Registration Dossier
Registration Dossier
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EC number: 200-175-5 | CAS number: 53-43-0
Carcinogenicity
Administrative data
Description of key information
No relevant carcinogenic potential for humans can be concluded from the available published data.
Key value for chemical safety assessment
Justification for classification or non-classification
Based on Read-Across using the data published for Prasterone enantate, the substance has not to be classified for carcinogenicty according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP).
Additional information
Tumorigenic data are cited in RTECS database (Jan 2012) for Prasterone enantate (Androst-5-en-17-one, 3-hydroxy-, (3.beta.)-):
A carcinogenicity study on male F-344 rats, receiving a dietary concentration of 0.45% (RTECS: 159 g/kg/84W) of an analogue/precursor of Androst-5-en-17-one, 3-hydroxy-, (3.beta.)- for 84 weeks, revealed a higher incidence of liver tumors compared to control. This was explained by the peroxisome-proliferative property of the substance. [Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106)V.1-1941-v. 52, p. 2977, 1992 (CNREA8)]. Thus, the substance is concluded to be a non-genotoxic hepatocarcinogen on rats.
Androst-5-en-17-one, 3-hydroxy-, (3.beta.)- administered via diet at a concentration of 0.1% (RTECS: 25 g/kg/52D) or via silicone implant (RTECS: 400 mg/kg 50D) was found to increase the rate of spontaneous ovarian granulosa cell tumors in SWXJ-9 inbred mice [Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106)V.1-1941-v. 48, p. 2788, 1988 (CNREA8)].
Adult female Sprague-Dawley rats with induced hepatocellular lesions showed an enhanced liver tumor progression after repeated administration of Androst-5-en-17-one, 3-hydroxy-, (3.beta.)- (RTECS: 42000 mg/kg/20W) [Cancer Letters. (Shannon Ireland) (Elsevier Scientific Pub. Ireland Ltd., POB 85, Limerick, Ireland) V.1- 1975- v. 140, p. 75, 1999 (CALEDQ)].
Repeated exposure of high dosages of reproductive hormones can promote the growth of hormone sensitive tumors and tissues (see Technical Rule for Hazardous Substances 905, Justifications for the assessment of substances, activities and processes as carcinogenic, mutagenic or toxic to reproduction (Sept. 1999), published by the Federal Ministry of Labor and Social Affairs, Germany).
Overall, no relevant carcinogenic potential for humans can be concluded from the available data.
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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