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: 1,4,7,10-tetraazacyclododecane
  • Other names
EC / List no.:
425-450-9
CAS no.:
294-90-6
Index number:
612-225-00-7
Molecular formula:
C8H20N4
SMILES:
C1CNCCNCCNCCN1
InChI:
InChI=1S/C8H20N4/c1-2-10-5-6-12-8-7-11-4-3-9-1/h9-12H,1-8H2
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:
ELINCS (European LIst of Notified Chemical Substances) List

Hazard classification & labelling

Danger! According to the harmonised classification and labelling (ATP01) approved by the European Union, this substance causes severe skin burns and eye damage, is very toxic to aquatic life, is very toxic to aquatic life with long lasting effects, is harmful if swallowed and is harmful in contact with skin.

Additionally, the classification provided by companies to ECHA in REACH registrations identifies that this substance is toxic in contact with skin and causes serious eye damage.

Breakdown of all 10 C&L notifications submitted to ECHA

Acute Tox. 4 H302 Harmonised Classification
Skin Corr. 1B H314 Harmonised Classification
Aquatic Acute 1 H400 Harmonised Classification
Aquatic Chronic 1 H410 Harmonised Classification
Acute Tox. 4 H312 Harmonised Classification
Acute Tox. 3 H311
Eye Irrit. 2 H319
Skin Corr. 1 H314
Eye Dam. 1 H318
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

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

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

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

Properties of concern

Regulatory activities

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

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 6 active registrations under REACH, 1 Joint Submission(s) and 2 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):

Classification Labelling & Packaging (CLP)

Harmonised C&L:
A European Union Harmonised Classification & Labelling has been assigned to this substance.
Notification:
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:

About this substance

This substance is manufactured and/or imported in the European Economic Area in 1+ tonnes per year.

This substance is used in formulation or re-packing and at industrial sites.

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 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 at dedicated facilities, closed processes with no likelihood of exposure, laboratory work 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).

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.

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

Prevention statements

When handling this substance: do not breathe the dust, fume, gas, mist, vapours or spray; avoid release to the environment; wear protective gloves and/or clothing, and eye and/or face protection as specified by manufacturer/supplier; wash parts of the body (as specified by manufacturer/supplier)in contact with substance thoroughly after handling.

Response statements

In case of incident: If on skin (or hair): take off immediately all contaminated clothing. Rinse skin with water or shower. If inhaled: remove victim to fresh air and keep at rest in a position comfortable for breathing. If in eyes: rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing. If swallowed: rinse mouth. Do not induce vomiting.

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

Registrants/suppliers

  • ACETO GmbH, Hans-Henny-Jahnn-Weg 51 22085 Hamburg Germany
  • Bayer AG, Kaiser-Wilhelm-Allee 51373 Leverkusen Germany
  • bracco imaging, Via Folli 50 20134 milan Italy
  • Justesa Imagen S.A.U., Avenida de San Pablo 27 28823 Coslada Madrid Spain
  • Menadiona SL, Pol Ind Mas Puigvert, Ctra Nacional II Km 680,5 08389 Palafolls Barcelona Spain

Other names

  • 1,4,7,10-Tetraazacyclododecane
  • CYCLEN
  • -
  • 1,4,7,10-tetraazacyclododecane
  • CYCLODODECANE, TETRA-AZA (1,4,7,10)
  • CYCLEN

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
  • 3 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 1
Supporting study 1
Weight of evidence
Other 1
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
  • 4 studies submitted
  • 2 studies processed
R Melting / freezing point
106.6 - 110 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other 2
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Melting / freezing point at 101 325 Pa
106.6 °C

Boiling point

Study results
  • 3 studies submitted
  • 1 study processed
R Boiling point
285.5 °C @ 101.3 kPa [1]

Type of Study provided
Studies with data
Key study 1
Supporting study
Weight of evidence
Other 2
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Boiling point at 101 325 Pa
285.5 °C

Density

Study results
  • 4 studies submitted
  • 2 studies processed
R Relative density
1.13 - 1.15 @ 20 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other 2
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Relative density at 20°C
1.14

Vapour pressure

Study results
  • 4 studies submitted
  • 2 studies processed
R Vapour pressure
0.004 - 0.4 Pa @ 20 - 38.15 °C [6]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other 2
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Vapour pressure
0.004 Pa @ 20 °C

