Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.021 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

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:
no hazard 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

Quantitative environmental exposure assessment and risk characterisation was conducted with the PETRORISK tool that is designed for environmental risk assessment of petroleum hydrocarbons. The model calculations are based on physical, chemical and ecotoxicological properties of individual hydrocarbon structures, so that PEC and PNEC and the risk characterisation by RCR are derived for representative structures that are used to simulate the UVCB substance. The sum of all individual RCR values indicates the overall risk for the substance as the environmental effects of the individual components are considered additive.

Risk assessment in the PETRORISK tool is based on PNEC values for water, wastewater, soil, and sediment. PNECair are not included. The PNEC values in the PETRORISK tool are HC5 values, which is the hazardous concentration that affects 5% of organisms. The HC5 values are derived from a database that includes effects data for aquatic and marine covering both pelagic and benthic species. The PNECsoil and PNECsediment are estimated using the Equilibrium Partitioning Method.

Conclusion on classification

The following data was used in classification and labelling of renewable hydrocarbons of wood origin (diesel type fraction)

Aquatic acute toxicity:

48-h EL50 (immobilisation) D. magna, 68 mg/l with 95% CI of 49 – 94 mg/l (OECD 202; WoE), read-across data from fossil diesel fuel (CAS no. 68334-30-5)

72-h EL50 (growth rate) Desmodesmus subspicatus, > 100 mg/l (OECD 201, GLP, key study)

96-h LL50 (mortality) Oncorhynchus mykiss, 21 mg/l with 95% CI of 12 - 40 mg/l (OECD 203, WoE), read-across data from fossil diesel fuel (CAS no. 68334-30-5)

Conclusion: No acute toxicity as the lowest toxicity value is > 1 mg/l.

Aquatic chronic toxicity:

No adequate long-term study results are available. Aquatic toxicity is evaluated based on the short-term study results presented above. Based on the available short-term study results, the toxicity is between 10-100 mg/l. Considering the difficulties in testing of the complex hydrocarbon UVCB substances, and the confidence limits of fish testing presented above, as worst case scenario the toxicity is considered to fulfil the criteria (EC/LC50 values between 10 to 100 mg/l) of Aquatic Chronic Category 3.

Biodegradation:

Laboratory studies on biodegradation water screening (OECD 301B; Ready Biodegradability: CO2 Evolution Test, 33 deg-% after 28 days) indicate that the substance can be considered as not readily biodegradable. Based on the composition this substance is hydrolytically stable.

Conclusion: Substance is not considered readily biodegradable.

Bioaccumulation:

Testing of the BCF was considered technically unfeasible for this UVCB substance. As determination of BCF experimentally was not feasible, the bioaccumulation potential of the substance was assessed based on test results from the octanol-water partitioning coefficient study (log Kow of 6). Based on the experimental data, the substance might contain substances having potential for bioaccumulation. For complex mixtures (e.g. UVCBs) a single value of Kow will not be definitive. The log Kow values were also estimated with the PETRORISK tool that was used for the environmental risk assessment. The estimation is based on log Kow values of individual compound structures, which are included in the CONCAWE Library. The overall range for the estimated log Kow values was from 2.55 to 13.23. The log Kow values of the representative individual structures that form the major part of the substance based on mass fraction (sum 0.64) were in the range 5.25 - 9.82.

Bioconcentration factors and bioaccumulation factors were also estimated with the BCFBAF v3.01 model. The estimated log BCF value for the ten most abundant individual structures of the substance ranged from 1.98 to 3.18 (BCF 95 to 1513 L/kg).

Conclusion: The range of log Kow values indicated that there might be constituents present in the substance having potential for bioaccumulation (log Kow values > 4). As the estimated BCF values are also > 500 L/kg substance is considered as having bioaccumulation potential. However, the substance as whole cannot be considered as bioaccumulative asthere is evidence that the majority of organic chemicals with log Pow values of > ca. 7 would show low tendency to bioaccumulate.

Classification and labelling according to CLP 1272/2008:

Aquatic Chronic Cat 3 (H412)

Classification and labelling according to DSD 67/548/EEC:

R52 -R53