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Diss Factsheets
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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
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1966
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, acceptable for assessment. However, the number of animals in study or the limited examined endpoints do fulfil recent standards.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of 30 m and 30 f rats were dosed for up to 100 weeks via drinking water.
Two additional groups dosed with 0 or 0.015% via drinking water and consisting of 40 males and 40 females each were included for reproduction studies. - GLP compliance:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight at study initiation: 145-160 g
Housing: individually caging
Diet: ad libitum
Water: ad libitum
ENVIRONMENTAL CONDITIONS
Temperature (°C): 26-28 - Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- Drinking water solutions were prepared daily
Concentration in vehicle: 0, 0.015, 0.075 or 0.3 % (w/v) - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- up to 100 weeks
- Frequency of treatment:
- continuously via drinking water
- Post exposure period:
- none
- Remarks:
- Doses / Concentrations:
0, 0.015, 0.075 or 0.3 % (w/v) (ca. 0, 15, 75 or 300 mg/kg bw)
Basis: - No. of animals per sex per dose:
- 30 m / 30 f
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- not further specified
- Positive control:
- none
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS / CLINICAL OBSERVATIONS: Yes (not further specified)
BODY WEIGHT: Yes (until week 13 every 2 weeks and every 4 weeks thereafter)
HAEMATOLOGY: Yes (in weeks 16, 32 and 55)
URINALYSIS: Yes (in weeks 38 and 85) - Sacrifice and pathology:
- Interim sacrifices in some animals of each group were done in week 32 and at this time point and also at termination endocrine glands were weighed and the heart, lungs, liver, spleen, kidneys, bladder, stomach, gut, thyroid gland, adrenal glands, ovaries, testes and pituitary gland were examined histopathologically.
- Statistics:
- not further specified
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Dose-dependent increased body weight gain compared with controls, especially in males
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Sex:
- male/female
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- In a well-documented, but older study (lower number of animals in study and limited examined endpoints), the dosing with up to 300 mg/kg bw via drinking water for up to 100 weeks gave no indications for a carcinogenic effect of diethyl carbonate in rats.
- Executive summary:
In a well-documented, but older study (lower number of animals in study and limited examined endpoints), the dosing with up to 300 mg/kg bw via drinking water for up to 100 weeks gave no indications for a carcinogenic effect of diethyl carbonate in rats. The dosing also caused no clear substance related signs of toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the negative results obtained in two long-term studies with oral dosing in rats and mice, no classification according to EU and GHS criteria is required.
Additional information
In a well-documented, but older study (lower number of animals in study and limited examined endpoints), the dosing with up to 300 mg/kg bw via drinking water for up to 100 weeks gave no indications for a carcinogenic effect of diethyl carbonate in rats. The dosing also caused no clear substance related signs of toxicity.
In another study, mice were dosed via drinking water with 0 - 1000 ppm for 83 weeks. The treatment had no adverse effects on mortality, body weight gain or the incidence of histopathological findings, including tumours. Although there were isolated differences between treated and control mice in haematological parameters and in liver weights of female mice, these were not considered to be treatment related. Therefore, the NOAEL was 1000 ppm (ca. 140 mg/kg bw/d).
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