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EC number: 203-924-4 | CAS number: 111-96-6
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
In accordance with Section 1.2 of REACH Annex IX, there is sufficient information from several studies leading to the conclusion that Diethylene glycol dimethyl ether has to be classified as reprotoxic category 2, because
- Diethylene glycol dimethyl ether caused severe toxic effects in testes and spermatogenesis of test animals (rats, mice) via oral and inhalatory route,
- Diethylene glycol dimethyl ether affected the fetal development in rabbits and mice
- There is a strong evidence in literature that Diethylene glycol dimethyl ether is metabolised to 2-Methoxyethanol which is known as a very potent reproduction toxicant.
It can therefore be concluded that Diethylene glycol dimethyl ether has to be labeled with H360FD – May damage fertility or the unborn child and that further testing is not scientifically necessary.
Effects on male reproductive system
- NOAEC (2 weeks inhalation toxicity study, male rats): 110 ppm (corresponding to 175.1 mg/kg bw/d)
- NOEC (5 day inhalation toxicity study, male mouse): 250 ppm (not assignable)
- NOEC (2 weeks inhalation toxicity study, male rats): < 110 ppm (not reliable)
- NOAEL (20 days oral toxicity study, male rat): < 684 mg/kg bw/d
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 684 mg/kg bw/day
- Study duration:
- subacute
Effect on fertility: via inhalation route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 110 ppm
- Study duration:
- subacute
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Several studies have been perfromed showing a reproduction toxicity of Diethylenglycoldimethylether on prenatal development without implications by maternal toxicity. Obtained threshold limits are listed below.
Developmental studies
- NOAEL (developmental/maternal, oral, mouse): < 3000 mg/kg bw/d)
- NOAEL (maternal, oral, rabbit): 50 mg/kg bw/d
- NOAEL (developmental, oral, rabbit): 25 mg/kg bw/d
- NOAEL (developmental, oral, mouse): 62.5 mg/kg bw/d
- NOAEL (maternal, oral, mouse): 500 mg/kg bw/d (highest dose tested)
- NOAEL (developmental, oral, mouse): < 537 mg/kg bw/d
- NOAEL (maternal, oral, mouse): 537 mg/kg bw/d (highest dose tested)
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 25 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rabbit
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The developmental toxicity of Diethylene glycol dimethyl ether was evaluated in two oral studies in rabbits and mice equivalent to OECD guideline 414 and in several non-guideline oral studies in mice. The lowest derived NO(A)ELs from a rabbit teratogenicity study were 25 mg/kg bw/d (developmental) and 50 mg/kg bw/d (maternal). These NO(A)ELs were based on adverse effects on prenatal growth, viability and morphological development (NOEL developmental) and increased maternal mortality.
Therefore, it is concluded that Diethylene glycol dimethyl ether is subject to classification and labelling according to Regulation 1272/2008/EC regarding reproductive toxicity. Ethylene glycol dimethyl ether has to be labeled with H360FD – May damage fertility or the unborn child (reproductive toxic, category 1B).
Justification for classification or non-classification
Due to the observed effects on testes of male test animals and the fetal toxicity of Diethylene glycol dimethyl ether a classification for reproductive toxicity is appropriate. It is concluded that the substance is subject to classification and labeling according to Regulation 1272/2008/EC regarding reproductive toxicity/teratogenicity. Ethylene glycol dimethyl ether has to be labeled with H360FD – May damage fertility or the unborn child.
Furthermore the substance is found to be not irritating and it is unlikely that higher amounts than tested in the inhalation reproductive/developmental toxicity studies will be systemically available via the skin barrier.No systemic adverse effects other than observed via inhalatory or oral route are expected to occur. Therefore, toxicity testing via dermal route is not scientifically necessary.
Additional information
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.
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