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EC number: 619-372-6 | CAS number: 98730-04-2
- 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:
- 0.022 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.014 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.002 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 10 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.559 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.056 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:
- 0.099 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
Calculation of PNECs with assessment factors
PNEC values have been determined for environmental compartments using the assessment factor approach in accordance with the ECHA guidance R.10 on the characterisation of dose [concentration]-response for the environment.
PNEC aqua (freshwater) = 0.022 mg/L
PNEC aqua (marine water) = 0.0022 mg/L
PNEC aqua (intermittent release) = 0.014 mg/L
PNECstp = 10 mg/L
PNEC sediment (freshwater) = 0.559 mg/kg dry weight
PNEC sediment (marine water) = 0.0559 mg/kg dry weight
PNEC soil = 0.099 mg/kg dry weight
Benoxacor has been also evaluated in accordance with the principles of the Plant Protection Directive 91/414/EEC. The risk assessments, and proposed endpoints used therein, have been evaluated by EU member States as part of pre-marketing authorisations of herbicidal products used with the safener benoxacor. Although the safener benoxacor has not been considered an active substance in accordance with 91/414/EEC, it has been evaluated with the same rigour with respect to exposure and risk to humans and the environment.
Calculation of PNECsoil with Equilibrium Partitioning Method(EPM)
The calculation of PNECsoil from PNECwater using the equilibrium partitioning method (EPM) is discussed and described in the following guidance documents:
· Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment (May 2008)
· Guidance on information requirements and chemical safety assessment, Chapter R.16: Environmental Exposure Estimation (V2, May 2010)
The calculation details are given in Equations R.10-5, R.16-4, R.16-5, R.16-6, R.16-7, R.16-16 and in Table R.16-9. The involved input, default and output values are given in the following table.
Variable/parameter (unit) |
Symbol |
Unit |
Value |
Source |
Molecular weight |
MOLW |
[g/mol] |
260.1 |
Input |
Vapour pressure |
VP |
[Pa] |
0.0018 |
Input |
Solubility in water |
SOL |
[mg/L] |
38 |
Input |
Henry’s law constant |
HENRY |
[Pa/m3/mol] |
0.0123 |
Output |
Gas constant |
R |
[Pa/m3/mol/K] |
8.314 |
Default |
Temperature at the air-water interface |
TEMP |
[K] |
285 |
Default |
Air-water partitioning coefficient |
Kair-water |
[-] |
5.1996E-06 |
Output |
Partition coefficient organic carbon -water |
Koc |
[L/kg] |
218 |
Input |
Fraction organic carbon in the soil |
Foc |
[-] |
0.02 |
Default |
Soil water partition coefficient |
Kpsoil |
[L/kg] |
4.36 |
Output |
Fraction air in soil |
Fair |
[-] |
0.2 |
Default |
Fraction water in soil |
Fwater |
[-] |
0.2 |
Default |
Fraction solid in soil |
Fsolid |
[-] |
0.6 |
Default |
Bulk density of solids |
RHOsolid |
[kg/m3] |
2500 |
Default |
Soil-water equilibrium partition distribution coefficient |
Ksoil-water |
[m3/m3] |
6.740 |
Output |
Bulk density of wet soil |
RHOsoil |
[kg/m3] |
1700 |
Default |
Bulk density of dry soil |
RHOsoil dry |
[kg/m3] |
1500 |
Default |
Remark: The value given in guidance R.10 on page 40 for RHOsoil (bulk density of wet soil) is considered wrong (value given: 1150 kg m-3, correct value: 1700 kg m-3; this assumption is supported by Equation R.16-16).
The final calculation of PNECsoil is made according to the following equation:
PNECsoil = (Ksoil-water/RHOsoil) * PNECwater * 1000
with [PNECsoil]: mg/kg, [PNECwater]: mg/L, [RHOsoil]: kg/m3
Based on PNECwater of 0.022 mg/L and the default values for the bulk density of soil (1700 kg/m3 for wet soil and 1500 kg/m3 for dry soil) the following values PNECsoil, based on EPM, were derived:
· PNECsoil: 0.087 mg/kg (EPM, based on wet soil)
· PNECsoil: 0.099 mg/kg (EPM, based on dry soil)
Conclusion on classification
CLP classification of the substance
For environmental classification, the results of available, reliable acute and chronic aquatic toxicity studies are considered. Aquatic toxicity studies are available for various species from three trophic levels.
Acute aquatic toxicity
All effect concentrations (LC50 or EC50 values) observed in these studies are greater than 1 mg/L, which is the cut-off value for classification for acute aquatic toxicity. One exception is the 72-hour EbC50 = 0.63 mg/L observed in a static algal toxicity test conducted with green algae (Scenedesmus subspicatus) according to OECD TG 201 (Rufli, 1989). This effect concentration is based on a decrease in the biomass of treated cultures. In Note 2 of Table 4.1.0 describing the classification criteria for hazards to the aquatic environment according to Regulation (EC) No. 1272/2008, amended by Commission Regulation (EU) No. 286/2011, it is stated that for classification the effect concentrations from algal toxicity studies should be based on the growth rate, where such data are available. A reliable algal toxicity study providing a growth-rate based ErC50 = 13.5 mg/L is available for benoxacor (Hertl, 1997). Therefore, the EbC50 value of less than 1 mg/L (Rufli, 1989) should not be taken into account for classification. It can be concluded that benoxacor should not be classified for acute aquatic toxicity according to CLP Regulation (EC) No. 1272/2008, amended by Commission Regulation (EU) No. 286/2011.
Chronic aquatic toxicity
Adequate and reliable chronic aquatic toxicity data are available for benoxacor from three long-term studies on species from three trophic levels. The NOEC values observed in long-term studies with fish, daphnids and algae were all in the range from >0.1 mg/L to ≤ 1mg/L. For the classification of long-term aquatic hazard, the results from a prolonged short-term toxicity study with rainbow trout are also considered. This study resulted in a NOEC <0.1 mg/L over the test period of 21 days. In combination with the finding that the substance was not readily biodegradable a precautionary classification into "Category Chronic 1" is derived from all available data according to CLP Regulation (EC) No. 1272/2008, amended by Commission Regulation (EC) No. 286/2011.
The proposed M-factor is 1, which is based on the robust information on the long-term aquatic toxicity of the substance.
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