Registration Dossier

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Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

The Hydrocarbons, C11-C16, n-alkanes, isoalkanes, <2% aromatics estimated 28-day LC50 value is 4950 mg/kg soil dw based on mortality and the EC10 value is 648 mg/kg soil dw based on reproduction for the terrestrial species Eisenia fetida.

The Hydrocarbons, C11-C16, n-alkanes, isoalkanes, <2% aromatics estimated 28-day LC50 value is 2800 mg/kg soil dw based on mortality and the EC10 value is 536 mg/kg soil dw based on reproduction for the terrestrial arthropod species Folsomia candida.

The Hydrocarbons, C11-C16, n-alkanes, isoalkanes, <2% aromatics estimated 14-day LC50 value is 12750 mg/kg soil dw based on seedling emergence and the 21-day EC10 value is 2443 mg/kg soil dw based on growth for the terrestrial plant monocot species Avena sativa.

The Hydrocarbons, C11-C16, n-alkanes, isoalkanes, <2% aromatics estimated 14-day LC50 value is 8191 mg/kg soil dw based on seedling emergence and the 21-day EC10 value is 1569  mg/kg soil dw for the terrestrial plant dicot species Brassica rapa.

These values were estimated using the Petrotox computer model.

The Hydrocarbons, C11-C16, n-alkanes, isoalkanes, <2% aromatics measured 21-day ER50 >30,000 ml/ha and NOER ≥ 30,000 ml/ha, no effects on mortality, phytotoxicity and plant height or weight (nominal concentration, highest concentration tested). The study met the validity criteria outlined in OECD test guideline 227 and was conducted in accordance with GLP.

Additional information

The registered substance is a complex hydrocarbon UVCB whose constituents have variable physicochemical properties. Therefore, a modelling framework is needed to account for the bioavailability of the constituents in the mixture, which was then used to predict the toxicity of the substance as a whole. The target lipid model (TLM) and HC5, have been applied to soils and sediment using equilibrium partitioning (EqP) model. As such, modelled data are considered fit for purpose.

21-day ER50 and NOER values of >30,000 and ≥30,000 ml/ha (nominal concentration, highest concentration tested) have been determined for the effects of the test substance, Hydrocarbons, C11-C16, n-alkanes, isoalkanes, <2% aromatics, GS1927, on the mortality, phytotoxicity and plant height and weight of six plant species: Allium cepa (onion), Zea mays (maize), Tagetes patula (marigold), Pelagonium hortorum (geranium), Salvia splendens (salvia) and Lycopersicon esculentum (tomato) (Privitera, 2020). The study was conducted in compliance with GLP (including certificate), according to OECD test guideline 227 and met the validity criteria: seedling emergence was at least 70% (100%), control plants did not exhibit phytotoxic effects, mean plant survival was at least 90% in the controls (100%) and environmental conditions, including substrate characteristics, were identical between treatments.

The highest test concentration was analysed using GC-FID. Recovery rates were between 80-120% of nominal concentrations, therefore results are reported in terms of the nominal rates. The relative humidity decreased (minimum value 40.9%) below the range specified in OECD test guideline 227 (70±25%) during the test. However, as control plants were healthy and the validity criteria were met, it was determined that this deviation did not affect the validity of the study.