Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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, cyclics, <2% aromatics are not expected to meet the Persistent (P) or very Persistent (vP) criteria.

Bioaccumulation (B) assessment

An evaluation of representative hydrocarbon structures indicates only few structures (C14n-paraffins, C14-C16isoparaffins and several cycloparaffins in the whole carbon range of the category) meet the Bioaccumulative (B) criteria (see CONCAWE, 2010).

Therefore, based on the screening criteria for bioaccumulation stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment - Part C: PBT Assessment (2008), Hydrocarbons, C14-C16, n-alkanes, isoalkanes, cyclics, <2% aromatics cannot be considered unlikely to be bioaccumulative.

Toxicity (T) assessment       

Enivironmental 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 the “Hydrocarbons, C14-C20, aliphatics (≤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 members of this category are not considered toxic (T).

Human health hazard assessment     

Carcinogenicity

The available data indicate that members of the Category “Hydrocarbons, C14-C20, aliphatics (≤2% aromatics)” do not warrant classification for carcinogenicity under Dir 67/548/EEC or GHS/CLP.

Mutagenicity

Members of the Category “Hydrocarbons, C14-C20, aliphatics (≤2% aromatics)” are not genotoxic or mutagenic and do not warrant classification for carcinogenicity under Directive 67/548/EEC or Regulation (EC) No 1272/2008.

Reproductive Toxicity

The available data indicate that members of this category are not toxic to reproduction and do not warrant classification under Directive 67/548/EEC or Regulation (EC) No 1272/2008.

Conclusion

Members of the category “Hydrocarbons, C14-C20, aliphatics (≤2% aromatics)” are 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.