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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: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-guideline non-GLP study but with adequate and well described methods and results from an original study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Follows the basic principles of an OECD 413 guideline study. Not all end points examined.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2-isopropoxyethanol
- EC Number:
- 203-685-6
- EC Name:
- 2-isopropoxyethanol
- Cas Number:
- 109-59-1
- Molecular formula:
- C5H12O2
- IUPAC Name:
- Propan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): isopropyl oxitol
- Lot/batch No.: 740731
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFE (Carworth Farm E-strain)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Tunstall Laboratory (bred under specific pathogen-free conditions)
- Age at study initiation: 12-13 weeks
- Housing: 4animals/cage, 40animals/chamber
- Diet: food was removed before every exposure
- Water: ad libitum
- Acclimation period: 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature of the air supply to the chambers was maintained at 65 +/- 2 degree F
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 10 m3 stainless steel inhalation chamber
- Method of conditioning air:
- Source and rate of air: Air was drawn from the main body of the laboratory in which the chambers were located by independent centrifugal fans mounted in the exit ducts from the chambers, preventing any leakage of the test atmospheres into the laboratory.
- System of generating particulates/aerosols: The test atmospheres were generated by vaporizing the solvent in an induced air flow to produce a concentrated vapor/air mixture which was then diluted to the desired concentration by the main air flow into the chamber. The vaporizer was a quartz-sheathed heating element wound with glass fiber tape to increase the surface area, and the solvent was fed onto this surface from a solvent reservoir by means of a micrometering pump.
- Temperature, humidity, pressure in air chamber: temperature of the air supply to the chambers was maintained at 65 +/- 2 degree F
- Air flow rate: Top dose chamber = 3.5 m3 min-1 ; three other chambers = 4.3 m3 min-1
TEST ATMOSPHERE
- Brief description of analytical method used: Two different analysis systems were used in this experiment.
One system, which was two Beckman 109A Total Hydrocarbon analysers, enabled a continuous monitoring of the test atmospheres to be carried out during the exposure period. These analysers quickly responded to changes made in the atmosphere generation system and/or total chamber air flow rate, so that adjustments could be made to maintain the desired concentration of toxicant in the test atmospheres. This was particularly useful during the start-up period.
The other system consisted of a Beckman GC 2A gas chromatograph fitted with a flame ionisation detector and an auto gas sampling valve. Test atmosphere from each of the three chambers in turn was drawn continuously through the gas sampling system, and a sample was transferred to the column every 6 min. The peak heights were averaged over the sampling period of approximately 75 min. The instrument was calibrated by means of an exponential dilution technique using a 12.5 liter stirred gas flask.
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The three test atmospheres were analyzed during the daily exposure period on both of the analysis systems, so that while continuous signals were obtained from the two Total Hydrocarbon analysers for two of the test atmospheres, the third atmosphere was being repeatedly chromatographed on the Beckman GC 2A. In this way, the concentrations of the solvent in the three test atmospheres could be determined, and any deviations from the desired values could be quickly spotted. The mean concentrations and ranges of solvent in the test atmospheres over the complete exposure period were 24 (16 to 30) ppm (v/v), 47 (32 to 56 ) ppm (v/v), and 197 (169 to 230 ) ppm (v/v).
- Duration of treatment / exposure:
- 26 weeks
- Frequency of treatment:
- 6hours/day, five days /week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 25, 50, 200 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 40 animals/sex/dose
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: Week 0, 1, 2, 9, 10, 12, 18, 21, 23, 26
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
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
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Week 0, 5, 9, 13, 18, 22, 26
- Anaesthetic used for blood collection: No data. Randomly selected rats were killed to provide blood samples by cardiac puncture
- Animals fasted: No data
- How many animals: week 0 = 12animals/sex/dose, week 5, 9, 13, 18, 22 = 3animals/sex/dose, week 26 = 22animals/sex/dose
- Parameters: Hb, PCV, RBC, WBC, MCV, MCH, MCHC, PT (prothrombin time), KCCT (kaolin cephalin coagulation time), Osmotic fragilities
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Week 0, 5, 9, 13, 18, 22, 26
- Animals fasted: No data
- How many animals: week 0 = 12animals/sex/dose, week 5, 9, 13, 18, 22 = 3animals/sex/dose, week 26 = 22animals/sex/dose
- Parameters : Protein, urea, ALP (Alkaline phosphatase), SGPT (Serum glutamic pyruvic transaminase), SGOT (Serum glutamic oxaloacetic transaminase), Na, K, Cl
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
The following organs were weighed at necropsy: brain, heart, liver, spleen, kidneys, testes.
