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EC number: 601-595-5 | CAS number: 119302-20-4
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 July to 5 November 1999
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- (3aS,3bR,9aS,9bR,11aS)-9a,11a-dimethyl-8-(morpholin-4-yl)-2-(pyrrolidin-1-yl)-hexadecahydro-1H-cyclopenta[a]phenanthrene-1,7-diol
- EC Number:
- 601-595-5
- Cas Number:
- 119302-20-4
- Molecular formula:
- C27H46N2O3
- IUPAC Name:
- (3aS,3bR,9aS,9bR,11aS)-9a,11a-dimethyl-8-(morpholin-4-yl)-2-(pyrrolidin-1-yl)-hexadecahydro-1H-cyclopenta[a]phenanthrene-1,7-diol
- Test material form:
- other: Solid
- Details on test material:
- - Name of test material (as cited in study report): Pymordiol
- Physical state: Cream white solid
- Purity of test material: 96 wt%
- Lot/batch No.:DGM096K1A
- Expiration date of the lot/batch: 1 January 2001
- Stability under test conditions: Stable through test period
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar Crl:(WI) BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approximately 7 weeks old
- Weight at study initiation: Within 20% of sex mean
- Fasting period before study: Overnight prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per sex per cage in polycarbonate cages containing purified sawdust as bedding material.
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (Carfil Quality BVBA, OUd-Turnhour, Belgium).
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21˚C
- Humidity (%): 50%
- Air changes (per hr): 15 Air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial fluorescent light/12 hours dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10mL/kg
- Justification for choice of vehicle: The vehicle was selected based on a pretest performed at NOTOX.
DOSAGE PREPARATION (if unusual): Formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Toxicity of the test substance was assessed by stepwise treatment of groups of 3 animals. - Doses:
- 200 mg/kg
2000 mg/kg - No. of animals per sex per dose:
- 3 Animals
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: Yes, by asphyxiation using oxygen/carbon dioxide procedure.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Twice daily viability/mortality; body weights Days 1 (pre-admin), 8 and 15 and at death; clinical signs were taken on day 1 and once daily thereafter, until day 15.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The incidence of mortality is reported in Table No. 1 below.
Two females and two males were found dead on days 2 and 4 and on days 4 and 5, respectively. The two other animals (one female and one male) were sacrificed moribund on day 7 and day 5, respectively, as indicated by the combination of clinical signs and considerable body weight loss observed in these animals. - Clinical signs:
- other: Within the 200 mg/kg dose group, signs of alopecia and/or scabs (in the neck) became apparent in two females during week 2. Based on the time of occurrence, these findings were considered not related to treatment and of no toxicological significance. Wi
- Gross pathology:
- Reduced spleen and thymus size was found among the 2000 mg/kg treated animals, at macroscopic post mortem examination.
Any other information on results incl. tables
Table 1:
Dose Level (mg/kg) | Mortality | Sex | Date of Treatment |
200 | 0/3 | females | 20-Jul-99 |
200 | 0/3 | males | 22-Jul-99 |
2000 | 3/3 | females | 27-Jul-99 |
2000 | 3/3 | males | 29-Jul-99 |
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the current test conditions the oral LD50 value for the test substance is within the following range 200-2000 mg/kg body weight.
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