Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no data available: testing technically not feasible

Marine water

Hazard assessment conclusion:
no data available: testing technically not feasible

STP

Hazard assessment conclusion:
no data available: testing technically not feasible

Sediment (freshwater)

Hazard assessment conclusion:
no data available: testing technically not feasible

Sediment (marine water)

Hazard assessment conclusion:
no data available: testing technically not feasible

Hazard for air

Air

Hazard assessment conclusion:
hazard related to composition of atmosphere identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no data available: testing technically not feasible

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Some ecotoxicology studies are available for streams within the High Benzene Naphthas as detailed below. These were all proprietary studies. The most sensitive endpoint was a 96 hr LL50 of 1.1 mg/L. This was a GLP compliant study which followed a standard guideline. It is considered reliable and suitable for use as a key study.

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

Data on the acute aquatic toxicity of 2 members of this category (CAS Numbers: 68513-69-9; 68921-67-5) were obtained from proprietary sources. No data was identified in the published literature. The data from these streams have 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/supporting studies. 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 sensitivity was found in all three trophic levels (fish 96 hr LL50 range 1.1 -5.6 mg/L; invertebrates 48hr EL50 1.2 -2.3 mg/L; algae 72 hr ErL50 range 2.2-2.3 mg/L)

WAF data can be used for comparison with the criteria for environmental classification under the CLP Regulation. However, its use must be considered carefully. Based on the available data (96 hr LL50 1.1 mg/L WAF) streams in this category should have the classification Chronic 2 under the CLP Regulation. The measured partition coefficients of three streams in this category have log Kow ranges from 2.2 to >6.5. Therefore, the classifications cannot be removed.

Conclusion.

Based on the available experimental data (96 hr LL50 1.1mg/L WAF) streams in this category should have the classification Chronic 2 under the CLP Regulation. 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 %