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EC number: 211-995-8 | CAS number: 734-32-7
- 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:
- July to Aug 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- Deviations:
- yes
- Remarks:
- In contrast to annex 3c of OECD TG 423 in its version of 1996 the starting dose (2000 mg/kg) was not applied to the second sex (females) although only 1/3 males died after application of 2000 mg/kg.
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Estr-4-ene-3,17-dione
- EC Number:
- 211-995-8
- EC Name:
- Estr-4-ene-3,17-dione
- Cas Number:
- 734-32-7
- Molecular formula:
- C18H24O2
- IUPAC Name:
- estr-4-ene-3,17-dione
- Test material form:
- other: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HAN: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG
- Weight at study initiation: males: 98-118 g, females: 89-95 g
- Fasting period before study: ca. 19-21 hours
- Housing: 1 animal/cage
- Diet (e.g. ad libitum): pell. Altromin® R, ad libitum 24 hours per day
- Water (e.g. ad libitum): demineralized acidified water, pH 2-3, ad libitum
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-24°C
- Humidity (%): 42-60%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: physiological saline with 0.085% (w/v) Myrj 53
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 and 200 mg/mi - Doses:
- 200 mg/kg (both sexes), 2000 mg/kg (only males)
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: start (day 1), on day 8 and at the end (day 14) of the study
- Necropsy of survivors performed: yes
- Clinical signs including body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One animal died after application of 2000 mg/kg on day 1 (3.5 hours post application) of the test.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- within normal range for rats (M+F) of the age and strain
- Gross pathology:
- Autopsy revealed no compound-related findings.
Applicant's summary and conclusion
- Conclusions:
- A single oral administration of the test substance by gavage to male rats at the limit-dose 2000 mg/kg was lethal for 1/3 animals. 200 mg/kg were tolerated without mortalities, clinical effects, effects on body weight gain and gross pathological findings in both sexes. According to OECD TG 423 the oral LD50 of the test substance is therefore: 1000 < LD50 < 2000 mg/kg body weight.
- Executive summary:
In an acute oral toxicity study similar to OECD TG 423, fasted Wistar rats were given a single oral dose by gavage of Norandrostendione in physiological saline with 0.085% (w/v) Myrj 53 at doses of 200 mg/kg (both sexes), 2000 mg/kg (only males) and observed for 14 days.
The administration of the test item at 2000 mg/kg bw resulted in transient clinical signs (apathy, prone position, unconsciousness, disturbances in gait and in respiration and eyelid closure). The surviving animals of this dose group were without findings from day 1 (4.5 hours after application) onwards. All animals treated with 200 mg/kg were without findings over the whole study period. The body weight gain observed on day 8 and at the end (day 14) of the test was within the normal range tor rats (M+F) of the age and strain. Autopsy revealed no compound-related findings.
The LD50 of the test item in male and female rats after a single oral application is > 1000 mg/kg body weight, probably near 2000 mg/kg.
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