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EC number: 216-653-1 | CAS number: 1634-04-4
- 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 cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant near-guideline study, no restrictions, fully adequate for assessment.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
- Reference Type:
- publication
- Title:
- Assessment of the in vivo mutagenic potential of methyl tertiary-butyl ether.
- Author:
- McKee RH, Vergnes JS, Galvin JB, Douglas JF, Kneiss JJ & Andrews LS
- Year:
- 1 997
- Bibliographic source:
- J Appl Toxicol, 17 Suppl 1, S31-6.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- Principles of method if other than guideline:
- Butterworth, B.E. et al. 1987. A protocol and guide for the in vivo rat hepatocyte DNA-repair assay. Mutational research 189: 123-133.
- GLP compliance:
- yes
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- tert-butyl methyl ether
- EC Number:
- 216-653-1
- EC Name:
- tert-butyl methyl ether
- Cas Number:
- 1634-04-4
- Molecular formula:
- C5H12O
- IUPAC Name:
- 2-methoxy-2-methylpropane
- Details on test material:
- - Name of test material (as cited in study report): MTBE
- Physical state: colourless non-viscous liquid
- Analytical purity: 99.68 %
- Lot/batch No.: Lot 7D-52 / BRRC nr 56-183
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: 4-5 weeks
- Weight at study initiation:
- Housing: 2 cage , at exposure individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°F):66-77
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- None
- Details on exposure:
- CD-1 mice (10 of each sex/dose) received by inhalation target MTBE vapour concentrations of 400, 3,000 and 8,000 ppm for 6 hours. The
hepatocytes from the positive control, N-nitrosodimethylamine (10mg/kg), were collected 2 hours after treatment.
TYPE OF INHALATION EXPOSURE: whole body
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber: Young and Bertke, Cincinnati, OH (900 Liter)
- System of generating particulates/aerosols: vapour generation by metering through a piston pump (G-20 FMI) into a heated glass evaporator
- Temperature, humidity, pressure in air chamber: temperature and humidity were recorded by using a Fishrebrand dial type thermometer and
Airguide humidity indicator, a Dwyer Magnehelic pressure gauge was used to monitor pressure
- Air flow rate: 200 L/min
- Air change rate: 13-14 /hour
TEST ATMOSPHERE
- Brief description of analytical method used: by flame ionisation gas chromatography
- Samples taken from breathing zone: yes - Duration of treatment / exposure:
- 2 consecutive days
- Frequency of treatment:
- 6 hours/day
- Post exposure period:
- 16 hours
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
400, 3000 and 8000 ppm
Basis:
other: target concentration
- Remarks:
- Doses / Concentrations:
415 (12.3), 3044 (81.5) and 8013 (101) ppm (SD in parentheses)
Basis:
analytical conc.
- Remarks:
- Doses / Concentrations:
458, 3300 and 8516 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes
- Positive control(s):
- N-nitrosodimethylamine, 10 mg/kg
Examinations
- Tissues and cell types examined:
- liver hepatocytes
- Details of tissue and slide preparation:
- The liver was removed and hepatocytes selected, counted and seeded into culture dishes containing cover slips (18 hours after the second exposure). Cultures were incubated. Approximaltely 1.5-2 hours after incubation at 37 oC the cultures were rinsed once. Subsequently the cultures were incubated in serum free WME containing 10 µCi/ml 3H-methyl thymidine for 4 hours at 37 oC, after which they were rinsed and then incubated in WME containing 0.25 mM thymidine for 16 hours.
Following the chase period, the cultures were rinsed and then fixed in 3:1 ethanol:acetic acid solution. The cover slips were rinsed, air dried, and then mounted, cell side up, on glass slides whihc were dipped in Kodak NTB-2 emulsion and then exposed for 7-14 days. the slides were developed and stained with hematoxylin-eosin.
100 nuclei were evaluated for each animal. A background grain count was also made for a cytoplasmic area, similar in size to a nucleus and taken from a heavily labeled area of the slide. Net grain counts were determined by subtracting the cytoplasmic grain count from the nuclear grain count. - Evaluation criteria:
- The number of cells in repair (net grain => 5) in air-only exposed animals must be less than 20%. The test results were considered positive if the mean net grain count for any treated group was greater than 0 and the percentage of cells in repair for that treated group was greater than 20%. The test results were considered negative if the mean net grain count for all treatment groups was less than 0 and the percentage of cells was in repaier was less than or equal to 20%. At least, 6 animals/sex/group (5 positive control animals/sex) must be suitable for evaluation.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Toxicity
No mortalities. Clinical signs were observed during exposure to 8000 ppm and included hypoactivity, abdominal breathing, ataxia and prostration. Hypoactivity and a lack of startle response were also noted in animals from the 3000 ppm group during exposures.
Genotoxicity
The net nuclear grain counts were all less than zero for all concentrations and both sexes. The percentage of cells in repair was not increased; the percentages were less than 2% at all dose levels and in both sexes.
Applicant's summary and conclusion
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