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Short-term toxicity to fish

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Description of key information

No toxic effects to fish up to the limit of water solubility (< 0.05 mg/L).

Key value for chemical safety assessment

Additional information

In accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 read across to three structurally related sub-category memberspentaerytritol tetraoleate (CAS 19321-40-5), 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) and fatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol (CAS 85711-45-1)was conducted to fulfill the data requirement according to Annex VII-IX offatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4)in regard to the short erm toxicity to fish,. 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 C16 and C18 of the read-across substances are identical to those of the target substance and all substances contain the same alcohol (pentaerythritol).

The first study with the read-across substancepentaerytritol tetraoleate (CAS 19321-40-5)was performed under static conditions and GLP according to OECD 203 (Bogers, 1997).Cyprinus carpiowas exposed to a nominal concentration of 100 mg/L. A stock solution was prepared in acetone. Blank and solvent controls were also tested. No mortalities occurred after the test duration of 96 hours resulting in an LC50 of > 100 mg/L. Therefore it can be concluded thatpentaerytritol tetraoleate (CAS 19321-40-5)will not exhibit short-term effects to fish up to the limit of water solubility.

For the second read-across substance2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6)a test under semi-static conditions according to ISO 7346-1 was performed (Richterich, 2008).Brachydanio rerio (new name Danio rerio)was exposed to nominal concentrations of 3000 and 10000 mg/L. The test substance was weighed directly into the vessels, filled up with water and stirred. No mortalities occurred after the test duration of 96 hours resulting in an LC50 of > 10000 mg/L (nominal). Therefore it can be concluded that2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6)will not exhibit short-term toxicological effects to fish up to the limit of water solubility.

For the third read-across substancefatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol (CAS 85711-45-1)a test under static conditions according to OECD 203 was performed (Muckle, 2013).Danio reriowas exposed to a nominal concentration of 100 mg/L. A water accommodated fraction (WAF) was prepared by adding the required amount of test substance to water with subsequent stirring. The lower phase was used as test medium. DOC analysis of the test substance concentrations indicated that the substance is not soluble in the test medium and the evaluation is hence based on nominal concentrations. No mortalities occurred after the test duration of 96 hours resulting in an LL50 of > 100 mg/L (nominal). Therefore it can be concluded thatfatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol (CAS 85711-45-1)will not exhibit short-term toxicological effects to fish up to the limit of water solubility.

This based on the available results from a 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 that fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) will not exhibit short-term toxicological effects to aquatic invertebrates up to the limit of water solubility. This conclusion is supported by data of the complete category, as 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 to fish or other aquatic organisms were observed up to the limit of water solubility.

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