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EC number: 203-311-1 | CAS number: 105-58-8
- 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
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Details about origin of study report/performing laboratory. No info about origin of method, the analyses of symptoms, the batch and purity of "Diätyhlcarbonat". However, details about test animals and test conditions were stated and as no symptoms and stable body weights were found for a relatively high number of animals (10) the report is regarded as reliable.
- Principles of method if other than guideline:
- single dose of 5 ml/kg bw administered by a stomach probe to 10 male rats; observation of clinicals symptoms over a period of 14 days
- GLP compliance:
- no
- Test type:
- other: single dose limit test
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: SPF rats, breeding strain Wistar TNO W 74
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: ca. 9 - 14 weeks
- Weight at study initiation: 169 g
- Fasting period before study: no data
- Housing: kept in conventional Makrolon cages type III and on dust-free wood granulate
- Grouping: animals kept in groups of 5
- Diet ad libitum: Altromin R 1324 (manufacturer: Altromin GmbH, Lage)
- Water ad libitum: tap drinking water
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature, 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 (artificial lighting from 7 am to 7 pm)
IN-LIFE DATES: From: To: no data
Identification of animals: with picric acid marking on fur and codes on cages - Route of administration:
- other: oral, with a rigid metal stomach probe
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5 ml/kg bw
- 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: weighing at the time of administration and at the end of the 14-day observation period (alive animals);
examinations several times/d on 1st day (day of administration), normally 2 times/d and on weekends and holidays 1 time/d.
- Necropsy of survivors performed: yes/no: no data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
weighing of body weights performed, limited data about other performed examinations:
"recording type, beginning, duration and intensity of clinical symptoms" - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: valid for all test animals (10)
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 876 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: This value was calculated by the author of this IUCLID dossier by multiplying the density of the test substance (0.9752 g/mL) with the measured LD50 volume (5 mL).
- Mortality:
- no mortality
- Clinical signs:
- other: none
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: other: as concluded in study report
- Conclusions:
- According to the determined LD50 of > 5.0 mL/kg (4876 mg/kg) of the test substance diethyl carbonate by oral administration to male Wistar rats, the test substance is practically nontoxic.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable publication
- GLP compliance:
- not specified
- Test type:
- other: acute oral toxicity study
- Species:
- rat
- Strain:
- other: Wistar-Stamm II BR 46
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight of animals: 200-340 g
- Route of administration:
- other: oral: stomach tube
- Vehicle:
- olive oil
- Doses:
- 22, 25, 28, 31, 34, 37 mL/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 28 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: after 24 hours
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 27.7 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: after 10 days
- Mortality:
- the mortiliy of the animals was 100 % at the highest administered dose (37 mL/kg bw).
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The LD50 of the test substance diethyl carbonate administered via a stomach tube as a 60 % solution in olive oil is 27.7 mL/kg bw (observation period 10 days). The corrected value for the LD50 is > 15.0 g/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: HSDB data (peer reviewed as stated there); original data source from Lewis (1996) could not be reviewed. No details on background data of LDLo value delivered (materials, methods, results).
- Principles of method if other than guideline:
- no information provided in data source
- Test type:
- other: no data
- Species:
- rat
- Sex:
- not specified
- Dose descriptor:
- LDLo
- Effect level:
- 15 other: g/kg
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The high LDLo Rat oral 15 g/kg suggests a low acute oral toxicity of diethyl carbonate.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The dose-response-descriptor LD50 has to be used in stead of the TDLo used in this reference (Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint specific guidance, R.7.4.1.2 Objective of the guidance on acute toxicity).
