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EC number: 618-460-1 | CAS number: 9010-89-3
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic information given.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
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:
- 225 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 64, 128, 300, 1500 mg/kg bw (= 0.085%, 0.17%, 0.4%, 2.0%)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, plain diet
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:
- Dietary concentrations of 0.4 and 2.0 % resulted in oxalate crystalluria and mild defects in renal function as measured by concentration tests. The only finding at a dietary level of 0.176 was a 13.2 % increase in urinary oxalate excretion in male, while with the lowest level (0.085%) no effects were observed.
Extrapolation: Since no effects were observed at the dietary level of 0.085 %, application of a safety factor of 100 in the extrapolation to man indicates an acceptable daily intake for a 70 kg man of 38 mg, and on a pro rata basis a lesser or greater value for individuals of different body weight. The significance of the 13.2 % increase in oxalate excretion found in rate on the 0.17% dietary level is debatable. If this level is considered to have no significant effect on the oxalate concentration of kidney and bladder urine, the acceptable daily intake (calculated as above) would be 76 mg/day for a 70 kg individual.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Since no effects were observed at the dietary level of 0.085%, application of a safety factor of 100 in the extrapolation to man indicates an acceptable daily intake for a 70-kg man of 38 mg, and on a pro rata basis a lesser or greater value for individuals of different body weight. The significance of the 13.2% increase in oxalate excretion found in rate on the 0.17% dietary level is debatable. If this level is considered to have no significant effect on the oxalate concentration of kidney and bladder urine, the acceptable daily intake (calculated as above would be 76 mg/day for a 70-kg individual.
Elevated levels of oxalic acid in urine in this study were considered to be a biomarker and do not indicate toxicity. Mild defects of renal function at 0.4% DEG (increased urine volume) were therefore considered to define the LOAEL as 230 mg/kg bw/d, and the NOAEL as 100 mg/kg bw/d.
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