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Diss Factsheets
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EC number: 233-007-4 | CAS number: 10016-20-3
- 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
Endpoint summary
Administrative data
Description of key information
Under the conditions of a repeated insult occlusive patch test the read-across substance .beta.-cyclodextrin did not induce irritation or allergic contact dermatitis in human subjects.
Additional information
.Alpha.-, .beta.- and .gamma.-cyclodextrin are composed of six, seven and eight identical α-D-glucopyranoside units, respectively. The water solubility is between 18 and 232 g/L at 25°C with .beta.-cyclodextrin being the least soluble within this group. The potential for skin irritancy and skin sensitisation can be considered similar and the results from a 9 Repeated Insult (occlusive) Patch Test (9 RIPT) with .beta.-cyclodextrin can be considered as valid and reliable also for the evaluation of .alpha.- and .gamma.-cyclodextrin.
The amount of test material applied to each test patch was approximately 0.2 g. The test material was placed onto Parke-Davis Readi-Bandage occlusive patch, which was applied to the back of each subject between the scapulae and waist, adjacent to the spinal mid-line.
The subjects removed the patch 24 hours after application. Twenty-four hour rest peri-ods followed the Tuesday and Thursday removals and 48-hour rest periods followed the Saturday removal. The site was scored by a trained examiner just prior to the next patch application. This procedure was repeated until nine (9) applications of the test material had been made. Procedurally, if a subject develops a positive reaction of a 2-level erythema or greater during the Induction Phase or, at the discretion of the Study Director, if the skin response warrants a change in site, the patch would be applied to a previously unpatched adjacent site for the next application. If a 2-level reaction (or greater) occurs on the new site, no further applications would be made. However, any reactive subjects would be subsequently challenged with the test material. After a rest period of 15 to 19 days (no further application of the test material, the challenge patch was applied to a previously unpatched (virgin) site. The site was scored 24 and 48 hours after application. The panelists were asked to report to the laboratory any delayed reaction which might have occurred after the last reading. A total of 55 subjects completed the test, 3 subjects discontinued for personal reasons unrelated to the conduct of the study. Scattered, transient, barely perceptible to mild (1 -level) non-specific patch test responses were observed on 3/55 test panelists (subject nos.6, 39, 41) during the induction or challenge phase of the study. None of the non-specific response was irritant or allergic in nature. Under the conditions of a repeated insult occlusive patch test the read-across substance .beta.-cyclodextrin did not induce irritation or allergic contact dermatitis in human subjects.
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