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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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication with very detailed description of the conducted methods.
Data source
Reference
- Reference Type:
- publication
- Title:
- Untersuchungen zur Toxikologie von Diäthylcarbonat; [english translation: Investigations on the toxicity of diethyl carbonate]
- Author:
- Bornmann, G., Loeser, A.
- Year:
- 1 966
- Bibliographic source:
- ARCH TOXICOL 22, 98
Materials and methods
- Principles of method if other than guideline:
- chronic oral administration of the test substance with regard to offspring development.
- GLP compliance:
- not specified
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
- Details on test material:
- Name of the test substance as stated in the publication: "Diäthylcarbonat"
Purity: > 99.5 %
Purchased from: "Farbenfabriken Bayer AG, Werk Uerdingen"
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar-Stamm II BR 46
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on mating procedure:
- Preliminary mating occurred during 20 days (daily changing of sexual partners) with 10 males and 10 females from two groups (treated with 0.015 % test substance, and control without test substance)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 100 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.0 % (w/v), 0.0 mg/kg bw (males, females) -> control group
0.015 % (w/v), 3 mg/day, 6.5 mg/kg bw (males), 10.7 mg/kg bw (females);
0.075 % (w/v), 10 mg/day, 20.7 mg/kg bw (males), 35.7 mg/kg bw (females);
0.3 % (w/v), 60 mg/day, 130 mg/kg bw (males), 214.3 mg/kg bw (females);
Basis:
nominal in water
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 130 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: histopathological examination of reproduction organs and fertility
- Remarks on result:
- other: Generation not specified (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 214.3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: histopathological examination of reproduction organs and fertility
- Remarks on result:
- other: Generation not specified (migrated information)
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- other: F3
- Effect level:
- 10.7 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: weights of ovaries were slightly lower in the two higher dosage groups compared to control
- Remarks on result:
- other:
- Remarks:
- F3 generation; according to publication, however, no clear treatment-related signs of toxicity or of macroscopic or microscopic effects on the organs
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The only diseases related to the reproductive system in the parental animals were vulvar cancers in one female of group III (administration of 0.3 % diethylcarbonate) and one female of the control group (possibly also a tumour of the intestine). Ovarian cysts were not taken into account as these are observed frequently in rats and were therefore not regarded as relevant. Fertility was not affected in treatment groups compared to the controls in any generation.
In group III of the F3 -generation the weights of the ovaries were slightly decreased compared to the control group and group II (25.0 mg/100 g bw in group II, 0.075 %; 20.5 mg/100 g bw in group III, 0.3 %; 26.1 mg/100 g bw in control group); 10 females per group.
According to the publication no clear treatment-related signs of toxicity or of macroscopic or microscopic effects on the organs were found in any of the treated groups.
The authors of the publication summarised that there were no indications of diethyl carbonate having an organotropic effect.
Applicant's summary and conclusion
- Conclusions:
- Rats were administered the test substance diethyl carbonate chronically at concentrations of up to 0.3 % (w/v) in drinking-water and possible effects on the reproduction system analysed. Histopathological analysis of testes and ovaries resulted in vulvar cancers in one treated female and one control female. Ovarian cysts were not taken into account as these would be frequently observed in rats. They were therefore not relevant in the opinion of the authors of the publication.
Another part of the experiment was a fertility-study over 3 generations (parent -> F1 -> F2 -> F3) in which the offsprings were always treated with the corresponding dose of the test substance of their parents. Compared to the controls the fertility of the treated animals was not affected by the test substance as stated in the publication. A lower weight of the ovaries in F3-females was observed in the highest dose group compared to the control group and the next lower treatment group (20.5 mg/100 g bw at 0.3 % versus 25.0 mg/100 g bw at 0.075 % and 26.1 mg/100 g bw in the control group). There was no statement made about the statistical significance of this data nor was it discussed in the results or discussion section. The data was only presented in a table. A concluding statement about the effect of the substance on ovary weight appears therefore not possible for this study. Other effects related to ovaries were not reported. There was no generation F4 bred with generation F3 as parents to investigate further influences on reproduction.
Date conclusive but not sufficient for classification.
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