Registration Dossier
Registration Dossier
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EC number: 802-122-7 | CAS number: 4494-16-0
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Hazard for air
Hazard for terrestrial organisms
Hazard for predators
Additional information
Conclusion on classification
According to Article 13 of Regulation (EC) No 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", Information on intrinsic properties of substances may be generated by means other than tests, e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint”. Since read-across to the target substance Octadec-9-enedioic acid (EC 802-122-7) was applied, data will in part be generated from the representative source substance (Z)-9-Octadecen-1,18-dioic acid (CAS 20701-68-2) to avoid unnecessary animal testing. Additionally, once the read-across approach is applied, substances will be classified and labelled on this basis.
Degradation
Biodegradation: readily biodegradable: 87.5% (O2consumption) after 28 d; experimental data
Aquatic acute toxicity
96 h, LC50 (Cyprinus carpio): > 100 mg/L (nominal); read-across
48 h, EC50 (Daphnia magna): = 258 mg/L (nominal); experimental data
72 h, ErL50 (Pseudokirchneriella subcapitata): > 100 mg/L (nominal); read-across
Aquatic chronic toxicity
72 h, NOErC (Pseudokirchneriella subcapitata): = 45% of filtered solution prepared at a nominal loading rate of 100 mg/L; read-across
CLP
Based on the data above, octadec-9-enedioic acid (EC 802-122-7) is considered to be readily biodegradable. No acute aquatic toxicity was observed up to the water solubility limit (300.7 µg/L at 20 °C) for fish, daphnids and algae. For classification purposes no adequate chronic data are available for the algae Pseudokirchneriella subcapitata given as percentage of a nominal loading rate, i.e. 45% of filtered solution prepared at a nominal loading rate of 100 mg/L. Consequently chronic classification is derived based on the use of acute data. Therefore, octadec-9-enedioic acid (EC 802-122-7) does not need to be classified and labelled as environmental hazard according to the Regulation (EC) No 1272/2008 (CLP).
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