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Diss Factsheets
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EC number: 203-699-2 | CAS number: 109-73-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions, only short communication, sufficiently documented
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- vehicle: corn oil instead of aqueous solution; survivors not examined at the end of the 14-d observation period
- Principles of method if other than guideline:
- Comparative study including tert. butylamine, sec-butylamine, isobutylamine and n-butylamine.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Butylamine
- EC Number:
- 203-699-2
- EC Name:
- Butylamine
- Cas Number:
- 109-73-9
- Molecular formula:
- C4H11N
- IUPAC Name:
- butan-1-amine
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): n-butylamine
- Analytical purity: >99%)
- Source: obtained from Tridom Chemical Inc., Hauppage, New York.
- other test materials also included: isobutylamine; sec. butylamine; tert. butylamine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, MA
- Age at study initiation: not stated
- Weight at study initiation: males: 195 +/- 20.5 g; females: : 156 +/- 16.8 g
- Fasting period before study: yes, overnight
- Housing: two animals per cage
- Diet: Rodent Laboratory Chow from Ralston Puirna Co. , St. Louis, MO; ad libitum
- Water: tap water ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-26
- Humidity (%): 22-49
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: treatement To: end of 14-day observation period
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: variable dose
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: no data
MAXIMUM DOSE VOLUME APPLIED: 4 mL/kg bw
- Doses:
- 100, 200, 300, 400, 500, 600 mg/kg bw (in 4 ml corn oil)
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not reported, probably daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight (bw not documented), necropsy of animals that died - Statistics:
- Statistical data evaluation: LD50-values were calculated using the probit method of Finney (1971). Data for male and female animals were compared statistically for each compound by the chi-square contingency table analysis (Snedecor and Cochran, 1967).
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 371.8 mg/kg bw
- 95% CL:
- 307.8 - 458.4
- Remarks on result:
- other: in corn oil
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 365.7 mg/kg bw
- 95% CL:
- 283.6 - 475.8
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 382.4 mg/kg bw
- 95% CL:
- 278.1 - 490.5
- Mortality:
- Number of deaths: not reported
Time to death: generally 1 - 3 h post-administration - Clinical signs:
- other: Sedation, ataxia, salivation, nasal discharge, gasping, and at higher doses, also convulsions
- Gross pathology:
- Deceased animals mainly exhibited pulmonary edema.
Surving animals appeared normal after 14 d and were not further examined.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the experimental conditions an oral LD50 of 371.8 mg/kg bw was determined in male/female rats.
- Executive summary:
The acute oral LD50value of n-butylamine was determined in male and female Sprague-Dawley CD rats in a dose range of 100 -600 mg/kg bw. Signs of toxicity observed after single oral doses of the monobutylamines included sedation, ataxia, nasal discharge, gasping, and salivation followed by convulsions and death at the higher dose levels. Gross pathological examination of animals that died after the monobutylamine treatment revealed pulmonary edema. The LD50 values were calculated by the probit method of D. J. Finney. The LD50 for n-butylamine after an observation period of 14 days was 365.4 mg/kg bw in male rats and 382.7 mg/kg bw for female rats (mean 371.8 mg/kg bw).
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