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EC number: 203-963-7 | CAS number: 112-36-7
- 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: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- Received for publication 1946
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Peer-reviewed publication but is an old study not conducted in accordance with any official guidelines. Also the dermal exposure was not occlusive.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 947
- Report date:
- 1946
Materials and methods
- Principles of method if other than guideline:
- No guidelines followed
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethanol
- EC Number:
- 203-919-7
- EC Name:
- 2-(2-ethoxyethoxy)ethanol
- Cas Number:
- 111-90-0
- Molecular formula:
- C6 H14 O3
- IUPAC Name:
- 2-(2-ethoxyethoxy) ethanol
- Reference substance name:
- Diethylene glycol ethyl
- IUPAC Name:
- Diethylene glycol ethyl
- Details on test material:
- - Name of test material (as cited in study report): Diethylene glycol monoethyl ether (DEGM)
- Molecular formula (if other than submission substance): C6H14O3
- Molecular weight (if other than submission substance): 134
- Smiles notation (if other than submission substance): OCCOCCOCC
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: organic
- Physical state: Liquid
- Analytical purity: Specially purified compound practically free from ethylene glycol
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: No data
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: 100 cm2
- % coverage: No data
- Type of wrap if used:
- Time intervals for shavings or clippings: One day before application
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.02,0.04,0.08, 0.16, 0.32, 1.25, 1.5, 2.5, 5.0 cm3 per kg body weight
- Concentration (if solution):
- Constant volume or concentration used: no
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 30 days
- Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.02,0.04,0.08, 0.16, 0.32, 1.25, 1.5, 2.5, 5.0
Basis:
other: mL/kg bw
- No. of animals per sex per dose:
- Variable - see table below
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No
DETAILED CLINICAL OBSERVATIONS: No
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations:
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION:
Records kept of food consumed
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
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined:
HAEMATOLOGY: No data
- Time schedule for collection of blood:
- Anaesthetic used for blood collection: Yes (identity) / No / No data
- Animals fasted: Yes / No / No data
- How many animals:
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood:
- Animals fasted: Yes / No / No data
- How many animals:
- Parameters checked in table [No.?] were examined.
URINALYSIS: No data
- Time schedule for collection of urine:
- Metabolism cages used for collection of urine: Yes / No / No data
- Animals fasted: Yes / No / No data
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined:
- Battery of functions tested: sensory activity / grip strength / motor activity / other:
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
lungs, heart, gonads
HISTOPATHOLOGY: Yes
Skin, kidneys, liver - Other examinations:
- Renal and hepatic efficiency. For testing renal function, phenol red and blood urea were used. After DEGM, these renal function tests were made
periodically during the life of the rabbits, but for not longer than sixty days. For testing hepatic functional
efficiency, rose bengal, 3.0 mg per Kg, was injected intravenously before, and periodically after, DEGM, samples of plasma being estimated
at end of two, fifteen and thirty minutes after injection of the dye.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 21% decrease in weight gain for surviving animals
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Kidney
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
From lowest to highest dose respectively 0.02, 0.04,0.08, 0.16, 0.32, 0.63, 1.25, 1.5, 2.5 and 5.0 mL/kg mortality was as follows: 0, 16.67, 30, 62.5, 47,89, 100, 100, 100, 100%
GROSS PATHOLOGY:
all organs appeared normal
HISTOPATHOLOGY: NON-NEOPLASTIC
The lungs, heart, and gonads showed no abnormal treatment-related changes. The skin showed a mild, lymphocytic infiltration of the corium in the majority of the animals. The majority of animals receiving 0.63 ml/kg DGEE or more showed hydropic degeneration of the tubular epithelial cells of the kidneys . Occasional animals receiving lower doses of diethylene glycol monoethyl ether had focal areas of degeneration. One of six rabbits receiving 0.04 ml/kg DEGM had evidence of mild tubular damage.
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The great majority (83 and 1/3 per cent) of rabbits tested, or 15 of 18, showed reductions in renal functional efficiency observed as changes in urinary phenol red and/or blood urea tests.
According to the test results, renal function is definitely impaired as mortality increased after repeated epidermal application of diethylene glycol monoethyl ether. Renal function was unchanged or decreased to a comparatively minor degree where there was no or minor mortality as after 30 daily applications at doses of 0.02 to 0.04 mL and perhaps 0.08 mL per Kg.
Applicant's summary and conclusion
- Conclusions:
- Repeated daily dermal applications of DEGM at doses of 0.02 to 5.0mL/kg resulted in cumulative effects with manifestations of ill health,
renal damage and death in the vast majority of animals. - Executive summary:
DEGDEE and DEGEE, which is in the above study tested for its repeated dose toxicity in rabbits, are both part of the diethylene glycol monoalkyl and dialkyl ethers category described and evaluated in the document titled "Category Approach-Read across Bis(2 -ethoxyethyl)ether" (2013).These substances have been demonstrated to be very similar in structure, physical/chemical properties and toxicological profile . Therefore, a read-across from DEGDEE to data obtained with DEGEE is scientifically justified
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