Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
LD50(oral, rat) <172 mg/kg bw (undiluted) / mean LD50(oral, rat) = 550 - 820 mg/kg bw (diluted in water or olive oil);
mean LC50(inh., rat) = 8.7 mg/L;
LD50(dermal, rat) > 400 mg/kg bw (diluted, 10 % in water; no animal died at this dose which already was corrosive to the skin) and a LD50 (dermal, rabbit) of 378 mg/kg has been reported in rabbits.
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- yes
- Remarks:
- only males tested; screening
- GLP compliance:
- not specified
- Test type:
- up-and-down procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: 3 - 4 wk
- Weight at study initiation: 90 -120 g
- Fasting period before study: unfasted
- Housing: no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS: no data
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Application by gavage through a commercial ball-end needle attached to a calibrated syringe (page 153)
- Doses:
- no details, dose range with spacing factor 2
- No. of animals per sex per dose:
- 5 males
- Control animals:
- not specified
- Statistics:
- Moving average method according to Thompson (1947) und Weil (1983)
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- < 0.25 mL/kg bw
- Remarks on result:
- other: undiluted
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- < 172 mg/kg bw
- Remarks on result:
- other: undiluted; transformation from volume (ml/kg bw) to mass (mg/kg bw) on the basis of a density of 0,6871 g/cm3
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1.07 mL/kg bw
- 95% CL:
- >= 0.72 - <= 1.59
- Remarks on result:
- other: 10% solution
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 735 mg/kg bw
- 95% CL:
- >= 495 - <= 1 092
- Remarks on result:
- other: 10% solution; transformation from volume (ml/kg bw) to mass (mg/kg bw) on the basis of a density of 0,6871 g/cm3
- Mortality:
- Time to death: 7 min. - 4d (undiluted), 4h - 14d (10% solution)
- Clinical signs:
- other: lethargy, labored breathing, piloerection, prostration
- Gross pathology:
- lung hemorrhage; kidney and adrenal congestion; gastric and intestinal hemorrhage, ulceration
Most surviving animals were without significant gross pathology (page 163) - Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the LD50 in male rats was < 172 mg/kg bw
- Executive summary:
Five male Wistar rats per group were gavaged with the test substance in doses spaced by a factor of 2 to derive LD50 values. The animals were kept for a 14 days observation period. Under the conditions of this study, the LD50 in male rats was < 172 mg/kg bw. Gross necropsy showed lung hemorrhage, kidney and adrenal congestion, gastric and intestinal hemorrhage and ulceration.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 172 mg/kg bw
- Quality of whole database:
- sufficient for evaluation
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1150 (Acute inhalation toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- 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., Raleigh, North Carolina, USA
- Age at study initiation: males 8 - 9 wk, females 10 - 11 wk
- Weight at study initiation: males: 242 g - 335g, females: 208g - 236g
- Housing: doubly housed during acclimation period, individually housed in Plexiglass chamber (100 L) during exposure
- Diet , water: ad libitum
- Acclimation period: 1 to 3 wk
ENVIRONMENTAL CONDITIONS during acclimation period
- Temperature (°C): 19 - 24°C
- Humidity (%): 40 - 70%
- Air changes (per hr): no data
- Photoperiod: 12hrs dark / 12hrs light)
ENVIRONMENTAL CONDITIONS during exposure
- Temperature (°C): 21 - 26°C
- Humidity (%): 46 - 65%
- Air flow rate: 20 L/min (= complete air change every 5 min)
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Plexiglass exposure chamber with glass front
- Exposure chamber volume: 100 L
- Method of holding animals in test chamber: individually
- Source and rate of air: 20 L/min, the air exchange was about once per every 5 min.
- Method of conditioning air: by passing air through a midget impinger containing the TS
- System of generating particulates/aerosols:
- Temperature: actual 21-26°C
- Relative humidity: 64-65%
- pressure: no information given
TEST ATMOSPHERE
- Brief description of analytical method used: MIRAN Ambient Air Analyser; test atmosphere was drawn through Balston DFU filter via Teflon line into the Analyser
- Samples taken from breathing zone: yes (hourly sampling)
- Particle size measurements were performed at hourly intervals - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.3, 2.8, 5.1, and 6.5 mg/L (analytical) [7.1, 3.4, 5.9, and 7.2 mg/L (nominal)], no aerosol
The nominal concentration was calculated from the consumption of TS from the reservoir divided by the total amount of air. - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days; detailed observations once daily for survivers; Assessment of viability twice daily
- Necropsy of survivors performed: yes (at post-exposure day 15)
- Examinations of dead and surviving animals of nasal passages, trachea, orifices, cranial cavity, brain and spinal cord, viscera, cervical tissues and organs - Statistics:
- Calculation of median lethal concentration, 95% CL (method according to Litchfield and Wilcoxon)
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- ca. 8.7 mg/L air (analytical)
- 95% CL:
- >= 6.5 - <= 12
- Exp. duration:
- 4 h
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- ca. 3 540 ppm
- Exp. duration:
- 4 h
- Remarks on result:
- other: calculated from formula 1 ppm = 2.46mg/m^3
- Key result
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 7.7 mg/L air (analytical)
- Exp. duration:
- 4 h
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- ca. 9.4 mg/L air (analytical)
- Exp. duration:
- 4 h
- Mortality:
- see table below
- Clinical signs:
- other: Labored breathing, lacrimation, nasal discharge, reduced activity, closed eyes. Respiratory distress and nasal discharge persisted the first week of post-exposure, but moist and dry rales were observed in most of the survivors throughout 14 d.
