Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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 gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction products of 2,2'-(1,3-phenylenebis(oxy))diethanol with 2-(phenoxymethyl)oxirane and 2-isocyanatoethyl methacrylate
- Cas Number:
- 1431303-59-1
- Molecular formula:
- Not assigned for UVCB substance.
- IUPAC Name:
- Reaction products of 2,2'-(1,3-phenylenebis(oxy))diethanol with 2-(phenoxymethyl)oxirane and 2-isocyanatoethyl methacrylate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, lot # 6252020
- Purity, including information on contaminants, isomers, etc.: >99%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, protected from light
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: No information
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: No information
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: No information
- Reactivity of the test material with the incubation material used (e.g. plastic ware): No information
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): solubolized in DMSO
- Preliminary purification step (if any): No information
FORM AS APPLIED IN THE TEST (if different from that of starting material) : solubolized in DMSO
Method
- Target gene:
- Tryptophan and Histidine operons.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : Aroclor 1254-induced rat liver S9
- method of preparation of S9 mix: The S9 was prepared from male Sprague-Dawley rats that were injected intraperitoneally with Aroclor™ 1254 (200 mg/mL in corn oil) at a dose of 500 mg/kg, five days before sacrifice.
- concentration or volume of S9 mix and S9 in the final culture medium : 10% v/v
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): No information - Test concentrations with justification for top dose:
- 33.3, 100, 333, 1000, 3333 and 5000 μg per plate per guideline
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: compatibility with target cells
- Justification for percentage of solvent in the final culture medium:The test article formed a clear solution in DMSO at a concentration of approximately 200 mg/mL in the solubility test
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: 1
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): 0.3x109 cells per milliliter
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: No information
- Exposure duration/duration of treatment: 48 to 72 hours at 37±2°C.
- Harvest time after the end of treatment (sampling/recovery times): No information
FOR GENE MUTATION:
- Expression time (cells in growth medium between treatment and selection): No information
- Selection time (if incubation with a selective agent): No information
- Fixation time (start of exposure up to fixation or harvest of cells): No information
- If a selective agent is used (e.g., 6-thioguanine or trifluorothymidine), indicate its identity, its concentration and, duration and period of cell exposure: NA
- Number of cells seeded and method to enumerate numbers of viable and mutants cells: 0.3x109 cells per milliliter; The condition of the bacterial background lawn was evaluated for evidence of test article toxicity by using a dissecting microscope. Precipitate was evaluated after the incubation period by visual examination without magnification. Toxicity and degree of precipitation were scored relative to the vehicle control plate using the codes shown in the following table. As appropriate, colonies were enumerated either by hand or by machine.
- Criteria for small (slow growing) and large (fast growing) colonies: No information
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: background growth inhibition; mitotic index (MI); relative population doubling (RPD); relative increase in cell count (RICC); replication index; cytokinesis-block proliferation index; cloning efficiency; relative total growth (RTG); relative survival (RS); other: No information
- Any supplementary information relevant to cytotoxicity: Toxicity was observed at 5000 μg per plate with tester strain TA1537 in the absence of S9 activation - Rationale for test conditions:
- Per OECD 471.
- Evaluation criteria:
- For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated and are reported.
For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test article as specified below:
Strains TA1535 and TA1537
Data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 3.0-times the mean vehicle control value and above the corresponding acceptable vehicle control range.
Strains TA98, TA100 and WP2 uvrA
Data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 2.0-times the mean vehicle control value and above the corresponding acceptable vehicle control range.
