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EC number: 203-919-7 | CAS number: 111-90-0
- 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: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.8 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- not specified
- GLP compliance:
- yes
- 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:
- C6H14O3
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethan-1-ol
- Reference substance name:
- 2-(2'-ethoxyethoxy)ethanol
- IUPAC Name:
- 2-(2'-ethoxyethoxy)ethanol
- Details on test material:
- Test material was 98.6% pure. Impurities included ethylene glycol (1%) and ethyl glycol (0.24%).
Source: Huls AG Germany
Test substance stored under nitrogen at room temperature.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd (Margate, Kent, UK)
- Age at study initiation: 8 weeks
- Housing: Stainless steel cages
- Diet (e.g. ad libitum): ad libitum except during exposure. SDS Rat and Mouse No. 1, Special Diet Services, Witham, Essex
- Water (e.g. ad libitum): ad libitum except during exposure
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: The measured mean exposure concentrations were 0.09 +/- 0.012, 0.27 +/- 0.031, and 1.1 +/- 0.20 mg/l. Vapour only was present at the low and intermediate concentrations. The high concentration consisted of 50% vapour and 50% respirable droplets (aerosol). The mass median aerodynamic diameter of the aerosol was 3.8 microns with a geometric standard deviation of 1.68. Note that the saturated vapour pressure (theoretical max) is 0.94mg/l.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: ADG Instruments, HItchin, Hertfordshire, England. Approx 50 liters
- Method of holding animals in test chamber: The rats were placed into polycarbonate restraining tubes for exposure and were attached to the chamber such that only the snout protruded into the chamber.
- Source and rate of air: Filtered air.
- Method of conditioning air: The top section of the exposure chamber incorporated a central vapor/droplet inlet port and a tangential diluent air inlet, which served to ensure homogeneity of the test atmosphere.
- System of generating particulates/aerosols: The test atmospheres were generated by atomizing the liquid test substance with jet atomizers. A supply of filtered air was connected to the atomizer and to the chamber diluent air supply. The test aerosol passed into an elutriation column before entering the exposure chamber. Large, nonrespirable droplets were removed by sedimentation and a proportion of the droplets evaporated. The liquid test substance was metered continuously to the atomizer using a syringe pump.
- Temperature, humidity, pressure in air chamber: no data
- Air flow rate: 30 liters/min
- Air change rate: no data
- Method of particle size determination: see MMAD/GSD
- Treatment of exhaust air: no data
TEST ATMOSPHERE
- Brief description of analytical method used: During each exposure, at least three samples were taken from each chamber (by charcoal absorption tubes) to determine the concentration of test material and one sample was taken from the high dose chamber (by a cascade impactor) to determine the size distribution of the aerosol. The amount of test material collected was determined by GLC following extraction with carbon disulfide.
- Samples taken from breathing zone: yes
VEHICLE (if applicable)n/a
- Justification for use and choice of vehicle:
- Composition of vehicle:
- Type and concentration of dispersant aid (if powder):
- Concentration of test material in vehicle:
- Lot/batch no. of vehicle (if required):
- Purity of vehicle: - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- As above
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 6 hr/day, 5 days/wk
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.085 mg/L air (analytical)
- Remarks:
- 0.1mg/L air nominal
- Dose / conc.:
- 0.27 mg/L air (analytical)
- Remarks:
- 0.3mg/L air nominal
- Dose / conc.:
- 1.1 mg/L air (analytical)
- Remarks:
- 1.0 mg/L air (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, sham-exposed
- Details on study design:
- Exposure levels selected following review of the results of a 5-day preliminary study in which no treatment-related effects were seen at exposure levels up to 2.2 mg/liter.
Examinations
- Observations and examinations performed and frequency:
- Rats were weighed prior to the start of exposure and weekly during exposure.
Clinical signs were recorded daily and during exposure.
Food and water consumption were measured weekly and daily, respectively.
Samples of blood were taken from the orbital sinus under light anaesthesia during the final week of exposure. Blood samples were examined for packed cell volume, hemoglobin, red cell count, white cell count (total and differential), platelet count, thrombotest, creatinine phosphokinase, total protein, albumin, globulin, glucose, urea nitrogen, bilirubin, creatinine, cholesterol, sodium, potassium, calcium, phosphate, chloride, glutamic-pyruvic transaminase, glutamic oxaloacetic transaminase, and gamma glutamyl transferase. - Sacrifice and pathology:
- All animals were killed at the end of the 4-week exposure.
