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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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Well documented, according to accepted guidelines
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 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
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-Butanediol diglycidyl ether
- Analytical purity: 50.95% weight/weight
- Lot/batch No.: 9113719/006
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories (Portage, Michigan)
- Age at study initiation: Approximately 8 weeks
- Weight at study initiation: 29.9 to 34.1 g
- Assigned to test groups randomly: Yes
- Housing: One/cage in stainless steel cages (cages had wire mesh floors and were suspended above absorbent paper. Non-woven gauze was placed in the cages to provide a cushion from the flooring for the rodents' feet. The gauze also provided environmental enrichment. Cages contained a hanging feeder and a pressure activated lixit valve-type watering system)
- Diet (e.g. ad libitum): LabDiet Certified Rodent Diet #5002 (PMI Nutrition International, St. Louis, Missouri) in pelleted form ad libitum
- Water (e.g. ad libitum): Municipal water ad libitum
- Acclimation period: At least 1 week prior to the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3 °C
- Humidity (%): 40 to 70%
- Air changes (per hr): 12 to 15 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 0.5% METHOCEL
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The dosing solutions of the test material were prepared on each of the two consecutive days of administration. A frozen stock solution of CP dissolved in distilled water (thawed and brought to room temperature prior to use) served as the positive control. The vehicle used to mix the test material (0.5% METHOCEL) served as the negative control. The concentrations of the test material in the dosing solutions used for the first day of dosing during the micronucleus test were verified using gas chromatography with flame ionization detection or mass spectrometry detection (GC/FID) detection and external standard quantitation.
- Duration of treatment / exposure:
- Approximately 4 days (2 days of dosing + collection of peripheral blood 48 hours after the last dosing).
- Frequency of treatment:
- Once/day for 2 consecutive days.
- Post exposure period:
- 48 hours.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 187.5, 375, or 750 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 6 mice/dose in all dose levels and controls except for the high-dose group where there were 8 mice.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide monohydrate
- Route of administration: oral (gavage)
- Doses / concentrations: 40 mg/kg bw
Examinations
- Tissues and cell types examined:
- Approximately 5,000 reticulocytes (RETS) were analyzed per blood sample. The number of normochromatic erythrocytes (NCE), micronucleated (MN)-NCE, RET, and MN-RET were recorded for each sample and the frequency of MN-RET was determined to provide an indication of genotoxic potential. The frequency of RETs relative to total erythrocytes was determined to provide an indication of perturbations in hematopoetic activity indicative of cell toxicity. For each of the treatment groups, a mean and standard deviation was calculated to describe the frequency of RET, MN-NCE, and MN-RET observed. The analyses were conducted utilizing a Coulter EPICS XL-MCL flow cytometer (Beckman Coulter).
- Details of tissue and slide preparation:
- Duplicate cell smears were prepared and stored to serve as backups in the event that the flow cytometric analysis was not possible. Blood was collected into a microtainer tube coated with EDTA (Becton Dickinson, Franklin Lakes, New Jersey). Wedge smears were prepared, fixed in methanol, and stored at room temperature.
- Evaluation criteria:
- A test was considered valid if all of the following conditions are met:
- The range of MN-RET values in the negative controls were within reasonable limits of the recent laboratory background range.
- There was a significant increase in the incidence of MN-RET in the positive control treatment as compared to the concurrent negative controls.
- The mean for percent RET value in one or more of the test material treated groups was >/= 20% of the control value indicating no undue effect on erythropoiesis (toxicity).
A test material was considered positive in this assay if the following criterion was met:
- Statistically significant increase in MN-RET frequency at one or more dose levels accompanied by a dose response.
A test material was considered negative in this assay if the following criterion was met:
- No statistically significant dose-related increase in MN-RET when compared to the negative control.
A test result not meeting the criteria for either the positive or the negative response was considered to be equivocal. - Statistics:
- Bartlett's test and one-way ANOVA.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- - 3 mice of the high-dose group had a decreased amount of feces.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Summary of Micronucleated Reticulocytes (MN-RET) Frequencies and Percent Reticulocytes (% RET) – Males
Peripheral Blood-Males |
|||
Exposure (mg/kg bw/day) |
No. animals |
‰ MN-RET |
% RET |
0 |
6 |
1.43 ± 0.43 |
1.60 ± 0.17 |
187.5 |
6 |
1.23 ± 0.34 |
1.65 ± 0.42 |
375 |
6 |
2.49 ± 0.96 |
1.94 ± 0.17 |
750 |
6 |
1.96 ± 0.95 |
1.67 ± 0.56 |
Positive Control (40 mg/kg CP) |
6 |
9.05 ± 1.71d |
0.55 ± 0.22 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative in the mouse peripheral blood micronucleus test
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