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Diss Factsheets
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EC number: 204-646-6 | CAS number: 123-72-8
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary source from OECD SIDS
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 412
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan/MAFF Guideline
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. EPA TSCA Guideline 40 CFR Parts 798.2450
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Guideline 92/69/EEC
- Deviations:
- no
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isobutyraldehyde
- EC Number:
- 201-149-6
- EC Name:
- Isobutyraldehyde
- Cas Number:
- 78-84-2
- Molecular formula:
- C4H8O
- IUPAC Name:
- 2-methylpropanal
- Details on test material:
- - Name of test material (as cited in study report): Isobutyraldehyde
- Molecular formula (if other than submission substance): Not documented
- Molecular weight (if other than submission substance): Not documented
- Smiles notation (if other than submission substance): Not documented
- InChl (if other than submission substance): Not documented
- Structural formula attached as image file (if other than submission substance): see Fig. Not documented
- Substance type: Not documented
- Physical state: Not documented
- Analytical purity: Not documented
- Impurities (identity and concentrations): Not documented
- Composition of test material, percentage of components: Not documented
- Isomers composition: Not documented
- Purity test date: Not documented
- Lot/batch No.: Not documented
- Expiration date of the lot/batch: Not documented
- Radiochemical purity (if radiolabelling): Not documented
- Specific activity (if radiolabelling): Not documented
- Locations of the label (if radiolabelling): Not documented
- Expiration date of radiochemical substance (if radiolabelling): Not documented
- Stability under test conditions: Not documented
- Storage condition of test material: Not documented
- Other: Not documented
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No information provided
- Age at study initiation: 75 - 84 days old.
- Weight at study initiation: No information provided
- Fasting period before study: No information provided
- Housing: No information provided
- Diet (e.g. ad libitum): No information provided
- Water (e.g. ad libitum): No information provided
- Acclimation period: No information provided
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No information provided
- Humidity (%): No information provided
- Air changes (per hr): No information provided
- Photoperiod (hrs dark / hrs light): No information provided
IN-LIFE DATES: From: To: No information provided
Administration / exposure
- Route of administration:
- other: not specified
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- Groups of 25 mated female Wistar rats were exposed to target concentrations of 1000, 2500, or 4000 ppm isobutyraldehyde for 6 hours per day, gestation day 6 through 15. Coital day 6 through post-coital day 15.
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- No information provided
- Details on mating procedure:
- No information provided
- Duration of treatment / exposure:
- 6 hours per day from gestation day 6 through 15 and coital day 6 through post-coital day 15.
- Frequency of treatment:
- Not specified
- Duration of test:
- 6 hours
- No. of animals per sex per dose:
- Groups of 25 mated female rats per dose level.
- Control animals:
- not specified
- Details on study design:
- No further information
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
- Time schedule: Not documented
- Cage side observations checked in table [No.?] were included. Not documented
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: Not documented
BODY WEIGHT: Yes
- Time schedule for examinations: Not documented
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: Not documented
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # Not documented
- Organs examined: Not documented
OTHER: No additional information - Ovaries and uterine content:
- No information provided
- Fetal examinations:
- - External examinations: Yes: No data on number of litter examined.
- Soft tissue examinations: Yes: No data on number of litter examined.
- Skeletal examinations: Yes: No data on number of litter examined.
- Head examinations: No data - Statistics:
- No information provided
- Indices:
- No information provided
- Historical control data:
- No information provided
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Decreased body weight gain; Lesions of nasal mucosa
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 3 mg/L air (nominal)
- Based on:
- no data
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEC
- Effect level:
- 12 mg/L air (nominal)
- Based on:
- no data
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No substance-related effects up to and including highest exposure concentration
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Isobutyraldehyde exposure resulted in a dose-related increase in maternal toxicity, as evidenced by a significant decrease in body weight gain in dams exposed to 4000 and 2500 ppm., but not at 1000 ppm. Exposure of dams to isobutyraldehyde had no effect ongestational or litter parameters and did not induce embryo/fetal toxicity. There was no increase in fetal malformations at any exposure level, up to the highest concentration tested, 4000 ppm.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, it can be concluded that the test substance, isobutyraldehyde, did not induce any reproductive toxicity when testedin female mated Wistar rats.
- Executive summary:
Garner et al. (1996) examined the potential of isobutyraldehyde to induce reproductive toxic effects when tested in groups of 25 mated female Wistar rats exposed to the test substance 6 hours per day on days 6 through 15 of gestation. The test animals were exposed to the test substance at concentrations of 1000, 2500 and 4000ppm. The results of this study indicate a dose-related increase in maternal toxicity but exposure of the dams to isobutyraldehyde had no effect on gestational or litter parameters and did not induce embryo/foetal toxicity. There was no increase in foetal malformations at any exposure level, up to the highest concentration tested. Based on the results of this study, it can be concluded that the test substance, isobutyraldehyde, did not induce any reproductive toxicity when tested in female mated Wistar rats.
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