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EC number: 203-539-1 | CAS number: 107-98-2
- 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
Endpoint summary
Administrative data
Description of key information
GLP guideline studies for acute toxicity via oral, dermal and inhalation exposure are available for propylene glycol methyl ether. These studies are supported by several non-GLP studies equivalent or similar to OECD guidelines 401, 402 and 403. The studies rated as Klimisch 1 (reliable without restrictions) have been selected as as key studies for the hazard assessment.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study methodology followed was equivalent or similar to EU Method B.1 and in accordance with the Principles of GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 180-250 g (male) and 110-170 g (female)
- Fasting period before study: overnight fasting (18 hours)
- Housing: 2-3 rats/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified in the report
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): not specified in the report
- Air changes (per hr): not specified in the report
- Photoperiod (hrs dark / hrs light): 12 hours light:dark cycle - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test material was administered undiluted.
- Doses:
- 2500, 3150, 3970 and 5000 mg/kg
- No. of animals per sex per dose:
- 5 males + 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: initial, day 7 and day 14
- Necropsy of survivors performed: yes - Statistics:
- probit analysis
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 4 277 mg/kg bw
- 95% CL:
- 3 478 - 5 572
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 739 mg/kg bw
- 95% CL:
- 2 573 - 7 986
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 016 mg/kg bw
- 95% CL:
- 3 503 - 4 915
- Mortality:
- Refer to Table 1 for further details.
- Clinical signs:
- other: Refer to Tables 2 and 3 for further details, rats in all the dose groups were overtly affected, the commonest clinical signs being gait abnormalities, chromodacryorrhoea and piloerection. The majority of the rats that died were comatose prior to death - i
- Gross pathology:
- Refer to Tables 2 and 3 for further details
- Other findings:
- - Organ weights: no data
- Histopathology: no data
- Potential target organs: no data - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, the LD50 for methyl proxitol to rats (combined) was 4016 mg/kg (3503-4915 mg/kg), for females was 4277 mg/kg (3478-5572 mg/kg) and for males was 3739 mg/kg (2573-7986 mg/kg)
- Executive summary:
The acute oral toxicity of methyl proxitol was evaluated in groups of rats (5 males + 5 females) at doses of 2500, 3150, 3970 and 5000 mg/kg. Mortality was observed in all the dose groups. Rats in all the dose groups were overtly affected, the commonest clinical signs being gait abnormalities, chromodacryorrhoea and piloerection. The majority of the rats that died were comatose prior to death - in some cases they were unconscious for 48 hours or more before death. Four rats from the 3970 mg/kg dose group and one male from the 5000 mg/kg dose group were comatose for part or all of day 2 but recovered. All surviving animals had gained weight relative to their day 0 body weights by the end of the 14-day observation period. Based on the results of the study, the LD50 for methyl proxitol to rats (combined) was 4016 mg/kg (3503-4915 mg/kg), for females was 4277 mg/kg (3478-5572 mg/kg) and for males was 3739 mg/kg (2573-7986 mg/kg)
Reference
Table 1: Mortality Table
Dose (mg/kg) | Cummulative mortality (14 days) | ||
Male | Female | Total | |
2500 | 1/5 | 0/5 | 1/10 |
3150 | 1/5 | 0/5 | 1/10 |
3970 | 3/5 | 2/5 | 5/10 |
5000 | 4/5 | 4/5 | 8/10 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 016 mg/kg bw
- Quality of whole database:
- Good (Klimisch 1)
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study methodology followed was equivalent or similar to OECD TG and was conducted in accordance with the Principles of GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: approximately 8-9 weeks
- Weight at study initiation: not specified in the report
- Fasting period before study: not specified in the report
- Housing: two/cage in stainless steel wire cages
- Diet (e.g. ad libitum): Purina certified Rodent Chow #5002 available ad libitum, except during exposure
- Water (e.g. ad libitum): Municipal tap water available ad libitum, except during exposure
- Acclimation period: one week prior to exposure
ENVIRONMENTAL CONDITIONS
- Temperature (°C): standard conditions
- Humidity (%): standard conditions
- Air changes (per hr): standard conditions
