Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 219-034-4 | CAS number: 2322-77-2
- 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:
- June to July 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
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:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Gona-2,5(10)-dien-17-one, 13-ethyl-3-methoxy
- IUPAC Name:
- Gona-2,5(10)-dien-17-one, 13-ethyl-3-methoxy
- Reference substance name:
- 13-β-ethyl-3-methoxygona-2,5(10)-dien-17-one
- EC Number:
- 219-034-4
- EC Name:
- 13-β-ethyl-3-methoxygona-2,5(10)-dien-17-one
- Cas Number:
- 2322-77-2
- Molecular formula:
- C20 H28 O2
- IUPAC Name:
- 3-Methoxy-18-methyl-2,5(10)-estradien-17-on
Constituent 1
Constituent 2
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: 103-114 g (males), 100-107 g (females)
- Fasting period before study: ca. 18 hours
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 54-64%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 900 mg NaCI + 85 mg Myrj 53 ad 100 ml bidist. water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml (males), 100 mg/ml female
- Amount of vehicle (if gavage): 10 ml/kg (males); 20 ml/kg (females)
- Lot/batch no.: G/9324-1 (males); G/9358-1 (females)
- Rationale for the selection of the starting dose: A higher dosage than 2000 mg/kg was not tested in the present study since this dose level is established as the upper limit dose for classification and labelling requirements concerning dangerous substances. - Doses:
- 2000 mg/kg
- 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 observations and weighing: day 1, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- none (limit test)
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died in the course of the study.
- Clinical signs:
- other: No compound related clinical findings.
- Gross pathology:
- Autopsy revealed no compound related findings.
Any other information on results incl. tables
No animal died in the course of the study. After application of 10 ml/kg of the formulation containing 200 mg test item/ml to the third animal it was established that this formulation was not homogeneous (although the vial was shaken between the applications a deposit of the substance was detected). Therefore the female animals were treated with a suspension containing 100 mg test item/ml with an application volume of 20 ml/kg. The applications to the male animals were not repeated because neither the female animals treated with a homogeneous formulation nor the male animals treated with the inhomogeneous suspension showed any compound-related findings. A single oral (gavage) application of 2000 mg/kg was tolerated without compound-related clinical findings. The body weight gain on days 7 and 14 was within the normal range for rats of this age and strain, which are routinely used in the laboratory. Autopsy revealed no compound-related findings.
Applicant's summary and conclusion
- Conclusions:
- A single oral administration of the test substance by gavage to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, clinical signs, effects on body weight gain and gross pathological findings. According to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight.
- Executive summary:
In an acute oral toxicity study similar to OECD TG 423 (adopted 22 March 1996), groups of fasted, Wistar rats, female and male weighing 100-107 and 103-114g, respectively, (3/sex) were given a single oral dose of D-ET-Dienon in 900 mg NaCI + 85 mg Myrj 53 ad 100 ml bidist. water at a dose of 2000 mg/kg bw and observed for 14 days.
Oral LD50 Combined => 2000 mg/kg bw
Limit test
No mortality occurred during the test
There were no treatment related clinical signs, necropsy findings or changes in body weight.
The test item is of low Toxicity based on the LD50 in male and female Wistar rats.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.