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EC number: 429-370-5 | CAS number: 220410-74-2
- 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
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-01-26 to 1999-03-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant Guideline study.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
- Reference Type:
- other: Amendment Final Report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 429-370-5
- EC Name:
- -
- Cas Number:
- 220410-74-2
- Molecular formula:
- C34H67N3O13
- IUPAC Name:
- tris(1,4-dihydroxy-2,2,6,6-tetramethylpiperidin-1-ium) 2-hydroxypropane-1,2,3-tricarboxylate
- Test material form:
- other: Ivory-peach flakes
- Details on test material:
- - Identification: TKA 45021
- Appearance: Ivory-peach flakes
- Lot/batch No.: pax 2068 rd 100
- Test Item arrived at Test Facility: 1998-11-25
- Storage conditions: desiccated at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc. (facility not specified), USA
- Age at study initiation: approximately seven to ten weeks
- Weight at study initiation: ranging from 238 to 300 g for males and 214 to 232 g for females
- Fasting period before study: yes
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rodent Chow #5002 (Purina Mills, Inc.), ad libitum
- Water: municipal tap water treated by reverse osmosis, ad libitum
- Acclimation period: minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C to 24°C
- Humidity: 35-51%
- Air changes: 10 to 15 air changes per hour
- Photoperiod: 12-hour light / 12-hour dark cycle
IN-LIFE DATES: From: 1999-01-26 To: 1999-03-01
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: deionized water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg / mL (fixed)
MAXIMUM DOSE VOLUME APPLIED:
- males: 6.41 mL / kg bw
- females: 4.272 mL / kg bw - Doses:
- males: 1068, 2136, 2670 or 3204 mg / kg bw
females: 534, 1068, 1602 or 2136 mg / kg bw - No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical abnormalities were recorded approximately 1, 2, 4, 8 and 24 hours post-dose and daily thereafter (days 2-14).
A general health/mortality check was performed twice daily (in the morning and in the afternoon).
Individual body weights were obtained prior to fasting (day -1), prior to dosing on day 0 and for all surviving animals on days 7 and 14.
Animals found dead after day 0 were also weighed.
Individual food consumption was recorded for all surviving animals weekly.
- Necropsy of survivors performed: yes - Statistics:
- The LD50 and 95% confidence intervals were calculated separately for males and the combined sexes using a computer adaption of the method of Litchfield and Wilcoxon.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 494.9 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 828.9 - 3 384.8
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 068 - < 1 602 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 757.8 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 872.6 - 3 541.1
- Mortality:
- All mortality occurred by study day 1:
males (mg / kg bw : fatalities / totals): 1068 : 0/5, 2136 : 1/5, 2670 : 4/5 or 3204 : 5/5
females (mg / kg bw : fatalities / totals): 534 : 0/5, 1068 : 0/5, 1602 : 5/5 or 2136 : 5/5 - Clinical signs:
- other: The most notable clinical abnormalities observed during the study included decreased activity, convulsions, wobbly gait, breathing abnormalities, prostration, decreased defecation, soft stools, piloerection, apparent hypothennia, skin blue in color, hunch
- Gross pathology:
- The most notable gross internal findings were observed in the animals that died and included abnormal content in the digestive tract, stained mucosa in the stomach and dark red lungs. Gross intemal findings observed at necropsy on study day 14 included three incidences of gray raised area(s) on the lungs in the 2136 mg/kg bw male rats.
- Other findings:
- Food consumption was consistent throughout the test period.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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