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Diss Factsheets
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EC number: 812-491-6 | CAS number: 1312943-23-9
- 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
Description of key information
Aquatic toxicity endpoints are based on test data following standard guidelines. All data are therefore considered to be reliable and relevant for the endpoint concerned.
Short-term toxicity to fish
Acute toxicity to fish has been assessed for four substances that would fall within the MDI category definition: a mixture of: 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea; 3-cyclohexyl-1-(4-(4-(3-octadecylureido) benzyl)phenyl)urea; 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-530-2), 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-370-3), 3,3'-dioctadecyl-1,1'-methylenebis (4,1-phenylene)diurea (EC 406-690-3). All studies used water accommodated fractions or saturated solutions as the test items are poorly soluble UVCBs and all determined LC50 values greater than the limit of solubility, with NOEC values equal to the limit of solubility. Based on these results, members of the MDI category are not expected to be acutely toxic to fish at the limit of solubility.
No data are available on the chronic toxicity to fish.
Short-term toxicity to aquatic invertebrates
Acute toxicity to Daphnia magna has been assessed for four substances that would fall within the MDI category definition: a mixture of: 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea; 3-cyclohexyl-1-(4-(4-(3- octadecylureido)benzyl)phenyl)urea; 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-530-2), 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-370-3), 3,3'-dioctadecyl-1,1'-methylenebis (4,1-phenylene)diurea (EC 406-690-3) and N,N''-(methylenedi-4,1-phenylene)bis[N'-octyl]urea (EC 445-760-8). All studies used water accommodated fractions or saturated solutions as the test items are poorly soluble UVCBs and all determined EC50 values greater than the limit of solubility, with NOEC values equal to the limit of solubility. Based on these results, members of the MDI category are not expected to be acutely toxic to aquatic invertebrates at the limit of solubility.
Long-term toxicity to aquatic invertebrates
Chronic toxicity to Daphnia magna has been assessed for one substance that would fall within the MDI category definition: Reaction product of 4,4’-methylenediphenyl diisocyanate and amines, coco alkyl. A Daphnia reproduction study conducted according to OECD guideline 211 was carried out using a water accommodated fraction at a single nominal loading rate of 100 mg/L, as the test item is a poorly soluble UVCB. The determined EL50 values, based on parental mortality and reproduction, were >100 mg/L, with a NOELR value of 100 mg/L, the only concentration tested. Based on these results, members of the MDI category are not expected to be chronically toxic to aquatic invertebrates at the limit of solubility.
Toxicity to aquatic algae and cyanobacteria
The effects of two MDI category members on the growth of Pseudokirchneriella subcapitata and Desmodesmus subspicatus, respectively, were investigated in separate studies. The study of Veryenhoef (2018) used a water accommodated fraction and determined EL50 values of >100 mg/L, with NOELR values of 100 mg/L, for both growth rate and yield, for the test item Reaction product of 4,4’-methylenediphenyl diisocyanate and amines, coco alkyl. For the study conducted with 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-370-3), used as a supporting study, the derived EC50 and NOEC values based on growth rate and yield are > 1 mg/L, the highest concentration tested.
One study conducted with N,N''-(methylenedi-4,1-phenylene)bis[N'-octyl]urea (EC 445-760-8), did show effects below the highest concentration tested. This study was included in a NONS registration and permission to refer has been granted by ECHA under an Article 25(3) request. A limited summary was provided in the data received from ECHA. Reference to the same study on the ECHA dissemination portal indicates that the study has subsequently been disregarded by the registrants as the study used very high nominal loading rates (up to 4000 mg/L) and only analysed for one constituent of the substance, which was found to be in solution at <LOQ (0.5 mg/L). As the analysed constituent was present at <LOQ but a dose-response relationship was observed at the highest loading rates, toxicity appears to be attributed to an unknown impurity in the test item. As it is not possible to determine which constituent the observed toxicity is attributed to, the water solubility of the main constituent should not be used for the reporting of results, as this is not the constituent that is leading to the observed toxicity. This study has therefore been disregarded as the results are unreliable.
Based on results from the reliable studies, members of the MDI category are not expected to be toxic to algae at the limit of solubility.
Toxicity to microorganisms
Toxicity to microorganisms has been assessed for two substances that would fall within the MDI category definition. All studies were conducted following standard guidelines. All studies determined IL50 values greater than the highest nominal loading rate. Members of the MDI category are not expected to be toxic to microorganisms at the limit of solubility.
Additional information
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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