Alkanes, C16-47, branched and linear

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Persistence (P) Assessment

A substance is not considered to be persistent if it can be demonstrated that it has potential to degrade (via photolysis, hydrolysis and/or biodegradation).

There are no data available for Alkanes, C16 -47, branched and linear. Data is available for GTL Base Oil Distillates and this data is used for read-across. The results from the ready biodegradability studies for GTL Base Oil Distillates ranged from 11-67% after 28 days. The main factors influencing the results include the guideline/method followed, the dosing method and the viscosity/composition of the test substance. In general, the biodegradability of the substances decrease as the viscosity (and hence carbon chain length/degree of branching) increases. In fact, the lowest viscosity substances almost meet the criteria for ready biodegradability. Overall GTL Base Oil Distillates is not considered to be readily biodegradable but is expected to be inherently biodegradable.

Therefore, Alkanes, C16 -47, branched and linear does not meet the Persistent (P) or very Persistent (vP) criteria.

Bioaccumulation (B) Assessment

There are no data available for Alkanes, C16 -47, branched and linear. Data is available for GTL Base Oil Distillates and this data is used for read-across. The bioconcentration factor at the steady state (BCFss) was ≤6 at the high concentration level (0.5 mg/L nominal), and ≤29 at the low concentration level (0.05 mg/L nominal). Based on the results, the bioaccumulation potential of GTL Base Oil Distillates in fish tissues is judged to be low.

Therefore, Alkanes, C16-47, branched and linear does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.

 

Toxicity (T) Assessment

Human Health Hazards Assessment (T)

Carcinogenicity: There are no carcinogenicity data available for Alkanes, C16 -47, branched and linear. Data for the read-across substance GTL Base OIl Distillates do not warrant classification for carcinogenicity under Dir 67/548/EEC or GHS/CLP.

Mutagenicity: There are no mutagenicity data available for Alkanes, C16 -47, branched and linear. Data for the read-across substance GTL Base Oil Distillates do not require classification for mutagenicity under Dir 67/548/EEC or GHS/CLP.

Reproductive Toxicity: There are no reproductive toxicity data available for Alkanes, C16 -47, branched and linear. Data for the read-across substance GTL Base Oil Distillates show there is no evidence that the substance causes reproductive or developmental toxicity and do not warrant classification under Dir 67/548/EEC or GHS/CLP.

 

Environmental Toxicity Assessment (T)

There are no data available on the ecotoxicity of Alkanes, C16 -47, branched and linear. Data are available for GTL Base Oil Distillates and these data are used for read across. None of the data for GTL Base Oil Distillates result in classification under Dir 67/548/EEC or GHS/CLP.

Therefore, Alkanes, C16 -47, branched and linear does not meet the criteria for Toxicity (T).

 

Conclusion of PBT/vPvB assessment

There is no data available for Alkanes, C16 -47, linear and branched therefore this PBT/vPVB assessment has been made based on read-across data. The available data showed that Alkanes, C16 -47, linear and branched is not classified as P or vP, B or vB, or T. Therefore, Alkanes, C16 -47, branched and linear is not classified as PBT or vPvB.