Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Conclusion on classification

There are no acute aquatic toxicity data available and as there is a mitigating factor of very low water solubility (15 µg/L), it is justified that no acute aquatic tests have to be performed for the substance. For the classification, environmental fate data (degradation and bioaccumulation) need to be considered in order to decide whether or not the safety net classification applies (See the Guidance on Information Requirements and Chemical Safety Assessment R. The substance was not biodegradable (0% after 28 days) and the BCF was determined to be < 45 and <594 L/Kg for nominal exposure levels of 10 and 1 µg/L, respectively. These BCF values were calculated from the only validated LOQ of 500 µg/kg wwt in fish and the mean measured water concentrations. As the validated LOQ in fish is the same for both tested concentrations, it is the water concentration that determines the BCF values; hence, testing even lower concentrations will result in increased BCF values. Also, an LOD was not derived in the study. As an LOD is in general significantly lower than the LOQ, and no significant response was observed in the fish samples, the actual concentrations in fish can be concluded to be significantly below the LOQ. Based on the analytical deficiency on the validated LOQ in fish (the non-validated LOQ was 4.6 µg/kg wwt), it can be judged acceptable that the BCF value of the substance is significantly lower than 500.

Based on the above, the safety net classification is not applicable.