HISTOPATHOLOGY: Yes
The following were examined: brain, heart, kidney, lung, spleen, liver, alimentary tract, pancreas, salivary gland, thymus, mesenteric lymph node, gonads, prostate or uterus, pituitary, adrenals, larynx, thyroid, eye and decalcified sections of nasal cavities. - Statistics:
- Body weights and organ weights were analyzed by covariance analysis using initial body weight as the covariate.Reported means were adjusted for initial body weight if a significant covariance relationship existed. Where no significant covariance relationship existed, means were reported unadjusted. Covariance analysis was also used with terminal body weight as the covariance to test whether organ weight differences could be attributed to the differences in terminal body weight or if differences in organ weight were concealed by body weight variation. Reported means were adjusted for terminal body weight if a significant covariance relationship existed. This is not a true covariance analysis since terminal body weight are dependent upon treatment and has only been reported when it aids the interpretation of body and organ weight difference.Clinical chemical and hematological parameters were examined using analysis of variance.The significance of any differences between treatment and control group means was tested using the Williams t-test.However, on some occasions a monotonic dose response relationship could not be assumed, in which case Dunnett’s test was used.
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):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No test substance related effects were observed.
BODY WEIGHT AND WEIGHT GAIN
No test substance related effects were observed.
HAEMATOLOGY
At 200 ppm a consistent and significant reduction in hemoglobin concentration was observed in male and female rats. This was accompanied by marginal reduction in packed cell volume and a consistently lower erythrocyte count. A consistent and significant elevated mean cell volume in the male and female rats exposed to 200 ppm isopropyl OXITOL was also noted. Small and inconsistent rises in erythrocyte counts occurred in both male and female rats. Changes in the osmotic fragility of rat erythrocytes occurred on occasions at all exposure levels (Table 1).At 25 ppm exposure level the 50% osmotic fragility was only statistically significant at week 22 in male rats and at week 13 and week 18 in female rats. No differences between control and 25 ppm treatment group were found at week 26, the end of the study.
CLINICAL CHEMISTRY
Significant decrease in plasma potassium was observed in both rats sexes in the 25, 50 and 200 ppm groups at week 26. The significance of this is not clear.
ORGAN WEIGHTS
Significant increase in the spleen weights were observed in male and female rats in the 200 ppm group.Significant increase in heart weight and decrease in liver weight were observed in male rats in the 200 ppm group.
GROSS PATHOLOGY
No test substance related effects were observed.
HISTOPATHOLOGY: NON-NEOPLASTIC
Amounts of brown pigment in kupffer cells of the liver in female rats in the 200 ppm group.Excessive amounts of hemosiderin in the red and white pulp of the spleen in male and female rats in the 50 ppm and 200 ppm groups.Extramedullary hematopoiesis was observed in the spleen of rats in the 200 ppm group.Small amounts of lipid in the liver parenchyma were observed in male rats in the 200 ppm group.
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 25 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Changes in osmotic fragility of erythrocytes
- Dose descriptor:
- NOAEC
- Effect level:
- 100 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Primary and secondary effects not related to haemolysis
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table-1. Osmotic fragilities of erythrocytes in rats.
