Registration Dossier
Registration Dossier
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EC number: 614-590-8 | CAS number: 68552-19-2
Endpoint summary
Administrative data
Description of key information
Additional information
Data on the aquatic toxicity of Fatty acids, C18-unsatd., dimers,
polymers with 2-ethylhexanol and neopentyl glycol (CAS 68552-19-2) are
not available.
In accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006,
read-across to the structurally related substances Fatty acids,
C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane
(CAS 147256-33-5) and Fatty acids, C18-unsatd., dimers, 2-ethylhexyl
esters (CAS 68334-05-4) was conducted to fulfil the standard information
requirements. 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 aquatic 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). According to
Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 substances can be
considered similar if their physicochemical, toxicological and
ecotoxicological properties are likely to be similar or follow a regular
pattern as a result of structural similarity. The target substance Fatty
acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl
glycol (CAS 68552-19-2) and the structurally similar source substances
Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and
trimethylolpropane (CAS 147256-33-5) and Fatty acids, C18-unsatd.,
dimers, 2-ethylhexyl esters (CAS 68334-05-4) result from esterification
of 2-ethylhexanol with the respective dimerized or trimerised C18 fatty
acid. A detailed justification of the Analogue Approach is attached in
IUCLID section 13.
In accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5, grouping and read-across the target substance Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol is not considered to be harmful to aquatic organisms based on the results of the available read-across studies conducted with fish, aquatic invertebrates and algae.
Experimental data on the acute toxicity of the read-across substances Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) and Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4) are available for fish, aquatic invertebrates and algae. None of the available tests determined any toxic effects of the substances up to the limit of water solubility.
Data on the toxicity to microorganisms (activated sludge) are available for Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4). Adverse effects of the substances to microorganisms were not observed.
Based on the available acute toxicity data for the read-across substances toxic effects of the target substance Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol are not expected. Consequently, additional acute and chronic testing for the target substance is omitted. Based on the result from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol (CAS 68552-19-2) will not show toxic effects on freshwater organisms up to the limit of the water solubility (WS < 5 µg/L).
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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