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EC number: 203-678-8 | CAS number: 109-53-5
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: In a dose range finding study according to OECD412 pregnant rats were used.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
- Principles of method if other than guideline:
- Report presented some data on developmental toxicity in the frame of a sub-acute inhalation toxicity study in pregnant rats according to OECD TG412.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Isobutyl vinyl ether
- EC Number:
- 203-678-8
- EC Name:
- Isobutyl vinyl ether
- Cas Number:
- 109-53-5
- Molecular formula:
- C6H12O
- IUPAC Name:
- 1-(ethenyloxy)-2-methylpropane
- Details on test material:
- lsobutylvinylether, clourless liquid
Batch No.: 03/0186-1 or 03/0186-2
Purity 99.56%
The stability under storage conditions over the exposure of the study period was guaranteed by the sponsor
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Time-mated Wistar rats (CrlGlxBrIHan :Wl) were supplied by Charles River Laboratories (Germany)
age 70 - 84 days and bw 144.1- 176.1 g at arrival
Acclimatisation: rats arrived at gestation day 1 and exposure starts gestation day 6.
housed singly
certified diet and tap water ad libitum
temperature 20 - 240C and relative humidity in the range of 30 - 70%
A light/dark rhythm of 12 hours
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- other: air
- Details on exposure:
- For each concentration the test substance was supplied to a thermostated vaporizer at a constant rate by means of the metering pump. The animals were kept singly in wire cages located in a glass-steel inhalation chamber, volume of 1.4 m³
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- determined analytically using gas chromatography
- Details on mating procedure:
- time pregnant rats used
- Duration of treatment / exposure:
- gestation day 6-20, sacrifice the day following the last exposure
- Frequency of treatment:
- once daily, 6 h/day
- Duration of test:
- sacrifice the day following the last exposure
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 500, 2000, 5000 ppm (0, 2080, 8300, 33200 mg/m³)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 2070+-118, 8352+-385, 33607+-2314 mg/m³
Basis:
analytical conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Clinical signs
Body weight - Ovaries and uterine content:
- Uterus weight at termination
resorptions - Fetal examinations:
- no further data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Even at the low dose level local effects in the nasal cavity were reported (hyperplasia of the respiratory epithelium, mucous cell reduction, and degeneration of the olfactory epithelium) but no other effects. At the mid dose level additional adaptive or secondary (to local effects) effects were seen (increased absolute and relative liver weights, decreased absolute and relative spleen weights, decreased absolute and relative thymus weights, starry sky appearance and decreased cellularity of the thymus cortex). At 8000 ppm (33200 mg/m³) clinical signs, reduced body weight, increased alkaline phosphatase and total bilirubin were found.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 2 000 ppm
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- LOAEC
- Effect level:
- 8 000 ppm
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- LOAEC
- Effect level:
- 500 ppm
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Decreased uterus weight and reduced number of pups and resorptions in 2 dams were reported.
No further details available.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Developmental toxicity (reduced number of pups, resorptions, reduced uterus weight) was found in rats exposed to 8000 ppm (33200 mg/m³) during gestation day 6-20 (6 h/day, whole body) but not at a dose level of 2000 ppm. Local effects in the nasal cavity of dams were seen even at 500 ppm (2080 mg/m³); clinical signs and reduction in maternal body weight were obvious at the high dose level (reliability 3).
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