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EC number: 213-195-4 | CAS number: 929-06-6
- 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

Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: OECD 411
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no deviation from OECD guideline (OECD 411). Not GLP.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 411
- Deviations:
- no
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2-(2-aminoethoxy)ethanol
- EC Number:
- 213-195-4
- EC Name:
- 2-(2-aminoethoxy)ethanol
- Cas Number:
- 929-06-6
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2-(2-aminoethoxy)ethanol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Name of test material (as cited in study report): DGA
- Substance type: clear, colorless
- Physical state: liquid
- Lot/batch No.: 9F10
- Expiration date of the lot/batch: 15 July 2001
- Stability under test conditions: stability information was not provided
- Storage condition of test material: room temp
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: between 10 and 20% of the body surface
- Type of wrap if used: gauze pad, rubber dam and an elastic bandage
- Time intervals for shavings or clipplings: minimum of twice weekly
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently cleansed with gauze soaked in warm water and gently dried
- Time after start of exposure: 6h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/kg bw /d
- Concentration (if solution): 0 - 17- 87- 175 mg/kg bw/d
- Constant volume or concentration used: yes
VEHICLE = deionized water
- Amount(s) applied (volume or weight with unit): 0.5 ml/kg bw/d
- Lot/batch no. (if required): 071099, 201099, 011199, 091199, 171199, 221199, 031299, 081299, 151299, 171299, 281299 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- nominal concentration (mg/kg bw/d): 0 - 50 - 250 - 500 respectively
actual concentration (mg/kg bw/d): 0 - 17 - 87 - 175 respectively - Duration of treatment / exposure:
- approximately 6h
- Frequency of treatment:
- once daily, 90 consecutive days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
17, 87, 175 mg/kg bw
Basis:
nominal in water
- No. of animals per sex per dose:
- 10 male and 10 female rats per dose
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: once daily
BODY WEIGHT: Yes
- Time schedule for examinations:
at the time of randomisation
prior to dose administration on day 1
weekly (after that)
on day 91 (fasted)
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes (weekly)
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: No data
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: before treatment + prior to terminal sacrifice
- Dose groups that were examined: all animals
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on day 91, prior to terminale sacrifice
- Anaesthetic used for blood collection: Yes, CO2
- Animals fasted: Yes , overnight
- How many animals: all surviving animals (= all animals, 80)
- Following parameters were examined.
* Hematology: differential white blood cell count, hematocrit, hemoglobin, mean corpuscular hemoglobin,
mean corpuscular hemoglobin concntration, mean corpuscular volume, platelet count, red blood cell count and morphology,
white blood cell count
* Coagulation: prothrombin time, acctivated partial thromboplastin time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood:on day 91, prior to terminale sacrifice
- Animals fasted: Yes , overnight
- How many animals: all animals (80)
- Following parameters were examined:
* serum clinical chemistry: alanine aminotransferase, albumin, albumin/globulin ratio (calculated), aspartate aminotransferase, calcium,
chloride, cholesterol, creatinine, creatine phosphokinase, globulin (calculated), glucose, phosphorus, potassium, sodium, total bilirubin,
total protein, triglycerides, urea nitrogen
URINALYSIS: Yes
- Time schedule for collection of urine: on day 90, urine was collected overnight
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Following parameters were examined:
* volume, specific gravity, appearance/color, semi-quantitative estimation: pH, protein, glucose, ketone, urobilinoen, bilirubin,
blood, leukocytes, nitrites, microscopic examination of spun deposit
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: on day 28 and day 90 during treatment
- Dose groups that were examined: all
- Battery of functions tested: observation of animals / sensory activity / grip strength / motor activity / other: loss of righting reflex,
spontaneous locomotor activity, right pupil examination, various reflex responses
OTHER:
Sacrifice and pathology
GROSS PATHOLOGY: Yes
external surface of the body, all orifices, cranial, thoracic and abdominal cavities together with their content
HISTOPATHOLOGY: Yes
gross abnormalities, adrenals, aorta, whole brain, cecum, colon, duodenum, epididymides, esophagus, exorbital lachrymal gland,
eyes w/optic nerve, femur, fat (mesentery), heart, ileum, jejunum, kidneys, liver, lungs with mainstem bronchus, mammary gland(s), mesenteric
lymph nodes, ovaries, pancreas, pituitary, prostate, rectum, salivary glands (mandibular lymph nodes), sciatic nerve, seminal vesicle(s),
skin (with subcutis from a site other than the treated site), spinal cord at three levels - cervical, midthoracic, lumbar - spleen, sternum with bone
marrow, stomach, testes, thigh musculature (skeletal muscle), thymus, thyroids/parathyroids, tongue, trachea, treated site (dorsal thoracic region
with subcutis), urinary bladder, uterus, vagina
- Statistics:
- evaluation of equality of means: one-way analysis of variance usiing the F distribution to assess statistical significance
is differences between the means are statistically significant, Dunnett's test was used to determine the degree of significance.
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 17 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: dermal effects
- Dose descriptor:
- NOAEL
- Effect level:
- >= 175 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: systemic effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Application of DGA to an intact cutaneous site for approximately six hours, once daily for 90 consecutive days to male and female Sprague-Dawley rats, results in ulceration, epidermal hyperplasia, fibrosis and/or inflamation at doses of 87 and 175 mg/kg bw/d. These changes represent local irritation following topical administration.
Based on the results of the study, the dermal NOAEL was at least 17 mg/kg bw/d while the systemic NOAEL was at least 175 mg/kg bw/d.
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