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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
Endpoint summary
Administrative data
Description of key information
Dermal, 12 weeks (Rabbit, NZW, non-GLP, doses: 0 / 5 / 25 mg/kg, 5 h/day 7 times/week): NOEL < 5 mg/kg
[Schering AG, Report No: 2679, 1977-05-11]
Additionally, results of repeated dose toxicity studies with hydrocortisone-21-acetate are cited in RTECS database (Feb 2010):
Subcutaneous, 35 days (rat); TDLo: 175 mg/kg/35D-I
(Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951- v. 27, p. 2102, 1977 (ARZNAD))
Subcutaneous, 3 days(rat); TDLo: 22.5 mg/kg/3D-I
(Comparative Biochemistry and Physiology. (Elmsford, NY) V.1-37, 1960-70. v. 139, p. 11, 2004 (CBCPAI))
Oral, 8 days (rat); TDLo: 1000 mg/kg/8D-I
(Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) v. (2), p. 42, 2002 (TOVEFN))
Oral, 7 days (rat); TDLo: 875 mg/kg/7D-I
(Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (2), p. 42, 2002 (TOVEFN))
Oral, 14 days (rat); TDLo: 1750 mg/kg/14D-I
(Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (2), p. 42, 2002 (TOVEFN))
Oral, 30 days (rat); TDLo: 3750 mg/kg/30D-I
(Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (2), p. 42, 2002 (TOVEFN))
Dermal, 61 days (rat); TDLo: 2.25 mg/kg/61D-I
(Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (2), p. 42, 2002 (TOVEFN))
Key value for chemical safety assessment
Additional information
Dermal application of ZK 5192 (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 [Schering AG, Report No: 2679, 1977-05-11]
Additionally, results of repeated dose toxicity studies with hydrocortisone-21-acetate are cited in RTECS database (Feb 2010):
Subcutaneous application of hydrocortisone-21-acetate to rats over 35 days results in weight loss or decreased weight gain and death; TDLo: 175 mg/kg/35D-I [Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951- v. 27, p. 2102, 1977 (ARZNAD)]
Subcutaneous application of hydrocortisone-21-acetate to rats over 3 days leads to adrenal cortex hypoplasia and changes in adrenal weight; TDLo: 22.5 mg/kg/3D-I [Comparative Biochemistry and Physiology. (Elmsford, NY) V.1-37, 1960-70. For publisher information, see CBPBB8. v. 139, p. 11, 2004 (CBCPAI)]
Daily oral administration to rats over 8 days results in death; TDLo: 1000 mg/kg/8D-I [Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (2), p. 42, 2002 (TOVEFN)]
Rat were treated with hydrocortisone-21-acetate orally over 7 days. Animals developed somnolence (general depressed activity) and hemorrhages; TDLo: 875 mg/kg/7D-I [Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (2), p. 42, 2002 (TOVEFN)]
Daily oral application to rats over 14 days leads to weight loss or decreased weight gain; TDLo: 1750 mg/kg/14D-I [Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (2), p. 42, 2002 (TOVEFN)]
Rats were treated orally over 30 days, resulting in changes in heart, kidney, thymus and spleen weight, impairment in liver function tests and depressed renal function tests; TDLo: 3750 mg/kg/30D-I [Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (2), p. 42, 2002 (TOVEFN)]
Dermal treatment to rats over 61 days results in alteration of classical conditioning and intermediar metabolism and in paternal effects on testes, epididymis and sperm duct; TDLo: 2.25 mg/kg/61D-I [Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown v. (2), p. 42, 2002 (TOVEFN)]
Justification for classification or non-classification
Classification with R 48/20/21/22 according to 67/548/EEC and STOT Cat 2 according to Regulation (EC) No. 1272/2008 (CLP) is required.
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.
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