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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: dermal
Administrative data
- Endpoint:
- chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from USEPA HPV report
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Repeated dose dermal toxicity 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 F 82-3
- Principles of method if other than guideline:
- 13 weeks repeated dose toxicity (dermal) study of Ethanol, 2-(hydroxymethylamino) was conducted in Sprague-Dawley rats according to US EPA Pesticide Assessment Guidelines Subdivision F, 82-3.
- 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
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-(hydroxymethylamino)ethanol
- Molecular formula : C3H9NO2
- Molecular weight :91.11 g/mole
- Substance type: Organic
- Physical state:Liquid
- SMILES: OCCNCO
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: No data
- Impurities (identity and concentrations): No data
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- Distilled water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test chemical was dissolved in distilled water to give a dose range of 0, 50, 250 or 1000 mg/Kg bw
TEST SITE
- Area of exposure: No data
- % coverage: 10% of the total body surface area
- Type of wrap if used: occlusive dressing held in place by means of nonirritating tape.
- Time intervals for shavings or clipplings: No data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg
- Concentration (if solution): No data
- Constant volume or concentration used: No data
- For solids, paste formed: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Distilled water
- Amount(s) applied (volume or weight with unit): 2 ml/kg
- Concentration (if solution): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available
USE OF RESTRAINERS FOR PREVENTING INGESTION: No data available - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 13 Weeks
- Frequency of treatment:
- 6hr/d, 5d/wk (Monday - Friday)
Doses / concentrations
- Remarks:
- 0, 50, 250, 1000 mg/kg/day
- No. of animals per sex per dose:
- Total: 80
0 mg/Kg: 10 males and 10 females
50 mg/Kg: 10 males and 10 females
250 mg/Kg: 10 males and 10 females
1000 mg/Kg: 10 males and 10 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: No data
- 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 available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data available
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data available
DERMAL IRRITATION (if dermal study): Yes, inflammation, dermal fibrosis, epithelial hyperplasia and ulceration was noted
- Time schedule for examinations: No data available
BODY WEIGHT: Yes
- Time schedule for examinations: No data available
FOOD CONSUMPTION: yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Y No data available
FOOD EFFICIENCY: No data available
- 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 available
WATER CONSUMPTION: Yes
- Time schedule for examinations: No data available
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: before treatment commenced and during Week 12 of the study
- Dose groups that were examined: 0 and 1000 mg/Kg
HAEMATOLOGY: Yes
- Time schedule for collection of blood: during Week 13
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined.: Hemoglobin, total red blood cell count, total white blood cell count, differential white cell count, hematocrit, calculations of absolute indices, and Hepato Quick test (on sample obtained by tail snip without anesthesia)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: during Week 13
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. blood urea nitrogen, glucose, aspartate aminotransferase, alanine aminotransferase, sodium, potassium, calcium, chloride, total protein, albumin, albumin-globulin ratio, alkaline phosphatase, Creatinine, phosphate, total bilirubin.
URINALYSIS: No data available
- Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: No data available sensory activity / grip strength / motor activity / other: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, After 13 weeks of dosing all rats were killed and necropsied and adrenals, kidneys, liver, ovaries (with fallopian tubes), testes (plus epididymides) were weighed
HISTOPATHOLOGY: Yes, animals from the control group and 1000 mg/Kg underwent histopathological examination of a comprehensive list of tissues. Rats from 50 and 250 mg/Kg dose groups had only lungs, liver, kidneys and skin sections examined.
Tissues examined in situ and fixed: Adrenals, aortic arch, any abnormal tissue, bladder, bone (sternum and rib), brain, eyes, femur, heart, intestine (duodenum, jejunum, ileum, caecum, colon, rectum), kidneys, liver, lungs (perfused), mammary gland, mesenteric lymph node, muscle (thigh), nasal cavity, esophagus, ovaries (with fallopian tubes), pancreas, pituitary, prostate, sciatic nerve, seminal vesicles, skin (normal), skin (treated), spleen, stomach (glandular and nonglandular), spinal cord (cervical, thoracic and lumbar portions), submaxillary salivary gland, submandibular lymph node, testes (plus epididymides), thymus, thyroids, tongue, trachea, uterus - Other examinations:
- No data available
- Statistics:
- Hematology, clinical chemistry, organ weight and body weight data were statistically analysed for homogeneity of variance using the F-max test. If the group variances appeared homogeneous a parametric ANOVA was used and pairwise comparisons made via Student\s t-test using Fischer's F-protected LSD. If the variances were heterogeneous, log or square root transformations were used in an attempt to stabilize the variances. If the variances remained heterogeneous, then a non-parametric test such as Kruskal-Wallis ANOVA was used and pairwise comparisons made via Dunn Z test where considered appropriate.
Organ weights were also analyzed conditional on body weight (i.e. analysis of covariance).
Histopathology data were analayzed using Fischer's Exact Probability test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- 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:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Clinical signs and mortality:
Clinical signs: There were no notable intergroup differences. The most notable clinical signs included scabbing on and yellow staining around the dosing site, which were seen in all dose groups that received the test material.
Mortality: There was one premature death (male at 250 mg/kg/day dose), which was not considered due to treatment with the test material.
Dermal Irritation: No data available
Body weight and weight gain: There were no consistent dose related effects seen in body weight gain.
Food consumption and compound intake: There were no notable intergroup differences in food consumption
Food efficiency: No data available
Water consumption and compound intake: There were no notable intergroup differences in water consumption
Opthalmoscopic examination: There were no abnormal opthalmoscopic findings
Haematology: There were no notable hematological intergroup differences.
Clinical chemistry: No data available
Urinanalysis: No data available
Neurobehaviour: No data available
Organ weights: No detailed data available
Gross pathology: No detailed data available
Histopathology: No detailed data available
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effect observed for clinical signs, body weight, food and water consumption and opthalmology parameters 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 Ethanol, 2 (hydroxymethylamino) is 1000 mg/kg/day when applied dermally to male and female Sprague-Dawley rats.
- Executive summary:
13 weeks repeated dose toxicity (dermal) study of Ethanol, 2-(hydroxymethylamino) was conducted in Sprague-Dawley rats according to US EPA Pesticide Assessment Guidelines Subdivision F, 82-3. The test chemical was dissolved in distilled water and used at dose levels of 0, 50, 250 or 1000 mg/Kg. The chemical was applied daily (Monday – Friday) at a constant volume of 2 ml/kg over an area of approximately 10% of the total body surface area. The treated area was protected for approximately 6 hours by an occlusive dressing held in place by means of nonirritating tape. The animals were observed for mortality, clinical signs, changes in body weight, water and food consumpton, opthamological, hematological and clinical chemistry signs were recorded and the animals underwent gross and histo- pathology. There was one premature death (male at 250 mg/kg/day dose), which was not considered due to treatment with the test material. No dose related changes in body weight, water and food consumption, ophthalmology and no notable hematological intergroup differences were noted. The most notable clinical signs included scabbing on and yellow staining around the dosing site was observed, which were seen in all dose groups that received the test material. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for Ethanol, 2 (hydroxymethylamino) is 1000 mg/kg/day when applied dermally to male and female Sprague-Dawley rats.
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