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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 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
- Study period:
- August 1990
- 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: Schlegel and MacGregor, (Mutation Res. 104:367-369, 1982), MacGregor et al., (Ibid. 189: 103-112, 1987) and Heddle et al., (Ibid 123:61-118, 1983)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
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.: 15497-237-1
Purity: Not specified
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 30±5 grams
- Assigned to test groups randomly: yes
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: distill water containing 5% methylcellulose
- Justification for choice of solvent/vehicle:
- Concentration of test material in vehicle:
- Amount of vehicle (if gavage or dermal):0.3 mL/30 g
- Type and concentration of dispersant aid (if powder):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- three days
- Frequency of treatment:
- once per day
- Post exposure period:
- 24 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1000 and 2000 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C
- Route of administration: i.p. adminstration
- Doses / concentrations: 0.5 mg/kg/day
Examinations
- Tissues and cell types examined:
- For each preparation, 1000 PCEs (polychromatic erythrocyte) were scored for presence of micronuclei. Also, the ratio of PCE to NCE (normochromatic erythrocytes) in 200 erythrocytes was determined as an index of cytotoxicity.
- Details of tissue and slide preparation:
- Twenty-four hours after the final treatment, mice were sacrificed by cervical dislocation and swears were made from the bone marrow of the femora from each mouse. At least two slides were prepared. Slides were fixed in absolute methanol within one hour of collection and were then coded hy independent technician. Immediately prior to scoring, slides were stained 1-3 minutes in acridine orange (0.125 mg/mL) in phosphate buffer, rinsed in buffer and coverslips were mounted in the buffer.
- Evaluation criteria:
- A positive response is defined as a substantial, dose-related and reproducible elevation in the number of micronucleated PCEs in the treated animals. Where a positive response is indicated, statistical analysis can be conducted using a one-tailed trend test and also a pairwise comparison of the results for each treatment group with the concurrent negative control (Margolin et al., A general purpose statistical analysis program for the micronucleus assay-working document. ILS Committee for the Development of a Software Program for the Micronucleus Assay, 1990).
- Statistics:
- None stated
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Drug-associated reduction in the percent of PCEs
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The frequencies of MNPCE at all dose levels of test substance are within the acceptable historical negative control limits. Positive controls showed a significant elevation in micronucleated PCEs in accordance with historical control data. Negative controls showed expected results. There was evidence of drug-related bone marrow toxicity as indicated by a dose-related decrease in percent PCEs. There was no substantial increase in micronucleated PCEs. The test substance produced a dose-related decrease in the percentage of PCEs indicating drug-related toxicity.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
These studies demonstrate that the test subsance does not induce micronuclei in PCEs in bone marrow in male or female mice. Drug-associated reduction in the percent of PCEs in both sexes confirms that the dose level used were at or near the maximum tolerated dose.
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