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EC number: 202-510-0 | CAS number: 96-49-1
- 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
Endpoint summary
Administrative data
Description of key information
The LD50/LC50 values from the key-studies were: LD50 (oral, rat) 10400 mg/kg bw, LD50 (dermal, rat) > 2000 mg/kg bw, LC50 (inhalation, rat) > 730 mg/m3 air. The studies were performed respectively according to OECD guidelines 401, 402 and 403.
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: Comparable with OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details on test substance or concentration in vehicle; dose levels not clearly specified, no data on clinical signs or necropsy)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- see rationale for reliability
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Carworth-Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Source: rats raised in the authors own colony
Diet: Rockland rat diet complete
Initial body weight: 90 to 120 g
Rats not fasted before dosing
No further data - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- No details
- Doses:
- dosages in a logarithmic series (no further data)
- No. of animals per sex per dose:
- Groups of five male rats
- Control animals:
- no
- Details on study design:
- Post exposure observation period 14 days
- Statistics:
- The LD50 value and its fiducial range are estimated by the method of Thompson (Bact. Rev. 11 :115, 1947) using the tables of Weil (Biometrics 8 :249, 1952).
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 10 400 mg/kg bw
- 95% CL:
- 7 940 - 13 620
- Mortality:
- no further data
- Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- no
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In male rats the LD50 is 10400 mg/kg bw.
- Executive summary:
The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details on test substance or concentration in vehicle; dose levels not clearly specified, no data on clinical signs or necropsy).
Groups of 5 male Carworth-Wistar rats were gavaged with dosages in a logarithmic series. The post exposure observation period was 14 days. The authors calculated a LD50 value of 10400 mg/kg bw. The test substance is practically non-toxic.
Conclusion: In male rats the LD50 is 10400 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 400 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: Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) with acceptable restrictions (partly limited documentation; post exposure observation period 7 days; low number of rats)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- Annex of the Guideline 403
- Deviations:
- yes
- Remarks:
- see rationale for reliability
- GLP compliance:
- no
- Test type:
- other: inhalation hazard test
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No details
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air
- Details on inhalation exposure:
- Rats exposed for 8 h to a vapour saturated atmosphere.
Vapour was generated by bubbling 200 l/h dry air (no CO2) through the liquid substance column (volume ca. 50 ml) of about 5 cm above a fritted glass disc in a glass cylinder. The liquid had a temperature of 50°C; air pressure was 754 mm Hg. Temperature in the exposure chamber presumably 26°C (not clearly stated) - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 8 h
- Concentrations:
- Saturated vapour. The authors calculated a concentration of 730 mg/m³ (1.17 g substance loss).
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: observations performed (no details), body weight determined at day 0 and 4
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- 730 mg/m³ air
- Exp. duration:
- 8 h
- Remarks on result:
- other: saturated vapour
- Mortality:
- No mortality
- Clinical signs:
- other: No clinical signs
- Body weight:
- No effects on body weight (measured day 0 and day 4)
- Gross pathology:
- No effects detected at necropsy
- Other findings:
- No
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No mortality in male and female rats exposed to saturated vapour for 8 h.
- Executive summary:
The study is comparable to the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) with acceptable restrictions (partly limited documentation; post exposure observation period 7 days; low number of rats).
Three male and 3 female rats were exposed for 8 h to saturated vapour. The authors calculated a concentration of 730 mg/m³. No clinical signs were observed and no mortality occurred during the 7 days of post exposure observation period. No effects were detected at necropsy.
Conclusion: No mortality in male and female rats exposed to saturated vapour for 8 h.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 730 mg/m³ air
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:
- April 17-June 19,1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study was performed according to following guidelines: OECD 402, EU Method B.3 and in compliance with GLP Regulations (German and OECD). No significant deviations can be observed from the study guidelines, which could have an impact on the performed study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- stability not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- German Principles of GLP (1994), OECD, GLP regulations (1983)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstraße 27, 33176 Borchen
- Age at study initiation: adult
- Weight at study initiation: 200-300g
- Fasting period before study: no data
- Housing: in Makrolon type Ill cages, each cage containing one rat
- Diet (e.g. ad libitum): Ssniff R 10 diet in pelletform (laboratory standard rat diet), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: min.5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h light, 12h dark
IN-LIFE DATES: From: 18-04-1996 To: 02-05-1996 (males), From: 05-06-1996 To : 16-05-1996 (females) - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lumbar region (clipped free of fur)
- % coverage: app. 10%
- Type of wrap if used: no
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cleaned corn oil and absorbent paper
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 10 (5 males and 5 females)
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: at least twice daily; weighing: day 0 , 7 , 14
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, dermal response, macroscopic examination - Statistics:
- not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortality observed
- Mortality:
- -no deaths following a single dermal application of Ethylene Carbonate at 2000 mg/kg bw
- Clinical signs:
- other: - no signs of systemic reaction to treatment
- Gross pathology:
- -no macroscopic abnormalities were observed for animals killed on day 14
- Other findings:
- -no local dermal irritations at the treatment site were observed following removal of the dressings until the end of the observation period
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal dermal dose to rats of Ethylene carbonate was found to be greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute toxicity: oral (via gavage)
The Klimisch 2 study of Smyth (1954), performed according to OECD guideline 401, reported the lowest LD50 value of 10400 mg/kg bw (95% C.I. 7940 - 13620 mg/kg bw) in male Carworth-Wistar rats. Therefore, this study is designated as key study. The other reliable studies reported following LD50 values in rats: 11700 mg/kg bw (BASF, 1960), > 5000 mg/kg bw (limit test of Huntsman, 1990) and > 2000 mg/kg bw (limit test of Huels, 1996).
Acute toxicity: inhalation
The study of BASF (1960), performed according to OECD guideline 403, was selected as key study and reported a LC0 value of 730 mg/m3 air. Male and female rats were exposed for 8 hours to saturated vapour. Smith (1954) didn't observe deaths either in male albino rats that were exposed for 8 hours to saturated vapour.
Acute toxicity: dermal
The Klimisch 1 study of Krueger (1996), performed according to OECD guideline 402, was selected as key study and reported an LD0 > 2000 mg/kg bw in male and female Wistar rats. Smith (1954) reported a LD50 value > 26420 mg/kg bw in male New Zealand White rabbits.
Justification for classification or non-classification
- Acute toxicity - oral: LD50 = 10400 mg/kg bw and the substance is practically non-toxic (no further data on mortality); as the LD50 is > 2000 mg/kg bw, no classification is warranted under CLP. In addition, the LD50 of 5000 mg/kg after intraperitoneal injection does not warrant classification under CLP.
The available data on ethylene carbonate do not highlight any acute oral toxicity by the oral route of exposure. However, based on the information reported in section 7.1 about toxicokinetics of the test item, it is suggested that it was rapidly and extensively metabolized to ethylene glycol (CAS 107-21-1), with a half-life of 0.25h. Ethylene glycol is classified as R22 according to Annex I of Directive 67/548/EEC and for acute toxicity category 4 (H302) according to the Annex VI of EC 1272/2008, due to human exposure data (see also section 5.10.2 of the CSR). Given these findings, ethylene carbonate should also be classified for acute toxicity category 4.
- Acute toxicity - dermal: LD50 > 2000 mg/kg bw, no mortality and no signs of systemic reaction to treatment were observed; therefore no classification warranted under CLP
- Acute toxicity - inhalation: LC50 is > 730 mg/m³ air (limit test); the concentration tested does not enable us to decide on the classification for acute inhalation toxicity as the guideline specifies a concentration of 20 mg/L for vapours and 5 mg/L for dusts and mists.
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