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EC number: 200-888-1 | CAS number: 75-64-9
- 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

Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 02. Jul 1980 - 02. Oct 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- 1. Food consumption was not determined 2. No measurement of blood clotting potential was performed 3. No individual data were available to the reviewer. This hampers the evaluation of the results. 4. The slight decrease in liver weight seen at 0.2 mg/L was not accompanied by histopathological or clinical chemistry findings 5. A quality assurance statement was included
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
- Principles of method if other than guideline:
- see details in remarks on material and methods
- GLP compliance:
- no
Test material
- Reference substance name:
- tert-butylamine
- EC Number:
- 200-888-1
- EC Name:
- tert-butylamine
- Cas Number:
- 75-64-9
- Molecular formula:
- C4H11N
- IUPAC Name:
- 2-methylpropan-2-amine
- Details on test material:
- CAS 75-64-9 (tert-butylamine), purity 99.5%.
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, Inc. (Portage, MI)
- Age at study initiation: 49 days
- Weight at study initiation: 222-250 g (males), 169-186 g (females)
- Housing: individually
- Diet: Ralston Purina Rodent Chow 5002, ad libitum
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72 ± 2°F
- Humidity (%): 35-60%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- MMAD / GSD: no data
- Details on inhalation exposure:
- - Type of exposure: inhalation
- Particle size: not applicable (vapour)
- Air changes: 10/hour - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- 4 samples per exposure day by infrared spectrophotometer
Distribution: 5 samples at different locations in the test chamber (3 times during the study) - Duration of treatment / exposure:
- 13 weeks (62 exposure days)
- Frequency of treatment:
- 6 hours/day, 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.2, 0.5, 2.01 mg/l
Basis:
analytical conc.
- No. of animals per sex per dose:
- 15
- Control animals:
- yes
- Details on study design:
- - Nominal concentration: the amount of test material metered into the test chamber per unit of time divided by the air-flow per unit of time
- Actual concentration: as determined by analyses
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily prior and after exposure; during exposure for activity
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: week 13
- Anaesthetic used for blood collection: No data
- Animals fasted: Yes, 22 h
- How many animals: 10
- Parameters examined:Red Blood Cell Count ( RBC), White Blood Cell Count ( WBC), Leukocyte Differentials Hemoglobin ( HGB), Hematocrit ( HCT), Mean Corpuscular Volume ( MCV), Mean Corpuscular Hemoglobin ( MCH), Mean Corpuscular Hemoglobin Concentration ( MCHC).
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: week 13
- Animals fasted: Yes, 22 h
- How many animals: 10
- Parameters examined: Alkaline Phosphatase (ALP), Total Bilirubin, Blood Urea Nitrogen (BUN), Glucose, Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic, Transaminase (SGPT), Total Protein
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes; heart, lungs, nasal turbinates, trachea, salivary gland, liver, pancreas, oesophagus, stomach, duodenum, jejunum, ileum, ceacum, colon, mammary gland, kidneys, urinary bladder, skeletal muscle, bone and bone marrow (femur), spleen, thymus, lymphnodes (mesenteric), thyroid, testes, epididymides, prostate, ovaries,uterus, pituitary, adrenals, brain, skin and eyes
HISTOPATHOLOGY: Yes; gross lesions and organs mentioned under macroscopy for control and high dose animals; bone marrow and nasal turbinates from low and mid dose groups - Other examinations:
- Organ weights: adrenals, brain, heart, liver, spleen, pituitary, kidneys, testes
- Statistics:
- Dunnett's test, Mann-Whitney test, Fisher's exact test, Kolmogorov-Smirov (one-tailed test)
Results and discussion
Results of examinations
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- ACTUAL DOSE RECEIVED:
Nominal (mg/L): 0.20, 0.50, 2.04
Actual (mg/L): 0.20, 0.50, 2.01
Distribution: uniformly
MORTALITY:
- Number of deaths at each dose (time): High dose: 2 males (day 43), 1 female (day 45), 1 female (day 59); 2 males and 5 females killed in extremis (between day 48 and 73)
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
Clinical Signs During Exposure:
- At 0.2 mg/L: hypoactivity (>=25%) during first exposure
- At 0.5 mg/L: hypoactivity during first exposure (>=25%), irritation of nose and eyes (>=25%), respiratory difficulties (>=25%) during first exposure
- At 2.0 mg/L: hypoactivity (>=25%) during first exposure, hypoactivity (>=75%), irritation of nose and eyes (>=100%), respiratory difficulties (>=75%) throughout the study
Clinical Signs Before and After Exposure:
- At 0.2 mg/L: nasal discharge (2/10), breathing problems and sneezing (1/10), alopecia
- At 0.5 mg/L: incidental: nasal discharge, nose and eye irritation, listlessness, piloerection, alopecia
- At 2.0 mg/L: in general: irritation of nose and eyes, breathing problems, sneezing, listlessness, distended abdomen, alopecia; Incidental: corneal opacity, chromodacryorrhea, fur dicoloration, piloerection, salivation, behavioral abnormalities, hyperactivity, hypoactivity, ataxia, dicolored urine, urine stained fur and a mass (1/5 females) respiratory difficulties (75%) throughout the study
Body weight gain:
- Significant decrease at 0.5 (week 3 females only) and 2.0 mg/L (all animals) (dose related)
Haematology:
- RBC/WBC: not evaluated due to technical problems 2.0 mg/L
- Neutrophils: significant increase
- Lymphocytes: significant decrease
Clinical chemistry:
- At 0.2 mg/L glucose: significant increase (males)
- At 0.5 mg/L glucose: significant increase (males)
- At 2.0 mg/L glucose: significant increase (males and females)
- ALP: significant increase (males and females)
- ASAT: significant increase (males and females)
- ALAT: significant increase (females)
- BUN: significant increase (males)
MACROSCOPIC/MICROSCOPIC EXAMINATIONS:
Organ weights:
- At 0.2 mg/L: liver: significant decrease abs/rel (males)
- At 0.5 mg/L liver: significant decrease abs (males); pituitary: significnat decrease abs/rel (females)
- At 2.0 mg/L liver: significant decreasse abs/rel (males and females); adrenals: significant increase abs/rel (males and females); brain, heart, kidney: significant decrease abs (males), significant increase rel (males and females); pituitary: significant decrease abs (females)/significant increase rel (males); spleen: significant decreased abs/rel (males); testes: significant decrease abs/significant increase rel (males)
Gross pathology:
- At 2.0 mg/L In general: emaciation, gaseous distension of the intestine
Histopathology:
- At 2.0 mg/L in general: chronic inflammation of the nasal passages and the upper respiratory tract (infiltration of lymphocytes), myeloid hyperplasia (increased proportion of neutrophilic leukocytes in bone marrow)
- No nasal lesions were found in the middle and low dose group
- The gonads were examined histologically in the highest dose group: no effects found
Effect levels
open allclose all
- Dose descriptor:
- NOEC
- Effect level:
- 0.2 mg/L air (analytical)
- Sex:
- female
- Dose descriptor:
- NOAEC
- Effect level:
- < 0.2 mg/L air (analytical)
- Sex:
- male
- Basis for effect level:
- other: 0.2 mg of TBA/liter of air appears to be a "minimal effect" level.
- Remarks on result:
- not determinable
- Remarks:
- no NOAEC identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Applicant's summary and conclusion
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