Registration Dossier
Registration Dossier
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EC number: 208-307-3 | CAS number: 521-18-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
There is no fertility study with androstanolone available. However, results of some studies are cited in RTECS database (Jan 2010):
Intramuscular administration of androstanolone to male monkeys over 70 days results in effects on spermatogenesis including genetic material, sperm morphology, motility, and count;: TDLo: 14 mg/kg (70D male) [Andrologia. (Grosse Verlag GmbH, Kurfuerstenstr. 112-113, D-1000 Berlin 30, Fed. Rep. Ger.) V.6- 1974- v. 22, p. 144, 1990 (ANDRDQ)]
Subcutaneous application to female rats over 14 days prior to mating results in maternal effects on uterus, cervix, vagina and effects on fertility not further specified; TDLo: 1400 ug/kg (14D pre) [Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1- 1970- v. 5, p. 489, 1972 (CCPTAY)]
Subcutaneous application of androstanolone to female rats 14 days prior to mating leads to maternal effects on ovaries and fallopian tubes; TDLo: 700 ug/kg (14D pre) [Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1- 1970- v. 5, p. 489, 1972 (CCPTAY)]
Subcutaneous application over 10 days to female mice prior to mating results in maternal effects on uterus, cervix and vagina; TDLo: 40 mg/kg (10D pre) [Endocrinologia Japonica. (Japan Pub. Trading Co., Ltd., POB 5030, Tokyo International, Tokyo, Japan) V.1- 1954- v. 23, p. 327, 1976 (ECJPAE)]
Implant application of androstanolone to male rats 42 days prior to mating results in paternal effects on testes, epididymis, sperm duct
and effects on fertility: male fertility index (e.g., number of males impregnating females per number of males exposed to fertile non-pregnant females), Litter size (e.g., number of fetuses per litter, measured before birth); TDLo: 24 mg/kg (42D male) [Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282) V.1- 1950- v. 35, p. 691, 1981 (FESTAS)]
Implant application of androstanolone to male monkeys over 90 days prior to mating leads to paternal effects on testes, epididymis and sperm duct; TDLo: 3420 ug/kg (90D male) [International Journal of Fertility. (Allen Press, 1041 New Hampshire, St., Lawrence, KS 66044) V.1- 1955- v. 19, p. 133, 1974 (INJFA3)]
Single parental application to male rats prior to mating results in paternal effects on prostate, seminal vessicle, Cowper's gland and accessory glands; TDLo: 168 mg/kg (1D male) [Journal of Andrology. (Lippincott/Harper, Journal Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1980- v. 7, p. 55, 1986 (JOAND3)]
Parental application to female rats over 10 days prior to mating results in maternal effects on ovaries and fallopian tubes; TDLo: 2500 ug/kg (10D pre) [Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960- v. 25, p. 309, 1971 (JRPFA4)]
Single subcutaneous application to female mice prior to mating leads to maternal effects on ovaries and fallopian tubes and effects on fertility: litter size (e.g., number of fetuses per litter, measured before birth); TDLo: 40 mg/kg (1D pre) [Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960- v. 62, p. 21, 1981 (JRPFA4)]
Androstanolone is applied daily in the muscle of male monkeys over 20 days prior to mating. This results in paternal effects on spermatogenesis (including genetic material, sperm morphology, motility, and count); TDLo: 200 ug/kg (20D male) [Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960- v. 89, p. 69, 1990 (JRPFA4)]
Daily subcutaneous application of androstanolone to female rats over 35 days prior to mating leads to effects on fertility: female fertility index (e.g., number of females pregnant per number of sperm-positive females, number of females pregnant per number of females mated); TDLo: 17500 ug/kg (35D pre) [Recent Progress In Hormone Research. Proceedings of the Laurentian Hormone Conference. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1947- v. 20, p. 395, 1964 (RPHRA6)]
Daily application of androstanolone (route unreported) to female rats over 30 days prior to mating results maternal effects on uterus, cervix and vagina; TDLo: 150 mg/kg (30D pre) [Recent Progress In Hormone Research. Proceedings of the Laurentian Hormone Conference. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1947- v. 20, p. 395, 1964 (RPHRA6)]
Short description of key information:
There is no fertility study with androstanolone available. However, results of fertility studies with adrostanolone are cited in RTECS database (Jan 2010). Tests and results are further described in chapter DISCUSSION.
