Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 200-568-1 | CAS number: 63-91-2
- 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:
- no hazard identified
Marine water
- Hazard assessment conclusion:
- no hazard identified
STP
- Hazard assessment conclusion:
- no hazard identified
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 hazard identified
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential to cause toxic effects if accumulated (in higher organisms) via the food chain
Additional information
Conclusion on classification
Toxicity to fish:
The estimation of the acute toxicity to fish by SAR/QSAR prediction Fathead minnow 96h LC50 - Danish QSAR DB SciQSAR model predicted a LC50 = 324 mg/L indicating that aquatic toxicity is unlikely to occur.
Toxicity to aquatic invertebrates:
The results from a GLP study for short-term toxicity to daphniae reveal that L-phenylalanine does not show aquatic toxicity.
The 48-hour NOEC was determined to be 100 mg test item/L. The 48-hour LOEC was determined to be > 100 mg test item/L and the 48-hour EC50 value was determined to be > 100 mg test item/L.
Toxicity to algae:
The results from a GLP growth inhibition study reveal that L-phenylalanine does not inhibit the growth of algae.
The NOEC-value of the test item for both inhibition of growth rate and inhibition of yield after 72 hours was 100 mg/L. The EC50-values of the test item for both inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were > 100 mg/L.
The results of the daphnia and algae studies do not trigger classification.
In line with EU-GHS (Regulation 1272/2008), which refer to potential harmonized classification of L-phenylalanine, L-phenylalanine does not fulfil the criteria relating to environmental hazards.
In respect of the registration Article 14 in conjunction with Annex I of the REACH Regulation requires a chemical safety assessment which includes an exposure assessment if the particular substance meets the criteria for classification as “dangerous” under the Directive 67/548/EEC or is assessed to be a PBT / vPvB. Annex I, Section 5.0 of the REACH Regulation states that the exposure assessment “shall cover any exposures that may relate to the hazards identified in Sections 1 to 4”. Thus REACH requires that the exposure assessment is closely linked to the hazard assessment, which may identify hazards either for the environment, or for human health, or for both. The hazard assessment (including the classification) as well as the performance of an exposure assessment are focused either on possible effects on the environment or on possible effects on human health. L-Phenylalanine is not classified as dangerous for the environment (wording of DSD) nor does it fulfil the criteria relating to environmental hazards (wording of EU-GHS, in particular Art. 3). Thus an exposure assessment within the Chemical Safety Assessment for phenylalanine is not legally required.
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