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EC number: 252-471-9 | CAS number: 35265-04-4
- 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:
- 24 September 2009 - 31 May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- The temperature and relative humidity recorded in the animal room were sometimes outside of the target ranges specified in the study plan.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- The temperature and relative humidity recorded in the animal room were sometimes outside of the target ranges specified in the study plan.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[(1-methylpropyl)amino]ethanol
- EC Number:
- 252-471-9
- EC Name:
- 2-[(1-methylpropyl)amino]ethanol
- Cas Number:
- 35265-04-4
- Molecular formula:
- C6H15NO
- IUPAC Name:
- 2-[(butan-2-yl)amino]ethan-1-ol
- Details on test material:
- Chemical name: 2-[(1-methylpropyl)amino]ethanol
- Physical state: colorless liquid
- Analytical purity: 99.73%
- Impurities (identity and concentrations): EAC =0.066%, sum of unknown=0.171%, sum of organics =0.237%, water =0.035%
- Lot/batch No.: V68M010101
- Expiration date of the lot/batch: 28 January 2011
- Storage conditions of test material: at room temperature and protected from humidity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks old
- Weight at study initiation: 200 +/- 5 g
- Fasting period before study: 18 hours
- Housing: polycarbonate cages with stainless steel lid
- Diet (e.g. ad libitum): SSNIFF R/M-H pelleted maintenance diet (SSNIFF Spezialdiäten GmbH, Soest, Germany)
- Water (e.g. ad libitum): drinking water filtered by a FG Millipore membrane (0.22 micron)
- Acclimation period: at least 5 days before beginning ot the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
IN-LIFE DATES: From: 29 September 2009 To: 28 October 2009
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- purified
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
The test item was prepared at the chosen concentrations in the vehicle.
The pH of each dosage form was measured before each treatment. The obtained values were as follows:
- 15 mg/mL (first treatment): pH = 11.58,
- 100 mg/mL: pH = 11.95,
- 15 mg/mL (second treatment): pH = 11.65.
- Concentration in vehicle: 15 or 100 mg/L, at 300 or 2000 mg/kg
- Amount of vehicle (if gavage): 20 mL/kg
- Justification for choice of vehicle: standard vehicle used for specifie routes of administration
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: according to information available on the test item, for animal welfare reasons, the starting
dose-level of 300 mg/kg was chosen. - Doses:
- 300 and 2000 mg/kg.
- No. of animals per sex per dose:
- Three females per dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: a period of up to 14 days
- Frequency of observations and weighing: The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day.
Type, time of onset and duration of clinical signs were recorded for each animal individually.
Time of death was recorded individually, in terms of the number of hours or days after dosing.
The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 - 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose-level of 300 mg/kg (three females then confirmation on three other females): no mortality.
Dose-level of 2000 mg/kg (three females): all the females were found dead 4 hours after treatment. - Clinical signs:
- other: Dose-level of 300 mg/kg: no clinical signs were noted at this dose-level. Dose-level of 2000 mg/kg : hypoactivity or sedation and dyspnea (all the animals), piloerection (one animal), loud breathing and hypersalivation (another animal) were observed prior
- Gross pathology:
- At necropsy, a reddish discoloration of mucous membranes was observed in the stomach, intestines and liver of all the females given 2000 mg/kg.
Macroscopic examination of the main organs of the animals given 300 mg/kg revealed no apparent abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information category 4 Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 of the test item was comprised between 300 and 2000 mg/kg in rats.
- Executive summary:
- The acute oral toxicity of 2-[(1-methylpropyl)amino]ethanol was evaluated in rats according to OECD (No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. 2-[(1-methylpropyl)amino]ethanol was prepared in purified water and was administered by oral route (gavage), under a volume of 20 mL/kg, at the dose levels of 300 and 2000 mg/kg bw to 6 or 3 fasted female Sprague-Dawley rats, respectively. Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration. All animals were subjected to necropsy. Neither mortality nor clinical signs were noted at 300 mg/kg.When compared to historical control animals, a lower body weight gain was noted in 1/6 females between day 8 and day 15. At necropsy, no apparent abnormalities were observed in any animal. All the 3 females were found dead 4 hours after treatment at 2000 mg/kg. Hypoactivity or sedation and dyspnea (all the animals), piloerection (one animal), loud breathing and hypersalivation (another animal) were observed prior to the death. At necropsy, a reddish discoloration of mucous membranes was observed in the stomach, intestines and liver of all the females. The oral LD50of 2-[(1-methylpropyl)amino]ethanol was comprised between 300 and 2000 mg/kg in rats.
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