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EC number: 243-175-0 | CAS number: 19592-55-3
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 14 to 28, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 3,20-bis(ethylenedioxy)pregna-5,7-diene
- EC Number:
- 243-175-0
- EC Name:
- 3,20-bis(ethylenedioxy)pregna-5,7-diene
- Cas Number:
- 19592-55-3
- Molecular formula:
- C25H36O4
- IUPAC Name:
- (1S,3aR,9aR,9bS,11aS)-9a,11a-dimethyl-1-(2-methyl-1,3-dioxolan-2-yl)-1,2,3,3a,6,8,9,9a,9b,10,11,11a-dodecahydrospiro[cyclopenta[a]phenanthrene-7,2'-[1,3]dioxolane]
- Test material form:
- other: Crystalline powder
- Details on test material:
- Off-white crystalline powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan/CPB, Zeist, The Netherlands
- Weight at study initiation: 175-200 g- male; 150-175 g-females
- Fasting period before study: About 18 hours
- Housing: 2 to 3 rats per Macrolon cage containing sawdust
- Diet (e.g. ad libitum): a standard laboratory diet RHM-TM, Hope Farms, Woerden
- Water (e.g. ad libitum): tap water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 40-60 %
- Air changes (per hr): 16
- Photoperiod: Artificial light from 7 a.m. till 7 p.m.; Radio-sound 24 hours per day
Administration / exposure
- Route of administration:
- other: stomach tube
- Vehicle:
- other: tragacanth mucilage in distilled water
- Details on oral exposure:
- From the test material suspension samples with a volume of 10 ml/kg were taken, equivalent to 2000 mg/kg, and were administered by stomach tube to five male and five female fasted rats.
- Doses:
- dose level:2000 mg/kg ( males and females)
- No. of animals per sex per dose:
- 5 females/males per dose
- Control animals:
- no
- Details on study design:
- The test procedure used was in accordance with EEC Directive 84-449, Annex V, Part Bl. The animals were individually identified by means of a dye marking system on the fur. From the test material suspension samples with a volume of
10 ml/kg were taken, equivalent to 2000 mg/kg, and were administered by stomach tube to five male and five female fasted rats.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the observation period.
- Clinical signs:
- During the 14-day observation period no clinical signs were observed.
- Body weight:
- Oral administration of proketal had no appreciable effect on body weights and body weight-gains of male rats during the observation period.
In females, relatively low body weight-gains were observed during the second week of the study. - Gross pathology:
- At autopsy 14 days after dosing, dark adrenals in one male, slightly enlarged adrenals in three females, slightly swollen livers in two males and in one female, a not completely empty bladder in one male and a slightly swollen uterus in one female rat was seen.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material was > 2000 mg/kg bodyweight.
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