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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
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: Guideline study (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- CIBA-GEIGY Limited, Toxicology Services, Short-term Toxicology
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
The test was conducted in 1993. However, the original Test Guideline (TG) for the determination of skin sensitization in the mouse, the Local Lymph Node Assay (LLNA; TG 429) was adopted in 2002.
Test material
- Reference substance name:
- 2,2,6,6-tetramethylpiperidin-4-ol
- EC Number:
- 219-291-2
- EC Name:
- 2,2,6,6-tetramethylpiperidin-4-ol
- Cas Number:
- 2403-88-5
- Molecular formula:
- C9H19NO
- IUPAC Name:
- 2,2,6,6-tetramethylpiperidin-4-ol
- Details on test material:
- - Name of test material (as cited in study report): TK 11725/1, HTMP
- Physical state: solid, white
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, 4332 Stein / Switzerland
- Weight at study initiation: 300 to 431 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: physiolog. saline and vaseline
- Concentration / amount:
- 1. induction: 1 % in physio. saline
2. induction: 50% in vaseline
challenge: 30% in vaseline
rechallenge: 10% in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: physiolog. saline and vaseline
- Concentration / amount:
- 1. induction: 1 % in physio. saline
2. induction: 50% in vaseline
challenge: 30% in vaseline
rechallenge: 10% in vaseline
- No. of animals per dose:
- 20 for test group (10 females and 10 males)
10 for control group (5 females and 5 males) - Details on study design:
- RANGE FINDING TESTS: The following concentrations of test article have been prepared for intradermal injection: 1, 3, and 5 % in physiological saline.
Because necrosis was observed with 3 and 5% the following concentration was used for intradermal induction: Concentration of test article : 1%
Vehicle: physiological saline.
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of the test substance have been examined on separate animals for the determination of the maximum subirritant concentration: 10, 20, 30, and 50% in vaseline. Only minimal erythema reactions were observed with 50% test substance in vaseline. Therefore for epidermal induction 50% in vaseline, for epidermal challenge 30% in vaseline and epidermal rechallenge 10% were used.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs of intradermal injections and one closed patch epidermal induction
- Exposure period: 2 weeks
- Test groups: 1
- Control group: 1
- Site: neck region
- Frequency of applications: once per week
- Duration: epidermal induction: 48 hours
- Concentrations: 1% intradermal, 50% epidermal
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: week 5
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: flank
- Concentrations: 30%
- Evaluation (hr after challenge): 24 and 48 hours
OTHER: Rechallenge: (week 6): 10% test substance in vaseline - Positive control substance(s):
- yes
- Remarks:
- Potassiumdichromate
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 9
- Total no. in group:
- 16
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 9.0. Total no. in groups: 16.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 9
- Total no. in group:
- 16
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 9.0. Total no. in groups: 16.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 5
- Total no. in group:
- 16
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 5.0. Total no. in groups: 16.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 11
- Total no. in group:
- 16
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 11.0. Total no. in groups: 16.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30%. No with. + reactions: 7.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30%. No with. + reactions: 7.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%. No with. + reactions: 9.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 1%. No with. + reactions: 9.0. Total no. in groups: 10.0.
Any other information on results incl. tables
- In all animals of the test group hunched posture, piloerection, and sedation were observed on experimental day 11. Hunched posture and piloerection were observed in several animals up to experimental day 17.
- One moribund male and one female were sacrificed on experimental day 11 and 14, respectively. On experimental day 15 two females were found dead.
- Macroscopical investigations of all animals of the test and control group revealed a dilatation of the small and large intestine in two animals and a dilatation of the large intestine including caecum in further two animals, being common findings in moribund sacrificed guinea pigs or in guinea pigs found dead. Additionally, in one female multiple bilateral nodules of the kidneys were noted. All other animals of the test and control group were devoid of macroscopical changes indicative of systemic toxicity. Histopathological investigations were not considered necessary. Since initially symptoms were observed in all animals of the test group and with respect to the mortality recorded treatment-relation cannot be fully excluded.
- After the first challenge application 56% of the animals of the test group and 70% of the animals of the control group showed skin
reactions (erythema of score 1). After a second challenge application, using a lower test article concentration and a new control group, 31 and 69% of the animals of the test group were sensitised 24 and 48 hours after removing the dressings, respectively (erythema score 1, one animal also edema score 1). None of the animals of the control group showed skin reactions during the second challenge.
The test substance is therefore classified as a moderate to strong sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman.
Applicant's summary and conclusion
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