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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
Toxicity to reproduction
Administrative data
- Endpoint:
- multi-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1966
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Older study described in sufficient detail, but not all endpoints according to recent standard protocols examined
Data source
Reference
- Reference Type:
- publication
- Title:
- Untersuchungen zur Toxikologie von Diaethylcarbonat
- Author:
- Bornmann G & Loeser A
- Year:
- 1 966
- Bibliographic source:
- Arch Toxicol 22, 98-114
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- see below
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Diethyl carbonate
- EC Number:
- 203-311-1
- EC Name:
- Diethyl carbonate
- Cas Number:
- 105-58-8
- Molecular formula:
- C5H10O3
- IUPAC Name:
- diethyl carbonate
- Test material form:
- other: liquid
- Details on test material:
- Purity: > 99.5 %
Constituent 1
Test animals
- 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
Administration / exposure
- 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) - Details on mating procedure:
- the animals were mated for 20 days with daily changes of partner
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- breeding was done until F3 generation
- Frequency of treatment:
- continuously via drinking water
- Details on study schedule:
- After 9 weeks of treatment, 10 male and 10 female rats dosed with 0 or 0.015 % were mated for 20 days (daily changes of partner). After 27 weeks of treatment, groups of 10 rats dosed with 0.075 and 0.3 % were mated in the same way. For the F1 generation a comparable dosage/treatment regimen was used and at an appropriate age and weight they were used for breeding the F2-generation. The F3-generation was bred from the F2-generation in the same way.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.015, 0.075 or 0.3 % (ca. 0, 4, 22 or 90 mg/rat/day)
Basis:
nominal in water
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS / CLINICAL OBSERVATIONS: Yes (not further specified)
BODY WEIGHT: Yes (not further specified)
HAEMATOLOGY: Yes (blood glucose) - Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- not examined
- Litter observations:
- PARAMETERS EXAMINED: number of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain
GROSS EXAMINATION OF DEAD PUPS: abnormalities - Postmortem examinations (parental animals):
- SACRIFICE: up to 10 m and 10 f from each generation
GROSS NECROPSY: yes
HISTOPATHOLOGY: yes (not described in detail)
ORGAN WEIGHTS: yes (pituitary, thyroid, adrenals, ovaries) - Postmortem examinations (offspring):
- not described in detail
- Statistics:
- no data
- Reproductive indices:
- not described in detail
- Offspring viability indices:
- not described in detail
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 90 other: mg/animal/day
- Sex:
- male/female
- Remarks on result:
- other: Generation: P to F3 generation (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a multi-generation study, groups of 10 male and 10 female Wistar rats were dosed with 0 - 0.3 % (up to 90 mg/rat/day) via drinking water. In none of the different generations (P to F3) adverse effects were seen and the dosing had no adverse effects on fertility or on foetal development.
- Executive summary:
In a multi-generation study, groups of 10 male and 10 female Wistar rats were dosed with 0 - 0.3 % (up to 90 mg/rat/day) via drinking water. In none of the different generations (P to F3) adverse effects were seen and the dosing had no adverse effects on fertility or on foetal development.
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