Registration Dossier
Registration Dossier
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EC number: 200-020-1 | CAS number: 50-23-7
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
No acute toxicity studies were conducted with the substance. Results of acute toxicity studies with hydrocortisone ae cited in RTECS database (Feb 2010):
Acute oral toxicity study in mice results in changes of transaminases (inhibition, induction, or change in blood or tissue levels). TDLo: 20 mg/kg [Biological and pharmaceutical bulletin. (Pharmaceutical Society of Japan, 2-12-15, Shibuya, Shibuya-ku, Tokyo 150-0002, Japan) V.1- 1993- v. 25, p. 627, 2002 (BIPBU*)]
Acute dermal toxicity study in mice results in effects on inflammation or mediation of inflammation. TDLo: 8.7 mg/kg [Brazilian Journal of Medical and Biological Research. (Associacao Brasileira de Divulgacao Cientifica, Faculdade de Medicina de Ribeirao Preto, USP, 141000 Ribeirao Preto, SP, Brazil) V.14- 1981- v. 36, p. 105, 2003 (BJMRDK)]
Acute intraperitoneal toxicity study in mice results in analgesia and effects on inflammation or mediation of inflammation: TDLo: 25 mg/kg [Biological and Pharmaceutical Bulletin. (Pharmaceutical Society of Japan, 2-12-15-201 Shibuya Shibuya-ku, Tokyo 150, Japan) V.16- 1993- v. 31, p. 1761, 2008 (BPBLEO)]
Single application of hydrocortisone to men (route not reported) results in elevation of the blood pressure not characterized in autonomic section. TDLo: 1.14 mg/kg [Clinical and Experimental Pharmacology and Physiology. (Blackwell Scientific Publications, (Australia) Pty Ltd., 107 Barry St., Carlton, Vic. 3053, Australia) V.1- 1974- v. 32, p. 294, 2005 (CEXPB9)]
Single oral administration of hydrocortisone to men results in vascular changes not further specified. TDLo: 1.43 mg/kg [Clinical Pharmacology and Therapeutics. (American Society for Clinical Pharmacology and Therapeutics, St. Louis Mo Mosby-Year Book) V.1- 1960- v. 67, p. 22, 2000 (CLPTAT)]
Single intraperitoneal application to rats leads to effects on inflammation or mediation of inflammation. LD50: 150 mg/kg [Japanese Journal of Pharmacology. (Japanese Pharmacological Soc., c/o Dept. of Pharmacology, Faculty of Medicine, Kyoto Univ., Sakyo-ku, Kyoto 606, Japan) V.1- 1951- v. 21, p. 377, 1971 (JJPAAZ)]
Acute subcutaneous toxicity study in mice results in LD50: >500 mg/kg [Khimiko-Farmatsevticheskii Zhurnal. Chemical Pharmaceutical Journal. For English translation, see PCJOAU. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1- 1967- v. 24(3), p. 26, 1990 (KHFZAN)]
Single intraperitoneal application of hydrocortisone to mice induces changes in transaminases (enzyme inhibition, induction, or change in blood or tissue levels). TDLo: 50 mg/kg [Molecular Carcinogenesis. (John Wiley and Sons, 605 Third Avenue, New York, NY 10158) V.1- 1988- v. 44, p. 223, 2005 (MOCAE8)]
Single intraperitoneal application of hydrocortisone to rats induces changes in transaminase (enzyme inhibition, induction, or change in blood or tissue levels). TDLo: 50 mg/kg [Molecular Carcinogenesis. (John Wiley and Sons, 605 Third Avenue, New York, NY 10158) V.1- 1988- v. 44, p. 223, 2005 (MOCAE8)]
Single oral administration of hydrocortisone to human results in changes in surface EEG and changes in psychophysiological tests. TDLo: 0.429 mg/kg [Neuropsychopharmacology. (Elsevier Science, 655 Avenue of the Americas, New York, NY 10010) V.1- 1987- v. 26, p. 505, 2002 (NEROEW)]
Single oral application of hydrocortisone to men leads to changes in psychophysiological tests, respiratory stimulation and other endocrine changes. TDLo: 0.71 mg/kg [Neuropsychopharmacology. (Elsevier Science, 655 Avenue of the Americas, New York, NY 10010) V.1- 1987- v. 28, p. 1677, 2003 (NEROEW)]
Single intravenous administration of hydrocortisone to human induces changes in surface EEG, REM sleep and other endocrine changes. TDLo: 1 mg/kg [Neuropsychopharmacology. [Elsevier Science, 655 Avenue of the Americas, New York, NY 10010) V.1- 1987- v. 29, p. 598, 2004 (NEROEW)]
Single oral administration to human results in change in cardiac rate and other endocrine changes. TDLo: 1.43 mg/kg [Psychopharmacology (Berlin). (Springer-Verlag New York, Inc., Service Center, 44 Hartz Way, Secaucus, NJ 07094) V.47- 1976- v. 153, p. 380, 2001 (PSCHDL)]
Single oral application of hydrocortisone to men leads to changes in psychophysiological tests. TDLo: 1.4 mg/kg [Psychopharmacology (Berlin). (Springer-Verlag New York, Inc., Service Center, 44 Hartz Way, Secaucus, NJ 07094) V.47- 1976- v. 167, p. 431, 2003 (PSCHDL)]
Single oral administration to men results in endocrine changes not further specified. TDLo: 0.29 mg/kg [Psychopharmacology (Berlin). (Springer-Verlag New York, Inc., Service Center, 44 Hartz Way, Secaucus, NJ 07094) V.47- 1976- v. 171, p. 458, 2004 (PSCHDL)]
Acute toxicity study in rats (route unreported) results in changes in liver, in serum composition (e.g., TP, bilirubin, cholesterol) and in phosphatases (enzyme inhibition, induction, or change in blood or tissue levels). TDLo: 100 mg/kg [Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- v. 197, p. 206, 2004 (TXAPA9)]
Subcutaeous single application to rats leads to weight loss or decreased weight gain. LD50: 449 mg/kg [Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- v. 8, p. 250, 1966 (TXAPA9)]
Acute inhalation toxicity study in rats results in changes of liver, kidney, ureter, and bladder. TCLo: 31 mg/m3 ["Vrednie chemichescie veshestva. Prirodnie organicheskie soedinenia" (Hazardous substances. Nature products.) Volkova N.V. et al., Sankt-Peterburg, 1998. v. -, p. 490, 1998 (VCVPS*)]
Acute oral toxicity study in rats results in LD50: 5000 mg/kg ["Vrednie chemichescie veshestva. Prirodnie organicheskie soedinenia" (Hazardous substances. Nature products.) Volkova N.V. et al., Sankt-Peterburg, 1998. v. -, p. 490, 1998 (VCVPS*)]
Acute oral toxicity study in mice results in LD50: 5000 mg/kg ["Vrednie chemichescie veshestva. Prirodnie organicheskie soedinenia" (Hazardous substances. Nature products.) Volkova N.V. et al., Sankt-Peterburg, 1998. v. -, p. 490, 1998 (VCVPS*)]
Acute dermal toxicity study in mice results in LD50: 23 mg/kg ["Vrednie chemichescie veshestva. Prirodnie organicheskie soedinenia" (Hazardous substances. Nature products.) Volkova N.V. et al., Sankt-Peterburg, 1998. v. -, p. 490, 1998 (VCVPS*)]
Justification for classification or non-classification
Based on the study results a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.
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