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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 31 May to 15 Jun 1988
- 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:
- 1 989
- Report date:
- 1989
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Standard Procedures of the Centre de Recherche, Amboise
- Deviations:
- no
- GLP compliance:
- yes
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.: 15497-120-1
Purity: 92.1%
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charies River, St-Aubin-Les-Eibeuf, France
- Age at study initiation: 80 days (mean)
- Weight at study initiation: 240.4±6.1 (mean, grams±SD)
- Fasting period before study:
- Housing: individually on decontaminated (autoclaved) sawdust bedding (Litalabo, Societe Parisienne des Sciures, France) in makrolon cages (425x266x150 mm)
- Diet (e.g. ad libitum): Animals had free access to a pelleted commercial laboratory animal food (diet A04C, from Usine d'Alimentation Rationnelie, Villemolsson-sur-Orge, France)
- Water (e.g. ad libitum): Animals had free access to tap water.
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 60±20
- Air changes (per hr): 14 times per hour
- Photoperiod (hrs dark / hrs light): From 7:00H to 19:00H.
IN-LIFE DATES: From 31 May To 15 Jun 1988
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: 0.6 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Lot/batch no. (if required): A21606, A21395
- Purity: - Duration and frequency of treatment / exposure:
- 10 days (day 6 to day 15 p.i.)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
6 mg/kg/day
- No. of animals per sex per dose / concentration:
- 5 females
- Control animals:
- yes, concurrent vehicle
- Positive control reference chemical:
- None stated
- Details on study design:
- None stated
- Details on dosing and sampling:
- On day 15 p.i. blood was taken, by puncture of the orbital sinus under light ether anaesthesia, at 1, 3, and 5 hours after dosing. The females were sacrificed with their fetuses after the last blood withdrawal. Amniotic fluid was then collected, pooled and about 2 mL kept for test substance estimation. Fetuses were taken for detection of test substance in their tissues.
- Statistics:
- None stated
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- not specified
Any other information on results incl. tables
1. Maternal plasma
Plasma test substance concentrations were sustained for at least 5 hours with maximal individual values between 0.48 and 1.27 μg/mL.
2. Fetal homogenates
Fetal test substance concentrations were comparable to those found in maternal plasma at 5 hours with individual values ranging from 0.27 to 1.10 μg/g wet weight.
3. Amniotic fluid
Drug concentrations were much lower than in fetal homogenates with values between 0.007 and 0.025 μg/mL.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the reproductive study in rats, the dams and their fetuses were exposed to similar concentrations of the unchanged drug. However, very little drug was found in the amniotic fluid.
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