- Body weight:
- Transient losses were prominent.
- Gross pathology:
- Nasal tubinates and lungs were reddened and swollen with lung emphysema present in a few animals.
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the mean LC50 in male and female rats was 8.7 mg/L (8700 mg/m3)
- Executive summary:
The study was designed to assess the acute inhalation toxicity (median lethal concentration). Groups of 5 rats per sex were exposed to 5.3, 2.8, 5.1, and 6.5 mg/L (analytical) [7.1, 3.4, 5.9, and 7.2 mg/L (nominal)] of test substance vapour for 4 h. The post-exposure observation period was 14 days. The LC50 for combined sexes was 8.7 mg/L. Clinical signs during exposure were laboured breathing, lacrimation, nasal discharge, reduced activity, closed eyes. Respiratory distress and nasal discharge persisted the first week of post-exposure, but moist and dry rales were observed in most of the survivors throughout 14 d. Significant body weight losses were evident following exposure, but recovery occured over time. No clear treatment-related postmortem findings were observed.
Reference
Group Mean Exposure Nominal [mg/L] Mortalitytration Concentration No.dead/No.exposed
---------------------------------------------------------------- I* 5.3 7.1 5/5 2/5 7/10 II 2.8 3.4 0/5 0/5 0/10 III 5.1 5.9 2/5 0/5 2/10 IV 6.5 7.2 1/5 2/5 3/10 ================================================================ * Group I was excluded from evaluation due to technical problems during exposure The LD50 of 8.7 mg/L (95% C.I. = 6.5 - 12 mg/L) is the combined extrapolated value.
-----------------
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 8 700 mg/m³ air
- Quality of whole database:
- sufficient for evaluation
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- only one dose level tested
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. THOMAE GmbH, Biberach, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: Animals of comparable weight (200 - 300 g)
- Housing: singly in stainless stell wire mesh cages, Type DK-III
- Diet: KLIBA-Labordiaet 343, Klingenthalmuehle AG, Switzerland, ad libitum
- Water: water ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- other: aqua bidest
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 50 cm2
- Type of wrap if used: Four layers of absorbent gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Concentration (if solution): 10 % - Duration of exposure:
- 24 h
- Doses:
- 400 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Several times at the day of application and at least once daily therafter.
- Frequency of weighing: Shortly before application, weekly thereafter and at the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 400 mg/kg bw
- Based on:
- act. ingr.
- Remarks:
- (10% dilution in water because of corrosivity)
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 400 mg/kg bw
- Based on:
- act. ingr.
- Remarks:
- (10% dilution in water because of corrosivity)
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: On the day of application the animals showed the following syptoms: dyspnoea, apathy, staggering, spastic gait, tremor, piloerection, exophthalmos and poor general state.
- Gross pathology:
- Sacrificed animals:
Organs: no pathologic findings noted.
Skin: full thickness necrosis (4 males/4 females), superficial necrosis (1 female), superficial crust formation (1 male) - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the mean LD50 in male and female rats was > 400 mg/kg bw
- Executive summary:
Acute dermal toxicity was investigate in male and female Wistar rats (5 animals per sex). Application of 400 mg/kg test item (applied as 10% dilution in water) for 24 hours under semi-occlusive conditions did not cause lethal effects. On the day of application animals showed dyspnoea, apathy, staggering, spastic gait, tremor, piloerection, exophthalmos and poor general state. The diluted test material caused full thickness necrosis in 4/4 females and 4/4 males.
Reference
The acute dermal LD50 of the test material was found to be greater than 400 mg/kg bw for the male und female animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 400 mg/kg bw
- Quality of whole database:
- sufficient for evaluation
Additional information
Oral route
Undiluted isopropylamine administered by gavage to male Wistar rats (5 per group) resulted in an LD50of <172 mg/kg bw, with deaths occurring between 7 minutes and 4 days (Myers and Ballantyne, 1997). Clinical signs included lethargy, labored breathing, piloerection and prostration. There were no significant findings in survivors at necropsy.
