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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
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 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Limited, Animal Production, Switzerland
- Weight at study initiation: 327 - 425 g
- Housing: single
- Diet: standard guinea pig pellets, NAFAG No. 845, Gossau SG (ad libitum)
- Water: ad libitum
- Acclimation period: yes, not further specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal and epicutaneous, occlusive
- Vehicle:
- other: Oleum arachidis or vaseline
- Concentration / amount:
- - induction phase: intradermal: 1% (in Oleum arachidis); epicutaneous: 50% (in vaseline);
- challenge phase: 50% (in vaseline);
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Oleum arachidis or vaseline
- Concentration / amount:
- - induction phase: intradermal: 1% (in Oleum arachidis); epicutaneous: 50% (in vaseline);
- challenge phase: 50% (in vaseline);
- No. of animals per dose:
- - test group: 10 males and 10 females;
- control group: 5 males and 5 females; - Details on study design:
- RANGE FINDING TESTS:
The following concentrations of test article have been prepared for intradermal injection: 1, 3, and 5 % in Oleum arachidis. In a pretest 3 and 5% in Oleum arachidis induced skin necrosis at the injection sites. Therefore 1% in Oleum arachidis was used for intradermal induction.
The following concentrations of TK 11831 have been examined on separate animals for the determination of the maximum subirritant concentration: 1, 5, 10, 20, 30, and 50% in vaseline. Erythema reactions were observed with 30 and 50% TK 11831 in vaseline. Therefore 50% in vaseline was used for epidermal induction and challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
First inductionweek, intradermal injection:
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- test article TK 11831 in Oleum arachidis (w/v)
- test article TK 11831 in the adjuvant/saline mixture (w/v)
Second inductionweek, epidermal application:
In the second week of induction TK 11831 was incorporated in vaseline (w/w) and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g paste per patch; occluded administration for 48 hours).
Rest period:
During weeks 3 and 4 no treatments were performed.
- Control group: treated with adjuvant and the vehicle
- Site: neck region
- Concentrations: intradermal: 1% (in oleum arachidis); epidermal: 50% (in vaseline);
B. CHALLENGE EXPOSURE
The animals were tested on the flank with TK 11831 in vaseline (w/w) and the vehicle alone (patch 2x2 cm; approx. 0.2 g paste per patch; occluded administration for 24 hours).
- No. of exposures: 1
- Control group: treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals
- Site: flank
- Concentrations: 50% in vaseline
- Evaluation (hr after challenge): 24 and 48 h after removing the dressings, the challenge reactions were graded according to the Draize scoring scale
- Positive control substance(s):
- yes
- Remarks:
- see below (positive control results)
Results and discussion
- Positive control results:
- The sensitivity of the strain is checked once or twice per year with a known sensitiser, such as mercaptobenzothiazole, benzocaine, or potassium-dichromate. The results of the latest positive control test are presented in this report.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge control (no treatment in the induction period)
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control (no treatment in the induction period). Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control (no treatment in the induction period)
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control (no treatment in the induction period). Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 18.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Vehicle controls (treatment only in the induction period): 24 h after challenge: 0/20; 48 h after challenge: 0/20;
Challenge reactions of the test group after epidermal application (mean Draize score):
24 h after removal of the dressing: erythema: 1.8; edema: 0.5;
48 h after removal of the dressing: erythema: 1.2; edema: 0.3;
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- According to the test conditions, the test substance has to be classified: Xi, R43 (EU) and Cat. 1 (GHS).
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