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Diss Factsheets
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EC number: 200-004-4 | CAS number: 50-03-3
- 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
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Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 27. April 1976 to 21. July 1976
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 10 rabbits (5/sex) were treated dermally once daily over 5 hours with 1% (w/w) (0, 5 and 25 mg/kghydrocortisone-21-acetate 7 days/week over a period of 12 weeks.
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Hydrocortisone 21-acetate
- EC Number:
- 200-004-4
- EC Name:
- Hydrocortisone 21-acetate
- Cas Number:
- 50-03-3
- Molecular formula:
- C23H32O6
- IUPAC Name:
- 11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): hydrocortisone-21-acetate (ZK9152)
- Lot/batch No.: 14606583
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: one-phase fat cream
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 5 hours 7 days/week over period of 12 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5 and 25 mg/kg
Basis:
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- < 5 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: reduced body weight gain
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Reduced body weight gain (females) and reduced thickness of skin fold (atrophy) including reduction of inflammation cells in corium infiltate at 5 and 25 mg/kg bw. Hematology showed reduced hemoglobin, HK, erythrocytes, lymphocytes, eosinophiles in the high dose group. Erythrocyte sedimentation rate, neutrophiles, glucose, total protein, lipids, phosphatide, trigyceride, cholsterol, fibrinogen, GOT and GPT were increased in animals treated with 25 mg/kg hydrocortisone-acetate. Organ weight was increased in liver and kidneys and decreased in adrenal glands, spleen and sceletal muscles (females). Histopathology showed lipid infiltration, swelling and focal necroses of liver cells, increase in kidney protein cylinders, enlargement of tubuli in Bowman capsule, lipid infiltration in medulla of kidney, haemosideroses in spleen, atrophy of zona fasciculata in adrenal gland and inflated cells in zona fasciculata and reticularis, thymus involution, atrophy of lymphatic tissue in lymph nodes. In pancreas ductus proliferation, degranulation, hypertrophy and hyperplasia of the B-cells were observed. Testes developed tubuli atrophy. Reduction in reaction of inflammation cells in liver.
Applicant's summary and conclusion
- Conclusions:
- NOEL below 5 mg/kg
- Executive summary:
Dermal application of hydrocortisone-21 -acetate (0, 5 and 25 mg/kg, 5 h/day 7 times/week) to rabbits (5/sex/group)over 12 weeks results in reduced body weight gain (females) and reduced thickness of skin fold (atrophy) including reduction of inflammation cells in corium infiltate. Hematology showed reduced hemoglobin, HK, erythrocytes, lymphocytes, eosinophiles. Erythrocyte sedimentation rate, neutrophiles, glucose, total protein, lipids, phosphatide, trigyceride, cholsterol, fibrinogen, GOT and GPT were increased. Organ weight was increased in liver and kidneys and decreased in adrenal glands, spleen and sceletal muscles (females). Histopathology showed lipid infiltration, swelling and focal necroses of liver cells, increase in kidney protein cylinders, enlargement of tubuli in Bowman capsule, lipid infiltration in medulla of kidney, haemosideroses in spleen, atrophy of zona fasciculata in adrenal gland and inflated cells in zona fasciculata and reticularis, thymus involution, atrophy of lymphatic tissue in lymph nodes. In pancreas ductus proliferation, degranulation, hypertrophy and hyperplasia of the B-cells were observed. Testes developed tubuli atrophy. Reduction in reaction of inflammation cells in liver. NOEL below 5 mg/kg.
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