Registration Dossier
Registration Dossier
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EC number: 200-004-4 | CAS number: 50-03-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
ZK 5192 did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurium strains TA98, TA100, TA102, TA1535, TA1537) when tested up to the highest recommended dose level of 5.0 mg/plate in the absense or presense of extrinsic metabolic activation (liver S9 mix form Aroclor 1254 -treated rats). [Schering AG, Report No. A22952; 2004-07-04]
Additionally, results of genotoxicity studies with hydrocortisone-21-acetate are cited in RTECS database (Feb 2010):
After intraperitoneal application to mice mutation was found in a muation test system not specified at 150 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. 77, p. 437, 1974 (BEXBAN)]
DNA damage was seen after intraperitoneal application of hydrocortisone-21 -acetate to mice at 60 mg/kg [Okajimas Folia Anatomica Japonica. (Keio Univ., School of Medicine, Dept. of Anatomy, 35 Shinano-machi, Shinjuku-ku, Tokyo 160, Japan) V.14- 1936- v. 51, p. 1, 1974 (OFAJAE)]
Short description of key information:
Gene mutation (bacterial reverse mutation assay / Ames test, GLP, OECD TG 471): negative with and without metabolic activation
(Schering AG, Report No. A22952; 2004-07-04)
Additionally, results of genotoxicity studies with hydrocortisone-21-acetate are cited in RTECS database (Feb 2010):
Intraperitoneal, (mouse); muation test system not specified; 150 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. 77, p. 437, 1974 (BEXBAN))
Intraperitoneal, (mouse); DNA damage; 60 mg/kg
(Okajimas Folia Anatomica Japonica. (Keio Univ., School of Medicine, Dept. of Anatomy, 35 Shinano-machi, Shinjuku-ku, Tokyo 160, Japan) V.14- 1936- v. 51, p. 1, 1974 (OFAJAE))
Endpoint Conclusion:
Justification for classification or non-classification
Limited test systems for investigation of genotoxic properties of hydrocortisone-21-acetate have led to contradictive results.
In RTECS database two publications with positive results have been cited. The GLP AMES test from Schering AG was negative.
Hydrocortisone-21-acetate is metabolized via ester cleavage to the endogenous substance hydrocortisone after administration. As an endogenous substance it does not have to be labelled with regard to mutagenicity.
Hydrocortisone-21-acetate is not classified according to German legislation (TRGS-905).
Classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
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