In another study, male and female rats (strain not specified) were administered a single gavage dose of 14, 55, 218, 346, 548, 869 or 3457 mg/kg bw isopropylamine (BASF, 1960). There was 1 rat exposed at 14 and 55 mg/kg bw; 5 rats exposed at 218 and 869 mg/kg bw; 10 rats exposed at 346 and 548 mg/kg bw and 2 rats exposed at 3457 mg/kg bw (sex not specified). Clinical signs were as follows by dose group: 3457 mg/kg bw: 1 animal showed 2 minute post-application dyspnea, convulsions, and gasping and the second animal showed intermittent respiration and slight abdominal position; at 869 mg/kg bw, staggering, slightly accelerated respiration, and slight abdominal position, followed on the next morning with lacrimation, ruffled fur, and blood crusted eyes; at 548 mg/kg bw, 24 hours post application showed ruffled fur; and at 346 mg/kg bw, intermittent respiration, blood crusted noses and ruffled fur. At necropsy, surviving animals dosed at 548 mg/kg bw group showed adhesion of the stomach with the peritoneum and fluffy-yellowish stomach content (residual test substance). The acute oral LD50was 552 mg/kg bw (combined sexes).
Another study of sufficient reliability reported an oral LD50 of 820 mg/kg bw (range 670 -1070 mg/kg bw) isopropylamine in male rats (Smyth et al., 1951 and further publications).
Inhalation route
In a study conducted according to EPA OPPTS 798.1150 (Acute inhalation toxicity), groups of 5 male and 5 female Sprague-Dawley rats were exposed by whole body vapor inhalation for four hours to concentrations of 2.3, 2.8, 5.1, and 6.5 mg/L (measured) (Hoffman and Newton, 1990). Clinical signs included labored breathing, lacrimation, nasal discharge, reduced activity and closed eyes. Respiratory distress and nasal discharge persisted the first week post-exposure, but moist and dry rales were observed in most of the survivors throughout 14 d. Transient body weight losses were noted. At gross necropsy, the nasal turbinates and lungs were reddened and swollen with lung emphysema present in a few animals. Group I (5.3 mg/L) was excluded from evaluation due to technical problems during exposure. The acute inhalation LC50was = 8.7 mg/L (combined sexes).
In a study performed similar to OECD Guideline 403, groups of 5 male and 5 female Charles River Crl:CD BR VAF/PLUS rats/group were exposed to isopropylamine for 6 min (13,700, 16,400, 16,600, 17,300 and 19,100 ppm); 20 min (5,180, 6,160, 7,050, 7,110, 8,060 and 9,580 ppm) or 60 min (2,750, 3,360, 4,200, 4,780, 4,810 and 5,090 ppm) by whole body vapor inhalation (IRDC, 1992). Death, gasping, labored breath, rales and corneal opacity was observed in all exposure groups. The 60 minute LC50was 4770 ppm. Based on a molecular weight of 59.11, this value corresponds to 11,73 mg/L (at 20 °C). This data cannot be used for classification due to the short exposure duration.
Another study reported an inhalation LC50 of > 9.8 - < 19.6 mg isopropylamine/L air (Smyth et al., 1951 and further publications). No LC50 was calculated. However, the data point to a slightly higher LC50 than in the key study and are in agreement with the observations of the key study.
Dermal route
In a study conducted according to OECD Guideline 402 (Acute Dermal Toxicity) 5 male and 5 female Wistar rats were exposed for 24 hours to 400 mg/kg bw isopropylamine (purity 99.9%) with a semi-occlusive coverage (BASF AG, 1993). There were no mortalities. Clinical signs included dyspnea, apathy, staggering, spastic gait, tremor, piloerection, exophthalmos and poor general state. Body weights were not affected by treatment. There were no findings at necropsy except full skin thickness necrosis (4 males/4 females), superficial necrosis (1 female), and superficial crust formation (1 male). No LD50 can be derived from this study (combined sexes) as no mortality occurred.
Another study reported a dermal LD50 of 378 mg/kg bw for isopropylamine (Smyth et al., 1951 and further publications) in 4 male rabbits. Exposure was for 24 h under occlusive conditions. No information on local effects were provided.
A further study reported a dermal LD50 > 1000 mg/kg bw (Bioresearch, 1975). However, the reliability of this data is restricted due to major methodological deficiencies.
The acute dermal study in rats (BASF, 1993), which was performed under GLP conditions, was selected as key study as a sufficient number of animals was exposed to a dose of 400 mg/kg of a high purity substance for 24 h under semi-occlusive conditions. No animal died under these conditions which already caused necrosis, therefore no testing of higher doses was possible. The results of the rabbit study, which was performed under occlusive conditions before GLP came into place and which revealed a LD 50 of 378 mg/kg bw/d, points to a classification for acute dermal toxicity Cat. 3. Taking into consideration the occlusive conditions in the rabbit study the results of both studies seem to be in good agreement. Therefore, in a conservative manner a classification for acute dermal toxicity Cat. 3 is suggested.
Justification for classification or non-classification
Based on the experimental findings and according to Regulation (EC) No 1272/2008 the substance should be classified for acute oral toxicity Category 3 after oral (H301), dermal (H311) and inhalation (H331) exposure.
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.