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Diss Factsheets
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EC number: 940-417-3 | 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
Key value for chemical safety assessment
Additional information
Overall assessment on the genotoxicity of the registration substance
Four in-vitro studies are avaiable for the assessment of the genotoxicity of the registration substance. One Amest test on the registration substance and three tests (Ames test, chomosome aberration test and HPRT) on the read-across supporting substance. In all four studies no mutagenicity or no clastogenicity was found. The genotoxicity potential of the registration substance is considered to be of no concern.
Justification for the use of diethylenglycoldibutylether (DEGDBE) as read-across supporting substance
DEGDBE belongs to the homologues of butyl-O-(CH2CH2O)n-butyl with n =2, whereas the main components of the registration substance (PolyEGDBE) correspond to the homologues with n = 2,3,4.
Read-across supporting substance |
Diethylene glycol dibutyl ether (DEGDBE)** CAS 112-73-2 |
Butyl-O- (CH2CH2-O)2-Butyl |
Registration substance (Target chemical) |
Polyethylene glycol dibutyl ether (PolyEGDBE)*** CAS 31885-97-9 |
Butyl-O- (CH2CH2-O-)n-Butyl n = 2,3,4 |
The only difference for the registration substance and DEGDBE being the number of ethylenglycol unit in the center of the molecule, the basic concept of "chain length category" can be applied. A comparable toxicity profile is expected.
In addition, the available data for the endpoint repeated dose toxicity are strongly supporting the proposed approach, in that the both substances induced hemolysis and liver effect (OECD 422 study on the registration substance, 28 -day toxicity study on DEGDBE; both studies provided in corresponding endpoint study records), whereas DEGDBE was found to be more potent than the registration substance.
Taking account that DEGDBE is of lower molecular size than the registration substance and that DEGDBE is of less potency than the registration substance after prolonged oral exposure, the registration substance is not likely to exhibit enhanced toxicity than DEGDBE.
In conclusion, the data of DEGDBE can be soundly used for the hazard assessment of the registration substance.
Justification for selection of genetic toxicity endpoint
Four in-vitro tests are available (two Ames test, Chromosome aberration test, HPRT; one Ames test on the registration substance and other tests on the read-across supporting substance). These studies are considered to be of equal validity.
Short description of key information:
No genotoxicity found in in-vitro tests.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No classification is derived based on the in-vitro data on the registration substance and on the read-across supporting substance.
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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