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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:

According to Annex XIII of the REACH Regulation (EC) No 1907/2006, a PBT substance has to fulfil all three of the criteria for persistence, bioaccumulation and toxicity, as listed in part 1 of Annex XIII, and a vPvB substance has to fulfil all criteria for persistence and bioaccumulation, as listed in part 2 of Annex XIII.

Fatty acids, C8 - 18 (CAS 90990 -08 -2) is not identified as PBT nor as vPvB substance on the basis of the relevant data provided and discussed below.

 

Persistence (P) Assessment:

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 acids, C8 - 18 (CAS 90990 -08 -2) do not meet the Persistent (P) or very Persistent (vP) criteria.

 

Bioaccumulation (B) Assessment:

The BCF value obtained for whole organisms after exposure to the fatty acid analogue substance C12 fatty acid sodium laurate is below the bioaccumulation criterion of BCF > 2000 set in Annex XIII of REACH Regulation (EC) No 1907/2006. In addition rapid metabolism of fatty acids within the organism is expected. 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, fatty acids are considered unlikely to be bioaccumulative.

 

Toxicity (T) Assessment:

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. The worst-case NOEC obtained for daphnids, was ≥1.3 mg/L on the basis of read-across fromdecanoic acid (CAS 334-48-5). Therefore, fatty acids, C8 - 18 (CAS 90990 -08 -2) is not considered as a toxic substance regarding ecotoxicological endpoints.

 

Moreover, the substance is not classified as carcinogenic, mutagenic or toxic for reproduction according to Regulation (EC) No. 1272/2008 and its further amendments.