Fatty acids, C16-18

PBT assessment

PBT assessment: overall result

Reference

Name:

Fatty acids, C16-18

Type of composition:

boundary composition of the substance

State / form:

solid: bulk

Reference substance:

Fatty acids, C16-18

Reference substance:

Fatty acids, C16-18

Reference substance:

Fatty acids, C16-18

Reference substance:

Fatty acids, C16-18

Reference substance:

Fatty acids, C16-18

Reference substance:

Fatty acids, C16-18

Reference substance:

Fatty acids, C16-18

Reference substance:

Fatty acids, C16-18

Reference substance:

Fatty acids, C16-18

Reference substance:

Fatty acids, C16-18

Reference substance:

Fatty acids, C16-18

PBT status:

the substance is not PBT / vPvB

Justification:

The PBT assessment for Fatty acids C16-18 (CAS 67701-03-5) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

Persistence

Fatty acids C16-18 (CAS 67701-03-5) is readily biodegradable according to OECD criteria (> 60 % in 28 d, read-across). Thus, the substance does not meet the screening criterion for persistence and is not considered to be persistent (P) or very persistent (vP).

Bioaccumulation

Fatty acids C16-18 (CAS 67701-03-5) is characterized by a low water solubility (< 0.05 mg/L at 20 °C) and a high log Kow (6.96 - 7.94). Based on the physico/chemical properties such as low water solubility and high potential for adsorption a reduced availability in water is expected. Additionally, bioaccumulation potential is considered to be low due to common metabolism of fatty acids in the animal kingdom. In addition, fatty acids are naturally stored in the form of triacylglycerols primarily within fat tissue until they are used for energy production (fat storage tactic). It can be concluded that the bioaccumulation potential of Fatty acids C16-18 (CAS 67701-03-5) is negligible. This is supported by a fish bioaccumulation study for the analogue substance C12 fatty acid-sodium laurate which showed negligible evidence of bioaccumulation potential in fish tissues with an estimated BCF of 225 L/kg after 28 days exposure. Please refer to IUCLID Section 5.3 of the Technical dossier for a detailed overview on bioaccumulation. Hence, the substance does not pose a risk to organisms with regard to bioaccumulation/biomagnification and is not considered to be B or vB.

Toxicity

For Fatty acids C16-18 (CAS 67701-03-5) the available acute effect concentrations are > 0.1 mg/L (fish, aquatic invertebrates, algae) and the chronic effect concentration (fish, daphnia, algae) is > 0.01 mg/L. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. Therefore, the test substance is not considered to meet the T criterion.

 

In conclusion, the substance is not PBT/vPvB.