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EC number: 241-482-4 | CAS number: 17465-86-0
- 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:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cyclooctapentylose
- EC Number:
- 241-482-4
- EC Name:
- Cyclooctapentylose
- Cas Number:
- 17465-86-0
- Molecular formula:
- C48H80O40
- IUPAC Name:
- cyclooctapentylose
- Details on test material:
- Designation: .gamma.-cyclodextrin
CAS no.: 17465-86-0
Batch no.: 80P200
Receipt no.: 24323
Date of receipt: February 15th, 2002
Characteristics: white solid powder
Storage conditions: at room temperature, dark, tightly closed
Stability under storage conditions: at +25 °C: <1 year
Expiry date: February, 2003
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- Species / strain: rabbit / Himalayan, an albino rabbit
Breeder: LPT Laboratory of Pharmacology and Toxicology KG; branch Löhndorf; D-24601 Löhndorf/Post Wankendorf
Selection of species: the rabbit is a commonly used non-rodent species for acute skin irritation tests (patch Test)
Sex: female animals
Number of animals: 3
Initial age: approx. 10 months
Initial body weight: 2.4-2.9 kg
Identification of animals: by tattooed number assigned by the Löhndorf breeding station
Duration of study: at least 20 adaptation days, 1 test day and a follow-up period of 72 hours
Diet:
ssniff K-H (ssniff Spezialdiäten GmbH, 0-59494 Soest) served as food. The food was available ad libitum before and after the exposure period.
At regular intervals (at least twice a year), the food is analysed for contaminants. Certificates of analysis of the composition and for contaminants were supplied by the manufacturer.
Drinking Water:
Drinking water was offered ad libitum before and after the exposure period. Samples of the drinking water are examined according to the 'Deutsche Trinkwasserverordnung, Bundesgesetzblatt, Jahrgang 1990' [German Regulations on drinking water, public notice of the law, 1990] by the Wasserbeschaffungsverband Harburg, D-21220 Seevetal twice a year.
In addition, drinking water samples taken at LPT are analysed by LUFA-ITL once a year for means of bacteriological investigations according to the German 'Deutsche Trinkwasserverordnung, Bundesgesetzblatt, Jahrgang 1990, Anlage 4' [German Regulations on drinking water, public notice of the law, 1990, Addendum 4].
Housing:
Before and after the 4-hour exposure period, the animals were kept singly in cages measuring 425 mm x 600 mm x 380 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, D-16352 Schönwalde) at a room temperature of 20°C ± 3°C (maximum range) and relative humidity of 55% ± 15% (maximum range). Deviations from the maximum range caused for example during cleaning procedures are dealt with in SOPs.
During the exposure period, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn. The cages excluded irritation of the skin by excrements and urine.
The rooms were lit (150 lux at approx. 1.5 m room height) and darkened on a 12-hour light/12-hour dark cycle.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 500 mg/6 cm² moistured with water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- Route of administration: dermal application to the shaved, intact dorsal skin
Selection of route of administration: according to OECD/EC guidelines
Exposure period: 4 hours
Frequency of administration: single administration
Dose level: 500 mg/patch and animal
Approximately 24 hours before the test, the fur was removed by shaving from the dorsal area of the trunk of the animals. Care was taken to avoid abrading the skin. Only animals with healthy intact skin were used. A dose of 500 mg was moistured sufficiently with water, to ensure good contact with the skin and applied to the test site (area: approx. 6 cm2). The test substance was applied to the test site and then covered with a gauze patch.
The patch was held in contact with the skin by means of a semi-occlusive dressing (non-irritating tape) for the duration of the exposure period. The surrounding untreated skin served as a control. Exposure time was four hours. During the exposure the animals were kept in comfortable restrainers.
Protective clothing:
All personnel handling the animals met the requirements for strict cleanliness. All experimental manipulations were performed by the designated personnel wearing a sterile cap, mask, gown and gloves.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Under the present test conditions three rabbits were exposed for 4 hours to 500 mg .gamma.-cyclodextrin/patch and animal (semi-occlusive condition). An erythema (grade 1) was noted in animal nos. 1 and 3 from 60 minutes up to 24 hours after patch removal. Animal no. 2 showed no substance related changes at the examination time-points 60 minutes, 24, 48 and 72 hours.
There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There were no systemic intolerance reactions.
- Executive summary:
Test system: acute skin irritation test (patch test) in rabbits according to EC guideline B.4. and OECD guideline 404
Test substance: .gamma.-cyclodextrin
Under the present test conditions three rabbits were exposed for 4 hours to 500 mg .gamma.-cyclodextrin/patch and animal (semi-occlusive condition). An erythema (grade 1) was noted in animal nos. 1 and 3 from 60 minutes up to 24 hours after patch removal. Animal no. 2 showed no substance related changes at the examination time-points 60 minutes, 24, 48 and 72 hours.
There were no systemic intolerance reactions.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments on the approximation of the laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present test conditions .gamma.-cyclodextrin was non – irritating to skin, hence, no labelling is required.
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