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Diss Factsheets
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EC number: 218-871-2 | CAS number: 2269-22-9
- 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
- Study period:
- 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study design deviates from OECD Guidelines, but is still scientifically valid and well reported, for read-across substance
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: NTP study design
- Deviations:
- yes
- Remarks:
- non-pregnant females included to test for maternal effects
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Methyl ethyl ketone
- IUPAC Name:
- Methyl ethyl ketone
- Reference substance name:
- Butanone
- EC Number:
- 201-159-0
- EC Name:
- Butanone
- Cas Number:
- 78-93-3
- Molecular formula:
- C4H8O
- IUPAC Name:
- butan-2-one
- Test material form:
- other: clear colorless liquid
- Details on test material:
- > 99.9% purity
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- Housing: stainless steel cages - sexes separated
Food and water: Ad libitum
Room temperature: 72 - 78 F
Relative humidity: 40-70%
Light cycle: 12 hours
Pathogen screen: yes - 10 animals sacrificed during quarantine to ensure absence of significant pathogens/lesions.
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Virgin females were added in addition to the treated and concurrent controls to test the effect of pregnant status on maternal toxicity.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Test material concentration was monitored every 4 hours, with a gas chromatographic system having a detection limit of 0.5 ppm, and a precision of 1%.
- Details on mating procedure:
- Not provided
- Duration of treatment / exposure:
- 10 days
- Frequency of treatment:
- 7 hours/day, 7 days/week
- Duration of test:
- 16 days
- No. of animals per sex per dose:
- 10 (controls)
30 (MEK treatment groups) - Control animals:
- yes, sham-exposed
Examinations
- Maternal examinations:
- Body weights were obtained throughout the study period, and uterine and fetal body weights were obtained at sacrifice on the 18th gestational day.
- Ovaries and uterine content:
- Uterine implants were enumerated and their status recorded.
- Fetal examinations:
- Live fetuses were sexed and examined for gross, visceral, skeletal, and soft-tissue craniofacial defects.
- Statistics:
- Means and standard deviations analysed using SAS General Linear Models. ANOVA with Tukey's T-test was used to separate treatment-related effects. The litter was used as the basis for analysis of fetal variables.
- Indices:
- * Implantations/dam
* Live fetuses/litter
* Resorptions/litter
* Dead fetuses/litter
* Litters with resorptions
* % males
* No. live malformed fetuses/litter
* No. litters with malformed fetuses - Historical control data:
- Not shown
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Exposure of pregnant mice to these concentrations of MEK did not result in overt maternal toxicity although there were treatment-related increases in relative liver and kidney weights which was statistically significant for the 3000-ppm group.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEC
- Effect level:
- 1 000 ppm (nominal)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Mild developmental toxicity was evident at 3000-ppm as a reduction in mean fetal body weight. This reduction was statistically significant for the males only, although the relative decrease in mean fetal body weight was the same for both sexes.
There was no increase in the incidence of intrauterine death in the fetuses of mice exposed to MEK, but there was an increased incidence of misaligned sternebrae (a variation) which was correlated to increasing exposure concentration. The increase was statistically significant for the 3000-ppm group. Although there were no significant increases in the incidence of malformations, several malformations were present at a low incidence which were not observed in the O-ppm group or in the contemporary control data; cleft palate (1 fetus), fused ribs (2), missing vertebrae (1), and syndactyly (5 [all in the same litter]).
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
There were no differences in MEK toxicity observed between pregnant and non-pregnant females, and all shown comparisons were limited to pregnant animals.
Applicant's summary and conclusion
- Conclusions:
- In summary, pregnant Swiss (CD-1) mice appear to be relatively insensitive to the toxic effects of MEK at the exposure levels employed in this study. However, the offspring of the mice exhibited significant signs of toxicity at the 3000-ppm exposure level. Neither maternal nor developmental toxicity were observed at 1000 ppm MEK or below.
- Executive summary:
Swiss (CD-1) mice were exposed to 0, 400, 1000 or 3000 ppm MEK vapors for 7 hours/day, 7 days/week for 10 consecutive days (GD 6 -15). Groups consisted of ten virgin females and 30 plug-positive females.
Exposures to these concentrations of MEK did not result in overt maternal toxicity although there were slight, treatment-related increases in relative liver and kidney weights which was statistically significant for the 3000 ppm group. Mild developmental toxicity was evident at 3000 ppm as a slight reduction in mean fetal body weight. This reduction was statistically significant for the males only, although the relative decrease in mean fetal body weight was the same for both sexes.
There was no increase in the incidence of intrauterine death in the fetuses of mice exposed to MEK, but there was an increased incidence of misaligned sternebrae (a variation) which was correlated to increasing exposure concentration. The increase was statistically significant for the 3000 ppm group. Although there were no significant increases in the incidence of malformations, several malformations were present at a low incidence which were not observed in the O-group or in the contemporary control data; cleft palate (1 fetus), fused ribs (2), missing vertebrae (1), and syndactyly (5 [all in the same litter]).
In summary, pregnant Swiss (CD-1) mice appear to be relatively insensitive to the toxic effects of MEK at the exposure levels employed in this study. However, the offspring of the mice exhibited significant signs of toxicity at the 3000 ppm exposure level. Neither maternal nor developmental toxicity were observed at 1000 ppm MEK or below.
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