- Photoperiod (hrs dark / hrs light): standard conditions - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel and glass Rochester-type inhalation chamber (50 x 50 x50 cm) with a pyramidal top, under dynamic conditions
- Exposure chamber volume: 157 liter stainless steel
- Method of holding animals in test chamber: whole-body exposure
- Source and rate of air: ambient
- Method of conditioning air: not specified in the report
- Treatment of exhaust air: not specified in the report
- Temperature, humidity, pressure in air chamber: 22 °C and 50%
TEST ATMOSPHERE
- Brief description of analytical method used: The analytical concentration of DOWANOL PM in the breathing zone of the animals was determined continuously with a Miran 1A infrared (IR) spectrophotometer at a wavelength of 8.9 microns. The IR was calibrated and a standard curve compiled, prior to start of the study, with air standards of DOWANOL PM, prepared by vaporizing measured volumes of DOWANOL PM into Saran fim bags containing metered volumes of dry, compressed air. The analytical concentration during each exposure was interpolated from a standard curve. The analytical system was checked prior to each exposure with at least one standard of known concentration. The nominal concentration of the test material in the chamber was calculated based on the amount of test material used and the total amount of air passed through the chamber during the exposure period.
- Samples taken from breathing zone: not specified in the report - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 6 h
- Concentrations:
- 6000 ppm nominal (6038 ppm analytical), 7000 ppm nominal (7559 ppm analytical)
- No. of animals per sex per dose:
- 5 male + 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation and animals weighed on days 1, 2, 4, 8, 11 and 15
- Necropsy of survivors performed: yes - Statistics:
- Descriptive statistics - means and standard deviations of body weights, chamber concentration (time-weighted average, only), temperatures, relative humidity and air-flows were calculated
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- > 7 000 ppm
- Exp. duration:
- 6 h
- Remarks on result:
- other: 7559 ppm (analytical)
- Mortality:
- No mortalities observed
- Clinical signs:
- other: 6000 ppm: All rats were generally unresponsive to noise with only staggered movement the last three and one half hours of the exposure. Upon removal from the chamber, all rats were laterally recumbent with sporadic, staggered movement. By day 2, all male
- Body weight:
- 6000 ppm: Body weights of both the sexes were decreased 11%, from pre-exposure values, on the day of exposure, but had exceeded pre-exposure weights within a week.
7000 ppm: Male body weights were decreased 10% from pre-exposure values, on the day after exposure, but had exceeded pre-exposure weights within a week. Female body weights on day 4 were decreased 11% from pre-exposure values and did not exceed pre-exposure values until day 11 - Gross pathology:
- 6000 ppm: Gross examination of all animals after the two-week post-exposure period only found a unilateral corneal opacity in one female and there were no effects attributable to DOWANOL PM exposure.
7000 ppm: Gross examination of all animals after the two-week post-exposure period did not find any effects attributable to DOWANOL PM exposure - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In summary, female rats seemed to be affected to a greater degree as they required a longer period of time than males before returning to normal. There were no mortality or lesions in male or female Fischer 344 rats attributable to exposure to either 6000 ppm nominal (6038 ppm analytical) and 7000 ppm nominal (7559 ppm analytical) DOWANOL PM. The LC50 of DOWANOL PM to male and female Fischer 344 rats is in excess of 7000 ppm nominal (7559 ppm analytical)
- Executive summary:
Groups of five male and five female Fischer 344 rats were exposed for six hours to nominal concentrations of 6000 ppm and 7000 ppm (analytical concentrations of 6038 ppm and 7559 ppm) of DOWANOL PM. Animals were observed daily, weighed two to three times per week and survivors were necropsied two weeks after exposure.
All rats survived the exposure to 6038 ppm and the two -week post-exposure period. All rats were laterally recumbent and generally unresponsive to noise during most of the exposure to 6038 ppm and did not appear normal until day 2 (males and two females) or day 3 (remaining females). For exposure to 7559 ppm, all rats appeared normal on day 3. Mean body weights of both sexes for either exposure were decreased to 10 -11%, from pre-exposure levels, on the day after exposure, but exceeded pre-exposure values generally within a week. There were no exposure-related, grossly visible lesions noted in any animal necropsied fourteen days after exposure to the test material.
