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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
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 28 Oct to 11 Nov 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:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Acute toxicology Standard Procedure
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
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.: 15497-87-3
Purity: 95.3%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories Inc., Wilmington MA
- Age at study initiation: Six-week old
- Weight at study initiation: 164.3 to 176.0 grams
- Fasting period before study:
- Housing: Polycarbonate shoe box-type cages, males or females given the same dose were housed together (three per cage). The cage floor was covered with hardwood chip bedding (Ab-sob-dri, Lab products). All test animals were transferred into a clean cage each day.
- Diet (e.g. ad libitum): Prolab RMH-3000 pelleted rodent diet (Agway) ad libitum
- Water (e.g. ad libitum): Drinking water was obtained from a municipal water source subject to regulation by the U.S. Environmental Protection Agency. Water was suplied ad libitum from bottles that were changed two times a week.
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 70±2
- Humidity (%): 50±5
- Air changes (per hr): approximately 18 times per hour with air filtered through 80-90% efficiency filters and finally through HEPA filters.
- Photoperiod (hrs dark / hrs light): illuminated by fluorescent lighting 12 hours a day (7:00 am-7:00pm).
IN-LIFE DATES: From 28 Oct to 11 Nov 1987
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- other: 0.1% (w/v) aqueous methylcellulose solution
- Details on exposure:
- Concentration in vehicle: 2%
- Doses:
- 50, 150, and 300 mg/kg
- No. of animals per sex per dose:
- 3 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rats were observed for clinical signs and mortality for 14 days after dosing. The individual body weights of the animals was obtained at least six times during the study, i.e. on the day of dosing (day 0) and on the day 1, 4, 7, 10, and prior to the sacrifice on day 14.
- Necropsy of survivors performed: Animals that died during the study and those that survived to sacrifice were necropsied for gross pathological changes.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Statistics:
- None stated
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was produced by an intraperitoneal dose of 50 or 150 mg/kg, but one of three rats given high dose of 300 mg/kg died.
- Clinical signs:
- Clinical signs were observed at all doses tested (50, 150 and 300 mg/kg). Within 15 minutes of dosing, all rats were pulling in the sides of their abdomen. By 1 to 2 hours post dose, the activity and respiration of the animals was decreased, and most tended to remian in a stationary position. In addition, those given 150 or 300 mg/kg walked hunched and with slow placement of the feet.
All rats given the low dose of 50 mg/kg appeared essentially normal on the day after dosing (day 1) and throughout the remainder of the 14-day observation period. The activity and respiration of the rats given 150 or 300 mg/kg were still decreased on day 1. In addition, one high dose animal appeared thin, was shaky and weak, and walked in a crawling fashion. This animal was nearly prostrate on day 2 and was found dead on the morning of day 3. Rats given a dose of 150 mg/kg recovered within 2 or 3 days of dosing. One of the two survivors given the high dose of 300 mg/kg recovered completely by day 4. However, the condition of the other high dose rat began to deteriorate on day 2, and by day 3, it was also weak, appear thin, and by day 5, the rat appeared essentiallty normal. - Body weight:
- On day 3, all rats given the low dose of 50 mg/kg weighed several grams less than they did on day 2, but their weight on day 4 was above that recorded on day 2. The overall weight gain of these loe dose animals was normal. Most of the rats given 150 or 300 mg/kg weighted less than they did prior to dosing on day 1. Rats given a dose of 150 mg/kg exhibited a slight loss of weight on day 3, but showed progressive weight gain from day 4 on, and their overal weight gain at the end of the study was essentially normal. One of the two survivors given the high dose of 300 mg/kg was gaining weight by day 3. However, the other high dose rat continued to lose weight by day 3. By day 4, the animal was gaining weight, but at sacrifice on day 14 , this animal weighed considerably less than all other surviving rats.
- Gross pathology:
- White material (presumably test article) was evident in the abdominal cavity of the high dose animal found dead on day 3. The liver was dark and mottled, a whitish haze was apparent over its surface, and portions of the small intestine were reddened. In all survivors sacrificed on day 14, white material was evident within the peritoneal cavity and was often adhered to the pancreas and liver. In rats given 150 or 300 mg/kg, there was a whitish haze over the surface of the kidneys and/or spleen. In addition, the pancreas, liver, and/or testicular fat bodies were often adhered via the white material.
Applicant's summary and conclusion
- Conclusions:
- The approximate acute intraperitoneal median lethal dose (LD50) of the test item in the Sprague-Dawley male rat was estimated to be greater than 300 mg/kg body weight.
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