Registration Dossier
Registration Dossier
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EC number: 208-307-3 | CAS number: 521-18-6
Endpoint summary
Administrative data
Description of key information
No repeated dose studies are available with androstenolone. However some study results are cited in RTECS database (Jan 2010):
Dermal, 28 days (Hamster): TDLo: 0.112 mg/kg/28D-I
[Biological and pharmaceutical bulletin. (Pharmaceutical Society of Japan, 2-12-15, Shibuya, Shibuya-ku, Tokyo 150-0002, Japan) V.1- 1993- v. 25, p. 622, 2002 (BIPBU*)]
Subcutaneous, 10 weeks (Rat): TDLo: 35 mg/kg/10W-I
[European Journal of Cancer (Elsevier Science, P.O.Box 7247-7682,Philadelphia,PA 19170 -7682,USA OR Elsevier Science B.V.,P.O.Box 1270,1000 BG Amsterdam,The Netherlands) V. 1- 1965- v. 37, p. 443, 2001 (EJCAAH)]
Subcutaneous, 32 days (Quail): TDLo: 320 mg/kg/32D-I
[Hormones and Behavior. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1969- v. 49, p. 4, 2006 (HOBEAO)]
Intramuscular, 33 days (domestic animal: sheep, goat): TDLo: 240 ug/kg/4D-I
[Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960- v. 123, p. 527, 2002 (JRPFA4)]
Subcutaneous, 15 days (Rat): TDLo: 75 mg/kg/15D-I
[Pharmacology, Biochemistry and Behavior. (ANKHO International Inc., P.O. Box 426, Fayetteville, NY 13066) V.1- 1973- v. 89, p. 241, 2008 (PBBHAU)]
Subcutaneous, 3 days (Rat): TDLo: 600 mg/kg/3D-I
[Toxicology. (Elsevier Scientific Pub. Ireland, Ltd., POB 85, Limerick, Ireland) V.1- 1973- v. 170, p. 21, 2002 (TXCYAC).]
Oral, 10 days (Rat): TDLo: 400 mg/kg/10D-I
[Toxicology. (Elsevier Scientific Pub. Ireland, Ltd., POB 85, Limerick, Ireland) V.1- 1973- v. 195, p. 177, 2004 (TXCYAC)]
Key value for chemical safety assessment
Additional information
There are no repeated dose studies available with androstenolone. However some study results are cited in RTECS database (Jan 2010):
The daily dermal application of adrostanolone to hamsters over 28 days results in androgenic effects not further specified; TDLo: 0.112 mg/kg/28D-I [Biological and pharmaceutical bulletin. (Pharmaceutical Society of Japan, 2-12-15, Shibuya, Shibuya-ku, Tokyo 150-0002, Japan) V.1- 1993- v. 25, p. 622, 2002 (BIPBU*)]
The daily subcutaneous application of androstanolone over 10 weeks to rat protects against induction of experimental tumors; TDLo: 35 mg/kg/10W-I [European Journal of Cancer (Elsevier Science, P.O.Box 7247-7682,Philadelphia,PA 19170 -7682,USA OR Elsevier Science B.V.,P.O.Box 1270,1000 BG Amsterdam,The Netherlands) V. 1- 1965- v. 37, p. 443, 2001 (EJCAAH)]
Androstanolone daily applied subcutaneously to quails over 32 days results in aggressiv behaviour and changes in testicular weight; TDLo: 320 mg/kg/32D-I [Hormones and Behavior. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1969- v. 49, p. 4, 2006 (HOBEAO)]
The daily intramuscular application of androstanolone to domestic animals (sheep, goat) over 33 days leads to changes in gonadotropins on menstrual cycle; TDLo: 240 ug/kg/4D-I [Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960- v. 123, p. 527, 2002 (JRPFA4)]
Androstanolone applied daily subcutaneously over a period of 15 days to rats leads to a paternal effects on male not further specified; TDLo: 75 mg/kg/15D-I [Pharmacology, Biochemistry and Behavior. (ANKHO International Inc., P.O. Box 426, Fayetteville, NY 13066) V.1- 1973- v. 89, p. 241, 2008 (PBBHAU)]
The daily subcutaneous application over 3 days to rats results in maternal effects on uterus, cervix and vagina; TDLo: 600 mg/kg/3D-I [Toxicology. (Elsevier Scientific Pub. Ireland, Ltd., POB 85, Limerick, Ireland) V.1- 1973- v. 170, p. 21, 2002 (TXCYAC).]
Oral application over 10 days to rats leads to effects on prostate, seminal vessicle, Cowper's gland and accessory glands; TDLo: 400 mg/kg/10D-I [Toxicology. (Elsevier Scientific Pub. Ireland, Ltd., POB 85, Limerick, Ireland) V.1- 1973- v. 195, p. 177, 2004 (TXCYAC)]
Justification for classification or non-classification
There is no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).
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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