Brief Profile

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Please be aware that the REACH registration parts of this Brief Profile are no longer maintained; they remain frozen as of 19th May 2023. All other data parts (substance identity, C&L, key regulatory lists etc. are up to date).

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Brief Profile

The Brief Profile summarizes the non-confidential data on substances as it is held in the databases of the European Chemicals Agency (ECHA), including data provided by third parties. The Brief Profile is automatically generated; note that it does not currently distinguish between harmonised classification and minimum classification; information requirements under different legislative frameworks may therefore not be fully up to date or complete. For accuracy reasons, substance manufacturers and imports have the responsibility to consult official sources, e.g. the electronic edition of the Official Journal of the European Union.
This Brief Profile is covered by the ECHA Legal Notice.

Substance Description

Substance identity

  • EC / List name:
  • IUPAC name: 2-[(1S,2R,3aS,3bS,9aS,11aS)-1,2-dihydroxy-9a,11a-dimethyl-7-oxo-1H,2H,3H,3aH,3bH,4H,5H,7H,9aH,11H,11aH-cyclopenta[a]phenanthren-1-yl]-2-oxoethyl acetate
  • Substance names and other identifiers
EC / List no.:
278-593-2
CAS no.:
77017-20-0
Index number:
Molecular formula:
C23H28O6
SMILES:
[H][C@@]12C[C@@H](O)[C@](O)(C(=O)COC(C)=O)[C@@]1(C)CC=C1[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
InChI:
InChI=1S/C23H28O6/c1-13(24)29-12-20(27)23(28)19(26)11-18-16-5-4-14-10-15(25)6-8-21(14,2)17(16)7-9-22(18,23)3/h6-8,10,16,18-19,26,28H,4-5,9,11-12H2,1-3H3/t16-,18+,19-,21+,22+,23+/m1/s1
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
4
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:
EINECS (European INventory of Existing Commercial chemical Substances) List

Hazard classification & labelling

Warning! According to the classification provided by companies to ECHA in REACH registrations this substance is toxic to aquatic life with long lasting effects, causes serious eye irritation, is suspected of damaging fertility or the unborn child, causes skin irritation and may cause respiratory irritation.

Breakdown of all 4 C&L notifications submitted to ECHA

Aquatic Chronic 2 H411
Eye Irrit. 2 H319
Repr. 2 H361
Skin Irrit. 2 H315
STOT SE 3 H335
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

https://www.echa.europa.eu/o/diss-blank-theme/images/cnl/graph/tick.png Harmonised Classification

https://www.echa.europa.eu/o/diss-blank-theme/images/cnl/graph/Reach.png REACH registration dossiers notifications

https://www.echa.europa.eu/o/diss-blank-theme/images/cnl/graph/CLP.png CLP notifications

Properties of concern

Regulatory context

Registration, Evaluation, Authorisation & Restriction of Chemicals (REACH)

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 4 active registrations under REACH, 1 Joint Submission(s) and 0 Individual Submission(s).
Please see Registrants/Suppliers details.
Evaluation
Dossier Evaluation:
Substance Evaluation:
Authorisation
Candidate List:
Annex XIV (Authorisation List):
Restriction
Annex XVII (Restriction List):

Persistent Organic Pollutants Regulation (POPs)

List of substances subject to the POPs Regulation:
List of substances proposed as POPs:

Classification Labelling & Packaging (CLP)

Harmonised C&L:
Seveso Annex I:
Notified C&L:
Classification & Labelling has been notified by industry to ECHA for this substance.

Biocidal Products Regulation (BPR)

Active Substance:
Biocidal Products:

Prior Informed Consent (PIC)

Annex I:
Annex V:

European Union Observatory for Nanomaterials (EUON)

EUON:

About this substance

This substance is registered under the REACH Regulation and is manufactured in and / or imported to the European Economic Area, at ≥ 1 to < 10 tonnes per annum.

This substance is used at industrial sites and in manufacturing.

ECHA has no public registered data indicating whether or in which chemical products the substance might be used.

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

ECHA has no public registered data on the use of this substance in activities or processes at the workplace.

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

ECHA has no public registered data indicating whether or into which articles the substance might have been processed.

ECHA has no public registered data indicating whether or in which chemical products the substance might be used.

ECHA has no public registered data on the types of manufacture using this substance.

ECHA has no public registered data on the use of this substance in activities or processes at the workplace.

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

ECHA has no public registered data indicating whether or in which chemical products the substance might be used.

ECHA has no public registered data on the use of this substance in activities or processes at the workplace.

