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Diss Factsheets
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EC number: 223-672-9 | CAS number: 4016-14-2
- 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:
- other: publication
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically reasonable method with some deficiencies in documentation on the registered substance itself.
Data source
Reference
- Reference Type:
- publication
- Title:
- "The toxicology of glycidol and some glycidyl ethers"
- Author:
- Hine , Kodoma , Wellington , Dunlap , Anderson
- Year:
- 1 956
- Bibliographic source:
- Hine, C. H., J. K. Kodoma, J. S. Wellington, M. K. Dunlap, H. H. Anderson: "The toxicology of glycidol and some glycidyl ethers", Arch. Ind. Health 14, 250 (1956)
Materials and methods
- Principles of method if other than guideline:
- A group of ten male Long-Evans rats was exposed to an isopropyl glycidyl ether concentration of 400 ppm (vapour), 7 hours daily, 5 days per week for 10 weeks.
- GLP compliance:
- no
- Remarks:
- conducted prior to GLP implementation
Test material
- Reference substance name:
- 2,3-epoxypropyl isopropyl ether
- EC Number:
- 223-672-9
- EC Name:
- 2,3-epoxypropyl isopropyl ether
- Cas Number:
- 4016-14-2
- Molecular formula:
- C6H12O2
- IUPAC Name:
- 2-[(propan-2-yloxy)methyl]oxirane
- Test material form:
- not specified
- Details on test material:
- No details available
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: commercial laboratory in Gilroy, Calif.
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- not specified
- Remarks on MMAD:
- MMAD / GSD: no data
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: chambers of 200 liters capacity
- Method of holding animals in test chamber:
- Source and rate of air:
- Method of conditioning air: The constant-metering device, similar to that described in the section on acute exposures (The motor-driven syringe assembly delivered measured amounts of the test compound from a 10 ml. Luer-Lok syringe into an evaporator through which metered air moved, at a uniform rate.), delivered the liquid in measured amounts to the evaporator, where they were vaporized in the air entering the chamber. The air in the chamber was allowed to equilibrate to a theoretical 95% to 99% of the desired concentration before the animais were introduced.
- Air flow / change rate: air flow ranged from 11.7 to 22.0 liters per minute (3.5 to 6.6 air changes per hour)
TEST ATMOSPHERE
- Brief description of analytical method used: Vapor concentrations were monitored by frequent analysis of air drawn from a sampling port and absorbed in a magnesium chloride and hydrochloric acid solution - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Vapor concentrations were monitored by frequent analysis of air drawn from a sampling port and absorbed in a magnesium chloride and hydrochloric acid solution.
- Duration of treatment / exposure:
- 10 Weeks
- Frequency of treatment:
- 7 hours daily, 5 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
400 ml/m³
Basis:
no data
- No. of animals per sex per dose:
- 10 male animals
- Control animals:
- yes
- Details on study design:
- No details available
- Positive control:
- No details available
Examinations
- Observations and examinations performed and frequency:
- The rats were carefully observed at intervals during the exposure and were weighed weekly.
- Sacrifice and pathology:
- At the end of the experimental period all survivors were decapitated under light ether anesthesia, and blood was collected for hemoglobin determination (Sahli method). At necropsy the animals were carefully examined for gross pathologic changes, and the lungs, livers, and kidneys of all animals were freed of connective tissue and excess moisture and weighed for determination of organ/body weight ratios. Sections of these tissues were retained for histologic examination, and also tissues from alternate animals, as follows: brain, thyroid, thymus, heart, stomach, intestine, pancreas, adrenal, testis, and bladder.
Organ/body weight ratios, percentage weight gain, and hemoglobin concentrations of the experimental animals were compared with those of the controls by the "Student" t-test. - Other examinations:
- No details available
- Statistics:
- Organ/body weight ratios, percentage weight gain, and hemoglobin concentrations of the experimental animals were compared with those of the controls by the "Student" t-test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- no mortality occurred
- Mortality:
- no mortality observed
- Description (incidence):
- no mortality occurred
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- weight loss or decreased weight gain
- 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 specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Organ/body weight ratio for liver, kidney unchanged
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Slight ocular irritation and respiratory distress were seen, similar to the signs shown with glycidol at the same level. However, there was a significantly greater decrease in the mean weekly weight gains (P=<0.01).
At necropsy some decrease in peritoneal fat was seen, and the lungs of 4 of the 10 rats appeared somewhat emphysematous; two showed some mottling of the liver. One of the latter showed confluent pneumonia on microscopic examination, but all other sections examined were within normal limits.
Effect levels
open allclose all
- Dose descriptor:
- LOEC
- Effect level:
- 400 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: decreased bodyweight gain, hemoglobin increase
- Dose descriptor:
- NOEC
- Effect level:
- 400 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Body/organ weight ratios liver, kidney; mortality
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The method was conducted scientifically reasonable with some deficiencies in documentation. It can be used to support the data of the key study via oral application.
- Executive summary:
A group of ten male Long-Evans rats was exposed to an isopropyl glycidyl ether concentration of 400 ppm (400 ml/m³), 7 hours daily, 5 days per week for 10 weeks. Slight eye irritation and laboured breathing were observed; the body weight gain of the exposed animals was less than that of the controls. Mild emphysema was found in the lungs of four of the ten rats. [Hine, C. H., J. K. Kodoma, J. S. Wellington, M. K. Dunlap, H. H. Anderson: "The toxicology of glycidol and some glycidyl ethers", Arch. Ind. Health 14, 250 (1956)]
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