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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-03-24 to 1999-07-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- adopted July 21,1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
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:
- solid: flakes
- Details on test material:
- - Identification: TKA 45021
- Appearance: light-red flakes
- Analytical purity: 93.64%
- Lot/batch No.: pax 2068 / rd 100
- Test Item arrived at Test Facility: 1999-03-29
- Storage conditions: ambient temperature
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Canada, St. Constant, Canada (Dose Limit and Dose Range Finding); and Raleigh, North Carolina, USA (Micronucleus Study)
- Housing: in sanitary polycarbonate cages separated by gender, with up to five animals per cage during acclimation, and full dose group after randomization
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: 28.5-35.0 g (males only in main study)
- Diet: PMI® Feeds, Inc. Certified Rodent Diet # 5002 (pellets) ad libitum
- Water: municipal tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 64 to 79°F (17,8 °C to 26,1 °C)
- Humidity: 30 to 70%
- Air changes: 10 to 15 air changes per hour
- Photoperiod: 12-hour light / 12-hour dark cycle
IN-LIFE DATES: From: 1999-04-01 To:1999-04-29
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- - Vehicle/solvent(s) used: sterile water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Prior to dosing, the top stock of the test item was prepared by adding the appropriate volume of sterile water for injection, to a preweighed quantity of the test article. The remaining stocks were prepared by dilution from the top stock. - Duration of treatment / exposure:
- not applicable (single i.v. treatment)
- Frequency of treatment:
- once
- Post exposure period:
- Micronucleus assay: 24 or 48 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50.0, 100, and 200 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 6 males (a replacement dose group of 8 animals was included at the top dose level in anticipation of mortality)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: p.o.
- Doses / concentrations: 80.0 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes (polychromatic erythrocytes, PCEs)
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Observed toxicity in Dose Range Finding assay
SAMPLING TIME: Bone marrow was sampled 24 and 48 hours after treatment.
DETAILS OF SLIDE PREPARATION: Bone marrow was removed from the femurs of the first five surviving animals in a dose group. Following centrifugation to pellet the tissue, the supenatant was removed by aspiration and portions of the pellet were spread on slides, air dried and stained in May-Grünwald solution followed by Giemsa.
METHOD OF ANALYSIS:
The micronucleus frequency (expressed as percent micronucleated cells) was determined by analyzing the number of micronucleated PCEs from at least 2000 PCEs per animal.
The frequency of PCE:NCE ratio was determined by scoring the number of PCEs and NCEs observed in the optic fields while scoring at least the first 200 erythrocytes on the slide. - Evaluation criteria:
- The criteria for a positive response was the detection of a statistically significant increase in micronucleated PCEs for at least one dose level, and a statistically significant dose-related response. A test item that did not induce both of these responses was considered negative. Statistical significance was not the only determinant of a positive response; the Study Director also considered the biological relevance of the results in the final evaluation.
The criteria for the identification of micronuclei were those of Schmid (1976). The unit of scoring was the micronucleated cell, not the micronucleus; thus, the occasional cell with more than one micronucleus was counted as one micronucleated PCE, not two (or more) micronuclei. - Statistics:
- ANOVA (Winer, 1971) was applied when the variances were homogeneous, ranked proportions were used for heterogeneous variances. If the ANOVA was statistically significant (p <0.05), a Dunnett's t-test (Dunnett, 1955; 1964) was performed.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 100, 150, 200, 300 and 500 mg/kg bw
- Clinical signs of toxicity in test animals: at 200 mg/kg bw and above
500 mg/kg bw: all animals died (6/6)
300 mg/kg bw - fatalities: 2/3 males, 1/3 females
200 mg/kg bw - fatalities: 1/2 males, 0/2 females
lower concentrations: no deaths, no clinical signs
- Evidence of cytotoxicity in tissue analyzed: no
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei: no
- Ratio of PCE/NCE: no statistically significant decrease
- Appropriateness of dose levels and route: the high dose produced mortality in two animals of the 24 h harvest group
- Statistical evaluation: Yes
Applicant's summary and conclusion
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