Registration Dossier
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EC number: 206-156-8 | CAS number: 304-59-6
- 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:
- 1.85 mg/L
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 10 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.185 mg/L
- Assessment factor:
- 500
- 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:
- no exposure of sediment expected
Sediment (marine water)
- Hazard assessment conclusion:
- no exposure of sediment expected
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- no exposure of soil expected
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
According to the available data the following PNEC values can be calculated:
PNEC freshwater = 1.85 mg/L
Rationale:An AF of 50 is applied to the lowest NOEC value (92.5 mg/L) obtained in two taxonomic groups. In this case this corresponds to a GLP compliant 21d daphnid reproduction test. Although there is no long-term test available in fish and the available long-term values are not obtained in fish, the available data on LC50 in medaka do not support that this is the most sensitive taxonomic group, it only reflects that no effect was seen at the highest concentration tested. The LC50 for fumaric acid supports the low toxicity of the group, but is not used in the calculation as its acidity at high concentrations in contrast with Na or K salts is likely to overestimate toxicity.
PNEC freshwater (intermittent release) = 10 mg/L
Rationale:An AF of 100 is applied to the lowest reliable LC50 value available for a C4 carboxyllic acid salt (>997 mg/L).
LC50 of malic and fumaric acid indicate low toxicity of the group as a whole but have not been used as they are likely to overestimate toxicity due to the higher acidity of the test solutions.
PNEC marine = 0.185 mg/L
Rationale: Given the limited availability of reliable marine data, the PNEC would have to be derived from the lowest of 2 freshwater NOEC values, as in the previous case. An additional safety factor of 10 is introduced to take account of greater diversity in marine taxons, thereby leadin to applying an AF of 500 upon the Daphnid NOEC of 92.5 mg/L. The suitability and usefulness of this PNEC is questionable given the very rapid degradability of the carboxyllic acid and the low likelihood of its entry into the marine environment after passing a sewage treatment plant.
PNEC STP = 10 mg/L
Rationale:An AF of 10 is applied to the lowest concentration which is known to have no effect on the innoculum in a rapid biodegradability test (92.5 mg/L). In this case this is 100 mg/L of analogue disodium tartrate in an OECD 301C 14d biodegradation test performed under GLP by the Japanese MoE (2001).
Conclusion on classification
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