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EC number: 200-860-9 | CAS number: 75-31-0
- 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
Isopropylamine produced no systemic but local effects (nasal inflammation in rats exposed by inhalation to 500 mg/m3 for 13 weeks), while 100 mg/m3 showed no adverse effects at all.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratory, Kingston, NY
- Age at study initiation: 54 days
- Weight at study initiation: 241-300g (males), 163-207 g (females)
- Fasting period before study: no
- Housing: individually
- Diet: ad libitum, Purina Rodent Chow (5002), except inhalation exposure
- Water: ad libitum, except inhalation exposure
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 35-60
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Routinely sampled five times per exposure at approximately one hour intervals. Test atmosphere was drawn through a MIRAN 1A General Purpose Gas Analyzer
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 h/d, 5d/wk
- Dose / conc.:
- 20 mg/m³ air (analytical)
- Dose / conc.:
- 101 mg/m³ air (analytical)
- Dose / conc.:
- 499 mg/m³ air (analytical)
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent no treatment
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily during exposure and immediately after exposure
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once weekly
BODY WEIGHT: Yes
- Time schedule for examinations: once weekly
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
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
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: all animals before first exposure, control and high exposure groups during last week of exposure
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on day of scheduled necropsy
- Anaesthetic used for blood collection: No
- Animals fasted: Yes
- How many animals: 15 per sex and group
- Parameters checked: Red blood cell count (RBC), white blood cell count (WBC), platelet count (PLT), hematocrit (Hct), level of hemoglobin (Hgb), and red blood cell indices [mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC)], leukocyte differentials, reticulocyte count s
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on day of scheduled necropsy
- Animals fasted: Yes
- How many animals: 15 per sex and group
- Parameters checked: albumin, total protein, blood urea nitrogen (BUN), total bilirubin, glucose, glutamic pyruvic transaminase (D-GPT/ALT), alkaline phosphatase, glutamic oxaloacetate transaminase (D-GOT/AST), creatinine, cholesterol (Chol), calcium, phosphorus, chloride, sodium, and potassium. Globulin was determined by subtraction of albumin from the total protein value
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
All animals subjected to gross necropsy, organ weights were determined, and tissues were obtained: Internal cavities (abdominal, thoracic, cranial, and scrotal)
were opened, and organs were removed and examined
HISTOPATHOLOGY: Yes
Tissues Obtained (when present): aorta, adrenals, bone, brain, diaphragm, esophagus, eyes with optic nerve, gonads (ovaries. testes with
epididymides) , hearts intestine (duodenum, colon, ileum), kidneys, liver, lung, lymph nodes (thymic and mesenteric) , mammary gland, nasal passages, pancreas, pituitary, prostate, salivary gland (submaxillary) ,
sciatic nerve, seminal vesicle, skeletal muscle, skin, spinal cord, spleen, stomach, thymus, thyroid/parathyroid, trachea, urinary bladder, uterus, vagina, and gross lesions (at the discretion of the
pathologist).
All tissues from control and high level animals were examined microscopically; nasal passages from low and mid level females were also examined - Statistics:
- Dunnett's Multiple Comparison Test, Mann-Whitney Test, with with Bonferroni Inequality Procedure, Fisher’s Exact Test with Bonferroni Inequality Procedure, (partially uncorrected) chi-square Test
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- A low level female and a high level male died approximately 12 weeks into the study. The reason for the death of the low level female could not be determined, but it was not thought to be treatment-related. The death of the high level animal was due to mechanical trauma and was not treatment-related.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The mean body weight of high exposure level males was reduced slightly (approximately 6-9%) throughout most of the study. Slight (approximately 4-6%) body weight reductions were also
noted in high level females during weeks 6-13. These effects were not considered as toxicologically relevant. - Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The WBC count was significantly decreased in high exposure level males. Erythrocyte parameters (RBC, HCT, HGB) were increased in all male exposure groups. The reticulocyte count was decreased in high level males. The MCHC values were decreased in all three female’exposure groups. However, the changes were minimal (<3.5%), not dose-related, and thus not considered to be treatment-related.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Serum glucose was decreased approximately 25% in high level females (197, 181, 193 and 147 mg/dL in control, low, mid and high exposure level, respectively). Males were unaffected (224, 221, 241 and 223 mg/dL, respectively). See Overall remarks for discussion.
