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EC number: 205-864-4 | CAS number: 156-87-6
- 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
Acute Oral toxicity
Rat:
LD50 = 1348 mg/kg bw (comp. OECD 401; BASF,
1979)
LD50 = 3920 mg/kg bw (BASF, 1958)
LD50 = 2773 mg/kg bw (Smyth & Carpenter, 1962)
LD50 = 2830 mg/kg bw (Benya & Raymond in Clayton: Patty’s Industrial Hygiene Toxicology, 4th ed., 1994)
LD50 = 2800 mg/kg bw (American Cyanamide
Co., 1954, Val. 4)
Mouse:
LD50 = 4250 mg/kg bw (American Cyanamide
Co., 1954, Val. 4)
Acute Inhalation toxicity
Rat:
IHT: 1h: LC50 >16.4 mg/L air (BASF, 1979)
IHT: 8h: no mortality in a saturated vapour atmosphere (BASF, 1958)
IHT: 8h: no mortality in a saturated vapour atmosphere (Smyth & Carpenter, 1962)
IHT: 6h: no mortality in a saturated vapour
atmosphere (American Cyanamide Co., 1954, Val. 4)
Acute Dermal toxicity
Rat:
LD50 >2000 mg/kg bw (BASF AG, 1979)
Rabbit:
LD50 ca.1250 mg/kg bw (Smyth & Carpenter, 1962)
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Substance-ID: 78/701 - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA
- Weight at study initiation: male: 220-260 g, female: 160-180 g
- Fasting period before study: 15-20 h - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 4.64, 6.85, 10, 14.7, 21.5 %
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg - Doses:
- 464, 681, 1000, 1470, 2150 mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female animals per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: before study, after 2-4 days, 7 days and 13 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 348 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1 of 10 animals died at 464 mg/kg
1 of 10 animals died at 681 mg/kg
no animals died at 1000 mg/kg
5 of 10 animals died at 1470 mg/kg
all animals died at 2150 mg/kg - Clinical signs:
- other: clinical signs included: apathy, dyspnoea, stertorous respiration, gasping, apathy, staggering, urine of strong yellow colour, scrubby fur, anaemic paleness, blood in nose and saliva, bad general condition. Most of these clinical signs were only observed
- Gross pathology:
- The sacrificed animals were without findings.
The following findings were made in animals that died during the study:
heart: acute right dilation
liver: circumferential delineation of the liver lobes
stomach: atonic, reddened mucosa
intestine: reddened mucosa
lung: slight emphysema - Interpretation of results:
- Category 4 based on GHS criteria
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 348 mg/kg bw
- Quality of whole database:
- similar to OECD TG 401
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Inhalation hazard test, animals exposed for 1 hour
- GLP compliance:
- not specified
- Test type:
- traditional method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Substance-ID: 78/701
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: MUS RATTUS, Brunnthal
- Weight at study initiation: 185 +/- 15 g
- Diet: Herilan MRH, ad libitum
- Water: Tap water, ad libitum - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: head-nose inhalation system
- Method of holding animals in test chamber: animals are held in a tube, the head/nose being exposed to the inhalation chamber
TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography
- Samples taken from breathing zone: yes - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gas chromatography
- Duration of exposure:
- 1 h
- Concentrations:
- 0, 6.64, and 16.35 mg/L analytical concentration
- No. of animals per sex per dose:
- 10 male and 10 female animals per dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: day 0, 7 and 14
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Data were anlysed according to the "Binominaltest" (Wittig H, Mathematische Statisik, 1974, pp 32-35)
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 16.4 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Mortality:
- no death occurred
- Clinical signs:
- other: aqueous, reddish eye and nose secretion, irregular respiration, scrubby and clotted fur, hairless necrotic areas with bloody eschar. The animals were not free of symptoms at the end of the observation period (14 days).
- Body weight:
- male and female animals of the 16.35 mg/L dose group showed no differences compared to the control group. Male animals of the 6.64 mg/L dose group showed no differences compared to the control group. The female animals of the 6.64 mg/L dose group showed a slight weight loss after 7 days and decreased body weight gain after 14 days compared to controls.
