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EC number: 601-490-4 | CAS number: 117704-25-3
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Aug to Sep 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Mutation Research 123: 363-410
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- DNA damage and repair assay, unscheduled DNA synthesis in mammalian cells in vitro
Test material
- Reference substance name:
- (1'R,2S,4'S,5S,6R,8'R,10'E,12'S,13'S,14'E,16'E,20'R,21'R,24'S)-6-cyclohexyl-21',24'-dihydroxy-12'-{[(2R,4S,5S,6S)-5-{[(2S,4S,5S,6S)-5-hydroxy-4-methoxy-6-methyloxan-2-yl]oxy}-4-methoxy-6-methyloxan-2-yl]oxy}-5,11',13',22'-tetramethyl-5,6-dihydro-3',7',19'-trioxaspiro[pyran-2,6'-tetracyclo[15.6.1.1⁴,⁸.0²⁰,²⁴]pentacosane]-10',14',16',22'-tetraen-2'-one
- EC Number:
- 601-490-4
- Cas Number:
- 117704-25-3
- Molecular formula:
- C50H74O14
- IUPAC Name:
- (1'R,2S,4'S,5S,6R,8'R,10'E,12'S,13'S,14'E,16'E,20'R,21'R,24'S)-6-cyclohexyl-21',24'-dihydroxy-12'-{[(2R,4S,5S,6S)-5-{[(2S,4S,5S,6S)-5-hydroxy-4-methoxy-6-methyloxan-2-yl]oxy}-4-methoxy-6-methyloxan-2-yl]oxy}-5,11',13',22'-tetramethyl-5,6-dihydro-3',7',19'-trioxaspiro[pyran-2,6'-tetracyclo[15.6.1.1⁴,⁸.0²⁰,²⁴]pentacosane]-10',14',16',22'-tetraen-2'-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Batch No.: 15497-41-2
Purity: Not specified
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- hepatocytes: rat
- Test concentrations with justification for top dose:
- Preliminary cytotoxicity test: 10.0, 20.0, 40.0, 60.0, 80.0, 100.0 and 200.0 μg/mL;
Definitive test: 1.7, 5.0, 7.5, 10.0, 15.0, 20.0 μg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The primary choice of solvent is an aqueous solvent (culture medium or saline) due to their non-toxic properties in mammalian cultures. An alternative choice is a non-toxic concentration of an organic solvent such as dimethylsulfoxide (DMSO) or ethyl alcohol (ETOH).
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- no
- Remarks:
- Preliminary cytotoxicity test
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Remarks:
- Definitive test
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period:
- Exposure duration: Preliminary cytotoxicity test: 18-20 hours; Definitive test: 18-20 hours
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells): 10 mins
SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays): trypan blue
NUMBER OF REPLICATIONS: Preliminary cytotoxicity test: duplicate; Definitive test: four
NUMBER OF CELLS EVALUATED: Preliminary cytotoxicity test: At least one hundred attached cells; Definitive test: One culture from each treatment group counted at least 100 attached cells for viability, then at least 1000 non S-phase nuclei were scored for UDS from each cultre.
DETERMINATION OF CYTOTOXICITY
- Method: relative survival
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:
OTHER: - Evaluation criteria:
- A positive nucleus is one that has >4 net nuclear grain count. The criteria used for deermining a positive result is a statistically significant, reproducible and dose-related increase in the number of positive nuclei compared to the test solvent controls and the negative historical controls.
- Statistics:
- For statistical analysis, a two sample t-test is performed to determine significance.
Results and discussion
Test results
- Species / strain:
- hepatocytes: rat
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- up to 10 μg/mL
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the evaluation of the preliminary cytotoxicity of test substance, there was a substantial reduction in cell viability at 20 μg/mL. Test substance at ≥ 40.0 μg/mL, was toxic to the cultures. There was evidence of insolubility in the cultures at test concentrations of ≥ 60.0 μg/mL.
For the UDS assay, at test concentrations at 1.7, 5.0 and 7.5 μg/mL, there was no increase in UDS compared to the concurrent solvent controls. Test substanse at 10.0 μg/mL produced insufficient viability (less than 25%) and therefore should not be considered in the UDS evaluation. A two sample t-test performed at concentrations of 1.7, 5.0, and 7.5 μg/mL, indicated there was no statistically significant difference (at the p≤5 level) in the number of positive cells between the solvent controls and the treated cultures. Test substance at ≥ 15.0 μg/mL was toxic to the cultures. - 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
These studies indicate that the test substance does not induce UDS in primary cultures of rat hepatocytes at concentrations which produce marked reductions in cell viabilities.
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