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EC number: 258-053-2 | CAS number: 52628-03-2
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP/Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, phosphate
- EC Number:
- 258-053-2
- EC Name:
- 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, phosphate
- Cas Number:
- 52628-03-2
- Molecular formula:
- C6 H10 O3 . x H3 O4 P
- IUPAC Name:
- 2-(methacryloyloxy)ethyl phosphate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Reaction product of 2-Hydroxyethyl methacrylate (HEMA) with Polyphosphoric Acid (PPA)
- Physical state: clear yellow liquid
- Lot/batch No.: A022C73001
- Expiration date of the lot/batch: August 20, 2014
- Stability under test conditions: Test substance was expected to be stable for the duration of testing.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, Inc., Frederick, MD
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 134-148 grams at experimental start.
- Fasting period before study: overnight
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): Harlan Teklad Certified Global 16% Protein Rodent Diet® #2016C. The diet was available ad libitum, except during fasting.
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 21-34 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22ºC
- Humidity (%): 40-70%
- Air changes (per hr): 13 or 14
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
IN-LIFE DATES: October 16 – November 12, 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on an estimate of the LD50 supplied by the Sponsor (1,800 mg/kg and an assumed sigma of 0.3), a
Main Test was conducted using a default starting dose level of 900 mg/kg. - Doses:
- 900 mg/kd or 2000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 (termination) following dosing or after death. The animals were observed for mortality, signs of gross toxicity, and behavioral changes during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing or until death occurred.
- Necropsy of survivors performed: yes - Statistics:
- The Acute Oral Toxicity (Guideline 425) Statistical Program was used for all data analyses including: dose progression selections, stopping criteria determinations and/or LD50 and confidence limit calculations.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One animal dosed at 2000 mg/kg died within one day of test substance administration. All other animals survived until necropsy.
- Clinical signs:
- other: 900 mg/kg Dose Level (2 animals) - There were no signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior. 2,000 mg/kg Dose Level (4 animals) - Prior to death, one animal was hypoactive and exhibited hunched posture, irregular respirat
- Gross pathology:
- 900 mg/kg Dose Level (2 animals) - No gross abnormalities were noted for these animals when necropsied at the conclusion of the 14-day observation period.
2,000 mg/kg Dose Level (4 animals) - Gross necropsy of the decedent revealed moderately distended stomach, filled with dark blackish liquid. No gross abnormalities were noted for any of the euthanized animals when necropsied at the conclusion of the 14-day observation period. - Other findings:
- none
Any other information on results incl. tables
No additional information available.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category V
- Remarks:
- Migrated information Criteria used for interpretation of results: other: UN GHS
- Conclusions:
- Under the conditions of this study and according to OECD Guideline 425, the acute oral LD50 of the test substance is greater than 2,000 mg/kg of
body weight in female rats, because there were three consecutive survivors at 2,000 mg/kg. - Executive summary:
An acute oral toxicity test (Up and Down Procedure) was conducted with female Fischer 344 rats to determine the potential forReaction product of 2-Hydroxyethyl methacrylate (HEMA) with Polyphosphoric Acid (PPA)to produce toxicity from a single dose via the oral route. Under the conditions of this study and according to OECD Guideline 425, the acute oral LD50 of the test substance is greater than 2,000 mg/kg of body weight in female rats, because there were three consecutive survivors at 2,000 mg/kg.
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