Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Although the substance appears to be persistent in both aquatic and terrestrial envionments, it does not meet the criteria for PBT / vPvB because the measured BCF value for the substance in fish is significantly below 2000 mg/L and toxicokinetic testing demonstrates that the substance does not appear to be transported across biological membranes in mammals and is eliminated, unchanged, in feces. Further, the substance adsorbs strongly to sediment and soil preventing that it becomes significantly available for aquatic or sediment dwelling organisms. A long-term toxicity study with aquatic invertebrates showed no significant effect on survival, growth or reproduction at 0.7 mg/L (maximum attainable concentration using a vehicle). Hence, in spite of its persistency in sediment, environmental concentrations toxic to aquatic organisms will never be reached considering an actual water solubility of < 0.014 mg/L.

Likely routes of exposure:

Releases to the environment are expected to result from the product's use as a UV Absorber in consumer cosmetic products subject to Regulation (EC) 1223/2009. Such releases are expected to result from the substance being washed off during use while swimming or after use at home and subsequently partitioning to soil and sediment. Results of an adsorption study in five soils showed a relatively high binding capacity of the test substance on organic matter of soil (log Koc = 5.7 - 6.8). Hence, adsorbed to sediment or soil, the substance is only very limited available to aquatic or soil dwelling organisms. Bioavailability is a crucial property to assess the potential of exposure of sediment or soil dwelling organisms.