Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 219-110-7 | CAS number: 2362-14-3
- 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
Biodegradation in soil
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in soil: simulation testing
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because direct and indirect exposure of soil is unlikely
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Information requirement 9.2.1.3. (soil simulation testing) is waived on the basis of exposure-based waiving. More specifically - in accordance with Section 3 of REACH Annex XI, testing in accordance with Annex IX and X may be omitted on the basis of substance-tailored exposure-driven testing.
Exposure-based waiving is considered justified based on the following rationale:
• The registrant does not supply the substance (as a reacted monomer in polymers) to the EU and has never supplied the substance in unreacted form to the EU. Furthermore, there are no co-registrants and hence there is currently no substance supply to the EU;
• Previously, the registrant has only ever supplied the substance to the EU in the form of the substance being a reacted monomer in imported polymers. In this historic case, the substance was permanently embedded within the polymer matrix throughout its entire life cycle. Hence, there was no substance release (either to man or the environment) during its past life cycle. Indeed, it would not have been reasonable to expect that there would have been any substance exposure to workers, the general public or the environment following normal and reasonably foreseeable conditions of use. Furthermore, when the substance was previously supplied as a reacted monomer in polymers, the relevant polymers were handled according to the conditions set out in Article 18(4)(a) to (f) during all manufacturing and production stages including the waste management of the substance during these stages;
• The likelihood of depolymerization (and back-formation) of the polymer to the substance monomer is negligible;
• A hypothetical, worst-case exposure based on previous EU use of the polymer demonstrates the absence of or no significant exposure to the registered substance throughout the lifecycle of the polymer. This exposure assessment has been conducted even though the EU supply level for the substance is zero, even though the substance has only ever been supplied as a reacted monomer in previously imported polymers, and even though analysis of residual levels in the previously imported polymer have been determined to be below 0.1 %.
• There have never been any professional or consumer uses of the substance.
A more detailed justification of these points is included in the attached justification document. Please also refer to the various assessment reports as included in section 13.2.
Furthermore, and in accordance with column 2 of REACH Annex IX, information requirement 9.2.1.3, a study does not need to be conducted if direct and indirect exposure of soil is unlikely. Both direct and indirect exposure to the soil is unlikely and hence it is not considered necessary to perform a study.
Additionally, and in accordance with section 9.2 of Column 2 of REACH Annex IX, further degradation studies are only needed if indicated as necessary based on the result of Chemical Safety Assessment. For this registration, the Chemical Safety Assessment does not indicate a need for such further studies. The available data are adequate for classification and labelling purposes and PBT assessment. Moreover, the substance is hydrolytically stable and available biodegradation in water screening tests indicate that the substance will not degrade and hence there will be no degradation products to test.
Overall, it is therefore considered justified to omit the study on sediment simulation testing as included under section 9.2.1.3. of REACH Annex IX. - Transformation products:
- not measured
Reference
Description of key information
The endpoint soil simulation testing is waived in accordance with Section 3 of REACH Annex XI (substance-tailored exposure-driven testing) due to a demonstrable lack of exposure to the substance in the EU to either man or the environment.
In accordance with column 2 of REACH Annex IX (information requirement 9.2.1.3) is additionally waived since direct and indirect exposure of soil is unlikely.
Moreover, and in accordance with section 9.2 of Column 2 of REACH Annex IX, further degradation studies are only needed if indicated based on the result of the Chemical Safety Assessment. For this registration, the Chemical Safety Assessment does not indicate a need for these studies. The available data are adequate for classification and labelling purposes and PBT assessment. Moreover, the substance is hydrolytically stable and available biodegradation in water screening tests indicate that the substance will not degrade and hence there will be no degradation products to test.
Therefore, soil simulation testing - specified in section 9.2.1.3 of Annex IX - is not considered to be necessary.
Key value for chemical safety assessment
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.