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EC number: 219-371-7 | CAS number: 2425-79-8
- 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 / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Guideline study without detailed documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- -reliability scoring based on 1997 guideline
- Deviations:
- yes
- Remarks:
- -incubation temperature was not reported and less than 200 metaphase cells were scored per concentration and controls
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 1,4-bis(2,3-epoxypropoxy)butane
- EC Number:
- 219-371-7
- EC Name:
- 1,4-bis(2,3-epoxypropoxy)butane
- Cas Number:
- 2425-79-8
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- N,N-dimethylacetamide
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): 1,4-butandiol-bis (2,3-epoxypropylether)
- Physical state: Clear liquid
- Analytical purity: 93.9%
- Expiration date of the lot/batch: Stable until December 31, 1992
- Stability under test conditions: Reported as "stable 4h"
- Storage condition of test material: Dark at approximately 20 °C
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver homogenate (S-9 fraction)
- Test concentrations with justification for top dose:
- Preliminary experiment: 1.0, 5.0, 10.0, 20.0, 30.0, 40.0, 50.0, and 100.0 μg/mL (-S9) and 100.0, 125.0, 150.0, 175.0, 200.0, and 250.0 μg/mL (+S9)
Main study:
0 or 10.0 μg/mL (7 hr, -S9)
0 or 100.0 μg/mL (7 hr, +S9)
0, 1.0, 5.0, and 10.0 μg/mL (18 hr, -S9)
0, 10.0, 50.0, and 100.0 μg/mL (18 hr, +S9)
0 or 10.0 μg/mL (28 hr, -S9)
0 or 100.0 μg/mL (28 hr, +S9) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Test substance was dissolved as a solution in minimum essential medium at appropriate concentrations.
- Justification for choice of solvent/vehicle: Not reported.
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated cells only
- Negative solvent / vehicle controls:
- yes
- Remarks:
- minimum essential medium
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ethylmethanesulfonate (-S9) or cyclophosphamide (+S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hrs at 37 °C
- Expression time (cells in growth medium): 0.5, 11.5, and 21.5 hrs at 37 °C
- Fixation time (start of exposure up to fixation or harvest of cells): 7, 18, or 28 hrs
SPINDLE INHIBITOR (cytogenetic assays): Colcemide
STAIN (for cytogenetic assays): Staining for 10 minutes in approx. 2% orcein solution
NUMBER OF REPLICATIONS: Reported as 2 independent cell cultures but interpreted as duplicates.
NUMBER OF CELLS EVALUATED: 50 to 100 metaphases per concentration per preparation time (for all treated and control groups)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: Yes
- Determination of endoreplication: No
- Evaluation criteria:
- Evaluation of the results was performed as follows:
-The test substance is classified as mutagenic if it induces a significantly increased aberration rate as compared with the solvent controls with one of the concentrations tested. The significance is obvious either by an enhancement of the rate clearly exceeding the control range or it is proven by adequate biometry.
-The test substance is classified as mutagenic if there is a reproducible concentration related increase in the aberration rate.
-The test substance is classified as non-mutagenic when it tests negatively both with and without metabolic activation. - Statistics:
- The biometry of the results was performed with a one-sided Fisher - Exact test.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations of ≥40 μg/mL (-S9) and ≥175 μg/mL (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- other: results were not reported
- Positive controls validity:
- other: Yes, valid at 18 h, which was the only time point at which the positive control was tested
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Results of the duplicates were not consistent at every concentration tested (100 μg/mL at 7 h and 50 μg/mL at 18 h).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: positive without metabolic activation; positive with metabolic activation
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