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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary source: IUCLID 07/1997 Only insufficient documents about study available and documentation/performance of study insufficient.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
- Reference Type:
- publication
- Title:
- No information
- Author:
- Ballantyne B et al
- Year:
- 1 986
- Bibliographic source:
- The Toxicologist 6, 59
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- other:
- Principles of method if other than guideline:
- No information provided
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Butyraldehyde
- EC Number:
- 204-646-6
- EC Name:
- Butyraldehyde
- Cas Number:
- 123-72-8
- Molecular formula:
- C4H8O
- IUPAC Name:
- butanal
- Details on test material:
- - Name of test material (as cited in study report): Butyraldehyde
- Molecular formula (if other than submission substance): Not documented
- Molecular weight (if other than submission substance): 72.1
- 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: Organic
- Physical state: Liquid
- Analytical purity: 98.59 % by weight
- 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:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No information provided
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Remarks on MMAD:
- MMAD / GSD: No information provided
- Details on inhalation exposure:
- No information provided
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No information provided
- Duration of treatment / exposure:
- up to 13 weeks
- Frequency of treatment:
- 6 h/day, 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5.44, 1.36, 0.34 mg/l (2000, 500, 125 ppm)
Basis:
no data
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Post-exposure period: no data
- Positive control:
- No information provided
Examinations
- Sacrifice and pathology:
- Groups of 10 rats per sex per group were sacrificed at 6 and 13 weeks.
- Other examinations:
- .Animals were monitored for signs of toxicity and body weight gain during the exposure interval. Urinalysis, hematology, and blood chemistry tests were performed prior to initiation of exposure and again on 5 rats per sex per group after 6 and 13 weeks of exposure. Tissues from control and high dose (2000 ppm) animals were examined microscopically; tissues from lower-dose animals were examined if lesions were observed at the highest dose.
- Statistics:
- No information provided
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- effects observed, treatment-related
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Interim sacrifice was conducted after 6 and 13 weeks. Body weight did not show treatment-related changes. Haematological examinations revealed a significant increase in albumin in females treated with 0.34 mg/L after 63 - 64 days and in total protein in females treated with 0.34 and 5.44 mg/L after 29 days. Treatment-related histopathological changes were mainly found in the nasal cavity in all treated groups. The changes included metaplasia in the squamous epithelium of the nasal mucous membrane, rhinitis and starting atrophy of the goblet cells followed by hyperplasia. These changes were more pronounced in animals exposed 6 weeks to butyraldehyde than in those that inhaled butyraldehyde for 13 weeks.
Signs of eye and respiratory irritation (lacrimation, salivation, nasal discharge) were observed at all dose levels. There was only one death, which was not related to treatment. There were no significant differences in body weight gains between exposed and control animals. There were no differences in organ weights observed in exposed animals sacrificed at 6 and 13 weeks as compared to controls. Rats at all treatment levels had treatment-related changes in the nasal cavity, indicating an inflammatory response to chronic irritation. Changes consisted of squamous metaplasia of the mucosal epithelium, rhinitis, goblet cell atrophy, and goblet cell hyperplasia. Changes appeared to be more severe in rats sacrificed after 6 weeks of exposure than in those sacrificed at 13 weeks. No other treatment-related effects were noted.
Effect levels
- Dose descriptor:
- LOAEC
- Effect level:
- 125 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No toxic effects observed at 125ppm
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the LOAEC was determined to be 125ppm.
- Executive summary:
In a non verifiable repeated-dose inhalation study, groups of male and female rats were exposed to butyraldehyde vapor by inhalation at concentrations of 0, 125, 500 and 2000 ppm ( 0.34, 1.36, and 5.44 mg/l) for 6 hr/day for 5 days/wk for 13 weeks. Rats in all exposure groups had treatment-related changes in the nasal cavity, including squamous metaplasia of the mucosal epithelium, rhinitis, goblet cell atrophy, and goblet cell hyperplasia. No other effects were observed. The LOAEC for rats in this study was 125 ppm (= 0.34 mg/L), based on local irritation in the nasal region (from SIAR draft March 2006).
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.
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