Week No. |
Atomosphere |
|
|
Male |
|
|
|
|
Female |
|
No. of |
Osmotic fragilities |
|
No. of |
Osmotic fragilities |
||||||
0% |
50% |
100% |
|
0% |
50% |
100% |
||||
0 |
0 |
3 |
0.611 |
0.403 |
0.213 |
|
3 |
0.620 |
0.441 |
0.283 |
25 |
3 |
0.611 |
0.389 |
0.233 |
|
3 |
0.623 |
0.444 |
0.210* |
|
50 |
3 |
0.622 |
0.393 |
0.200 |
|
3 |
0.662 |
0.443 |
0.210* |
|
200 |
3 |
0.590 |
0.390 |
0.200 |
|
3 |
0.655 |
0.443 |
0.230 |
|
Standard deviation of |
|
0.0251 |
0.0162 |
0.0115 |
|
|
0.0288 |
0.0126 |
0.0329 |
|
5 |
0 |
2 |
0.720 |
0.47. |
0.230 |
|
3 |
0.608 |
0.463 |
0.248 |
25 |
3 |
0.632 |
0.455 |
0.203 |
|
3 |
0.713** |
0.490 |
0.217 |
|
50 |
3 |
0.695 |
0.460 |
0.195 |
|
3 |
0.708** |
0.505* |
0.255 |
|
200 |
3 |
0.760 |
0.515* |
0.257 |
|
3 |
0.799** |
0.550** |
0.171** |
|
Standard deviation of |
|
0.0425 |
0.0148 |
0.0230 |
|
|
0.0231 |
0.0159 |
0.0266 |
|
9 |
0 |
3 |
0.662 |
0.382 |
0.173 |
|
3 |
0.677 |
0.433 |
0.190 |
25 |
3 |
0.732 |
0.383 |
0.135 |
|
3 |
0.697 |
0.431 |
0.158 |
|
50 |
3 |
0.730 |
0.407 |
0.179 |
|
2 |
0.760** |
0.450 |
0.180 |
|
200 |
3 |
0.722 |
0.463** |
0.175 |
|
3 |
0.767** |
0.523** |
0.190 |
|
Standard deviation of |
|
0.0421 |
0.0187 |
0.0309 |
|
|
0.0149 |
0.0296 |
0.0353 |
|
13 |
0 |
3 |
0.660 |
0.369 |
0.117 |
|
3 |
0.653 |
0.402 |
0.145 |
25 |
3 |
0.665 |
0.427 |
0.160 |
|
3 |
0.707 |
0.428* |
0.165 |
|
50 |
3 |
0.682 |
0.427 |
0.128 |
|
3 |
0.730* |
0.437* |
0.150 |
|
200 |
3 |
0.717 |
0.473** |
0.160* |
|
3 |
0.774** |
0.507** |
0.167 |
|
Standard deviation of |
|
0.0307 |
0.0304 |
0.0203 |
|
|
0.0303 |
0.0131 |
0.322 |
|
18 |
0 |
2 |
0.645 |
0.350 |
0.113 |
|
1 |
0.661 |
0.390 |
0.160 |
25 |
3 |
0.673 |
0.397 |
0.118 |
|
3 |
0.663 |
0.423** |
0.150 |
|
50 |
3 |
0.657 |
0.398 |
0.130 |
|
3 |
0.643 |
0.443** |
0.153 |
|
200 |
3 |
0.713* |
0.467** |
0.114 |
|
3 |
0.750* |
0.493** |
0.150 |
|
Standard deviation of |
|
0.0246 |
0.0339 |
0.0198 |
|
|
0.735 |
0.528 |
0.188 |
|
22 |
0 |
3 |
0.660 |
0.375 |
0.193 |
|
3 |
0.662 |
0.420 |
0.157 |
25 |
3 |
0.700 |
0.433* |
0.163 |
|
3 |
0.663 |
0.407 |
0.168 |
|
50 |
3 |
0.725** |
0.428* |
0.210 |
|
3 |
0.715 |
0.448 |
0.227* |
|
200 |
3 |
0.744** |
0.480** |
0.178 |
|
3 |
0.735* |
0.528** |
0.188* |
|
Standard deviation of |
|
0.0254 |
0.0256 |
0.0349 |
|
|
0.0339 |
0.0336 |
0.0259 |
|
26 |
0 |
22 |
0.694 |
0.398 |
0.284 |
|
3 |
0.671 |
0.396 |
0.266 |
25 |
22 |
0.708 |
0.400 |
0.274 |
|
3 |
0.723 |
0.420 |
0.266 |
|
50 |
22 |
0.726** |
0.431** |
0.306** |
|
3 |
0.722 |
0.452** |
0.307 |
|
200 |
22 |
0.754** |
0.478** |
0.317** |
|
3 |
0.747** |
0.488** |
0.289 |
|
Standard deviation of |
|
0.0361 |
0.0223 |
0.0218 |
|
|
0.0924 |
0.0565 |
0.0515 |
*: p <0.05, **:p<0.01
Applicant's summary and conclusion
- Conclusions:
- Hemolytic effects occurred marginally at 25 ppm and clearly at 50 ppm and 200 ppm.The osmotic fragility of the erythrocytes of rats was significantly changed at 25, 50 and 200 ppm.
- Executive summary:
Ethylene glycol isopropyl ether was studied for subchronic inhalation toxicity in rats at concentrations of 0, 25, 50, or 200 ppm for 26 week, 6 h/day, 5 day/week. Haemolytic effects occurred marginally at 25 ppm and clearly at 50 ppm and 200 ppm.The osmotic fragility of the erythrocytes was significantly changed at 25, 50 and 200 ppm. Changes not associated as primary or secondary effects of haemolysis were only observed at 200ppm (changes in heart and liver weight).
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