Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
2.06 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
1.68 mg/kg soil dw
Extrapolation method:
sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.01 g/kg food
Assessment factor:
90

Additional information

Discussion concerns tests of the whole substance and also an understanding of the properties of blocks and constituents. The constituent properties are needed for the risk characterisation conducted using the hydrocarbon block method and for the PBT assessment.

As part of the New Substance dossier (under Directive 67/548/EEC) it was demonstrated by prediction that short term E(L)C50values would not be achieved at up to 1000 mg/l loading as WAF. This is consistent with the measured data. Prediction for long-term effects data is difficult since it depends markedly on the model used. The available measured long-term data are not inconsistent with the properties of the constituents. PNECs are therefore based on HC5 values calculated using PETROTOX for the hydrocarbon blocks identified (see CSR, table 1.3.5).

Conclusion on classification

Based on the result of the environmental hazard assessment the following can be concluded for the classification and labelling:

It is proposed that GTL Gasoil should not be classified in the EU for acute or chronic toxicity on the grounds that modelled ecotoxicity properties indicate that the substance would not be toxic at a loading rate of 100 mg/l. This proposal is supported by measured data for representative samples of the substance (as reported in the CSR, section 7.1).

Although constituents are present which have high log Kow, their degradability (CSR, section 4.1) is sufficiently rapid to suggest that the classification R53 (acc. to Directive 67/548/EEC) should not apply.

Classification with R52/53 (or 'Aqu. Chron. 4; H413' acc. to Regulation (EC) No 1272/2008) is not warranted based on measured chronic data NOECs above 1 mg/l as water accommodated fractions.

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