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Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

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Administrative data

Link to relevant study record(s)

Description of key information

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

Key value for chemical safety assessment

Additional information

In accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the two structurally related category members fatty acids C8-10, mixed esteres with DiPE, isooctanoic acid, PE and TriPE (CAS 189200-42-8) andDecanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate(CAS 11138-60-6) was conducted to fulfill the data requirements according to Annex IX of fatty acids, C8-10, tetraesters with pentaerythritol (CAS 85586-24-9) in regard to toxicity toaquatic algae and cyanobacteria. This read-across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the category justification in IUCLID Section 13. 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 fatty acid chain length of C8 – C10 of the read-across substances are identical to those of the target substance. In addition, the first read-across substancefatty acids, C8-10 mixed esters with dipenaterythritol, isooctanoic acid, pentaerythritol and tripentaerythritol contains the same alcohol component, i.e. pentaerythritol, and is a tetra-ester.

The first 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 algaeScenedesmus capricornutumwas 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 through the outlet at the bottom of the vessels. No inhibition of growth ofScenedesmus capricornutumup to the limit of water solubility was observed resulting in an EL50 > 1000 mg/L (nominal). A NOELR of ≥ 1000 mg/L was determined based on effects on growth rate.

For the second read across substancedecanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate(CAS 11138-60-6) one key study and one supporting study are available. The key study was conducted according to OECD 201 and GLP (Häner. 2007) as limit test. The green algaeDesmodesmus subspicatuswas exposed to a limit concentration of 100 mg/L (nominal). A water accommodated fraction (WAF) was prepared by stirring the test substance in algal medium for 24 h and removing undissolved materials by filtration. No inhibition of growth rate and effects on biomass were observed up to the limit of water solubility resulting in an EL50 > 100 mg/L. The supporting study conducted according to OECD 201 resulted in an EL50 of > 1000 mg/L (Craig, 2005).

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, C8-10, tetraesters with pentaerythritol (CAS 85586-24-9)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 organisms up to the limit of water solubility.