Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 948-065-2 | 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Registrant indicates - intention to read-across to test currently under (test proposal) assessment by the agency (ECHA). For further information see: ‘Justification for type of information’
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.4 : appropriate in vivo mutagenicity studies shall be considered in case of positive result in any of the genotoxicity studies in Annex VII or VIII. With further reference to REACH Regulation (EC) No. 1907/2006 : Article 25(1) and Article 40 and in lieu of formal testing proposal on the present substance, the registrant intends to firstly adapt the information requirement according to REACH Regulation (EC) No. 1907/2006 Annex XI : section 1.5 : Grouping of substances and read-across approach, by utilising data generated associated with a test proposal already under agency (ECHA) assessment under REACH Regulation (EC) No. 1907/2006 : Article 40 and Article 41.
The registrant has contacted the agency (ECHA) and/or is contacting the test proposer in order to acquire access to the proposed and/or yet to be conducted study/studies.
NON-CONFIDENTIAL NAME OF (SOURCE) SUBSTANCE AND DETAILS OF TEST PROPOSAL
(associated with the test proposal not made by the current registrant, but which is intended to be used within the current registration):
- Name/identifiers: Reaction products of 2-hydroxyethyl methacrylate and diphosphorus pentaoxide (POEMA) ; EC/List Number: 810-703-1 / CAS Number: 1187441-10-6
- Details on the test proposal: According to the test proposer: “it is proposed to address the potential genotoxic properties of POEMA in an in vivo Comet assay. This assay addresses all potential mode-of-actions (the COMET assay recognises primary DNA damage that would lead to gene mutations and/or chromosome aberrations, but will also detect DNA damage that may be effectively repaired or lead to cell death), performance of this in vivo study is considered to be sufficient to conclude on this endpoint. The oral route is considered to be the most appropriate route. As no sex-specific toxicity is expected, the test is performed in a single species. As no tissue-specific toxicity is expected, blood and liver samples will be tested (sic).”
- Test Guideline: OECD TG 489 /
OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- GLP compliance: YES
- Status: Under Agency (ECHA) assessment (2020/2021)
For the target substance: the aforementioned study will address the positive chromosome aberrations (precautionary conclusion, due to potentially artefactual positive results due to low pH of the test item replicates in comparison to the solvent control replicates) detected in an available OECD TG 473 in vitro chromosome aberration assay. This would provide further information in accordance with the requirements of REACH Regulation (EC) No. 1907/2006 Annex VIII, column 2 section 8.4 and/or REACH Regulation (EC) No. 1907/2006 Annex XI : section 1.5 : Grouping of substances and read-across approach. And is a required step prior to the proposal to test on the present (target) substance. The demonstration of ‘chemical similarity’ is provided between source and target is given in Section 13 of the current registration dossier.
References:
1. REACH Regulation (EC) No. 1907/2006 Annex VIII, column 2 section 8.4
2. ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.7, July 2017)
3. REACH Regulation (EC) No. 1907/2006 Annex XI : section 1.5 : Grouping of substances and read-across approach
4. ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.6: QSARs and grouping of chemicals, May 2008)
5. ECHA Read-Across Assessment Framework (RAAF), 2017 (as amended)
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.