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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
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 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- .beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose
- IUPAC Name:
- .beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose
- 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
- Details on test material:
- - Name of test material (as cited in study report): hydroxypropyl .beta.-cyclodextrin
- Physical state:solid
- Analytical purity: 100%
- Storage condition of test material: tightly closed containers
- Other: Source: American Maize-Products Company
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mohican Valley Rabbitry, Inc. Loudonville, Ohio
- Age at study initiation: young adult
- Weight at study initiation: 2.203 - 2.415 kilograms
- Housing: housed individually in suspended stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61-70
- Humidity (%): 40 - 60
- Air changes (per hr): equal to 11 or more
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 lm of deionized water - Duration of treatment / exposure:
- 72 hours
- Observation period:
- Body weights were recorded within 16-30 hours prior to dosing. All rabbits were observed at least once daily during quarantine acclimation and twice daily during the experimental period for mortality and moribundity.
- Number of animals:
- 3 males
3 females - Details on study design:
- TEST SITE
- Area of exposure: back
- coverage site: one square inch in size
- Type of wrap if used: hypoallergenic Dermicel tape and elastic Vetrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wiped with disposable paper towels wetted with water
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- no effects
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, hydroxypropyl .beta.-cyclodextrin, did not produce erythema, edema or other dermal effects in rabbits. The primary irritation index was 0.0. The material was considered to be a nonirritant to the skin of albino rabbits.
- Executive summary:
The study equivalent to OECD 404 was conducted to determine the dermal irritation produced by a single application of the test material, hydroxypropyl .beta.-cyclodextrin, in albino rabbits. A dose of 0.5g of the test material was administered to a dorsal skin site on each of six New Zealand White rabbits. The material was maintained at each site over a four-hour exposure period, the sites were wiped with paper towels wetted with water to aid in the removal of any remaining test material. Each of the sites was examined and scored for signs of irritation at 30 to 60 minutes and approx. 24, 48 and 72 hours following the removal of the bandaging and patch.
No erythema, edema or other dermal effects were observed in any of the six rabbits during the study.
The primary irritation index for the test material, hydroxypropyl .beta.-cyclodextrin, was 0.0. The material was considered to be a nonirritant to the skin of albino rabbits.
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