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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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- see Principles
- Principles of method if other than guideline:
- The strains subcultured from storage dishes have been cultivated at 37°C in a nutritive medium (oxoid No 2 CM67). They have been collected in the morning from the shelf (approx. 2 x 10 x e9 bacteria/ml) and used the same day after approx. 16 hours of culture. The minimum medium used to evi-dence the mutants His+ is the V.B. medium.
The spreadings have been made with an overlayer containing a concentra-tion of 0.6 .% agar oxoid, 0.5 % sodium chloride, 0.05 mM biotine and L- Histidine, for a total volume of 2.5 ml. The amount of histidine has been cal-culated so as to allow the bacteria to divide 2 or 3 times on the plates since some mutagene agents operate only on growing cells.
A 500 mg/kg dose of Araclar 1254 dissolved in maize oil has been injected to 5prague-Oawley rats, through the peritoneum. On the 5th day after injec-tion, the rats were slaughtered. Livers were taken and homogenized at 4 •C in 0,15 M potassium chloride, and the mix was centrifuged 20 minutes at 9000 g. After centrifugation, the supernatant which constitutes the 59 frac-tion was kept in liquid nitrogen in 2 ml fractions.
The product Lab 870 has been solubilized in water for injection (Aguettant, batch 7428) at the concentration of 20 mg/ml. Successive dilutions have been carried out in the same solvent at following concentrations 10 - 5 - 1 - 0.1 mg/ml. The solutions and the pure product have been kept at 5°C for the trial duration. - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation 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:
- PRODUCT Lab 870 (Beta-Cyclodextrin)
LOT 392344
Constituent 1
Method
- Target gene:
- not applicable
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Pretest: 0.01 - 0.05 - 0.1 - 0.5 - 1 - 2 -4 mg /plate
Test: 0.1 - 0.5 - 1 - 2 - 4 mg/plate. - Vehicle / solvent:
- water for injection
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: amino-2-anthracene (2-anthramine)
- Remarks:
- all strains with S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98, TA1538 without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA100 without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- TA1535 without S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation);
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index - Evaluation criteria:
- None of the values obtained in presence of the product tested has been higher than, or equal to twice the value obtained in the presence of a soLvent with and without metabol ic activation on the 5 bacterial strains used.
- Statistics:
- not reported
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not reported
- Effects of osmolality: not reported
- Evaporation from medium: not reported
- Water solubility: not reported
- Precipitation: not reported
- Other confounding effects: not reported
RANGE-FINDING/SCREENING STUDIES: yes
COMPARISON WITH HISTORICAL CONTROL DATA: not reported
ADDITIONAL INFORMATION ON CYTOTOXICITY: not reported - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Substance is not mutagenic under the conditions used. - Executive summary:
The substance Beta-Cyclodextrin (LAB 870) has been tested on the 5 strains of Salmonella typhimurium (TA 98, TA 100, TA 1535, TA 1537, TA 1538) with and without metabolic activation (S9 -mix) according to the protocol of Ames and similar to OECD Guideline 471. A range of non-toxical concentrations had been determined in a preliminary experimentation on the strain TA 100 without metabolic activation. The 5 concentrations chosen (0.1, 0.5, 1, 2 and 4 mg/plate)have been tested in triplicate on the 5 strains quoted above, with and without metabolic activation. The results were confirmed in a second experiment separately from the first one.In each test a negative control (solvent) and a positive one (specific standard mutagene) had been included. The values obtained were consistent with the standards. Under these circumstances, the product did not show any mutagene power towards thestrains TA98, TA 100, TA 1535, TA 1537, TA .1538 with and without metabolic activation.
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