The following effects were not considered by the authors as toxicologically relevant: Sodium was decreased in mid and high level females, but the changes were minimal (<1.4%) and not considered to be biologically significant. Increased serum potassium values in mid and high level males were not dose-related and thus not considered to be treatment-related. - Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The absolute and relative adrenal weights were significantly increased (approximately 18 and 22%, respectively) in high level females. Absolute spleen weights were significantly decreased (approximately 15%) in high level males.
Remark: Histology of organs was unremarkable. - Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- The only microscopic change which may have been related to treatment was inflammation of the nasal mucosa in high level females.
- Histopathological findings: neoplastic:
- not examined
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 500 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: systemic effects (excluding local effects)
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 100 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: local effects: histopathology (nose)
- Key result
- Critical effects observed:
- not specified
- Conclusions:
- Under the conditions of this study, the only toxicologically relevant effect observed in this study was local irritation of the respiratory tract at 500 mg/m3, with a NOAEC of 100 mg/m3.
The glucose reduction in high dose females was considered toxicologically not relevant, for details see Overall remarks above - Executive summary:
Four groups of 15 males and 15 females each were exposed for 6 hrs/day, 5 days/wk for approximately 13 weeks. Mean analytical exposure concentrations were 20, 101, and 499 mg/m3 in air. The mean
body weight of high exposure level males was reduced throughout much of the study. The only significant change in hematology and clinical chemistry values which appeared to be treatment-related was a decrease in serum glucose (high level females). There was no gross pathology change which was considered to be treatment related. The only microscopic change which may have been related to treatment was inflammation of the nasal mucosa in high level females. Because of these microscopic changes as well as decreases in body weights and serum glucose values in high level animals, the no observed adverse effect level is considered (by the study authors) to be 100 mg/m3 in air.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 500 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Study reliable: Klimisch code 1
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratory, Kingston, NY
- Age at study initiation: 54 days
- Weight at study initiation: 241-300g (males), 163-207 g (females)
- Fasting period before study: no
- Housing: individually
- Diet: ad libitum, Purina Rodent Chow (5002), except inhalation exposure
- Water: ad libitum, except inhalation exposure
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 35-60
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Routinely sampled five times per exposure at approximately one hour intervals. Test atmosphere was drawn through a MIRAN 1A General Purpose Gas Analyzer
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 h/d, 5d/wk
- Dose / conc.:
- 20 mg/m³ air (analytical)
- Dose / conc.:
- 101 mg/m³ air (analytical)
- Dose / conc.:
- 499 mg/m³ air (analytical)
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent no treatment
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily during exposure and immediately after exposure
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once weekly
BODY WEIGHT: Yes
- Time schedule for examinations: once weekly
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
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
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: all animals before first exposure, control and high exposure groups during last week of exposure
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on day of scheduled necropsy
- Anaesthetic used for blood collection: No
- Animals fasted: Yes
- How many animals: 15 per sex and group
- Parameters checked: Red blood cell count (RBC), white blood cell count (WBC), platelet count (PLT), hematocrit (Hct), level of hemoglobin (Hgb), and red blood cell indices [mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC)], leukocyte differentials, reticulocyte count s
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on day of scheduled necropsy
- Animals fasted: Yes
- How many animals: 15 per sex and group
- Parameters checked: albumin, total protein, blood urea nitrogen (BUN), total bilirubin, glucose, glutamic pyruvic transaminase (D-GPT/ALT), alkaline phosphatase, glutamic oxaloacetate transaminase (D-GOT/AST), creatinine, cholesterol (Chol), calcium, phosphorus, chloride, sodium, and potassium. Globulin was determined by subtraction of albumin from the total protein value
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
All animals subjected to gross necropsy, organ weights were determined, and tissues were obtained: Internal cavities (abdominal, thoracic, cranial, and scrotal)
were opened, and organs were removed and examined
HISTOPATHOLOGY: Yes
Tissues Obtained (when present): aorta, adrenals, bone, brain, diaphragm, esophagus, eyes with optic nerve, gonads (ovaries. testes with
epididymides) , hearts intestine (duodenum, colon, ileum), kidneys, liver, lung, lymph nodes (thymic and mesenteric) , mammary gland, nasal passages, pancreas, pituitary, prostate, salivary gland (submaxillary) ,
sciatic nerve, seminal vesicle, skeletal muscle, skin, spinal cord, spleen, stomach, thymus, thyroid/parathyroid, trachea, urinary bladder, uterus, vagina, and gross lesions (at the discretion of the
pathologist).
