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Diss Factsheets
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EC number: 218-080-2 | CAS number: 2050-08-0
- 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:
- 0.77 µg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 7.7 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.077 µg/L
- Assessment factor:
- 10 000
- 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:
- 0.389 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.039 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:
- 1.786 mg/kg soil dw
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 80 mg/kg food
- Assessment factor:
- 90
Additional information
The PNECs for the aquatic environment are derived from the lowest effect level observed in the available acute aquatic toxicity tests by applying the appropriate assessment factors to the lowest L(E)C50 of 0.77 mg/L.
PNECSTP can be calculated via biodegradation endpoints using the concentration where no toxicity to microorganisms was observed, which can be considered the NOEC. In this case, no toxicity was observed at the test concentration of 100mg/l. An assessment factor of 10 should be used when evaluation PNECSTP in this way. Therefore PNECSTP = 10 mg/l.
The PNEC secondary poisoning was derived from the available information on 90-day repeat dose toxicity NOAEL of 360mg/kg bw/day by multiplying by a conversion factor of 20 (rattus norvegicus > 6 weeks) to derive a NOEC, and then dividing by assessment factor of 90 (sub-chronic study) in accordance with ECHA guidance R.10.8.
For sediment PNECs, wet weight PNECs were calculated using the equilibrium partitioning method as described in Guidance R.10 & R.16, conversion to dry weight was performed with factor of 4.6.
The PNECsoil was derived from soil toxicity data. The observed LC50 from the acute earthworm test (OECD 207) was 127.8 mg/kg soil dw. Chronic or long-term toxicity testing on soil microorganisms (OECD 216) and terrestrial plants (OECD 208 with six species, two monocotyledonous and four dicoyledonous) gave respectively a NOEC of ≥500 mg/kg soil dw and EC10 of 89.3 mg/kg soil dw (tomato, most sensitive species). According to ECHA guidance (Chapter R.7c, section R.7.11.5.3) where data from chronic or long-term tests are available, they should be used in preference to short-term tests to derive the PNEC. Since two long-term NOECs/EC10s are available, the PNEC has been derived from the lowest long-term result of the two trophic levels using, in accordance with ECHA Table R.10 -10, an assessment factor of 50 to give a PNECsoil of 1.786 mg/kg soil dw.
Conclusion on classification
Short-term aquatic toxicity data is available for all three trophic levels. The lowest short-term L(E)C50 was for algae with a 72-hour EC50 value of 0.77 mg/l based on growth rate. Chronic aquatic toxicity data is only available for algae: the 72-hour NOEC is 0.2 mg/L (based on growth rate). Amyl salicylate is readily biodegradable, has a BCF of 380 -570 L/kg (based on an experimentally determined BCF for the analogue substance, cyclohexyl salicylate, and supported by QSAR) and a log Kow of 4.4 to 4.5.
Based on the above data, amyl salicylate is classified as R50/53 according to Directive 67/548/EEC (DSD) and Aquatic Acute 1 (H400) & Chronic 1 (H410) according to Regulation 1272/2008/EC & adaptation 286/2011/EC (CLP). According to Regulation (EC) No. 286/2011, Table 4.1.3, in order to classify a mixture containing the substance an M-factor of 1 should be used when applying the summation method.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.