Registration Dossier
Registration Dossier
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EC number: 203-906-6 | CAS number: 111-77-3
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Published study which contains sufficient detail, including in results, to judge it reliable for hazard assessment purposes. Limited experimental detail provided. No data on vehicle used. Justification for read-across is given in the attached document, Chapter 13: Glycol ether E series Chemical Category
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity testing of diethylene glycol monobutyl ether
- Author:
- Thompson ED, Coppinger WJ, Valencia R, Iavicoli J
- Year:
- 1 984
- Bibliographic source:
- Environmental Health Perspectives 57, 105-112
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Remarks:
- , no significant deviations noted from the information available.
- Principles of method if other than guideline:
- Test performed according to the method of Clive (Mut Res, 59, 61-108, 1979)
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 2-(2-butoxyethoxy)ethanol
- EC Number:
- 203-961-6
- EC Name:
- 2-(2-butoxyethoxy)ethanol
- Cas Number:
- 112-34-5
- Molecular formula:
- C8H18O3
- IUPAC Name:
- 2-(2-butoxyethoxy)ethanol
- Details on test material:
- - Name of test material (as cited in study report): diethylene glycol monobutyl ether, butyl carbitol
- Analytical purity: no data
- Lot/batch No.: S767216
- Other: supplied by Union Carbide Chemical Company (commercial grade material)
Test substance differs from dossier substance in having a butyl terminal alkyl chain rather than a methyl chain.
Constituent 1
Method
- Target gene:
- TK
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
- Periodically "cleansed" against high spontaneous background: yes, twice weekly
- source: Burroughs-Welcome, Research Triangle Park, NC - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 0.42, 0.56-7.5 ul/ml without metabolic activation
0.56-10.0 ul/ml with metabolic activation - Vehicle / solvent:
- - Vehicle: yes but no further data. Presumed to be water.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Migrated to IUCLID6: without metabolic activation, 0.5 and 1.0ul/ml
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- Migrated to IUCLID6: with metabolic activation, 5 and 7.5uml/ml
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plating in selective medium
DURATION
- Expression time (cells in growth medium): 2 days to detect mutation at the TK locus
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
No further data on method available. - Evaluation criteria:
- no data available
- Statistics:
- no data available
Results and discussion
Test resultsopen allclose all
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- ambiguous
- Remarks:
- see overall remarks
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >90% between 5.6 - 7.5ul/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >90% between 7.5 - 10.0ul/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- no additional information.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
A potentially ambiguous conclusion arises from a weak positive response in the absence of S9 in the context of a negative response in the presence of S9. Mutation frequencies were 1.75, 3.75 and 4.5 at the top three doses tested (relative to controls) which produced levels of toxicity of 87%, 75% and 40% respectively. Results can be considered ambiguous when the mutatant frequency per viable cell is only 2 -3 times control (especially in the context of the high toxicity). It should be noted that the response is very weak on a molar basis (1umole induces 1.1 mutations per million survivors per hour of exposure compared to 812 for the positive control) and also that there is a lack of response in the presence of S9 and a lack of functional groups associated with genotoxicity in the absence of metabolism. When the relative suspension growth compared to controls was greater than 50%, mutation frequencies were the same as negative control levels.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
ambiguous without metabolic activation
negative with metabolic activation
The substance does not cause genotoxicity in the presence of metabolic activation and the results in the absence of metabolic activation are ambiguous. - Executive summary:
In a mammalian gene mutation study in which the genotoxic potential of 2 -(2 -butoxyethoxy)ethanol was examined in vitro using the the L5178Y TK+/- mouse lymphoma test, ambigous results were obtained in the absence of metabolic activation. Mutation frequencies up to 4.5x those of the solvent control were seen. These result was considered ambigous because of the associated toxicity seen at the higher doses, the lack of biological plausibility, the weakness of the response when expressed on a molar basis relative to positive controls and the fact that the result was clearly negative in the presence of metabolic activation. Because of the structural similarity between this substance and 2 -(2 -methoxyethoxy)ethanol, particularly with respect to function groups and their surrounding atomic environment, this result can be reliably extrapolated to the latter.
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