Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Sediment (marine water)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
10 mg/kg food
Assessment factor:
300

Additional information

No acute environmental toxicity is recorded at levels up to 100 mg/L which is in excess of the solubility limit (<0.115 mg/L). Long term studies for algae and Daphnia are available, both showing NOEL > 100 mg/L. As no fixed E(L)C50 value can be set, a PNEC aqua cannot be derived.

No ecotoxicological data for soil- and sediment-dwelling organisms are available. In absence of a PNEC aqua and since the log Kow could not be determined exactly, the PNEC sediment and soil cannot be derived by equilibrium partition method calculation.

For soil a long-term toxicity study (Annex IX) is proposed with Linseed oil, polymerized. The result of this study will be read across to Soybean oil, polymerized.

Conclusion on classification

The lowest toxicity value between Daphnia, algae and fish are the WAF results with Daphnia and algae, both resulting in an EL50 > 100 mg/L and NOEL > 100 mg/L. Thus according to Directive 67/548/EEC and according to Regulation 1272/2008/EC (CLP), Soybean oil, polymerized does not need to be classified for acute toxicity to aquatic organisms.

 

Soybean oil, polymerized is a poorly soluble substance (water solubility <0.115 mg/l) for which no acute toxicity is found at levels up to the water solubility. The substance is not readily biodegradable and has a log Kow >4. A 21d reproduction toxicity test with Daphnia and Linseed oil, polymerized resulted in a NOELR of 100 mg/L, indicating that long-term effects are not to be expected. The results of this test are read across to this dossier. Based on these results, soybean oil, polymerized is not classified for environmental hazards.