- Principles of method if other than guideline:
- Method: other: no data
- GLP compliance:
- not specified
- Test type:
- other: oral toxicity
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- other: oral
- Vehicle:
- not specified
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- other: TDLo
- Effect level:
- 500 mg/kg bw
- Conclusions:
- The determined value for the oral toxicity of the test substance diethyl carbonate was a TDLo (Lowest toxic dose) of 500 mg/kg in the mouse as testing organism. However, this low value was not used as key data for the endpoint acute toxicity oral, because the dose-response-descriptor has to be the LD50 (Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint specific guidance, R.7.4.1.2 Objective of the guidance on acute toxicity) and not the here given TDLo. There is no information given on how the CODEN (BCPCA6 2,168,59) is to be used or interpreted confirming the fact not to use the given value as key data.
- Endpoint:
- acute toxicity: oral
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only a statement in Hawley Condensed Chemical Dictionary (handbook)
- Conclusions:
- According to the cited reference the test substance diethyl carbonate was moderately toxic by ingestion. No information was given on what this result was based (no testing animal, no testing method).
Referenceopen allclose all
Information extracted from the study report:
Based on the test results the LD50 is > 5 ml/kg bw for male rats. No symptoms developed and the body weights were stable. Therefore, Diäthylcarbonat (engl.: diethyl carbonate) has proven to be relatively non-toxic in this acute toxicity test.
The predominant sign of toxicity was narcosis.
Information given in Sax, N.I. Dangerous properties of industrial materials 6th ed., page 1006:
orl-mus TDLo: 500 mg/kg TFX:ETA, BCPCA6 2,168,59
Assumptions of the author of this IUCLID data set:
Mice were administered the test substance diethyl carbonate orally. No information is given on the experimental procedure of this oral toxicity test or the gender of the animals. Other toxic effects which seem to have been observed were equivocal tumorigenic effects (TFX:ETA, other toxic effects:equivocal tumorigenic agents). The determined TDLo (lowest toxic dose) was 500 mg/kg.
There is no information given on how the CODEN is to be used or interpreted.
The reference was listed in the BG Chemie Report (1984) but the mentioned author (MacDougal, J.R.) was not listed on page 1006 of Sax, N.I. Dangerous properties of industrial materials 6th ed.
Cited from Hawley Condensed Chemical Dictionary (1977):
Moderately toxic by ingestion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 876 mg/kg bw
- Quality of whole database:
- Good quality of the data (study report).
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: acceptable study report on the acute inhalative toxicity determined for male and female rats.
- Principles of method if other than guideline:
- Inhalation studies were carried out according to methods from Farbenfabriken Bayer A.G., Werk Wuppertal-Elberfeld, Germany.
- GLP compliance:
- no
- Test type:
- other: acute toxicity inhalative
- Species:
- rat
- Strain:
- other: Male and female Wistar-II-rats (weight 160-200 g), male and female Wistar-II-SPF-rats (weight 130-150 g) from the breeder Winkelmann, Kirchborchen, Germany;
- Sex:
- male/female
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- other: probably whole body
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gas chromatography; Details on methodology see under 8 Analytical methods in this IUCLID dossier
- Duration of exposure:
- 7 h
- Remarks on duration:
- on day 1
- Concentrations:
- 4h on day 1: 17.75 mg/L (males), 18.30 mg/L (females);
7 h on day 1: 19.50 mg/L (males, females); - No. of animals per sex per dose:
- 20
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- other: NOEC
- Effect level:
- 19.5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 7 h
- Remarks on result:
- other: The endpoint NOEC was not mentioned in the study report and was assumed by the author of this IUCLID dossier as at this concentration no symptoms or deaths occurred.
- Mortality:
- 0
- Clinical signs:
- other: none
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- According to the results of an acute toxicity inhalation study of the test substance diethyl carbonate in male and female rats, no signs of toxicity or irritation were observed at a concentration of 19.5 mg/L. At this concentration no deaths occurred. Regarding these results, the author of this IUCLID dossier assumed that the NOEC of diethyl carbonate (acute toxicity inhalation) is 19.5 mg/L. It can therefore be concluded that the substance should not be classified in any of the four categories. As the NOEC is assumed to be 19.5 mg/L it can be concluded that the corresponding LC50 should be much greater than 19.5 mg/L which represents the upper limit for classification in category 4 (10 < LC50 ≤ 20 mg/L, Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures (2009)).
