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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Substance is a hydrocarbon UVCB. Tests for biodegradation in water are designed for use with single chemical substances and results used for classification. For the purpose of risk assessment, this endpoint is characterized using quantitative structure property relationships for representative hydrocarbon structures that comprise the hydrocarbon blocks. The environmental risk of this substance is assessed using the PETRORISK model (see Product Library in PETRORISK report attached to IUCLID Section 13).

Diesel / gas oil fractions are not readily biodegradable but are considered inherently biodegradable. In a report on environmental classification (Concawe 2001), it was concluded that, based on the known properties of hydrocarbons in the range C9 to C26,diesel/gas oil fractions are not readily biodegradable, but are regarded as being inherently biodegradable, since they can be degraded by micro-organisms.

In a further investigation (Concawe 2012) on PBT evaluation of petroleum substances CONCAWE developed QSAR estimates (BioHCwin) and reviewed existing data for individual hydrocarbons representative of the various ‘hydrocarbon blocks’ covering a range of petroleum substances. Using the Hydrocarbon Block method and data on biodegradation of representative hydrocarbons in the range C9 to C26, it is concluded that diesel / gas oil fractions do not meet the persistence criteria and can be regarded as being inherently biodegradable.

Concawe 2001:Environmental classification of petroleum substances - summary data and rational. Report No 01/54. Concawe Brussels.

Concawe 2012:An evaluation of the Persistence, Bioaccumulation and Toxicity of Petroleum Hydrocarbons (revised), May 2012

The material is a complex UVCB substance that comprises a large number of individual hydrocarbon constituents. These constituents exhibit different properties relevant to environmental risk assessment. Consistent with REACH technical guidance and Annex VIII criteria, the PBT assessment was undertaken using the hydrocarbon block method. Measured data and model predictions were evaluated for representative structures of the hydrocarbon blocks covering the diesel fuel/gas oil range. Further details can be found in dossier Section 13.

Results of the analysis show that none of the representative hydrocarbon structures present in the diesel/gas oil range meet the vPvB or PBT criteria. Hence the material is not considered a vPvB or PBT.

Substance is however classified as carcinogenic Category 2 (CLP Regulation EC 1272/2008), based on read-across evidence of skin cancer in mice. It is also classified as STOT-RE Category 2, based on haematological effects seen in studies in rats.