Registration Dossier
Registration Dossier
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EC number: 946-056-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
The dataset for aquatic toxicity of Hexanedioic acid, di-C16-18 alkyl esters (CAS 92969-90-9) is not complete. Therefore, the aquatic toxicity of the target substance was assessed by a read-across approach to one structurally and chemically closely related source substances in order to fulfill the standard information requirements laid down in Annex XI, 1.5 of the REACh Regulation (EC) No 1907/2006.
According to Article 13(1) of this regulation, "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.” For aquatic toxicity in particular, 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). In regard to the general rules for grouping of substances and the read-across approach, the regulation specifies (Annex XI, Item 1.5) that 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. A detailed justification of the analogue approach is attached in IUCLID section 13.
All available studies with the target and the source substance were conducted according to internationally accepted guidelines and GLP. The source substance Bis(tridecyl) adipate (CAS 16958-92-2) did not indicate any toxicity up to the water solubility limit for freshwater fish and aquatic algae. Since the target substance is poorly soluble in water, a chronic study with Daphnia magna instead of an acute study was considered to be relevant in order to assess to toxicity to aquatic invertebrates adequately. The experimental data demonstrate no effect up to the solubility level (< 0.05 mg/L).
Data on the toxicity to microorganisms were used from the toxicity control of the biodegradation study according to OECD 301B. The toxicity control attained 28% degradation after 14 days of incubation. Hence, the substance is not toxic to activated sludge microorganisms and the test item concentration of 15.5 mg/L can be used as NOEC (in accordance with ECHA Guidance R.7b; ECHA, 2017).
Based on the available results from the target substance and a structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that Hexanedioic acid, di-C16-18 alkyl esters (CAS 92969-90-9) has no toxic effects on freshwater organisms up to the limit of the water solubility (< 0.05 mg/L at 20 °C).
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