Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/L

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

This category contains members with a carbon number range up to C15. The model was run until the calculated aliphatic PNEC was below the level of solubility. This occurred at a carbon number of C13 and the aliphatic boiling point range 195-240°C. Based on this information the PNEC aqua aliphatic derived was 0.001 mg/L. For C13 aliphatic compounds Petrotox v3.05 calculates an indicative HC5 of 0.001 mg/L. For C15 aromatic compounds Petrotox v3.05 calculates an indicative HC5 of 0.002 mg/L. Soil and sediment PNECs were derived using the aquatic PNEC and using the equilibrium partitioning method. The HC5 model states that it is expect that substances with a Log Kow higher than 5 will not pose a toxicity hazard to other WWTP microbes due to solubility and organism constraints, therefore only an aromatic STP PNEC was derived.

Conclusion on classification

Tested streams

Ecotoxicology data are available for CAS numbers 68478-10-4 and 68477-54-3. The studies showed similar results across the three trophic levels. The fish studies provided a 96 hour LL50 range between 0.73 – 6.3 mg/L WAF. The invertebrate studies provided 48 hour EL50 range of 0.91 – 3.2 mg/L WAF. The algae studies provided a 72 hour ErL50 range of 1.3-1.5 mg/L WAF.  The aquatic hazard assessment is currently under evaluation as part of the LOA Environmnental Testing Program.

Ecotoxicity Labelling for Resin Oils and Cyclic Dienes Category

Data on the acute aquatic toxicity of 5 members of this category have been read across to the other category members. The studies were conducted to standard guidelines and according to GLP and so are considered reliable for use as key studies. For some of the studies, the authors report the LC50 based 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. Similar sensitivities were shown in all three trophic levels.

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. It is considered that based on the available data (most conservative result: 96 hour LL50 for fish of 0.73 mg/L), streams in this category should have the classification R50/53 under the DSD and Acute 1 Chronic 1 under the CLP regulations.

The measured partition coefficients of three streams in this category have log Pow ranges from 2.8 ->6.5. Therefore the classifications cannot be removed.

Conclusion

Based on the available experimental data, streams in this category should have the classification Acute 1 Chronic 1 under the CLP regulations.

However, the classification of streams in this category may be impacted by other constituents. Components which may impact the classification 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 CLP Regulations

Acute 1 applies where: Acute 1 x M ≥ 25 %

Chronic 1 applies where: Chronic 1 × M ≥ 25 %

Chronic 2 applies where: (M × 10 × Chronic 1) + Chronic 2 ≥ 25 %

Chronic 3 applies where: (M × 100 × Chronic 1) + (10 × Chronic 2) + Chronic 3 ≥ 25 %

Chronic 4 applies where: Chronic 1 + Chronic 2 + Chronic 3 + Chronic 4 ≥ 25 %