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EC number: 201-145-4 | CAS number: 78-81-9
- 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
Endpoint summary
Administrative data
Description of key information
Isobutylamine was tested for acute oral toxicity in Wistar rats and Sprague-Dawley rats. Both non GLP studies were conducted with a method similar or comparable to the OECD 401 guideline.
In the first study (Hoechst 1979) the Oral LD50 in female Wistar rats was determined to be 591 mg/kg and in the second study publised (The acute Oral toxcity of isomeric Monobutylamines in the adult male and female rat; Toxicology and appied Pharmacology 63, 150 -152 (1982)), the Oral LD50 in male and female Sprague-Dawley rats was found to be 228 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- data were published in 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Isobutylamine (>98%) was purchased from Tidom Chemical Inc., Hauppauge, New York
- 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, Massachusetts.
- Age at study initiation: adult rats; all animals testes were from the same age.
- Fasting period before study: 18 hours
- Housing: two animals per cage
- Diet: Rodent Laboratory Chow (Ralston Purina Co., St. Louis, Mo.)
- Water: Tab water was available ad libitum
- Acclimation period: 2 weeks
- Weight: males 194.7 ± 20.5 g and females 156 ± 16.8 g
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 26°C
- Humidity (%): 22 to 49%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): A 12 hours light-dark schedule was maintained with the light cycle beginning at 7:00 AM
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100, 200, 300, 400, 500 and 600 mg/kg body wt
- Amount of vehicle (if gavage): constant 4 ml volume
MAXIMUM DOSE VOLUME APPLIED: 600 mg/kg body
CLASS METHOD
- Rationale for the selection of the starting dose: in a range-finding study, rats were treated in groups of two males and two females with various amoutns of the test compound. - Doses:
- 100, 200, 300, 400, 500 and 600 mg/kg body wt
- No. of animals per sex per dose:
- 24 dosage groups, each group consisting of 10 male and 10 female rats
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: no
- Other examinations performed: signs of toxicity included sedation, ataxia, nasal discharge, gasping, salivation and , at higher doses, convulsions and death
- Gross pathological examination of animals that died following treatment - Statistics:
- Data for male and females were compared statistically for each compound by the χ2 contigency table analysis (Snedecor and Cochran, 1967).
The LD50 value was calculated by the probit method of D.J. Finney (1971, Probit Analysis, 3rd ed., Cambridge Univ. Press, Cambridge) - Preliminary study:
- In a range-finding study, rats were treated in groups of two males and two females with various amount of the test compount.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 224.4 mg/kg bw
- 95% CL:
- >= 136.3 - <= 303.1
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 231.8 mg/kg bw
- 95% CL:
- >= 106.1 - <= 345.9
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 227.9 mg/kg bw
- 95% CL:
- >= 161.5 - <= 289.5
- Mortality:
- At the dose levels tested, death generally occurred within 1 to 3 hr after adminisation of the test substance.
- Clinical signs:
- other: sedation, ataxia, nasal discharge, gasping, salivation and, at higher doses convulstions and death
- Gross pathology:
- pulmonary edema
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The single-dose LD50 value was of 224.4 mg/kg body wt for the males and 231.8 mg/kg body wt for females rates; for males + females, it results in a LD50 value of 227.9 mg/kg body wt. The study is comparable to a study guideline with acceptable deviations. Therefore, it can be used for GHS classification.
- Executive summary:
This paper reports the acute oral toxicity of the test substance in male and female rats. The test substance was administrated by gavage to all rats with the corresponding dosage groups. The solution of the test substance were preapred in corn oil such that doses of 100, 200, 300, 400, 500 and 600 mg/kg body weight.
The single-dose LD50 value was of 224.4 mg/kg body wt for the males and 231.8 mg/kg body wt for females rates; for males + females, it results in a LD50 value of 227.9 mg/kg body wt.
The study is comparable to a study guideline with acceptable deviations. Therefore, it can be used for GHS classification.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 228 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the above stated assessment of the acute oral toxicity, isobutylamine does have to be classified as Acute Toxicity Oral Category 3 (H301 Toxic if swallowed) according to CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council.
Although the acute toxicity of the substance is related to corrosive properties, there is sufficient evidence that the substance maybe harmful by acute exposure and is therefore also classified as acute dermal toxicity Category 3 (H311 Toxic in contact with skin) and acute inhalation toxicity Category 3 (H331 Toxic if inhaled).
The substance may also cause respiratory irritation following inhalation exposure and is therefore also classified as STOT SE Category 3.
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