Brief Profile

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: (1S,2R,3aS,3bS,9aR,9bS,10S,11aS)-1,2,10-trihydroxy-1-(2-hydroxyacetyl)-9a,11a-dimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
  • Substance names and other identifiers
EC / List no.:
237-731-1
CAS no.:
13951-70-7
Index number:
Molecular formula:
C21H28O6
SMILES:
[H][C@@]12C[C@@H](O)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
InChI:
InChI=1S/C21H28O6/c1-19-6-5-12(23)7-11(19)3-4-13-14-8-16(25)21(27,17(26)10-22)20(14,2)9-15(24)18(13)19/h5-7,13-16,18,22,24-25,27H,3-4,8-10H2,1-2H3/t13-,14-,15-,16+,18+,19-,20-,21-/m0/s1
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
7
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 suspected of damaging fertility or the unborn child.

Additionally, the classification provided by companies to ECHA in CLP notifications identifies that this substance causes damage to organs through prolonged or repeated exposure, may damage fertility or the unborn child, may cause harm to breast-fed children and may cause an allergic skin reaction.

Breakdown of all 38 C&L notifications submitted to ECHA

Repr. 2 H361
Repr. 1A H360
Lact. H362
STOT RE 2 H373
Not Classified
STOT RE 1 H372
Skin Sens. 1 H317
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

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

https://chesar.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 5 active registrations under REACH, 2 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 in formulation or re-packing, 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.

This substance is used in the following activities or processes at workplace: closed batch processing in synthesis or formulation and transfer of chemicals at dedicated facilities.

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: transfer of chemicals, closed batch processing in synthesis or formulation, batch processing in synthesis or formulation with opportunity for exposure, laboratory work and closed processes with no likelihood of exposure.

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: transfer of chemicals, closed batch processing in synthesis or formulation, batch processing in synthesis or formulation with opportunity for exposure and laboratory work.

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: do not handle until all safety precautions have been read and understood; obtain special instructions before use; use personal protective equipment as required..

Response statements

In case of incident: If exposed or concerned: get medical advice/attention.

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

  • Aspen Oss BV, Kloosterstraat 6 5349 AB Oss Netherlands
  • Industriale Chimica s.r.l., via E.H. Grieg, 13 21074 Saronno (VA) Italy
  • Minakem Dunkerque Production, 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht 59640 DUNKERQUE France
  • RSI ChemRep Europe Ltd (P001), 27-30 Merchants Quay Merchants House 8 Dublin Ireland
  • Sicor - Società Italiana Corticosteroidi S.r.l., Piazzale Luigi Cadorna 4 20123 Milano (MI) Italy

Substance names and other identifiers

11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione
EC Inventory
11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione
REACH pre-registration
(11.beta.,16.alpha.)-11,16,17,21-tetrahydroxy-pregna-1,4-diene-3,20-dione
C&L Inventory
(1S,2R,3aS,3bS,9aR,9bS,10S,11aS)-1,2,10-trihydroxy-1-(2-hydroxyacetyl)-9a,11a-dimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
Other
11,16,17,21-tetrahydroxypregna-1,4-diene-3,20-dione
C&L Inventory, Registration dossier
11a,16b,17,21-Tetrahydroxy-pregna-1,4-diene-3,20-dione
C&L Inventory
11beta,16alpha,17,21-Tetrahydroxypregna-1,4-diene-3,20-dione
Registration dossier
11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione
Registration dossier
11β,16α,17,21-tetrahydroxypregna-1,4 diene-3,20-dione
C&L Inventory
11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione
C&L Inventory
16-alpha
Registration dossier
16alpha-Hydroxyprednisolone
Registration dossier
16alpha-Hydroxyprednisolone
C&L Inventory
13951-70-7
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
Not specified (100%) [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Physical state at 20°C and 1013 hPa
Solid (100%)

Melting/freezing point

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
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Boiling point

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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Density

Study results
  • 1 study submitted
  • 1 study processed
R Relative density
1.28 @ 20 °C [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
Relative density at 20°C
1.28

Vapour pressure

Study results
  • 1 study submitted
  • 1 study processed
R Vapour pressure
0 Pa @ 25 °C [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
Vapour pressure
0 Pa @ 25 °C

Partition coefficient

Study results
  • 1 study submitted
  • 1 study processed
R Log Pow
0.8 @ 25 °C [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
Log Kow (Log Pow)
0.8 @ 25 °C

Water solubility

Study results
  • 1 study submitted
  • 1 study processed
R Water solubility (mass/vol.)
815 mg/L @ 20 °C [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
Water solubility
815 mg/L @ 20 °C

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Flash point

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 1
Sci. unjustified
Exposure cons.
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Auto flammability

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
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Flammability

Study results
  • 3 studies 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
Not feasible
Sci. unjustified 2
Exposure cons.
Other
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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

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
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

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
  • 2 studies submitted
  • 1 study processed
R BOD5
0 mg O2/g test material [1]
C Interpretation of results
Under test conditions no biodegradation observed (100%) [1]

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
C Summaries
  • 1 summary submitted
  • 1 summary processed
Biodegradation in water
Under test conditions no biodegradation observed (100%)

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
  • 1 study submitted
  • 1 study processed
P/RResults
EC50 (48 h) 109 mg/L [1]
EC50 (24 h) 206 mg/L [1]
NOEC (48 h) 41.6 mg/L [1]
NOEC (24 h) 206 mg/L [1]

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

No automatically processable data submitted

Long–term toxicity to aquatic invertebrates

Data not provided by the registrant

Toxicity to aquatic algae and cyanobacteria

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
EC50 (4 days) 272.731 - 797.442 mg/L [3]
NOEC (72 h) 160 mg/L [1]

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence 1 1
Other
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 for freshwater algae
272.731 mg/L
EC10 or NOEC for freshwater algae
160 mg/L

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
  • 1 study submitted
  • 1 study processed
P/RResults
LD50 2 000 mg/kg bw (rat) [1]
M/CInterpretations of results
Not classified [1]

Type of Study provided
oral
Studies with data
Key study 1
Supporting study
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
  • 0 studies submitted
  • 0 studies processed

No data available

dermal
Studies with data
Key study
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
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Oral route:
No adverse effect observed LD50 2 000 mg/kg bw

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 2
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
Study data: eye
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin
No adverse effect observed (not irritating)
Eye
No adverse effect observed (not irritating)
Respiratory
No study available

Sensitisation

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
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 1
Exposure cons.
Other
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
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin sensitisation
No adverse effect observed (not sensitising)
Respiratory sensitisation
No study available

Repeated dose toxicity

Data not provided by the registrant

Genetic toxicity

Study results
Study data: in vitro
  • 1 study 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
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
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Toxicity - InVitro
No adverse effect observed (negative)

Carcinogenicity

Data not provided by the registrant

Toxicity to reproduction

Data not provided by the registrant

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