Registration Dossier

Diss Factsheets

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.