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Ecotoxicological information

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There are no data available covering the short-term fish toxicity, short-term toxicity to aquatic invertebrates and algae toxicity of Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates (CAS 91052-16-3). In order to fulfill the standard information requirements set out in Annex VII - X, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from one structurally related substance (Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts (CAS 91744-38-6)) was conducted. In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across). Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

In accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5, grouping and read-across, the target substance Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates (CAS 91052-16-3) and the source substance Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts (CAS 91744-38-6) are considered to be structurally very similar. The difference between both substances is that the source substance is the potassium salt of the target substance.

Based on the close structural similarity it is justified to use Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts (CAS 91744-38-6) as read-across substance to cover the endpoints. Moreover, the target and the source substance are characterized by a similar profile in relevant physico-chemical properties like log Kow, log Koc and water solubility implying a similar environmental behaviour and distribution.

For the target substance one study investigating the chronic toxicity to aquatic invertebrates is available. Since a long-term study is available, short-term testing was omitted in accordance with Regulation (EC) No 1907/2006, Annex VII. The available chronic study resulted in effects at the highest test loading rate of 100 mg/L. Thus, a NOELR (21 d) of 60 mg/L (nominal) was derived. This loading rate is far above water solubility which was calculated to be 1.86E-37 to 1.2721 mg/L based on QSAR calculations. All other loading rates did not result in significant effects on the number of offspring or time to first brood. Thus, this result may overestimate the possible effects to aquatic invertebrates. It is possible that after transferring the mid fractions of the settled test solution to the exposure vessels undissolved particles were transferred as well which might have caused physical effects.

No acute effects on fish up to the limit of water solubility limit were observed in the study conducted with the read-across substance Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts in a study according to OECD 203 resulting in a LL50 (96 h) > 100 mg/L (nominal). The same was recorded for aquatic algae (Pseudokirchneriella subcapitata) resulting in an EL10/50 (72 h) > 100 mg/L and a NOELR (72 h) ≥ 100 mg/L. A long term test with fish is considered to be unnecessary since the chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish. Therefore, due to animal welfare reasons and to avoid unnecessary vertebrate tests, no further long-term test on fish is provided. Based on the result from a standard OECD 209 study it can be concluded that the test substance is not toxic to activated sludge microorganisms. A NOEC (3 h) of 1000 mg/L (nominal) was derived. However, an increase of respiration rate was recorded. Thus, an inhibition of the degradation process in commercial sewage treatment plants is not expected.

Based on the result for the target substance itself and from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that the target substance Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates exhibits no toxic effects on freshwater organisms up to the limit of the water solubility.

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