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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
further information relevant for the PBT assessment is necessary
Justification:

All studies referred to in this justification were performed in compliance with GLP with FAT 41030 a structural analogue of FAT 41045. In addition, water solubility and Log Pow (by HPLC at pH ca. 6) were measured for FAT 41045. Both substances are very similar in their chemical structure and, as demonstrated, in a number of physicochemical properties. Therefore, the use of the studies conducted with FAT 41030 for read-across extrapolation to FAT 41045 is considered to be appropriate and the conclusions drawn regarding PBT and vPvB assessment are considered to be valid and identical for both substances.

 

Based on 0% degradation in two biodegradability studies with FAT 41030, the technical difficulties arising from low water solubility when testing FAT 41030 for abiotic degradability and the low water solubilty of FAT 41045, both FAT41030 and FAT 41045 are considered to be very persistent. From the high log Pow values (for FAT 41045 experimentally demonstrated to be > 6.2 at about pH 6) a bioaccumulation potential cannot be ruled out, but the very low water solubility of both substances (FAT 41030 < 2.7 µg/l in aquatic toxicity test medium) may limit their bioavailability to aquatic organisms thus hindering bioaccumulation. Therefore, the currently available data do not permit a final conclusion regarding the bioaccumulation potential of FAT 41030 or FAT 41045. PBT classification is inappropriate, because relevant toxicity was not evident in any of the available toxicology or ecotoxicology studies.

 

In conclusion, FAT 41030 and FAT 41045 are considered to be very persistent. A decision on bioaccumulation potential is currently not possible, although the log Pow > 6.2 for FAT 41045 indicates a potential for bioaccumulation. PBT classification is inappropriate, because relevant toxicity was not evident.