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EC number: 807-619-2 | CAS number: 65535-29-7
- 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:
- Feb to Apr 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Commission Directive no. 79/831 EEC of.18. September 1979 (equivalent to the corresponding German regulations)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- study was conducted prior to implementation of OECD TG 423
- GLP compliance:
- yes
- Remarks:
- - but a QA check was not performed
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 9beta, 11beta-Epoxy-6alpha-fluoro-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione
- Cas Number:
- 65535-29-7
- Molecular formula:
- C27 H35 F O5
- IUPAC Name:
- 9beta, 11beta-Epoxy-6alpha-fluoro-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG
- Weight at study initiation: males: 102-115 g; females: 89-91 g
- Fasting period before study: Males ca. 20.25 h, females ca. 18.5 h
- Housing: individually under conventional conditions
- Diet (e.g. ad libitum): pell. Altromin R ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 50-76
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 900 mg NaCl + 85 mg Myrj 53 ad 100 ml bidest water
- 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 at 30 min, 1 h, and 3 h after dosing, day 2-14. Body weight at day 1, 7, 8 and 14
- Necropsy of survivors performed: yes
- Clinical signs including body weight: apathy, slight; diarrhea, slight
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: The administration of 2000 mg/kg bw provoked slight apathy in two females as well as slight diarrhea in one female on application day 1. All animals were without any clinical findings from day 2 onwards.
- Gross pathology:
- Necropsy revealed no compound-related findings after 2000 mg/kg bw.
Applicant's summary and conclusion
- Conclusions:
- A single oral administration (gavage) of the test substance to male and female rats at the limit-dose 2000 mg/kg bw was tolerated without mortalities, effects on body weight gain and gross pathological findings. Slight apathy in two females as well as slight sialorrhea in one female was seen on application day 1. All animals were without any clinical findings from day 2 onwards. According to OECD TG 423 the oral LD50 of ZK 50992 (epoxide valerate) in male and female rats is therefore > 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study conducted equivalent to OECD TG 423, groups Wistar rats, female and male (3/sex) were given a single oral dose of Epoxide-Valerate in 0.9 % NaCl + 0.085 % Myrj 53 in 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
The administration of 2000 mg/kg bw provoked slight apathy in two females as well as slight diarrhea in one female on application day 1. All animals were without any clinical findings from day 2 onwards. There were no necropsy findings or changes in body weight.
The test item is of low Toxicity based on the LD50 in male and female Wistar rats.
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