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No experimental data investigating the aquatic toxicity of the target substance Isooctadecanoic acid, mixed esters with oxybis[propanediol] are available. In order to fulfil the standard information requirements in compliance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, a read across was conducted to evaluate the toxicity of the target substance to fish (short-term), daphnia (short-term), algae and microorganism. Based on the high degree of similarity between the structural and physico-chemical properties of the target and source substances, the source substances are considered suitable representatives for the assessment of the aquatic toxicity of the target substance. A detailed analogue approach justification is provided in the technical dossier (please refer to IUCLID Section 13).

All experimental studies available for the target and the source substances were performed according to internationally accepted guidelines. They cover all three trophic levels of an aquatic ecosystem.

No toxicity of the target substance Isooctadecanoic acid, mixed esters with oxybis[propanediol] was observed below the limit of water solubility (WS < 0.15 mg/L). Thus, the substance is not considered hazardous to the aquatic ecosystem.

For short-term toxicity to fish, a read-across to the structurally related source substances Isooctadecanoic acid, ester with oxybis[propanediol] (CAS 73296-86-3) and Di(isooctadecanoic) acid, diester with oxydi(propanediol) (CAS 67938-21-0) was conducted. One study is available for each of the two grades of the source substance Isooctadecanoic acid, ester with oxybis[propanediol] (CAS 73296-86-3). Both studies were performed in a static design according to OECD 203 and EU method C.1. An EC50 (96 h) of 93.8 mg/L was determined in one study, whereas the second study was disregarded due to non-dose-related mortality. The study with source substance Di(isooctadecanoic) acid, diester with oxydi(propanediol) (CAS 67938-21-0) was performed in a static design according to OECD 203. An LC50 of > 500 mg/L was derived.

For short-term toxicity to aquatic invertebrates, a read-across to the structurally related source substances Isooctadecanoic acid, ester with oxybis[propanediol] (CAS 73296-86-3) and Di(isooctadecanoic) acid, diester with oxydi(propanediol) (CAS 67938-21-0) was conducted. The study with the source substance Isooctadecanoic acid, ester with oxybis[propanediol] (CAS 73296-86-3) was performed in a static design according to OECD 202 and EU method C.2. An EL50 (48 h) of 60.53 mg/L was determined. The study with the source substance Di(isooctadecanoic) acid, diester with oxydi(propanediol) (CAS 67938-21-0) was performed according to OECD 202. An EL50 (48 h) of 53.5 mg/L was determined.

For toxicity to algae, a read-across to the structurally related source substance Di(isooctadecanoic) acid, diester with oxydi(propanediol) (CAS 67938-21-0) was conducted. The study was performed according to OECD 201. The NOEC and EL50 (72 h) for growth rate and yield were determined at > 250 mg/L.

The toxicity to microorganisms was assessed using the toxicity control of the biodegradation test (OECD 301B) for Isooctadecanoic acid, ester with oxybis[propanediol] (CAS 73296-86-3). The toxicity control of the biodegradation study attained 43.7% degradation after 14 days of incubation. Hence, the substance is not toxic to aquatic microorganisms in the toxicity control and a NOEC (14 d) of 17.3 mg/L was derived. In addition to the toxicity control of the biodegradation study, one study is available for each of the two grades of Isooctadecanoic acid, ester with oxybis[propanediol] (CAS 73296-86-3) which investigated the inhibition of cell multiplication of Pseudomonas putida. An EC50 (16 h) of 8,062 mg/L was calculated for the first study and an EC50 (16h) of 9,411 mg/L for the second study.

Based on the results for the structurally related read-across substances (in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that no toxicity of the target substance Isooctadecanoic acid, mixed esters with oxybis[propanediol] to fish, aquatic invertebrates and algae is expected up to the limit of the water solubility (< 0.15 mg/L). Furthermore, the substance is expected to be non-inhibitory to microorganisms.

 

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