Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Persistence 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).

In a ready biodegradation study conducted according to OECD Guideline 301F, Hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics attained 75% biodegradation in 28 days (Best, 2014). The substance was therefore concluded to be readily biodegradable.

Based on the available measured data, the substance is biodegradable. Therefore, based on initial persistence screening Hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics is not expected to meet the Persistent (P) or very Persistent (vP) criteria.

Bioaccumulation (B) assessment

An evaluation of representative hydrocarbon structures indicate some structures meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria. For further information view Section 13.2 Assessment report PBT (Concawe, 2019).

Toxicity (T) assessment       

Environmental toxicity     

No representative structures were identified as PB or vPvB, therefore a toxicity assessment is not needed.

None of the measured or calculated data for Hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics exceed the criteria for toxicity stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment - Part C: PBT Assessment (2008). Therefore the substance is not considered toxic (T).

Human health hazard assessment     

Carcinogenicity

The available data indicate that Hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics does not warrant classification for carcinogenicity under Regulation (EC) No 1272/2008.

Mutagenicity

Hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics is not genotoxic or mutagenic and does not warrant classification for carcinogenicity under Regulation (EC) No 1272/2008.

Reproductive Toxicity

The available data indicate that Hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics is not toxic to reproduction and does not warrant classification under Regulation (EC) No 1272/2008.

Conclusion

Hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics is considered not to be T on the basis of the data relevant to human health.

Summary and overall conclusions on PBT and vPvB properties       

No representative hydrocarbon structures were found to meet the PBT / vPvB criteria.

Therefore the PBT/vPvB assessment stops at this point.