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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data from review article or handbook
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- ETHANOL, 2-(HYDROXYMETHYLAMINO)(CAS No. 34375-28-5) - Developmental Toxicity/Teratogenicity
- Author:
- (HPVIS) EPA
- Year:
- 1 990
- Bibliographic source:
- U.S Environmental Protection Agency/ High Production Volume Information System (HPVIS) 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- In developmental toxicity study, the effect of test substance Ethanol, 2-(hydroxymethylamino) in female Sprague-Dawley rat were evaluated
- GLP compliance:
- no
- 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 (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
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- - Source: No data available
- Age at study initiation: Approximately 9 weeks
- Diet (e.g. ad libitum):Food ad libitum
- Water (e.g. ad libitum):water ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Details on 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
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 - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available
- Details on mating procedure:
- - M/F ratio per cage: 2 females to each male
- Length of cohabitation: cohabitation with a male was continuous until mating was detected
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy A vaginal lavage was examined each morning and the day of detection of sperm in the lavage, or of a copulatory plug in situ, was considered as Day 0 of gestation.
- After … days of unsuccessful pairing replacement of first male by another male with proven fertility. No data available
- Further matings after two unsuccessful attempts: [no / yes (explain)] No data available
- After successful mating each pregnant female was caged (how): No data available
- Any other deviations from standard protocol: No data available - Duration of treatment / exposure:
- 20 days after gestation.
Exposure Period: 6 - 16 days, inclusive of gestation - Frequency of treatment:
- Once daily
- Duration of test:
- 20 days after gestation.
Doses / concentrations
- Remarks:
- 0, 100, 250 and 500 mg/kg/day
- No. of animals per sex per dose:
- Total:100
0 mg/kg bw : 25 female
100 mg/kg bw : 25 female
250 mg/kg bw : 25 female
500 mg/kg bw : 25 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Further details on study design
- Dose selection rationale: The dose levels for this study were selected after evaluation of a separate dose
range finding study (IRI Project No. 438026).
- Rationale for animal assignment (if not random): No data available
- Other: No data available
Examinations
- Maternal examinations:
- Mortality, Clinical sign, body weight, food consumption, gross pathology and histopathology were examined.
- Ovaries and uterine content:
- corpora lutea graviditatis and implantation sites were examined.
- Fetal examinations:
- live or death fetal fetus, (after ca. Day 16 of gestation), a late embryonic death (ca Day 12-16) or an early embryonic death (death judged to have occurred prior to ca Day 12) and fetal weight, externally visible abnormalities, visceral and skeletal abnormalities
- Statistics:
- Maternal body weight gains were analyzed by analysis of variance, treatmentgroups 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 groupvalues. - Indices:
- No data available
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- 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:
- effects observed, treatment-related
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- Body weight and weight gain Reduction in body weight was observed at 500 mg/Kg bw
Food consumption: Reduction in food consumption was observed at 500 mg/Kg bw
Gross pathology: Gastro-intestinal abnormalities were observed at 500 mg/Kg bw
No effect was observed on the dam or conceptus at 250 mg/kg bw
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- gross pathology
- other: No adverse effect observed
- Dose descriptor:
- LOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- gross pathology
- other: adverse effect observed
Maternal abnormalities
- Abnormalities:
- not specified
- Localisation:
- not specified
Results (fetuses)
- Fetal body weight changes:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- not specified
- Skeletal malformations:
- effects observed, treatment-related
- Visceral malformations:
- effects observed, treatment-related
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Moderately increased incidence of advanced ossification, coupled with a decrease in the incidence of patchy ossification in the fetuses were observed at 500 mg/kg bw as compared to control.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- skeletal malformations
- visceral malformations
- other: No effect observed
- Dose descriptor:
- LOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- skeletal malformations
- visceral malformations
Fetal abnormalities
- Abnormalities:
- not specified
- Localisation:
- other: not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL value of the substance Ethanol, 2-(hydroxymethylamino) for developmental toxicity to fetal is 250 mg/kg bw/day and LOAEL value is 500 mg/kg bw/day.
- Executive summary:
In developmental toxicity study, the effect of test substance Ethanol, 2-(hydroxymethylamino) in femaleSprague-Dawleyrat were evaluated. The test substance was administered by oral-gavage in the concentration 0, 100, 250 and 500 mg/kg/day.Under the conditions of this study, no effect was seen on the dam, or conceptus, at dose levels of up to 250 mg/kg/day. There was a moderately increased incidence of advanced ossification, coupled with a decrease in the incidence of patchy ossification in the fetuses at 500 mg/kg/day. Maternal 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.The NOAEL value of the substanceEthanol, 2-(hydroxymethylamino) for developmental toxicity to fetal is 250 mg/kg bw/day and LOAEL value is 500 mg/kg bw/day.
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