Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-475-4 | CAS number: 107-25-5
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to GLP guideline study. Acceptable restriction: OECD TG 474 requires 2000 immature cells to be examined instead of 1000/animal in this study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- (CIVO TNO)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Methyl vinyl ether
- EC Number:
- 203-475-4
- EC Name:
- Methyl vinyl ether
- Cas Number:
- 107-25-5
- Molecular formula:
- C3H6O
- IUPAC Name:
- methoxyethene
- Details on test material:
- Methyl vinyl ether (MVE)
obtained from BASF AG; purity 99.7% (analysis available)
reanalysis after termination: no evidence for change of test material
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Five male and 5 female Swiss mice (Charles River CD-1 strain; breeder Charles River France SA, St. Aubin-les Elboeuf, France) were used per group.
Mean body weight: about 30.5 g 22.5 g for males and females, respectively.
Feeding: commercial diet
Drinking water ad libitum
Room temperature: 22 +/- 2 °C Relative humidity: 30 - 70% Ventilation: about 10 air changes per hour Lightening: 12 hours light/12 hours dark
Caging: single Makrolon cages
Administration / exposure
- Route of administration:
- inhalation: vapour
- Vehicle:
- air
- Details on exposure:
- Whole body
Exposure chamber: glass cylinder (length 0.90 m, diameter 15 cm) with sampling ports at the inlets and outlets. Perforated stainless steel plates allowed to house the animals in individual compartments. Atmosphere generation: MVE was added to an air flow (15 l/min) to give concentrations of 0, 5000, and 25 000 ppm. Concentration measurements: 22 measurements/day by infra red-analysis at regular intervals. - Duration of treatment / exposure:
- 6 hrs/day on 5 consecutive days
- Frequency of treatment:
- once daily
- Post exposure period:
- 24 h after the last exposure mice were sacrificed
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0; 5000; 25000 ppm (0; 12; 60 mg/L)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 4898+-200 ppm, 25046+-71 ppm
Basis:
analytical conc.
mean of means on days 1-5 (+/- standard deviation); range of analytical means: 0, 4960-5030, 24970-25110 ppm
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, sham-exposed
- Positive control(s):
- Positive control substance: single i.p. dose of Mitomycin C at 1.5 mg/kg bw at 24 hrs before sacrifice.
Examinations
- Tissues and cell types examined:
- Animals were killed by decapitation the day after the last inhalation exposure (positive control: 24 hrs after i.p. injection). Bone marrow was prepared from femoral bone marrow according to Schmidt, 1976.
- Details of tissue and slide preparation:
- Slides were stained with acridine orange according to Hayashi et al. (1983) and examined using a fluorescence microscope. Further slides were Giemsa stained and stored because the acridine orange staining is not stable. Counting: The incidence of micronucleated polychromatic erythrocytes (MPE) was determined in a total of 1,000 polychromatic erythrocytes on one slide from each animal. Size distribution: MPEs were categorized according to micronuclear size comparing the diameter of the micronucleus (d) with the diameter of the erythrocyte (D): M (d<0.1D); + 0.1D
- Evaluation criteria:
- not clearly stated but statistically significant and dose dependent increase assumed
- Statistics:
- 2 linear logistic regression models with factors: sex (male, female) and group and their mutual interactions; levels of the factor group were successivily : 1) negative control, 5000 ppm MVE, 25000 ppm MVE and 2) negative control; Mitomycin C
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- (but very high dose levels tested: 60 mg/L)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Signs of toxicity: In treated animals no apparent signs of intoxication or body weight changes were noted.
Any other information on results incl. tables
Erythrocyte count:
No increased frequency of micronucleated polychromatic
erythrocytes (MPE) containing either small or large
micronuclei was seen in animals receiving MVE. The positive
control substance gave results as expected indicating the
sensitivity of the test system.
Results of repeat study
Mean number of MPE / 1000 PE
Males Females
--------------------------------------------------
Control 3.2 5.2
MVE 5000 ppm 3.0 4.2
MVE 25000 ppm 2.8 4.6
Mitomycin C 42.8*** 37.8***
--------------------------------------------------
*** p</= 0.001
There was no inhibition of erythropoiesis since the ratio of
polychromatic to normochromatic erythrocytes was not
significantly affected in the treated animals:
Ratio PE:NE
Males Females
--------------------------------------------------
Control 3.41 3.62
MVE 5000 ppm 1.03 2.01
MVE 25000 ppm 1.97 3.33
Mitomycin C 1.91 2.22
--------------------------------------------------
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
No signs of toxicity were noted in male and female CD-1 mice repeatedly
exposed to MVE at 5000 or 25000 ppm (n=5 per dose per sex; 6 h/day for 5 days; the high dose level is very close to the lower explosion level; corresponding to 0; 12; 60 mg/L). Examination of erythrocytes from bone marrow (sacrifice 24 h after the last exposure) gave no
indication of an induction of clastogenic/aneugenic effects or
cytotoxicity.
Vehicle control and positive control were valid.
Positive results seen in only one subgroup (high-dose males) in a previous study are outweighed and attributable to some technical flaw in the procedure.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.