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EC number: - | CAS number: -
- 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
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- Explosiveness
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- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
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- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
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- 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
Endpoint summary
Administrative data
Description of key information
Waiver Justification & additional Endpoints
Additional information
Incroslip SL
Terrestrial Compartment
Background
Soil toxicity data are used in the chemical safety assessment to establish a PNECsoil as part of a quantitative assessment of risk to the soil compartment. ECHA’s first preference would be for PNECsoilto be calculated from long-term toxicity studies on soil organisms covering plants, invertebrates and micro-organisms.
For Incroslip SL, no such data existed at the time of dossier submission to ECHA for Annex X REACh registration (>1000t).
The initial proposal from Croda was to undertake an earthworm reproduction study, assess the results and submit a second proposal for testing or justification to ECHA. ECHA agreed to this proposal. Between the time of submission and the response from ECHA, an Earthworm Acute (OECD 207) study was conducted as a limit-test at 1000 mg/kg with no effects (NOAEC = 1000 mg/kg dry soil), LC50>1000 mg/kg).
In light of this new ecotoxicology data for the soil compartment, the following information is available.
1a: Weight of Evidence
In general, where there is no toxicity L(E)C50in the standard acute toxicity tests at >10 mg/l, or no effects in chronic toxicity at the limit of water solubility, or the screening assessment based on EPM shows no concern, then a single short-term soil test on a suitable species would be adequate to meet the requirements of Annex IX. For Incroslip SL the following experimental endpoints are available:
Short-term toxicity to fish NOEC 100 mg/L (100% saturated solution)
Long-term toxicity to aquatic invertebrates NOEC 0.0038 mg/L
Toxicity to aquatic algae and cyanobacteria NOEC 100% saturated solution
Toxicity to microorganisms NOEC No inhibitory effect
The soil PNEC would be derived by application of appropriate assessment factors to the aquatic data, and the soil short-term data, and the lowest value taken. Where the substance is highly adsorptive, e.g. where the log Kow/Koc>5, and/or the substance is very persistent in soil, this single test should be a long-term test. Substances with a half-life >180 days are considered to be very persistent in soil.
Incroslip SL is not persistent, with a DT50of around 28 days and has a Kocof <5. Therefore a short-term terrestrial test is appropriate.
Earthworm Acute Toxicity Study (OECD 207), Klimisch 1.
In circumstances where less than a full soil toxicity data-set is available, both the available soil data and the EPM modified aquatic toxicity data should be used in deriving the PNECsoil. In such circumstances, where the subsequent PEC:PNEC <1, this would constitute an adequate data-set and no further testing would be required
1b: Mitigation (EPM)
Study data may not be needed to characterize the risk for soil. In defining what can be considered as sufficiency of information, it is also necessary to have all available information on water solubility, octanol/water partitioning (log Kow), vapour pressure, and biotic and abiotic degradation, and the potential for exposure.
For Incroslip SL the following experimental data exist:
Water solubility 1.91 ×10-5g/L
Biotic and abiotic degradationNot readily biodegradable. >50% degradation in 28 days
For Incroslip SL the following modelled data exist:
Vapour pressure 1.91×10-4
Octanol/water partitioning (log Kow) 6.7 (max)
Adsorption Coefficient (log Koc) 4.59-4.67*
When soil exposure is considered negligible, then neither a PEC, nor PNEC can or need be calculated and no soil toxicity data are necessary.
The potential for exposure was determined to be low. It could not be considered negligible as elimination is predominantly via the sewage treatment works and may reach the soil compartment during irrigation and waste dispersal on agricultural land.
*Koc, as the solid matter partition co-efficient is considered a more reliable indicator of the potential adsorption to soil than the Kow(octanol: water partition coefficient). The Log Kocof Incroslip SL is below 5 (modelled data), the potential for soil adsorption is low.
Equilibrium Partitioning Method (EPM) Approach
Where the data available are sufficient to derive a PNEC for aquatic organisms, this PNEC can be used in a screening assessment for soil risks through the use of the EPM approach. If comparison of a PNECsoil derived by EPM from the aquatic PNEC, shows a PEC:PNEC ratio <1, then the information available may be sufficient to conclude the soil assessment.
PECsoilderived from Simplebox (v 4.01 31 May 2015) model using the following settings and input:
Scenario EUSES
Case + soil depth
Chemical class Amides
Molecular weight (g·mol-1) 283.5
Octanol/water partition coefficient (Kow) 0.820989*
Vapour pressure (Pa) 25oC 0.000283*
Water solubility (mg·L-1) 25oC 0.0191
*modelled values
All other values were set to default.
Output (regional Scale):
Natural soil 4.73×10-10g/kg
Agricultural soil 2.35×10-10g/kg
Other soil 4.73×10-10g/kg
Total soil (PECsoil) 1.181×10-9g/kg
PNECwaterderived from Daphnia reproductive endpoint NOEC ≥0.0038 mg/L (3.8 g/L).
The PECsoil:PNECwaterratio was calculated as follows:
1.181×10-9g/kg : 3.8 g/L = 3.108×10-9
Where the adsorption is likely to be high, i.e. where the log Kowor Log Koc>5, the PECsoil:PNECsoilratio is multiplied by 10. As Incroslip SL has a Kocvalue close to the threshold, this safety (assessment) factor has been applied:
PECsoil:PNECsoil = 3.108×10-10
The PEC:PNEC ratio <1 and was derived based on long-term aquatic toxicity data and included an additional safety factor. In addition, the Log Kocis predicted to be low and biodegradation of over 50% has been observed within 28 days.
Furthermore, acute terrestrial toxicity data exists. The calculation of PECsoil:PNECsoilbased on the acute terrestrial data gives a ratio <1:
1.181×10-9g/kg : 1 g/kg = 1.181×10-9
As artificial soil in the OECD 207 study contains 10% peat, a doubling safety factor should be applied:
1.181×10-9· 2 = 2.362×10-9
Where the adsorption is likely to be high, i.e. where the log Kowor Log Koc>5, the PECsoil:PNECsoilratio is multiplied by 10. As Incroslip SL has a Kocvalue close to the threshold, this safety (assessment) factor has been applied:
PECsoil:PNECsoil = 2.362×10-8
An additional safety/uncertainty factor, as the endpoint is acute and not long-term of 100 is applied:
2.362×10-8·100 = 2.362×10-6
Conclusion
The EPM approach uses long-term aquatic data and factors in all safety factors required when deriving PEC:PNEC ratios for the terrestrial compartment from aquatic data. The PEC:PNEC ratio is far below the required value of 1 indicating a high margin of safety based on default PEC values set using available information. As the EPM shows no concern, there is no long-term aquatic toxicity concern and an acute terrestrial study now exists which demonstrates a NOAEC of 1000 mg/kg, no further testing is proposed.
Using acute terrestrial data and taking into account all safety factors required when deriving PEC:PNEC ratios for the terrestrial compartment from acute data in artificial soil. The PEC:PNEC ratio is far below the required value of 1 indicating a high margin of safety based on default PEC values set using available information. Furthermore, the earthworm covers a wide range of exposure scenarios through soil and porewater exposure.
No further testing is proposed.
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