Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
3.2 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.32 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Conclusion on classification

Based on the read across data the reproduction LOEL was estimated to be 1.0 mg/L and the EL10 was estimated to be 0.54 mg/L from the Long term toxicity study to invertebrates (Daphnia magna) of the source study BQ63YK. As explained in the justification for the type of information, the differences in molecular structure between target and source are unlikely to lead to differences in values of the LOEL and EL10.

With respect to acute toxicity it is noted that the two out of three available acute Daphnia Magna immobilisation studies indicated significant toxicity to aquatic invertebrates (EC50<0.01 mg/L). However a third acute toxicity study in Daphnia indicated no significant toxicity (EC50>100 mg/L). Furthermore in a long term Daphnia Magna reproduction test (BQ63YK

) no immobilisation was seen at 1 mg/L over 21 days. The Daphnia Magna reproduction test is considered as most reliable of the available studies on the basis that this study indicated low potential for immobilisation. It is concluded that the substance presents little concern for acute toxicity in aquatic species. Therefore the substance will not be classified for acute aquatic toxicity. Based on result from Daphnia Magna reproduction study (OECD 211) and as noted in the Aquatic toxicity endpoint summary the NOEL for long term exposure in aquatic invertebrates was 0.45 mg/L and this was found the most sensitive species. In accordance with Annex I Table 4.1.0 (b) (i) of the CLP Regulation a classification of Chronic Cat 2 will be applied.