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EC number: 248-227-6 | CAS number: 27107-89-7
- 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:
- 5.78 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 144.58 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 82 mg/kg/day x (1/0.38 x 6.7/10) - No correction for inhalatory and oral absorption rates. The vapour pressure is small (0.00287 Pa at 20°C), therefore MOTE has a low volatility
- AF for dose response relationship:
- 1
- Justification:
- use of a NOAEL as dose descriptor and the low toxicity of the test substance
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- no allometric scaling factor is applied because an oral-to-inhalation route extrapolation is performed
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of the whole database
- AF for remaining uncertainties:
- 2.5
- Justification:
- remaining differences
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
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 82 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 8 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- 82 mg/kg/day x (100/1)
- AF for dose response relationship:
- 1
- Justification:
- use of a NOAEL as dose descriptor and the low toxicity of the test substance
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default for rat
- AF for other interspecies differences:
- 1
- Justification:
- no difference in dermal absorption between rats and human as worst-case assumption (rat skin is generally more permeable than human skin)
- AF for intraspecies differences:
- 5
- Justification:
- default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of the whole database
- AF for remaining uncertainties:
- 2.5
- Justification:
- remaining differences
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
For acute effects, no significant effects that would justify systemic DNEL derivation were observed in the corresponding acute toxicity studies. For local effects, the substance was only slightly irritating to the rabbit skin, with mean values not triggering classification and with no data on dose-response available, and not-irritating to the rabbit eye.
Occupational exposure to MOTE may occur by inhalation or dermal route. For long-term systemic effects, DNEL derivation was performed following the method proposed in the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8.
In a previously conducted OECD TG 421 study (Waalkens-Berendsen, 2009 - Reproduction/Developmental Toxicity Sceening Test), evidence was already obtained that possible effects on thymus weights from repeated exposure to MOTE of pregnant/lactating females were not accompanied by any microscopic findings. As the OECD TG 408 study (Lina, 2014 - Repeated Dose 90-Day Oral Toxicity in Rodents), performed at the same dose levels, lasts considerably longer and includes many more toxicological endpoint, this study has been considered the more appropriate and the key study for systemic long-term DNELs derivation.
For the inhalation long-term systemic DNEL, no correction for inhalatory and oral absorption rates was applied. The vapour pressure is very low (0.00287 Pa at 20°C), therefore MOTE has a low volatility and would not be available for inhalation as a vapour.
For the dermal long-term systemic DNEL, an in-vitro dermal absorption study performed on DOT(EHMA) (Ward, 2003) showed a very low absorption rate through the rat skin. Reading-across from this substance was considered appropriate, because both substances are liquid, with a high molecular weight (>500 g/mol), and may be too large to be absorbed though the skin. Moreover, their vapour pressure are very low. Although the rat skin is generally considered to be more permeable than human skin, as a worst-case assumption the same extent of dermal absorption (1%) has been used.
General Population - Hazard via inhalation 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
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 41 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 8 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- 82 x (100/1)
- AF for dose response relationship:
- 1
- Justification:
- use of a NOAEL as dose descriptor and the low toxicity of the test substance
- AF for differences in duration of exposure:
- 2
- Justification:
- subchonic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default for rat
- AF for other interspecies differences:
- 1
- Justification:
- no difference in dermal absorption between rats and humans as worst-case assumption
- AF for intraspecies differences:
- 10
- Justification:
- default for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of the whole database
- AF for remaining uncertainties:
- 2.5
- Justification:
- Remaining differences
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.41 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 82 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- same extent of oral absorption in rats and humans
- AF for dose response relationship:
- 1
- Justification:
- use of a NOAEL as dose descriptor and the low toxicity of the test substance
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default for rat
- AF for other interspecies differences:
- 1
- Justification:
- same extent of oral absorption in rats and humans
- AF for intraspecies differences:
- 10
- Justification:
- default for the genral population
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of the whole database
- AF for remaining uncertainties:
- 2.5
- Justification:
- remaining differences
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
The same endpoint used for setting the long-term systemic DNELs for workers has been used for deriving long-term systemic DNELs for the general population; the increased AF of 10 for intraspecies sensitivity has been considered to be sufficiently protective.
The inhalation route of exposure is considered to be not relevant for the general population and therefore no DNEL has been derived.
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