All tissues from control and high level animals were examined microscopically; nasal passages from low and mid level females were also examined - Statistics:
- Dunnett's Multiple Comparison Test, Mann-Whitney Test, with with Bonferroni Inequality Procedure, Fisher’s Exact Test with Bonferroni Inequality Procedure, (partially uncorrected) chi-square Test
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- A low level female and a high level male died approximately 12 weeks into the study. The reason for the death of the low level female could not be determined, but it was not thought to be treatment-related. The death of the high level animal was due to mechanical trauma and was not treatment-related.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The mean body weight of high exposure level males was reduced slightly (approximately 6-9%) throughout most of the study. Slight (approximately 4-6%) body weight reductions were also
noted in high level females during weeks 6-13. These effects were not considered as toxicologically relevant. - Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The WBC count was significantly decreased in high exposure level males. Erythrocyte parameters (RBC, HCT, HGB) were increased in all male exposure groups. The reticulocyte count was decreased in high level males. The MCHC values were decreased in all three female’exposure groups. However, the changes were minimal (<3.5%), not dose-related, and thus not considered to be treatment-related.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Serum glucose was decreased approximately 25% in high level females (197, 181, 193 and 147 mg/dL in control, low, mid and high exposure level, respectively). Males were unaffected (224, 221, 241 and 223 mg/dL, respectively). See Overall remarks for discussion.
The following effects were not considered by the authors as toxicologically relevant: Sodium was decreased in mid and high level females, but the changes were minimal (<1.4%) and not considered to be biologically significant. Increased serum potassium values in mid and high level males were not dose-related and thus not considered to be treatment-related. - Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The absolute and relative adrenal weights were significantly increased (approximately 18 and 22%, respectively) in high level females. Absolute spleen weights were significantly decreased (approximately 15%) in high level males.
Remark: Histology of organs was unremarkable. - Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- The only microscopic change which may have been related to treatment was inflammation of the nasal mucosa in high level females.
- Histopathological findings: neoplastic:
- not examined
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 500 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: systemic effects (excluding local effects)
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 100 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: local effects: histopathology (nose)
- Key result
- Critical effects observed:
- not specified
- Conclusions:
- Under the conditions of this study, the only toxicologically relevant effect observed in this study was local irritation of the respiratory tract at 500 mg/m3, with a NOAEC of 100 mg/m3.
The glucose reduction in high dose females was considered toxicologically not relevant, for details see Overall remarks above - Executive summary:
Four groups of 15 males and 15 females each were exposed for 6 hrs/day, 5 days/wk for approximately 13 weeks. Mean analytical exposure concentrations were 20, 101, and 499 mg/m3 in air. The mean
body weight of high exposure level males was reduced throughout much of the study. The only significant change in hematology and clinical chemistry values which appeared to be treatment-related was a decrease in serum glucose (high level females). There was no gross pathology change which was considered to be treatment related. The only microscopic change which may have been related to treatment was inflammation of the nasal mucosa in high level females. Because of these microscopic changes as well as decreases in body weights and serum glucose values in high level animals, the no observed adverse effect level is considered (by the study authors) to be 100 mg/m3 in air.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 100 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Study reliable: Klimisch code 1
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
In the absence of information on species specific sensitivity the observed effects are regarded as relevant for humans.
Additional information
In a study conducted in a manner equivalent or similar to OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day), groups of 15 male and female Sprague-Dawley rats were exposed by vapor inhalation for 6 h/d, 5d/w for 13 weeks to 20, 101, and 499 mg/m3isopropylamine (Heydens and Thake, 1988). The highest concentration, 500 mg/m3 (LOAEC), produced nasal inflammation (females), a slight decrease in body weight of < 7 % (males), and a decrease in serum-glucose level (females only). The systemic effects were considered to be of no pathological relevance.
The NOAEC was 100 mg/m3 for local effects and 500 mg/m³ for systemic effects. .
Because of the highly irritating activity of isopropylamine, oral and dermal application was not indicated.
Justification for classification or non-classification
Based on the available experimental results no classification according to Regulation (EC) No 1272/2008 for repeated dose toxicity is recommended.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.