Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-953-2 | CAS number: 112-27-6
- 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:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Principles of method if other than guideline:
- This study was performed to reveal any toxicological effects which might result from repeated long-term exposure to airborne concentrations of PEG 200.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- EC Number:
- 500-038-2
- EC Name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Cas Number:
- 25322-68-3
- IUPAC Name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male mice weighed approx. 30 mg and females approximately 25 mg. All animals were selected quarantined and examined. Mice were exposed in compartmented stainless-steel wire mesh cages. Each mouse cage compartment measured 3 in. x 2 in. x 2-1/4 in. The compartments were labeled with a number so that each animal was in the same cage and compartment for the daily exposures. Following the 6-hour exposure, the caged animals were removed from the chamber, placed on carts and carried to adjoining holding rooms. One room was for control and another room was for exposed animals. The animals were removed from the exposure cages and placed in individually labeled stainless steel mesh holding cages. Mouse holding cages measured 9-1/2 in. x 4 in. x 6 in. Food and water was available to the animals only while in the holding cages and not during exposures.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- Exposures were conducted in two 3000-liter dynamic flow stainless-steel chambers operated under negative pressure. Air was drawn into the system and the test substance aerosol was dispersed into the intake air and passed through collective protective filters before exiting into the atmosphere. Chamber design assured that the airborne concentration of the test substance was uniform. The chamber airflow was held constant throughout the test. The flow rate was used to calculate the nominal test substance concentration. Air pressure through the generators was adjusted to achieve the different test concentrations of the test substance.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 h/d, 5 d/wk
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.1 mg/L air (nominal)
- Dose / conc.:
- 1 mg/L air (nominal)
- No. of animals per sex per dose:
- A total of 90 mice were required, 30 to be exposed to the high dose level, 30 to the low dose level and 30 to serve as controls. Each of these groups were divided into three subgroups:
(a) 6-week exposure group of 10 animals
(b) 13-week exposure group of 10 animals
(c) a group of 10 animals to be held for 30 days after the 13-week exposure. - Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- The animals were sex-segregated at all times. The exposed and control animals were observed daily for toxic signs and death. The animals used were weighed individually at approximately 2-week intervals.
- Sacrifice and pathology:
- Pathological and haematological examinations were performed on the respective groups at the termination of the exposure-holding periods. The animals were anesthetised with pentobarbital sodium and blood samples taken by cardiac puncture. Because of the small amount of blood obtainable for the mice, only hemograms were determined for this species. Groups of male and female mice were euthanatised following 6 and 13 weeks of exposure to the test substance aerosol. Another group was euthanatised 30 days after exposure to the test substance. At termination and necropsy, tissues were evaluated grossly and preserved in 10% buffered formalin. The tissues were embedded in paraffin and subsequently processed for staining with hematoxylin and eosin. Tissues from the following were evaluated microscopically: brain, eye, adrenal, thyroid, trachea, lung, turbinates, kidney, liver, spleen, heart, esophagus, stomach, small intestine, large intestine, pancreas, urinary bladder, testes, ovaries, and uterus. Before fixing the hearts, lungs, livers, kidneys and gonads, they were weight, and organ-to-body-weight ratios were calculated.
- Statistics:
- The data were compared statistically using an analysis of variance (ANOVA) which distinguish differences according to sex, exposure levek, and the effect of dose within sexes.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No obvious pattern of overt toxic signs was seen. After each exposure, the fur of the animals exposed to the high dose appeared oily.
- Mortality:
- no mortality observed
- Description (incidence):
- No spontaneous deaths occurred.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There was no definite pattern in the body weights of male or female mice. There were weeks when the average weights of the exposed animals were slightly less or greater than the control weights. Both male and female exposed mice weighed more than the controls during the 30-day post-exposure period.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- There were no consistently significant changes in red blood cell count, total and differential white blood cell count, haematocrit, or haemoglobin.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No consistently significant changes in blood chemistry.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- - 6 weeks: Interstitial pneumonia was found in 3 low dose mice (one male, two females). Atelectasis was observed in the lungs of a male and a female control. This probably reflects improper inflation during the necropsy procedure. Adrenal cortical degeneration was seen in a control female. Renal tubular vacuolar degeneration was seen in all of the male mice. Mild degenerative changes were observed in the liver of one female mouse exposed to the high dose. Cystic endometrial hyperplasia (minimal mild) was found in 10 females (5 controls, 5 exposed). One male control mouse died spontaneously at the end of 6 weeks. No significant microscopic lesions were found. There was a swollen area in the cervical region, probably due to accidental injury when the mouse was loaded into the cage.
- 13 weeks: Infiltration of foamy macrophages in the lung, a common incidental finding in rodents, was found in one exposed (low dose) male. Interstitial pneumonia occurred in 4 mice (2 males and 1 female control and 1 female - high dose). Renal tubular degeneration was again observed in all of the male mice. Cystic endometrial hyperplasia was noted in 10 females (5 controls - 4 low dose and 1 high dose). Endometriosis was found in 1 low dose mouse. occurred.
- 13 weeks exposure + 30-day post-exposure: Adrenal cortical degeneration was found in 1 exposed (low dose) female. Interstitial pneumonia occurred in 4 males (1 control, 2 low, 1 high dose). Infiltration of foamy macrophages was seen in the lung of 1 exposed (high dose) male. Tubular degeneration was identified in all males. Endometrial cysts were found in 12 females (5 controls, 4 low, 3 high dose). Hydronephrosis was found in 1 exposed (high dose) male. - Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 1 mg/L air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.