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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

From CSR Chapter 8.1 :

8.1.1.Summary and overall conclusions on PBT or vPvB properties

The results reported in Chapter 4.1 Degradation indicate that the substance is neither persistent (not P) nor very persistent (not vP) in the environment.

Furthermore the results reported in Chapter 4.3 Bioaccumulation demonstrate that the substance is neither bioaccumulative (not B) nor very bioaccumulative (not vB). Based on the results obtained from the aquatic toxicity studies documented in Chapter 7.1 (Aquatic compartment including sediment) and the data on mammalian toxicity studies (Chapter 5. Human Health Hazard Assessment), the substance is considered not toxic (not T).

8.1.2.PBT/vPvB criteria and justification

Data for the definitive conclusion on the PBT or vPvB properties of the substanceare not available. Thus, the screening criteria given in the‘Guidance on information requirements and chemical safety assessment, chapter R.11: PBT assessment’ (ECHA, 2008) are used as surrogate information to decide whether the substance may potentially fulfil the PBT or vPvB criteria.

Persistence Assessment

The screening criterion for persistence is the potential of a substance for ready biodegradation. As the substanceFatty acids, C16-18, 2-ethylhexyl estersisreadily biodegradable, the substance is considered to be not persistent and does not meet the “P” criterion.

Bioaccumulation Assessment

The screening criterion for bioaccumulative substances, which has to be classified as “B” or “vB”, is a log Kow > 4.5. The log Kow value (calculated) of the test substance is 10.61-11.59 (Chapter 1.3). As a result, the substance Fatty acids, C16-18, 2-ethylhexyl esters suggests bioaccumulation due to its physico-chemical properties. However, as the substance is readily biodegradable, no chronic exposure of aquatic organisms is expected. Should the substance be taken up by fish, the group of linear aliphatic fatty acid esters has been shown to be rapidly metabolised and excreted via the enzyme carboxylesterase. A QSAR calculation reveals no significant bioaccumulation potential with 18.9-57.2 L/kg as regression based estimate, and also no significant bioaccumulation potential with the more realistic Arnot-Gobas method including biotransformation with a resulting BCF value of 1.00-1.48 L/kg (upper trophic). Therefore, in accordance with the ECHA Guidance Document R.11, the substance is neither bioaccumulative (BCF < 2000 L/kg) nor very bioaccumulative (BCF < 5000 L/kg).

Toxicity Assessment

The screening criterion for toxicity is based on short-term aquatic toxicity studies.Aquatic organisms (algae, daphnia, and fish) did not show any toxicity up to the limit of the water solubility (< 0.05 mg/L, read across). Hence, the substance will not be classified as “T” substance.

In addition, the substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to Directive 67/548/EEC and Regulation (EC) No 1272/2008. Therefore, the substance does not meet the “T” criterion.