Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-065-8 | CAS number: 115-10-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- other: study comparison
- Adequacy of study:
- supporting study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Evaluation report only with limited data
Data source
Reference
- Reference Type:
- other: evaluation report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
- Type of study / information:
- Evaluation of studies with DME performed in two different laboratories
- Principles of method if other than guideline:
- Developmental toxicity studies (equivalent/similar to OECD 414) had been carried out in two different laboratories. In both labs, pregnant rats had been exposed to the test substance during day 6 through day 15 of pregnancy (rather than from day 6-19 as is required in the current guideline)
- GLP compliance:
- no
Test material
- Reference substance name:
- Dimethyl ether
- EC Number:
- 204-065-8
- EC Name:
- Dimethyl ether
- Cas Number:
- 115-10-6
- Molecular formula:
- C2H6O
- IUPAC Name:
- dimethyl ether
- Details on test material:
- Test compound: dimethylether (DME)
Purity (TNO studies): 99.8%
Purity (Haskell studies) : 99.9%
Constituent 1
Results and discussion
Any other information on results incl. tables
From the results obtained in the different studies it was concluded - by the authors of the Haskell report that:
a. the exposure of rats during day 6 through 15 of pregnancy to test atmospheres containing up to 4.0% was demonstrated to have a maternal effect at the 2.0% level and higher
b. the "no-effect level", demonstrated for the conceptus was 0.125%.
By the authors of the CIVO report that:
a. the exposure of rats during day 6 through 15 of pregnancy to test atmospheres containing up to 2.8% was non-toxic to pregnant females (only a slight reduction in BW gain was noted in females exposed to 2.8% during the exposure-period)
b. the "no-adverse-embryo/foetotoxic effect level" demonstrated for the conceptus was 2.8%.
By both that:
a. embryo/foetotoxicity was evident at the 4.0% level as expressed by decreased foetal body weights and an increased incidence of several skeletal variations
b. the exposure of rats to test atmospheres, containing 0.125, 0.5, 2.0 or 4.0% during day 6 through day 15 of pregnancy did not induce any teratogenic effect in rat fetuses
c. DME was not demonstrated to represent a unique hazard to the rat conceptus.
Applicant's summary and conclusion
- Executive summary:
Data from different embryotoxicity/teratogenicity studies with the test substance, carried out at the Haskell Laboratory for Toxicology and Industrial Medicine, Newark, Delaware, U.S.A. and at the Institute CIVO-Toxicology and Nutrition TNO, Zeist, the Netherlands, were studied and mutually compared to evaluate the embryo/foetotoxic or teratogenic potential.
In a pilot and a main study carried out at CIVO, pregnant rats were exposed to atmospheres containing 0 (control), 2.0 or 2.8% DME for 6 hours/day from day 6 through day 15 of pregnancy. In two successive studies carried out at Haskell, pregnant rats were exposed, under the same conditions, to either 0, 0.5, 2.0 of 4.0% in the first study or to 0, 0.125, 0.5 or 2.0% in the second study .
No abnormalities in condition or behaviour were observed in the CIVO studies. The significance of the decreased response to a sound stimulus, observed in the Haskell studies at the 4.0% and 2.0% dose level is not clear. Diminished weight gain during the exposure period was observed in the 4.0% group at Haskell, and a slight body weight gain reduction was observed in the 2.8% group at TNO. Body weights of the remaining test substance groups as well as food consumption figures did not indicate treatment-related effects. Decreased foetal bodyweight was apparent at the 4.0% dose level only.
Visceral examination of foetuses did not reveal any abnormality attributable to the treatment. Skeletal examination revealed an increased incidence of a number of minor skeletal variations in the 4.0% dose group. Although the incidence of one or two minor skeletal variations was slightly increased at the 0.5, 2.0 and 2.8% DME level, those observations were not classified as abnormalities since they were the only effects and these would not likely have any significant effect on the health or function of the individual.
From the results obtained in the different studies it was concluded
- by the authors of the Haskell report that:
a. the exposure of rats during day 6 through 15 of pregnancy to test atmospheres containing up to 4.0% was demonstrated to have a maternal effect at the 2.0% level and higher
b. the "no-effect level", demonstrated for the conceptus was 0.125%.
- by the authors of the TNO report that:
a. the exposure of rats during day 6 through 15 of pregnancy to test atmospheres containing up to 2.8% was non-toxic to pregnant females (except for a sight reduction in BW gain in females exposed to 2.8% during the exposure period)
b. the "no-adverse-embryo/£oetotoxic effect level" demonstrated for the conceptus was 2.8%.
- by both that:
a. embryo/foetotoxicity was evident at the 4.0% level as expressed by decreased foetal body weights and an increased incidence of several skeletal variants
b. the exposure of rats to test atmospheres, containing 0.125, 0.5, 2.0 or 4.0% during day 6 through day 15 of pregnancy did not induce any teratogenic effect in rat foetuses
c. DME was not demonstrated to represent a unique hazard to the rat conceptus.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)