Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

No toxic effects to fish up to the limit of water solubility.

Key value for chemical safety assessment

Additional information

Since no reliable studies investigating the short-term toxicity to fish of 2-hydroxyethyl palmitate (CAS 4219-49-2) are available for this endpoint, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the two structurally most similar category members decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) and ethylene distearate (CAS 627-83-8) was conducted. This read-across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the category justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substances were used for the assessment. Nevertheless, as it can be seen in the data matrix of the category justification in section 13 and the overall summary, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results.

The first study with the read-across substance decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) was performed according to the EU Method C.1 (GLP) with the zebrafish Brachydanio rerio under semi-static conditions (Scholz, 1995). A Water Accommodated Fraction (WAF) of 1000 mg/L did not result in any effects although oily drops were visible after 72 and 96 h. The analytical determination of the test substance based on TOC-analysis resulted in very different values since the test solutions were determined to be oversaturated, hence the effect concentration was based on the nominal values. Thus, a LL50 of > 1000 mg/L was determined and used for the chemical safety assessment.

The second read-across substance ethylene distearate (CAS 627-83-8) was tested in limit test according to the OECD Guideline 203 under GLP conditions with the rainbow trout (Oncorhynchus mykiss). A semi-static test design was chosen. No effects were observed after 96 h resulting in a LC50 of > 0.3 mg/L (nominal). 0.3 mg/L was the highest concentration which was soluble in the solubiliser tetrahydrofuran without precipitation. No mortality was observed in the control and solvent control.

One additional study for the target substance itself was rated reliability 4 since only a short abstract is available without detailed information on the method. However, the study was performed according to ISO 7346-1 with Brachydanio rerio and resulted in no effects up to the limit of water solubility (LC50 (96 h) > 10000 mg/L).

Based on the results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and the disregarded study for the target substance, it can be concluded that 2-hydroxyethyl palmitate will not exhibit acute effects to fish up to the limit of water solubility.

Categories Display