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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Cyclohexapentylose
- EC Number:
- 233-007-4
- EC Name:
- Cyclohexapentylose
- Cas Number:
- 10016-20-3
- Molecular formula:
- C36H60O30
- IUPAC Name:
- (1S,3R,5R,6S,8R,10R,11S,13R,15R,16S,18R,20R,21S,23R,25R,26S,28R,30R,31R,32R,33R,34R,35R,36R,37R,38R,39R,40R,41R,42R)-5,10,15,20,25,30-Hexakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29-dodecaoxahe ptacyclo[26.2.2.23,6.28,11.213,16.218,21.223,26]dotetracontane-31,32,33,34,35,36,37,38,39,40,41,42-dodecol
- Details on test material:
- Date of receipt: February 11, 1991
Designation: .alpha.-cyclodextrin
Batch no.: 8708644 (charge 0030)
CAS Reg. no.: 10016-20-3
General appearance: white powder
Storage conditions: at room temperature (circa 20°C).
All preparations were made just prior to use.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: SPF-bred albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Species: SPF-bred albino guinea pigs (Crl:(HA)BR)
Supplier: Charles River Wiga GmbH, F.R. Germany
Sex and age: males and females, young adult
Identification: earmarking
Date of arrival: September 15, 1992
Start date of study: September 29, 1992
Termination date of study: October 23, 1992
Body weight range prior to start of study: males 328-395 g; females 308-387 g
Caging: individually in suspended, stainless steel cages, fitted with wire mesh floor and front
Lighting: 12 hours light/12 hours dark cycle
Temperature: 22 +/- 3°C
Humidity: 42.5% - 90% (upper limit higher than the intended 70%, because of meteorological circumstances or because of wet cleaning of the animal room)
Ventilation: ca 10 air changes/hour
Diet: pelleted, natural ingredient diet for guinea pigs (Hope Farms, Woerden, The Netherlands) and tap water, ad libitum
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1 ml each
Test animals: two injections with Freund's Complete Adjuvant (FCA) and demi-water (1: 1); two injections with a 3% dilution of the test substance in demi-water; two injections with a 3% dilution of the test substance in demi-water and FCA (1:1)
control animals: two injections with FCA and demi-water (1:1); two injections with demi-water; two injections with FCA and demi-water (1:1).
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- 0.1 ml each
Test animals: two injections with Freund's Complete Adjuvant (FCA) and demi-water (1: 1); two injections with a 3% dilution of the test substance in demi-water; two injections with a 3% dilution of the test substance in demi-water and FCA (1:1)
control animals: two injections with FCA and demi-water (1:1); two injections with demi-water; two injections with FCA and demi-water (1:1).
- No. of animals per dose:
- Preliminary test: 3 animals
Main study: 15 animals per sex per group
Test group: 10 per sex
Control group: 5 per sex - Details on study design:
- The study consisted of an induction treatment, followed by a resting period of 14 days, which preceded the challenge treatment. Preliminary observations were made to establish the concentrations of the test substance for intradermal injection and for topical application in the main study.
Preliminary tests
The irritation response upon intradermal injection of various concentrations was examined in 3 guinea pigs. A sufficiently large area of the flanks was clipped free from hair with electric clippers. Amounts of 0.1 ml of a 10%, a 3%, and a 1% dilution of the test substance in demi-water were applied by intradermal injection. Due to viscosity, higher concentrations were not examined. A concentration causing slight to moderate irritation but otherwise well-tolerated by the animals, is usually taken for intradermal injection of the test substance in the induction phase of the main study.
The irritation response to topical treatment of a 30%, a 10%, and a 3% dilution of the test substance in vaseline was examined. Concentrations higher than 30% were not tested, because usually they form dry and tough pastes which are less suitable for topical application. The flanks of each of three animals were clipped free from hair with electric clippers.
Patches were loaded with the various test dilutions. The patches, each loaded with a different concentration, were placed separately on an intact area of the clipped skin of each animal, and covered with a piece of hypoallergenic paper bandage (Leukopor) that was secured by elastic adhesive bandage (Tensoplast, 7.5 cm in width), wound around the torso of the animal. The dressing was left in place for 24 hours. After removal of the dressing and 24 hours later, the animals were examined for signs of skin irritation. A concentration causing slight to moderate skin irritation is usually chosen for topical induction and a non-irritant concentration for topical challenge.
Main study
Fifteen male and 15 female guinea pigs were randomly divided into two groups, viz. a test group of 10 males and 10 females and a control group of 5 males and 5 females. The animals were weighed one day before the study was initiated and at the completion of the study.
Induction
Induction was effected in two different ways, firstly by intradermal injections and secondly, one week later, by topical application over the injection sites.
Intradermal injections
For this purpose an area of about 24 cm2 of dorsal skin in the scapular region was clipped free from hair with electric clippers.
