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Diss Factsheets
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EC number: 204-679-6 | CAS number: 124-09-4
- 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:
- 0.42 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.32 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.04 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 29.1 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 65.35 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 6.54 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:
- 3.52 mg/kg soil dw
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
The calculated PNEC aquatic for the submission substance is 0.42 mg/L using an assessment factor of 10 based on the fact that chronic toxicity results are available for two trophic levels and combined with the fact that acute toxicity data for fish demonstrated that this trophic level is clearly the least sensitive by far more than a factor of 10 in acute tests compared to other taxa. Due to the short carbon chain lengths of HMD the submission substance does not show surface active properties and the octanol-water partition coefficient is very low. Because there is no potential for bioaccumulation, secondary poisoning needs not to be assessed. Aliphatic amines are readily protonated at environmental pH and due to their positive charge are prone to bind to negatively charged solid matter. According to the available adsorption-desorption study (OECD 106; RL1), HMD binds to soil and sediment. In spite of this adsorptive behaviour, HMD was shown to be readily biodegradable fulfilling the 10-day window requirement with total nitrification within 28 days. From these properties, rapid degradation in sewage treatment plants or the environment is expected which would lead to overall low environmental concentrations. In addition, due to adsorption on suspended matter or soil, bioavailable concentrations in the aquatic phase are expected to be very low. Due to the observed rapid mineralization, accumulation in soil or sediment is not anticipated. This is confirmed by the recently performed study on nitrogen-transformation by soil organisms (OECD 216; RL 1): independently from the submission substance concentration (between 62.5 and 1000 mg/kg soil dry weight), consistently between 50% and 64% of the submission substance borne nitrogen was transformed to nitrate within 28 days, in addition to the nitrate stemming from amending soil with Lucerne meal containing nitrogen. As cleavage of the C-N-bonds is a prerequisite for nitrification and will reduce adsorption and increase bioavailability of the submission substance; considering in addition its ready biodegradability allows concluding on rapid mineralization of the submission substance within natural soil. With regard to the terrestrial compartment, reliable long-term results on earthworm (OECD 222; RL 1) and soil microorganisms (OECD 216; RL1) are available. A PNEC_soil was derived from these data in parallel to the EPM-method, as required according to ECHA guidance R.7c, sections R.7.11.5.3 and R.7.11.6.3. From these experimental data (two trophic levels, i.e. detrivors and consumers; AF 50 according to ECHA guidance R.10), a terrestrial PNEC of 3.52 mg/kg soil (dw) results. This value is lower compared to the terrestrial PNEC obtained from EPM (14.2 mg/kg soil dw after application of additional factor of 10) and is therefore used for environmental risk assessment. As there is no indication of risk from these confirmatory long-term soil toxicity results (PEC/PNEC_exp <1), no further toxicity testing for soil organisms is required (ECHA guidance R.7c).
With regard to the sediment compartment, PNEC was calculated using the Equilibrium Partitioning Method based on the experimentally determined adsorption data. For sediment a lower adsorption was observed as compared to soil and following ECHA’s criterion of log Koc > 4 it is concluded that HMD is not strongly adsorbing to sediment. Hence, no additional factor is applied for sediment compartments with regard to the RCR based on PNECsediment derived via the equilibrium partition method. As there is no indication of risk from this RCR (PEC/PNEC_EPM <1), no further toxicity testing for sediment organisms is required.
Conclusion on classification
1 Classification according to Regulation (EC) 2008/1272 (CLP)
Classification according to Regulation (EC) 2008/1272 (CLP) is performed independently for acute and chronic hazards. If data for chronic hazards are incomplete (data not available for all three trophic levels), chronic classification is performed both, based on acute data and environmental fate and based on available chronic data and the more stringent outcome is taken for final chronic classification.
Acute hazard category:
The lowest acute aquatic toxicity of three trophic levels was determined for Daphnia with a geometric mean EC50(48 h) of 31.5 mg/L. Under Regulation (EC) 2008/1272 (CLP), only one acute category is implemented (category 1). This category is assigned to substances presenting L/EC50≤1 mg/L.
Thus,no acute classificationresults from the available acute aquatic ecotoxicity data on HMD.
Chronic hazard category:
Using available acute data, decisive for a possible chronic classification is failure or fulfillment of (1) rapid degradability and / or (2) presence or absence of a bioaccumulation potential.
As substitute for an experimentally determined BCF in fish, log KOWis taken as an indicator of bioaccumulation potential. As log KOW of the submission substance is clearly below the cut-off value according to CLP of 4.0 (log Kow HMD ≤0.4), the submission substance is regarded as non-bioaccumulative.
Rapid degradability according to CLP is given for substances which were assessed as “readily biodegradable” in screening studies (OECD 301) with a minimum of 60% O2-depletion of theoretical maximum (for respirometric OECD 301 methods) within 28 days and at the same time fulfillment of the 10-day-window. This is met by the submission substance. The submission substance is therefore considered as rapidly degradable.
No chronic classification results for the submission substance from the available acute data on ecotoxicity, the degradation and bioaccumulation potentials.
Chronic data are availablefor algae with an EC10(72 h, growth rate) of 118.0 mg/L and for aquatic invertebrates (Daphnia magna): NOEC (21 d) 4.2 mg/L. To trigger a chronic classification, such chronic data have to be inferior or equal to 1 mg/L; which is not the case here. Thus, also based on available chronic data, no chronic classification results.
Final conclusion: HMD is not classified regarding hazards for the aquatic environment according to CLP.
2 Classification according Directive 67/548/EEC (DSD)
The lowest acute aquatic toxicity of three trophic levels was determined for Daphnia with a geometric mean EC50(48 h) of 31.5 mg/L.
The submission substance is considered as rapidly biodegradable and without potential for bioaccumulation (log Kow HMD << 3.0).
Thus, no classification according to Directive 67/548/EEC (DSD) is resulting.
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