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EC number: 203-953-2 | CAS number: 112-27-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
- Reference Type:
- publication
- Title:
- Subchronic Peroral Toxicity of Triethylene Glycol in the Fischer 344 Rat.
- Author:
- VanMiller, J.P., Ballantyne, B.
- Year:
- 2 001
- Bibliographic source:
- Vet. Human Toxicol. 43 (5), 269 - 276, Oct. 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-(ethylenedioxy)diethanol
- EC Number:
- 203-953-2
- EC Name:
- 2,2'-(ethylenedioxy)diethanol
- Cas Number:
- 112-27-6
- Molecular formula:
- C6H14O4
- IUPAC Name:
- 2-[2-(2-hydroxyethoxy)ethoxy]ethan-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Source: Union Carbide Corporation (Texas City, TX)
- Purity: ≥ 99.74%
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Details on species / strain selection:
- A pretest health screen was carried out 2 d after arrival, using 5 males and 5 females from the 14-d study, and 10 males and 10 females from the subchronic study. The screen consisted of clinical examination, examination for fecal parasites, viral screen, necropsy, and histology of multiple organs and tissues. They were housed 2/side of divided stainless steel cages mounted on a stainless steel rack. One to two weeks later, they were housed in similar cages but 1/side and this was maintained throughout the study. They were allowed free access to food and water from an automatic system. Environmental temperature was maintained at 19 - 25 °C and relative humidity at 40 - 70%. A 12-h photoperiod was used.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: The rats were approx. 6 weeks of age at first dose.
- Housing: Animals were housed 2/side of divided stainless steel cages mounted on a stainless steel rack. One to two weeks later, they were housed in similar cages but 1/side and this was maintained throughout the study. A layer of Deotized Animal Cage Board (Shepherd Specialty Papers, Inc., Kalamazoo, MI) was kept under each cage and changed at least three times pew week.
- Diet: Ground Purins Certified Rodent Chow #5002 (Ralston Purins Co., St. Louis, MO) was available ad libitum.
- Water: Water (Municipal Authority of Westmoreland County, Greensburg, PA) was provided by an automatic watering system with demand control valves mounted on each rack. Water was available ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 40-70%
- Photoperiod: 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Experimental diets were analysed using a gas chromatographic procedure developed at BRRC. Homogeneity of the test substance at each diet concentration was established prior to the start of the study. Stability of the test substance in diets at the 10000 and 50000 ppm concentrations was determined prior to administration of the diets to the animals for the first four preparations. Thereafter, one sample from each preparation (concentration selected sequentially) was retained frozen and analysed in weeks 8 and 13 with one control sample.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 748 mg/kg bw/day (actual dose received)
- Remarks:
- low dose males (10000 ppm)
- Dose / conc.:
- 848 mg/kg bw/day (actual dose received)
- Remarks:
- low dose females (10000 ppm)
- Dose / conc.:
- 1 522 mg/kg bw/day (actual dose received)
- Remarks:
- mid dose males (20000 ppm)
- Dose / conc.:
- 1 699 mg/kg bw/day (actual dose received)
- Remarks:
- mid dose females (20000 ppm)
- Dose / conc.:
- 3 849 mg/kg bw/day (actual dose received)
- Remarks:
- high dose males (50000 ppm)
- Dose / conc.:
- 4 360 mg/kg bw/day (actual dose received)
- Remarks:
- high dose females (50000 ppm)
- No. of animals per sex per dose:
- - 262 rats (130 males, 132 females) were used
- 30/sex/group in the control and high dose and 20/sex/group in the low and mid dose groups - Control animals:
- yes, plain diet
- Details on study design:
- Fresh diet was prepared and offered to the animals each week. All diet concentrations were prepared by dilution of the premix and mixing for 15 minutes.
Homogeneity of the test substance at each concentration was established prior to the start of the study. Stability of the test material in the diets at 10000 and 50000 ppm was determined prior to dosing after storage in open glass feed jars. Diet concentrations were verified for all dose levels prior to administration of the diets to the animals for the first 4 preparations.
Examinations
- Observations and examinations performed and frequency:
- - Detailed clinical observations were conducted weekly and daily observations were made for overt clinical signs.
