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EC number: 203-055-0 | CAS number: 102-79-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1967
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an acceptable BASF-test which in principle was similar to OECD 401; GLP was not compulsory at the time the study was conducted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Observation period was 7 days in place of 14.
- Principles of method if other than guideline:
- The study was conducted according to an acceptable BASF-test which in principle was similar to OECD guideline 401.
Five male and five female rats per test group were administered following doses of test item: 200, 2000, 3200, 4000, 5000 and 6400 mg/kg bw; the dose level 3200 mg/kg bw was tested twice. The test item was administered by gavage (single application) as aqueous solution; the application volume depending on the test dose ranged from 10 to 21 mL/kg bw.
Following treatment, the animals were regularly examined for mortality and clinical signs of toxicity over an observation period of 7 days; body weights were recorded at test starting. All rats that died during the observation period as well as the surviving rats, which were sacrificed at the end of the observation period, were subjected to necropsy. - GLP compliance:
- no
- Remarks:
- GLP was not compulsory at the time the study was conducted
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-butyliminodiethanol
- EC Number:
- 203-055-0
- EC Name:
- 2,2'-butyliminodiethanol
- Cas Number:
- 102-79-4
- Molecular formula:
- C8H19NO2
- IUPAC Name:
- 2-[butyl(2-hydroxyethyl)amino]ethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Butyldiäthanolamin
- Physical state: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: US-Rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: young adult, no more data provided
- Weight at study initiation: males, 175 - 286 g; females, 150 - 210 g
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: water with Traganth
- Details on oral exposure:
- - Concentration in vehicle (%): 2 %, 20 % and 30 %
- Amount of vehicle: from 10 to 21 mL/kg bw - Doses:
- Original values as given in study report: 200, 2000, 3200, 4000, 5000 and 6400 mm3/kg bw
Values converted into mg/kg bw (density: 0.970 g/cm3): ca. 190, 1900, 3100, 3900, 4850 and 6200 mg/kg bw - No. of animals per sex per dose:
- 10 animals /sex/dose group (dose level 3100 mg/kg bw was repeated).
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- The animals were observed for mortality twice each workday and once daily at weekends or public holidays;
- They were regularly observed for clinical symptoms of toxicity after following treatment and once daily thereafter.
- Body weight was determined before the start of the study only and served for the determination of the dosage.
- At the end of the observation period, the surviving animals were sacrificed for the purpose of necropsy;
- Animals that died during the observations period also were subjected to necropsy.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 4 800 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: original value was given as 5000 mm3/kg bw
- Mortality:
- - At 190 mg/kg bw, none of the treated animals died.
- At 1900 mg/kg bw, none of the treated animals died.
- At 3100 mg/kg bw, in the first test, mortality was 30 % (3/5 females died).
- At 3900 mg/kg bw, mortality was 10 % (1/5 females died).
- At 4800 mg/kg bw, none of the treated animals died.
- At 6200 mg/kg bw, mortality reached 80 % (4/5 males and 4/5 females).
- At 3100 mg/kg bw, in the second test, none of the treated animals died.
Almost all cases of death occurred within 48 hours following treatment. - Clinical signs:
- other: - At the lowest dose levels of 190 and 1900 mg/kg bw, slight dyspnoea, prostration and piloerection were observed for 3 to 4 days following treatment; thereafter, the animals were free of symptoms. - At a dose level of 3100 mg/kg bw, slight dyspnoea, pros
- Gross pathology:
- Necropsy of some of the sacrificed animals revealed signs of bronchitis and bronchiectasis. In two cases, necropsy of animals that died revealed a poor nutritional status and diarrhea. No further abnormalities were noticed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- LD50 was determined to be ca. 4800 mg/kg bw, for both male and female rats.
CLP: not classified
DSD: not classified - Executive summary:
Butyldiethanolamine was tested for acute oral toxicity by gavage in rats according to a BASF internal method. The test method is considered to be scientifically acceptable since similar to the OECD TG 401. Five rats per sex and group were treated by single application at following dose levels: ca. 190, 1900, 3100, 3900, 4850 and 6200 mg/kg bw. For the 3100 mg/kg bw dose level, the initial test was repeated. The animals were observed over a period of 7 days for mortalities and clinical symptoms of toxicity. At the end of the observation period, those animals that had survived the experiment were sacrificed for the purpose of necropsy. Those animals that died during the experiment also were subjected to gross pathological examination.
At 190 and 1900 mg/kg bw, none of the treated animals died. At 3100 mg/kg bw, in the first test, mortality was 30 % (3/5 females died), while in the second test at the same dose level, none of the treated animals died. At 3900 mg/kg bwm mortality was 10 % (1/5 females died), while at 4800 mg/kg bw, again, none of the treated animals died. At 6200 mg/kg bw, mortality reached 80 % (4/5 males and 4/5 females). Almost all cases of death occurred within 48 hours following treatment. Among clinical signs, slight dyspnoea, prostration, piloerection, irregular breathing, unclean fur in the anal region and red incrusted noses were observed at the dose levels of 190, 1900 and 3100 mg/kg bw. The surviving animals recovered from day 3 post treatment.
At the highest tested doses (3900, 4800 and 6200 mg/kg bw), irregular breathing, slight dyspnoea, agitation, slight salivation, high legged walking, and slight tremor when touched, were the main symptoms reported. Regarding the surviving animals, these showed partly incrusted eyes, piloerection, prostration and unclean fur; they recovered from day 5 to 6 post treatment. Necropsy of some of the sacrificed animals revealed signs of bronchitis and bronchiectasis. In two cases, necropsy of animals that died revealed a poor nutritional status and diarrhea. No further abnormalities were noticed.
LD50 was determined to be ca. 4800 mg/kg bw, for both male and female rats.
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