Registration Dossier
Registration Dossier
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EC number: 200-175-5 | CAS number: 53-43-0
Endpoint summary
Administrative data
Description of key information
No repeated dose studies available for the substance. The outcomes of chronic studies in rat and dogs investigating the structural analogue & precursor Prasterone enantate, which is known to release Prasteron in vivo, in combination with estradiol-valerinate were instead used for classification. The studies on rats and dogs, with intramuscular administration, reveal effects (predominantly regressive changes on reproductive tissues) related to the endocrine nature of the substance.
[Schering AG, Report No. 174, 1971-10-25; Schering AG, Report No. 283, 1971-10-25]
This mode of action is confirmed by published data cited in RTECS.
No classification is concluded for repeated dose toxicity, but for reproductive toxicity/fertility.
Key value for chemical safety assessment
Additional information
No repeated dose toxicity studies are available for the substance. However, chronic studies with repeated intramuscular administration of a structural analogue/precursor of Androst-5-en-17-one, 3-hydroxy-, (3.beta.)- on rats and dogs are available, with the limit doses of 200 and 120 mg/kg bw, respectively. The precursor is known to release in vivo Androst-5-en-17-one, 3-hydroxy-, (3.beta.)-, therefore these data are relevant for classification. The studies reveal predominantly regressive changes on reproductive tissues, accompanied by changes such as hyperplasia in the adrenal cortices, atrophy of basophilic cells in the pituitary or mammary gland proliferation, which are all seen as a consequence of the hormonal effect of the substance.
No other substance-related symptoms of intolerance could be detected in these studies.
From the view of risk assessment no NOAEL could be concluded from these data, due to the effects on reproductive tissues.
Multiple dose toxicity data of Androst-5-en-17-one, 3-hydroxy, (3.beta.)-, cited in RTECS (Jan 2012) confirm the mode of action solely based on the hormonal effects of the substance:
oral, rat
[TDLo 8400 mg/kg/28D (continuous), Liver - changes in liver weight, Endocrine - changes in spleen weight; Proceedings of the society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1 -1903/04- v. 209, p. 92, y. 1995 (PSEBAA)]
[TDLo 18900 mg/kg/10W (continuous), Liver - tumors, Tumorigenic - protects against induction of experimental tumors, Tumorigenic - active as anti-cancer agent; Carcinogenesis (London). (Oxford Univ. Press, Pinkhill House, Southfield Road, Eynsham, Oxford OX8 1JJ, UK) V.-1980- v. 21, p. 301, y. 2000 (CRNGDP)]
[TDLo 840 mg/kg/28D (continuous), Related to Chronic Data - changes in uterine weight; Proceedings of the society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1 -1903/04- v. 223, p. 288, y. 2000 (PSEBAA)]
[TDLo 2800 mg/kg/28D (continuous), Reproductive Maternal Effects - uterus, cervix, vagina; Proceedings of the society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1 -1903/04- v. 223, p. 288, y. 2000 (PSEBAA)]
[TDL0 1050 mg/kg/14D (continuous), Liver - other changes, Liver - changes in weight, Biochemical - Metabolism (Intermediary) - lipids including transport; Biochemical Pharmacology. (Pergamin Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.1 -1958- v. 65, p. 1583, y. 2003 (BCPCA6)
[TDLo 1667 mg/kg/7D (intermittent), Liver - other changes, Biochemical - Enzyme inhibition, induction, or change in blood or tissue levels - multiple enzyme effect; Life Sciences (Pergamin Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.1 -8, 1962 -69; V.14- v. 73, p. 289, y. 2003 (LIFSAK)] [TDLo 400 mg/kg/21D (intermittent), Liver - other changes, Biochemical - Enzyme inhibition, induction, or change in blood or tissue levels - hepatic microsomal mixed oxidase (dealkylation, hydroxylation, etc.); Life Sciences (Pergamin Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.1 -8, 1962 -69; V.14- v. 73, p. 289, y. 2003 (LIFSAK)] [TDLo 16800 mg/kg/8W (intermittent), Liver - other changes; Biological and Pharmaceutical Bulletin. (Pharmaceutical Society of Japan, 2 -12 -15 -201 Shibuya Shibuya-ku, Tokyo 150, Japan) V.16 -1993- v. 28, p. 1301, y. 2005 (BPBLEO)] [TDLo 4200 mg/kg/2W (intermittent), Biochemical - Enzyme inhibition, induction, or change in blood or tissue levels - catalases, Biochemical - Effect on specific coenzyme - not otherwise specified; Biological and Pharmaceutical Bulletin. (Pharmaceutical Society of Japan, 2 -12 -15 -201 Shibuya Shibuya-ku, Tokyo 150, Japan) V.16 -1993- v. 28, p. 1301, y. 2005 (BPBLEO)]
subcutaneous, rat
[TDLo 1200 mg/kg/20D (intermittent), Endocrine - changes in adrenal weight, Endocrine - changes in thymus weight; Endocrine Research. (Marcel Dekker Journals, POB 5005, Monticello, NY 12701) V.10 -1984- v. 24, p. 113, y. 1998 (ENRSE8)]
[TDLo 1680 mg/kg/2W (intermittent), Biochemical Metabolism (Intermediary) - other proteins; Neuropsychopharmacology. (Elsevier Science, 655 Avenue of the Americas, New York, NY 10010) V.1 -1987- v. 23, p. 69, y. 2000 (NEROEW)]
[TDLo 144 mg/kg/12W (intermittent), Tumorigenic - active as anti-cancer agent; Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1 -1941- v. 65, p. 2269, y. 2005 (CNREA8)]
Justification for classification or non-classification
Based on the data the substance has not to be classified for repeated dose toxicity according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP).
Reason: According to (EC) No. 1272/2008 (CLP) Annex I, 3.9.1.1., specific toxic effects covered by other hazard classes should not classified for STOT-RE. Based on the available data a classification for Toxicity to Reproduction/Fertility is appropriate.
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