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Diss Factsheets
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EC number: 203-794-9 | CAS number: 110-71-4
- 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
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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 Ethylene glycol dimethyl ether has to be classified as reprotoxic category 2, because
- Ethylene glycol dimethyl ether caused severe toxic effects in testes of test animals (rats, mice) via oral and inhalatory route,
- Ethylene glycol dimethyl ether effected the fetal development in rats, rabbits and mice
- There is a strong evidence in literature that Ethylene glycol dimethyl ether is metabolised to 2-Methoxyethanol which is known as a very potent reproduction toxicant.
It can therefore be concluded that Ethylene glycol dimethyl ether has to be labeled with H360FD – May damage fertility, may damage the unborn child; and that further testing is not scientifically necessary.
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 132.6 mg/kg bw/day
Effect on fertility: via inhalation route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 187 mg/m³
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In accordance with Section 1.2 of REACH Annex IX, there is sufficient information from several studies leading to the conclusion that Ethylene glycol dimethyl ether has to be classified as reprotoxic category 2, because
- Ethylene glycol dimethyl ether caused severe toxic effects in testes of test animals (rats, mice) via oral and inhalatory route,
- Ethylene glycol dimethyl ether effected the fetal development in rats, rabbits and mice
- There is a strong evidence in literature that Ethylene glycol dimethyl ether is metabolised to 2-Methoxyethanol which is known as a very potent reproduction toxicant.
It can therefore be concluded that Ethylene glycol dimethyl ether has to be labeled with H360 – May damage fertility or the unborn child and that further testing is not scientifically necessary.
NOAEL calculation from repeated dose study:
- NOAEC:
0.187 mg/L
- respiratory volume (male rat):
20.5 L/hour (according to Guidance on Information Requirements and Chemical Safety Assessment, Chapter R8, Appendix 8-2, Table 8-17, p. 70)
- exposure duration:
6 hours per day
- mean body weight:
173.5 g
NOAEL:
=> 20.5 L/hour x 6 hours = 123 L per 6 hours equivalent to 123 L/d
=> 23 mg/rat/d (NOAEL)
=> 132.6 mg/kg bw/d = NOAEL (systemic)
Effects on developmental toxicity
Description of key information
Several studies (oral, inhalation) have been performed investigating developmental toxicity of Monoglyme.
NOAEC (developmental/maternal, inhalatory, rabbit): 0.06 mg/L (corresponding to 5.6 mg/kg bw/d)
NOEC (maternal, inhalatory, rat): 0.374 mg/L (corresponding to 183.3 mg/kg bw/d, highest dose tested)
NOEC (developmental, inhalatory, rat): 0.037 mg/L (corresponding to 18.2 mg/kg bw/d)
NOAEC (developmental, inhalatory, rat/rabbit): < 0.374 mg/L
Oral (mainly none-guideline studies):
NOAEL (maternal, oral, rat): 120 mg/kg bw/d
NOAEL (developmental, oral, rat): < 30 mg/kg bw/d
NOAEL (maternal/developmental, oral, mouse): < 2000 mg/kg bw/d
NOAEL (maternal, oral, mouse): 361 mg/kg bw/d
NOAEL (developmental, oral, mouse): < 361 mg/kg bw/d
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 5.6 mg/kg bw/day
- Quality of whole database:
- NOAEL according to oral study < 30 mg/kg bw/d
Effect on developmental toxicity: via inhalation route
- Dose descriptor:
- NOAEC
- 60 mg/m³
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The developmental toxicity of Ethylene glycol dimethyl ether was evaluated in two inhalation studies in rabbits and rats according to OECD guideline 414 study and in several non-guideline oral studies in rats and mice. The lowest derived NOAEC from a rabbit teratogenicity study was 0.06 mg/L corresponding to a systemic concentration of 5.6 mg/kg bw/d (for calculations please see below). This NOAEC was based on slightly reduced food consumption of the dams and decreased vitality of the pups within the first 24 hours after parturition.
Therefore, it is concluded that Ethylene 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 H360 – May damage fertility or the unborn child (reproductive toxic, category 2).
NOAEL/NOAEL-calculations:
1. Rabbit
- NOAEC (maternal/developmental):
0.06 mg/L
- respiratory volume:
94 L/kg bw/6 hours (according to Snipes, M.B.; long-term Retention and Clearance of Particles inhaled by mammalian Species; Crit. Rev. Toxicol. 20, 175-211, cited by the Federal Institute for occupational Safety and Health, 1998)
- exposure duration:
6 hours per day
=> 94 L respired volume/kg bw/d
=> 0.06 mg x 94 L =5.6 mg/kg bw/d = NOAEL(systemic)
2. Rat
- NOAEC (maternal):
0.374 mg/L
- NOAEC (developmental):
0.037 mg/L
- respiratory volume (female rat):
15.7 L/hour (according to Guidance on Information Requirements and Chemical Safety Assessment, Chapter R8, Appendix 8-2, Table 8-17, p. 70)
- exposure duration:
6 hours per day
- mean body weight:
192 g
maternal NOAEL:
=> 15.7 L/hour x 6 hours = 94.2 L per 6 hours equivalent to 94.2 L/d
=> 35.2 mg/rat/d (maternal NOEL)
=> 183.3 mg/kg bw/d = NOAEL(maternal, systemic)
developmental NOAEL:
=> 15.7 L/hour x 6 hours = 94.2 L per 6 hours equivalent to 94.2 L/d
=> 3.5 mg/rat/d (developmental NOEL)
=> 18.3 mg/kg bw/d = NOAEL (developmental, systemic)
Toxicity to reproduction: other studies
Additional information
Please refer to "Effects on fertility" and "Developmental toxicity"
Justification for classification or non-classification
Due to the observed effects on testes of male test animals and the fetal toxicity of Ethylene 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, may damage the unborn child.
Furthermore the substance is found to be moderately 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.
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.
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