Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.9 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
9 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
90 ng/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.9 µg/L

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

With respect to acute aquatic toxicity the EC50 for the most sensitive species (aquatic vertebrates, aquatic invertebrates, aquatic plants) was determined to be 0.90 mg/L (EC50 based on growth rate, algal inhibition study). In addition to the toxic effect seen in algae, B331 was observed to be toxic to both fish and daphnia however the toxic effect was less severe (relevant 50% effect concentrations were in the range 1-10 mg/L in each case). With respect to chronic aquatic toxicity the substance was observed not to be readily biodegradable; as chronic data are only available for aquatic plants (algae), the classification for chronic toxicity is considered with reference to the EC50 values for fish and daphnia, and the NOEC for algae.

With reference to Regulation (EC) 1272/2008 including amendments to the 4th May 2017 Appendix 1 table 4.1.0 (a) it is concluded that B331 meets the criteria for classification as Acute Category 1; the applicable hazard phrase is H400: "Very toxic to aquatic life". On the basis that the EC50 of the most sensitive species is in the range 0.1 mg/L - 1 mg/L and M-factor of 1 should be applied. Additionally in accordance with table 4.1.0 (b)(i) and (iii) it is concluded that B331 meets the criteria for classification as Chronic Category 2; the applicable hazard phrase is H411: "Toxic to aquatic life with long lasting effects".