- Rats were given ophthalmoscopic observations (indirect ophthalmoscopy) before dosing and at the end of the dietary dosing period.
- Body weights and food consumption were measured at weekly intervals. Body weight gains were calculated at each weighing period for the time since initial (day 0) body weight measurement.
- Blood was collected on day 30, immediately following the end of dietary dosing, and at the end of the recovery period for hematology and serum chemistry (10 animals/sex/group).
- The following blood parameters were measured or calculated: hemoglobin concentration, erythrocyte count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, total and differential leukocyte count.
- The following elements were measured or calculated in serum: glucose, urea nitrogen, albumin globulin, total protein creatinine, bilirubin (total, conjugated and unconjugated), phosphorus, Ca++, Na+, K+, CI-, aspartate and alanine aminotransferases, alkaline phosphatase, gamma-glutamyl transferase, creatine kinase, lactate and sorbitol dehydrogenases.
- The following urine values were determined: volume, pH, specific gravity, colour, microscopy, blood, protein, ketones, glucose, bilirubin and urobilinogen. - Sacrifice and pathology:
- 20 rats/sex/group were sacrificed at the end of the dosing period, and 10 rats/sex from the control and high-dose groups were sacrificed after the recovery periods and subjected to necropsy examination for any signs of gross pathology. The following organs were removed and weighed: liver, kidneys, heart, spleen, brain, adrenal glands, testes, and ovaries. A further number of tissues and organs were removed and processed for histological examination.
- Other examinations:
- - Examination for fecal parasites was conducted using a cellophane tape test and by zinc sulfate flotation from cecal contents obtained at neropsy on 5 animals per sex. Histopathology was performed on 3 sacrificed animals/sex. At least the following tissues were examined: liver, kidneys, trachea, lungs, heart, spleen, salivary glands, submandibular lymph notes, and nasal cavities.
- Each rat was uniquely numbered by ear notch and toe-clipping. Only rats with body weights within +/-20% of the population mean for each sex were used. - Statistics:
- Data for continuous, parametric variables were intercompared for the dose and control groups using Levene's test for homogneity of variances, by analysis of variance, and by pooled variance t-tests. Frequency data were compared using Fisher's exact tests where appropriate. All statistical tests, except the frequency comparisons were performed using BMDP Statistical Software. The fiducial limit of 0.05 was used as the critical level of significance for all tests.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight depression compared to controls occurred in males from the high dose group throughout the study and in females during the latter weeks of the study. Body weights for males from the recovery group were similar to controls after the 6-week period but females did not show recovery of body weight. In fact, the largest difference from the control value occurred during the recovery period for the females. Based on the larger magnitude of change in the high dose group than was observed for the other dose groups, the body weight differences were considered related to treatment. A transient decrease from control in cumulative body weight gain was observed for the animals from both sexes in the middle weeks of the study. Due to the unusual pattern of weight differences, the relationship to treatment of these decreases was unclear.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Haematology measurements, including decreased erythrocytes and haematocrit in males from the high and mid dose groups and decreased haemoglobin and increased MCV in the high dose group only, were altered at the 13-week measurement period. These changes were considered to be of questionable biological significance based on a lack of similar effect in the females, the small magnitude of the changes, and the lack of corresponding effects in other cell indexes.
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Decrease in urine pH at all dose levels in males and the mid and high dose levels in females and an increase in urine volume in males from the high dose group were considered to be related to TEG treatment.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Observations of small increases in kidney weight (high dose group females) and kidney weight relative to body weight (all groups of males and mid and high dose group females) were considered to be probably treatment related. Based on the lack of any other significant toxic effects, particularly the lack of histologic evidence of renal injury, hyperplasia, or hypertrophy, the altered urine measurements were considered to be most likely related to excretion of the large amounts of test material (or metabolites) during the course of this study.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 20 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- organ weights and organ / body weight ratios
- urinalysis
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 522 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- organ weights and organ / body weight ratios
- urinalysis
- Dose descriptor:
- NOAEL
- Effect level:
- 1 699 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- organ weights and organ / body weight ratios
- urinalysis
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.