An equivocal response is a biologically relevant increase in a revertant count that partially meets the criteria for evaluation as positive. This could be a dose-responsive increase that does not achieve the respective threshold cited above or a non-dose responsive increase that is equal to or greater than the respective threshold cited. A response was evaluated as negative if it was neither positive nor equivocal.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Data on pH: No information
- Data on osmolality: No information
- Possibility of evaporation from medium: No information
- Water solubility: No information
- Precipitation and time of the determination: Toxicity and degree of precipitation were scored relative to the vehicle control plate
- Definition of acceptable cells for analysis: No information
RANGE-FINDING/SCREENING STUDIES (if applicable):
In the initial preliminary toxicity assay (A1), the dose levels tested were 6.67, 10.0, 33.3, 66.7, 100, 333, 667, 1000, 3333 and 5000 μg per plate. No toxicity was observed. Precipitate was observed beginning at 3333 μg per plate with all conditions except tester strain WP2 uvrA in the presence of S9 activation. The S9 lot was not recorded for having been added to the S9 mix. There were no revertant counts for WP2A in the presence of S9 activation. An unacceptable vehicle control value was observed for tester strain TA100 in the presence of S9 activation (higher than the acceptable range stated in the protocol). Due to these observations, the preliminary toxicity assay was repeated with all conditions.
In the retest preliminary toxicity assay (A2), the dose levels tested were 6.67, 10.0, 33.3, 66.7, 100, 333, 667, 1000, 3333 and 5000 μg per plate. No toxicity was observed. Precipitate was observed beginning at 1000, 3333 or at 5000 μg per plate. Unacceptable vehicle control values were observed with tester strains TA100 and TA1537 in the presence of S9 activation (higher than the acceptable Historical Control Limit range stated in the protocol). As the preliminary toxicity assay is used to assess toxicity and precipitate to aid in the selection of dose levels for the mutagenicity evaluation, the unacceptable vehicle control values do not invalidate the assay. Based upon these results, the maximum dose tested in the mutagenicity assay was 5000 μg per plate.
STUDY RESULTS
- Concurrent vehicle negative and positive control data : Available
For all test methods and criteria for data analysis and interpretation:
- Concentration-response relationship where possible : No information
- Statistical analysis; p-value if any : No information
Ames test:
- Signs of toxicity : For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test article as specified. Strains TA1535 and TA1537: Data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 3.0-times the mean vehicle control value and above the corresponding acceptable vehicle control range. Strains TA98, TA100 and WP2 uvrA: Data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 2.0-times the mean vehicle control value and above the corresponding acceptable vehicle control range.
- Individual plate counts : Available
- Mean number of revertant colonies per plate and standard deviation : No increase in revertant colonies was observed in treated plates
- Genotoxicity results:
o Number of cells treated and sub-cultures for each cultures : 0.3x109 cells/mL
o Number of cells plated in selective and non-selective medium : 0.3x109 cells/mL
o Number of colonies in non-selective medium and number of resistant colonies in selective medium, and related mutant frequency : Available
HISTORICAL CONTROL DATA (with ranges, means and standard deviation, and 95% control limits for the distribution as well as the number of data)
- Positive historical control data: Contract research lab maintains records of historical positive control data for reference.
- Negative (solvent/vehicle) historical control data: Contract research lab maintains records of historical negative control data for reference.
Applicant's summary and conclusion
- Conclusions:
- ERGP-IEM is not mutagenic in the presence or absence of metabolic activation up to 5000 μg/plate in the bacterial reverse mutation assay.
- Executive summary:
ERGP-IEM was tested in a GLP-compliant, OECD 471 (1997) bacterial reverse mutation assay. Salmonella typhimurium TA98, TA1535, TA100, and TA1537 and Escherichia coli strain WP2uvrA were exposed to ERGP-IEM in DMSO at 33.3, 100, 333, 1000, 3333 and 5000 μg per plate with and without an exogenous metabolic activation system, Aroclor 1254-induced rat liver S9. No toxicity was observed. Positive and negative controls behaved as expected. Precipitate was observed beginning at 1000 or 3333 μg per plate with all conditions. No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation. Based on the results of the study, ERGP-IEM is negative in the bacterial reverse mutation assay (Ames assay) in the presence and absence of metabolic activation.
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.