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EC number: 203-919-7 | CAS number: 111-90-0
- 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:
- From 18 November 1998 to 12 February 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Study conducted according to guideline protocol
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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:
- EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethanol
- EC Number:
- 203-919-7
- EC Name:
- 2-(2-ethoxyethoxy)ethanol
- Cas Number:
- 111-90-0
- Molecular formula:
- C6H14O3
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Transcutol P
- Physical state: Colourless liquid; Density 0.98
- Analytical purity: 100%
- Lot/batch No.: 9833703
- Storage condition of test material: Room temperature
Constituent 1
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from liver of rats treated with a mixture of phenobarbital and methylcholantrene
- Test concentrations with justification for top dose:
- Preliminary experiment and Experiment 1: 52, 164, 512, 1600, 5000 ug/plate
Experiment 2: 492, 878, 1568, 2800 and 5000 ug/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water (supplier Biosedra, batch number LR82159, LR 82414 and LR 82274)
- Justification for choice of solvent/vehicle: the test article was soluble in water at 50mg/ml
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- yes
- Remarks:
- untreated
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Migrated to IUCLID6: 2-nitrofluorene, t-butyl hydroperoxide, 2-aminoanthracene
- Positive controls:
- yes
- Positive control substance:
- other: t-butyl hydroperoxide, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: For each experiment, the test strain cultures were grown in nutrient broth for 6-16 hrs at 37C.
- Exposure duration: minimum 48hrs at 37C
NUMBER OF REPLICATIONS: triplicates
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - reduction in bacterial lawn and/or reduction in the number of revertants with evidnece of a dose relationship - Evaluation criteria:
- Based on the validity of the study (mean negative control counts within range of historical data; positive controls inducing clear increases in revertant numbers; and no more than 5% of the plates in the assay lost through contamination or any other unforeseen event), statistically significant (p<=0.05), dose related or reproducible increases in the number of revertant cells with evidence of a biological effect.
- Statistics:
- Dunnett's t test
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
RANGE-FINDING/SCREENING STUDIES: The mean numbers of revertant colonies on negative control plates were within the range of historical negative control values and the revertant frequency was significantly increased on positive control plates. No plates were lost through contamination or any other unforeseen event. All the criteria for a valid preliminary study were met. In the absence of cytotoxicity these results were used as the actual mutagenicity data for TA100 for Experiment 1.
COMPARISON WITH HISTORICAL CONTROL DATA: within range of historical negative control values
ADDITIONAL INFORMATION ON CYTOTOXICITY: no cytotoxicity was observed- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Scoring of mutants
1) Experiment 1:
Without metabolic activation: when compared to the negative (vehicle) control value, a statistically significant increase in the number of revertants (1.43 -fold the value obtained with the negative control) was noted in the strain TA98 at 5000ug/plate. No statistically significant increases in the number of revertants were noted in the other strains. All the man values were in the range of historical negative control data.
With metabolic activation: When compared to the negative (vehicle) control value, no statistically significant increases in the number of revertants were noted in the 5 strains used. All the mean values were in the range of historical negative control data.
2) Experiment 2:
Without metabolic activation: when compared to the negative (vehicle) control value, no statistically significant increases in the number of revertants were noted in the 5 strains used. All the mean values were in the range of historical negative control data.
With metabolic activation: when compared to the negative (vehicle) control value, a statistically significant increase in the number of revertants (1.14 -fold the value obtained with the negative control) was noted in the strain TA102 at 1568ug/plate. No statistically significant increases in the number of revertants were noted in the other strains. all the mean values were in the range of historical negative control data.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance is not considered to be mutagenic under the conditions of this Ames study. - Executive summary:
The mutagenicity of 2 -(2 -ethoxyethoxy)ethanol was studied in Salmonella typhimurium strains TA98, TA100, TA102, TA1535, and TA1537. Two independent experiments were conducted at 52, 162, 512, 1600 and 5000ug/plate, and 492, 878, 1568, 2800 and 5000ug/plate, respectively, with and without S9 metabolic activation systems. No signs of cytotoxicity and no precipitate were observed up to the highest dose tested, and the test article did not induce any biological relevant or statistically significant increases in the number of revertants in any of the 5 test strains, either with or without metabolic activation. Therefore, the test substance is considered non-mutagenic under the conditions of this study.
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