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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 810-703-1 | CAS number: 1187441-10-6
- 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
- Type of information:
- experimental study planned
- Study period:
- Within 2 years after ECHA consent
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Reaction products of 2-hydroxyethyl methacrylate and diphosphorus pentaoxide (POEMA)
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: In a valid AMES test POEMA was found not to be mutagenic with or without metabolic activation. The outcome of a valid mouse lymphoma assay indicates that POEMA can have mutagenic properties in mammalian cells.
- Available non-GLP studies: There are no non-GLP studies available for the endpoint genetic toxicity.
- Historical human data: There are no historical human data that can be considered for this endpoint. The publicly available databases were consulted for information, but no data were found to further conclude on the genotoxicity of POEMA.
- (Q)SAR: The outcome of a QSAR assessment (eg an OECD toolbox assessment) is not considered sufficient information to fill the endpoint in vivo genetic toxicity.
- In vitro methods: The outcome of a valid mouse lymphoma assay triggered the necessity to perform an in vivo genotoxicity study, further in vitro testing was waived.
- Weight of evidence: The positive result in a mouse lymphoma assay indicates that POEMA potentially induces structural chromosome aberrations. To further address this mode-of-action, the In vivo alkaline single-cell gel electrophoresis assay for DNA strand breaks (COMET assay) is proposed. As the Comet assay addresses all potential mode-of-actions (structural chromosome aberrations and/or gene mutations), the outcome of this in vivo study will overrule any in vitro result, therefore further in vitro testing is omitted.
- Grouping and read-across: Read across to structurally related substances (with shared sub-structures) has been considered. No potential analogues were identified that could be used for read across.
- Substance-tailored exposure driven testing: Not applicable for genetic toxicity endpoint
- Approaches in addition to above: Not applicable
- Other reasons: Not applicable
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
The specific rules for adaptation from column 1 as given in column 2 are not applicable for in vivo genotoxicity testing.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design: 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.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- Version / remarks:
- Most recent version
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian comet assay
Test material
- Reference substance name:
- Bis(methacryloyloxyethyl) hydrogen phosphate
- EC Number:
- 251-040-2
- EC Name:
- Bis(methacryloyloxyethyl) hydrogen phosphate
- Cas Number:
- 32435-46-4
- Molecular formula:
- C12H19O8P
- IUPAC Name:
- 2-[hydroxy-[2-(2-methylprop-2-enoyloxy)ethoxy]phosphoryl]oxyethyl 2-methylprop-2-enoate
- Reference substance name:
- 2-(phosphonooxy)ethyl methacrylate
- EC Number:
- 246-342-6
- EC Name:
- 2-(phosphonooxy)ethyl methacrylate
- Cas Number:
- 24599-21-1
- Molecular formula:
- C6H11O6P
- IUPAC Name:
- 2-phosphonooxyethyl 2-methylprop-2-enoate
- Test material form:
- liquid: viscous
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Propylene glycol
Examinations
- Tissues and cell types examined:
- Liver and blood
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.