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable study report on various acute and subacute inhalative toxicity trials in which the LC50 was determined for male and female rats
- Principles of method if other than guideline:
- no official test method; for detailed information about methodology is referred to various sources (see above under Data source)
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals:
Breeds/strain: Wistar-II-rats, Wistar-II-SPF-rats
It is unclear which of the two breeds was actually used or if the test animals were possibly from both breeds.
Animal supply:
Animals received from: breeder Winkelmann, Kirchborchen (Germany)
Animal weights: Wistar-II-rats (160-200 g), Wistar-II-SPF-rats (130-150 g) - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- other: presumably whole body
- Vehicle:
- other: mixture of equal amounts of alcohol and lutrol
- Details on inhalation exposure:
- The inhalation experiments were carried out with a dynamic inhalation device (NIESSEN, TIETZ, HECHT und KIMMERLE, Arch. Toxikol. 20, 44, 1963) developed by Farbenfabriken Bayer A.G., Werk Wuppertal-Elberfeld, Germany.
Diethyl carbonate was determined in the air being inhaled according to a modified method of H. GARSCHAGEN (Z. analyt. Chem. 241, 32, 1868; Weinberg and Keller 14, 131, 1967). The air being inhaled was conveyed through a vessel cooled down to -30 °C (absorption vessel). Determination by gas chromatography. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gas Chromatography; Details on methodology see under 8 Analytical methods in this IUCLID dossier
- Duration of exposure:
- 7 h
- Remarks on duration:
- on 1 day; 2 wk observation period post exposure
- Concentrations:
- LC50 determination: 1.83 mg/l (male rats); 1.268 mg/l (female rats)
- No. of animals per sex per dose:
- LC50 determination: 20 female rats; 20 male rats
- Control animals:
- other: from the information given in the study report the use of control animals is not apparent
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- > 1.268 mg/L air (analytical)
- Remarks on result:
- other: one of two stated rat breeds used or mixed - unclear from info given in study report
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 1.83 mg/L air (analytical)
- Remarks on result:
- other: one of two stated rat breeds used or mixed - unclear from info given in study report
- Interpretation of results:
- other: no mortalities and no signs of acute toxicity or irritation; low acute inhalation toxicity assumed; final conclusion about classification not possible
- Conclusions:
- The test was only performed at one concentration for male and female rats respectively. No signs for acute toxicity via the inhalation route were found up to concentrations of 1268 mg/m³ (female rats) and 1830 mg/m³ (male rats). It can therefore be assumed that the toxic potential via inhalation is low, as no animals died and no signs of toxicity were found.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable study report on various acute and subacute inhalative toxicity trials
- GLP compliance:
- no
- Limit test:
- yes
- Details on test animals or test system and environmental conditions:
- Test animals:
male NMRI mice
male and female Wistar-II-rats
male and female Wistar-II-SPF-rats
male and female rabbits (not purebred).
No further info how many rats from either strain were actually used in the experiment.
Animals received from: mice and rats from breeder Winkelmann, Kirchborchen (Germany), no data on deliverer of rabbits
Animal weights: NMRI-mice (18-24 g), Wistar-II-rats (160-200 g), Wistar-II-SPF-rats (130-150 g), rabbits (2.3-32 kg) - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- other: presumably whole body
- Vehicle:
- other: mixture of equal amounts of alcohol and lutrol
- Details on inhalation exposure:
- The inhalation experiments were carried out with a dynamic inhalation device (NIESSEN, TIETZ, HECHT und KIMMERLE, Arch. Toxikol. 20, 44, 1963) developed by Farbenfabriken Bayer A.G., Werk Wuppertal-Elberfeld, Germany.