Based on the results of the study, the six-hour LC50 for DOWANOL PM to male and female Fischer 344 rats is greater than 7000 ppm nominal (analytical 7559 ppm).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Good (Klimisch 1)
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study methodology followed was equivalent or similar to EU Method B.3 and was conducted in accordance with the Principles of GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 180-250 g (male) and 110-170 g (female)
- Fasting period before study: no
- Housing: 2-3 rats/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified in the report
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): not specified in the report
- Air changes (per hr): not specified in the report
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area
- % coverage: 60% of the dorsal area
- Type of wrap if used: waterproof adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: at the end of the 24-hour exposure period
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Constant volume or concentration used: no data= - Duration of exposure:
- 24-hours followed by a 14-day observation period
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 male + 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weights recorded on days 0, 7 and 14
- Necropsy of survivors performed: not specified in the report
- Other examinations performed: clinical signs - Statistics:
- not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality was observed
- Clinical signs:
- other: No overt clinical signs were observed
- Gross pathology:
- not specified in the report
- Other findings:
- no data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, the LD50 of methyl proxitol to rats (combined) was greater than 2000 mg/kg (the maximum dose applied)
- Executive summary:
The acute dermal toxicity study was evaluated in a group of rats (5 male + 5 female) at the maximum applicable dose of 2000 mg/kg, no mortality and clinical signs were recorded and all rats gained weight during the 14 day observation period. Based on the results of the study, the LD50 of methyl proxitol to rats (combined) was greater than 2000 mg/kg (the maximum dose applied)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Good (Klimisch 1)
Additional information
Oral - The oral LD50 value for propylene glycol methyl ether in experiments in rats ranges from 4016 to 7950 mg/kg. Oral LD50 values from other animal experiments were 10,800 mg/kg for mice; 1840 to 5300 mg/kg for rabbits, and 4600 to 9000 mg/kg for dogs. The key study identified for acute oral toxicity is the Shell (1985) study in rats and the LD50 value (male and female) is 4016 mg/kg body weight.
Dermal - When applied occluded to the skin of rabbits, the LD50 value was found to be in the range of 13 -14 g/kg. The acute (24 hr) percutaneous LD50 of the undiluted test material in rats was greater than 2000 mg/kg (the maximum dose that could be applied). The key study identified for acute dermal toxicity is the Shell (1985) study in rats and the LD50 value (male and female) is greater than 2000 mg/kg.
Inhalation - The LC0 values were >6000 to 15000 ppm (22478 to 56197 mg/m3) for rats; <6038 to 7559 ppm for mice (22620 to 28319 mg/m3), and >14600 ppm (54697 mg/m3) for guinea pigs. The key study is the Dow (1991) study in rats with an LC0 of greater than 7000 ppm (duration 6 hours), which would be equivalent to approximately 26.22 mg/l (based on conversion equation at 20 degree celsius and 1 atmosphere). Using Haber's law for converting this six hour exposure to a 4 -hour exposure, the equivalent value is 30.02 mg/l or 30020 mg/m3.
Justification for selection of acute toxicity – oral endpoint
Guideline equivalent study in accordance with the Principles of GLP
Justification for selection of acute toxicity – inhalation endpoint
Guideline equivalent study in accordance with the Principles of GLP
Justification for selection of acute toxicity – dermal endpoint
Guideline equivalent study in accordance with the Principles of GLP
Justification for classification or non-classification
LD50 values for oral and dermal route are greater than 2000 mg/kg/bw and LC0 values for the inhalation route are greater than 20 mg/l. As in the other acute oral studies and dermal and inhalation studies, there were no clinical signs and no mortalities observed, propylene glycol methyl ether will not be classified for acute oral toxicity as per UN-GHS (4th edition).
According to the EU criteria for classification and labeling, propylene glycol methyl ether is not classified for acute toxicity for any route of exposure.
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