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EC number: 611-173-2 | CAS number: 54605-02-6
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not applicable
- Remarks:
- pre-guideline study
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 6α,9-difluoro-11β,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-valerate
- EC Number:
- 261-655-8
- EC Name:
- 6α,9-difluoro-11β,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-valerate
- Cas Number:
- 59198-70-8
- Molecular formula:
- C27 H36 F2 O5
- IUPAC Name:
- 6 α,9-Difluoro-11 β-hydroxy-16 α-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Tierzüchter Dr. Hagemann (not further specified)
- Age at study initiation: no data
- Weight at study initiation: 84 -117 g
- Fasting period before study: approx. 20 hours
- Housing: conventional (1 animal per cage) macrolon cages type II
- Diet (ad libitum): Altromin R
- Water (ad libitum): tap water
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 - 24.0
- Humidity (%): 50 - 63
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.9 g NaCl + 0.5 g CMC + 0.085 g Myrj ad 100 ml aqua dest.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10 g in 100 mL
- Amount of vehicle (if gavage): 2, 2.5, 3, 3.5, 4 mL/kg
MAXIMUM DOSE VOLUME APPLIED: 4.0mL/kg - Doses:
- 2000, 2500, 3000, 3500 and 4000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 39 days
- Kind of observations: clinical signs, mortality
- Necropsy of survivors performed: yes - Statistics:
- Probit analysis
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 100 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 700 - <= 3 800
- Mortality:
- Mortality was observed at 2000 mg/kg bw and above in both sexes. Animals died between 5 and 22 days after application (details see Table 1).
- Clinical signs:
- other: After single oral administration animals of all dose levels showed emaciation from day 5 to day 39 of the observation period. At 2000 mg/kg bw and above ungroomed coat and apathy was observed. At 2500 mg/kg bw and above sporadic increased girth of abdomen
- Gross pathology:
- At necropsy perforating ulcers in the cutaneous stomach mucosa were observed in sacrificed animals at the end of the observation period (from 2500 mg/kg bw). In animals found dead perforating ulcers in the cutaneous stomach mucosa and splenic athropy (from 2000 mg/kg bw), hyperemia in the gastrointestinal tract and necrobiosis in the liver (from 2500 mg/kg bw) as well as petechial bleedings in the glandular stomach mucosa and anaemic renal infarction (from 3000 mg/kg bw) were recorded.
Any other information on results incl. tables
Table 1: Number of dead animals per dose group after single oral application of difluocortolon-valerinat (ZK 22612) to rats:
Dose [mg/kg] | No of dead males/ No of treated males |
No of dead females/ No of treated females |
No of dead animals (total 39 days after admin.) / No of treated animals |
2000 | 3/5 | 2/5 | 5/10 |
2500 | 1/5 | 3/5 | 4/10 |
3000 | 3/5 | 4/5 | 7/10 |
3500 | 4/5 | 1/5 | 5/10 |
4000 | 2/5 | 4/5 | 6/10 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- In the present study conducted according to OECD test guideline 401, 25 female and 25 male Wistar rats were orally administered single doses of Difluocortolon-valerianat in 0.9 g NaCl + 0.5 g CMC + 0.085 g Myrj ad 100 mL Aqua dest. at concentrations of 2000, 2500, 3000, 3500 and 4000 mg/kg bw. The animals were observed for 39 days and subsequently sacrified if no premature mortality occurred. The LD50 value was obtained from Probit analysis. The LD50 is 3100 mg/kg bw.
- Executive summary:
After single oral administration of the test item difluocortolon-valerianat (diflucortolone-21-valerate) in doses of 2000, 2500, 3000, 3500 and 4000 mg/kg bw to male and female Wistar rats (5/sex/group) and during an observation period of 39 days clinical signs (emaciation, ungroomed coat, apathy, sporadic increased girth of abdomen, individual anaemic animals) were observed starting at 2000 mg/kg bw. Mortality was observed at 2000 mg/kg bw and above in both sexes. Animals died between 5 and 22 days after application. At necropsy perforating ulcers in the cutaneous stomach mucosa were observed in sacrificed animals at the end of the observation period (from 2500 mg/kg bw). In animals found dead perforating ulcers in the cutaneous stomach mucosa and splenic athropy (from 2000 mg/kg bw), hyperemia in the gastrointestinal tract and necrobiosis in the liver (from 2500 mg/kg bw) as well as petechial bleedings in the glandular stomach mucosa and anaemic renal infarction (from 3000 mg/kg bw) were recorded. The acute oral toxicity (LD50) of diflucortolone-21-valerate was determined to be 3100 mg/kg bw for male and female Wistar rats using probit analysis.
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