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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-159-0 | CAS number: 78-93-3
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Apr. 21, 1979 to May 24, 1979
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- no
- Limit test:
- no
Test material
- 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
- Details on test material:
- - Name of test material (as cited in study report): Methyl ethyl ketone
- Analytical purity: 99.605 %
- Lot/batch No.: 36799
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Spartan Research Animals, Haslett, Michigan
- Age at study initiation: Reported as adult
- Weight at study initiation: 250 g
- Fasting period before study: None
- Housing: Individuall housed in stainless steel, wire-bottom cages. (group housed in exposure chambers for 7 hours/day during exposure period)
- Diet (e.g. ad libitum): Commercial laboratory chow (Ralston Purina company).
- Water (e.g. ad libitum): ad libitum when not in exposure chamber
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (F): 70 ± 3 F
- Humidity (%): 45 ± 5%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: Not reported
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- other: airstream
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:exposure cage
- Method of holding animals in test chamber: cage
- Source and rate of air: filtered air
- Method of conditioning air: Not reported
- System of generating particulates/aerosols: Not aplicable
- Temperature, humidity, pressure in air chamber: Not reported
- Air flow rate: Not reported
- Air change rate: Not reported
- Method of particle size determination: Not aplicable
- Treatment of exhaust air: Not reported
TEST ATMOSPHERE
- Brief description of analytical method used:
- Samples taken from breathing zone: yes
VEHICLE (if applicable)
- Justification for use and choice of vehicle:Filtered air
- Composition of vehicle:Filtered air
- Type and concentration of dispersant aid (if powder): Not applicable
- Concentration of test material in vehicle: 400, 1000, or 3000 ppm
- Lot/batch no. of vehicle (if required): Not applicable
- Purity of vehicle:not reported - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Chamber concentrations monitored 15 min/hr/chamber using Miran I Variable Filter Infrared Analyzer.
- Details on mating procedure:
- - Impregnation procedure: purchased timed pregnant
- If cohoused:not reported (bred by supplier)
- M/F ratio per cage: not reported (bred by supplier)
- Length of cohabitation: not reported (bred by supplier)
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility: not reported (bred by supplier)
- Further matings after two unsuccessful attempts: not reported (bred by supplier)
- Verification of same strain and source of both sexes: not reported (bred by supplier)
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Day 6 through day 15 of gestation
- Frequency of treatment:
- Daily, 7 hours/day
- Duration of test:
- 18 days
- No. of animals per sex per dose:
- 25 females/group, 35 females/control group
- Control animals:
- other: Filtered room air
- Details on study design:
- - Dose selection rationale: Based on previous teratologic studies
- Rationale for animal assignment (if not random): Random
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: At day 21 of gestation
BODY WEIGHT: Yes
- Time schedule for examinations: Day 6, 8, 10, 16 and 21 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Not a feeding study
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not a drinking water study
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 21
- Organs examined: Liver - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes
- Number of early resorptions: only in non-pregnant animals.
- Number of late resorptions: Not specified - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: 1/3 per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes: 1/3 per litter - Statistics:
- The frequency of alterations and resorptions among litters and the fetal population was evaluated by the Wilcoxon test. Other incidence data were analyzed by the Fisher exact probability test. Analysis of body weights, liver weights and body measurements were made by analysis of variance. Group means were compared to control values using Dunnett's test.
- Indices:
- Not reported
- Historical control data:
- Not reported
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Maternal body weights were significantly decreased on day 16 and a decrease in maternal body weight gain occured on days 10 through 15 in rats exposed to 3000 ppm of MEK. Water consumption of rats exposed to the high dose level of MEK was significantly increased on days 15 through 17 of gestation
Effect levels (maternal animals)
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 1 002 ppm (analytical)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Significant decrease in delayed ossification of interparietal bones and significant increase in the incidence of extra lumbar ribs at 3000 ppm.
Effect levels (fetuses)
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 1 002 ppm (analytical)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)