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Diss Factsheets
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EC number: 947-942-7 | CAS number: -
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Assessment based on physico-chemical properties and toxicological data
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The assessment of toxicokinetics of the substance is based on physico-chemical properties and on toxicological data. No experimental studies were performed.
Reference
The following remarks on the toxicokinetics of the substance are based on physicochemical properties and on toxicological data. Experimental toxicokinetic studies were not performed.
Description of key information
Key value for chemical safety assessment
Additional information
The following remarks on the toxicokinetics of the substance are based on physicochemical properties and on toxicological data. Experimental toxicokinetic studies were not performed.
The substance is a colourless liquid at normal ambient conditions (Currenta GmbH & Co. OHG 2014 and 2015), with a very low vapour pressure (0.0022 Pa at 20 °C, Fonseca 2014) and a dynamic viscosity of 87.3 mPa s (at 20 °C, Neuland 2015). The major constituent, with an amount of 78-90 %, contains isocyanate groups, which are responsible for the unstable character of the substance towards nucleophiles, e.g. water, alcohol and amino groups. Due to the hydrolytic instability data like water solubility or log Pow are not available.
The substance has a molecular weight of 298 and 429 g/mol for the two constituents 2-ethylhexyl N-(6-isocyanatohexyl)carbamate (78-90 %) and bis(2-ethylhexyl) hexane-1,6-diylbiscarbamate (10-22 %), respectively. These molecular weights are in a range that is favourable for absorption after oral exposure. However, the available studies with gavage administration, which is an acute oral toxicity study (Kroetlinger 2002; OECD 423) and a reproductive toxicity screening study (Hudson 2017; OECD 421), give no clear indication for systemic availability, since only unspecific effects (OECD 423: diarrhoea, decreased motility; OECD 421: slight effect on bodyweight gain, hepatic enzyme induction) were observed, which might be attributed solely to local effects at the gastrointestinal tract. Dermal absorption is expected to be low, due to the unstable nature of the isocyanate groups and due to the molecular weight well above a favourable limit for dermal absorption (cp. ECHA Guidance Chapter R.7c, 2017). This is not contradicted by the fact, that the substance has irritant properties (no classification required according to GHS; Leuschner 2002, OECD 404 and 405), which may impair the barrier of the skin.
With respect to inhalation the available studies (Kopf 2018, OECD 412; Kopf 2014, OECD 403) reveal as well no indications for systemic availability. Instead, the data especially from histopathology and broncho-alveolar lavage fluid analysis point to a local irritant “port-of-entry” toxicity. This is evidenced by inflammatory processes in the respiratory tract with squamous metaplasia in the larynx as secondary sequelae.
Overall, with the exception of a positive skin sensitisation potential (Vohr 2003; OECD 429) no indications for systemic availability are revealed from the available studies, however, due to this result it cannot be completely ruled out.
Based on the results of the in vitro genotoxicity tests (Herbold 2002, OECD TG 471; Wollny 2016, OECD TG 476; Sokolowski 2015, OECD 487; all with and without metabolic activation) it can be concluded that DNA-reactive metabolites of the substance will not be generated in mammals in the course of hepatic biotransformation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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