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EC number: 939-702-5 | 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 vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05-Dec-2012 to 14-Jan-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- Version / remarks:
- 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Reaction mass of (1-methylethylidene)bis(4,1-phenyleneoxy-2,1-ethanediyl) bismethacrylate and 2-{4-[2-(4-{2-[2-(methacryloyloxy)ethoxy]ethoxy}phenyl)propan-2-yl]phenoxy}ethyl methacrylate
- EC Number:
- 939-702-5
- Molecular formula:
- C23H24O4 (C2H4O)n
- IUPAC Name:
- Reaction mass of (1-methylethylidene)bis(4,1-phenyleneoxy-2,1-ethanediyl) bismethacrylate and 2-{4-[2-(4-{2-[2-(methacryloyloxy)ethoxy]ethoxy}phenyl)propan-2-yl]phenoxy}ethyl methacrylate
- Test material form:
- other: Clear colourless highly viscous liquid
- Details on test material:
- - Name of test material (as cited in study report): 2 moles ethoxylated bisphenol A dimethacrylate
Constituent 1
Method
- Target gene:
- n/a
Species / strain
- Species / strain / cell type:
- lymphocytes: human peripheral blood
- Details on mammalian cell type (if applicable):
- Blood samples were collected by venapuncture using the Venoject multiple sample blood collecting system with a suitable size sterile vessel containing sodium heparin. Immediately after blood collection lymphocyte cultures were started.
- Culture medium
Culture medium consisted of RPMI 1640 medium, supplemented with 20% (v/v) heat-inactivated (56°C; 30 min) foetal calf serum, L-glutamine (2 mM), penicillin/streptomycin (50 U/mL and 50 µg/mL respectively) and 30 U/mL heparin.
- Lymphocyte cultures
Whole blood (0.4 mL) treated with heparin was added to 5 mL or 4.8 mL culture medium (in the absence and presence of S9-mix, respectively). Per culture 0.1 ml (9 mg/mL) phytohaemagglutinin was added. - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone
- Test concentrations with justification for top dose:
- Dose range finding test:
Without and with S9-mix, 3hr exposure; 27 hr fixation: 10, 33 and 100 µg/mL
Without S9-mix, 24 exposure; 24 hr fixation: 1, 3, 10, 33 and 100 µg/mL
First cytogenetic test:
Without and with S9-mix, 3hr exposure; 27 hr fixation: 10, 33 and 100 µg/mL
Second cytogenetic test:
Without S9-mix, 24 hr exposure; 24 hr fixation: 10, 30 and 40 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle:
Test compound was soluble in DMSO and DMSO has been accepted and approved by authorities and international guidelines
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Without S9: 0.25 µg/mL for a 3 hours exposure period and 0.15 µg/mL for a 24 hours exposure period
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- colchicine
- Remarks:
- without S9: 0.1 µg/ml for a 3 hours exposure period and 0.05 µg/ml for a 24 hours exposure
period
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9: 15 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 48 hr
- Exposure duration:
Short-term treatment
Without and with S9-mix: 3 hr treatment, 24 hr recovery/harvest time
Continuous treatment
Without S9-mix: 24 hr treatment/harvest time
ARREST OF CELL DIVISION: 5 µg/mL Cytochalasine B
STAIN: Giemsa
NUMBER OF REPLICATIONS: duplicates
NUMBER OF CELLS EVALUATED: 1000/culture (mono- and binucleated cells)
DETERMINATION OF CYTOTOXICITY
- The cytostasis/cytotoxicity was determined using the cytokinesis-block proliferation index (CPBI index) - Evaluation criteria:
- A test substance was considered positive (clastogenic or aneugenic) in the in vitro micronucleus test if:
a) It induces a dose-related statistically significant (Chi-square test, one-sided, p < 0.05) increase in the number of mono or binucleated cells with micronuclei.
b) A statistically significant and biologically relevant increase is observed in the number of mono or binucleated cells with micronuclei in the absence of a clear dose-response relationship.
A test substance was considered negative (not clastogenic or aneugenic) in the in vitro micronucleus test if:
a) none of the tested concentrations induced a statistically significant (Chi-square test, one-sided, p < 0.05) increase in the number of mono and binucleated cells with micronuclei.
b) The number of mono and binucleated cells with micronuclei was within the laboratory historical control data range. - Statistics:
- The incidence of micronucleated cells (cells with one or more micronuclei) for each exposure group was compared to that of the solvent control using Chi-square statistics.
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: human peripheral blood
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No
- Effects of osmolality: No
- Precipitation: Precipitation in the exposure medium was observed at dose levels of 40 µg/ml and above
RANGE-FINDING/SCREENING STUDIES:
- Toxicity was only observed at dose levels of 33 µg/ml and above in the absence of S9 for the continuous treatment of 24 hr.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The number of cells with chromosome aberrations found in the solvent and positive control cultures was within the laboratory historical control data range.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- At the 3 hour treatment, no toxicity was observed up to and including the highest tested dose level.
