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EC number: 246-904-0 | CAS number: 25371-54-4
- 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
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.1 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 1 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.01 mg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 0.1 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 4 270 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 427 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 854 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 20 mg/kg food
- Assessment factor:
- 300
Additional information
Micro-organisms
An activated sludge respiration inhibition study was not performed since it was considered technically infeasible to perform testing given that DMOP is highly insoluble in water (7.656E-07 g/l 25°C derived from the (Q)SAR WSKOW (v1.42)).
Exposure to STP microorganisms is expected to be limited, according to the ATIEL Group Specific Environmental Release Categories (SpERCs) factsheet for formulation of lubricant additives, lubricants and greases (SPERC Factsheet Ai-add-pack-(2012-10-05)) “User sites are assumed to be provided with oil/water separators or equivalent and for waste water to be discharged via public sewer system”.
In addition, the exposure and risk assessment for formulation (note:- formulation is considered to represent a worst case scenario relative to professional and consumer use) of DMOP, based on EU tonnage, and calculated using OECD ESD No.10 for Lubricants and Lubricant Additives combined with EUSES v2.1.2, indicates that there is no cause for concern for the aquatic environment. The PNEC Micro-organisms was therefore based on the aquatic toxicity data.
Water compartment
The current strategy for deriving a protective PNEC water, outlined in the REACH Guidance (R.10: Characterisation of dose [concentration] – response for environment), indicates that the appropriate assessment factor should be applied to the lowest acute L(E)C 50 value obtained from toxicity testing in fish, aquatic invertebrate and algal species. In the event that chronic toxicity data are available from three separate trophic levels, the appropriate assessment factor is applied to the lowest NOEC value derived. Given that DMOP is highly insoluble, short-term toxicity testing has been performed only in invertebrates (Daphnia magna), as detailed below.
48-hour static acute toxicity study with Daphnia magna was performed in a test designed to meet the requirements of OECD Test Guideline 202. As DMOP is highly insoluble in water the Water Accommodated Fraction (WAF) procedure was applied to prepare the test solutions. In the limit test where 20 daphnids were exposed to a nominal loading rate of 100 mg/l for 48 hours and a second group of 20 daphnids was exposed to dilution test water (control solution), no immobilisation was observed in any of the test solutions at 0, 24 or 48 hours. The (Median Effective Loading rate) was >100 mg/l and the No Observed Effect Loading rate was ≥100mg/l.
The data derived from the daphnia study demonstrate that DMOP is not toxic at a loading rate of 100 mg/L. In consideration of these data and the difficulties in testing due to the very low water solubility of DMOP, further aquatic testing was not performed and the PNEC has been derived from the EL50 of >100 mg/l.
The proposed PNEC fresh water of 0.1 mg a.i./L is based on the EL50 derived from the daphnia study with an assessment factor of 1000. The proposed PNEC marine of 0.01 mg a.i./L is based on the application of an additional assessment factor of 10 to the assessment factor of 1000 applied to the EL50 value obtained from the invertebrate toxicity study.
Sediment
A PNEC sediment freshwater has been determined using the equilibrium partitioning method based on the PNEC freshwater derived above, in accordance with Equation R.10-2.
Where:-
RHOsusp = 1150 kg/m3
PNEC freshwater = 0.1 mg/l
PNEC sediment freshwater = 928 mg/kg wwt
PNEC sedimentfreshwater = 4270 mg/kgdwt
A PNEC sediment marine has been determined using the equilibrium partitioning method based on the PNEC marine water derived above, in accordance with the Equation R.10-2.
Where:-
RHOsusp = 1150 kg/m3
PNEC marine water = 0.01 mg/l
PNEC sediment marine = 92.8 mg/kg wwt
PNEC sediment marine = 427 mg/kgdwt
Terrestrial Compartment
A PNEC soil has been determined using the equilibrium partitioning method based on the PNEC freshwater derived above in accordance with Equation R.10-5.
Where:-
RHO soil = 1700 kg/m3
PNEC freshwater = 0.1 mg/l
PNEC soil = 753 mg/kg wwt
PNEC soil = 854 mg/kg dwt
Exposure to Man via the Environment
The PNEC oral for man via the environment of 2.5 mg/kg bw/d is based on the NOAEL of 300 mg/kg bw/d from the 28 day combined rat repeat dose toxicity and reproduction/developmental toxicity screening test. The PNEC was derived using a correction factor of 120 (assessment factors of 4 × 5 × 6 were applied for interspecies, intraspecies and conversion from sub-acute to chronic exposure, respectively).
Secondary Poisoning of Birds and Mammals
The PNEC oral of 20 mg/kg food is based on the NOAEL of 300 mg/kg bw/d from the 28 day combined rat repeat dose toxicity and reproduction/developmental toxicity screening test. A conversion factor of 20 was used to convert from mg/kg bw/day to mg/kg food/day together with an assessment factor of 300 to extrapolate from subchronic to chronic.
Environmental No effect Concentrations (PNECs)
Compartments |
PNEC |
|
Micro-organisms in STP |
0.1* |
mg/L |
Fresh water aquatic |
0.1 |
mg/L |
Fresh water sediment |
928 4270 |
mg/kg wwt mg/kg dwt |
Sea water |
0.01 |
mg/L |
Marine sediment |
92.8 427 |
mg/kg wwt mg/kg dwt |
Terrestrial compartment |
753 854 |
mg/kg wwt mg/kg dwt |
Man via the environment (total daily intake) |
2.5 |
mg/kg bw/d |
Secondary Poisoning of Birds and Mammals |
20 |
mg/kg food |
* Based on PNEC freshwater as there are no data on STP micro-organisms.
Conclusion on classification
The EL50 (Median Effective Loading rate) for DMOP is >100 mg/l, therefore, DMOP does not merit classification based on toxicity as "Hazardous to Aquatic Environment - Chronic Category 1, 2 or 3".
DMOP however fulfils the criterion defined in Regulation (EC) No 1272/2008 DMOP for classification as Chronic Category 4 since DMOP is a poorly soluble substance for which no acute toxicity is recorded at levels up to the water solubility and has a log Kow of ≥ 4 (the estimated BCF derived from BCFBAF v3.01 is 684.6 L/kg).
In conclusion, the proposed classification for DMOP is:
Hazardous to the Aquatic Environment-Chronic Category 4
H413: May cause long lasting harmful effects to aquatic life.
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