- Gross pathology:
- nothing abnormal detected
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 16 400 mg/m³ air
- Quality of whole database:
- Inhalation hazard test
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:
- no guideline followed
- Principles of method if other than guideline:
- 3 male and 3 female animals were subjected to a limit test. The test substance was applied to a 2.5 x 2.5 cm application site for 20 h under occlusive conditions. The skin was either intact or abraded. After the application time, the skin was washed with water which may have contained a mild detergent. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded and graded as described in OECD test guideline 404.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Substance-ID: 78/701
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Wiga
- Weight at study initiation: average weight male animals: 210 g; female animals: 183 g - Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 48 cm²
TEST MATERIAL
- Amount applied: 2.02 ml/kg bw - Duration of exposure:
- not applicable, test substance was not washed off 24 hours after application as recommended in the OECD guideline 402.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 male and 3 female animals were used
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no deaths occurred
- Clinical signs:
- other: no signs of general toxicity could be observed;
- Gross pathology:
- Skin necrosis pathologically confined
- Other findings:
- Necrosis were observed at the site of applicatation on the day following substance application.
- Interpretation of results:
- GHS criteria not met
Reference
The skin irritation properties of the test substance seem to be the limiting factor of acute dermal toxicity. No further clinical signs of toxicity were observed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral
In an acute oral toxicity study comparable to OECD guideline 401 5 male and 5 female Sprague Dawley rats per dose were treated with up to 2150 mg/kg bw under standardized conditions. The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 was calculated to about 1350 mg/kg bw for male and female rats. Mortalities were observed at all dose levels except the 1000 mg/kg dose level, clinical signs included apathy, dyspnoea, stertorous respiration, gasping, apathy, staggering, urine of strong yellow color, scrubby fur, anaemic paleness, blood in nose and saliva and a bad general condition. Necropsy findings included circumferential delineation of the liver lobes, atonic and reddened gastric mucosa as well as reddened intestinal mucosa in the deceased animals; all survivors displayed no abnormal pathological findings.
Interestingly, previous investigations to that study using an aqueous solution of the test compound that was neutralized to pH 7 resulted in much higher tolerability of the test substance with LD50 values calculated to ca. 3920 mg/kg bw. In addition, no signs of intestinal or gastric mucosal irritation were reported, suggesting that the alkaline properties of the test substance might influence the toxicity of the test substance. On the other hand, in previous studies in cats and rabbits (BASF, 1961, val. 3) using also a neutralized aqueous solution signs of gastric mucosal irritation was also observed in both species. But these data cannot be taken into account, since the animals have been repeatedly dosed with the test substance two weeks after the initial exposure.
Supporting information on the acute oral toxicity of 3-amino-1-propanol is further provided by several authors, but all of these references only provide basic data and no further details on the study or the study design are available. LD50 values found in these studies are in the range of 2800 mg/kg bw (Smyth et al. 1962 and Benya et al., in Clayton: Patty’s Industrial hygiene Toxicology, fourth ed. 1994).
Inhalation
In an acute inhalation test (nose/head only) 10 male and 10 female rats were exposed to various concentrations of 3-aminopropan-1-ol. At the highest concentration tested clinical signs observed included aqueous, reddish eye and nose secretion, irregular respiration, scrubby and clotted fur, hairless necrotic areas with bloody eschar formation. Mortalities did not occur and no pathological abnormalities were detected in post mortem necropsy (BASF 1979). In a standardized inhalation hazard test with a saturated vapour atmosphere, 0/6 rats died after 8 h exposure (BASF 1958). No abnormal clinical signs of toxicity or abnormal pathological findings were reported in that study. Similar results were reported by Smyth et al. (1962) after 8 h whole body exposure and American Cyanamide Co. (1954) after an exposure of 6h.
Dermal
In a limit test 3 male and 3 female rats were exposed to a dose of 2000 mg/kg bw (BASF, 1979). No animal died and no signs of general toxicity could be observed. The most frequent observed clinical sign were necrosis at the site of substance application, suggesting that the irritative/corrosive property of the test substance represents the most toxic principle of 3-amino-1-propanol. Penetration of rabbit skin was estimated by a technique closely akin to the one-day cuff method of Draize et al. using groups of four male albino rabbits. The LD50 was calculated to be 1250 mg/kg bw (Smyth 1962). Further data on mortality, clinical signs of toxicity or post mortem necropsy were not provided.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The substance is considered to be classified as Acute Tox. oral Cat. 4 (H302: Harmful if swallowed) according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.
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