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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

The PBT Assessment for CAS 871 -70 -5 is based on the criteria set out in the "Guidance on information requirements and chemical safety assessment, Chapter R. 11: PBT Assessment" (ECHA 2012).

P: Persistence Assessment:

A substance is not considered to be persistent if it can be demonstrated that it has potential to degrade (via photolysis, hydrolysis or biodegradation).

Several studies using standardized OECD, EU- and ISO test guidelines are available for fatty acids that could all demonstrate the ready biodegradability of the substances within 28 days.

Therefore, Fatty acid CAS 871 -70 -5 does not meet the Persistent (P) or very Persistent (vP) criteria.

B: Bioaccumulation Assessment:

The BCF value obtained for whole organisms after exposure to the fatty acid surrogate substance C12 fatty acid sodium laurate (CAS 629-25-4) is below the bioaccumulation criterion of BCF > 2000. In addition rapid metabolism of fatty acids within the organism is expected. Please see also Fatty acid CAS 871 -70 -5 EPIWin Calculated BCF value.

Therefore, based on the screening criteria for bioaccumulation stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment - Chapter R. 11: PBT Assessment", fatty acids are considered unlikely to be bioaccumulative (B) or very bioaccumulative (vB).

T: Toxicity Assessment:

Environmental Toxicity:

According to Annex XIII of REACH Regulation (EC) No 1907/2006, a substance is considered to be toxic in terms of PBT criteria if long-term NOEC values for aquatic organisms are lower than 0.01 mg/L.Data for long term toxicity on algae and fish are available showing no effects up to the limit of water solubility.Long term toxicity data on invertebrates are not available, since testing for fatty acids with a chain length greater than C10 is technically not feasible.

Therefore Fatty acid CAs 871 -70 -5 is not considered as a toxic substance regarding ecotoxicological endpoints.

Human Health Hazards Assessment:

The substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any other evidence for chronic toxicity according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (2nd ATP). The criteria for “T” based on mammalian effects are therefore not met.

Thus, Fatty acid CAS 871 -70 -5 does not meet the Toxicity (T) criteria set out in Annex XIII of Regulation (EC) No. 1907/2006.