Pairs of intradermal injections (0.1 ml each) were made simultaneously in the clipped area. The following preparations were injected:
test animals
- two injections with Freund's Complete Adjuvant (FCA) and demi-water (1: 1) ,
- two injections with a 3% dilution of the test substance in demi-water,
- two injections with a 3% dilution of the test substance in demi-water and FCA (1:1),
control animals
- two injections with FCA and demi-water (1:1),
- two injections with demi-water,
- two injections with FCA and demi-water (1:1).
Skin readings were made at 24 hours after the treatment.
Topical application
One week after the intradermal injections, the dorsal skin in the scapular region of the test and control animals was closely shaved again. The induction by topical application was made in this region. The test animals were treated as follows:
A circa 2 x 4 cm patch of Whatman No. 3 MM filter paper was loaded with a 30% dilution of the test substance in vaseline. The loaded patch was placed over the sites of the intradermal injections. The dressing was left in place for 48 hours. The control animals were similarly treated with patches loaded with vaseline only. Skin readings were made directly after removal of the patches. - Challenge controls:
- The topical challenge was carried out two weeks after the topical induction as follows:
An area of circa 5 x 5 cm on both flanks of each test and control animal was clipped free from hair. Patches were loaded with a 30% or a 10% test dilution in vaseline, or with vaseline only. One patch loaded with the 10% test dilution was placed on the clipped area of the left flank of each test and control animal. The right flank was treated with the 30% test dilution in vaseline and with vaseline alone. The patches were covered with Leukopor bandage, and held in place by Tensoplast for 24 hours. Skin readings were made at 24 and 48 hours after removal of the patches. - Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene
Results and discussion
- Positive control results:
- preliminary tests
The degree of irritation observed after intradermal treatment with a 3% dilution in demi-water was considered acceptable for intradermal treatment during the induction phase.
The degree of irritation observed after topical treatment with the 30% test dilution in vaseline was considered acceptable for topical treatment during the induction phase of the study. The 30% and 10% test dilution in vaseline induced signs of skin irritation at 1 hour after treatment. The next day, the skin effects on all 10% test sites had cleared completely, while one 30% test site still showed very slight erythema. On the basis of these results, the 30% and 10% test concentrations were considered acceptable for topical treatment during the challenge phase of the study.
Main study
All animals remained in good health during the experimental period.
Induction
The intradermal injections generally caused the following skin reactions:
test animals
- with FCA and demi-water mixture (1:1): severe erythema,
- with the 3% dilution of the test substance in demi-water: slight erythema,
- with the 3% dilution of the test substance in a mixture of FCA and demiwater (1:1): moderate or severe erythema and abcesses,
control animals
- with FCA and demi-water mixture (1:1): severe erythema and abscesses,
- with demi-water alone: slight erythema (2 animals),
- with FCA and demi-water mixture (1:1): moderate or severe erythema and abscesses.
After topical application of the patches loaded with vaseline only, no signs of skin irritation were observed in the controls. Topical application of the 30% test dilution in vaseline induced very slight erythema in 6 test animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% dilution of .alpha.-CD in vaseline
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% dilution of .alpha.-CD in vaseline. No with. + reactions: 3.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% dilution of .alpha.-CD in vaseline
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% dilution of .alpha.-CD in vaseline. No with. + reactions: 2.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The challenge treatment with the 30% test dilution, the 10% test dilution, and with vaseline alone produced a similar skin response in animals of the test and control group. Therefore, the skin effects observed after the challenge treatment were attributed to skin irritation, rather than sensitization. Because none of the test animals showed positive signs of sensitization, it was concluded that under the conditions of this study and according to the EEC-standards (mentioned in EEC-Directive 91/325/EC and published in the Official Journal of the European Communities, L 180, Volume 34, 8 July 1991), .alpha.-cyclodextrin is not a sensitizer.
- Executive summary:
The test substance .alpha.-cyclodextrin was examined for possible sensitizing properties by a maximization test in guinea pigs using 20 test animals and 10 controls.
The test comprised:
test animals
- induction treatment by intradermal injections of Freund's Complete Adjuvant (FCA) 1:1 diluted with demineralized water (demi-water), a 3% dilution of the test substance in demi-water, and a 3% dilution of the test substance in a 1:1 mixture of FCA and demi-water, followed one week later by topical application of a 30% dilution in vaseline,
- challenge treatment, 14 days after the last induction, by topical application of a 30% and a 10% dilution in vaseline, and of Vaseline alone,
controls
- induction treatment by intradermal injections of FCA 1:1 diluted with demi-water, demi-water alone, and a 1:1 mixture of FCA and demiwater, followed one week later by topical application of Vaseline alone, and
- challenge treatment, 14 days after the last induction, by topical application of a 30% and a 10% dilution of the test substance in vaseline, and of vaseline alone.
The challenge treatment with .alpha.-cyclodextrin did not induce signs of sensitization in the test animals. On the basis of the results, it was concluded that under the conditions of this study and according to the EEC-standards, the test substance .alpha.-cyclodextrin is not a sensitizer.
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