Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
16.24 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.62 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
3.24 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

Fish and invertebrate toxicity studies are available with read across substance (i.e., mono- and di- C16-18 PSE) and an algae toxicity study is available with the test substance. No toxicity was observed in either of the tests. The lowest ErC50 value based on measured TWA (WAF) was determined to be >0.017 mg/L from the algae study with the test substance, which exceeded the maximum soluble concentration of test substance in test medium at a loading rate of 100 mg/L. Therefore, the test substance is considered not to qualify for acute aquatic classification according to CLP (EC 1271/2008) criteria.

With regard to chronic toxicity potential, although the substance is not readily biodegradable, the long-term equivalent NOEC from the algae toxicity study was considered to be >0.01 mg/L (i.e., 0.017 mg/L (geometric mean measured; WAF). Further, based on the weighted average BCF estimates using BCFBAF v.3.01, and the stearic hindrance due to branched and long chain constituents, the test substance is considered to have a low bioaccumulation potential. This is further supported by the absence of adverse effects in a combined repeated dose and reproductive/development toxicity study in mammals up to the highest tested dose of 1000 mg/kg bw/day. Based on the above information, the test substance can be expected not to have significant chronic toxicity potential. Nevertheless, a safety net classification of Chronic 4 – H413: May cause long lasting harmful effects to aquatic life, has been assigned according to CLP criteria (Regulation 1272/2008/EC).