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

This substance is used in the following products: pharmaceuticals. This substance has an industrial use resulting in manufacture of another substance (use of intermediates).

This substance is used for the manufacture of: chemicals.

This substance is used in the following activities or processes at workplace: closed batch processing in synthesis or formulation, transfer of chemicals, laboratory work, closed processes with no likelihood of exposure, batch processing in synthesis or formulation with opportunity for exposure and transfer of substance into small containers.

Release to the environment of this substance can occur from industrial use: as an intermediate step in further manufacturing of another substance (use of intermediates).

This substance is used in the following activities or processes at workplace: closed batch processing in synthesis or formulation, transfer of chemicals, laboratory work, closed processes with no likelihood of exposure, batch processing in synthesis or formulation with opportunity for exposure and transfer of substance into small containers.

Release to the environment of this substance can occur from industrial use: manufacturing of the substance.

Precautions for using this substance have been recommended by its registrants under REACH, as follows:

Prevention statements

When handling this substance: obtain special instructions before use; wash parts of the body (as specified by manufacturer/supplier)in contact with substance thoroughly after handling; use personal protective equipment as required.; avoid breathing the dust, fume, gas, mist, vapours or spray.

Response statements

In case of incident: If inhaled: remove victim to fresh air and keep at rest in a position comfortable for breathing. If on skin: wash with soap and water. If in eyes: rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.

Storage statements

Store this substance locked up.

Disposal statements

The substance must be disposed in accordance with local/regional/national/international regulation.

Guidance on the safe use of the substance provided by manufacturers and importers of this substance.

Registrants/suppliers

  • CURIA SPAIN, S.A.U., Parque Tecnológico de Boecillo, parcela 105 47151 Boecillo Valladolid Spain
  • Farmabios Spa, Via Pavia, 1 27027 Gropello Cairoli PV Italy
  • NEWCHEM S.P.A., VIA EDMONDO DE AMICIS 47 20123 MILANO ITALY Italy
  • Sicor - Società Italiana Corticosteroidi S.r.l., Piazzale Luigi Cadorna 4 20123 Milano (MI) Italy

Substance names and other identifiers

16α,17,21-trihydroxypregna-1,4,9(11)-triene-3,20-dione 21-acetate
EC Inventory
16α,17,21-trihydroxypregna-1,4,9(11)-triene-3,20-dione 21-acetate
REACH pre-registration
16,17-dihydroxy-3,20-dioxopregna-1,4,9(11)-trien-21-yl acetate
Registration dossier
16α,17,21-trihydroxypregna-1,4,9(11)-triene-3,20-dione 21-acetate
C&L Inventory, Registration dossier
16α,17,21-trihydroxypregna-1,4,9(11)-triene-3,20-dione 21-acetate
Registration dossier
2-[(1S,2R,3aS,3bS,9aS,11aS)-1,2-dihydroxy-9a,11a-dimethyl-7-oxo-1H,2H,3H,3aH,3bH,4H,5H,7H,9aH,11H,11aH-cyclopenta[a]phenanthren-1-yl]-2-oxoethyl acetate
Other
77017-20-0
CAS number
EC Inventory, C&L Inventory, Registration dossier, REACH pre-registration

Scientific properties

Physical and chemical properties

This section provides physicochemical information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Appearance/physical state / colour

Study results
  • 1 study submitted
  • 1 study processed
C Physical state at 20°C and 1013 hPa
Solid (100%) [1]
C Form
Crystalline (100%) [1]
C Substance type
Organic (100%) [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Melting/freezing point

Study results
  • 5 studies submitted
  • 5 studies processed
R Melting / freezing point
201.4 - 204.8 °C @ 101.3 kPa [5]

Type of Study provided
Studies with data
Key study 5
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Boiling point

Study results
  • 2 studies submitted
  • 2 studies processed
R Boiling point
515.48 - 516.4 °C @ 101.325 kPa [2]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 2
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Boiling point at 101 325 Pa
515.94 °C

Density

Study results
  • 5 studies submitted
  • 5 studies processed
R Bulk density
0.457 - 0.504 g/cm³ @ 25 °C [5]
R Tap density
0.67 - 0.718 g/cm³ @ 25 °C [5]

Type of Study provided
Studies with data
Key study 5
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
0.693

Vapour pressure

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 2
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Partition coefficient

Study results
  • 7 studies submitted
  • 1 study processed
R Log Pow
2.26 [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 6
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Log Kow (Log Pow)
2.26 @ 25 °C

