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EC number: 906-936-4 | 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:
- 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: basic information given.
- Justification for type of information:
- Read across is based on the category approach. Please refer to attached category document.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
- Reference Type:
- publication
- Title:
- Human Health Assessment for Long-term Oral Ingestion of Diethylene Glycol
- Author:
- WM Snellings, KE McMartin, MI Banton, F Reitman, J Klapcz, S Green
- Year:
- 2 016
- Bibliographic source:
- Manuscript under peer-review
Materials and methods
- Principles of method if other than guideline:
- The present experiments were initiated to provide adequate short-term investigations, with particular reference to effects on urinary oxalate excretion, using a DEG sample with a low (less than 0-01 %) MEG content.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-oxydiethanol
- EC Number:
- 203-872-2
- EC Name:
- 2,2'-oxydiethanol
- Cas Number:
- 111-46-6
- Molecular formula:
- C4H10O3
- IUPAC Name:
- 2,2'-oxydiethanol
- Details on test material:
- The sample of DEG sed was supplied by Imperial Chemical Industrial Ltd. (Petrochemical Divisions) and gave the following analysis:
Colour (Hazen units), less than 5; specific gravity (15.5/15.5°C), 1 .120; initial boiling point, 244.4 °C; dry point, 250.3 °C; ash (w/w), less than 0.002%; acidity (as acetic), 0.0015; water (w/w), 0.035%; iron, less than 0.1 ppm; monoethylene glycol (w/w), less than 0.01%; triethylene glycol (w/w), 0.03%.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: obtained from a specified-pathogen-free colony
- Housing: five per cage
- Diet: Spillers' Laboratory Small Animal Diet, ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 40 - 50%
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 98 days (first experiment)
225 days (second experiment) - Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
First experiment: 0, 300, 1500 or 3000 mg/kg bw for 98 days (= 0, 0.4 , 2.0 or 4.0 %)
Basis:
- Remarks:
- Doses / Concentrations:
Second experiment: 0, 64, 128, 300, 1500 mg/kg bw for 225 days (= 0 %, 0.085 %, 0.17 %, 0.4 %, 2.0 %)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 15-20 rats in the first experiment (99 days)
10 rats in the second experiment (225 days) - Control animals:
- yes, plain diet
- Details on study design:
- Groups of 15-20 rats of each sex were given diets containaing 0, 0.4 . 2.0 or 4.0 % diethylene glycol (DEG) containing less than 0 .01 %
monoethylene glycol for 98 days .
In a second experiment groups of 10 rats of each sex were given diets containing 0, 0.085, 0.17, 0.4 or 2 .0 % of the same sample of DEG for 225 days.
Examinations
- Observations and examinations performed and frequency:
- The animals were weighed initially, on days 1, 4 and 8 and then at approximately weekly intervals throughout the study.
Food and water intake over a 24-hr period were measured at the same intervals.
Urine samples were collected in week 8, 13 and 19 from the males and in week 9, 14 and 19 from the females over 24-hr periods, during which the rats were denied access to food and water. These samples were rendered strongly acid with hydrochloric acid and analysed for oxalic acid by the method of Hodgkinson & Williams (1972). Urine analyses, renal concentration and dilution tests and urinary cell counts on samples collected during the last week of the study, post mortem examinations, organ-weight analyses and collection of blood for haematological examination were carried out. - Sacrifice and pathology:
- In the haematological examination the reticulocyte and differential leucocyte preparations were not examined. Histological examination was confined to the kidneys.
Results and discussion
Results of examinations
- Details on results:
- 14 week study:
4% - deaths, dpressed body weight, increased water intake, increased urine volume, hematuria, increased kidney weight, abnormal gross/microscopic kidney findings, increased liver weight, and abnormal gross/microscopic liver findings noted
2% - kidney hydropic degeneration in the proximal tubule (1/15 rats)
32 week study:
2% - no hydropic degeneration of the kidneys observed; lower body weights in both males and females observed
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- (98 days)
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Based on renal hydropic degeneration.
- Dose descriptor:
- NOAEL
- Remarks:
- (225 days)
- Effect level:
- 234 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Fifteen to twenty Wistar rats/sex/dose were fed 0, 0.4, 2.0, or 4.0% DEG (equivalent to 300, 1600, and 3000 mg/kg/day in males and 400, 1800 and 3700 mg/kg/day in females) for 14 weeks (phase 1) or ten male and ten female Wistar rats were fed 0, 0.085, 0.17, 0.4, or 2.0% DEG (equivalent to 50, 100, 230, and 1200 mg/kg/day in males and 60, 130, 290, and 1500 mg/kg/day in females) for 32 weeks (phase 2). Observations and measurements included body weights, food and water intake, urinalysis, hematology, clinical chemistry (14 week), and organ weight and histopathology (kidneys only in 32 week). In the 14 week study, effects included death, decreased body weight, and kidney hydropic degeneration at the high dose of 4% DEG. Oxalic acid observed in the urine in some animals of all dose groups was considered a biomarker and does not indicate toxicity. Since hydropic degeneration of the kidney was observed in one animal exposed to 2% DEG and decreased male and female body weights were observed, the LOAEL is considered 2% for the 14 week exposure. The 14 week NOAEL was therefore 0.4% (300 mg/kg/day). For the 32 week study, reduced body weight was observed at 2%, resulting in a NOAEL of 0.4% (234 mg/kg/day).
- Executive summary:
Fifteen to twenty Wistar rats/sex/dose were fed 0, 0.4, 2.0, or 4.0% DEG (equivalent to 300, 1600, and 3000 mg/kg/day in males and 400, 1800 and 3700 mg/kg/day in females) for 14 weeks (phase 1) or ten male and ten female Wistar rats were fed 0, 0.085, 0.17, 0.4, or 2.0% DEG (equivalent to 50, 100, 230, and 1200 mg/kg/day in males and 60, 130, 290, and 1500 mg/kg/day in females) for 32 weeks (phase 2). Observations and measurements included body weights, food and water intake, urinalysis, hematology, clinical chemistry (14 week), and organ weight and histopathology (kidneys only in 32 week). In the 14 week study, effects included death, decreased body weight, and kidney hydropic degeneration at the high dose of 4% DEG. Oxalic acid observed in the urine in some animals of all dose groups was considered a biomarker and does not indicate toxicity. Since hydropic degeneration of the kidney was observed in one animal exposed to 2% DEG and decreased male and female body weights were observed, the LOAEL is considered 2% for the 14 week exposure. The 14 week NOAEL was therefore 0.4% (300 mg/kg/day). For the 32 week study, reduced body weight was observed at 2%, resulting in a NOAEL of 0.4% (234 mg/kg/day).
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