Registration Dossier
Registration Dossier
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EC number: 200-175-5 | CAS number: 53-43-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
No explicit studies on reproduction toxicity/fertility are available for the substance. However, repeated dose studies on rats and dogs with an analogue/precursor of Androst-5-en-17-one, 3-hydroxy-, (3.beta.)- (see endpoint summary Repeated dose toxicity) showed that repeated administration resulted in regressive changes on reproductive organs, both for males and females.
RTECS database (Jan 2012) cites for Androst-5-en-17-one, 3-hydroxy-, (3.beta.)- further reproductive data, for example:
Repeated subcutaneous administration of 15 mg/kg Androst-5-en-17-one, 3-hydroxy-, (3.beta.)-, to mature female mice starting from the day of estrus for up to 20 days, resulted in disruption of the ovary cycle and induced polycystic ovaries (RTECS: Dose data 300 mg/kg) [Biology of Reproduction. (Soc. For the Study of Reproduction, 309 W. Clark St., Champaign, IL 61820) V.1-1969-v. 18, p. 614, 1978 (BIREBV)].
Daily subcutaneous administration of 60 mg/kg Androst-5-en-17-one, 3-hydroxy-, (3.beta.)- , to rats for 10 days resulted in ovarian and hormonal changes compared to controls, e.g. higher levels of circulating androgens, estradiol and prolactin were detected (RTECS: Dose data 600 mg/kg) [Anatomical record. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1-1906/08-v. 231, p. 185, 1991 (ANREAK)].
Short description of key information:
No explicit studies on reproduction toxicity/fertility are available for the substance. Repeated dose studies of an analogue/precursor of Androst-5-en-17-one, 3-hydroxy-, (3.beta.)-, which is known to release in vivo Androst-5-en-17-one, 3-hydroxy-, (3.beta.)- were instead used for classification. The studies on rats and dogs, with intramuscular administration, reveal regressive changes on reproductive tissues).
[Schering AG, Report No. 174, 1971-10-25; Schering AG, Report No. 283, 1971-10-25; see chapter "repeated dose toxicity"]
Effects on reproductive function/fertility are confirmed by published data cited in RTECS (Jan 2012).
Classification is warranted for reproductive toxicity/fertility based on mode of action and data from repeated dose toxicity.
Effects on developmental toxicity
Description of key information
Published data on animal studies provide evidence that the substance is a developmental toxicant.
[Neuroimmunomodulation. (S. Karger Publishers, POB 529, Farnington, CT 06085) V.1-1994-v.12, p. 285, 2005 (NROIEM)].
Therefore classification is warranted for developmental toxicity.
Additional information
No explicit studies on developmental toxicity are available for the substance. However, RTECS database (Jan 2012) cites for Androst-5-en-17-one, 3-hydroxy-, (3.beta.)- data for developmental toxicity, for example:
Body weight of prepubertal male and female offspring of substance- treated female rats (Androst-5-en-17-one, 3-hydroxy-, (3.beta.)- ; drinking water study) was significantly and dose-dependently decreased. In contrast, thymus weights were significantly higher in the offspring. The splenic lymphocyte proliferative response was reduced for prepubertal male offspring only. (RTECS: Dose data 3500 mg/kg) [NeuroImmunoModulation. (S. Karger Publishers, POB 529, Farnington, CT 06085) V.1-1994-v. 4, p. 154, 1997 (NROIEM)].
Androst-5-en-17-one, 3-hydroxy-, (3.beta.)-, caused a marked reduction in fetal weight after being administered intramuscularly in doses of 30 or 100 mg/kg to the dams on days 13 to 20 of pregnancy. Furthermore, the substance led to a dose-dependent increase of the anogenital distance in female fetuses (RTECS: Dose data 240 mg/kg) [Endocrinology (Baltimore). (Williams &Wilkins Co., 428 E. Preston St. , Baltimore, MD 21203) V.1-1917-v.87, p. 432, 1970 (ENDOAO)]. With respect to maternal toxicity the same study revealed significantly decreased weights of the adrenals at 100 mg/kg and significantly increased ovary weights at either dose.
A more recent publication, not yet cited in RTECS, investigates the role of high levels of Androst-5-en-17-one, 3-hydroxy-, (3.beta.)-, on the ovarian function and embryonic resorption during early pregnancy in BALB/c-mice. Pregnant mice injected subcutaneously with 6 mg/kg from day 6 to 7 or from day 2 to 7 of pregnancy revealed 40% and 100 % of embryonic resorption, respectively. [Neuroimmunomodulation. (S. Karger Publishers, POB 529, Farnington, CT 06085) V.1-1994-v.12, p. 285, 2005 (NROIEM)].
Justification for classification or non-classification
Based on animal experiments and according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) the substance has to be classified for reproductive toxicity (fertility and developmental toxicity) as Repr. 1B (H360FD: May damage fertility or the unborn child).
Additionally for effects via lactation H362 (May cause harm to breast-fed children) is warranted.
Additional information
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