- At the continous treatment, appropriate toxicity was reached at the dose levels selected for scoring.
ADDITIONAL RESULTS:
In the first cytogenetic assay, 2 moles ethoxylated bisphenol A dimethacrylate was tested up to 100 µg/ml for a 3 hours exposure time with a 27 hours harvest time in the absence and presence of S9-fraction. 2 moles ethoxylated bisphenol A dimethacrylate precipitated in the culture medium at 100 µg/ml.
In the second cytogenetic assay, 2 moles ethoxylated bisphenol A dimethacrylate was tested up to 40 µg/ml for a 24 hours exposure time with a 24 hours harvest time in the absence of S9-mix. 2 moles ethoxylated bisphenol A dimethacrylate precipitated in the culture medium at 40 µg/ml.
The number of mono- and binucleated cells with micronuclei found in the solvent control cultures was within the historical control data range per 2000 mono- or binucleated cells after 3 h exposure time. However, the number of mononucleated and binucleated cells with micronuclei after 24 h exposure time were out of the historical control data (3 and 8 per 1000 cells, respectively in one culture each). However, the results of the test substance treated cultures were clearly negative. In addition, the positive control chemicals mitomycin C showed a statistically significant increase in the number of binucleated cells with micronuclei and colchicine showed a statistically significant increase in the number of mononucleated cells with micronuclei.
The positive control chemicals, mitomycin C and cyclophosphamide both produced a statistically significant increase in the number of binucleated cells with micronuclei. The positive control chemical colchicine produced a statistically significant increase in the number of mononucleated cells with micronuclei. It was therefore concluded that the test conditions were adequate and that the metabolic activation system (S9-mix) functioned properly.
2 moles ethoxylated bisphenol A dimethacrylate did not induce a statistically significant or biologically relevant increase in the number of mono- and binucleated cells with micronuclei in the absence and presence of S9-mix, in either of the two independently repeated experiments.
Applicant's summary and conclusion
- Conclusions:
- 2 moles ethoxylated bisphenol A dimethacrylate did not induce a statistically significant or biologically relevant increase in the number of mono- and binucleated cells with micronuclei in the absence and presence of S9-mix, in either of the two independently repeated experiments.
Finally, it is concluded that this test is valid and that 2 moles ethoxylated bisphenol A dimethacrylate is not clastogenic or aneugenic in human lymphocytes under the experimental conditions described in this report. - Executive summary:
An in vitro micronucleus assay was performed with 2 moles ethoxylated bisphenol A dimethacrylate in cultured peripheral human lymphocytes (in two independent experiments) to describe the effect of the test substance on the number of micronuclei formed in cultured peripheral human lymphocytes in the presence and absence of a metabolic activation system (phenobarbital and ß-naphthoflavone induced rat liver S9-mix).
The study procedures described in this report were based on the OECD guideline 487.
2 moles ethoxylated bisphenol A dimethacrylate was soluble in dimethyl sulfoxide.
In the first cytogenetic assay, 2 moles ethoxylated bisphenol A dimethacrylate was tested up to 100 µg/ml for a 3 hours exposure time with a 27 hours harvest time in the absence and presence of S9-fraction. 2 moles ethoxylated bisphenol A dimethacrylate precipitated in the culture medium at 100 µg/ml.
In the second cytogenetic assay, 2 moles ethoxylated bisphenol A dimethacrylate was tested up to 40 µg/ml for a 24 hours exposure time with a 24 hours harvest time in the absence of S9-mix. 2 moles ethoxylated bisphenol A dimethacrylate precipitated in the culture medium at 40 µg/ml.
The number of mono- and binucleated cells with micronuclei found in the solvent control cultures was within the historical control data range per 2000 mono- or binucleated cells after 3 h exposure time. However, the number of mononucleated and binucleated cells with micronuclei after 24 h exposure time were out of the historical control data (3 and 8 per 1000 cells, respectively in one culture each). However, the results of the test substance treated cultures were clearly negative. In addition, the positive control chemicals mitomycin C showed a statistically significant increase in the number of binucleated cells with micronuclei and colchicine showed a statistically significant increase in the number of mononucleated cells with micronuclei.
The positive control chemicals, mitomycin C and cyclophosphamide both produced a statistically significant increase in the number of binucleated cells with micronuclei. The positive control chemical colchicine produced a statistically significant increase in the number of mononucleated cells with micronuclei. It was therefore concluded that the test conditions were adequate and that the metabolic activation system (S9-mix) functioned properly.
2 moles ethoxylated bisphenol A dimethacrylate did not induce a statistically significant or biologically relevant increase in the number of mono- and binucleated cells with micronuclei in the absence and presence of S9-mix, in either of the two independently repeated experiments.
Finally, it is concluded that this test is valid and that 2 moles ethoxylated bisphenol A dimethacrylate is not clastogenic or aneugenic in human lymphocytes under the experimental conditions described in this report.
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