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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study report, only one dose tested
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- see principles
- Principles of method if other than guideline:
- one dose used (100 mg/kg)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
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:
- LAB 870 (Beta-Cyclodextrin)
batch 392344
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: I.O.P.S., OFl (IFFA CREDO)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals (6 - 8 weeks old mouse) were housed in groups of 2 (prelimi-nary study) or 5 (final study) in plastic cages (dimensions: 205 x 118 x 127 mm) on a dust free litter. The temperature was kept at 22 + 3 °C. The rela-tive air humidity was 30 - 70 %, with air changes of at least 8 per hour; arti-ficial lighting : 12 hours out of 24.
Commercial pelleted rat-mouse A04 CR diet - batch 70.630 (U.A.R. - Usine d'Alimentation Rationelle, Villemoisson sur Orge, France). Each manufac-turing batch was analysed to detect contaminants. Drinking water ad libitum.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- carboxymethylcellulose hydrogel (1%)
- Details on exposure:
- one injection of 10 ml/kg
- Duration of treatment / exposure:
- 24, 48, and 72 hours respectively
- Frequency of treatment:
- once
- Post exposure period:
- 24, 48, and 72 hours respectively
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s):
- Route of administration:
- Doses / concentrations:
Examinations
- Tissues and cell types examined:
- erythrocytes from the femur bone marrow
- Details of tissue and slide preparation:
- The animals were killed at the end of the treatment period by dislocation of the cervical vertebrae. The bone marrow removed from both femurs was suspended in foetal calf serum and centrifugated. For each animal, two smears were prepared on slides stained with May-Grunwald-Giemsa.
For each animal 1000 polychromatic erythrocytes were examined. A count of the number of polychromatophile erythrocytes bearing micronuclei was performed. At the same time, an observation and a count of the number of normochromatophile erythrocytes were carried out.
The results are expressed for each animal by the following ratio : number of normochromatophile erythrocytes for 400 polychromatophile erythrocytes. The average test and standard deviation were calculated for each group. The results are reported in the appendix. - Evaluation criteria:
- not reported
- Statistics:
- The results are expressed as the number of cells bearing micronuclei for 1000 polychromatophile erythrocytes observed.
A statistical analysis wi th the aid of Student's test and the test of exact bilateral comparison were performed.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 100- 5000 mg/kg bw (intraperitoneal)
- Solubility: in vehicle soluble
- Clinical signs of toxicity in test animals: The results of the preliminary study show that the highest dose tolerated under the experimental conditions employed, averages 100 mg/kg. Therefore, the 100 mg/kg doses was chosen for the final trial.
- Evidence of cytotoxicity in tissue analyzed:
- Rationale for exposure: toxicity reasons, high mortality in higher concentrations
- Harvest times: 24, 48 and 72 h
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): no
- Ratio of PCE/NCE (for Micronucleus assay): NCE/PCE 1.32 for 24 h harvest time, 0.82 (48 h) and 0.67 (72 h)
:
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Substance is not mutagenic in the in vivo micronucleus assay under the conditions used - Executive summary:
The mutagenic potential of the test article beta-Cyclodextrin (purity not specified) was tested in the I.O.P.S., OFl (IFFA CREDO) mouse using the micronucleus test, at a preliminarily defined dose of 100mg/kg according to a procedure similar to OECD 474.
The animals (5 males and 5 females per group) were administered the product by the intraperitoneal route (vehicle 1% carboxymethylcellulose hydrogel) and killed 24, 48 or 72 hours after administration. For each animal an examination of 1000 polychromatic erythrocytes obtained from the femoral bone marrow was performed. The statistical analysis of the results does not show any significant increase in the number of polychromatic erythrocytes bearing micronuclei in the animals treated with the test substance. The results obtained with the positive control (cyclophosphamide) are significantly positive. Concerning the ratio normochromatic/polychromatic erythrocytes which in the absence of toxical effect is close to 1, there was no significant increase in this value in the animals treated with the test article. A significant increase was observed in the animals treated with the positive control. To conclude, the test article did not induce any mutagenic effect in the mouse when administered at a dose of 100 mg/kg.
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