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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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Isopropylamine
- EC Number:
- 200-860-9
- EC Name:
- Isopropylamine
- Cas Number:
- 75-31-0
- Molecular formula:
- C3H9N
- IUPAC Name:
- propan-2-amine
- Test material form:
- liquid: volatile
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 Laboratory, Kingston
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 54 days
- Weight at study initiation: males 241 g to 300 g
females 163 g to 207 g
- Fasting period before study: no
- Housing: Individual in suspended stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 to 74 ° F
- Humidity (%): 35 to 60 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Ten-cibic meter stainless steel chambers
- Method of holding animals in test chamber: Animals were placed in the middle four rows of the cage racks. rotated weekly through the cage positions
- System of generating particulates/aerosols: substance was metered from a pressurized tank through a capillary tube into a Laskin-style nebulizer located at the top of the cage.
TEST ATMOSPHERE
- Brief description of analytical method used: Test atmosphere was drawn through a NIRAN 1A Generla purpose Gas Analyser
- Samples taken from breathing zone: yes
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 h/day amd 5 d/week
Doses / concentrationsopen allclose all
- 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 animals
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS:
yes for mortality and moribundity; twice daily
During exposure between the second and fifth hour of exposure.
Immediatelky after exposure
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once a week for males and females
BODY WEIGHT: Yes
- Time schedule for examinations: Once a week for males and females
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: before exposure began and during last exposure week.
- Dose groups that were examined: Control and high level dose group.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on the day of scheduled necropsy
- Anaesthetic used for blood collection: Yes (identity not specified)
- Animals fasted: Yes
- How many animals: 15/level/sex
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on the day of scheduled necropsy
- Animals fasted: Yes
- How many animals: 15/level/sex
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- one low level female and a high level male.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The mean body weight of high exposure level males was reduced about 6% to 9% and slight body weight reductions were also seen in high level female at about 4% to 6%.
- 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 expsoure level males. Erythrocytes parameters (RB, HCT, HGB) were increased in all amles exposure groups. The retyculocyte count was decreased in high level males. The MCHC values were decreased in all three female expsoure groups. However, the changes were minimal (< 3.5%), not dose related and thus not considered to be treatment related.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Serum glucose was decreased approx. 25% in high level females. Sodium was decreased in mid and high level females but the chnages were minimal (< 1.4%) and not considerd to be biologically relevant. Increased serum potassium values in mid and high level males were not dose related and thus not considered to be tretament 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.
- 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 occurred at a statistically significant incidence was inflammation of the nasal mucosa in high level females.
- Histopathological findings: neoplastic:
- not examined
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 500 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: systemic effects (excluding local effects)
- Dose descriptor:
- NOAEC
- Effect level:
- 100 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Local effects: histopathology (nose)
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 500 mg/m³ air
- System:
- respiratory system: upper respiratory tract
- Organ:
- nasal cavity
- Treatment related:
- yes
- Dose response relationship:
- no
- Relevant for humans:
- yes
Applicant's summary and conclusion
- Conclusions:
- In conclusion, exposure to the test material showed microscopic changes in the nasal passages as well as decreases in body weights and serum glucose occurred at the high exposure level. No unequivocal effect was noted below this level. Therefore, the no observed adverse effect level is considered to be 100 mg IPA/cubic meter in air.
- Executive summary:
In the subchronic toxicity study, 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 IPA per cubic meter 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 treatmentrelated 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 to be 100 mg IPA/cubic meter in air.
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