Partition coefficient

Study results
  • 4 studies submitted
  • 2 studies processed
R Log Pow
-1.5 - -0.63 @ 20 - 25 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 1
Weight of evidence
Other 1
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
Log Kow (Log Pow)
-1.5 - -0.63 @ 20 - 25 °C

Water solubility

Study results
  • 4 studies submitted
  • 2 studies processed
R Water solubility (mass/vol.)
158 - 160.4 g/L @ 20 °C and pH 12.2 [2]

Type of Study provided
Studies with data
Key study 2
Supporting study 1
Weight of evidence
Other 1
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
Water solubility
158 g/L @ 20 °C

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

Study results
  • 3 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other 2
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 1 summary submitted
  • 0 summaries processed

No automatically processable data submitted

Flash point

Study results
  • 3 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other 2
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Auto flammability

Study results
  • 4 studies submitted
  • 0 studies processed

No automatically processable data submitted

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

No automatically processable data submitted

Flammability

Study results
  • 8 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other 2
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 4
C Summaries
  • 1 summary submitted
  • 1 summary processed
Flammability
Not classified (100%)

Explosiveness

Study results
  • 3 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other 2
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
C Summaries
  • 1 summary submitted
  • 1 summary processed
Explosiveness
Non-explosive (100%)

Oxidising

Study results
  • 3 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other 2
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
C Summaries
  • 1 summary submitted
  • 1 summary processed
Oxidising
Non oxidising (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

Study results
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

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

No data available

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
  • 4 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other 2
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

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

No data available

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
  • 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
Other 2
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
  • 4 studies submitted
  • 2 studies processed
P/RResults
EC50 (48 h) 25.1 - 100 mg/L [3]
EC50 (24 h) 73.3 - 86 mg/L [2]
EC100 (48 h) 50 mg/L [1]
NOEC (48 h) 10 - 12.5 mg/L [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other 2
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 / LC50 for freshwater invertebrates
25.1 mg/L

Long–term toxicity to aquatic invertebrates

Data not provided by the registrant

Toxicity to aquatic algae and cyanobacteria

Study results
  • 4 studies submitted
  • 2 studies processed
P/RResults
EC50 (72 h) 600 - 99 000 µg/L [4]
NOEC (72 h) 10 - 1 560 µg/L [4]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other 2
Data waiving
no waivers
R Summaries
  • 1 summary submitted
  • 1 summary processed
EC50 for freshwater algae
19 mg/L
EC10 or NOEC for freshwater algae
1.56 mg/L

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

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
Other 2
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

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

Study results
Study data: basic toxicokinetics
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: basic toxicokinetics
Studies with data
Key study
Supporting study
Weight of evidence
Other 2
Data waiving
no waivers
Study data: dermal absorption
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: dermal absorption
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

Acute toxicity

Study results
oral
  • 4 studies submitted
  • 2 studies processed
P/RResults
LD50 978 - 1 022 mg/kg bw (rat) [3]
Discriminating dose 200 mg/kg bw (rat) [1]
M/CInterpretations of results
Other [2]

Type of Study provided
oral
Studies with data
Key study 2
Supporting study
Weight of evidence
Other 2
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
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

dermal
Studies with data
Key study
Supporting study
Weight of evidence
Other 2
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:
Adverse effect observed Discriminating dose 200 mg/kg bw

Irritation / corrosion

Study results
Study data: skin
  • 4 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
Weight of evidence
Other 2
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
Supporting study
Weight of evidence
Other 2
Data waiving
Not feasible
Sci. unjustified
Exposure cons.
Other 1
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Skin
Adverse effect observed (corrosive)
Eye
No study available
Respiratory
No study available

Sensitisation

Study results
Study data: skin
  • 4 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
Weight of evidence
Other 2
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
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

Study results
Study data: oral
  • 2 studies 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
Other 2
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
  • 5 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 2
Supporting study
Weight of evidence
Other 3
Data waiving
no waivers
Study data: in vivo
  • 2 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 2
Data waiving
no waivers
M/C Summaries
  • 1 summary submitted
  • 1 summary processed
Toxicity - InVitro
No adverse effect observed (negative)
Toxicity - InVivo
No study 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