Purina Lab Rabbit Chow HF #5325, 150 g daily
- Water: Water supplied from a reverse-osmosis purifier, ad libitum
- Acclimation period: 14 days befor the first test-substance application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 40 %
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Approximateyl 24 hours prior to study initiation, fur was clipped from an area of approximateyl 240 cm2 on the back of each rabbit. A 0.5 g quantity of the test article was applied uniformly to each test side and was covered with a 2.5 x 2.3 cm adhesive dressing.
- Duration of treatment / exposure:
- 4 hours, afterwards application sites were rinsed with 0.9% saline
- Observation period:
- 21 days
- Number of animals:
- 3F / 3M
- Details on study design:
- Application sites were examined for signs of dermal irritiation and corrosivity 50-60 min, 24, 48, and 72 hours, and 7, 14, and 21 days following removal of the wrappings.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 72 h.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 72 h.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 72 h.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 72 h.
- Irritant / corrosive response data:
- Brown areas were seen within the test sites of all tested rabbits 30-60 minutes after removal of the wrappings and persisted through the 72-hour scoring interval. Eschar formation was apparent in five out of six rabbits at that time. Therefore, two rabbits exhibiting the strongest signs of dermal irritation (Nos 3 and 6) were sacrificed following the 72-hour scoring interval and most severely affected dermal sections were subjected to histopathological investigation and compared to untreated skin. As a result, severe necrosis of the epidermis and moderate necrosis of the dermis were observed in correlation with acute mild to moderate inflammation of the dermis. Deeper necrosis including adnexa was seen with foci distribution.
In the other four animals, eschar formation persisted through day 7 or day 14. Cracking and/or concavity of the test site was also seen during the study. New or repaired skin was evident within the test sites of three of the four remainign rabbits by day 21. - Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- Based on the irritation parameters and the histopathological evaluation following 4-hour occlusive test item application in an in vivo irritation/corrosion study in male and female rabbits, 2,2,6,6-tetramethylpiperidinooxy is considered to be corrosive to the skin.
As a conclusion, the test substance is classified for this endpoint in accordance to the CLP Regulation (EC) No 1272/2008 as corrosive to the skin, category 1C. - Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- Observation period too short, reversibility of effects cannot be assessed. Poor documentation of results.
- Principles of method if other than guideline:
- modified Draize protocol (Draize et al.1944, J. Pharmacol. Exp. Ther. 821, 377–390; Zisu 1995, Contact Dermatitis 32, 74–77)
- GLP compliance:
- no
- Species:
- guinea pig
- Details on test animals or test system 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 - Type of coverage:
- occlusive
- Preparation of test site:
- other: One flank was shaved, the other scarified on the day before administration.
- Vehicle:
- other: petrolatum
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- 0.5 mL / 10mM or 100 mM
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- The test substance (0.5 ml:10 mM, or 100 mM final concentration) in petrolatum was applied by an occlusive patch for 24 h on the flank carefully shaved the day before. The substances were also applied on the contralateral scarified flank. Petrolatum was used as a negative control and an aqueous solution of 5% sodium lauryl sulfate (SLS) as a positive control in each animal. Animals were observed for erythema and oedema. The scores 24 and 72 h after application of the substances were added (non-scarified and scarified zones). The primary irritation values are calculated by averaging values for erythema from all sites (abraded and non-abraded), averaging the values for edema from all sites and adding the average values. The total was divided by 4 corresponding to the sum of two scores (erythema and oedema) obtained after 24 and 72 h. The mean is termed the primary cutaneous irritation index and may be used to classify the test substance (Zisu, 1995).
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 and 72h
- Score:
- 1.7
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- positive control 5% SLS
- Basis:
- mean
- Time point:
- other: 24 and 72h
- Score:
- 2.5
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- At a concentration of 100 mM, the test item was found to be slightly irritant (score 1.7), when compared with the moderate irritant 5% SLS (score 2.5). At a concentration of 10 mM no signs of skin irritation were observed.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- As a result, this modified Draize test shows that the test item is slightly irritant to skin. However, there is too little information available for classification according to the CLP Regulation (EC) No 1272/2008.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 June to 24 June 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Study was not conducted in compliance with GLP, but is well documented and sufficient to cover this endpoint (conduction close to OECD 405).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 6 animals (3M / 3F) were used.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Species/Strain: Rabbit (New Zealand albino)
- Source: R and B Enterprise, Hamilton OH
- Body weigth: 2.9 to 3.2 kg
- Housing: single housing in stainless steel cages
- Diet: Purina Lab Rabbit Chow HF #5325, 150 g daily
- Water: Water supplied from a reverse-osmosis purifier, ad libitum
- Acclimation period: 14 days befor the first test-substance application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 40 %
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g undiluted test item
- Duration of treatment / exposure:
- Test substance was not removed.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3M / 3F
- Details on study design:
- Undiluted test substance (0.1 g) was placed in the conjunctival sac of one eye, the other served as control. Test substance was not removed. Evaluation of results 1, 2, 3, 4, 7, 14 and 21 days after instillation of the test substance.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 7 days.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 7 days.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 7 days.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 7 days.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 7 days.
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 7 days.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 7 days.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 7 days.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 7 days.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 7 days.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 7 days.
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animal was sacrificed after 7 days.
- Irritant / corrosive response data:
- In treated eyes an inceased density of opacity was noted, in 3 out of 6 animals the finding was reversible, however, in the other 3 animals density was increasing again starting day 4 or 7. For the iris, the conjunctiva and chemosis scores, a comparable trend was observed. Due to the severity of those findings, the 3 rabbits with the deteriorating process were euthanized after the 7-day examination.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- As a consequence of the instillation of 2,2,6,6-tetramethylpiperidinooxy into the rabbit eye, effects were noted on cornea, iris and conjunctiva in all animals. In half of the animals effects deteriorated after an initial improvement and became so severe that the animals needed to be sacrificed on day 7. Thus, the effects were not expected to reverse within the observation period of 21 days.
As a conclusion, the test substance is classified for this endpoint in accordance to the CLP Regulation (EC) No 1272/2008 in Category 1 (Irreversible Effects on the Eye).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In an in vivo skin irritation/corrosion study in male and female rabbits, 2,2,6,6-tetramethylpiperidinooxy was found to be corrosive to the skin. A supporting study according to a modified Draize protocol revealed the test item to be slightly irritant to skin. Further evidence for the corrosive effects to the skin resulted from an acute dermal toxicity study; the mean lethal dose (LD50) of the test substance was found to be lower than 2000 mg/kg bw in male and female rabbits in a limit test. Severe corrosive effects have been estimated to be the cause for mortality. As a conclusion, the test substance is classified for this endpoint in accordance to the CLP Regulation (EC) No 1272/2008 as corrosive to the skin, category 1C.
In an in vivo eye irritation study in rabbits, severe effects were noted on cornea, iris and conjunctiva in all animals that were considered not to be reversible. As a conclusion, the test substance is classified for this endpoint in accordance to the CLP Regulation (EC) No 1272/2008 in Category 1 (Irreversible Effects on the Eye).
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