Fatty acids, lanolin, esters with pentaerythritol

Toxicity to aquatic algae and cyanobacteria

Description of key information

No toxic effects to aquatic algae up to the limit of water solubility (< 0.15 mg/L).

Additional information

In accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to three structurally related category membersfatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4),2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)(CAS 62125-22-8)andfatty acids, C8-10 mixed esters with dipenaterythritol, isooctanoic acid, pentaerythritol and tripentaerythritol(CAS 189200-42-8) was conducted to fulfill the data requirements according to Annex IX of decanoic acid, mixed esters with fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5) in regard to toxicity to aquatic algae and cyanobacteria. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substances were used for the assessment.The read-across substances cover the variability of the category with different fatty acid chain lengths (longer chain length > C14 or shorter chain length of C8-C10). The target as well as the read-across substances contain the same alcohol (pentaerythritol).

The first study with the read-across substancefatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4)was performed according to OECD 201 (Junghans, 2010). The green algae Desmodesmus subspicatus was exposed to a nominal concentration of 100 mg/L. The test solution was prepared by adding the appropriate amount of test substance with subsequent stirring followed by filtration. No effect on growth rate and biomass of Desmodesmus subspicatus up to the limit of water solubility was observed resulting in an EL50 > 100 mg/L (nominal) and a NOELR of ≥ 1000 mg/L (nominal) for both endpoints.

The second study with the read-across substance2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8)was performed according to OECD 201 under GLP (Craig, 2005). The green algae Pseudokirchneriella subcapitata was exposed under static conditions to nominal concentration of 100, 180, 320, 560 and 1000 mg/L. The WAF (Water Accomodated Fraction) was prepared as by adding the appropriate amount of test substance with subsequent stirring followed by settling. After the test duration of 72 h an EL50 > 1000 mg/L (nominal) based on growth rate was determined.

The third study with the read-across substancefatty acids, C8-10 mixed esters with dipenaterythritol, isooctanoic acid, pentaerythritol and tripentaerythritol (CAS 189200-42-8) was performed according to OECD 201 under GLP conditions (Febbo, 1995). The green algae Scenedesmus capricornutum was exposed to nominal concentrations of 62.5 mg/L, 125 mg/L, 250 mg/L, 500 mg/L and 1000 mg/L. The WAF was prepared by adding the appropriate amount of test substance with subsequent stirring and sampling of the aqueous portions (WAFs) through the outlet at the bottom of the vessels. No inhibition of growth of the algae up to the limit of water solubility was observed resulting in an EL50 > 1000 mg/L (nominal) and a NOELR of ≥ 1000 mg/L. Based on these results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded thatfatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5)will not exhibit effects to aquatic algae up to the limit of water solubility.As it can be seen in the data matrix of the category justification in section 13 and the overall endpoint summary IUCLID 6.1, all reliable data in the polyol esters category support this hazard assessment by showing a consistent pattern of results, i.e no toxic effects were observed to aquatic algae or other aquatic organisms up to the limit of water solubility.