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EC number: 200-578-6 | CAS number: 64-17-5
- 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
ORAL (LD50 values)
Rat: female: 15010mg/kg; male (young adult): 10600mg/kg; male (old adult); 7060mg/kg; not sex specific: old adult: 11500mg/kg; young adult: 17750mg/kg; immature animal: 6160mg/kg, ~12000mg/kg, male/female :10470mg/kg; >7692mg/kg (female).
Mouse: 8350mg/kg
Human: LD50 ~2000mg/kg
INHALATION
Rat (4hr): LC50: male: 51mg/l, female: 55mg/l
Mouse: LC50>60000ppm
DERMAL
No reliable data. Information indicates LC50>15800mg/l
INTRAPERITONEAL (LD50 values)
Rat: young animals LD50 5500-6710mg/kg. Old animals LD50: 4070-5100mg/kg
Mouse: Male 9020, 9710mg/kg. Female: 9450mg/kg.
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:
- 1976-02-26 to 1976-03-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD guideline 401.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Cox CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not available
- Age at study initiation: not available
- Weight at study initiation: 199-215 g
- Fasting period before study: not available
- Housing: not available
- Diet (e.g. ad libitum): not available
- Water (e.g. ad libitum): not available
- Acclimation period: not available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not available
- Humidity (%): not available
- Air changes (per hr): not available
- Photoperiod (hrs dark / hrs light): not available
IN-LIFE DATES: From: 1976-02-26 To: 1976-03-19 - Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: not applicable
- Amount of vehicle (if gavage): not applicable
- Justification for choice of vehicle: not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
MAXIMUM DOSE VOLUME APPLIED: 19.6 ml/kg
DOSAGE PREPARATION (if unusual): not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not applicable - Doses:
- 8200, 9840, 11480 and 16070 mg/kg
- No. of animals per sex per dose:
- 10 animals total (5 male/5 female) at 8200, 9840, 11480 and 16070 mg/kg
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for observation and body weights were taken at initial and termination of the study
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight and mortalities - Statistics:
- Not applicable
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 10 470 mg/kg bw
- 95% CL:
- 9 720 - 11 380
- Mortality:
- 8200 mg/kg: 0/10
9840 mg/kg: 3 female animals/10
11480 mg/kg: 8 (5 female animals)/10
16070 mg/kg: 10 (5 female animals)/10 - Clinical signs:
- other: 8200 mg/kg: moderate decrease in motor activity and respiratory rate, moderate blanching, gripping and ataxia 9840 mg/kg: moderate decrease in motor activity and respiratory rate, moderate pupillary response moderate gripping and ataxia 11480 mg/kg: extre
- Gross pathology:
- No gross abnormalities were seen upon gross necropsy
- Other findings:
- - Organ weights: not available
- Histopathology: not available
- Potential target organs: not available
- Other observations: none - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 5% H2O in 95% Ethanol : OECD GHS: LD50= 10470 mg/kg (based on 95% active test material)
- Executive summary:
In a guideline acute oral toxicity study, the LD50 was determined to be 10470 mg/kgbw when dosed as a 95% solution in water.
Reference
None
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 10 470 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ethanol rein
- Physical state: clear liquid
- Analytical purity: 99.8% - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA, Sulzfeld
- Mean weight at study initiation: 185 ± 15 g
- Diet (e.g. ad libitum): Herilan MRH
- Water (e.g. ad libitum): Tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- The test substance was heated up to 65 °C, the vapors generated were mixed with a stream of fresh air and delived to the inhalation-system in constant amounts with the help of a dosing pump.
TEST ATMOSPHERE
- Brief description of analytical method used: Gas-chromatography
- Samples taken from breathing zone: yes - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gas-chromatography
- Duration of exposure:
- 4 h
- Concentrations:
- 155.0, 115.4, 93.4, 79.1, 62.0 mg/l
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were observed daily, body weight were measured at the begining of the study and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Probitanalysis as described in DJ Finney (Probitanalysis 1971, 1 - 150).
