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Diss Factsheets
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EC number: 200-699-4 | CAS number: 68-96-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- other: publications
- Adequacy of study:
- other information
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Genital Abnormalities in Infants Associated with Administration of Progesteroids to Their Mothers
- Author:
- Leibow S.G. and Gardner L.I.
- Year:
- 1 960
- Bibliographic source:
- Pediatrics, 26, 151
- Reference Type:
- publication
- Title:
- A Population-based Case Control Study of Congenital Abnormalities and Medication Use During Pregnancy Using the Czech National Register of Congenital Abnormalities
- Author:
- Maskova J., Sipek A., Kollar P.
- Year:
- 2 011
- Bibliographic source:
- Central European Journal of Medicine, 6 (4), 435-441
- Reference Type:
- publication
- Title:
- Embryo–fetal toxicity signals for 17a-hydroxyprogesterone caproate in high-risk pregnancies: A review of the non-clinical literature for embryo–fetal toxicity with progestins
- Author:
- Christian M.S., Brent R.L., Calda P.
- Year:
- 2 007
- Bibliographic source:
- The Journal of Maternal-Fetal and Neonatal Medicine, 20(2): 89–112
- Reference Type:
- publication
- Title:
- ‘‘Natural’’ Progesterone: Information on Fetal Effects
- Author:
- Golub M.S., Kaufman F.L., Campbell M.A., Li L.-H., Donald J.M.
- Year:
- 2 006
- Bibliographic source:
- Birth Defects Research (Part B) 77:455–470
- Reference Type:
- publication
- Title:
- Drugs in infertility and fetal safety
- Author:
- Elizur S.E., Tulandi T.
- Year:
- 2 008
- Bibliographic source:
- Fertility and Sterility, 89(6), 1595-1602
Materials and methods
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Due to the low gestagenic potency of 17-OHP and the limited oral bioavailability of OHPA very rare clinical data of both compounds are reported.
Regarding TRGS 905 (version 12.03.2020 and the justification document for Steroid Hormones, version Sept 1999) OHPA is classified as gestagen (group 7) with a reproduction toxicity RF= 1A and RD=1B (CLP), but 17-OHP is not listed here. RTECS shows a reproductive toxicity entry for 17-OHP based on a case study in 1960 reporting on genital abnormality of a child which mother was treated with 250 mg intramuscularly during pregnancy every second week (Leibow, 1960). It is unclear whether 17-OHP or its caproate OHPC was administered, the latter introduced for medical use in 1954/55 and typically applied until today as intramuscular depot with 250 mg/ml (Proluton®, Makena®) to prevent preterm birth. Nevertheless, a derived TDLo 65 mg/kg for 17-OHP is cited in RTECS.
Other case control studies revealed no conclusive evidence for higher incidences of congenital abnormalities or neural-tube defects after therapeutical administration of hydroxyprogesterone (no further data on substance identity) during pregnancy (Leibow, 1960; Medveczky, 2004). Consequently, after a history of precautionary labeling for therapeutic exposure of progestational drugs more recent epidemiologic analyses, animal studies and basic scientific principles disproved the risks and led 1987 to the FDA removing the warning label on oral contraceptives regarding nongenital malformation (Brent, 2005). Recent publications conclude even for the therapeutic use during pregnancy with almost no concern or signal for reproductive toxicity in association with progesterone or 17-hydroxyprogesterone (Christian et.al, 2007; Golub et al., 2006; Elizur et.al., 2008).
Leibow SG, Gardner LI, Pediatrics 1960, July:151-160
Maskova et al., Cent Eur J Med 2011; 6(4):435-441
Medveczky, Pharmacoepidem Drug Safety 2004; 13:443-455
Brent, Birth Defects Research (Part A) 2005; 73
Elizur et.al., Fertility and Sterility 2008; 89 (6):1595-1602
Christian et.al., J Mat-Fet Neonat Med 2007; 20(2):89-112
Golub et al., Birth Defects Res B Dev Reprod Toxicol, 2006 Oct;77(5):455-70
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