Diethyl carbonate was determined in the air being inhaled according to a modified method of H. GARSCHAGEN (Z. analyt. Chem. 241, 32, 1868; Weinberg and Keller 14, 131, 1967). The air being inhaled was conveyed through a vessel cooled down to -30 °C (absorption vessel). Determination by gas chromatography.
In rooms of 2 m3 which were stocked with 2 rabbits, 10 rats and 20 mice respectively, diethyl carbonate was evenly distributed in the air with a fan every half hour within the exposure period of 4 h. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Remarks on duration:
- on 1 day; 2 wk observation period post exposure
- Concentrations:
- test concentration 1: 0.235 mg/l;
test concentration 2: 2.179 mg/l - No. of animals per sex per dose:
- 2 rabbits, 10 rats and 20 mice (no detailed info about the sex of the test animals)
- Control animals:
- other: from the given information in the study report the use of control animals is not apparent
- Dose descriptor:
- other: NOEC
- Effect level:
- > 0.235 mg/L air (analytical)
- Remarks on result:
- other: for all tested rabbits, rats, mice
- Dose descriptor:
- other: NOEC
- Effect level:
- >= 2.179 mg/L air (analytical)
- Remarks on result:
- other: for all tested rabbits, rats, mice
- Interpretation of results:
- other: no mortalities and no signs of acute toxicity or irritation on mucosas of eyes or noses of the tested rabbits, rats and mice; low acute inhalation toxicity is assumed; classification not possible based on results
- Conclusions:
- Rabbits, rats and mice exposed to the test substance diethyl carbonate in an acute inhalative toxicity study as an aerosol (solution of substance in Lutrol and alcohol, 1:1) showed no signs of toxicity or irritation, no animals died. The highest concentration of the test substance provided in this experiment, 2.179 mg/L, can therefore be assumed to be the NOEC (as aerosol, assumed by the author of this IUCLID dossier).
Referenceopen allclose all
No signs of toxicity or irritation were observed in any animal, nor died any rats. No changes in the inner organs of the animals were seen. According to these results the author of this IUCLID dossier assumed that the NOEC for the test substance diethyl carbonate was 19.5 mg/L.
In LC50 determination with female and male rats:
No animals died. No symptoms of irritation or toxicity were found.
No animals died. No symptoms of irritation (mucosas of eyes and noses) or toxicity were found in the tested rabbits, rats and mice.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 19 500 mg/m³ air
- Quality of whole database:
- Good quality of the data (study report).
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of acute toxicity – oral endpoint
Lowest determined acute oral toxicity level from a highly reliable
data source
Justification for selection of acute toxicity – inhalation endpoint
Only available data on acute inhalation toxicity of diethyl
carbonate vapour.
Justification for classification or non-classification
According to the determined LD50 of > 5.0 mL/kg (4876 mg/kg) of the test substance diethyl carbonate by oral administration to male Wistar rats, the test substance is practically nontoxic (study report, Bayer AG, 1980, see endpoint record 7.2.1.001, key data).
According to the results of an acute toxicity inhalation study of the test substance diethyl carbonate in male and female rats, no signs of toxicity or irritation were observed at a concentration of 19.5 mg/L. At this concentration no deaths occurred. Regarding these results, the author of this IUCLID dossier assumed that the NOEC of diethyl carbonate (acute toxicity inhalation) is 19.5 mg/L. It can therefore be concluded that the substance should not be classified in any of the four categories. As the NOEC is assumed to be 19.5 mg/L it can be concluded that the corresponding LC50 should be much greater than 19.5 mg/L which represents the upper limit for classification in category 4 (10 < LC50 ≤ 20 mg/L, Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures (2009)).
Acute toxicity dermal (data waiver): The low acute oral and inhalative toxicity of diethyl carbonate and the possibility to minimise dermal exposure by the use of effective gloves and protective clothing justifies a data waiver for this endpoint.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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