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EC number: 203-685-6 | CAS number: 109-59-1
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well reported study. not to GLP. Rationale for using a read across substance is included in overall remarks section.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
- Reference Type:
- publication
- Title:
- Comparative acute and subchronic toxicity of ethylene glycol propyl ether and ethylene glycol monopropyl ether acetate
- Author:
- Katz GV, Krasavage WJ, Terhaar CJ
- Year:
- 1 984
- Bibliographic source:
- Env Hlth Persp, 57, 165-75
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- 6 week test period. Not all end points examined.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2-(propyloxy)ethanol
- EC Number:
- 220-548-6
- EC Name:
- 2-(propyloxy)ethanol
- Cas Number:
- 2807-30-9
- Molecular formula:
- C5H12O2
- IUPAC Name:
- 2-propoxy-1-ethanol
- Details on test material:
- - Name of test material (as cited in study report): Ethylene glycol mono propyl ether
- Physical state: liquid
- Analytical purity: >99.1%
- Other: EK Acc #:907124. TEX#:1115-2. PM#:9328. HS&HFL Lab#:79-419
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CR, COBS, CD, BR albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Weight at study initiation: 235.7+/-15.1g
- Housing: individual in suspended wire bottomed cages.
- Diet (e.g. ad libitum): ad libitum, Purina rodent chow 5001
- Water (e.g. ad libitum): ad libitum via automatic watering system
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Doses recalculated weekly to allow for animal growth.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6 weeks
- Frequency of treatment:
- daily, 5 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
195, 390, 780, 1560 mg/kg bw/day
Basis:
nominal in water
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: none
- Dose selection rationale: based on 50%, 25% , 12.5%, 6.25% of the fasted LD50. - Positive control:
- A number of other glycol ethers were assessed in the same study effectively acting as reference controls.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily, except weekends.
- Cage side observations: signs of systemic toxicity, appearance and behaviour. Urine and faeces appearance. Mortality.
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 3, 6, 13, 20, 27, 34, 41.
FOOD CONSUMPTION AND COMPOUND INTAKE - measured at same times as body weight.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / No data
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: from vena cava immediately prior to autopsy.
- Anaesthetic used for blood collection: Yes (identity) / No / No data
- Animals fasted: No data
- Parameters checked : Hgb, Hct, RBC count and indices, total and relative WBC count,
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: from vena cava immediately prior to autopsy.
- Animals fasted: No data
- Parameters checked: glutamic oxaloacetic transaminase, glutamic pyruvic transaminase (GPT), ALP, LDH, BUN, creatinine and glucose.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: Animals that died spontaneously were autopsied as soon as possible. Moribund animals were sacrificed and similarly autopsied. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Survivors killed by CO2 inhalation. Tissues examined: lung, heart, thymus, kidney, liver, spleen, brain, salivary glands, stomach, cecum, colon, duodenum, jejenum , ileum, pancreas, esophagus, adrenals, pituitary, thyroid, parathyroid, trachea, mesenteric lymph nodes, testes, epididymides, prostate, seminal vesicles, coagulating gland, bone marrow, tongue, nasal cavities, eyes. - Statistics:
- No information
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
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No significant mortality seen that could be attributed to the substance. All animals showed bloody urine after first dose. This resolved for the low dose groups but persisted for the mid and high dose animals. Clinical signs (third and high dose groups only) were weakness, prostration, laboured breath and rales.
BODY WEIGHT AND WEIGHT GAIN: Slight but statistically non-significant body weight gain reductions seen in all dose groups. A slight reduction in terminal body weight was seen in the top dose group only.
FOOD CONSUMPTION:The high dose group showed a statistically significant reduction in food consumption during the first 2 weeks.
HAEMATOLOGY: Decreased Hgb, total RBC and in all dose with a clear dose response relationship. No effect on packed cell volume or WBC count. The mid and high dose groups produced increased MCV and MCH and decreased MCHC. The two lower dose groups had no impact on the red cell indices.
ORGAN WEIGHTS: All dose groups showed increased spleen weights. The absolute and relative values were statistically significant in the top two dose groups. Slight but statistically significant increases in liver weight (both relative and absolute) were seen but not regarded as toxicologically significant. All other organ weights, including testes, were normal.
GROSS PATHOLOGY: Enlarged dark spleens at the two higher dose in around half the animals. A single animal showed this in the second dose group but none were seen in the lowest dose goup.
HISTOPATHOLOGY: NON-NEOPLASTIC: Splenic congestion and extramedullary hematopoesis were seen in all but the lowest dose group. Renal proteinaceous casts were seen along with haemosiderin in the proximal convoluted tubules. Liver effects were focal haemosiderin in the high dose group only.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- < 195 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: Clinical signs (discoloured urine), Haematology (RBC effects), Gross and histological effects on spleen.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The most significant toxic effects seen were adverse changes to the red blood cells followed by splenic congestion, enlargement and extramedullary haematopoesis. A true no effect level was not observed.
- Executive summary:
In a 6 week sub-acute gavage study using 2 -n-propoxyethanol that broadly followed the standards for such tests pertaining at the time, standard toxicological end points were studied for rats in doses up to 1560mg/kg. . The most significant adverse effects were changes to the red blood cells, manifest as reduced RBC count, decreased haemoglobin and increased MCH and MCV from the low dose group upwards. . Splenic congestion and enlargement along with extramedullary hematopoesis were also seen, possible as a secondary consequence of the apparent haemolytic effects. No no effect level was observed because of the haemolytic effects. Because of the structural similarities, 2 -isopropoxyethanol is likely to show similar toxicity.
Synopsis:
NOAEL(6 week, rat, oral gavage) = 195mg/kg/day
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