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 124.7 mg/L air
- Exp. duration:
- 4 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 116.9 mg/L air
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 133.8 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- see free text
- Clinical signs:
- other: In the top 4 dose groups: attempts to escape, reddish-watery eyes, nasal secretions, closing of eyelids, snout wiping, intermittent respiration, loss of pain reflex, narcosis, ruffled fur-coat and squatting position. The surviving animals were free from s
- Body weight:
- The body weight of males in higher dose groups was slightly decreased.
- Gross pathology:
- Deceased animals: acute dilation and hyperemia in heart. Lungs showed partly acute flatulence of middle grade. Additionally, lungs were partly spotted, infracted, blood-filled and edematous.
Sacrificed animals: no abnormalities - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results, the test substance do not require any classification according to EU and GHS standards.
- Executive summary:
In an acute inhalation study that approximated to guideline, ethanol vapour was found to be of very low acute toxicity to male and female rats. The LC50 (4hr) was established to be around the 117 -125mg/l and the LC0 around 62mg/l. It is worthy of note that the LD50 is well above the lower explosive limit (LEL).
Reference
Concentration (mg/L) |
Mortality |
|
male |
female |
|
155.0 |
7/10 |
9/10 |
115.4 |
7/10 |
1/10 |
93.4 |
2/10 |
0/10 |
79.1 |
1/10 |
0/10 |
62.0 |
0/10 |
0/10 |
Endpoint conclusion
- Dose descriptor:
- LC50
- Value:
- 50 000 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 15 800 mg/kg bw
Additional information
ORAL ROUTE
In two guideline studies, the LD50 of ethanol was determined to be in the region 10000 to 10500mg/kgbw when dosed at concentrations of 80 -95% in water. In an acute oral toxicity study to guideline using the up and down procedure, the Oral LD50 in female rats of SDA Alcohol (100% ethanol) was determined to be >7692 mg/kg bw. In an acute toxicity study in female rats using a relatively large number of animals over 7 closely spaced doses, an LD50 value of 14500 -15500mg/kg was obtained. Animals were only observed for a period of 24 hours. Another study examined the effect of age of male rats on the oral LD50. Using a relatively large number of animals and 6 -8 doses, an LD50 value of 10600mg/kg was obtained for young animals (~100 days old) whereas a significantly lower figure of 7060mg/kg was obtained for older rats (~11 -12 months old). Animals were again only observed for a period of 24 hours. Another study, for which only basic experimental detail is reported, also examined the effect of age of rats on the oral LD50, which was obtained for three groups of animals: immature 14 day old animals, young and old adults. The study confirmed that both old and young animals are more sensitive to toxic effects than are young adults. For those studies that only observed for 24 hours following dosing, it is unlikely that significant deaths would have occured after this point due to the known toxicokinetics of metabolism. In these studies, those animals that died showed severe CNS effects with death due to cardiorespiratory failure that was preceded by coma. In an acute toxicity study in male and female mice, an LD50 value of 8350mg/kg was obtained. All deaths occurred within the first 24 hours of dosing. The dose response curve was relatively steep; an LD50:LD16 ratio of 1.19 was obtained. In an acute oral toxicity study , the LD50 was determined for different concentrations of ethanol in water. The LD50 was consistently found to be around 12g/kgbw and independent of the concentration dosed (range used 30 -90% ethanol in water). The value chosen for the critical parameter is the figure from a guideline study. Older rats were shown to be somewhat more sensitive but such variations are taken into account in intraspecies assessment factors.
A comparison of the rat per oral versus intraperitoneal LD50 values suggests that first pass metabolism is significant and reduces effective systemic dose by ~50% by this route of exposure.
