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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
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 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no males tested; but no differences betweeen males and females noted in preliminary tests
- Principles of method if other than guideline:
- Method: other: similar to OECD Guide-line 401
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Isobutylamine
- EC Number:
- 201-145-4
- EC Name:
- Isobutylamine
- Cas Number:
- 78-81-9
- Molecular formula:
- C4H11N
- IUPAC Name:
- 2-methylpropan-1-amine
- Details on test material:
- Isobutylamine: no further details reported
- Name of test material (as cited in study report): isobutylamine
- Physical state: liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: not stated
- Weight at study initiation: mean 172 g (S.D. +/- 3.31 g; range: 160-172 g; n=50)
- Fasting period before study: 16 hours
- Housing: in plastic cages on wood shavings
- Diet: standard diet ALTROMIN 1324 ad libitum
- Water: tap water, ad libitum
- Acclimation period: not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not stated
- Humidity (%): not stated
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated
IN-LIFE DATES:
From: treatment To: end of the14-day observation period
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5%
- Amount of vehicle (if gavage): variable; 5 to 20 mL/kg
- Justification for choice of vehicle: solubility
- Purity: deionized water
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
- Doses:
- 250, 400, 630, 800, 1000 mg/kg bw
- 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: rats were observed daily; body weights were recorded weekly
- Necropsy of survivors performed: yes
- Necropsy of animals that died: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- Probit analysis (according to Lindner and Weber) was used to determine the LD50 value. Company software was also used to calculate the confidence range according to Fieller.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 591 mg/kg bw
- 95% CL:
- 491 - 674
- Mortality:
- Deaths occurred within 3 hours and 10 days after dosing.
- Clinical signs:
- other: Symptoms included squatting position, unkempt fur, unsteady gait, abdominal position, apathy, closed lids, and forced breathing. No symptoms were noted after 48 hours in animals that survived.
- Gross pathology:
- Animals that died: necropsy revealed macroscopically changes of the gastrointestinal blood vessels and red-brownish mucus in the stomach and in the small intestine. The stomach contents showed a pH of 11.1 and were positively tested for blood.
Animals sacrificed: the terminal necropsy of sacrificed animals revealed a pattern of the liver lobules, blue coloring of the diaphragm and the peritoneum, and a dark brown color of the liver and spleen.
Any other information on results incl. tables
No differences were noted between male and female animals in preliminary experiments .
Dose (mg/kg bw) |
Mortalities per group |
250 |
0/10 |
400 |
1/10 |
630 |
4/10 |
800 |
10/10 |
1000 |
10/10 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Isobutylamine, oral LD50, rat, male and female: 591 mg/kg bw
- Executive summary:
The oral LD50 of isobutylamine (rat, male and female) was 591 mg/kg bw in a valid non-GLP study (RL=2) that was conducted similar to OECD TG 401 using female rats. As no differences were noted between male and female animals in preliminary experiments, the LD50 is considered to be valid for both male and female rats. Gross pathology of animals that died revealed a high pH of 11.1 in the stomach, and congestion of the stomach blood vessels and teh GI tract (Hoechst, 1979).
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