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EC number: 601-101-8 | CAS number: 111497-86-0
- 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 April 2010 - 26 april 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine
- EC Number:
- 601-101-8
- Cas Number:
- 111497-86-0
- Molecular formula:
- Molecular formula not available for this UVCB.
- IUPAC Name:
- 2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine
- Details on test material:
- - Name of test material (as cited in study report): Ebecryl® P116 radiation curing resins- Substance type: Clear colourless liquid- Physical state: Liquid- Stability under test conditions: Stable- Storage condition of test material: At room temperature protected from light
Constituent 1
Method
- Target gene:
- S. typhimurium: Histidine geneE. coli: Tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by a combination of phenobarbital and β-naphthoflavone
- Test concentrations with justification for top dose:
- Experiment 1:Preliminary test (with and without S9) TA100 and WP2uvrA: 3; 10; 33; 100; 333; 1,000; 3,330 and 5,000 µg/plate.Main study: TA1535, TA1537 and TA98Without and with S9-mix: 100; 333; 1,000; 3,330 and 5,000 µg/plate.Experiment 2:Without and with S9-mix: 100; 333; 1,000; 3,330 and 5,000 µg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO- Justification for choice of solvent/vehicle: The test substance was soluble in DMSO. DMSO is accepted and approved by authorities and international guidelines.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (DMSO)
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 Migrated to IUCLID6: (5 µg/plate in saline for TA 1535)
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 Migrated to IUCLID6: (60 µg/plate in water for TA1537)
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9 Migrated to IUCLID6: (10 µg/platein DMSO for TA98)
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9 Migrated to IUCLID6: (6650 µg/platein DMSO TA100)
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9 Migrated to IUCLID6: (10 µg/plate in DMSO for WP2uvrA)
- Positive control substance:
- other: 2-aminoanthracene inDMSO for all tester strains
- Remarks:
- with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)DURATION:- Exposure duration: 48 hoursNUMBER OF REPLICATIONS:- Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.NUMBER OF CELLS EVALUATED: 10E8 per plateDETERMINATION OF CYTOTOXICITY- Method: Reduction of the bacterial background lawn, increase in the size of the microcolonies and reduction of the revertant colonies.OTHER EXAMINATIONS:- The presence of precipitation of the test substance on the plates was determined.
- Evaluation criteria:
- A test substance was considered negative (not mutagenic) in the test if:- The total number of revertants in tester strain TA100 was not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA 1535, TA1537, TA98 or WP2uvrA was not greater than three (3) times the concurrent control.- The negative response should have been reproducible in at least one independently repeated experiment.A test substance was considered positive if:- A two-fold (TA100) or more or a three-fold (TA1535, TA1537, TA98, WP2uvrA) or more increase above solvent control in the mean number of revertant colonies was observed in the test substance group.- When a positive response was observed in one of the tester strains, the positive response should have been reproducible in at least one independently repeated experiment.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS- Precipitation: No precipitation was observed up to and including the top dose of 5,000 µg/plate.RANGE-FINDING/SCREENING STUDIES:- No toxicity or mutagenicity was observed up to and including the top dose of 5,000 µg/plate.COMPARISON WITH HISTORICAL CONTROL DATA:- The negative and strain-specific positive control values were within our laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.ADDITIONAL INFORMATION ON CYTOTOXICITY:- No toxicity or mutagenicity was observed up to and including the top dose of 5,000 µg/plate.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the test substance was found to be non-mutagenic in the bacterial reverse mutation assay.
- Executive summary:
A study was conducted to determine the mutagenic potential of the test substance according to OECD Guideline 471 and EU Method B.13/14.
Tester strains TA98, TA100, TA1535, TA1537 of Salmonella typhimurium strain and WP2uvrA of Escherichia coli in the presence and absence of S9 were exposed to the test substance. The assay was performed in two phases, using the plate incorporation method. The first phase, the initial toxicity-mutation assay, was used to established the dose-range for the confirmatory mutagenicity assay and to provide a preliminary mutagenicity evaluation. The second phase, the confirmatory mutagenicity assay, was used to evaluated and confirm the mutagenic potential of the test substance.
DMSO was selected as the solvent based on its solubility of the test substance and compatibility with the target cells. In the initial toxicity-mutation assay, the dose levels tested were 3; 10; 33; 100; 333; 1,000; 3,330 and 5,000 µg/plate. In the main study, the dose levels tested were 100; 333; 1,000; 3,330 and 5,000 µg/plate.
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Under the test conditions, the test substance was found to be non-mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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