Human data
In a poisoning incident involving consumption of an ethanol based hand sanitiser, an estimated dose of 1.5g/kg ethanol caused marked intoxication of a 4 year old child but all effects were fully reversed within 24 hours (Engel, 2010). In another child, a dose of ~4.5g/kg caused unconciousness but the patient fully recovered with supportive treatment only. However, in a poisoning incident involving vodka consumption, an estimated dose of 2 -3g/kg ethanol proved fatal for a 5 year old child (Klys, 2008). In a case study, a 15 year of girl consumed a bottle of tequila sufficient to provide a resultant dose of 4.2 -4.8g/kg; the patient fully recovered after supportive treatment only. serum ethanol concentration of >526mg/dL proved fatal in an adult alcoholic (~3g/kg). In a poisoning case of an adult, a dose of 175g of ethanol (estimated 2.2g/kg) proved fatal. However, the patient was already intoxicated with alcohol (estimated blood ethanol concentration 188mg/l). The resulting blood ethanol concentration was at least 526mg/dL (252g ethanol for an 80kg person assuming a volume of distribution of 0.6L/kg). A retrospective study was carried out to examine ethyl alcohol poisoning related deaths in Ankara and surrounding cities between 2001 and 2011. Of the medico-legal autopsy cases performed, 39 (0.36% ) were identified as due to ethanol poisoning alone. The overwhelming majority of the cases were male (90.5%) and the mean age of the victims was 44.9 (range 10.9 to 92 years). The levels of postmortem blood alcohol levels were available for all cases and ranged from 136 to 608 mg/dL for ethanol (estimated 0.75 to 3.3g/kg) The lower end of the range may be unreliable as significant metabolism could have occured before death. (Celik, 2013). This suggests for humans the fatal dose for ethanol is variable but greater than 2g/kg along with blood ethanol concentrations in excess of 300mg/dL (which, assuming a volume of distribution of ~60% of human body weight, would equate to 1.8g/kg - remarkably consistent with the previous figure. Crudely, an LC50 of ~2g/kg in humans can be assumed.
DERMAL ROUTE
According to Annex VIII, testing by the dermal route for acute toxicity is appropriate if all of the following conditions are met: inhalation of the substance is unlikely, skin contact in production or use is likely and the physicochemical and toxicological properties suggest potential for a significant exposure. Clearly inhalation is likely and will be the dominant route of exposure. Whilst skin contact will occur, available data suggests that under non-occlusive conditions, evaporation is so rapid that dermal exposure is negligible. Annex VIII indicates that testing for acute toxicity is only required by two routes of exposure. Data is available on the oral and inhalation routes. In addition, there is sufficient data available to enable reliable extrapolation from the oral to the dermal route if required. There is data from a secondary source that cites an unreferenced result from an acute dermal toxicity study: a single dose of 15800mg/kg caused the death of 1 out of 4 rabbits. This indicates that the LD50 is greater than 15800mg/kg and is the figure used as the critical LD50.
INHALATION ROUTE
In an acute inhalation study that approximated to guideline but extended the exposure time to 6 hours, ethanol vapour was found to be of low toxicity. The LC50 (6hr) was established to be around 50 -55mg/l and the LC0 around 43 -44mg/l. In another acute inhalation study that approximated to guideline but extended the exposure time to 6 hours, the LC50 (6hr) was established to be around 50 -55mg/l and the LC0 around 43 -44mg/l. To put these results into context, it is worth noting that the lower explosive limit (LEL) is around 50mg/l.
In another study to determine non lethal as well as lethal effects, mice were exposed to ethanol for different periods of time up to 1 hour in order to determine the LC50 and the EC50 for motor performance. An LC50 could not be obtained for inhalation exposure; no deaths were reported for exposures up to 60,000ppm (114mg/l), which can be considered the saturated vapour concentration. In the motor performance test, an EC50 60 min value of 30,300ppm was established, with a slope for the dose effect curve of 12.6. This result differed only slightly from the EC50 30 min. It should be noted that all of the reported EC50 values are above the LEL reported in chapter 4.
Based on the results available, inhalation exposure poses little hazard at any feasible exposure concentration.
Justification for classification or non-classification
All LD50 and LC50 are by some margin above the thresholds for classification for acute toxicity either under directive 67/548 or the EU CLP regulations.
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