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EC number: 420-920-1 | CAS number: 128446-35-5
- 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
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 420-920-1
- EC Name:
- -
- Cas Number:
- 128446-35-5
- Molecular formula:
- Hill formula: (C42H70-nO35)(C3H7O)n; n(mittel)=5,25
- IUPAC Name:
- 5,10,15,25-tetrakis(hydroxymethyl)-40,44,47,49-tetrakis(2-hydroxypropoxy)-20,30,35-tris[(2-hydroxypropoxy)methyl]-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.2³,⁶.2⁸,¹¹.2¹³,¹⁶.2¹⁸,²¹.2²³,²⁶.2²⁸,³¹]nonatetracontane-36,37,38,39,41,42,43,45,46,48-decol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- rat/Sprague-Dawley, Hag: SD/LippischeVersuchstierzucht HAGEMANN GmbH, D-32699 Extertal
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- physiological saline
- Details on exposure:
- 0.9% NaO-solution on the day before injection the test substance was dissolved in 0.9% NaCl-solution and administered once by i.v. injection at a constant volume of 25.0 ml/kg b.w., adjusted according to the individual body weight recorded on the day of administration; before administration
the pH value and the osmolarity of the prepared solutions were verified - Doses:
- 1000 mg, 1470 mg, 2150 mg and 3160 mg/kg b.w., once by i.v.. injection
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Following administration, .observations were made and recorded•. systematically with individual records being maintained for each animal. Observations were performed immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 h after administration. All surviving animals were observed for a period of 14 days. Owing this follow-up period changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity and behaviour pattern were observed and recorded at least twice daily (morning and afternoon) until all symptoms subsided, and thereafter each working day. Attention was also paid to possible tremor, convulsions, salivation, diar-rhoea, lethargy, sleep. and coma. Observations on mortality were made at least twice daily with appropri-ate actions taken to minimize loss of animals during the study. Individual body weights were recorded before administration of the substance and on days 5, 8 and 14. Changes in weight were calculated and recorded as precisely as possible. The LD50 was calculated by regression analysis. The mortality rates at 24 h and 14 d were used.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 499 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 140 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The lowest lethal dose was 1470 mg/kg b.w. for male ·and 2150 mg/kg b.w. for female animals, the no-effect-Ievel was below 1000 mg/kg b.w. .
- Gross pathology:
- Macroscopic examination showed serverly enlarged kidneys (cherry sized) in 1 of 5 male animals treated with 1470 mg/kg b.w. i.v. One of 5 female animals treated with 2150 mg/kg b.w. showed spotted kidneys with coarse-grained surface. No macroscopic findings were observed in the female animals treated with 3160 mg/kg b.w..
- Other findings:
- At histopathology tubular nephrosis in the kidneys was regarded as the main substancerelated finding. The lymphatic oedema observed in the lungs· is probably related to a combination of the high volume injected and the test substance. These changes occurred from 1000 mg/kg b.w. . onwards, nearly in all animals examined. These changes were less pronounced at 2150 mg/kg b.w. in the males and at 3160 mg/kg b.w. in the females, but one has to take into consideration, that the animals died within 3 or 4 minutes after dosing. At nearly all dose-levels spontaneous fatty deposits were found in the liver and kidneys as well as congestion in the lungs and in the liver.
Applicant's summary and conclusion
- Executive summary:
The aim of this experiment was to establish the acute toxic symptoms and in case of mortality the cause of death of Methyl-beta-cyclodextrin after a single intravenous administration to rats.
Under the present test conditions first intolerance reactions were observed at microscopy at 1000 mg/kg b.w. i.v. In addition reduced motility, ataxia, dyspnoea and muscu1ar hypotonia occurred at 1470 mg/kg b.w. i.v.. The lowest lethal dose was 1470 mg/kg b.w. i.v. for male and 2150 mg/kg b.w. i.v. for female animals, the no-effect-Ievel was below 1000 mg/kg b.w. i.v..
The LD50 was calculated as 1499 mg/kg b.w. i.v. (24 h and 14 d) for males, 2140 mg/kg b.w. i.v.. (24 h) and 2108 mg/kg b.w. i.v. (14 d) for females.
Autopsy
Macroscopic examination showed severely enlarged kidneys (cherry sized) in 1 of 5 male animals treated with 1470 mg/kg b.w. i.v. One of 5 female animals treated with 2150 mg/kg b.w. i.v. showed spotted kidneys with coarse-grained surface. No macroscopic findings were observed in the female animals treated with 3160 mg/kg b.w. i.v..
Histopathology
At histopathology tubular nephrosis in the kidneys was regarded as the main substance related finding. The lymphatic oedema .observed in the lungs is probably related to a combination of the high volume injected and the test substance. These changes occurred from 1000 mg/kg b.w. i.v. onwards, nearly in all animals examined. These changes were less pronounced at 2150 mg/kg b.w. i.v. in the males and at 3160 mg/kg b.w. i.v. in the females, but one has to take into consideration, that the animals died within 3 or 4 minutes after dosing. At nearly all dose-levels spontaneous fatty deposits were found in the liver and kidneys as well as congestion in the lungs and in the liver.
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