Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Experimental data provided for this Category was generated via use of WAFs. Deriving PNEC?s for UVCB substances based on WAF information is inappropriate. PNECs were derived using the PETROTOX v.3.05 model.The hydrocarbon block method is used for environmental risk assessment (see REACH guidance, R7, app.13-1). PNECs for hydrocarbon blocks have been derived using the HC5 statistical extrapolation method and the target lipid model using representative structures. See Product Library tab in PETRORISK spreadsheet (Table B.3). Given the large database of organisms included in the target lipid model, an assessment factor of one has been applied to the HC5.

Conclusion on classification

Environmental classification justification

Tested streams

Some ecotoxicology studies are available for 68476-55-1 (Hydrocarbons, C5-rich). The most sensitive endpoint was a 48 hour EL50 for aquatic invertebrates of 6.96mg/l WAF. No other stream toxicity data has been submitted.

Ecotoxicity Labelling for Low Benzene Naphthas

Data on the acute aquatic toxicity of one member of this category (68476-55-1) was obtained from a proprietary source. No data was identified in the published literature. The data from this stream has been read across to the other category members.

The studies were conducted to standard guidelines and according to GLP and so are considered fully reliable for use as key studies. The authors report the LC50 based both on nominal loading rates (WAF) and mean measured concentrations. As the test substance is a hydrocarbon stream with various components reporting a measured concentration could be misleading as the measured concentration does not relate to a concentration of the raw stream. Instead, we have used the results reported as WAF, which better represent the potential toxicity of the test substance. Algae were found to be less sensitive than either invertebrates or fish which had similar sensitivity to the test substance (EL50 6.96 mg/l WAF and LC50 14.1 mg/l WAF respectively).

WAF data can be used for comparison with the criteria for environmental classification under both the DSD and CLP Regulations. However, its use must be considered carefully. Based on the available data (48 hour EC50 6.96mg/l WAF) streams in this category should have the classification R51/53 under the DSD and Chronic 2 under the CLP regulations.

The measured partition coefficients of three streams in this category have log Kow ranges from 2.8 to 6.5. Therefore, the classifications cannot be removed.

Conclusion

Based on the available experimental data (48 hour EC50 6.96mg/l WAF) streams in this category should have the classification R51/53 under the DSD and Chronic 2 under the CLP regulations

However, the classification of streams in this category may be impacted by other constituents. Components which may impact the classification (i.e. those that are R50/53) should be identified by the registrants and the impact of their environmental classification included in the assessment. The classification of each stream can be determined following the equations given in the notes below. 

Note: 

Under the DSD

R50/53 applies if sum of components with R50/53 is >25%.

R51/53 applies if sum of components with R51/53 is >25% or if sum of components with R50/53 is >2.5%.

R52/53 applies if sum of components with R52/53 is >25% or if sum of components with R51/53 is >2.5% or if sum of components with R50/53 is >0.25%.

Under the CLP Regulations

Acute 1 applies if sum of components with acute 1 is >25%.

Chronic 1 applies if sum of components with chronic 1 is >25%.

Chronic 2 applies if sum of components with chronic 1 multiplied by 10 plus the sum of components with chronic 2 is >25%.

Chronic 3 applies if sum of components with chronic 1 multiplied by 100 plus the sum of components with chronic 2 multiplied by 10 plus the sum of components with chronic 3 is >25%.

Chronic 4 applies is sum of components with chronic 1, 2, 3 and 4 is >25%.