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Diss Factsheets
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EC number: 946-383-6 | 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
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Reaction mass of 2-ethylhexyl (3-isocyanato-4-methylphenyl)carbamate and 2-ethylhexyl (5-isocyanato-2-methylphenyl)carbamate and 2-ethylhexyl (3-isocyanato-2-methylphenyl)carbamate
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- Reaction mass of 2-ethylhexyl (3-isocyanato-4-methylphenyl)carbamate and 2-ethylhexyl (5-isocyanato-2-methylphenyl)carbamate and 2-ethylhexyl (3-isocyanato-2-methylphenyl)carbamate
- Reference substance:
- Reaction mass of 2-ethylhexyl (3-isocyanato-4-methylphenyl)carbamate and 2-ethylhexyl (5-isocyanato-2-methylphenyl)carbamate and 2-ethylhexyl (3-isocyanato-2-methylphenyl)carbamate
- Reference substance:
- Reaction mass of 2-ethylhexyl (3-isocyanato-4-methylphenyl)carbamate and 2-ethylhexyl (5-isocyanato-2-methylphenyl)carbamate and 2-ethylhexyl (3-isocyanato-2-methylphenyl)carbamate
- PBT status:
- the substance is not PBT / vPvB
- Justification:
PBT assessment
Assessment of PBT/vPvB Properties has been conducted in accordance with the guidance given in Annex XIII of Regulation 1907/2006 (as amended by Commission Regulation No 253-2011 of 15 March 2011). A summary of these findings is as presented below:
Persistence
A key study is available on ready biodegradability of the substance which was conducted in accordance with OECD test guidelines 301B and EU-method C.4.C. The result of the study showed that the overall degradation over 28 days was 12% (CO2 evolution), and thus was concluded that the substance it Not Readily Biodegradable and as such meets the criterion for Persistent/very Persistent.
Bioaccumulation
The hydrophobic substance is highly insoluble (0.13237 mg/L (QSAR)) reaction mass with a molecular weight of 304.383.The substance is highly unstable in water, due to the reactivity of the isocyanate functionality to aqueous media (observations have shown that hydrolysis occurs in <15mins) forming amine which reacts with another isocyanate group to yield urea.
A key study is available assessing the substances n-Octanol/Water Partition Coefficients in accordance with OECD guideline 117 and EU-Method A.8. The study concluded that the test substance, based on 5 peak assignments from HPLC-UV analysis the corresponding log Kow values were as follows: 3.6, 3.8, 3.9, >6.5, and >6.5 (QSAR Log Kow: 6.26). According to Table C.4-1: Screening information for Persistence, Bioaccumulation, and Toxicity from Part C: PBT/vPvB assessment (2017), the substance is between the criteria for being not bioaccumulate and potentially bioaccumulative (not b or vB:Log Kow ≤ 4.5 / potentially b or vB: Log Kow > 4.5) in aquatic organisms.
The linear relationship between bioaccumulation and log kow > 6 the log BCF does not increase linearly with log Kow and as such it cannot be concluded as bioaccumulative on the basis of the octanol-water partition coefficient alone.
Due to the medium to high adsorption potential (log Koc 3.38 to > 5.63) it is expected that the substance or its metabolites will bind to sewage sludge and be removed from the water phase. In total, the concentrations in the environmental water phase are expected to be very low and not relevant for bioaccumulation.
From the aquatic toxicity studies using raphidocelis subcapitata, microorganisms from domestic sludge, daphnia magna and Pimephales promelas, there was no evidence of uptake in the organisms given the lack of effects above the limit of solubility under the conditions of the studies which were conducted to OECD test guidelines 201, 209, 203 and 202.
In conclusion, based on the information above it is proposed that the substance is or is not bioaccumulative/very bioaccumulative. The substance is extremely unstable in water, and does not exist for sufficient time to become bioaccumulated within aquatic organisms. Furthermore available measurements of log Kow indicate that the substance is likely to be outside of the ranges indicative of bioaccumulation should it be available for exposure. On this basis, bioaccumulation is not proposed.
Toxicity
The substance is classified as chronic aquatic toxicity category 4 based on the substance not being biodegradable, insoluble and having a log Kow >4. The substance however was not seen to be toxic above the limit of solubility to which the results are provided below:
Pimephales promelas 96-hour LC50 > 0.50 mg formulation/L
Raphidocelis subcapitata 72-hour >1.0 mg/L
Activated sludge microorganisms 3-hour EC50 1000 mg/L
Daphnia magna 48-hour EC50 > 0.50 mg formulation/L
The substance is classified for reproductive toxicity (category 2) according to Regulation (EC) 1272/2008 based on effects noted in a key OECD Guideline 422 study, therefore based on this the substance meets the criterion for T.
Overall conclusions
The biodegradation study determined that the substance is not readily biodegradable.
The substance is or is not bioaccumulative/very bioaccumulative. The substance is extremely unstable in water, and does not exist for sufficient time to become bioaccumulated within aquatic organisms. Furthermore available measurements of log Kow indicate that the substance is likely to be outside of the ranges indicative of bioaccumulation should it be available for exposure. On this basis, bioaccumulation is not proposed.
The substance is also classified as a suspected reproductive toxicant, therefore meeting the criterion for being toxic.
Based on the information above PBT / vPvB criteria are not fulfilled on the basis of the bioaccumulation potential
Reference
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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