Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Aquatic PNECs were derived using the PETROTOX model. As the aquatic PNEC are greater than the water solubility of the test substance toxicity is not expected and so soil and sediment PNECs are not calculated.

Conclusion on classification

All the ecotoxicity data for category members is expressed in terms of loading rate rather than exposure concentrations. This data is not suitable for comparison with the classification criteria. However, the data does indicate that acute aquatic toxicity is not observed at loading concentrations far in excess of the water solubility of the substance.

 

Poorly water soluble substances which do not exert acute toxicity at their limit of solubility may require a precautionary classification of R53 ‘May cause long term adverse effects in the aquatic environment’ under the DSD and Chronic Category 4 under the CLP Regulations. However, this precautionary stance is not required for members of this category as data is available to demonstrate that chronic effects are not observed at the limit of solubility (Putt, 2003a and 2003b). This experimental data is supported by the modeled data from PETROTOX which also indicates that chronic effects are not expected to be observed at the limit of solubility. In addition, although category members do not meet the strict criteria to be considered readily biodegradable, the data indicates that they will biodegrade in the environment and they are expected to be inherently biodegradable. Members of this category are therefore not classified in respect of the environment.

This substance is classified on Annex I of the DSD as R53, with a CLP harmonised classification of Chronic Aquatic 4. However, the ecotoxicity data available for this category and presented here indicate that a classification is not warranted, and so a self-classification is also proposed of no environmental classification under the DSD and CLP Regulations.