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EC number: 200-021-7 | CAS number: 50-24-8
- 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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- other: Case report study.
- Adequacy of study:
- weight of evidence
- Study period:
- 1968
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Case report study on humans should be considered sufficient to accept data from investigations which cannot be obtained through test guideline, but which are nevertheless well documented and scientifically acceptable.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
- Reference Type:
- secondary source
- Title:
- MORPHOLOGIC CHANGES IN THE DEVELOPING RAT PLACENTA FOLLOWING PREDNISOLONE ADMINISTRATION.
- Author:
- BLACKBURN, W. R.; KAPLAN, H. S.; MCKAY, D. G.
- Year:
- 1 965
- Bibliographic source:
- BLACKBURN, W. R.; KAPLAN, H. S.; MCKAY, D. G. American journal of obstetrics and gynecology. 1965, 92, 234-46.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
- Type of method:
- other: Case report study.
Test material
- Reference substance name:
- Prednisolone
- EC Number:
- 200-021-7
- EC Name:
- Prednisolone
- Cas Number:
- 50-24-8
- Molecular formula:
- C21H28O5
- IUPAC Name:
- 11,17,21-trihydroxypregna-1,4-diene-3,20-dione
Constituent 1
Results and discussion
Any other information on results incl. tables
Case no. | Age (yr.) | Parity | Disease | Daily dose of prednisolone (mg.) | Pregnancy, delivery, and fetal outcome(8 stillbirths, 11 babies "at risk", 16 normal healthy babies) |
1 | 22 | Primipara | Asthma | 10 | 40 wk., acute fetal distress, stillbirth, 2.8 kg. |
2 | 37 | G.5 P.3 | Eczema | 10 | 40 wk., anencephalic, stillbirth, 2.06 kg. |
3 | 21 | Primipara | Ulcerative colitis | 15 | I.U.D., 32 wk., 1.56 kg. |
4 | 35 | Primipara | Asthma | 10 | 40 wk., fetal distress, stillbirth, 3 kg. |
5 | 23 | G.2 P.1 | Asthma | 10 | I.U.D., 33 wk., 1.02 kg. |
6 | 28 | Primipara | Lupus erythematosus | 5 | P.E.T., I.U.D., 33 wk., 1.531 kg. |
7 | 27 | P.1 | Asthma | 5 -20 | 40 wk., fetal distress, stillbirth, 2.381 kg. |
8 | 41 | G.7 P.6 | Lupus erythematosus | 10 -30 | Twins 35 wk., anencephalic, 2.1 kg. |
9 | 25 | Primipara | Asthma | 10 -30 | Hypertension, 40 wk., placental insufficiency, fetal distress, L.S.C.S., 2.353 kg. |
10 | 28 | P.2 | Asthma | 10 -30 | Placental insufficiency, L.S.C.S., 35 wk., 1.814 kg. |
11 | 25 | Primipara | Asthma | 5 | Placental insufficiency, L.S.C.S., 35 wk., 1.814 kg. |
12 | 37 | P.1 | Asthma | 5 -10 | Placental insufficiency, L.S.C.S., 37 wk., 2.693 kg. |
13 | 39 | Primipara | Eczema | 40 | Placental insufficiency, failed induction, L.S.C.S., 40 wk., 2.6 kg. |
14 | 22 | Primipara | Lupus erythematosus | 30 | 38 wk., placental insufficiency, forceps, 2.38 kg. |
15 | 17 | Primipara | Eczema | 7.5 -15 | 40 wk., fetal distress, low forceps, 2.892 kg. |
16 | 23 | G.2 | Eczema | 5 -10 | 40 wk., fetal distress, L.S.C.S., 3.006 kg. |
17 | 24 | Primipara | Ulcerative colitis | 5 -10 | 42 wk., fetal distress, L.S.C.S., 3.006 kg. |
18 | 28 | Primipara | Asthma | 10 -15 | N.D., 38 wk., respiratory-distress syndrome, 3.09 kg. |
19 | 19 | Primipara | Eczema | 5 | N.D., twins, 3.317 kg. |
20 | 27 | G.3 P.2 | Eczema | 20 | N.D., 39 wk., 3.09 kg. |
21 | 24 | G.3 P.2 | Asthma | 10 | N.D., 40 wk., 3.373 kg. |
22 | 31 | G.3 P.2 | Arthritis | 2.5 | N.D., 40 wk., 3.43 kg. |
23 | 33 | G.8 P.7 | Asthma | 10 | N.D., 38 wk., 3.034 Kg. |
24 | 34 | G.2 P.1 | Asthma | 10 | Breech, 40 wk., 2.5 kg. |
25 | 32 | Primipara | Urticaria | 10 | N.D., 39 wk., 2.665 kg. |
26 | 24 | G.2 P.1 | Asthma | 10 | N.D., 40 wk., 3.062 kg. |
27 | 25 | Primipara | Sarcoidosis | 10 | N.D., 41 wk., 4.252 kg. |
28 | 34 | G.3 P.2 | Rheumatoid arthritis | 5 -10 | N.D., 39 wk., 2.722 kg. |
29 | 28 | G.3 P.2 | Asthma | 10 | N.D., 40 wk., 2.949 kg. |
30 | 33 | G.5 P.4 | Asthma | 2.5 -10 | N.D., 40 wk., 3.373 kg. |
31 | 28 | G.2 P.1 | Asthma | 20 | N.D., 40 wk., 3.29 kg. |
32 | 33 | P.1 | Lupus erythematosus | 5 | N.D., 38 wk., 3.091 kg. |
33 | 34 | P.1 | Asthma | 10 | N.D., 40 wk., 3.26 kg. |
34 | 22 | Primipara | Asthma | 10 | N.D., 40 wk., 2.75 kg. |
G, gravid; p, para; I.U.D., intrauterine death; I.S.C.S., lower segment cesarean section; N.D., normal delivery; P.E.T., pre-eclamptic toxemia.
Applicant's summary and conclusion
- Conclusions:
- The cause of risk to the fetus appears to be that of failure of placental function, manifesting itself either as a chronic process with a small fetus or as acute hypoxia in labour. This effect is apparently a direct result of prednisolone, since fetal mortality in the control group (i.e., with similar disease but not on prednisolone) was low. The effect is not a disturbance of fetal adrenal function, since none of the babies gave clinical evidence of adrenocortical insufficiency. Experimental work suggests that placentation is damaged by glucocorticoids; Blackburn et al. (1965) found that the administration of prednisolone to pregnant rats inhibited placental growth, caused morphological changes resembling premature ageing of the placenta, and significantly increased the incidence of intrauterine deaths. The high incidence of fetal death and fetal risk attributable to a placental fault in our series suggest that a similar change may occur in pregnant women.
- Executive summary:
Thirty-four pregnancies in thirty women receiving prednisolone in the course of treatment of a general disease resulted in eight stillbirths, and nine foetuses were judged to have been at risk during pregnancy or parturition. In contrast, thirty-four pregnancies in women not receiving glucocorticoids but with similar general diseases resulted in one stillbirth, three premature babies, and thirty healthy babies.
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