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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:

Fatty acids, C14-C18 and C16-18-unsatd., zinc salts do not fulfil any of the criteria of a PBT or vPvB substance.

Persistence

Fatty acids, C14-C18 and C16-18-unsatd., zinc salts do not fulfil the persistence criterion (P-):

Fatty acids, C14-C18 and C16-18-unsatd., zinc salts is considered readily biodegradable. Substance Fatty acids, C14-18 and C16-18-unsatd., zinc salts is produced by the oleochemistry sector, starting from natural fatty materials, and are a mixture of stearic (C18), palmitic (C16) and myristic acid (C14) and unsaturated C16-18 fatty acids. Fatty acids, C14-18 and C16-18-unsatd., zinc salts consist of 90% natural fatty acids and 10% zinc. In the Closed Bottle test according to OECD 301D, 93% of a structural analogue (i. e. similar zinc salt of a fatty acid: Fatty acids, C16-18, zinc salts) with a similar zinc content (i. e. 10%) biodegraded within 28 days. This value was calculated from the BOD, the biological oxygen demand, and the ThOD, the theoretical oxygen demand. Fatty acids, C16-18, zinc salt is readily biodegradable as the 60% level was passed within 28 days but failed the 10 day window criteria. A similar zinc salt of a fatty acid (i.e. zinc-12-hydroxystearate) biodegraded up to 71% after 28 days as determined in the OECD 301B test with 14.5 % after 4 days and 53.5% after 13 days. Zinc-12-hydroxystearate is also readily biodegradable as the 60% level was passed within 28 days but failed the 10 day window criteria. Thus, similar biodegradation rates are observed in different tests with similar zinc salts of fatty acids. It is concluded that Fatty acids, C14-C18 and C16-18-unsatd., zinc salts is readily biodegradable.

Bioaccumulation

Fatty acids, C14-C18 and C16-18-unsatd., zinc salts do not fulfil the bioaccumulation criterion (B-):

Based on read-across of zinc bioaccumulation data and the fact that Fatty acids, C14-C18 and C16-18-unsatd., zinc salts is readily biodegradable, bioaccumulation and biomagnification are not expected to be relevant for Fatty acids, C14-C18 and C16-18-unsatd., zinc salts. These conclusions are similar to the conclusions from the EU RAR for the structural analogue Zinc distearate (CAS-No.: 557-05-1 & 91051-01-3 EINECS-No.: 209-151-9 & 293-049-4) Part 1 - Environment (Final report R074_0805_env, May 2008):

"Based on data on bioaccumulation of zinc in animals and on biomagnification (i.e. accumulation and transfer through the food chain), secondary poisoning is considered to be not relevant in the effect assessment of zinc..." "Distearate is not expected to bioaccumulate, knowing that fatty acids will degrade by the β oxidation pathway."

Toxicity

Fatty acids, C14-C18 and C16-18-unsatd., zinc salts do not fulfil the toxicity criterion (T-):

The long-term no-observed effect concentration (NOEC) for marine or freshwater organisms is not less than 0,01 mg/L, or the substance is not classified as carcinogenic, mutagenic, or toxic for reproduction, and there is no other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

Likely routes of exposure:

According to Regulation (EC) No 1907/2006 article 14 (4) and Annex I Section 0.6 (5) as well an exposure assessment should be performed only in case if the substance meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC or is assessed to be a PBT or vPvB substance. Fatty acids, C14-18 and C16-18-unsatd., zinc salts is neither considered as dangerous in view of Directive 67/548/EEC nor a PBT or vPvB substance. Therefore, an exposure assessment which includes the preparation of exposure scenarios is not required. However, all identified uses of the registrant are included in IUCLID 5.2 section 3.5.