Registration Dossier
Registration Dossier
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EC number: 206-119-6 | CAS number: 302-23-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
No fertility studies of hydroxyprogesteronacetat are available. Results of nine fertility studies were found in RTECS database (Jan. 2010).
Effects on female rabbit fertility after oral administration of progesteronacetat once prior to mating: Other measures of fertility; TDLo: 5 mg/kg (1D pre) ["Control of Ovulation, Proceedings of the Conference, Dedham, MA, 1960," Villee, C.A., ed., Oxford, UK, Pergamon Press Ltd., 1961 -,37,1961 (13OPAL).]
Effects on female rabbit fertility after subutaneous application of progesteronacetat once prior to mating: Other measures of fertility; TDLo: 40 ug/kg (1D pre) ["Control of Ovulation, Proceedings of the Conference, Dedham, MA, 1960," Villee, C.A., ed., Oxford, UK, Pergamon Press Ltd., 1961 -,37,1961 (13OPAL).]
Effects on female mice fertility after subcutaneous application of hydroxyprogesteronacetat once prior to mating: Maternal Effects: Uterus, cervix, vagina; TDLo: 1 mg/kg (1D pre) ["The Control of Fertility," Pincus, G., New York, Academic Press, 1965 -,150,1965 (85GRAA).]
Effects on rabbit fertility after oral application of hydroxyprogesteronacetat: mating performance (e.g., number of sperm positive females per number of females mated; number of copulations per number of estrus cycles); TDLo: 2500 ug/kg (1D pre)[Acta Endocrinologica, Supplementum (Copenhagen). (Periodica, Skolegade 12 E, DK-2500 Valby, Denmark) No.1- 1948- v. 73, p. 17, 1963 (ACEDAB).]
Effects on female rabbit fertility after 5 days subcutaneous application of hydroxyprogesteronacetat prior to mating: Maternal Effects: Uterus, cervix, vagina; TDLo: 100 ug/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).]
Effects on male rat fertility after nine days oral application of hydroxyprogesteronacetat prior to mating: Paternal Effects: Prostate, seminal vessicle, Cowper's gland, accessory glands; TDLo: 72 mg/kg (9D male) [Proceedings of the Society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04- v. 100, p. 540, 1959 (PSEBAA).]
Effects on female dog fertility after 32 weeks oral application of hydroxyprogesteronacetat prior to mating: Maternal Effects: Menstrual cycle changes or disorders; TDLo: 896 mg/kg (32W pre) [Proceedings of the Society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04- v. 105, p. 23, 1960 (PSEBAA).] Effects on female dog fertility after 23 weeks oral application of hydroxyprogesteronacetat prior to mating: Maternal Effects: Uterus, cervix, vagina; TDLo: 80500 ug/kg (23W pre) [Proceedings of the Society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04- v. 105, p. 23, 1960 (PSEBAA).] Effects on rabbit fertility after subcutaneous application of hydroxyprogesteronacetat once prior to mating: Pre-implantation mortality (e.g., reduction in number of implants per female; total number of implants per corpora lutea); TDLo: 500 ug/kg (1D pre) [Steroids. (Holden-Day Inc., 4432 Telegraph Ave., Oakland, CA 94609) V.1- 1963- v. 7, p. 341, 1966 (STEDAM).]
Short description of key information:
No fertility studies of hydroxyprogesteronacetat are available. Results of nine fertility studies were found in RTECS database (Jan. 2010).
Oral (rabbit): TDLo: 5 mg/kg (1D pre)
(''Control of Ovulation, Proceedings of the Conference, Dedham, MA, 1960," Villee, C.A., ed., Oxford, UK, Pergamon Press Ltd., 1961 -,37,1961 (13OPAL))
Subcutan (rabbit): TDLo: 40 ug/kg (1D pre)
("The Control of Fertility," Pincus, G., New York, Academic Press, 1965 -,150,1965 (85GRAA).)
Subcutan (mouse): TDLo: 1 mg/kg (1D pre)
("The Control of Fertility," Pincus, G., New York, Academic Press, 1965 -,150,1965 (85GRAA).)
Oral (rabbit): TDLo: 2500 ug/kg (1D pre)
(Acta Endocrinologica, Supplementum (Copenhagen). (Periodica, Skolegade 12 E, DK-2500 Valby, Denmark) No.1- 1948- v. 73, p. 17, 1963 (ACEDAB).)
Subcutan (rabbit): TDLo: 100 ug/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).)
Oral (rat): TDLo: 72 mg/kg (9D male)
(Proceedings of the Society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04- v. 100, p. 540, 1959 (PSEBAA).)
Oral (dog): TDLo: 896 mg/kg (32W pre)
(Proceedings of the Society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04- v. 105, p. 23, 1960 (PSEBAA).)
Oral (dog): TDLo: 80500 ug/kg (23W pre)
(Proceedings of the Society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04- v. 105, p. 23, 1960 (PSEBAA).)
Subcutan (rabbit): TDLo: 500 ug/kg (1D pre)
(Steroids. (Holden-Day Inc., 4432 Telegraph Ave., Oakland, CA 94609) V.1- 1963- v. 7, p. 341, 1966 (STEDAM).)
Justification for classification or non-classification
No reproduction toxicological studies with ZK 5189 are available. However, impairment of fertility was found in studies with different animal species reported on RTECS database. Due to the progestagenic effect of the substance, impairment of the endogenous hormone production and reversible disturbance of fertility have to be also expected in both women and men following repeated uptake of pharmacologically effective doses. It has to be taken into consideration that, because of a possible antiandrogenic effect in humans, there is a risk of feminization in male offspring should hydroxyprogesterone acetate be taken in high doses during pregnancy. In addition, as a precautionary measure, it should be assumed that this substance, if taken by nursing women, can enter the mother's milk and thus influence the development of the infant.
Classified according to german legislation (TRGS-905) as Repr. (F) Cat. 1 and Repr. (E) Cat. 2 (EEC criteria).
Classified as Catergory 1A according to Regulation 1272/2008/EC (CLP).
According to the Directive 67/548 EEC, hydroxyprogesteron-acetate 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
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