Fatty acids, C14-18 and C16-18-unsatd., zinc salts

PBT assessment

PBT assessment: overall result

Reference

Name:

Fatty acids, C14-18 and C16-18 unsatd., zinc salts

Type of composition:

boundary composition of the substance

State / form:

solid: bulk

Reference substance:

Fatty acids, C14-18 and C16-18 unsatd., zinc salts

Reference substance:

Fatty acids, C14-18 and C16-18 unsatd., zinc salts

Reference substance:

Fatty acids, C14-18 and C16-18 unsatd., zinc salts

Reference substance:

Fatty acids, C14-18 and C16-18 unsatd., zinc salts

Reference substance:

Fatty acids, C14-18 and C16-18 unsatd., zinc salts

Reference substance:

Fatty acids, C14-18 and C16-18 unsatd., zinc salts

Reference substance:

Fatty acids, C14-18 and C16-18 unsatd., zinc salts

Reference substance:

Fatty acids, C14-18 and C16-18 unsatd., zinc salts

Reference substance:

Fatty acids, C14-18 and C16-18 unsatd., zinc salts

Reference substance:

Fatty acids, C14-18 and C16-18 unsatd., zinc salts

PBT status:

PBT assessment does not apply

Justification:

Persistence:

Based on studies with analogous substances, i.e. zinc salts of fatty acids with similar or shorter alkyl chain length, Fatty acids, C14-18 and C16-18-unsatd., zinc salts is readily biodegradable. In a Closed Bottle test according to OECD 301D, 93% of the analogue substance Fatty acids, C16-18, zinc salts was biodegraded after 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 saltsis readily biodegradable as the 60% level was passed within 28 days but failed the 10 day window criteria. Therefore, a similar biodegradability is assumed for Fatty acids, C14-18 and C16-18-unsatd., zinc salts.

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.

In addition, data is available on the biodegradation of the shorter-chained (C8) octanoic acid, zinc salt, basic (CAS 90480-58-3; consisting of approximately 77% natural fatty acids and 23% zinc) based on a static Manometric Respirometry Test (OECD 301 F): The biodegradation of octanoic acid, zinc salt was determined with 80% and 86% at 30 mg/L and 100 mg/L after 28 days, respectively, meeting the 10-day window criteria.

Thus, similar biodegradation rates are observed in different tests with similar zinc compounds. Therefore, in accordance to the criteria laid down in Regulation (EU) No 253/2011 and based on data from analogue substances, Fatty acids, C14-18 and C16-18-unsatd., zinc salts can be regarded as “not P” and “not vP”.

 

Bioaccumulation:

Based on read-across of zinc bioaccumulation data and the substance Fatty acids, C14-18 and C16-18-unsatd., zinc salts being considered readily biodegradable, bioaccumulation and biomagnification are not expected to be relevant for Fatty acids, C14-18 and C16-18-unsatd., zinc salts. These conclusions are similar to the conclusions from the EU RAR 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."

In accordance to ECHA TGD R.11.1.3.2, the substance Fatty acids, C14-18 and C16-18-unsatd., zinc salts can be regarded as “not P” and “not vP”.

 

Toxicity:

Based on studies with analogous substances, i.e. fatty acids, C16-18, zinc salts (CAS 91051-01-3), the EC50 or LC50 values for acute toxicity to algae, daphnia and fish are ≥ 0.1 mg/L. The long-term no-observed effect concentration (NOEC) of the structural analogue fatty acids, C16-18, zinc salts (CAS 91051-01-3) for marine or freshwater organisms is not less than 0.01 mg/L. In addition, the substance Fatty acids, C16-18, zinc salts does not meet the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), toxic for reproduction (category 1A, 1B, or 2) or specific target organ toxicity after repeated exposure according to Regulation (EC) No 1272/2008. Thus, based in data of a structural analogue, "T" criteria in respect of long-term toxicity to marine / freshwater organisms, carcinogenicity, germ cell mutagenicity, toxicity to reproduction and chronic toxicity as laid down in Regulation (EU) No 253/2011 are not fulfilled.

 

PBT/vPvB outcome:

Based in data of a structural analogue, the substance Fatty acids, C14-18 and C16-18-unsatd., zinc salts is not classified as PBT or vPvB.