Registration Dossier
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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

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 894 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 23 671 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- In a 2-year chronic/carcinogenicity study, 100 rats/grp/sex were exposed 6 h/d, 5 d/w to concentrations of DME of 0, 0.2, 1.0, or 2.5%. The NOAEC was established to be 2.5% = 47106 mg/m3. NOAEC workers = 6/8 * 6.7/10 * NOAEC rat.
- AF for dose response relationship:
- 1
- Justification:
- The robust database supports the confidence in the dose descriptor
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEC is based on a chronic (2-year) inhalation study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already included in NOAEC calculation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Available data are derived from studies of appropriate quality and validity, showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- A high quality, robust toxicity database exists for this substance.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
This is a volatile substance and potential worker exposure would likely occur via the inhalation route. Therefore, no worker oral or dermal route DNELs were derived.
No local effects were observed in acute or repeated exposure studies; therefore no DNEL for local effects was derived.
This substance is not classified as toxic under REACH regulations and guidance. The rat 4-hr inhalation LC50 is 164000 ppm (309018 mg/m3). The LOAEL for systemic toxicity effects after a 2-hour inhalation exposure is 84000 ppm (158277 mg/m3) air, at which levelacute toxicity was observed in the form of ataxia, anaesthesia in 2 hours, short jerky respirations and lung noise (post exposure). Various repeated dose inhalation studies, including 90-day exposures were conducted for this substance. In rats, no substance related adverse effects were observed at the highest concentration tested (20000 ppm, 37685 mg/m3). In hamsters, clinical chemistry changes were not consistently dose related or statistically significant, therefore, the rat was considered for use in assessment activities. Since a high quality, chronic inhalation exposure study was available in rats, it was the most appropriate study for further health assessments.
Male and female rats were exposed to 0, 0.2, 1 or 2.5% v/v via inhalation for 24 months. Body weight gain (male only) was occasionally higher than controls in the early phases of the study, but this finding was not consistent throughout the study. Further the observation in increased body weight was not seen in any other of the subchronic or repeated inhalation studies involving the test substance. While there was a statistically significant decrease in survivability (males only) at the termination of the 2-yr study, no impact on survivability is observed throughout the chronic toxicity portion of the study (12 months). There were no pathological, clinical or clinical chemistry effects observed that would support a conclusion that there was a substance-related reduction in survival. The study authors did not consider the possibility that the statistical difference in survivability at the 2-yr point is due to the high survival rate of the controls in this study, and that comparison with historical control values may have led to the dismissal of the effects. Based on careful consideration of the chronic portion of this study and the supporting information of several subchronic studies involving multiple species, the repeated inhalation NOAEL is determined to be 2.5% (47106 mg/m3).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 471 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 11 777 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- In a 2-year chronic/carcinogenicity study, 100 rats/grp/sex were exposed 6 h/d, 5 d/w to concentrations of DME of 0, 0.2, 1.0, or 2.5%. The NOAEC was established to be 2.5% = 47106 mg/m3. NOAEC general public = 6/24 * NOAEC rat.
- AF for dose response relationship:
- 1
- Justification:
- The robust database supports the confidence in the dose descriptor
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEC is based on a chronic (2-year) inhalation study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already included in NOAEC calculation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default for general public
- AF for the quality of the whole database:
- 1
- Justification:
- Available data are derived from studies of appropriate quality and validity, showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- A high quality, robust toxicity database exists for this substance.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
This is a volatile substance and potential worker exposure would likely occur via the inhalation route. Therefore, no worker oral or dermal route DNELs were derived.
No local effects were observed in acute or repeated exposure studies; therefore no DNEL for local effects was derived.
This substance is not classified as toxic under REACH regulations and guidance. The rat 4-hr inhalation LC50 is 164000 ppm (309018 mg/m3). The LOAEL for systemic toxicity effects after a 2-hour inhalation exposure is 84000 ppm (158277 mg/m3) air, at which levelacute toxicity was observed in the form of ataxia, anaesthesia in 2 hours, short jerky respirations and lung noise (post exposure). Various repeated dose inhalation studies, including 90-day exposures were conducted for this substance. In rats, no substance related adverse effects were observed at the highest concentration tested (20000 ppm, 37685 mg/m3). In hamsters, clinical chemistry changes were not consistently dose related or statistically significant, therefore, the rat was considered for use in assessment activities. Since a high quality, chronic inhalation exposure study was available in rats, it was the most appropriate study for further health assessments.
Male and female rats were exposed to 0, 0.2, 1 or 2.5% v/v via inhalation for 24 months. Body weight gain (male only) was occasionally higher than controls in the early phases of the study, but this finding was not consistent throughout the study. Further the observation in increased body weight was not seen in any other of the subchronic or repeated inhalation studies involving the test substance. While there was a statistically significant decrease in survivability (males only) at the termination of the 2-yr study, no impact on survivability is observed throughout the chronic toxicity portion of the study (12 months). There were no pathological, clinical or clinical chemistry effects observed that would support a conclusion that there was a substance-related reduction in survival. The study authors did not consider the possibility that the statistical difference in survivability at the 2-yr point is due to the high survival rate of the controls in this study, and that comparison with historical control values may have led to the dismissal of the effects. Based on careful consideration of the chronic portion of this study and the supporting information of several subchronic studies involving multiple species, the repeated inhalation NOAEL is determined to be 2.5% (47106 mg/m3).
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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