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PBT assessment

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PBT assessment: overall result

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

Persistence

The registered substance biodegraded to an extent of 76.3% after 28 days. The data support characterizing the test substance as rapidly biodegradable, readily biodegradable and not expected to persist in the environment under aerobic conditions. Although it did not meet the 10 -day window requirement, it is characterized as readily biodegradable because the criterion is not applied to multi-component substances when assessing their ready biodegradability. Since the registered substance is characterized as readily biodegradable, it is considered to be not Persistent.

Bioaccumulation

A reliable QSAR model was used to calculate the bioaccumulation potential of the Representative Categories for Hydrocarbons, C12-C16, n-alkanes, isoalkanes, alkenes. BCF values were calculated using the BCFBAF v3.01 module embedded within the EPISuite v4.11 computer model. The calculated BCF (Arnot-Gobas upper trophic) ranged from 1 L/kg wet-wt to 2278 L/kg wet-wt. Based on the results, only few structures of Hydrocarbons, C12-C16, n-alkanes, isoalkanes, alkenes (C12 iso alkane, C12 alkene and C14 linear alkane in the whole carbon range of the categories) meet the Bioaccumulative (B) criteria.

Based on the criteria for bioaccumulation stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment - Part C: PBT Assessment (2008), “Hydrocarbons, C12-C16, n-alkanes, isolkanes, alkenes” cannot be considered unlikely to be bioaccumulative.

Toxicity

Although a toxicity assessment is not required if the P and B criteria are not met (see above) it is discussed here. According to Annex XIII of Regulation (EC) No 1907/2006 and according to the Guidance on information requirements and chemical safety assessment Chapter 11 (PBT Assessment, May 2008), a substance does not fulfill the criterion if the NOEC for marine or freshwater organisms is 0.01 mg/l or higher and if there is no evidence of chronic toxicity considering human health and no classification as carcinogenic (category 1 or 2), mutagenic (category 1or 2) or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/ECC. Hydrocarbons, C12-C16, n-alkanes, isoalkanes, alkenes does not meet any of these criteria. Therefore, it can be concluded that the substance does not fulfill the toxicity (T) criterion as laid down in Annex XIII of regulation (EC) No 1907/2006.