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

No image available
EC / List no.:
618-226-9
CAS no.:
889652-22-6
Index number:
Molecular formula:
SMILES:
InChI:
Type of substance:
Mono constituent substance
Origin:
Organic
Registered compositions:
2
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:

Hazard classification & labelling

Warning! According to the classification provided by companies to ECHA in REACH registrations this substance is toxic to aquatic life, is toxic to aquatic life with long lasting effects, may cause damage to organs through prolonged or repeated exposure, causes skin irritation and may cause an allergic skin reaction.

Breakdown of all 2 C&L notifications submitted to ECHA

Aquatic Acute 2 H401
Aquatic Chronic 2 H411
STOT RE 2 H373
Skin Irrit. 2 H315
Skin Sens. 1B H317
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

  • Ss
There is broad agreement in that a majority of data submitters agree this substance is Skin sensitising (100% of REACH registrations).

Regulatory context

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

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 1 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, for intermediate use only.

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.

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

This substance is used for the manufacture of: chemicals.

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

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 activities or processes at workplace: closed processes with no likelihood of exposure, closed batch processing in synthesis or formulation, transfer of chemicals at dedicated facilities, transfer of substance into small containers and laboratory work.

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

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

Prevention statements

When handling this substance: contaminated work clothing should not be allowed out of the workplace; avoid release to the environment; wear protective gloves and/or clothing, and eye and/or face protection as specified by manufacturer/supplier; avoid breathing the dust, fume, gas, mist, vapours or spray.

Response statements

In case of incident: Collect spillage.

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

  • Gedeon Richter Plc., Gyomroi ut 19-21 1103 Budapest Hungary

Substance names and other identifiers

3'H-Cyclopropa[15,16]pregna-3,5,15-triene-21-carboxaldehyde, 15,16-dihydro-17-hydroxy-3-methoxy-, cyclic 1,2-ethanediyl acetal, (15α,16α)-
REACH pre-registration
(4aR,4bS,6aS,7S,7aS,8aS,8bR,8cR)-7-[2-(1,3-dioxolan-2-yl)ethyl]-2-methoxy-4a,6a-dimethyl-3,4,4a,4b,5,6,6a,7,7a,8,8a,8b,8c,9-tetradecahydrocyclopropa[4,5]cyclopenta[1,2-a]phenanthren-7-ol
Registration dossier
cyclopropyl-enolether-acetal
Registration dossier
3'H- Cyclopropa[15, 16]pregna- 3, 5, 15- triene- 21- carboxaldehyde, 15, 16- dihydro- 17- hydroxy- 3- methoxy- , cyclic 1, 2- ethanediyl acetal, (15α, 16α) - (9CI)
REACH pre-registration
889652-22-6
CAS number
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
Solid: 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
  • 1 study submitted
  • 1 study processed
R Melting / freezing point
174 °C @ 100.1 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

Boiling point

Data not provided by the registrant

Density

Data not provided by the registrant

Vapour pressure

Data not provided by the registrant

Partition coefficient

Study results
  • 1 study submitted
  • 1 study processed
R Log Pow
6 @ 30 °C and pH 10.09 [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

Water solubility

Data not provided by the registrant

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

Data not provided by the registrant

Flash point

Data not provided by the registrant

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
  • 0 summaries submitted
  • 0 summaries processed

No data available

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
  • 0 summaries submitted
  • 0 summaries processed

No data available

Explosiveness

Data not provided by the registrant

Oxidising

Data not provided by the registrant

Oxidation reduction potential

Data not provided by the registrant

pH

Study results
  • 1 study submitted
  • 1 study processed
R pH
10.09 @ 23.2 °C and 1 000 g/L [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other
Data waiving
no waivers

No summary exists for this scientific endpoint

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
C Interpretation of results
Not readily biodegradable (100%) [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence 1
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

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 1
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Long–term toxicity to fish

Data not provided by the registrant

Short–term toxicity to aquatic invertebrates

Study results
  • 2 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 1
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
  • 2 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 1
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

Data not provided by the registrant

Irritation / corrosion

Study results
Study data: skin
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

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

Study data not processed for brief profile

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

No data available

Sensitisation

Study results
Study data: skin
  • 1 study submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study
Supporting study
Weight of evidence 1
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

Study results
Study data: oral
  • 1 study submitted
  • 0 studies processed

No automatically processable data submitted

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

No data available

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

No data available

Study data: dermal
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

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
Supporting study
Weight of evidence 1
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

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