Water solubility

Study results
  • 3 studies submitted
  • 1 study processed
R Water solubility (mass/vol.)
38.72 mg/L @ 25 °C [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Water solubility
38.72 mg/L @ 25 °C

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 2
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Flash point

Study results
  • 1 study submitted
  • 1 study processed
R Flash point
280.46 °C @ 101.325 kPa [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Flash point at 101 325 Pa
280.46 °C

Auto flammability

Study results
  • 1 study submitted
  • 1 study processed
R Autoflammability / self-ignition
357 °C @ 101.325 kPa [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Flammability

Study results
  • 1 study submitted
  • 1 study processed
C Interpretation of results
Non flammable (100%) [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Explosiveness

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
C Summaries
  • 1 summary submitted
  • 1 summary processed
Explosiveness
Non-explosive (100%)

Oxidising

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
C Summaries
  • 1 summary submitted
  • 1 summary processed
Oxidising
No (100%)

Oxidation reduction potential

Data not provided by the registrant

pH

Data not provided by the registrant

Dissociation constant

Data not provided by the registrant

Viscosity

Data not provided by the registrant

Environmental fate and pathways

This section provides environmental fate and pathways information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Phototransformation in air

Data not provided by the registrant

Hydrolysis

Data not provided by the registrant

Phototransformation in water

Data not provided by the registrant

Phototransformation in soil

Data not provided by the registrant

Biodegradation in water - screening tests

Study results
  • 3 studies submitted
  • 1 study processed
C Interpretation of results
Not inherently biodegradable (100%) [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Biodegradation in water & sediment - simulation tests

Data not provided by the registrant

Biodegradation in soil

Data not provided by the registrant

Bioaccumulation: aquatic / sediment

Data not provided by the registrant

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Data not provided by the registrant

Henrys law constant (H)

Data not provided by the registrant

Distribution modelling

Data not provided by the registrant

Ecotoxicological information

This section provides ecotoxicological information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Predicted No-Effect Concentration (PNEC)

Data not provided by the registrant

Short–term toxicity to fish

Data not provided by the registrant

Long–term toxicity to fish

Data not provided by the registrant

Short–term toxicity to aquatic invertebrates

Study results
  • 3 studies submitted
  • 1 study processed
P/RResults
LC50 (48 h) 4.43 mg/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Long–term toxicity to aquatic invertebrates

Data not provided by the registrant

Toxicity to aquatic algae and cyanobacteria

Study results
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Data not provided by the registrant

Sediment toxicity

Data not provided by the registrant

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

Data not provided by the registrant

Toxicity to terrestrial arthropods

Data not provided by the registrant

Toxicity to terrestrial plants

Data not provided by the registrant

Toxicity to soil microorganisms

Data not provided by the registrant

Toxicity to birds

Data not provided by the registrant

Toxicity to mammals

Data not provided by the registrant

Toxicological information

This section provides toxicological information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Derived No- or Minimal Effect Level (DN(M)EL)

Data not provided by the registrant

Toxicokinetics, metabolism, and distribution

Data not provided by the registrant

Acute toxicity

Study results
oral
  • 2 studies submitted
  • 1 study processed
P/RResults
LD50 2 000 mg/kg bw (rat) [1]
M/CInterpretations of results
Practically nontoxic [1]

Type of Study provided
oral
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
inhalation
  • 0 studies submitted
  • 0 studies processed

No data available

inhalation
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
dermal
  • 1 study submitted
  • 1 study processed
M/CInterpretations of results
Practically nontoxic [1]

dermal
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
other routes
  • 0 studies submitted
  • 0 studies processed

No data available

other routes
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Irritation / corrosion

Study results
Study data: skin
  • 3 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 1
Supporting study 1 1
Weight of evidence
Other
Data waiving
no waivers
Study data: eye
  • 3 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 1
Supporting study 1 1
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Sensitisation

Study results
Study data: skin
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
Study data: respiratory
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: respiratory
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Repeated dose toxicity

Data not provided by the registrant

Genetic toxicity

Study results
Study data: in vitro
  • 3 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: in vitro
Studies with data
Key study 1
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
Study data: in vivo
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: in vivo
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Carcinogenicity

Data not provided by the registrant

Toxicity to reproduction

Study results
Study data: reproduction
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: reproduction
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: developmental
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: other studies
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: other studies
Studies with data
Key study
Supporting study
Weight of evidence 2
Other
Data waiving
no waivers
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Neurotoxicity

Data not provided by the registrant

Immunotoxicity

Data not provided by the registrant

Endocrine disrupter mammalian screening - in vivo

Data not provided by the registrant