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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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 Diäthylcarbonate; [english translation: Investigations on the toxicity of diethyl carbonate]
- Author:
- Bornmann, G., and Loeser, A.
- Year:
- 1 966
- Bibliographic source:
- ARCH TOXICOL 22, 98
Materials and methods
- Principles of method if other than guideline:
- Method: other: multigeneration toxicity study
- GLP compliance:
- 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
- Details on test material:
- Name of the test substance as stated in the publication: german name [Diäthylcarbonat], english name [Diethyl Carbonate]
Purity: > 99.5 %
Purchased from: "Farbenfabriken Bayer AG, Werk Uerdingen"
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar II BR 46
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
Doses / concentrations
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 214.3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: other
- Remarks on result:
- other: -
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- LOAEL
- Effect level:
- 35.7 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: weight of organs, F3 generation
- Remarks on result:
- other: -
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
In summary it is stated in the publication that the administration of the test substance in every treatment group (I-III) and every generation (F1 -F3) did not affect the fetal development nor the development of the newborns compared to the control.
In an additional experiment male and female animals from the F1 -generation of the lowest treatment group and control group (10 weeks old, average weight 230 g) were used to measure the respiration of oxygen. In both groups no differences were observed (respiratory quotient 0.82 for both groups).
In 20 weeks old F3 -animals of the two highest treatment groups (0.075, 0.3 % (w/v)) and the control group analysis of the blood sugar was conducted. The obtained values did not differ between the treatment groups and the control.
In the publication it is summarised that the histological analysis of treatment animals and control animals including weights of endocrine organs did not show any differences between treated and control animals for the generation F1 -F3.
However, for the F3 generation it is in addition referred to a table where organ weights are listed upon treatment.
There is no info about the statistical significance of this table data. This data is also not further discussed. Abnormalities in shape etc. have apparentyl not occurred.
Overview of organ weights for F3 generation:
Dose group | Sex | Number of animals | Pituitary average weight (mg) | Pituitary average weight (mg/100 g bw) | Thyroid average weight (mg) | Thyroid average weight (mg/100 g bw) | Adrenal gland average weight (mg) | Adrenal gland average weight (mg/100 g bw) | Ovaries average weight (mg) | Ovaries average weight (mg/100 g bw) |
Control | m | 10 | 11.3 | 2.4 | 20.9 | 4.5 | 49.2 | 10.4 | / | / |
0.075 % | m | 10 | 11.1 | 2.3 | 20.5 | 4.3 | 37.8 | 7.9 | / | / |
0.3 % | m | 10 | 11.3 | 2.4 | 21.2 | 4.5 | 42.8 | 9.0 | / | / |
Control | f | 10 | 11.8 | 4.0 | 14.7 | 4.9 | 64.3 | 21.7 | 77.1 | 26.1 |
0.075 % | f | 10 | 12.1 | 4.2 | 16.7 | 5.8 | 56.7 | 19.5 | 72.3 | 25.0 |
0.3 % | f | 10 | 11.4 | 3.8 | 18.1 | 6.0 | 53.0 | 17.6 | 61.8 | 20.5 |
Control | m+f | 20 | 11.6 | 3.2 | 17.8 | 4.7 | 56.8 | 16.1 | / | / |
0.075 % | m+f | 20 | 11.6 | 3.2 | 18.6 | 5.0 | 47.3 | 13.7 | / | / |
0.3 % | m+f | 20 | 11.4 | 3.1 | 19.7 | 5.2 | 47.9 | 13.3 | / | / |
For the author of the IUCLID dossier, it may be disputable if there was some effect of the substance on weight development for the following organs (boldly marked numbers): thyroid, adrenal gland, ovaries.
Applicant's summary and conclusion
- Conclusions:
- In this study rats administered the test substance diethyl carbonate via drinking-water (0.015, 0.075, 0.3 % (w/v)) were mated and the resulting offsprings treated as their parents. In total three generations were bred like this and all offsprings received the corresponding parental concentration of the test substance. The authors of the publication summarised that they never found any differences in fetal development, development of the newborns, blood sugar composition, oxygen respiration and histopathological analysis, including weights of endocrine organs, in the treated groups and the control. The authors of the publication concluded that the test substance diethyl carbonate had no embryotoxic or teratogenic effects. They also pointed out that it may, however, not possible to fully exclude the possibility of teratogenicity.
For the author of the IUCLID dossier, it may be disputable if there was some effect of the substance on weight development of the following organs (boldly marked numbers in the table, in results section): thyroid, adrenal gland, ovaries. These data on the F3 generation were presented in a table of the publication but was not further discussed in respect of their significance.
Data conclusive but not sufficient for classification.
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