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EC number: 251-974-0 | CAS number: 34375-28-5
- 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: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from USEPA HPVIS report
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Repeated dose oral toxicity study for Ethanol, 2-(hydroxymethylamino) _ (CAS# 34375-28-5)
- Author:
- US EPA HPV Chemical Challenge Program- Troy Corporation
- Year:
- 2 005
- Bibliographic source:
- U.S Environmental Protection Agency/ High Production Volume Information System (HPVIS) 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Guideline 83-3(a)
- Principles of method if other than guideline:
- Repeated dose dermal toxicity study was performed to determine the oral toxic nature of Ethanol, 2-(hydroxymethylamino) as per the EPA Guideline 83-3(a)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-(hydroxymethylamino)ethanol
- EC Number:
- 251-974-0
- EC Name:
- 2-(hydroxymethylamino)ethanol
- Cas Number:
- 34375-28-5
- Molecular formula:
- C3H9NO2
- IUPAC Name:
- 2-[hydroxy(methyl)amino]ethanol
- Details on test material:
- - Name of test material (as cited in study report): Ethanol, 2-(hydroxymethylamino)
- Molecular formula (if other than submission substance): C3H9NO2
- Molecular weight (if other than submission substance): 91.1091 g/mole
- Substance type: Organic
- Physical state: Liquid
- Impurities (identity and concentrations): Purity: 98.5%
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Troysan 174, (2[(Hydroxymethyl)amino] ethanol)
- IUPAC name: 2-[hydroxy(methyl)amino]ethanol
- Molecular formula: C3H9NO2
- Molecular weight: 91.1091 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 98.5%
- Impurities (identity and concentrations): 1.5%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No data
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: Approx. 9 weeks
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): Food ad libitum
- Water (e.g. ad libitum): water ad libitum
- 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
IN-LIFE DATES: From: To: No data
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- No data
- Vehicle:
- water
- Remarks:
- Distilled water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test chemical was dissolved in distilled water to give a dose range of 0, 100, 250 and 500 mg/kg/day
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Distilled water
- Concentration in vehicle: 0, 100, 250 and 500 mg/kg/day
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- Day 6-16 inclusive of gestation (20 days)
- Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- 0, 100, 250 or 500 mg/Kg/day
- No. of animals per sex per dose:
- 25 Females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The dose levels for this study were selected after evaluation of a separate dose range finding study
- Rationale for animal assignment (if not random): No data
- Rationale for selecting satellite groups: No data
- Post-exposure recovery period in satellite groups: No data
- Section schedule rationale (if not random): No data - Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule:
Viability: at the beginning of each day, and again as late as possible on each day
Reaction: Each day
- Cage side observations checked in table [No.?] were included. All the animals were examined for viability at the beginning of each day, and again as late as possible on each day and reaction to
treatment on each day
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Specific examinations were made 1-1.5 hours after dosing, during which the nature, onset, duration and intensity of any signs were recorded
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 6, 9, 13, 17 and 20 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes, The weight of food consumed by each mated female was recorded daily throughout the study, commencing on Day 4 of gestation
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: No data
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data - Animals fasted: No data - Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, On Day 20 of gestation, the animals were killed by carbon dioxide asphyxiation. The contents of the thoracic and abdominal cavities were examined
macroscopically for abnormalities
HISTOPATHOLOGY: Yes, The reproductive tract was removed and weighed intact then opened and the contents were examined - Other examinations:
- No data
- Statistics:
- Maternal body weight gains were analyzed by analysis of variance, treatment groups being compared using an F-protected Least Significant Difference (LSD) procedure.
For other parameters no formal statistical analyses were considered necessary, interpretation of the data being based on inspection of the individual and group values.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Clinical signs and mortality: No data
Body weight and weight gain: Reduction in body weight was noted at 500 mg/Kg bw
Food consumption and compound intake: Reduction in food consumption was noted at 500 mg/Kg bw
Food efficiency: No data
Water consumption and compound intake: No data
Opthalmoscopic examination: No data
Haematology: No data
Clinical chemistry: No data
Urinanalysis No data
Neurobehaviour: No data
Organ weights: No data
Gross pathology: No data
Histopathology: Gastro-intestinal abnormalities were noted at 500 mg/Kg bw
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No significant observations were made in body weight, food consumption and histopathology at the mentioned dose level
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for the test compound Ethanol, 2-(hydroxymethylamino) is 250 mg/Kg bw.
- Executive summary:
Repeated dose dermal toxicity study was performed to determine the oral toxic nature ofEthanol, 2-(hydroxymethylamino). The study was performed using 25 female Sprague Dawley rats at dose levels of 0, 250, 500 or 1000 mg/Kg bw. The chemical was dissolved in distilled water. The animals were observed clinical signs, changes in body weight and food consumption, gross and histopathology was performed. Under the conditions of this study, no effect was seen on the rats, at dose levels of up to 250 mg/kg/day. Repeated dose toxicity was observed at 500 mg/kg/day indicated by gastro-intestinal abnormalities, reduced body weight gain and reduced food consumption during the treatment period. Hence theNo Observed Adverse Effect Level (NOAEL) for the test compoundEthanol, 2-(hydroxymethylamino) is 250 mg/Kg bw.
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