The adrenals, kidneys, liver, lungs and testes were weighed and fixed.
All gross abnormalities, heart, larynx, head, pharynx, spleen and trachea were also fixed. Nasal passages were decalcified with formic acid.
All fixed tissues were examined microscopically for the control and high dose group, and the larynx (males only) and turbinates from rats in the other groups were also examined. - Statistics:
- If data consisted predominantly of one particular value, Fisher's exact and Mantel's test were used to assess difference from mode. Barlett's test for heterogeneity of variance between treaments, with or without logarithmic transformation. If not significant, one way ANOVA. If significant heterogeneity of variance was present and could not be removed, Kruskal-Wallis analysis of rank used followed by Shirley's test. Student's t test and Williams test used for dose related response analysis although only latter reported. Where appropriate analysis of covariance was used in place of ANOVA.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- A slight increase in water consumption in females exposed to 1.1 mg/l was not considered to be biologically significant.
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- 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):
- - High dose group: Slight increase in eosinophilic inclusions in the olfactory epithelium. Focal necrosis of the ventral cartilage in 3/5 male rats
- Mid dose group: Focal necrosis in the ventral cartilage in 2/5 male rats. No effects in female rats
-Low dose group: no effects
Mild local irritation of the larynx and nasal turbinates was found in rats exposed to 0.27 or 1.1 mg/l (numbers affected were not listed). Foci of necrosis in the small ventral cartilage of the larynx were noted in males exposed to these concentrations (2/5 and 3/5, respectively). There was no evidence of damage to the overlying spuamous epithelium. There was a slight increase in eosinophilic inclusions in the olfactory epithelium of the nasal mucosa of rats exposed to 1.1 mg/l (9/10 treated vs. 5/10 control, all graded "trace" or "minimal"). These inclusions were predominantly located on the dorsal and ventral scrolls of ethmoturbinate 3, but were also found on numbers 2 and 5. - Histopathological findings: neoplastic:
- not specified
- Details on results:
- The only changes attributable to treatment were observed in the respiratory tract.
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Remarks:
- systemic effects
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOAEC
- Remarks:
- local effects
- Effect level:
- 0.09 mg/L air
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Local irritation of the respiratory tract
- Dose descriptor:
- NOAEC
- Remarks:
- local effects
- Effect level:
- 0.27 mg/L air
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Local irritation of the respiratory tract by aerosol
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 0.27 mg/L air
- System:
- respiratory system: upper respiratory tract
- Organ:
- nasal cavity
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Any other information on results incl. tables
Incidence of eosinophilic cytoplasmic inclusions in nasal turbinates
MALES (out of 5 animals)
Severity |
Control |
Low dose |
Mid dose |
High dose |
Trace |
2 |
2 |
2 |
3 |
Slight |
0 |
0 |
0 |
1 |
FEMALES (out of 5 animals)
Severity |
Control |
Low dose |
Mid dose |
High dose |
Trace |
3 |
3 |
1 |
2 |
Slight |
0 |
0 |
0 |
3 |
Applicant's summary and conclusion
- Conclusions:
- Well conducted study according to GLP and EU guidelines. The highest dose did not induce systemic toxicity but 0.27 and 1.1 induced local irritation.
- Executive summary:
In a 28 -day study conducted according to guideline, male and female rats were exposed to 0.09, 0.27 or 1.1mg/l of 2 -(2'-ethoxyethoxy)ethanol in an inhalation chamber for 6 hours per day, 5 days per week. There were no changes indicative of a systemic effect at any of the doses tested. Changes indicative of mild local respiratory tract irritation were seen in rats exposed at 0.27mg/liter or 1.1mg/liter, and a slight increase in eosinophilic inclusions in the olfactory epithelium of the nasal mucosa at 1.1mg/liter. No effects indicative of mild local irritation were observed at 0.09mg/liter. In conclusion, the NOAEL for systemic effects can be established at 1.1mg/liter and for local effects at 0.09mg/liter.
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