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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

There are no fertility studies with nandrolone available. However, results of fertility studies are cited in RTECS database (Jan 2010):

Subcutaneous application of nandrolone to female rats 3 days premating results in not further specified effects on fertility; TDLo: 1200 ug/kg (3D pre) [Acta Endocrinologica (Copenhagen). (Periodica, Skolegade 12 E, DK-2500 Valby, Denmark) V.1- 1948- v. 47, p. 444, 1964 (ACENA7)]

Daily subcutaneous application to female rabbits 5 days prior to mating leads to maternal effect in uterus, cervix and vagina; TDLo: 2 mg/kg (5D pre) [Anatomical Record. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1906/08- v. 142, p. 469, 1962 (ANREAK)]

Daily subcutaneous administration of nandrolone to female rats over 14 days prior to mating results in maternal effects on ovaries and fallopian tubes and not further specified effects on fertility; 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)]

Nandrolone is applied daily subcutaneously to female rat over 14 days premating. This results in maternal effects on uterus, cervix and vagina;

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)]

Intravaginal application of nandrolone to female mice 1 day premating results in maternal effects on uterus, cervix and vagina ; TDLo: 6400 ng/kg (1D pre) [Journal of Endocrinology. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1939- v. 20, p. 198, 1960 (JOENAK)]

Dermal application to male rats 30 days prior to mating leads to paternal effects on testes, epididymis, sperm duct, prostate, seminal vessicle, Cowper's gland and accessory glands; TDLo: 240 mg/kg (30D male) [Steroids. (Holden-Day Inc., 4432 Telegraph Ave., Oakland, CA 94609) V.1- 1963- v. 10, p. 687, 1967 (STEDAM)]


Short description of key information:
There are no fertility studies with nandrolone available. However, results of fertility studies are cited in RTECS database (Jan 2010):

Subcutaneous (Rat, females, 3 days premating): TDLo: 1200 ug/kg (3D pre)
(Acta Endocrinologica (Copenhagen). (Periodica, Skolegade 12 E, DK-2500 Valby, Denmark) V.1- 1948- v. 47, p. 444, 1964 (ACENA7))

Subcutaneous (rabbit, females, 5 days premating): TDLo: 2 mg/kg (5D pre)
(Anatomical Record. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1906/08- v. 142, p. 469, 1962 (ANREAK))

Subcutaneous (rat, females, 14 days premating): 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 (rat, females, 14 days premating): 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))

Intravaginal (mouse, females, 1 day premating): TDLo: 6400 ng/kg (1D pre)
(Journal of Endocrinology. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1939- v. 20, p. 198, 1960 (JOENAK))

Dermal (rat, males, 30 days premating): TDLo: 240 mg/kg (30D male)
(Steroids. (Holden-Day Inc., 4432 Telegraph Ave., Oakland, CA 94609) V.1- 1963- v. 10, p. 687, 1967 (STEDAM).)

Effects on developmental toxicity

Description of key information
There is no developmental toxicity study with nandrolone available. However, the result of one teratogenicity study is cited in RTECS database (Jan 2010):
Subcutaneous (rat, 3-9 day of pregnancy): TDLo: 140 mg/kg (3-9D preg)
(Acta Endocrinologica (Copenhagen). (Periodica, Skolegade 12 E, DK-2500 Valby, Denmark) V.1- 1948- v. 47, p. 444, 1964 (ACENA7))
Additional information

There is no developmental toxicity studies with nandrolone available. However, the result of one teratogenicity study is cited in RTECS database (Jan 2010):

Subcutaneous application of nandrolone to female rats on day 3 to 9 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: 140 mg/kg (3-9D preg) [Acta Endocrinologica (Copenhagen). (Periodica, Skolegade 12 E, DK-2500 Valby, Denmark) V.1- 1948- v. 47, p. 444, 1964 (ACENA7)]

Justification for classification or non-classification

Only very limited data on the reproduction toxicity of nandrolone (ZK5221) are not available. As other anabolic steroids, nandrolone 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 nandrolone 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).

Classified as Category 1B according to Regulation (EC) 1272/2008 (CLP).

According to the Directive 67/548/EEC, nandrolone 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

Additional information