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EC number: 907-132-6 | CAS number: -
- 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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented study report, GLP, similar to OECD 408
- Justification for type of information:
- Read across is based on the category approach. Please refer to attached category document.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
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)
- Remarks:
- testing lab.
- 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'-[ethane-1,2-diylbis(oxy)]diethanol
- Details on test material:
- purity: 99.74 - 99.9%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female Fischer 344 rats were used. 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 2 w 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 66-77°F and relative humidity at 40-70%. A 12-h photoperiod was used.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 748, 1522, 3849 mg TEG/kg/day (= 0, 10000, 20000 or 50000 ppm) for males and 0, 848, 1699, 4360 mg TEG/kg/day (= 0, 10000, 20000, 50000 ppm) for females.
Basis:
nominal in diet
- No. of animals per sex per dose:
- 30/sex/group in the control and high dose and 20/sex/group in the low and mid dose groups
- Control animals:
- yes, concurrent no treatment
- 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:
- Observations for mortality wer emade twice daily. Detailed clinical observations were performed weekly, and observations for overt clinical signs were performed on other days. Opthalmic examinations were performed prior to the start of dosing and prior to interim (13 week) sacrifice). Body weight and food consumption data were collected for all animals weekly.
Blood was collected on day 30. Prior to termination, hematology ,clinical chemistry and urinalysis were performed.
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.
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, color, microscopy, blood, protein, ketones, glucose, bilirubin and urobilinogen. - Sacrifice and pathology:
- Twenty 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.
- 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 Saftware. The fiducial limit of 0.05 was used as the critical level of significance for all tests.
Results and discussion
Results of examinations
- Details on results:
- Treatment of rats with TEG for 13 weeks did not result in abnormal or biologically significant clinical signs, ophthalmological changes, changes in food consumption, alterations in clinical chemistry measurements, necropsy findings, or histologic findings. 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. Hematology measurements, including decreased erythrocytes and hematocrit in males from the high and mid dose groups and decreased hemoglobin 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. Decrease in urine pH at all dose levels in males and the mid and high dose levels in females and an increase in urine volulme in males from the high dose group were considered to be related to TEG treatment. 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 also 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.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 20 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Dose descriptor:
- NOAEL
- Effect level:
- 1 522 mg/kg diet
- Sex:
- male
- Basis for effect level:
- other: overall effects
- Dose descriptor:
- NOAEL
- Effect level:
- 1 699 mg/kg diet
- Sex:
- female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In the currently reported study with TEG there was no evidence for any specific organ or tissue toxicity. TEG did not show the repeated exposure toxicity characteristic of the lower molecular weight homologues. In this present study, a NOAEL of 20,000 ppm of dietary TEG for the rat was observed.
- Executive summary:
Fischer 344 rats (30/sex/group in the control and high dose groups and 20/sex/group in the low and mid dose groups) were exposed to triethylene glycol (TEG) in the diet at concentrations of 0, 10000, 20000, or 50000 ppm for 13 weeks. The doses corresponded to approximate mean consumption values of 748, 1522 and 3849 mg TEG/kg/day for the males from the 10000, 20000, and 50000 ppm groups, respectively. The extra 10 animals/sex in the control and high dose groups were monitored without additional treatment for a 6-week recovery period following the dosing phase of the study. Observations or measurements for clinical signs of toxicity, ophthalmologic changes, food consumption, body weight, clinical pathology (interim and final), organ weights, necropsy, and histology were made.
Treatment of rats with TEG at doses of 10000, 20000, or 50000 ppm for 13 weeks did not result in abnormal or biologically significant clinical signs, ophthalmologic changes, changes in food consumption, alterations in clinical chemistry measurements, necropsy findings, or histological findings. Body weight depression compared to controls occurred in males from the high dose group throughout the study in females during the latter weeks of the study (starting at approximately week 8) 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 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. Hematology measurements, including decreased erythrocytes and hematocrit in males from the high and mid dose groups and decreased hemoglobin 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 red cell indexes.
Decreases in urine pH at all dose levels in males and 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. 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 also 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. Due to the alterations in urine pH in the males from the 10000 ppm level and the abnormal body weight measurements, a clear NOEL could not be established.
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