Registration Dossier
Registration Dossier
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EC number: 261-521-9 | CAS number: 58958-60-4
Endpoint summary
Administrative data
Description of key information
Additional information
There are no data available covering the short-term fish toxicity of Isooctadecyl pivalate (CAS 58958-60-4). In order to fulfil the standard information requirements set out in Annex VII - IX, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from one structurally related substance (isononyl pivalate) 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 Isooctadecyl pivalate. 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 Isooctadecyl pivalate (CAS 58958-60-4) and the source substance isononyl pivalate are considered to be structurally very similar. The difference between both substances is the chain length of the alcohol component. The alcohol chain length is C18 for the target substance and C9 for the source substance whereas the fatty acid component is the same for both substances (pivalic acid). The shorter chain length of the alcohol component is expected to increase the overall water solubility and thus bioavailability of the substance. Water solubility is negatively correlated with the C-chain length of the fatty alcohol and fatty acid (Lide, 2005). Therefore, it is possible to extrapolate from a read-across substance with higher water solubility due to its increased bioavailability in the water phase (ECHA, 2014). Based on the close structural similarity it is justified to use isononyl pivalate as read-across substance and to cover the endpoint “Short-term toxicity to fish” by read-across. 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 studies investigating the toxicity to aquatic invertebrates (chronic), algae and activated sludge microorganisms are available. No acute effects on fish up to the limit of water solubility (1.0 - 27 µg/L, mean: 11.7 µg/L) were observed in the study conducted with the read-across substance Isononyl pivalate 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 performed for the target substance. Chronic toxicity of the target substance to aquatic organisms is not expected and confirmed in a chronic study with Daphnia magna indicating no effects on reproduction. 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 with fish is provided.
Based on the result from the toxicity control of a standard biodegradation study according to OECD 301F it can be concluded that the test substance is not toxic to activated sludge microorganisms. A NOEC (14 d) ≥ 100 mg/L (nominal) was derived. 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 structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that the target substance Isooctadecyl pivalate exhibits no toxic effects on freshwater organisms up to the limit of the water solubility.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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