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
- Toxic effect type:
- dose-dependent
Additional information
No repeated dose toxicity studies of hydrocortisone available. Results of repeated dose toxicity studies are cited in RTECS database (Feb 2010):
Daily intermittant application of hydrocortisone to men (route not reported) over 5 days results in elevation of the blood pressure (not characterized in autonomic section). TDLo: 5.71 mg/kg/5D-I [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)]
Daily intraperitoneal administration to rats over 10 days leads to changes in urine composition and intermediary metabolism (amino acids including renal excretion and others not further specified). TDLo: 150 mg/kg/10D-I [Chinese medicine [electronic resource] (London : BioMed Central) V.1- 2006- v. 3, p. 3, 2008 (CHMED*)]
Daily subcutaneous intermittant administration of hydrocortisone to mice over 2 weeks leads to changes in liver and agranulocytosis (changes in bone marrow not included). TDLo: 560 mg/kg/2W-I [Cellular Immunology. (Academic Press, 6277 Sea Harbor Drive, Orlando, FL 32887) V.1- 1970- v. 194, p. 28, 1999 (CLIMB8)]
Dermal intermittant application to mice over 10 days leads to effect on inflammation or mediation of inflammation. TDLo: 300 mg/kg/10D-I [Farmakologiya i Toksikologiya (Moscow). For English translation, see PHTXA6 and RPTOAN. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.2- 1939- v. 47, p. 84, 1984 (FATOAO)]
Continuous intravenous application of hydrocortisone to women over 5 days result in convulsions or effect on seizure threshold. TDLo: 50 mg/kg/5D-C [Journal of Toxicology, Clinical Toxicology. (Marcel Dekker, 270 Madison Ave., New York, NY 10016) V.19- 1982- v. 41, p. 995, 2003 (JTCTDW)]
Subcutaneous application to mice over 11 days result in not further specified endocrine changes. TDLo: 62 mg/kg/11D-I [Nature. (Nature Subscription Dept., POB 1018, Manasguan, NJ 08736) V.1- 1869- v. 201, p. 83, 1964 (NATUAS)]
Subcutaneous application to rats over 85 days result in changes in adrenal weight and weight loss or decreased weight gain. TDLo: 175 mg/kg/85D-I [Proceedings of the Society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04- v. 109, p. 10, 1962 (PSEBAA)]
Daily subcutaneous application to mice over 4 days leads to changes in liver weight. TDLo: 100 mg/kg/4D-I [Teratology, The International Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968- v. 33, p. 29, 1986 (TJADAB)]
Daily oral application to mice over 7 days results in changes in thymus weight, weight loss or decreased weight gain. TDLo: 140 mg/kg/7D-I [Zhongguo Yaoxue Zazhi. Chinese Pharmacuetical Journal. (China International Book Trading Corp., POB 2820, Beijing, Peop. China) V.24- 1989- v. 24, p. 283, 1989 (ZYZAEU)]
Justification for classification or non-classification
There are no internal company data on chronic toxicity available. The therapeutic dosage for oral substitution is 10 - 30 mg/day. Following repeated exposure at comparable doses typical glucocorticoid effects (degragation of lymphatic tissue, inhibition of the adrenal cortex, impairment of hematogenic tissue ( bone marrow)) are to be expected.
Classification with STOT-RE Cat 2 according to Regulation (EC) No. 1272/2008 (CLP) is required.
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