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EC number: 231-493-2 | CAS number: 7585-39-9
- 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: GLP compliant OECD Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cycloheptapentylose
- EC Number:
- 231-493-2
- EC Name:
- Cycloheptapentylose
- Cas Number:
- 7585-39-9
- Molecular formula:
- C42H70O35
- IUPAC Name:
- 5,10,15,20,25,30,35-heptakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.2~3,6~.2~8,11~.2~13,16~.2~18,21~.2~23,26~.2~28,31~]nonatetracontane-36,37,38,39,40,41,42,43,44,45,46,47,48,49-tetradecol (non-preferred name)
- Details on test material:
- BETA-CYCLOOEXTRIN (KLEPTOSE®),
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino (no further details reported)
- Details on test animals or test system and environmental conditions:
- Species: rabbit
Strain: albino
Origin: VASSEUR, PROUZEL. FRANCE
Sex: males
Weight: 2.0 kg - 3.0 kg
Number :6/group
Housing: individual stainless steel cage. wire-floor size 61 x 48 x 37 cm
Feed: SANDERS / LAPIPLUS - ROBENZ
Beverage: drinking water, automatic drinking bowl
Environment:
temperature 20° C +/- 1
hygrometry 50 %+/- 10
artificial lighting 12 hrs/day
air renewal 12 times/hr
The animals were housed for at least one week before the beginning of the experiment.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes, untreated area of animal
- Amount / concentration applied:
- 0.5 g of solid substance, on each flank
- Duration of treatment / exposure:
- 23 hr
- Observation period:
- up to 14 days
- Number of animals:
- 6
- Details on study design:
- About 24 hrs prior to the study, the six rabbits were clipped with a fine-tooth electric clipper to bare a skin surface of 14 cm x 14 cm (cutting
height = 1/20th mm); thus a precise cut can be achieved without irritating the skin mechanically. The animals were left to rest for 24 hours; then only those with a perfectly healthy skin were chosen for the test.
Three incisions of about 2 cm long, 0.5 cm apart, were made into the right flank of each rabbit, parallel to the vertebral axis, by means of a sterile
vaccinostyle. The incisions were made so as to attack the epidermis without reaching the dermis. Any bleeding has to be avoided, and in any case, the
underlying muscle must not appear.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: none
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0.5
- Reversibility:
- fully reversible
- Remarks on result:
- other: none
- Irritant / corrosive response data:
- The figures for erythema and oedema obtained 1 hr. 24 and 48 hrs after removal of the dressings on both flanks were added for the 6 rabbits; then the index of primary cutaneous irritation (Pci) was calculated by dividing the total by the number of data
The results were interpreted according to the following scale:
less than 0.5 non irritant
from 0.5 up to 2 slightly irritant
from 2 up to 5 moderately irritant
from 5 up to 8 severely irritant - Other effects:
- none reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Beta-Cyclodextrine showed practically no irritating potential when applied to the skin of rabbits.
- Executive summary:
In a skin irrtation assay with beta-Cyclodextrin (purity 100%) according to OECD Guideline 404 on 6 albino rabbits 0.5 g of the substance was administered to the clipped and shaved skin. A primary cutaneous irritation scheme ranging from 0 to 8 was used. The substance was left under occlusive conditions for 23 h. The skin was then observed after 1, 24 and 48 hr, showing an edema score of 0 and also an erythema score of 0 for all animals at all observation times. Only one animal exhibited a erythema score of 0.5 at the 24 h observation interval. The erythema score of this animal returned to 0 after 48 hr and showed full reversibility. Under the conditions used beta Cyclodextrin has to be clssified as not irritant to the skin of rabbits.
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