Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-020-1 | CAS number: 50-23-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Results of genotoxicity with hydrocortisone are cited in RTECS database (Feb 2010):
DNA inhibiton was found in rat mammary gland cells at 1 mg/L [Acta Pathologica et Microbiologica Scandinavica, Section A: Pathology. (Copenhagen, Denmark) V.78-89, 1970-81. For publisher information, see ACPADQ. v. 85, p. 57, 1977 (AMBPBZ)]
Cytogenetic analysis after intraperitoneal application of hydrocortisone to mice at 50 mg/kg [Acta Pathologica et Microbiologica Scandinavica, Section C: Immunology. (Copenhagen, Denmark) V.83-89, 1975-81. For publisher information, see ACPADQ. v. 84, p. 185, 1976 (APSCD2)]
DNA inhibition in mouse cells was seen at 100 nmol/L [Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951- v. 36, p. 1782, 1986 (ARZNAD)]
DNA inhibition after intraperitoneal application of guinea pigs at 50 mg/kg [Bulletin of Experimental Biology and Medicine (English Translation). Translation of BEBMAE. (Plenum Pub. Corp., 233 Spring St., New York, NY 10013) V.41- 1956- v. 78, p. 1417, 1974 (BEXBAN)]
After intraperitoneal application of hydrocortisone to rats DNA inhibition appeared at 100 mg/kg [Bulletin of Experimental Biology and Medicine (English Translation). Translation of BEBMAE. (Plenum Pub. Corp., 233 Spring St., New York, NY 10013) V.41- 1956- v. 81, p. 90, 1976 (BEXBAN)]
After intraperitoneal application to rats unscheduled DNA synthesis was found at 20 mg/kg [Bulletin of Experimental Biology and Medicine (English Translation). Translation of BEBMAE. [Plenum Pub. Corp., 233 Spring St., New York, NY 10013) V.41- 1956- v. 94, p. 1511, 1982 (BEXBAN)]
In human liver cells DNA adducts were reported after exposure to 2 mmol/L and 2 mmol/L/1H and 2 mmol/plate/1H [Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964- v. 370, p. 49, 1996 (MUREAV)]
Guinea pig lung cells unscheduled DNA synthesis was found 1 mg/L [Proceedings of the Society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04- v. 171, p. 109, 1982 (PSEBAA)]
Guinea pig lung cells developed DNA inhibition after exposure to 1 mg/L [Proceedings of the Society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04- v. 171, p. 109, 1982 (PSEBAA)]
Justification for classification or non-classification
Various in vitro and in vivo test systems for investigation of genotoxic properties of hydrocortisone have led to contradictive results.
In RTECS database some publications with positive results have been cited. Available GLP-studies from Schering AG indicated weak clastogenicity in human lymphocytes and a weak positive result in an AMES test. However, an in vivo mouse micronucleus test as well as other in vitro tests were negative. Hydrocortisone as an endogenous substance does not have to be labelled with regard to mutagenicity.
Classification according to Regulation (EC) No. 1272/2008 (CLP) is not 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