Effects on developmental toxicity
Description of key information
There is no teratogenicity study with androstanolone available. However, results of different studies are cited in RTECS database (Jan 2010):
Subcutaneous, day 14 of preg (mouse, female): TDLo: 2 gm/kg (14D preg)
(Archives d'Anatomie Microscopique et de Morphologie Experimentale. (SPPIF, B.P.22, F-41353 Vineuil, France) V.36-76, 1947-1987. For publisher information, see BSTME2. v. 63, p. 63, 1974 (AAMMAU))
Route not specified, day 1-3 of preg (rabbit, female): TDLo: 1500 ug/kg (1-3D preg)
(Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1- 1970- v. 2, p. 85, 1970 (CCPTAY))
Subcutaneous, day 14-21 of preg (rat, female): TDLo: 160 mg/kg (14-21D preg)
(Endocrinology (Baltimore). (Williams and Wilkins Co., 428 E. Preston St., Baltimore, MD 21203) V.1- 1917- v. 94, p. 979, 1974 (ENDOAO))
Intramuscular, day 13-20 of preg (rat, female): TDLo: 80 mg/kg (13-20D preg)
(Endocrinology (Baltimore). (Williams and Wilkins Co., 428 E. Preston St., Baltimore, MD 21203) V.1- 1917- v. 99, p. 1490, 1976 (ENDOAO))
Subcutaneous, day 3 of preg (mouse, female): TDLo: 24 mg/kg (3D preg)
(Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282) V.1- 1950- v. 20, p. 211, 1969 (FESTAS))
Subcutaneous, day 1-3 of preg (rabbit, female):TDLo: 30 mg/kg (1-3D preg)
(Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282) V.1- 1950- v. 20, p. 211, 1969 (FESTAS))
Additional information
There is no teratogenicity study with androstanolone available. However, results of different studies are sited in RTECS database (Jan 2010):
Single subcutaneous application to mice on day 14 of pregnancy results in specific developmental abnormalities on skin and skin appendages; TDLo: 2 gm/kg (14D preg) [Archives d'Anatomie Microscopique et de Morphologie Experimentale. (SPPIF, B.P.22, F-41353 Vineuil, France) V.36-76, 1947-1987. For publisher information, see BSTME2. v. 63, p. 63, 1974 (AAMMAU)]
Application of androstanolone (route not specified) to rabbits on day 1-3 of pregnancy results in pre-implantation mortality (e.g., reduction in number of implants per female; total number of implants per corpora lutea); TDLo: 1500 ug/kg (1-3D preg) [Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1- 1970- v. 2, p. 85, 1970 (CCPTAY)]
Daily subcutaneous administration to rats on day 14-21 of pregnancy leads to specific developmental abnormalities of the urogenital system; TDLo: 160 mg/kg (14-21D preg) [Endocrinology (Baltimore). (Williams and Wilkins Co., 428 E. Preston St., Baltimore, MD 21203) V.1- 1917- v. 94, p. 979, 1974 (ENDOAO)]
Intramuscular injections of androstanolone to rats on day 13-20 of pregnancy results in specific developmental abnormalities of skin and skin appendages and urogenital system; TDLo: 80 mg/kg (13-20D preg) [Endocrinology (Baltimore). (Williams and Wilkins Co., 428 E. Preston St., Baltimore, MD 21203) V.1- 1917- v. 99, p. 1490, 1976 (ENDOAO)]
Single subcutaneous application to mice on day 3 of pregnancy leads to maternal effects on uterus, cervix and vagina; TDLo: 24 mg/kg (3D preg) [Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282) V.1- 1950- v. 20, p. 211, 1969 (FESTAS)]
Subcutaneous administration of androstanolone to rabbits on day 1-3 of pregnancy results in following effects on fertility: pre-implantation mortality e.g., reduction in number of implants per female; total number of implants per corpora lutea; TDLo: 30 mg/kg (1-3D preg) [Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282) V.1- 1950- v. 20, p. 211, 1969 (FESTAS)]
Justification for classification or non-classification
Internal company data on the reproduction toxicity of androstanolone (ZK5145) are not available. As other anabolic steroids, androstanolone has an androgenic activity and long-term uptake of pharmacological doses can result in masculisation, cyclus abnormalities, and impaiment of fertility in women. In men the endogenous hormon production may be impaired, together with disturbed fertility (reduced spermatogenesis). The exposure during pregnancy can result in masculinization of the sexual organs of female fetusses in the womb. When androstanolone is taken up by the nursing mother, it may be absorbed with the mothermilk and the development during infancy may be impaired.
Classified according to German legislation (TRGS-905) as Repr. (F) Cat. 1 and Repr. (E) Cat. 2 (EEC criteria).
According to the Directive 67/548 EEC, androstanolone is classified:
Category 1; R60 - May impair fertility.
Category 2; R61 - May cause harm to the unborn child.
R64 - May cause harm to breastfed babies.
Classified as Category 1B according to Regulation (EC) 1272/2008 (CLP).
Additional information
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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